"applicationdocsid","applicationdocstypeid","applno","submissiontype","submissionno","applicationdocstitle","applicationdocsurl","applicationdocsdate","tecode"
43991,10,793,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
45,1,793,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/000793s025ltr.pdf","2007-10-04 00:00:00",
32916,2,793,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf","2007-10-04 00:00:00",
46,1,1546,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/1546s011.pdf","2002-04-24 00:00:00",
53724,3,2918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/002918Orig1s000.pdf","2018-04-18 00:00:00",
47,1,3444,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/03444slr020ltr.pdf","2003-11-25 00:00:00",
43992,10,4782,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm","2009-06-02 00:00:00",
48,1,4782,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf","1998-09-08 00:00:00",
40641,3,4782,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093.cfm","1998-09-08 00:00:00",
49,1,4782,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf","2003-05-16 00:00:00",
10665,2,4782,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf","2003-04-28 00:00:00",
40642,3,4782,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf","2007-04-09 00:00:00",
1,1,4782,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf","2003-07-28 00:00:00",
2,1,4782,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf","2002-11-27 00:00:00",
10666,2,4782,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf","2002-11-27 00:00:00",
50,1,4782,"SUPPL",129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf","2003-01-07 00:00:00",
10667,2,4782,"SUPPL",129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf","2003-01-07 00:00:00",
3,1,4782,"SUPPL",130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf","2003-05-16 00:00:00",
20003,3,4782,"SUPPL",130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf","2007-04-09 00:00:00",
32917,2,4782,"SUPPL",130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf","2003-04-30 00:00:00",
51,1,4782,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf","2004-04-29 00:00:00",
10668,2,4782,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf","2004-05-04 00:00:00",
52,1,4782,"SUPPL",136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf","2004-04-29 00:00:00",
10669,2,4782,"SUPPL",136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf","2004-11-17 00:00:00",
53,1,4782,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf","2004-08-31 00:00:00",
10670,2,4782,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf","2004-08-31 00:00:00",
4,1,4782,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf","2005-04-12 00:00:00",
32918,2,4782,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf","2005-04-12 00:00:00",
54,1,4782,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf","2005-04-12 00:00:00",
10671,2,4782,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf","2005-04-12 00:00:00",
5,1,4782,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf","2005-08-04 00:00:00",
32919,2,4782,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf","2005-08-04 00:00:00",
6,1,4782,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf","2005-11-03 00:00:00",
10672,2,4782,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf","2005-11-03 00:00:00",
55,1,4782,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf","2006-04-25 00:00:00",
32920,2,4782,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf","2006-04-25 00:00:00",
7,1,4782,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf","2006-09-18 00:00:00",
32921,2,4782,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf","2006-09-12 00:00:00",
56,1,4782,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf","2008-03-05 00:00:00",
32922,2,4782,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf","2008-03-05 00:00:00",
57,1,4782,"SUPPL",162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf","2011-10-31 00:00:00",
32923,2,4782,"SUPPL",162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf","2011-11-01 00:00:00",
8,1,4782,"SUPPL",164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf","2011-10-31 00:00:00",
10673,2,4782,"SUPPL",164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf","2011-11-01 00:00:00",
9,1,4782,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf","2011-10-31 00:00:00",
32924,2,4782,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf","2011-11-01 00:00:00",
10,1,4782,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf","2014-12-04 00:00:00",
32925,2,4782,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf","2014-12-10 00:00:00",
50350,1,4782,"SUPPL",176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/004782Orig1s176ltr.pdf","2017-11-09 00:00:00",
11,1,5010,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr047ltr.pdf","2003-03-10 00:00:00",
58,1,5010,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr048ltr.pdf","2003-06-08 00:00:00",
12,1,5010,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005010s049ltr.pdf","2009-03-10 00:00:00",
10674,2,5010,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf","2009-03-17 00:00:00",
13,1,5010,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s050ltr.pdf","2011-04-13 00:00:00",
10675,2,5010,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf","2011-04-11 00:00:00",
59,1,5010,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s051ltr.pdf","2011-11-02 00:00:00",
10676,2,5010,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf","2011-10-31 00:00:00",
46194,1,5010,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/005010Orig1s054ltr.pdf","2016-12-19 00:00:00",
46420,2,5010,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf","2016-12-21 00:00:00",
49449,2,5010,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf","2017-08-17 00:00:00",
49450,8,5010,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf#page=29","2017-08-17 00:00:00",
49572,1,5010,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005010Orig1s055ltr.pdf","2017-08-29 00:00:00",
55644,1,5010,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005010Orig1s056s057ltr.pdf","2018-09-28 00:00:00",
55838,2,5010,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf","2018-10-05 00:00:00",
55840,8,5010,"SUPPL",56,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30","2018-10-05 00:00:00",
55645,1,5010,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005010Orig1s056s057ltr.pdf","2018-09-28 00:00:00",
55839,2,5010,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf","2018-10-05 00:00:00",
55841,8,5010,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30","2018-10-05 00:00:00",
40643,3,5213,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005213Orig1s023.pdf","2013-02-27 00:00:00",
14,1,5213,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005213s037ltr.pdf","2009-01-30 00:00:00",
32926,2,5213,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf","2009-02-04 00:00:00",
46872,2,5213,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf","2017-01-13 00:00:00",
46896,1,5213,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005213Orig1s038ltr.pdf","2017-01-19 00:00:00",
54750,2,5213,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf","2018-07-05 00:00:00",
54787,8,5213,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27","2018-07-06 00:00:00",
54850,1,5213,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005213Orig1s039ltr.pdf","2018-07-06 00:00:00",
43993,10,5378,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
32927,2,5378,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf","2003-04-03 00:00:00",
60,1,5378,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05378s024ltr.pdf","2006-04-13 00:00:00",
32928,2,5378,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf","2006-04-13 00:00:00",
61,1,5378,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/005378s026ltr.pdf","2007-05-16 00:00:00",
10677,2,5378,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf","2007-05-16 00:00:00",
15,1,5378,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s027ltr.pdf","2013-08-27 00:00:00",
32929,2,5378,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf","2013-08-27 00:00:00",
62,1,5378,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s028ltr.pdf","2013-12-09 00:00:00",
32930,2,5378,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf","2013-12-04 00:00:00",
63,1,5378,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/005378Orig1s030ltr.pdf","2015-04-21 00:00:00",
32931,2,5378,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf","2015-04-20 00:00:00",
46719,2,5378,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s031lbl.pdf","2017-01-06 00:00:00",
46795,1,5378,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s031ltr.pdf","2017-01-11 00:00:00",
48483,2,5378,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf","2017-05-22 00:00:00",
48484,8,5378,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf#page=13","2017-05-22 00:00:00",
48507,1,5378,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s034ltr.pdf","2017-05-24 00:00:00",
16,1,5619,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619s16ltr.pdf","2004-05-27 00:00:00",
64,1,5619,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619slr018ltr.pdf","2004-05-28 00:00:00",
65,1,5619,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/005619s020ltr.pdf","2005-06-07 00:00:00",
66,1,5619,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005619s021ltr.pdf","2011-03-23 00:00:00",
32932,2,5619,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf","2011-03-21 00:00:00",
23085,8,5856,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf","2012-06-15 00:00:00",
17,1,5856,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005856s020ltr.pdf","2009-04-29 00:00:00",
67,1,5856,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/005856s021ltr.pdf","2012-06-08 00:00:00",
32933,2,5856,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf","2012-06-11 00:00:00",
18,1,5929,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf","2003-07-31 00:00:00",
32934,2,5929,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf","2003-05-08 00:00:00",
68,1,5929,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf","2003-07-31 00:00:00",
10678,2,5929,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf","2003-05-08 00:00:00",
49009,2,5929,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005929s044lbl.pdf","2017-07-18 00:00:00",
19,1,5939,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/05939s007Ltr.pdf","2007-04-25 00:00:00",
10679,2,5939,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005939s007lbl.pdf","2007-04-20 00:00:00",
20004,3,5970,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S13_Sotradecol_toc.cfm","2003-08-08 00:00:00",
40644,3,5970,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S18_Sotradecol_toc.cfm","2003-08-08 00:00:00",
20005,3,5970,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S22_Sotradecol_toc.cfm","2003-08-08 00:00:00",
40645,3,5970,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S27_Sotradecol_toc.cfm","2003-08-08 00:00:00",
40646,3,5970,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S28_Sotradecol_toc.cfm","2003-08-08 00:00:00",
20006,3,5970,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S30_Sotradecol_toc.cfm","2003-08-08 00:00:00",
20007,3,5970,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S35_Sotradecol_toc.cfm","2003-08-08 00:00:00",
20,1,6002,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06002slr039ltr.pdf","2003-06-22 00:00:00",
32935,2,6002,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf","2003-06-22 00:00:00",
21,1,6002,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/006002s042ltr.pdf","2009-06-17 00:00:00",
69,1,6002,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006002Orig1s043ltr.pdf","2013-11-08 00:00:00",
32936,2,6002,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf","2013-11-08 00:00:00",
49005,1,6002,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006002Orig1s044ltr.pdf","2017-07-17 00:00:00",
49014,2,6002,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006002s044lbl.pdf","2017-07-18 00:00:00",
22,1,6035,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06035slr072ltr.pdf","2004-03-02 00:00:00",
23,1,6035,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06035slr073ltr.pdf","2003-10-09 00:00:00",
70,1,6035,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/006035s07LTRd.pdf","2007-05-01 00:00:00",
32937,2,6035,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf","2007-05-01 00:00:00",
71,1,6035,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf","2012-06-27 00:00:00",
10680,2,6035,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf","2012-06-25 00:00:00",
40647,3,6035,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/006035Orig1S078.pdf","2013-01-28 00:00:00",
43994,10,6134,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm","2009-08-12 00:00:00",
44437,14,6134,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
24,1,6134,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/06134s028ltr.pdf","2006-12-04 00:00:00",
20008,3,6134,"SUPPL",28,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/006134_s028_dolophine_hydrochloride.pdf","2006-11-17 00:00:00",
32938,2,6134,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf","2006-11-21 00:00:00",
72,1,6134,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s030ltr.pdf","2012-07-11 00:00:00",
73,1,6134,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s031ltr.pdf","2012-07-11 00:00:00",
10681,2,6134,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf","2012-07-12 00:00:00",
25,1,6134,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006134Orig1s032ltr.pdf","2013-04-16 00:00:00",
26,1,6134,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s035ltr.pdf","2014-04-17 00:00:00",
32939,2,6134,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf","2014-04-16 00:00:00",
27,1,6134,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s036ltr.pdf","2014-08-20 00:00:00",
74,1,6134,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s037ltr.pdf","2015-06-29 00:00:00",
75,1,6134,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s038ltr.pdf","2015-04-03 00:00:00",
10682,2,6134,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf","2015-04-07 00:00:00",
28,1,6134,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s039ltr.pdf","2016-04-22 00:00:00",
46195,1,6134,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf","2016-12-19 00:00:00",
46275,2,6134,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf","2016-12-20 00:00:00",
46196,1,6134,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf","2016-12-19 00:00:00",
46274,2,6134,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf","2016-12-20 00:00:00",
45458,1,6134,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s042ltr.pdf","2016-10-04 00:00:00",
48581,1,6134,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006134Orig1s044ltr.pdf","2017-05-31 00:00:00",
52253,2,6134,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf","2018-02-01 00:00:00",
52254,8,6134,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf#page=31","2018-02-01 00:00:00",
52282,1,6134,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s045ltr.pdf","2018-02-02 00:00:00",
55642,1,6134,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf","2018-09-28 00:00:00",
55818,2,6134,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf","2018-10-05 00:00:00",
55820,8,6134,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf#page=33","2018-10-05 00:00:00",
55643,1,6134,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf","2018-09-28 00:00:00",
55819,2,6134,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf","2018-10-05 00:00:00",
55821,8,6134,"SUPPL",48,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf#page=33","2018-10-05 00:00:00",
32940,2,6188,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf","2008-11-28 00:00:00",
10683,2,6188,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf","2008-11-28 00:00:00",
76,1,6188,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006188s020ltr.pdf","2010-04-05 00:00:00",
10684,2,6188,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf","2010-04-04 00:00:00",
23087,8,6188,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020MedGuide.pdf","2010-04-04 00:00:00",
29,1,6188,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf","2011-07-29 00:00:00",
32941,2,6188,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf","2011-07-28 00:00:00",
77,1,6188,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf","2011-07-29 00:00:00",
10685,2,6188,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf","2011-07-28 00:00:00",
78,1,6188,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006188Orig1s024ltr.pdf","2015-02-12 00:00:00",
10686,2,6188,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf","2015-02-12 00:00:00",
79,1,6188,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006188Orig1s025ltr.pdf","2016-01-20 00:00:00",
32942,2,6188,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006188s025lbl.pdf","2016-03-08 00:00:00",
55533,2,6188,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf","2018-09-20 00:00:00",
55534,8,6188,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf#page=7","2018-09-20 00:00:00",
46198,1,6383,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006383Orig1s017ltr.pdf","2016-12-19 00:00:00",
46418,2,6383,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006383s017lbl.pdf","2016-12-21 00:00:00",
52252,2,6383,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006383s018lbl.pdf","2018-02-01 00:00:00",
52283,1,6383,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006383Orig1s018ltr.pdf","2018-02-02 00:00:00",
20009,3,6488,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/006488Orig1s019.pdf","2012-01-27 00:00:00",
80,1,6488,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006488s074ltr.pdf","2010-03-18 00:00:00",
10687,2,6488,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf","2010-02-25 00:00:00",
50963,1,6488,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006488Orig1s095, s090ltr.pdf","2017-12-29 00:00:00",
51044,2,6488,"SUPPL",90,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf","2018-01-12 00:00:00",
50962,1,6488,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006488Orig1s095, s090ltr.pdf","2017-12-29 00:00:00",
51043,2,6488,"SUPPL",95,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf","2018-01-12 00:00:00",
32943,2,6530,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf","2013-01-23 00:00:00",
30,1,6695,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06695slr030ltr.pdf","2003-03-26 00:00:00",
81,1,6695,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06695slr031ltr.pdf","2004-03-02 00:00:00",
32944,2,6695,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf","2004-04-05 00:00:00",
31,1,6773,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06773slr036ltr.pdf","2003-07-06 00:00:00",
40648,3,6773,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/006773_S036_ARTANE.pdf","2009-01-12 00:00:00",
32,1,6882,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06882slr033ltr.pdf","2003-06-08 00:00:00",
33,1,6927,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf","2004-06-03 00:00:00",
32945,2,6927,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf","2004-06-03 00:00:00",
82,1,6927,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf","2003-07-06 00:00:00",
10688,2,6927,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf","2003-07-08 00:00:00",
83,1,7073,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/07073s115ltr.pdf","2004-05-27 00:00:00",
32946,2,7073,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/7073s115lbl.pdf","2003-05-07 00:00:00",
84,1,7073,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7073slr120ltr.pdf","2004-05-27 00:00:00",
32947,2,7073,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/007073s124lbl.pdf","2009-10-21 00:00:00",
85,1,7073,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/007073Orig1s125ltr.pdf","2012-12-18 00:00:00",
32948,2,7073,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/007073s125lbl.pdf","2012-12-13 00:00:00",
34,1,7073,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007073Orig1s126ltr.pdf","2013-07-22 00:00:00",
32949,2,7073,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007073s126lbl.pdf","2013-07-23 00:00:00",
86,1,7073,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/007073Orig1s128ltr.pdf","2014-03-06 00:00:00",
10689,2,7073,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf","2014-03-05 00:00:00",
40649,3,7337,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/007337-S24_Percodan_toc.cfm","2003-08-08 00:00:00",
35,1,7337,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07337slr029ltr.pdf","2004-06-15 00:00:00",
10690,2,7337,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07337slr029_percodan_lbl.pdf","2004-06-15 00:00:00",
36,1,7337,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/07337s043LTR.pdf","2006-08-21 00:00:00",
10691,2,7337,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/007337s043lbl.pdf","2006-08-14 00:00:00",
87,1,7337,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s045ltr.pdf","2010-03-18 00:00:00",
10692,2,7337,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s045lbl.pdf","2010-03-18 00:00:00",
37,1,7337,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s046ltr.pdf","2010-07-30 00:00:00",
10693,2,7337,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s046lbl.pdf","2010-07-31 00:00:00",
46199,1,7337,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/007337Orig1s049ltr.pdf","2016-12-19 00:00:00",
46417,2,7337,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf","2016-12-21 00:00:00",
46560,8,7337,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24","2016-12-27 00:00:00",
55648,1,7337,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/007337Orig1s050s051ltr.pdf","2018-09-28 00:00:00",
55822,2,7337,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf","2018-10-05 00:00:00",
55824,8,7337,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25","2018-10-05 00:00:00",
55649,1,7337,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/007337Orig1s050s051ltr.pdf","2018-09-28 00:00:00",
55823,2,7337,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf","2018-10-05 00:00:00",
55825,8,7337,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25","2018-10-05 00:00:00",
23527,10,7392,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
88,1,7409,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf","2007-02-12 00:00:00",
32950,2,7409,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf","2007-02-21 00:00:00",
133,1,7409,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf","2011-08-02 00:00:00",
32951,2,7409,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf","2011-08-01 00:00:00",
38,1,7409,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf","2013-01-15 00:00:00",
32952,2,7409,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf","2013-01-15 00:00:00",
134,1,7513,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007513s024ltr.pdf","2007-10-04 00:00:00",
32953,2,7513,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf","2014-12-01 00:00:00",
10694,2,7517,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf","2009-03-13 00:00:00",
39,1,7638,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf","2006-01-30 00:00:00",
40,1,7638,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf","2008-02-07 00:00:00",
135,1,7638,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/007638Orig1s038ltr.pdf","2015-12-29 00:00:00",
43995,10,7935,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-04-26 00:00:00",
41,1,7935,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf","2002-12-26 00:00:00",
136,1,7935,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf","2002-12-26 00:00:00",
42,1,7935,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf","2002-12-26 00:00:00",
43,1,7935,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07935s030ltr.pdf","2004-11-15 00:00:00",
32954,2,7935,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf","2004-11-15 00:00:00",
137,1,7959,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf","2002-04-24 00:00:00",
138,1,7959,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf","2002-04-24 00:00:00",
139,1,7961,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf","2007-02-12 00:00:00",
32955,2,7961,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf","2007-02-21 00:00:00",
44,1,7961,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf","2011-08-02 00:00:00",
10695,2,7961,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf","2011-08-01 00:00:00",
89,1,8085,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf","2003-11-05 00:00:00",
32956,2,8085,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf","2003-11-05 00:00:00",
90,1,8085,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf","2002-02-20 00:00:00",
140,1,8085,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf","2002-02-20 00:00:00",
91,1,8085,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf","2003-11-05 00:00:00",
32957,2,8085,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf","2003-11-05 00:00:00",
141,1,8085,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/008085s058LTR.pdf","2006-06-02 00:00:00",
142,1,8085,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008085Orig1s066ltr.pdf","2016-02-01 00:00:00",
32958,2,8085,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf","2016-02-18 00:00:00",
53042,2,8085,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008085s068lbl.pdf","2018-03-16 00:00:00",
53061,1,8085,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008085Orig1s068ltr.pdf","2018-03-20 00:00:00",
143,1,8107,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08107s54ltr.pdf","2002-02-12 00:00:00",
40650,3,8107,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/08107s054_LeucovorinTOC.cfm","2005-07-13 00:00:00",
144,1,8107,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08-107scm055ltr.pdf","2003-12-22 00:00:00",
145,1,8173,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08173slr015ltr.pdf","2003-04-15 00:00:00",
10696,2,8173,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08173slr015_benoquin_lbl.pdf","2003-03-28 00:00:00",
10697,2,8303,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf","2008-01-22 00:00:00",
40651,3,8306,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008306_S029_PHENERGA-CODEINE_AP.pdf","2007-07-06 00:00:00",
92,1,8306,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf","2008-11-28 00:00:00",
10698,2,8306,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf","2009-01-02 00:00:00",
146,1,8306,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008306Orig1s031ltr.pdf","2013-05-13 00:00:00",
32959,2,8306,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf","2013-05-14 00:00:00",
46871,2,8306,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf","2017-01-13 00:00:00",
46882,1,8306,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s032ltr.pdf","2017-01-18 00:00:00",
49601,2,8306,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s033lbl.pdf","2017-08-30 00:00:00",
49623,1,8306,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s033ltr.pdf","2017-08-30 00:00:00",
54751,2,8306,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf","2018-07-05 00:00:00",
54788,8,8306,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29","2018-07-06 00:00:00",
54849,1,8306,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008306Orig1s034ltr.pdf","2018-07-06 00:00:00",
93,1,8316,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08316slr015ltr.pdf","2003-06-22 00:00:00",
10699,2,8316,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl.pdf","2003-06-22 00:00:00",
94,1,8316,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008316s017ltr.pdf","2008-08-13 00:00:00",
32960,2,8316,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008316s017lbl.pdf","2008-08-13 00:00:00",
95,1,8316,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008316Orig1s021ltr.pdf","2015-04-17 00:00:00",
10700,2,8316,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf","2015-04-17 00:00:00",
96,1,8316,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008316Orig1s022ltr.pdf","2016-07-29 00:00:00",
32961,2,8316,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008316s022lbl.pdf","2016-07-28 00:00:00",
48826,1,8316,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008316Orig1s023ltr.pdf","2017-06-26 00:00:00",
48831,2,8316,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008316s023lbl.pdf","2017-06-26 00:00:00",
97,1,8370,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-370slr030ltr.pdf","2002-08-12 00:00:00",
147,1,8370,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf","2007-02-12 00:00:00",
32962,2,8370,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf","2007-02-21 00:00:00",
148,1,8370,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf","2011-08-02 00:00:00",
10701,2,8370,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf","2011-08-01 00:00:00",
149,1,8370,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf","2013-01-15 00:00:00",
10702,2,8370,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf","2013-01-15 00:00:00",
150,1,8372,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008372Orig1s044ltr.pdf","2015-03-25 00:00:00",
32963,2,8372,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008372s044lbl.pdf","2015-05-08 00:00:00",
98,1,8372,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008372s045ltr.pdf","2012-07-09 00:00:00",
53826,2,8372,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf","2018-04-27 00:00:00",
53889,1,8372,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008372Orig1s057Ltr.pdf","2018-05-01 00:00:00",
99,1,8381,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf","2003-07-06 00:00:00",
151,1,8381,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf","2003-07-06 00:00:00",
152,1,8381,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf","2008-04-09 00:00:00",
32964,2,8381,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf","2008-04-16 00:00:00",
100,1,8381,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf","2008-11-13 00:00:00",
32965,2,8381,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf","2008-11-12 00:00:00",
20010,3,8453,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf","2000-06-12 00:00:00",
20011,3,8453,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf","2000-06-12 00:00:00",
20012,3,8453,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf","2000-06-12 00:00:00",
20013,3,8453,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf","2000-06-12 00:00:00",
101,1,8453,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008453s027ltr.pdf","2010-11-30 00:00:00",
10703,2,8453,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf","2010-11-22 00:00:00",
55028,2,8453,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008453s036lbl.pdf","2018-07-27 00:00:00",
55042,1,8453,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008453Orig1s036Ltr.pdf","2018-07-30 00:00:00",
48806,2,8578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf","2017-06-22 00:00:00",
153,1,8578,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf","2004-06-02 00:00:00",
32966,2,8578,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf","2002-10-10 00:00:00",
102,1,8578,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf","2003-11-25 00:00:00",
10704,2,8578,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf","2003-12-01 00:00:00",
47580,2,8578,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf","2017-03-17 00:00:00",
47592,1,8578,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008578Orig1s019ltr.pdf","2017-03-20 00:00:00",
48807,2,8578,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf","2017-06-22 00:00:00",
40652,3,8604,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008604_S026_PHENERGRAN_VC_AP.pdf","2007-07-06 00:00:00",
154,1,8678,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf","2007-05-01 00:00:00",
155,1,8678,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf","2007-05-01 00:00:00",
156,1,8678,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008678Orig1s028ltr.pdf","2016-07-14 00:00:00",
10705,2,8678,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf","2016-07-21 00:00:00",
20014,3,8693,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm","2006-05-10 00:00:00",
32967,2,8697,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf","2015-04-15 00:00:00",
45253,1,8697,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf","2016-09-09 00:00:00",
45257,2,8697,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf","2016-09-09 00:00:00",
45252,1,8697,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf","2016-09-09 00:00:00",
45258,2,8697,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf","2016-09-09 00:00:00",
157,1,8708,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr022ltr.pdf","2004-06-02 00:00:00",
158,1,8708,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr023ltr.pdf","2004-01-09 00:00:00",
40653,3,8708,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/008708Orig1s023.pdf","2011-10-10 00:00:00",
103,1,8708,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008708s025ltr.pdf","2008-04-09 00:00:00",
20015,3,8708,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/008708Orig1s025.pdf","2012-02-28 00:00:00",
32968,2,8708,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf","2008-04-16 00:00:00",
159,1,8720,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08720s016ltr.pdf","2004-09-07 00:00:00",
104,1,8762,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
160,1,8762,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
105,1,8762,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
161,1,8762,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
162,1,8762,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08762slr031ltr.pdf","2003-03-26 00:00:00",
106,1,8762,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf","2011-12-01 00:00:00",
32969,2,8762,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf","2011-12-14 00:00:00",
163,1,8762,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008762s036ltr.pdf","2009-04-29 00:00:00",
32970,2,8762,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf","2009-04-28 00:00:00",
107,1,8762,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s038ltr.pdf","2011-01-24 00:00:00",
10706,2,8762,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf","2011-01-25 00:00:00",
108,1,8762,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf","2011-12-01 00:00:00",
10707,2,8762,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf","2011-12-14 00:00:00",
40654,3,8762,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/008762Orig1s039.pdf","2012-06-26 00:00:00",
109,1,8762,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf","2011-12-01 00:00:00",
32971,2,8762,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf","2011-12-14 00:00:00",
164,1,8762,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf","2011-12-01 00:00:00",
32972,2,8762,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf","2011-12-14 00:00:00",
110,1,8762,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s042ltr.pdf","2011-05-31 00:00:00",
165,1,8762,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf","2011-12-01 00:00:00",
32973,2,8762,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf","2011-12-14 00:00:00",
111,1,8762,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008762Orig1s047ltr.pdf","2013-03-08 00:00:00",
10708,2,8762,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf","2013-03-08 00:00:00",
166,1,8762,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s050,010151Orig1s038ltr.pdf","2014-01-28 00:00:00",
10709,2,8762,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf","2014-01-28 00:00:00",
112,1,8762,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151Orig1s039ltr.pdf","2014-04-04 00:00:00",
32974,2,8762,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf","2014-04-04 00:00:00",
113,1,8762,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008762Orig1s052,10151Orig1s040ltr.pdf","2015-04-17 00:00:00",
32975,2,8762,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf","2015-04-16 00:00:00",
167,1,8762,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/08762Orig1s054,10151Orig1s041ltr.pdf","2016-01-26 00:00:00",
32976,2,8762,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf","2016-01-26 00:00:00",
32977,2,8762,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf","2016-06-21 00:00:00",
45991,2,8762,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf","2016-12-01 00:00:00",
46055,1,8762,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf","2016-12-06 00:00:00",
45992,2,8762,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf","2016-12-01 00:00:00",
46056,1,8762,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf","2016-12-06 00:00:00",
49452,2,8762,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s059lbl.pdf","2017-08-17 00:00:00",
49566,1,8762,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008762Orig1s059,010151Orig1s046ltr.pdf","2017-08-29 00:00:00",
50251,2,8762,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf","2017-11-01 00:00:00",
50254,8,8762,"SUPPL",60,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18","2017-11-01 00:00:00",
50312,1,8762,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf","2017-11-06 00:00:00",
50252,2,8762,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf","2017-11-01 00:00:00",
50253,8,8762,"SUPPL",61,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18","2017-11-01 00:00:00",
50313,1,8762,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf","2017-11-06 00:00:00",
168,1,8809,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8809s046ltr.pdf","2002-06-04 00:00:00",
169,1,8809,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809scf052ltr.pdf","2004-04-29 00:00:00",
32978,2,8809,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf","2004-05-04 00:00:00",
114,1,8809,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809s054ltr.pdf","2004-09-10 00:00:00",
10710,2,8809,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf","2004-09-10 00:00:00",
170,1,8809,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008809s065ltr.pdf","2012-06-15 00:00:00",
10711,2,8809,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf","2012-06-18 00:00:00",
115,1,8809,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008809Orig1s066ltr.pdf","2013-03-28 00:00:00",
10712,2,8809,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf","2013-04-01 00:00:00",
50369,1,8809,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008809Orig1s073ltr.pdf","2017-11-13 00:00:00",
50386,2,8809,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008809s073lbl.pdf","2017-11-13 00:00:00",
116,1,8816,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08816s032ltr.pdf","2004-07-28 00:00:00",
10713,2,8816,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf","2004-07-28 00:00:00",
117,1,8845,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008845s065ltr.pdf","2010-11-30 00:00:00",
32979,2,8845,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf","2010-11-22 00:00:00",
55027,2,8845,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf","2018-07-27 00:00:00",
55043,1,8845,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008845Orig1s073Ltr.pdf","2018-07-30 00:00:00",
20016,3,8848,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008848_S018_Pamine Tablets_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
118,1,8848,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08848scf024ltr.pdf","2004-06-14 00:00:00",
171,1,8848,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/008848s025ltr.pdf","2005-05-18 00:00:00",
172,1,8922,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008922s016ltr.pdf","2009-05-26 00:00:00",
32980,2,8922,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf","2009-06-05 00:00:00",
119,1,9000,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf","2002-06-04 00:00:00",
10714,2,9000,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf","2002-06-04 00:00:00",
20017,3,9000,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
173,1,9000,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf","2004-05-28 00:00:00",
32981,2,9000,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf","2004-05-28 00:00:00",
40655,3,9000,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
120,1,9048,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09048slr037ltr.pdf","2003-04-15 00:00:00",
32982,2,9048,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09048slr037_methoxsalen_lbl.pdf","2003-03-28 00:00:00",
121,1,9053,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09053s020ltr.pdf","2002-03-22 00:00:00",
122,1,9053,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09053slr021ltr.pdf","2002-09-06 00:00:00",
174,1,9053,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09053slr022ltr.pdf","2003-01-10 00:00:00",
32983,2,9053,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09053slr022_purinethol_lbl.pdf","2003-01-10 00:00:00",
10715,2,9053,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09053s024lbl.pdf","2004-07-21 00:00:00",
123,1,9053,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009053s032ltr.pdf","2011-05-31 00:00:00",
10716,2,9053,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009053s032lbl.pdf","2011-05-31 00:00:00",
54317,2,9053,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/09053s035lbl.pdf","2018-05-24 00:00:00",
54333,1,9053,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009053Orig1s035ltr.pdf","2018-05-24 00:00:00",
124,1,9112,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf","2003-07-06 00:00:00",
10717,2,9112,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf","2003-07-08 00:00:00",
175,1,9112,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009112s022ltr.pdf","2009-07-15 00:00:00",
11862,1,9165,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf","2007-03-15 00:00:00",
32984,2,9165,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s030lbl.pdf","2007-03-15 00:00:00",
125,1,9165,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009165s031_ltr.pdf","2007-07-30 00:00:00",
32985,2,9165,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009165s031lbl.pdf","2007-07-27 00:00:00",
126,1,9165,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009165Orig1s032ltr.pdf","2014-06-23 00:00:00",
10718,2,9165,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009165s032lbl.pdf","2014-06-23 00:00:00",
11863,1,9165,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009165Orig1s033ltr.pdf","2015-05-13 00:00:00",
32986,2,9165,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009165s033lbl.pdf","2015-05-13 00:00:00",
45670,1,9165,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009165Orig1s034ltr.pdf","2016-10-27 00:00:00",
45745,2,9165,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009165s034lbl.pdf","2016-11-01 00:00:00",
11864,1,9170,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009170s031ltr.pdf","2008-06-16 00:00:00",
127,1,9170,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s033ltr.pdf","2009-02-03 00:00:00",
128,1,9170,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s034ltr.pdf","2009-05-13 00:00:00",
32987,2,9170,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf","2009-10-15 00:00:00",
129,1,9170,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009170s035ltr.pdf","2010-07-23 00:00:00",
10719,2,9170,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf","2010-07-30 00:00:00",
23090,8,9170,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035MedGuide.pdf","2010-07-30 00:00:00",
11865,1,9170,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s036ltr.pdf","2009-05-01 00:00:00",
32988,2,9170,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf","2009-05-13 00:00:00",
11866,1,9170,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009170s038ltr.pdf","2011-08-12 00:00:00",
20018,3,9175,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm","2006-05-10 00:00:00",
11867,1,9175,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009175s033ltr.pdf","2008-06-03 00:00:00",
11868,1,9175,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009175Orig1s036ltr.pdf","2013-11-07 00:00:00",
32989,2,9175,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf","2013-11-04 00:00:00",
130,1,9175,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009175s037ltr.pdf","2009-02-13 00:00:00",
32990,2,9175,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf","2009-02-10 00:00:00",
131,1,9175,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s038ltr.pdf","2010-11-02 00:00:00",
32991,2,9175,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf","2016-03-18 00:00:00",
132,1,9175,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s039ltr.pdf","2010-10-19 00:00:00",
176,1,9190,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s021ltr.pdf","2014-03-24 00:00:00",
32992,2,9190,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf","2014-03-25 00:00:00",
177,1,9190,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s024ltr.pdf","2014-04-07 00:00:00",
10720,2,9190,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf","2014-04-08 00:00:00",
11869,1,9193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf","2003-04-16 00:00:00",
178,1,9193,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf","2001-05-22 00:00:00",
20019,3,9218,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf","1998-06-01 00:00:00",
40656,3,9218,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf","1998-06-01 00:00:00",
40657,3,9218,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf","1998-06-01 00:00:00",
20020,3,9218,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf","2000-02-17 00:00:00",
179,1,9218,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf","2002-05-03 00:00:00",
11870,1,9218,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf","2002-05-03 00:00:00",
180,1,9218,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf","2005-09-07 00:00:00",
32993,2,9218,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf","2005-09-07 00:00:00",
40658,3,9218,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf","2005-09-02 00:00:00",
10721,2,9218,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf","2006-10-05 00:00:00",
11871,1,9218,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf","2006-10-05 00:00:00",
181,1,9218,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf","2007-08-17 00:00:00",
32994,2,9218,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf","2007-08-16 00:00:00",
182,1,9218,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf","2011-10-05 00:00:00",
32995,2,9218,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf","2011-10-05 00:00:00",
10722,2,9218,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf","2010-01-24 00:00:00",
11872,1,9218,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf","2010-01-28 00:00:00",
183,1,9218,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf","2015-10-30 00:00:00",
10723,2,9218,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf","2015-10-29 00:00:00",
45265,2,9218,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf","2016-09-09 00:00:00",
45278,1,9218,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf","2016-09-12 00:00:00",
48516,2,9218,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf","2017-05-24 00:00:00",
48517,8,9218,"SUPPL",117,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf#page=31","2017-05-24 00:00:00",
49429,2,9218,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf","2017-08-16 00:00:00",
49486,1,9218,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009218Orig1s118ltr.pdf","2017-08-21 00:00:00",
184,1,9321,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009321Orig1s028ltr.pdf","2015-07-09 00:00:00",
10724,2,9321,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf","2015-07-13 00:00:00",
47883,2,9321,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009321s030lbl.pdf","2017-04-06 00:00:00",
47972,1,9321,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009321Orig1s030ltr.pdf","2017-04-12 00:00:00",
20021,3,9330,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/9330-s020_lanoxin.pdf","2001-09-14 00:00:00",
185,1,9330,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9330s021ltr.pdf","2002-06-17 00:00:00",
186,1,9330,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009330s025ltr.pdf","2010-03-18 00:00:00",
32996,2,9330,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009330s025lbl.pdf","2010-02-16 00:00:00",
10725,2,9330,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf","2011-11-14 00:00:00",
11873,1,9330,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009330s026ltr.pdf","2011-11-16 00:00:00",
10726,2,9330,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf","2013-05-21 00:00:00",
11874,1,9330,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009330Orig1s027ltr.pdf","2013-05-22 00:00:00",
187,1,9330,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009330Orig1s030ltr.pdf","2015-07-29 00:00:00",
32997,2,9330,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009330s030lbl.pdf","2015-07-30 00:00:00",
46019,2,9330,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009330s031lbl.pdf","2016-12-05 00:00:00",
46054,1,9330,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009330Orig1s031ltr.pdf","2016-12-06 00:00:00",
55729,1,9330,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009330Orig1s033ltr.pdf","2018-10-01 00:00:00",
55302,1,9330,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009330Orig1s034ltr.pdf","2018-08-24 00:00:00",
55344,2,9330,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009330s034lbl.pdf","2018-08-28 00:00:00",
32998,2,9386,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf","2004-01-15 00:00:00",
10727,2,9386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf","2003-03-06 00:00:00",
11875,1,9386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386scm019ltr.pdf","2003-01-23 00:00:00",
40659,3,9386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/9-386s019_Myleran.cfm","2003-07-08 00:00:00",
11876,1,9386,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr021ltr.pdf","2003-05-16 00:00:00",
32999,2,9386,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf","2003-04-17 00:00:00",
11877,1,9386,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr023ltr.pdf","2004-01-09 00:00:00",
33000,2,9386,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf","2004-02-03 00:00:00",
188,1,9402,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf","2003-12-16 00:00:00",
10728,2,9402,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf","2004-06-02 00:00:00",
189,1,9402,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf","2003-12-16 00:00:00",
33001,2,9402,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf","2003-12-16 00:00:00",
190,1,9402,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09402s040ltr.pdf","2004-07-28 00:00:00",
33002,2,9402,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf","2004-07-28 00:00:00",
191,1,9402,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009402s041ltr.pdf","2007-10-15 00:00:00",
50267,2,9402,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009402s052lbl.pdf","2017-11-02 00:00:00",
50306,1,9402,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009402Orig1s052ltr.pdf","2017-11-06 00:00:00",
11878,1,9435,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09435slr034ltr.pdf","2004-06-23 00:00:00",
33003,2,9435,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf","2004-06-22 00:00:00",
10729,2,9435,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf","2010-02-25 00:00:00",
11879,1,9435,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf","2010-03-18 00:00:00",
192,1,9435,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf","2010-03-18 00:00:00",
33004,2,9435,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf","2010-02-25 00:00:00",
52433,14,9470,"APPL",0,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/009470_SLCOrderLtr.pdf","2018-02-06 00:00:00",
53934,14,9470,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/009470_SLCOrderLtr.pdf","2018-05-01 00:00:00",
11880,1,9470,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009470Orig1s025ltr.pdf","2014-09-25 00:00:00",
33005,2,9470,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf","2014-09-26 00:00:00",
193,1,9486,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09486slr028ltr.pdf","2003-11-05 00:00:00",
52873,2,9509,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/009509s026lbl.pdf","2018-03-08 00:00:00",
47019,1,9768,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf","2017-01-30 00:00:00",
47025,2,9768,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf","2017-01-27 00:00:00",
11881,1,9768,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009768s041ltr.pdf","2007-07-05 00:00:00",
33006,2,9768,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf","2007-06-27 00:00:00",
47020,1,9768,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf","2017-01-30 00:00:00",
47026,2,9768,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf","2017-01-27 00:00:00",
47021,1,9768,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf","2017-01-30 00:00:00",
47027,2,9768,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf","2017-01-27 00:00:00",
10730,2,9818,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf","2011-07-07 00:00:00",
11882,1,9818,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009818s018ltr.pdf","2011-07-07 00:00:00",
10731,2,9829,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf","2003-04-03 00:00:00",
10732,2,9830,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf","2005-06-21 00:00:00",
194,1,9866,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s79ltr.pdf","2009-11-09 00:00:00",
33007,2,9866,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf","2009-10-05 00:00:00",
10733,2,9866,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf","2009-10-05 00:00:00",
11883,1,9866,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s079ltr.pdf","2009-11-09 00:00:00",
195,1,9866,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009866s080ltr.pdf","2010-06-28 00:00:00",
10734,2,9866,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf","2010-07-01 00:00:00",
45254,1,9866,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf","2016-09-09 00:00:00",
45259,2,9866,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf","2016-09-09 00:00:00",
11884,1,9866,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009866Orig1s104ltr.pdf","2014-07-08 00:00:00",
33008,2,9866,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf","2014-07-08 00:00:00",
45255,1,9866,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf","2016-09-09 00:00:00",
45260,2,9866,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf","2016-09-09 00:00:00",
43996,10,10021,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
196,1,10040,"SUPPL",163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10040spd163ltr.pdf","2003-10-01 00:00:00",
11885,1,10040,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10040slr168ltr.pdf","2002-10-23 00:00:00",
10735,2,10040,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf","2015-07-13 00:00:00",
11886,1,10040,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010040Orig1s171ltr.pdf","2015-07-10 00:00:00",
11887,1,10060,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10060slr017ltr.pdf","2004-06-30 00:00:00",
52765,3,10104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/010104Orig1s000.pdf","2018-02-28 00:00:00",
11888,1,10104,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10104slr022ltr.pdf","2004-03-02 00:00:00",
10736,2,10104,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf","2012-11-27 00:00:00",
11889,1,10104,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010104s028ltr.pdf","2010-01-26 00:00:00",
197,1,10151,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
20022,3,10151,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S022_DILANTIN_AP.pdf","2007-07-06 00:00:00",
11890,1,10151,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
20023,3,10151,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S029_DILANTIN_AP.pdf","2007-07-06 00:00:00",
198,1,10151,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
20024,3,10151,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S030_DILANTIN_AP.pdf","2007-07-06 00:00:00",
199,1,10151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
40660,3,10151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S032_DILANTIN_AP.pdf","2007-07-06 00:00:00",
200,1,10151,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
20025,3,10151,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S033_DILANTIN_AP.pdf","2007-07-06 00:00:00",
11891,1,10151,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf","2001-11-20 00:00:00",
40661,3,10151,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S034_DILANTIN_AP.pdf","2007-07-06 00:00:00",
10737,2,10151,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf","2011-11-16 00:00:00",
11892,1,10151,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010151s036ltr.pdf","2011-11-21 00:00:00",
201,1,10151,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010151Orig1s037ltr.pdf","2013-03-08 00:00:00",
10738,2,10151,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf","2013-03-08 00:00:00",
202,1,10151,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s050,010151Orig1s038ltr.pdf","2014-01-28 00:00:00",
33009,2,10151,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf","2014-01-28 00:00:00",
10739,2,10151,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf","2014-04-04 00:00:00",
11893,1,10151,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151Orig1s039ltr.pdf","2014-04-04 00:00:00",
203,1,10151,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008762Orig1s052,10151Orig1s040ltr.pdf","2015-04-17 00:00:00",
33010,2,10151,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf","2015-04-16 00:00:00",
204,1,10151,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/08762Orig1s054,10151Orig1s041ltr.pdf","2016-01-26 00:00:00",
10740,2,10151,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf","2016-01-26 00:00:00",
10741,2,10151,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf","2016-06-21 00:00:00",
46057,1,10151,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf","2016-12-06 00:00:00",
46058,1,10151,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf","2016-12-06 00:00:00",
49454,2,10151,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s046lbl.pdf","2017-08-17 00:00:00",
49567,1,10151,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008762Orig1s059,010151Orig1s046ltr.pdf","2017-08-29 00:00:00",
50256,2,10151,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf","2017-11-01 00:00:00",
50255,2,10151,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf","2017-11-01 00:00:00",
11894,1,10155,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10155slr021ltr.pdf","2003-03-10 00:00:00",
205,1,10155,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010155s022s023ltr.pdf","2011-11-16 00:00:00",
33011,2,10155,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s022lbl.pdf","2011-11-14 00:00:00",
206,1,10155,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010155s022s023ltr.pdf","2011-11-16 00:00:00",
10742,2,10155,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010155s023lbl.pdf","2011-11-14 00:00:00",
10743,2,10155,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/010155s024lbl.pdf","2014-12-26 00:00:00",
11895,1,10155,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/010155Orig1s024ltr.pdf","2014-11-28 00:00:00",
23528,10,10187,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
207,1,10187,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf","2004-05-27 00:00:00",
208,1,10187,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf","2004-05-27 00:00:00",
209,1,10187,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf","2002-01-11 00:00:00",
210,1,10187,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
10744,2,10187,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
211,1,10187,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
10745,2,10187,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
212,1,10187,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf","2007-05-01 00:00:00",
10746,2,10187,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf","2007-05-01 00:00:00",
213,1,10187,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf","2010-11-18 00:00:00",
10747,2,10187,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf","2010-11-17 00:00:00",
214,1,10187,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf","2010-12-15 00:00:00",
33012,2,10187,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf","2010-12-10 00:00:00",
215,1,10187,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf","2013-06-11 00:00:00",
33013,2,10187,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf","2013-06-11 00:00:00",
10748,2,10187,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf","2013-12-17 00:00:00",
11896,1,10187,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf","2013-12-16 00:00:00",
216,1,10187,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf","2015-04-21 00:00:00",
33014,2,10187,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf","2015-04-21 00:00:00",
46705,2,10187,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf","2017-01-06 00:00:00",
46823,8,10187,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf#page=11","2017-01-13 00:00:00",
46824,1,10187,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf","2017-01-13 00:00:00",
11897,1,10251,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10251scm024ltr.pdf","2002-10-18 00:00:00",
217,1,10379,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10379s45ltr.pdf","2001-09-13 00:00:00",
11898,1,10379,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10379S047ltr.pdf","2002-05-17 00:00:00",
33015,2,10379,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf","2002-05-17 00:00:00",
218,1,10392,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF","2001-03-21 00:00:00",
33016,2,10401,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf","2005-11-21 00:00:00",
23529,10,10402,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm","2009-06-02 00:00:00",
219,1,10402,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10402slr046ltr.pdf","2004-04-29 00:00:00",
10749,2,10402,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf","2004-04-23 00:00:00",
11899,1,10402,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf","2005-01-21 00:00:00",
33017,2,10402,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/10402s047lbl.pdf","2005-01-21 00:00:00",
11900,1,10402,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf","2005-09-07 00:00:00",
33018,2,10402,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf","2005-09-07 00:00:00",
11901,1,10402,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf","2006-08-04 00:00:00",
33019,2,10402,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf","2006-07-27 00:00:00",
220,1,10402,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s051LTR.pdf","2006-06-06 00:00:00",
221,1,10402,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/010402s055ltr.pdf","2008-03-04 00:00:00",
33020,2,10402,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/010402s055lbl.pdf","2008-03-05 00:00:00",
10750,2,10402,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf","2012-04-17 00:00:00",
11902,1,10402,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010402Orig1s063ltr.pdf","2012-04-13 00:00:00",
50283,2,10402,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010402s068lbl.pdf","2017-11-03 00:00:00",
50305,1,10402,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010402Orig1s068ltr.pdf","2017-11-06 00:00:00",
222,1,10417,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010417s027ltr.pdf","2010-02-25 00:00:00",
33021,2,10417,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf","2010-02-25 00:00:00",
11903,1,10485,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF","2001-03-21 00:00:00",
49496,14,10515,"APPL",0,"View In-Use Labeling","https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a58f95fa-18f9-4938-8e3f-f33244f68298","2017-08-22 00:00:00",
10751,2,10515,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/10515s22lbl.pdf","1999-05-04 00:00:00",
11904,1,10515,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/10515s22ltr.pdf","1999-05-04 00:00:00",
40662,3,10515,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/10515s022_Isuprel.pdf","1999-05-05 00:00:00",
40663,3,10515,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/010515Orig1s023.pdf","2015-11-05 00:00:00",
40664,3,10515,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010515Orig1s024.pdf","2015-11-05 00:00:00",
10752,2,10515,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010515s031lbl.pdf","2013-03-26 00:00:00",
40665,3,10515,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/010515Orig1s031.pdf","2015-11-17 00:00:00",
223,1,10571,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
11905,1,10571,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010571s096ltr.pdf","2005-08-08 00:00:00",
33022,2,10571,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf","2005-08-08 00:00:00",
23091,8,10596,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf","2010-10-13 00:00:00",
224,1,10596,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf","2001-04-09 00:00:00",
225,1,10596,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf","2001-04-09 00:00:00",
226,1,10596,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10596s17ltr.pdf","2002-04-17 00:00:00",
11906,1,10596,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010596s021ltr.pdf","2009-04-29 00:00:00",
33023,2,10596,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf","2009-04-28 00:00:00",
10753,2,10596,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf","2010-10-11 00:00:00",
11907,1,10596,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010596s022ltr.pdf","2010-10-13 00:00:00",
11908,1,10596,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010596s023ltr.pdf","2011-06-17 00:00:00",
227,1,10669,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf","2001-07-24 00:00:00",
11909,1,10669,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf","2001-07-24 00:00:00",
228,1,10669,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf","2001-07-24 00:00:00",
11910,1,10669,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s24ltr.pdf","2001-06-20 00:00:00",
229,1,10669,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10669slr028ltr.pdf","2003-11-25 00:00:00",
10754,2,10669,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.pdf","2003-12-02 00:00:00",
230,1,10669,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010669s029ltr.pdf","2005-05-25 00:00:00",
231,1,10669,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010669s030ltr.pdf","2010-04-28 00:00:00",
33024,2,10669,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010669s030lbl.pdf","2010-05-03 00:00:00",
232,1,10669,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010669s032ltr.pdf","2011-11-03 00:00:00",
33025,2,10669,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010669s032lbl.pdf","2011-11-01 00:00:00",
233,1,10679,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10679slr029ltr.pdf","2004-06-01 00:00:00",
33026,2,10679,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf","2004-06-01 00:00:00",
234,1,10721,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010721Orig1s058ltr.pdf","2012-10-24 00:00:00",
33027,2,10721,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf","2012-10-24 00:00:00",
53682,2,10721,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721s061lbl.pdf","2018-04-16 00:00:00",
53694,1,10721,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010721Orig1s061ltr.pdf","2018-04-16 00:00:00",
235,1,10742,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
11911,1,10775,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf","2001-03-15 00:00:00",
20026,3,10775,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/10-775SLR029.pdf","2003-02-04 00:00:00",
236,1,10775,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10775s031ltr.pdf","2002-05-10 00:00:00",
33028,2,10775,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf","2002-05-10 00:00:00",
40666,3,10775,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/010775_S031_TRILAFON_AP.pdf","2007-07-06 00:00:00",
237,1,10841,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf","2003-10-01 00:00:00",
11912,1,10841,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf","2003-10-01 00:00:00",
238,1,10841,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010841s020LTR.pdf","2007-02-12 00:00:00",
33029,2,10841,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf","2007-02-21 00:00:00",
239,1,10841,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010841s021ltr.pdf","2009-04-29 00:00:00",
33030,2,10841,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf","2009-04-28 00:00:00",
11913,1,10841,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010841s022ltr.pdf","2010-06-14 00:00:00",
33031,2,10841,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf","2010-06-14 00:00:00",
43581,8,10841,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf","2010-06-24 00:00:00",
240,1,10841,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010841s023ltr.pdf","2011-06-02 00:00:00",
241,1,10909,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10909s13ltr.pdf","2002-02-06 00:00:00",
242,1,10926,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf","2002-12-26 00:00:00",
11914,1,10926,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf","2002-12-26 00:00:00",
11915,1,10926,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf","2002-12-26 00:00:00",
243,1,10926,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf","2002-12-26 00:00:00",
244,1,10926,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10926s030ltr.pdf","2004-11-15 00:00:00",
10755,2,10926,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf","2004-11-15 00:00:00",
11916,1,10996,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf","2002-08-01 00:00:00",
245,1,10996,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10996scm068ltr.pdf","2004-06-01 00:00:00",
246,1,10997,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf","2002-08-01 00:00:00",
11917,1,10997,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-11-13 00:00:00",
33032,2,10997,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf","2009-09-30 00:00:00",
43582,8,10997,"SUPPL",51,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf","2009-10-01 00:00:00",
247,1,10997,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-10-26 00:00:00",
23092,8,10997,"SUPPL",52,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf","2009-10-01 00:00:00",
33033,2,10997,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf","2009-10-01 00:00:00",
11918,1,11000,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
248,1,11011,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11011slr070,slr071ltr.pdf","2003-05-16 00:00:00",
10756,2,11011,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf","2003-05-06 00:00:00",
11919,1,11011,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11011slr070,slr071ltr.pdf","2003-05-16 00:00:00",
33034,2,11011,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/011011s070s071lbl.pdf","2003-05-06 00:00:00",
11920,1,11111,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF","2001-03-21 00:00:00",
11921,1,11120,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11120S86ltr.pdf","2001-04-03 00:00:00",
249,1,11127,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
250,1,11145,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf","2004-09-29 00:00:00",
11922,1,11145,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf","2004-09-29 00:00:00",
251,1,11145,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s092ltr.pdf","2004-10-29 00:00:00",
252,1,11145,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf","2005-08-11 00:00:00",
33035,2,11153,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011153s051lbl.pdf","2015-12-31 00:00:00",
54965,2,11153,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011153s075lbl.pdf","2018-07-25 00:00:00",
54996,1,11153,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011153Orig1s075Ltr.pdf","2018-07-26 00:00:00",
11923,1,11188,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
10757,2,11210,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf","2011-01-25 00:00:00",
11924,1,11210,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf","2011-01-25 00:00:00",
11925,1,11213,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf","2001-03-15 00:00:00",
40667,3,11213,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/10-775SLR029.pdf","2003-02-04 00:00:00",
253,1,11213,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10775s031ltr.pdf","2002-05-10 00:00:00",
10758,2,11213,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf","2002-05-10 00:00:00",
40668,3,11213,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011213_S024_TRILAFON_AP.pdf","2007-07-06 00:00:00",
11926,1,11245,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011245s032ltr.pdf","2005-08-31 00:00:00",
40669,3,11265,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/011265_S027_PHERGAN_AP.pdf","2007-07-06 00:00:00",
254,1,11265,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11265slr028ltr.pdf","2004-01-22 00:00:00",
255,1,11265,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf","2008-04-09 00:00:00",
33036,2,11265,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf","2008-04-16 00:00:00",
256,1,11265,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011265s031ltr.pdf","2009-11-09 00:00:00",
257,1,11287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr017ltr.pdf","2003-06-08 00:00:00",
258,1,11287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr018ltr.pdf","2003-12-11 00:00:00",
259,1,11287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s021ltr.pdf","2009-05-04 00:00:00",
33037,2,11287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf","2009-05-13 00:00:00",
10759,2,11287,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf","2009-10-01 00:00:00",
11927,1,11287,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s022ltr.pdf","2009-11-19 00:00:00",
11928,1,11287,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011287s023ltr.pdf","2011-01-05 00:00:00",
33038,2,11287,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf","2011-01-03 00:00:00",
49156,2,11287,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011287s026lbl.pdf","2017-07-31 00:00:00",
49186,1,11287,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011287Orig1s026ltr.pdf","2017-08-02 00:00:00",
11929,1,11324,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11324s28ltr.pdf","2002-04-17 00:00:00",
10760,2,11340,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf","2002-04-12 00:00:00",
11930,1,11340,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf","2002-04-12 00:00:00",
11931,1,11366,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011366s028ltr.pdf","2012-03-19 00:00:00",
11932,1,11366,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011366Orig1s030ltr.pdf","2015-08-10 00:00:00",
33039,2,11366,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf","2015-08-10 00:00:00",
11933,1,11459,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF","2001-03-21 00:00:00",
11934,1,11459,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf","2004-12-29 00:00:00",
11935,1,11459,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf","2014-06-05 00:00:00",
33040,2,11459,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf","2014-06-04 00:00:00",
260,1,11459,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf","2016-02-22 00:00:00",
33041,2,11459,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf","2016-03-10 00:00:00",
45864,1,11459,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s051,011795Orig1s028ltr.pdf","2016-11-10 00:00:00",
45869,2,11459,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf","2016-11-10 00:00:00",
11936,1,11483,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011483Orig1s027ltr.pdf","2013-05-13 00:00:00",
33042,2,11483,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf","2013-05-14 00:00:00",
46201,1,11483,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011483Orig1s029ltr.pdf","2016-12-19 00:00:00",
46416,2,11483,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf","2016-12-21 00:00:00",
49587,2,11483,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf","2017-08-30 00:00:00",
49588,8,11483,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf#page=26","2017-08-30 00:00:00",
49631,1,11483,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011483Orig1s030ltr.pdf","2017-08-30 00:00:00",
55652,1,11483,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf","2018-09-28 00:00:00",
55826,2,11483,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf","2018-10-05 00:00:00",
55828,8,11483,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf#page=27","2018-10-05 00:00:00",
55653,1,11483,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf","2018-09-28 00:00:00",
55827,2,11483,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf","2018-10-05 00:00:00",
55829,8,11483,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf#page=27","2018-10-05 00:00:00",
43997,10,11522,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm","2007-05-31 00:00:00",
40670,3,11522,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf","2000-06-12 00:00:00",
261,1,11522,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11522scf030ltr.pdf","2002-11-08 00:00:00",
40671,3,11522,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/11-522S030_Adderall.cfm","2004-04-14 00:00:00",
262,1,11522,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf","2005-08-04 00:00:00",
10761,2,11522,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf","2005-08-04 00:00:00",
11937,1,11522,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf","2005-08-04 00:00:00",
33043,2,11522,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf","2005-08-04 00:00:00",
263,1,11522,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf","2006-07-27 00:00:00",
10762,2,11522,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf","2006-07-27 00:00:00",
264,1,11522,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf","2006-07-27 00:00:00",
33044,2,11522,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf","2006-07-27 00:00:00",
265,1,11522,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011522s040ltr.pdf","2007-06-14 00:00:00",
33045,2,11522,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf","2007-06-12 00:00:00",
11938,1,11522,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s041ltr.pdf","2015-04-20 00:00:00",
33046,2,11522,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf","2015-04-19 00:00:00",
266,1,11522,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s042ltr.pdf","2015-10-06 00:00:00",
10763,2,11522,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf","2015-10-07 00:00:00",
43583,8,11522,"SUPPL",42,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf","2015-10-23 00:00:00",
46684,2,11522,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf","2017-01-06 00:00:00",
46726,1,11522,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011522Orig1s043ltr.pdf","2017-01-09 00:00:00",
267,1,11525,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011525s017LTR.pdf","2006-09-27 00:00:00",
33047,2,11525,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf","2006-09-25 00:00:00",
10764,2,11525,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf","2015-10-08 00:00:00",
268,1,11529,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11529s048ltr.pdf","2002-06-28 00:00:00",
269,1,11552,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11552S112ltr.pdf","2001-04-03 00:00:00",
40672,3,11552,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/11-552SLR112.pdf","2003-02-04 00:00:00",
270,1,11556,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11556slr053ltr.pdf","2002-08-26 00:00:00",
11939,1,11559,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf","2001-07-13 00:00:00",
11940,1,11559,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf","2004-05-28 00:00:00",
10765,2,11559,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf","2004-06-01 00:00:00",
11941,1,11559,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf","2004-06-01 00:00:00",
271,1,11559,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011559s041ltr.pdf","2008-05-08 00:00:00",
10766,2,11559,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf","2008-06-12 00:00:00",
272,1,11559,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011559Orig1s045ltr.pdf","2014-01-24 00:00:00",
33048,2,11559,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf","2014-01-28 00:00:00",
48188,1,11559,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011559Orig1s051ltr.pdf","2017-05-02 00:00:00",
48216,2,11559,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf","2017-05-02 00:00:00",
10767,2,11600,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf","2016-01-21 00:00:00",
47849,2,11601,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011601s036lbl.pdf","2017-04-04 00:00:00",
273,1,11613,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11613slr026ltr.pdf","2003-10-16 00:00:00",
11942,1,11613,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011613Orig1s027ltr.pdf","2012-12-11 00:00:00",
33049,2,11613,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/011613s027lbl.pdf","2012-12-07 00:00:00",
274,1,11641,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf","2002-05-16 00:00:00",
40673,3,11641,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf","2006-10-26 00:00:00",
275,1,11641,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf","2002-05-16 00:00:00",
40674,3,11641,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf","2006-10-26 00:00:00",
276,1,11641,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11641slr061ltr.pdf","2004-01-09 00:00:00",
20027,3,11641,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011641_S061_DIABINESE_TABLETS_AP.pdf","2007-07-06 00:00:00",
277,1,11641,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011641s064ltr.pdf","2008-10-29 00:00:00",
33050,2,11641,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf","2008-11-07 00:00:00",
10768,2,11641,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf","2009-09-17 00:00:00",
20028,3,11641,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/011641Orig1s065.pdf","2011-10-10 00:00:00",
10769,2,11641,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf","2011-02-04 00:00:00",
11943,1,11641,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011641s066ltr.pdf","2011-02-04 00:00:00",
11944,1,11642,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642S012_Cardioquin_Approv.pdf","1999-06-16 00:00:00",
20029,3,11642,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642s012_Cardioquin.cfm","2002-08-14 00:00:00",
33051,2,11642,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642S012_Cardioquin_prntlbl.pdf","1999-06-16 00:00:00",
11945,1,11664,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11664slr062ltr.pdf","2004-05-27 00:00:00",
33052,2,11664,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11664slr062_decadron_lbl.pdf","2004-05-27 00:00:00",
40675,3,11664,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011664_S062_DECADRON.pdf","2007-07-20 00:00:00",
278,1,11664,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011664Orig1s063ltr.pdf","2016-08-02 00:00:00",
10770,2,11664,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011664s063lbl.pdf","2016-08-02 00:00:00",
53797,2,11664,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011664s065lbl.pdf","2018-04-24 00:00:00",
53805,1,11664,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011664Orig1s065_ltr.pdf","2018-04-24 00:00:00",
10771,2,11665,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf","2005-06-21 00:00:00",
279,1,11685,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011685Orig1s026ltr.pdf","2014-07-08 00:00:00",
33053,2,11685,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf","2014-07-08 00:00:00",
11946,1,11689,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf","2002-12-26 00:00:00",
11947,1,11689,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf","2002-12-26 00:00:00",
280,1,11689,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf","2002-12-26 00:00:00",
281,1,11689,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf","2002-12-26 00:00:00",
10772,2,11689,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf","2004-11-15 00:00:00",
11948,1,11689,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11689s024ltr.pdf","2004-11-15 00:00:00",
10773,2,11707,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011707s031lbl.pdf","2006-10-18 00:00:00",
11949,1,11707,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011707s031ltr.pdf","2006-10-23 00:00:00",
46202,1,11707,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011707Orig1s036ltr.pdf","2016-12-19 00:00:00",
46415,2,11707,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011707s036lbl.pdf","2016-12-21 00:00:00",
282,1,11719,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf","2002-02-20 00:00:00",
11950,1,11719,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf","2002-02-20 00:00:00",
283,1,11719,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr104ltr.pdf","2003-01-03 00:00:00",
11951,1,11719,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf","2003-08-06 00:00:00",
10774,2,11719,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf","2004-02-03 00:00:00",
11952,1,11719,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf","2004-02-02 00:00:00",
11953,1,11719,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf","2004-12-30 00:00:00",
11954,1,11719,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf","2005-04-19 00:00:00",
11955,1,11719,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf","2011-11-03 00:00:00",
33054,2,11719,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf","2011-11-04 00:00:00",
10775,2,11719,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf","2015-11-25 00:00:00",
11956,1,11719,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf","2015-11-23 00:00:00",
54036,2,11719,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf","2018-05-07 00:00:00",
54048,1,11719,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s125ltr.pdf","2018-05-08 00:00:00",
53041,2,11719,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s126lbl.pdf","2018-03-16 00:00:00",
53060,1,11719,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s126ltr.pdf","2018-03-20 00:00:00",
284,1,11722,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11722s029,12546s032ltr.pdf","2004-09-07 00:00:00",
10776,2,11722,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf","2004-09-07 00:00:00",
46203,1,11730,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011730Orig1s031ltr.pdf","2016-12-19 00:00:00",
46413,2,11730,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011730s031lbl.pdf","2016-12-21 00:00:00",
10777,2,11757,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf","2009-04-16 00:00:00",
11957,1,11757,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf","2009-04-16 00:00:00",
11958,1,11757,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf","2009-04-16 00:00:00",
33055,2,11757,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf","2009-04-16 00:00:00",
285,1,11757,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011757Orig1s103ltr.pdf","2014-07-08 00:00:00",
10778,2,11757,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf","2014-07-09 00:00:00",
45251,1,11757,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011757Orig1s104ltr.pdf","2016-09-09 00:00:00",
45261,2,11757,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf","2016-09-09 00:00:00",
47598,1,11757,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011757Orig1s111ltr.pdf","2017-03-20 00:00:00",
54964,2,11757,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf","2018-07-25 00:00:00",
54997,1,11757,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011757Orig1s114Ltr.pdf","2018-07-26 00:00:00",
10779,2,11790,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11790slr046_robaxin_lbl.pdf","2004-05-04 00:00:00",
11959,1,11790,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11790slr046ltr.pdf","2004-05-04 00:00:00",
286,1,11792,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011792s035LTR.pdf","2006-06-12 00:00:00",
10780,2,11792,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf","2006-06-12 00:00:00",
11960,1,11792,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011792s041ltr.pdf","2007-09-25 00:00:00",
20030,3,11792,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf","2012-11-16 00:00:00",
33056,2,11792,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf","2007-09-19 00:00:00",
11961,1,11792,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011792s043ltr.pdf","2010-01-06 00:00:00",
33057,2,11792,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf","2009-11-17 00:00:00",
287,1,11792,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011792Orig1s045ltr.pdf","2013-02-04 00:00:00",
33058,2,11792,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf","2013-02-06 00:00:00",
11962,1,11792,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011792Orig1s046ltr.pdf","2015-02-25 00:00:00",
55272,2,11792,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf","2018-08-23 00:00:00",
288,1,11795,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF","2001-03-21 00:00:00",
11963,1,11795,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf","2004-12-29 00:00:00",
11964,1,11795,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf","2014-06-05 00:00:00",
33059,2,11795,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf","2014-06-04 00:00:00",
11965,1,11795,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf","2016-02-22 00:00:00",
33060,2,11795,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf","2016-03-10 00:00:00",
45865,1,11795,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s051,011795Orig1s028ltr.pdf","2016-11-10 00:00:00",
45870,2,11795,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf","2016-11-10 00:00:00",
289,1,11808,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF","2001-03-15 00:00:00",
43998,10,11838,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
11966,1,11839,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11839S68LTR.PDF","1998-08-04 00:00:00",
40676,3,11839,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11839-S068_Provera.pdf","1998-08-04 00:00:00",
10781,2,11839,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf","2007-10-04 00:00:00",
11967,1,11839,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011839s071ltr.pdf","2007-10-04 00:00:00",
10782,2,11839,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf","2015-05-08 00:00:00",
11968,1,11839,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf","2015-05-11 00:00:00",
290,1,11839,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf","2015-05-11 00:00:00",
10783,2,11839,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf","2015-05-08 00:00:00",
291,1,11856,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf","2011-10-25 00:00:00",
33061,2,11856,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf","2011-10-25 00:00:00",
10784,2,11856,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf","2011-10-25 00:00:00",
11969,1,11856,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf","2011-10-25 00:00:00",
11970,1,11856,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/011856s107ltr.pdf","2010-06-28 00:00:00",
33062,2,11856,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf","2010-07-01 00:00:00",
11971,1,11856,"SUPPL",123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011856Orig1s123ltr.pdf","2014-07-07 00:00:00",
33063,2,11856,"SUPPL",123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf","2014-07-09 00:00:00",
45249,1,11856,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf","2016-09-09 00:00:00",
45262,2,11856,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf","2016-09-09 00:00:00",
45250,1,11856,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf","2016-09-09 00:00:00",
45263,2,11856,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf","2016-09-09 00:00:00",
53571,2,11856,"SUPPL",131,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s131lbl.pdf","2018-04-01 00:00:00",
53584,1,11856,"SUPPL",131,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s131ltr.pdf","2018-04-01 00:00:00",
54963,2,11856,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s133lbl.pdf","2018-07-25 00:00:00",
54998,1,11856,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s133Ltr.pdf","2018-07-26 00:00:00",
11972,1,11870,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf","2004-09-29 00:00:00",
11973,1,11870,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf","2005-08-11 00:00:00",
11974,1,11870,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011870s039ltr.pdf","2007-08-07 00:00:00",
10785,2,11870,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf","2009-06-10 00:00:00",
11975,1,11870,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011870s040ltr.pdf","2009-06-16 00:00:00",
23530,10,11909,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
43584,8,11909,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf","2009-11-19 00:00:00",
292,1,11909,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11909slr033ltr.pdf","2003-09-09 00:00:00",
10786,2,11909,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf","2003-09-09 00:00:00",
11976,1,11909,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11909s035ltr.pdf","2005-02-23 00:00:00",
10787,2,11909,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf","2007-02-21 00:00:00",
11977,1,11909,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011909s036ltr.pdf","2007-02-12 00:00:00",
293,1,11909,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
33064,2,11909,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf","2007-08-03 00:00:00",
23093,8,11961,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088633.pdf","2009-11-19 00:00:00",
43999,10,11961,"ORIG",1,"0","http://www.fda.gov/cder/drug/antidepressants/default.htm","2007-05-09 00:00:00",
10788,2,11961,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf","1998-08-18 00:00:00",
11978,1,11961,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11961ltr.pdf","1998-08-18 00:00:00",
20031,3,11961,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11961-s017.cfm","1998-12-14 00:00:00",
11979,1,11961,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11961s035ltr.pdf","2005-01-13 00:00:00",
33065,2,11961,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf","2005-01-13 00:00:00",
294,1,11961,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011961s039ltr.pdf","2007-08-14 00:00:00",
33066,2,11961,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf","2007-08-14 00:00:00",
295,1,11963,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011963s034ltr.pdf","2006-03-23 00:00:00",
10789,2,11963,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf","2006-03-14 00:00:00",
54779,1,11963,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011963Orig1s048ltr.pdf","2018-07-06 00:00:00",
296,1,12003,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
297,1,12003,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
11980,1,12003,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
298,1,12003,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
299,1,12003,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12003s24ltr.pdf","2002-02-04 00:00:00",
11981,1,12015,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf","2001-05-22 00:00:00",
11982,1,12015,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf","2013-04-24 00:00:00",
33067,2,12015,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf","2013-04-22 00:00:00",
300,1,12015,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf","2013-04-24 00:00:00",
10790,2,12015,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf","2013-04-22 00:00:00",
11983,1,12041,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012041s033ltr.pdf","2006-12-04 00:00:00",
33068,2,12041,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf","2006-11-22 00:00:00",
301,1,12041,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,014901s037ltr.pdf","2010-02-05 00:00:00",
33069,2,12041,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf","2010-02-04 00:00:00",
302,1,12041,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf","2011-06-17 00:00:00",
10791,2,12041,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf","2011-06-16 00:00:00",
40677,3,12041,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/012041Orig1s038.pdf","2012-02-28 00:00:00",
11984,1,12041,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf","2011-07-19 00:00:00",
33070,2,12041,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf","2011-07-18 00:00:00",
11985,1,12041,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901Orig1s042ltr.pdf","2014-07-08 00:00:00",
33071,2,12041,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf","2014-07-09 00:00:00",
53572,2,12041,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s044lbl.pdf","2018-04-01 00:00:00",
53583,1,12041,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s044ltr.pdf","2018-04-01 00:00:00",
54701,1,12041,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s045ltr.pdf","2018-06-27 00:00:00",
54731,2,12041,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf","2018-06-29 00:00:00",
11986,1,12093,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12093s44ltr.pdf","2001-09-26 00:00:00",
11987,1,12093,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012093Orig1s052ltr.pdf","2015-01-16 00:00:00",
33072,2,12093,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf","2015-01-15 00:00:00",
303,1,12097,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12907slr016LTR.pdf","2002-09-03 00:00:00",
33073,2,12097,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf","2002-09-03 00:00:00",
304,1,12104,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012104s032ltr.pdf","2011-08-03 00:00:00",
33074,2,12104,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf","2011-08-01 00:00:00",
305,1,12141,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12141slr087ltr.pdf","2003-03-10 00:00:00",
10792,2,12141,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf","2012-04-02 00:00:00",
11988,1,12141,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012141s089ltr.pdf","2012-04-04 00:00:00",
10793,2,12141,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf","2013-05-09 00:00:00",
11989,1,12141,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142Orig1s112ltr.pdf","2013-05-10 00:00:00",
11990,1,12142,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12142scf107ltr.pdf","2003-11-25 00:00:00",
306,1,12142,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012142s109ltr.pdf","2012-04-04 00:00:00",
33075,2,12142,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf","2012-04-02 00:00:00",
307,1,12142,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142Orig1s112ltr.pdf","2013-05-10 00:00:00",
10794,2,12142,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf","2013-05-09 00:00:00",
10795,2,12151,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf","2009-01-02 00:00:00",
11991,1,12151,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012151s062ltr.pdf","2008-11-26 00:00:00",
11992,1,12151,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012151s067ltr.pdf","2011-09-26 00:00:00",
308,1,12151,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012151Orig1s068ltr.pdf","2012-09-20 00:00:00",
33076,2,12151,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf","2012-09-17 00:00:00",
309,1,12151,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012151Orig1s071ltr.pdf","2013-06-13 00:00:00",
10796,2,12151,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf","2013-06-18 00:00:00",
10797,2,12151,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf","2014-10-24 00:00:00",
52875,2,12151,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf","2018-03-08 00:00:00",
52909,1,12151,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012151Orig1s075ltr.pdf","2018-03-12 00:00:00",
11993,1,12154,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12154slr023ltr.pdf","2004-06-29 00:00:00",
310,1,12157,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012157s028ltr.pdf","2007-04-09 00:00:00",
33077,2,12157,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf","2007-04-06 00:00:00",
20032,3,12209,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/12209-S038_Fluorouracil.pdf","1999-01-20 00:00:00",
311,1,12209,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012209Orig1s040ltr.pdf","2016-08-02 00:00:00",
10798,2,12209,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf","2016-08-02 00:00:00",
11994,1,12223,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12223S36ltr.pdf","2001-05-18 00:00:00",
312,1,12223,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr038ltr.pdf","2003-03-10 00:00:00",
313,1,12223,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr039ltr.pdf","2003-06-08 00:00:00",
33078,2,12223,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf","2015-09-03 00:00:00",
48555,2,12223,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012223s040lbl.pdf","2017-05-30 00:00:00",
48562,1,12223,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012223Orig1s040ltr.pdf","2017-05-30 00:00:00",
52879,2,12223,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s041lbl.pdf","2018-03-08 00:00:00",
52998,1,12223,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012223Orig1s041ltr.pdf","2018-03-15 00:00:00",
46311,2,12249,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf","2016-12-20 00:00:00",
46452,1,12249,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012249Orig1s049ltr.pdf","2016-12-21 00:00:00",
46583,8,12249,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf#page=8","2016-12-29 00:00:00",
10799,2,12250,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf","2005-09-30 00:00:00",
11995,1,12250,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012250s028ltr.pdf","2005-10-20 00:00:00",
314,1,12250,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012250s033ltr.pdf","2010-02-25 00:00:00",
33079,2,12250,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf","2010-02-25 00:00:00",
315,1,12281,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf","2004-03-02 00:00:00",
11996,1,12281,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf","2004-03-02 00:00:00",
316,1,12281,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12281slr050,051,051ltr.pdf","2004-03-02 00:00:00",
317,1,12301,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12301s023ltr.pdf","2002-05-07 00:00:00",
23094,8,12342,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088674.pdf","2009-11-20 00:00:00",
44000,10,12342,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
318,1,12342,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
319,1,12342,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
11997,1,12342,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
320,1,12342,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
11998,1,12342,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
11999,1,12342,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
12000,1,12342,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF","2001-03-15 00:00:00",
321,1,12342,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12342s055ltr.pdf","2005-01-13 00:00:00",
10800,2,12342,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf","2005-01-13 00:00:00",
12001,1,12342,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf","2006-01-30 00:00:00",
322,1,12342,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf","2006-01-30 00:00:00",
12002,1,12342,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf","2007-08-07 00:00:00",
33080,2,12342,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012342s059lbl.pdf","2007-08-03 00:00:00",
10801,2,12342,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf","2009-12-02 00:00:00",
12003,1,12342,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012342s063ltr.pdf","2010-05-21 00:00:00",
33081,2,12342,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012342s063lbl.pdf","2010-05-28 00:00:00",
50974,2,12342,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf","2018-01-05 00:00:00",
50975,1,12342,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012342s064ltr.pdf","2018-01-05 00:00:00",
12004,1,12365,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s035ltr.pdf","2009-04-03 00:00:00",
33082,2,12365,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s035lbl.pdf","2009-04-03 00:00:00",
323,1,12365,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s038ltr.pdf","2010-01-06 00:00:00",
33083,2,12365,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s038lbl.pdf","2009-11-17 00:00:00",
324,1,12365,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf","2013-02-04 00:00:00",
10802,2,12365,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf","2013-02-01 00:00:00",
10803,2,12366,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf","2008-11-07 00:00:00",
12005,1,12366,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012366s031ltr.pdf","2008-10-28 00:00:00",
10804,2,12366,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf","2009-11-16 00:00:00",
12006,1,12366,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012366s032ltr.pdf","2010-01-06 00:00:00",
10805,2,12366,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf","2013-02-01 00:00:00",
12007,1,12366,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf","2013-02-04 00:00:00",
10806,2,12366,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf","2013-05-14 00:00:00",
12008,1,12366,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012366Orig1s034ltr.pdf","2013-05-13 00:00:00",
12009,1,12380,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf","2001-04-09 00:00:00",
325,1,12380,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf","2001-04-09 00:00:00",
12010,1,12380,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf","2001-04-09 00:00:00",
12011,1,12380,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12380s029.pdf","2002-04-19 00:00:00",
326,1,12380,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012380s030ltr.pdf","2006-09-18 00:00:00",
12012,1,12380,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012380s031ltr.pdf","2009-04-29 00:00:00",
33084,2,12380,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012380s031lbl.pdf","2009-04-28 00:00:00",
327,1,12380,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012380s032ltr.pdf","2010-09-20 00:00:00",
10807,2,12380,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf","2010-09-20 00:00:00",
328,1,12380,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012380s033ltr.pdf","2011-06-17 00:00:00",
329,1,12380,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012380s034ltr.pdf","2012-05-09 00:00:00",
10808,2,12380,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf","2012-05-07 00:00:00",
43585,8,12380,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034mg.pdf","2012-05-07 00:00:00",
330,1,12380,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012380Orig1s036ltr.pdf","2016-05-20 00:00:00",
33085,2,12380,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012380s036lbl.pdf","2016-05-20 00:00:00",
12013,1,12418,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
331,1,12418,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
332,1,12418,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
12014,1,12418,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf","2001-07-23 00:00:00",
333,1,12427,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012427s026ltr.pdf","2010-02-17 00:00:00",
10809,2,12427,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf","2010-02-16 00:00:00",
12015,1,12429,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12429s17ltr.pdf","2003-05-08 00:00:00",
334,1,12429,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr019ltr.pdf","2003-07-06 00:00:00",
10810,2,12429,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf","2003-07-08 00:00:00",
10811,2,12429,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf","2003-12-29 00:00:00",
12016,1,12429,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr021ltr.pdf","2003-12-24 00:00:00",
10812,2,12429,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf","2004-11-16 00:00:00",
12017,1,12429,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12429s022ltr.pdf","2004-11-16 00:00:00",
54330,1,12429,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012429Orig1s028ltr.pdf","2018-05-24 00:00:00",
54342,2,12429,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012429s028lbl.pdf","2018-05-25 00:00:00",
335,1,12462,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf","2006-05-02 00:00:00",
49965,2,12462,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012462s045lbl.pdf","2017-10-06 00:00:00",
49979,1,12462,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012462Orig1s045ltr.pdf","2017-10-06 00:00:00",
52627,2,12462,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf","2018-02-14 00:00:00",
52638,1,12462,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012462Orig1s048ltr.pdf","2018-02-14 00:00:00",
12018,1,12541,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012541Orig1s083ltr.pdf","2015-06-12 00:00:00",
33086,2,12541,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012541s083lbl.pdf","2015-06-12 00:00:00",
10813,2,12541,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s084lbl.pdf","2016-06-13 00:00:00",
12019,1,12541,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012541Orig1s084ltr.pdf","2016-06-14 00:00:00",
46235,2,12541,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s085lbl.pdf","2016-12-20 00:00:00",
46453,1,12541,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012541Orig1s085ltr.pdf","2016-12-21 00:00:00",
47853,2,12541,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541s086lbl.pdf","2017-04-04 00:00:00",
47869,1,12541,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012541Orig1s086ltr.pdf","2017-04-05 00:00:00",
47571,2,12541,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541Orig1s088lbl.pdf","2017-03-16 00:00:00",
47599,1,12541,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012541Orig1s088ltr.pdf","2017-03-20 00:00:00",
10814,2,12546,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf","2004-09-07 00:00:00",
12020,1,12546,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11722s029,12546s032ltr.pdf","2004-09-07 00:00:00",
10815,2,12583,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf","2002-06-20 00:00:00",
12021,1,12583,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf","2002-06-20 00:00:00",
336,1,12583,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf","2002-06-20 00:00:00",
33087,2,12583,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf","2002-06-20 00:00:00",
10816,2,12616,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf","2011-05-23 00:00:00",
12022,1,12616,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf","2011-05-24 00:00:00",
12023,1,12616,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf","2011-09-26 00:00:00",
10817,2,12616,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf","2013-06-18 00:00:00",
12024,1,12616,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf","2013-06-13 00:00:00",
12025,1,12616,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf","2014-01-21 00:00:00",
33088,2,12616,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf","2014-01-22 00:00:00",
12026,1,12616,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf","2014-03-07 00:00:00",
33089,2,12616,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf","2014-03-07 00:00:00",
10818,2,12616,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf","2014-10-24 00:00:00",
337,1,12623,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12623slr058ltr.pdf","2003-05-28 00:00:00",
10819,2,12623,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf","2003-05-28 00:00:00",
12027,1,12623,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12623slr059ltr.pdf","2004-03-24 00:00:00",
33090,2,12623,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf","2004-04-05 00:00:00",
12028,1,12623,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf","2010-08-24 00:00:00",
33091,2,12623,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf","2010-08-20 00:00:00",
338,1,12623,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012623Orig1s065ltr.pdf","2013-08-20 00:00:00",
10820,2,12623,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf","2013-08-21 00:00:00",
12029,1,12623,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012623Orig1s066ltr.pdf","2015-07-15 00:00:00",
33092,2,12623,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012623s066lbl.pdf","2015-07-16 00:00:00",
53605,2,12623,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf","2018-04-04 00:00:00",
53623,1,12623,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012623Orig1s067, 020334Orig1s010, 020868Orig1s012ltr.pdf","2018-04-05 00:00:00",
20033,3,12649,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/12649-S046_Periactin.pdf","1999-09-24 00:00:00",
12030,1,12699,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf","2006-05-02 00:00:00",
44001,10,12703,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
339,1,12703,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12704S45LTR.PDF","2001-03-27 00:00:00",
12031,1,12703,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12703slr093,12704slr046ltr.pdf","2003-08-06 00:00:00",
44002,10,12704,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
12032,1,12704,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12704S45LTR.PDF","2001-03-27 00:00:00",
12033,1,12704,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12703slr093,12704slr046ltr.pdf","2003-08-06 00:00:00",
46860,2,12750,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf","2017-01-13 00:00:00",
46900,8,12750,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf#page=8","2017-01-19 00:00:00",
46901,1,12750,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012750Orig1s065ltr.pdf","2017-01-19 00:00:00",
46456,1,12750,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012750Orig1s066ltr.pdf","2016-12-22 00:00:00",
340,1,12770,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/012770s024ltr.pdf","2016-07-18 00:00:00",
10821,2,12770,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf","2016-07-18 00:00:00",
10822,2,12787,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf","2013-04-01 00:00:00",
10823,2,12787,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf","2013-04-09 00:00:00",
341,1,12796,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12796s49ltr.pdf","2002-02-21 00:00:00",
33093,2,12796,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf","2003-05-14 00:00:00",
342,1,12802,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf","2004-05-28 00:00:00",
12034,1,12802,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf","2004-05-27 00:00:00",
12035,1,12802,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf","2010-01-26 00:00:00",
33094,2,12802,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf","2010-01-20 00:00:00",
12036,1,12802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf","2014-07-08 00:00:00",
33095,2,12802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf","2014-07-08 00:00:00",
12037,1,12806,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12806scm028ltr.pdf","2002-07-17 00:00:00",
343,1,12806,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012806Orig1s036ltr.pdf","2013-06-14 00:00:00",
10824,2,12806,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf","2013-07-30 00:00:00",
49019,2,12813,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012813s062lbl.pdf","2017-07-19 00:00:00",
49034,1,12813,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012813Orig1s062ltr.pdf","2017-07-21 00:00:00",
20034,3,12827,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul & Robinul Forte_Tablets.pdf","2009-09-14 00:00:00",
40678,3,12827,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf","2009-09-14 00:00:00",
40679,3,12827,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf","2009-09-14 00:00:00",
20035,3,12827,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s014_Robinul_Forte_Tabs.pdf","2009-09-14 00:00:00",
40680,3,12827,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s015_Robinul - Robinul_Forte_Tabs.pdf","2009-09-14 00:00:00",
20036,3,12827,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s017_Robinul-Robinul_Forte_Tabs.pdf","2009-09-14 00:00:00",
40681,3,12827,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf","2009-09-14 00:00:00",
20037,3,12827,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf","2009-09-14 00:00:00",
40682,3,12827,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf","2009-09-14 00:00:00",
20038,3,12827,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf","2009-09-14 00:00:00",
48242,2,12827,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/012827s034lbl.pdf","2017-05-05 00:00:00",
40683,3,12827,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s035_Robinul Forte Tablets.pdf","2009-09-14 00:00:00",
344,1,12827,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12827scp049ltr.pdf","2003-08-06 00:00:00",
12038,1,12836,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf","2004-08-06 00:00:00",
345,1,12836,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012836s057ltr.pdf","2005-08-03 00:00:00",
33096,2,12836,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf","2005-08-03 00:00:00",
346,1,12885,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12885slr037ltr.pdf","2003-11-25 00:00:00",
10825,2,12892,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf","2012-10-04 00:00:00",
12039,1,12892,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/012892Orig1s015,s016ltr.pdf","2012-10-04 00:00:00",
12040,1,12892,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/012892Orig1s015,s016ltr.pdf","2012-10-04 00:00:00",
33097,2,12892,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf","2012-10-04 00:00:00",
347,1,12911,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12911slr023ltr.pdf","2004-05-07 00:00:00",
10826,2,12911,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf","2010-11-04 00:00:00",
12041,1,12911,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012911s026ltr.pdf","2010-11-08 00:00:00",
348,1,12911,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012911Orig1s033ltr.pdf","2014-03-04 00:00:00",
10827,2,12911,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf","2014-03-04 00:00:00",
12042,1,12940,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12940s44ltr.pdf","2001-09-16 00:00:00",
349,1,12945,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf","2005-03-18 00:00:00",
10828,2,12945,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf","2005-03-18 00:00:00",
20039,3,12945,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s037.pdf","2015-01-28 00:00:00",
12043,1,12945,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf","2005-03-18 00:00:00",
20040,3,12945,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s038.pdf","2015-01-28 00:00:00",
33098,2,12945,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf","2005-03-18 00:00:00",
350,1,13025,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013025s040ltr.pdf","2006-07-21 00:00:00",
33099,2,13025,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf","2006-07-20 00:00:00",
351,1,13026,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf","2004-11-15 00:00:00",
10829,2,13026,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf","2004-11-15 00:00:00",
352,1,13026,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf","2004-11-15 00:00:00",
33100,2,13026,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf","2004-11-15 00:00:00",
353,1,13026,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013026s024LTR.pdf","2006-06-20 00:00:00",
33101,2,13026,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013026s024lbl.pdf","2006-06-20 00:00:00",
45108,2,13026,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013026s029lbl.pdf","2016-08-23 00:00:00",
45156,1,13026,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013026Orig1s029ltr.pdf","2016-08-22 00:00:00",
354,1,13055,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013055s021ltr.pdf","2008-02-14 00:00:00",
10830,2,13055,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf","2008-02-14 00:00:00",
355,1,13217,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217scf036LTR.pdf","2002-08-30 00:00:00",
10831,2,13217,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf","2002-08-30 00:00:00",
40684,3,13217,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/013217_S037_SKELAXIN.pdf","2009-09-14 00:00:00",
40685,3,13217,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S040_SKELAXIN.pdf","2009-09-14 00:00:00",
40686,3,13217,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S041_SKELAXIN.pdf","2009-09-14 00:00:00",
20041,3,13217,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S043_SKELAXIN.pdf","2009-09-14 00:00:00",
356,1,13217,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217s044ltr_2.pdf","2002-06-20 00:00:00",
20042,3,13217,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217s044_SkelexinTOC.cfm","2006-05-10 00:00:00",
20043,3,13217,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S045_SKELAXIN.pdf","2009-09-14 00:00:00",
12044,1,13217,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013217s046ltr.pdf","2006-12-04 00:00:00",
33102,2,13217,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013217s046lbl.pdf","2006-12-04 00:00:00",
12045,1,13217,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013217s053ltr.pdf","2008-11-03 00:00:00",
33103,2,13217,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013217s053lbl.pdf","2012-11-27 00:00:00",
52874,2,13217,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013217s057lbl.pdf","2018-03-08 00:00:00",
52908,1,13217,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/013217Orig1s057ltr.pdf","2018-03-12 00:00:00",
357,1,13263,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf","2004-06-29 00:00:00",
40687,3,13263,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf","2007-07-06 00:00:00",
12046,1,13263,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf","2002-02-07 00:00:00",
40688,3,13263,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf","2007-07-06 00:00:00",
12047,1,13263,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf","2008-05-14 00:00:00",
20044,3,13263,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf","2007-07-06 00:00:00",
12048,1,13263,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf","2001-05-09 00:00:00",
40689,3,13263,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
358,1,13263,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf","2008-05-14 00:00:00",
10832,2,13263,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf","2008-06-05 00:00:00",
359,1,13263,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf","2002-02-12 00:00:00",
40690,3,13263,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf","2007-07-09 00:00:00",
12049,1,13263,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf","2013-10-24 00:00:00",
33104,2,13263,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf","2013-10-25 00:00:00",
46318,2,13263,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf","2016-12-20 00:00:00",
46457,1,13263,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013263Orig1s094ltr.pdf","2016-12-22 00:00:00",
46584,8,13263,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf#page=14","2016-12-29 00:00:00",
360,1,13295,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13295slr060ltr.pdf","2003-06-22 00:00:00",
361,1,13295,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/013295Orig1s066ltr.pdf","2014-07-10 00:00:00",
12050,1,13295,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/013295Orig1s068,016983Orig1s035ltr.pdf","2015-07-10 00:00:00",
33105,2,13295,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf","2015-07-09 00:00:00",
47880,2,13295,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013295s070lbl.pdf","2017-04-06 00:00:00",
47971,1,13295,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf","2017-04-12 00:00:00",
12051,1,13400,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13400s086ltr.pdf","2004-09-21 00:00:00",
33106,2,13400,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf","2004-09-21 00:00:00",
362,1,13402,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13402s085ltr.pdf","2004-12-30 00:00:00",
363,1,13416,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13416spd021ltr.pdf","2002-11-25 00:00:00",
364,1,13422,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13422slr035ltr.pdf","2003-05-29 00:00:00",
33107,2,13422,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pdf","2003-05-28 00:00:00",
50324,2,13422,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013422s045lbl.pdf","2017-11-07 00:00:00",
50357,1,13422,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013422Orig1s045ltr.pdf","2017-11-09 00:00:00",
365,1,13483,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/13483s042ltr.pdf","2005-03-11 00:00:00",
40691,3,13601,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/013601Orig1s029.pdf","2012-06-26 00:00:00",
12052,1,13684,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s091ltr.pdf","2005-06-14 00:00:00",
33108,2,13684,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s091lbl.pdf","2005-06-14 00:00:00",
10833,2,13684,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-09-07 00:00:00",
12053,1,13684,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-09-07 00:00:00",
366,1,13718,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf","2001-11-05 00:00:00",
33109,2,13718,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf","2003-06-10 00:00:00",
10834,2,13718,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf","2003-06-10 00:00:00",
12054,1,13718,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf","2001-11-05 00:00:00",
12055,1,13718,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13718slr022ltr.pdf","2003-05-29 00:00:00",
33110,2,13718,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13718slr022_Oxandrin_lbl.pdf","2003-05-28 00:00:00",
40692,3,13718,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/013718_S022_Oxandrin Tabs_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
367,1,13718,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013718s023ltr.pdf","2005-06-21 00:00:00",
10835,2,13718,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf","2005-06-21 00:00:00",
12056,1,13790,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13790scm018ltr.pdf","2003-11-25 00:00:00",
12057,1,13790,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/013790s021ltr.pdf","2011-07-29 00:00:00",
33111,2,13790,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf","2011-07-28 00:00:00",
368,1,14134,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/014134s022ltr.pdf","2010-09-13 00:00:00",
10836,2,14134,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/014134s022lbl.pdf","2010-09-10 00:00:00",
12058,1,14134,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14134slr024ltr.pdf","2002-09-27 00:00:00",
33112,2,14134,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/14134s24lbl.pdf","2002-09-27 00:00:00",
20045,3,14214,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm","2004-08-10 00:00:00",
40693,3,14214,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm","2004-08-10 00:00:00",
12059,1,14214,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf","2004-09-10 00:00:00",
33113,2,14214,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf","2004-09-10 00:00:00",
369,1,14214,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf","2004-09-10 00:00:00",
10837,2,14214,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf","2004-09-10 00:00:00",
12060,1,14214,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf","2004-09-10 00:00:00",
33114,2,14214,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf","2004-09-10 00:00:00",
370,1,14214,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014214s057ltr.pdf","2007-05-29 00:00:00",
10838,2,14214,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf","2007-05-29 00:00:00",
12061,1,14214,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014214s058ltr.pdf","2009-04-01 00:00:00",
33115,2,14214,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014214s058lbl.pdf","2009-04-03 00:00:00",
12062,1,14214,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014214s059ltr.pdf","2011-05-03 00:00:00",
33116,2,14214,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014214s059lbl.pdf","2011-05-02 00:00:00",
371,1,14214,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014214Orig1s060ltr.pdf","2012-11-29 00:00:00",
33117,2,14214,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014214s060lbl.pdf","2012-12-10 00:00:00",
372,1,14215,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014215s009, s015ltr.pdf","2006-07-21 00:00:00",
10839,2,14215,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf","2006-07-13 00:00:00",
373,1,14215,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014215s009, s015ltr.pdf","2006-07-21 00:00:00",
10840,2,14215,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014215s009s015lbl.pdf","2006-07-13 00:00:00",
44003,10,14399,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
374,1,14399,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf","2005-01-13 00:00:00",
33118,2,14399,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf","2005-01-13 00:00:00",
375,1,14399,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf","2006-04-13 00:00:00",
10841,2,14399,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf","2006-04-12 00:00:00",
12063,1,14399,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf","2007-07-31 00:00:00",
33119,2,14399,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf","2007-07-31 00:00:00",
10842,2,14399,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf","2009-10-30 00:00:00",
12064,1,14399,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf","2009-11-19 00:00:00",
12065,1,14399,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf","2012-11-21 00:00:00",
33120,2,14399,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf","2012-11-26 00:00:00",
376,1,14399,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf","2012-11-21 00:00:00",
23096,8,14399,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf","2012-11-26 00:00:00",
33121,2,14399,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf","2012-11-26 00:00:00",
377,1,14399,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf","2014-07-03 00:00:00",
10843,2,14399,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf","2014-07-03 00:00:00",
12066,1,14602,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014602s019ltr.pdf","2006-07-21 00:00:00",
378,1,14602,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/014602s047ltr.pdf","2008-06-30 00:00:00",
33122,2,14602,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf","2008-06-26 00:00:00",
40694,3,14602,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/014602Orig1s056.pdf","2013-06-04 00:00:00",
379,1,14602,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014602Orig1s058ltredt.pdf","2014-07-08 00:00:00",
33123,2,14602,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602Orig1s058lbledt.pdf","2014-07-08 00:00:00",
10844,2,14602,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf","2015-02-05 00:00:00",
12067,1,14602,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/014602Orig1s059ltr.pdf","2015-02-06 00:00:00",
52562,2,14602,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s061lbl.pdf","2018-02-12 00:00:00",
52632,1,14602,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014602Orig1s061ltr.pdf","2018-02-14 00:00:00",
53651,2,14602,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014602s062lbl.pdf","2018-04-11 00:00:00",
53653,1,14602,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014602Orig1s062ltr.pdf","2018-04-12 00:00:00",
44004,10,14684,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
44005,10,14685,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
10845,2,14685,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf","2005-01-13 00:00:00",
12068,1,14685,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14685s026ltr.pdf","2005-01-13 00:00:00",
10846,2,14685,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf","2007-07-31 00:00:00",
12069,1,14685,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014685s028ltr.pdf","2007-07-31 00:00:00",
380,1,14691,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14691s20ltr.pdf","2001-05-24 00:00:00",
40695,3,14691,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2001/14-691S20_Alkeran.cfm","2003-07-05 00:00:00",
381,1,14691,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf","2002-01-07 00:00:00",
10847,2,14691,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf","2003-05-28 00:00:00",
12070,1,14691,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf","2003-06-08 00:00:00",
382,1,14691,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/014691s028ltr.pdf","2005-06-14 00:00:00",
12071,1,14691,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf","2011-06-14 00:00:00",
33124,2,14691,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf","2011-06-14 00:00:00",
383,1,14691,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s030ltr.pdf","2011-05-04 00:00:00",
10848,2,14691,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf","2011-05-02 00:00:00",
52435,14,14694,"APPL",0,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/014694_SLCOrderLtr.pdf","2018-02-06 00:00:00",
53935,14,14694,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/014694_SLCOrderLtr.pdf","2018-05-01 00:00:00",
384,1,14694,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014694Orig1s030ltr.pdf","2014-07-17 00:00:00",
33125,2,14694,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf","2014-07-17 00:00:00",
44006,10,14713,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
12072,1,14713,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf","2002-05-10 00:00:00",
385,1,14713,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf","2002-05-10 00:00:00",
23531,10,14715,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
386,1,14879,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14879s36ltr.pdf","2001-08-23 00:00:00",
387,1,14879,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014879s037ltr.pdf","2006-04-05 00:00:00",
12073,1,14879,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf","2004-04-20 00:00:00",
33126,2,14879,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf","2004-05-03 00:00:00",
388,1,14879,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14879s044ltr.pdf","2005-03-23 00:00:00",
10849,2,14879,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf","2005-03-23 00:00:00",
40696,3,14879,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/014879_S044_Dopram Injection_APPROVAL_ PACKAGE.pdf","2007-07-09 00:00:00",
40697,3,14901,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S009_Kenalog_40.pdf","2009-01-12 00:00:00",
40698,3,14901,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S010_Kenalog_40.pdf","2009-01-12 00:00:00",
40699,3,14901,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S028_Kenalog.pdf","2009-01-12 00:00:00",
20046,3,14901,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S029_Kenalog_40.pdf","2009-01-12 00:00:00",
389,1,14901,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014901s034ltr.pdf","2006-12-04 00:00:00",
10850,2,14901,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf","2006-11-22 00:00:00",
20047,3,14901,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/014901_S034_Kenalog_40.pdf","2009-01-12 00:00:00",
10851,2,14901,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf","2010-02-04 00:00:00",
12074,1,14901,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,01401s037ltr.pdf","2010-02-05 00:00:00",
390,1,14901,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf","2011-06-17 00:00:00",
33127,2,14901,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf","2011-06-16 00:00:00",
12075,1,14901,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf","2011-07-19 00:00:00",
33128,2,14901,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s039lbl.pdf","2011-07-18 00:00:00",
391,1,14901,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901Orig1s042ltr.pdf","2014-07-08 00:00:00",
10852,2,14901,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf","2014-07-09 00:00:00",
48411,3,14901,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/014901Orig1s043.pdf","2017-05-17 00:00:00",
53573,2,14901,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf","2018-04-01 00:00:00",
53581,1,14901,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014901Orig1s044ltr.pdf","2018-04-01 00:00:00",
54712,2,14901,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf","2018-06-28 00:00:00",
43588,8,15034,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088692.pdf","2009-11-20 00:00:00",
40700,3,15034,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/015034_S032_PONSTEL.pdf","2008-08-11 00:00:00",
20048,3,15034,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/015034_S034_PONSTEL.pdf","2008-08-04 00:00:00",
392,1,15034,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/015034s039ltr.pdf","2006-01-20 00:00:00",
33129,2,15034,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf","2006-01-20 00:00:00",
393,1,15034,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015034s040ltr.pdf","2008-03-17 00:00:00",
33130,2,15034,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf","2008-03-07 00:00:00",
394,1,15034,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015034Orig1s044ltr.pdf","2016-05-11 00:00:00",
10853,2,15034,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf","2016-05-11 00:00:00",
10854,2,15193,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf","2003-05-14 00:00:00",
12076,1,15193,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/15193s020ltr.pdf","2002-05-22 00:00:00",
395,1,15197,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf","2004-06-25 00:00:00",
33131,2,15197,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf","2004-06-25 00:00:00",
396,1,15197,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf","2004-06-25 00:00:00",
33132,2,15197,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf","2004-06-25 00:00:00",
10855,2,15197,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf","2004-06-25 00:00:00",
12077,1,15197,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf","2004-06-25 00:00:00",
397,1,15197,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf","2004-06-25 00:00:00",
33133,2,15197,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf","2004-06-25 00:00:00",
12078,1,15197,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf","2004-08-25 00:00:00",
10856,2,15197,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf","2008-08-26 00:00:00",
12079,1,15197,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf","2008-08-22 00:00:00",
12080,1,15229,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf","2004-08-25 00:00:00",
12955,1,15230,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf","2003-09-09 00:00:00",
398,1,15230,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf","2003-09-09 00:00:00",
12956,1,15230,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf","2003-09-09 00:00:00",
399,1,15230,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf","2004-08-25 00:00:00",
400,1,15230,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf","2008-08-22 00:00:00",
10857,2,15230,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf","2008-08-26 00:00:00",
10858,2,15230,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf","2009-02-04 00:00:00",
12957,1,15230,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf","2009-02-13 00:00:00",
10859,2,15296,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf","2012-11-26 00:00:00",
12958,1,15296,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/015296Orig1s064ltr.pdf","2012-11-21 00:00:00",
401,1,15539,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/15539s52ltr.pdf","2001-08-08 00:00:00",
10860,2,15539,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15539s52lbl.pdf","2001-08-08 00:00:00",
40701,3,15923,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/015923_S072_HALDOL_TABLETS_AP.pdf","2007-07-06 00:00:00",
402,1,15923,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf","2007-05-09 00:00:00",
10861,2,15923,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf","2007-05-07 00:00:00",
403,1,15923,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf","2011-08-15 00:00:00",
10862,2,15923,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf","2011-08-16 00:00:00",
12959,1,15923,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf","2007-09-25 00:00:00",
404,1,15923,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf","2008-05-14 00:00:00",
33134,2,15923,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf","2008-06-05 00:00:00",
10863,2,15923,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf","2008-08-29 00:00:00",
12960,1,15923,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf","2008-08-19 00:00:00",
405,1,15923,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf","2009-08-04 00:00:00",
10864,2,15923,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf","2009-08-14 00:00:00",
406,1,15923,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf","2010-12-06 00:00:00",
33135,2,15923,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/015923s085lbl.pdf","2010-12-04 00:00:00",
407,1,15923,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf","2011-03-07 00:00:00",
10865,2,15923,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf","2011-03-04 00:00:00",
12961,1,15923,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf","2013-05-07 00:00:00",
408,1,15923,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/015923Orig1s091ltr.pdf","2015-05-28 00:00:00",
10866,2,15923,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf","2015-05-29 00:00:00",
50628,1,15923,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/015923s092ltr.pdf","2017-12-07 00:00:00",
50645,2,15923,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s092lbl.pdf","2017-12-08 00:00:00",
409,1,15923,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf","2016-05-20 00:00:00",
10867,2,15923,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf","2016-05-20 00:00:00",
47358,2,15923,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s096,018701s074lbl.pdf","2017-02-27 00:00:00",
47375,1,15923,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/015923Orig1s096,018701Orig1s074ltr.pdf","2017-03-02 00:00:00",
44007,10,16012,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
52752,8,16012,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Vivactil.pdf","2018-02-28 00:00:00",
410,1,16012,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016012Orig1s053ltr.pdf","2014-07-21 00:00:00",
12962,1,16023,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf","2003-11-25 00:00:00",
33136,2,16023,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf","2004-04-27 00:00:00",
40702,3,16023,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm","2006-05-08 00:00:00",
10868,2,16023,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf","2007-03-07 00:00:00",
12963,1,16023,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf","2007-03-07 00:00:00",
12964,1,16023,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf","2008-09-26 00:00:00",
33137,2,16023,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf","2008-10-03 00:00:00",
12965,1,16023,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf","2009-02-03 00:00:00",
33138,2,16023,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf","2009-02-04 00:00:00",
411,1,16033,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16033s11ltr.pdf","2001-08-06 00:00:00",
33139,2,16033,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16033s11lbl.pdf","2001-08-06 00:00:00",
412,1,16042,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016042s074ltr.pdf","2007-05-29 00:00:00",
12966,1,16042,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf","2010-02-26 00:00:00",
33140,2,16042,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf","2010-03-03 00:00:00",
12967,1,16042,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf","2011-03-17 00:00:00",
33141,2,16042,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf","2011-03-21 00:00:00",
413,1,16059,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf","2005-03-29 00:00:00",
33142,2,16059,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf","2006-01-27 00:00:00",
12968,1,16059,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf","2007-02-02 00:00:00",
33143,2,16059,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf","2007-02-02 00:00:00",
10869,2,16059,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf","2016-05-11 00:00:00",
12969,1,16059,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf","2016-05-11 00:00:00",
414,1,16059,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf","2016-05-11 00:00:00",
33144,2,16059,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf","2016-05-11 00:00:00",
415,1,16084,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16084slr041ltr.pdf","2002-07-17 00:00:00",
20049,3,16084,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016084_S041_Zyloprim Tablets.pdf","2007-07-09 00:00:00",
12970,1,16087,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf","2002-02-07 00:00:00",
12971,1,16087,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf","2002-02-07 00:00:00",
40703,3,16092,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/16092s037_Edecrin.pdf","1999-10-19 00:00:00",
12972,1,16092,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16092slr039,16093slr043ltr.pdf","2004-03-02 00:00:00",
416,1,16092,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16092s042,16093s044ltr.pdf","2005-02-11 00:00:00",
10870,2,16092,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf","2005-02-11 00:00:00",
40704,3,16093,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/16092s037_Edecrin.pdf","1999-10-19 00:00:00",
12973,1,16093,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16092slr039,16093slr043ltr.pdf","2004-03-02 00:00:00",
12974,1,16093,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16092s042,16093s044ltr.pdf","2005-02-11 00:00:00",
33145,2,16093,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf","2005-02-11 00:00:00",
417,1,16096,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16096s30ltr.pdf","2001-06-19 00:00:00",
418,1,16096,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16096slr033,16097slr026ltr.pdf","2003-06-22 00:00:00",
10871,2,16096,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf","2003-06-22 00:00:00",
419,1,16097,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16096s30ltr.pdf","2001-06-29 00:00:00",
420,1,16097,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16096slr033,16097slr026ltr.pdf","2003-06-22 00:00:00",
10872,2,16097,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf","2003-06-22 00:00:00",
10873,2,16118,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16118slr023_teslac_lbl.pdf","2003-03-25 00:00:00",
12975,1,16118,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16118slr023ltr.pdf","2004-06-18 00:00:00",
40705,3,16126,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S017_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
40706,3,16126,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S020_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
20050,3,16126,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S023_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
40707,3,16126,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S024_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
10874,2,16126,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf","2003-06-10 00:00:00",
12976,1,16126,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16126s25ltr.pdf","2001-08-30 00:00:00",
40708,3,16126,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/016126_S025_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
40709,3,16126,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016126_S027_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
20051,3,16126,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S028_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
40710,3,16126,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S029_PRIMATENE MIST.pdf","2007-07-06 00:00:00",
421,1,16131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016131s026ltr.pdf","2012-10-24 00:00:00",
33146,2,16131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf","2012-10-22 00:00:00",
40711,3,16131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/016131Orig1s026.pdf","2016-02-02 00:00:00",
50760,2,16131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf","2017-12-19 00:00:00",
50908,1,16131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016131Orig1s028ltr.pdf","2017-12-27 00:00:00",
12977,1,16151,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016151s025ltr.pdf","2008-03-13 00:00:00",
33147,2,16151,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf","2008-03-13 00:00:00",
12978,1,16194,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16194scs068ltr.pdf","2004-06-01 00:00:00",
46209,1,16194,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016194Orig1s079,s080ltr.pdf","2016-12-19 00:00:00",
46409,2,16194,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf","2016-12-21 00:00:00",
46210,1,16194,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016194Orig1s079,s080ltr.pdf","2016-12-19 00:00:00",
46410,2,16194,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf","2016-12-21 00:00:00",
422,1,16199,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016199s035ltr.pdf","2008-02-25 00:00:00",
33148,2,16199,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf","2008-02-25 00:00:00",
423,1,16267,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16267S34ltr.pdf","2001-04-09 00:00:00",
424,1,16267,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16267s39ltr.pdf","2002-02-14 00:00:00",
425,1,16267,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016267s044ltr.pdf","2007-01-25 00:00:00",
33149,2,16267,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf","2007-01-24 00:00:00",
426,1,16267,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016267s045ltr.pdf","2009-01-30 00:00:00",
10875,2,16267,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf","2009-02-04 00:00:00",
12979,1,16267,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016267s047ltr.pdf","2010-09-09 00:00:00",
33150,2,16267,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf","2010-09-10 00:00:00",
10876,2,16267,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf","2011-12-20 00:00:00",
12980,1,16267,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016267s050ltr.pdf","2011-12-21 00:00:00",
427,1,16273,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016273s057ltr.pdf","2006-02-22 00:00:00",
12981,1,16273,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016273s060ltr.pdf","2008-10-23 00:00:00",
12982,1,16273,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016273s061ltr.pdf","2010-10-20 00:00:00",
33151,2,16273,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf","2010-10-18 00:00:00",
428,1,16273,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf","2012-03-28 00:00:00",
33152,2,16273,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf","2012-03-28 00:00:00",
10877,2,16273,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf","2016-03-08 00:00:00",
12983,1,16273,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016273Orig1s068ltr.pdf","2016-03-08 00:00:00",
55158,1,16273,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016273Orig1s069ltr.pdf","2018-08-10 00:00:00",
429,1,16295,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf","2001-04-04 00:00:00",
430,1,16295,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf","2003-07-06 00:00:00",
10878,2,16295,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf","2003-07-08 00:00:00",
40712,3,16295,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm","2004-04-14 00:00:00",
431,1,16295,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf","2004-03-02 00:00:00",
10879,2,16295,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf","2004-04-05 00:00:00",
432,1,16295,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf","2006-09-20 00:00:00",
33153,2,16295,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf","2006-09-20 00:00:00",
12984,1,16295,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf","2010-05-12 00:00:00",
33154,2,16295,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf","2010-05-17 00:00:00",
433,1,16295,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf","2012-01-30 00:00:00",
10880,2,16295,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf","2012-01-31 00:00:00",
434,1,16295,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf","2012-01-30 00:00:00",
33155,2,16295,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf","2012-01-31 00:00:00",
435,1,16295,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf","2015-07-20 00:00:00",
10881,2,16295,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf","2015-07-17 00:00:00",
436,1,16295,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf","2015-07-20 00:00:00",
33156,2,16295,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf","2015-07-17 00:00:00",
437,1,16295,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf","2016-03-25 00:00:00",
33157,2,16295,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf","2016-03-28 00:00:00",
33158,2,16295,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf","2016-03-28 00:00:00",
50772,2,16295,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf","2017-12-19 00:00:00",
50775,8,16295,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15","2017-12-19 00:00:00",
50787,1,16295,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.pdf","2017-12-20 00:00:00",
50773,2,16295,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf","2017-12-19 00:00:00",
50774,8,16295,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15","2017-12-19 00:00:00",
50788,1,16295,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.pdf","2017-12-20 00:00:00",
33159,2,16320,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf","2003-06-10 00:00:00",
10882,2,16320,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf","2003-02-06 00:00:00",
12985,1,16320,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf","2003-02-06 00:00:00",
438,1,16320,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf","2003-02-06 00:00:00",
33160,2,16320,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf","2003-02-06 00:00:00",
12986,1,16320,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16320slr060ltr.pdf","2004-03-28 00:00:00",
33161,2,16320,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf","2004-04-05 00:00:00",
439,1,16320,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf","2008-11-03 00:00:00",
10883,2,16320,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf","2008-11-07 00:00:00",
10884,2,16320,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf","2013-02-26 00:00:00",
440,1,16324,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf","2004-06-07 00:00:00",
12987,1,16324,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf","2005-07-29 00:00:00",
33162,2,16324,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf","2005-07-29 00:00:00",
10885,2,16324,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf","2008-07-10 00:00:00",
12988,1,16324,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf","2008-07-14 00:00:00",
10886,2,16324,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf","2011-05-25 00:00:00",
12989,1,16324,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf","2011-05-26 00:00:00",
441,1,16324,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf","2011-05-26 00:00:00",
33163,2,16324,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf","2011-05-25 00:00:00",
12990,1,16324,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf","2014-02-11 00:00:00",
33164,2,16324,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf","2014-02-07 00:00:00",
50509,1,16324,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016324Orig1s038ltr.pdf","2017-11-27 00:00:00",
49831,2,16366,"SUPPL",214,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf","2017-09-22 00:00:00",
49834,1,16366,"SUPPL",214,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016366Orig1s214ltr.pdf","2017-09-22 00:00:00",
442,1,16367,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016367s178ltr.pdf","2005-09-07 00:00:00",
10887,2,16367,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf","2005-09-07 00:00:00",
10888,2,16367,"SUPPL",182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf","2006-10-27 00:00:00",
12991,1,16367,"SUPPL",182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016367s182ltr.pdf","2006-10-31 00:00:00",
12992,1,16403,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16403slr071ltr.pdf","2002-09-30 00:00:00",
443,1,16418,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16418s073ltr.pdf","2004-08-25 00:00:00",
33165,2,16418,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf","2004-08-25 00:00:00",
444,1,16418,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016418s076ltr.pdf","2007-01-08 00:00:00",
12993,1,16418,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf","2007-03-06 00:00:00",
10889,2,16418,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf","2007-09-07 00:00:00",
12994,1,16418,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s078_ltr.pdf","2007-09-07 00:00:00",
12995,1,16418,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016418s079ltr.pdf","2008-05-09 00:00:00",
10890,2,16418,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf","2011-03-22 00:00:00",
12996,1,16418,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf","2011-03-23 00:00:00",
445,1,16419,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016419s026LTR.pdf","2006-07-27 00:00:00",
10891,2,16419,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf","2015-04-16 00:00:00",
12997,1,16419,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016419s029ltr.pdf","2008-04-09 00:00:00",
446,1,16466,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016466s027ltr.pdf","2006-02-02 00:00:00",
33166,2,16466,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf","2006-02-07 00:00:00",
12998,1,16466,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016466s036ltr.pdf","2007-03-07 00:00:00",
33167,2,16466,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf","2007-03-07 00:00:00",
447,1,16466,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf","2009-06-08 00:00:00",
10892,2,16466,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf","2009-06-04 00:00:00",
12999,1,16466,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf","2009-06-08 00:00:00",
33168,2,16466,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf","2009-06-04 00:00:00",
448,1,16466,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf","2014-07-08 00:00:00",
33169,2,16466,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf","2014-07-08 00:00:00",
449,1,16515,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016515s010ltr.pdf","2012-02-07 00:00:00",
33170,2,16515,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf","2012-02-06 00:00:00",
450,1,16515,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016515Orig1s012ltr.pdf","2014-03-21 00:00:00",
33171,2,16515,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf","2014-03-25 00:00:00",
451,1,16515,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016515Orig1s013ltr.pdf","2015-10-21 00:00:00",
33172,2,16515,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf","2015-10-22 00:00:00",
52501,2,16515,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016515s016lbl.pdf","2018-02-07 00:00:00",
52512,1,16515,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016515Orig1s016ltr.pdf","2018-02-08 00:00:00",
452,1,16517,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016517s009ltr.pdf","2012-02-07 00:00:00",
33173,2,16517,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016517s009lbl.pdf","2012-02-06 00:00:00",
453,1,16517,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016517Orig1s011ltr.pdf","2014-03-21 00:00:00",
10893,2,16517,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf","2014-03-25 00:00:00",
10894,2,16517,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf","2015-10-22 00:00:00",
13000,1,16517,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016517Orig1s013ltr.pdf","2015-10-21 00:00:00",
52497,2,16517,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016517s016lbl.pdf","2018-02-07 00:00:00",
52513,1,16517,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016517Orig1s016ltr.pdf","2018-02-08 00:00:00",
454,1,16584,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf","2001-07-31 00:00:00",
10895,2,16584,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf","2003-06-16 00:00:00",
455,1,16584,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf","2001-07-31 00:00:00",
10896,2,16584,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf","2004-06-09 00:00:00",
13001,1,16584,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf","2008-04-10 00:00:00",
33174,2,16584,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf","2008-04-16 00:00:00",
10897,2,16584,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf","2008-08-26 00:00:00",
13002,1,16584,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s058ltr.pdf","2008-08-19 00:00:00",
456,1,16584,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf","2009-07-23 00:00:00",
33175,2,16584,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf","2009-07-23 00:00:00",
13003,1,16584,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016584s060ltr.pdf","2010-12-06 00:00:00",
33176,2,16584,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016584s060lbl.pdf","2010-12-04 00:00:00",
20052,3,16608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016608_Tegretol.cfm","2004-12-08 00:00:00",
457,1,16608,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF","2001-03-07 00:00:00",
20053,3,16608,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/016608_S090_TEGRETOL_AP.pdf","2007-03-08 00:00:00",
33177,2,16608,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF","2001-03-07 00:00:00",
458,1,16608,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf","2007-08-17 00:00:00",
33178,2,16608,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf","2007-08-17 00:00:00",
10898,2,16608,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf","2015-09-03 00:00:00",
13004,1,16608,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf","2015-09-01 00:00:00",
10899,2,16608,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf","2007-12-12 00:00:00",
13005,1,16608,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf","2008-01-09 00:00:00",
44438,14,16608,"SUPPL",98,"Clinical Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710_ClinRev.pdf","2007-12-31 00:00:00",
459,1,16608,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf","2014-09-17 00:00:00",
10900,2,16608,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf","2014-09-19 00:00:00",
460,1,16608,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
33179,2,16608,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
461,1,16608,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016608s101,018927s043ltr.pdf","2009-05-01 00:00:00",
33180,2,16608,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf","2009-05-12 00:00:00",
462,1,16608,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
10901,2,16608,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
10902,2,16608,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf","2014-01-17 00:00:00",
13006,1,16608,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf","2014-01-17 00:00:00",
13007,1,16608,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf","2013-03-08 00:00:00",
33181,2,16608,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf","2013-03-08 00:00:00",
463,1,16608,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf","2011-11-10 00:00:00",
464,1,16608,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf","2012-12-13 00:00:00",
33182,2,16608,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf","2012-12-13 00:00:00",
53150,1,16608,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf","2018-03-22 00:00:00",
53418,2,16608,"SUPPL",116,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf","2018-03-26 00:00:00",
53450,8,16608,"SUPPL",116,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19","2018-03-27 00:00:00",
465,1,16619,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16619slr032ltr.pdf","2003-10-22 00:00:00",
13008,1,16619,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016619Orig1s034ltr.pdf","2013-07-08 00:00:00",
33183,2,16619,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf","2013-07-05 00:00:00",
46211,1,16619,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016619Orig1s038ltr.pdf","2016-12-19 00:00:00",
46408,2,16619,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf","2016-12-21 00:00:00",
20054,3,16620,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S016_Macrodantin Capsules.pdf","2007-07-09 00:00:00",
20055,3,16620,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S017_Macrodantin Capsules.pdf","2007-07-09 00:00:00",
40713,3,16620,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S018_Macodantin.pdf","2007-07-09 00:00:00",
40714,3,16620,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S019_Macrodantin Capsules.pdf","2007-07-09 00:00:00",
20056,3,16620,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S020_Macrodantin Capsules.pdf","2007-07-09 00:00:00",
40715,3,16620,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm","2006-05-10 00:00:00",
20057,3,16620,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16620_S047_MacrodantinTOC.cfm","2007-02-20 00:00:00",
20058,3,16620,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S053_MACRODANTIN.pdf","2008-02-19 00:00:00",
40716,3,16620,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S054_MACRODANTIN.pdf","2008-02-19 00:00:00",
40717,3,16620,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S055_MACRODANTIN.pdf","2008-02-19 00:00:00",
40718,3,16620,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S057_MACRODANTIN.pdf","2008-02-19 00:00:00",
20059,3,16620,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S059_MACRODANTIN.pdf","2008-02-19 00:00:00",
20060,3,16620,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016620_S062_MACRODANTIN.pdf","2008-08-11 00:00:00",
40719,3,16620,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016620_S063_MACRODANTIN.pdf","2008-08-11 00:00:00",
13009,1,16620,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16620slr064ltr.pdf","2003-02-04 00:00:00",
40720,3,16620,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016620_S064_MACRODANTIN.pdf","2008-08-01 00:00:00",
466,1,16620,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16620slr065ltr.pdf","2004-04-07 00:00:00",
20061,3,16620,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016620_S065_MACRODANTIN.pdf","2008-07-31 00:00:00",
33184,2,16620,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf","2004-04-05 00:00:00",
13010,1,16620,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016620s067ltr.pdf","2007-09-25 00:00:00",
33185,2,16620,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf","2007-09-19 00:00:00",
467,1,16620,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016620s068ltr.pdf","2009-03-06 00:00:00",
33186,2,16620,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf","2009-03-17 00:00:00",
13011,1,16620,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf","2011-06-09 00:00:00",
10903,2,16620,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf","2013-09-09 00:00:00",
13012,1,16620,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016620Orig1s072ltr.pdf","2013-09-10 00:00:00",
468,1,16624,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16624scm041ltr.pdf","2002-08-23 00:00:00",
10904,2,16624,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf","2002-08-23 00:00:00",
20062,3,16635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016635Orig1s000.pdf","2015-03-09 00:00:00",
469,1,16636,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf","2002-02-11 00:00:00",
33187,2,16636,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf","2015-03-02 00:00:00",
470,1,16636,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16636s52s54ltr.pdf","2002-02-11 00:00:00",
33188,2,16636,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/016636s052s054lbl.pdf","2015-03-02 00:00:00",
471,1,16672,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16672S46LTR.PDF","2001-03-23 00:00:00",
40721,3,16672,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-672S046_16806s028.pdf","2005-01-05 00:00:00",
40722,3,16672,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/16672-s047_ovral_ovral-28.pdf","1997-08-14 00:00:00",
472,1,16673,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf","2014-12-24 00:00:00",
10905,2,16673,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf","2015-01-09 00:00:00",
52964,2,16673,"SUPPL",149,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016673s149lbl.pdf","2018-03-14 00:00:00",
13013,1,16677,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
13014,1,16677,"SUPPL",131,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16677scs131ltr.pdf","2003-07-28 00:00:00",
13015,1,16677,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016677s137ltr.pdf","2005-05-25 00:00:00",
33189,2,16677,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016677s137lbl.pdf","2005-05-25 00:00:00",
473,1,16677,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-09-07 00:00:00",
10906,2,16677,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-09-07 00:00:00",
474,1,16677,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf","2013-09-13 00:00:00",
10907,2,16677,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf","2013-09-17 00:00:00",
475,1,16677,"SUPPL",148,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf","2014-12-30 00:00:00",
10908,2,16677,"SUPPL",148,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf","2015-01-08 00:00:00",
10909,2,16677,"SUPPL",150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf","2015-06-03 00:00:00",
53075,2,16677,"SUPPL",151,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016677s151lbl.pdf","2018-03-21 00:00:00",
53074,2,16677,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016677s160lbl.pdf","2018-03-21 00:00:00",
476,1,16678,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16678slr098,16687slr095,16696slr092ltr.pdf","2004-06-07 00:00:00",
477,1,16678,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
10910,2,16678,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
13016,1,16679,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16679slr096ltr.pdf","2004-05-27 00:00:00",
478,1,16679,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf","2011-10-24 00:00:00",
10911,2,16679,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf","2011-11-04 00:00:00",
50636,1,16679,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016679s108ltr.pdf","2017-12-07 00:00:00",
50639,2,16679,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016679s108lbl.pdf","2017-12-07 00:00:00",
479,1,16682,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf","2002-08-01 00:00:00",
13017,1,16682,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
13018,1,16682,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16682slr096ltr.pdf","2003-07-06 00:00:00",
13019,1,16682,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf","2011-10-24 00:00:00",
33190,2,16682,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf","2011-11-04 00:00:00",
480,1,16683,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
33191,2,16683,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
481,1,16687,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16678slr098,16687slr095,16696slr092ltr.pdf","2004-06-07 00:00:00",
482,1,16687,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
10912,2,16687,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
483,1,16689,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
10913,2,16689,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
484,1,16692,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf","2011-10-24 00:00:00",
33192,2,16692,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf","2011-11-04 00:00:00",
485,1,16693,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
13020,1,16693,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf","2013-09-13 00:00:00",
33193,2,16693,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf","2013-09-17 00:00:00",
10914,2,16693,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016693s098lbl.pdf","2016-05-05 00:00:00",
13021,1,16693,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016693Orig1s098ltr.pdf","2016-04-28 00:00:00",
13022,1,16694,"SUPPL",119,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf","2014-12-24 00:00:00",
33194,2,16694,"SUPPL",119,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf","2015-01-09 00:00:00",
13023,1,16696,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16678slr098,16687slr095,16696slr092ltr.pdf","2004-06-07 00:00:00",
486,1,16696,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
10915,2,16696,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
10916,2,16697,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf","2013-09-11 00:00:00",
13024,1,16697,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf","2013-09-12 00:00:00",
43590,8,16721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf","2009-11-18 00:00:00",
44008,10,16721,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
487,1,16721,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16721s74ltr.pdf","2001-06-14 00:00:00",
488,1,16721,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016721s076,s058ltr.pdf","2007-11-08 00:00:00",
33195,2,16721,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf","2007-11-07 00:00:00",
10917,2,16721,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf","2009-04-03 00:00:00",
13025,1,16721,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016721s077ltr.pdf","2009-04-01 00:00:00",
489,1,16733,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016733s049ltrs.pdf","2006-10-23 00:00:00",
13026,1,16741,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16741slr035ltr.pdf","2003-05-29 00:00:00",
490,1,16750,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16750slr018ltr.pdf","2002-11-08 00:00:00",
13027,1,16758,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf","2001-07-31 00:00:00",
13028,1,16758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf","2001-07-31 00:00:00",
10918,2,16758,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf","2004-06-09 00:00:00",
491,1,16758,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf","2008-04-17 00:00:00",
10919,2,16758,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf","2008-04-16 00:00:00",
492,1,16758,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf","2009-07-24 00:00:00",
10920,2,16758,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf","2009-07-27 00:00:00",
10921,2,16762,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf","2011-03-29 00:00:00",
13029,1,16762,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf","2011-04-01 00:00:00",
493,1,16774,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF","2001-03-15 00:00:00",
40723,3,16774,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf","2003-02-05 00:00:00",
494,1,16775,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF","2001-03-15 00:00:00",
40724,3,16775,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf","2003-02-05 00:00:00",
33196,2,16784,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016784s035lbl.pdf","2014-09-19 00:00:00",
13030,1,16785,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16785slr035ltr.pdf","2003-01-29 00:00:00",
44009,10,16792,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
20063,3,16792,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf","2002-05-02 00:00:00",
20064,3,16792,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf","2002-05-02 00:00:00",
40725,3,16792,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf","2002-05-02 00:00:00",
40726,3,16792,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S020.pdf","2002-05-02 00:00:00",
495,1,16792,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16792s024ltr.pdf","2005-01-13 00:00:00",
10922,2,16792,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf","2005-01-13 00:00:00",
10923,2,16792,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf","2007-08-02 00:00:00",
13031,1,16792,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016792s025ltr.pdf","2007-08-07 00:00:00",
10924,2,16792,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf","2012-12-03 00:00:00",
13032,1,16792,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016792Orig1s034ltr.pdf","2012-12-05 00:00:00",
10925,2,16792,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf","2014-07-29 00:00:00",
13033,1,16792,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016792Orig1s037ltr.pdf","2014-07-21 00:00:00",
55392,8,16792,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf#page=12","2018-09-06 00:00:00",
50097,2,16793,"SUPPL",59,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf","2017-10-19 00:00:00",
50186,1,16793,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/016793s059ltr.pdf","2017-10-26 00:00:00",
496,1,16796,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16796s39ltr.pdf","2003-06-16 00:00:00",
23532,10,16798,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
43591,8,16798,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf","2009-11-20 00:00:00",
497,1,16798,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17516slr020,16798slr050ltr.pdf","2003-10-09 00:00:00",
13034,1,16798,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16798s053,17516s022ltr.pdf","2005-02-23 00:00:00",
498,1,16798,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
33197,2,16798,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf","2007-08-03 00:00:00",
13035,1,16798,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516Orig1s025ltr.pdf","2014-07-15 00:00:00",
33198,2,16798,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf","2014-07-15 00:00:00",
13036,1,16806,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16672S46LTR.PDF","2001-03-23 00:00:00",
40727,3,16806,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-672S046_16806s028.pdf","2005-01-05 00:00:00",
20065,3,16806,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/16672-s047_ovral_ovral-28.pdf","1997-08-14 00:00:00",
13037,1,16807,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16807slr025ltr.pdf","2002-10-01 00:00:00",
499,1,16812,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16812slr032ltr.pdf","2003-07-31 00:00:00",
500,1,16812,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016812s039ltr.pdf","2012-03-13 00:00:00",
33199,2,16812,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf","2012-03-09 00:00:00",
55139,2,16812,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf","2018-08-09 00:00:00",
48189,1,16812,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016812Orig1s043ltr.pdf","2017-05-02 00:00:00",
48217,2,16812,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf","2017-05-02 00:00:00",
13038,1,16822,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16822scs065ltr.pdf","2004-06-01 00:00:00",
33200,2,16822,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf","2004-06-01 00:00:00",
40728,3,16831,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s008_efudex.pdf","2011-06-23 00:00:00",
20066,3,16831,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s011_efudex.pdf","2011-06-23 00:00:00",
40729,3,16831,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s028_efudex.pdf","2011-06-23 00:00:00",
20067,3,16831,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s030_efudex.pdf","2011-06-23 00:00:00",
40730,3,16831,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s031_efudex.pdf","2011-06-23 00:00:00",
40731,3,16831,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16831_s035_efudex.pdf","2011-06-23 00:00:00",
13039,1,16831,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831scm046ltr.pdf","2004-04-29 00:00:00",
501,1,16831,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831slr047ltr.pdf","2004-06-25 00:00:00",
33201,2,16831,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf","2004-06-25 00:00:00",
502,1,16831,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016831s049ltr.pdf","2005-10-19 00:00:00",
10926,2,16831,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf","2005-10-19 00:00:00",
503,1,16831,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016831s051ltr.pdf","2006-05-16 00:00:00",
23533,10,16832,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm","2011-12-20 00:00:00",
40732,3,16832,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s013.pdf","1997-12-12 00:00:00",
40733,3,16832,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s014.pdf","2003-06-17 00:00:00",
40734,3,16832,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016832a_s015.pdf","1997-12-12 00:00:00",
40735,3,16832,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016832a_s016.pdf","1998-05-08 00:00:00",
13040,1,16832,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr018ltr.pdf","2003-11-25 00:00:00",
33202,2,16832,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf","2005-10-19 00:00:00",
13041,1,16848,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16848slr020ltr.pdf","2003-11-25 00:00:00",
13042,1,16848,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16848s021ltr.pdf","2004-08-31 00:00:00",
33203,2,16848,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.pdf","2004-08-31 00:00:00",
10927,2,16851,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf","2003-06-16 00:00:00",
13043,1,16851,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16851s51ltr.pdf","2001-06-28 00:00:00",
504,1,16851,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016851Orig1s063ltr.pdf","2013-02-13 00:00:00",
10928,2,16851,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf","2013-02-14 00:00:00",
505,1,16860,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
13044,1,16860,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
506,1,16860,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
13045,1,16860,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
507,1,16860,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
508,1,16860,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
509,1,16860,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860slr073,17971slr019,18152slr017ltr.pdf","2004-06-03 00:00:00",
510,1,16860,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf","2004-03-16 00:00:00",
33204,2,16860,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf","2004-04-05 00:00:00",
40736,3,16862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016862_DARVON_N_ORIGINAL_AP.pdf","2007-04-09 00:00:00",
511,1,16862,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf","2004-06-02 00:00:00",
512,1,16862,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-11-13 00:00:00",
33205,2,16862,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf","2009-10-01 00:00:00",
43592,8,16862,"SUPPL",41,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf","2009-10-01 00:00:00",
10929,2,16862,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf","2009-10-01 00:00:00",
13046,1,16862,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-10-26 00:00:00",
13047,1,16885,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16885slr022ltr.pdf","2003-07-28 00:00:00",
20068,3,16885,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016885_S022_Lysodren.pdf","2009-01-12 00:00:00",
10930,2,16885,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf","2009-02-12 00:00:00",
13048,1,16885,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016885s023ltr.pdf","2009-02-13 00:00:00",
513,1,16885,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016885Orig1s025ltr.pdf","2013-11-18 00:00:00",
10931,2,16885,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf","2013-11-22 00:00:00",
10932,2,16885,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf","2016-03-15 00:00:00",
13049,1,16885,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016885Orig1s026ltr.pdf","2016-03-15 00:00:00",
48335,2,16885,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf","2017-05-10 00:00:00",
48357,1,16885,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016885Orig1s027ltr.pdf","2017-05-12 00:00:00",
514,1,16904,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf","2008-04-17 00:00:00",
10933,2,16904,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf","2008-04-16 00:00:00",
10934,2,16904,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf","2009-07-27 00:00:00",
13050,1,16904,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf","2009-07-24 00:00:00",
515,1,16908,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf","2006-01-19 00:00:00",
13051,1,16909,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf","2006-01-19 00:00:00",
33206,2,16909,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf","2016-06-13 00:00:00",
516,1,16921,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33207,2,16921,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
10935,2,16921,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13052,1,16921,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
10936,2,16921,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13053,1,16921,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
10937,2,16931,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf","2003-08-15 00:00:00",
13054,1,16931,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16931slr028ltr.pdf","2003-08-15 00:00:00",
517,1,16931,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016931s031ltr.pdf","2010-01-26 00:00:00",
10938,2,16931,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf","2010-01-24 00:00:00",
23534,10,16949,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
13055,1,16949,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16949s33ltr.pdf","2001-06-05 00:00:00",
13056,1,16949,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16949s035ltr.pdf","2005-01-13 00:00:00",
33208,2,16949,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf","2005-01-13 00:00:00",
13057,1,16949,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016949s038ltr.pdf","2007-08-07 00:00:00",
33209,2,16949,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf","2007-08-06 00:00:00",
10939,2,16949,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf","2016-04-27 00:00:00",
13058,1,16949,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s039ltr.pdf","2016-04-27 00:00:00",
46260,2,16949,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf","2016-12-20 00:00:00",
46458,1,16949,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s040ltr.pdf","2016-12-22 00:00:00",
46625,8,16949,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf#page=12","2016-12-30 00:00:00",
13059,1,16954,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16954slr092ltr.pdf","2003-10-09 00:00:00",
10940,2,16954,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf","2008-06-26 00:00:00",
13060,1,16954,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016954s101ltr.pdf","2008-06-24 00:00:00",
13061,1,16954,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016954Orig1s106ltr.pdf","2014-06-19 00:00:00",
33210,2,16954,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf","2014-07-02 00:00:00",
10941,2,16964,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016964s061lbl.pdf","2005-11-01 00:00:00",
13062,1,16964,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016964s061ltr.pdf","2005-11-01 00:00:00",
518,1,16964,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016964s069ltr.pdf","2010-02-25 00:00:00",
10942,2,16964,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016964s069lbl.pdf","2010-02-25 00:00:00",
519,1,16964,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf","2012-02-01 00:00:00",
10943,2,16964,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016964s070lbl.pdf","2012-01-30 00:00:00",
520,1,16968,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16968slr020ltr.pdf","2002-11-25 00:00:00",
10944,2,16968,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf","2002-11-25 00:00:00",
521,1,16968,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16968s022ltr.pdf","2004-11-16 00:00:00",
33211,2,16968,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf","2004-11-16 00:00:00",
10945,2,16968,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf","2016-01-26 00:00:00",
13063,1,16968,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016968Orig1s029ltr.pdf","2016-01-22 00:00:00",
522,1,16979,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16979slr051ltr.pdf","2002-08-27 00:00:00",
13064,1,16979,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16979slr052ltr.pdf","2002-01-06 00:00:00",
523,1,16983,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/013295Orig1s068,016983Orig1s035ltr.pdf","2015-07-10 00:00:00",
33212,2,16983,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf","2015-07-09 00:00:00",
47879,2,16983,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016983s037lbl.pdf","2017-04-06 00:00:00",
47970,1,16983,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf","2017-04-12 00:00:00",
10946,2,16988,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf","2016-07-27 00:00:00",
13065,1,16988,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016988Orig1s030ltr.pdf","2016-07-26 00:00:00",
13066,1,16997,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF","2001-03-15 00:00:00",
20069,3,16997,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf","2003-02-05 00:00:00",
524,1,17001,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf","2003-05-29 00:00:00",
33213,2,17001,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf","2003-05-06 00:00:00",
13067,1,17001,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf","2003-05-29 00:00:00",
33214,2,17001,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf","2003-05-06 00:00:00",
10947,2,17001,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf","2006-08-11 00:00:00",
13068,1,17001,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017001s027LTR.pdf","2006-08-11 00:00:00",
525,1,17001,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017001s028ltr.pdf","2009-05-07 00:00:00",
49521,2,17001,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017001s028lbl.pdf","2017-08-23 00:00:00",
50365,1,17001,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017001Orig1s032ltr.pdf","2017-11-13 00:00:00",
50484,2,17001,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017001s032lbl.pdf","2017-11-25 00:00:00",
52112,1,17007,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/017007Orig2s038Ltr.pdf","2018-01-30 00:00:00",
52116,2,17007,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017007Orig2s038Lbl.pdf","2018-01-30 00:00:00",
53652,2,17007,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017007s039lbl.pdf","2018-04-11 00:00:00",
53664,1,17007,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017007Orig1s039ltredt.pdf","2018-04-12 00:00:00",
54289,3,17010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017010Orig1s000Approv.pdf","2018-05-22 00:00:00",
48267,2,17011,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf","2017-05-08 00:00:00",
48301,1,17011,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017011Orig1s047ltr.pdf","2017-05-09 00:00:00",
54492,2,17011,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017011s050lbl.pdf","2018-06-11 00:00:00",
54557,1,17011,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017011Orig1s050ltr.pdf","2018-06-14 00:00:00",
526,1,17015,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017015s023ltr.pdf","2010-11-30 00:00:00",
10948,2,17015,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf","2010-12-01 00:00:00",
527,1,17016,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017016s156ltr.pdf","2011-04-19 00:00:00",
33215,2,17016,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017016s156lbl.pdf","2011-04-18 00:00:00",
528,1,17029,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17029s099ltr.pdf","2002-03-22 00:00:00",
529,1,17029,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017029s108ltr.pdf","2008-09-26 00:00:00",
33216,2,17029,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf","2008-10-03 00:00:00",
530,1,17029,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf","2010-06-14 00:00:00",
10949,2,17029,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf","2010-06-24 00:00:00",
13069,1,17029,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf","2011-07-05 00:00:00",
13070,1,17029,"SUPPL",131,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf","2011-12-29 00:00:00",
33217,2,17029,"SUPPL",131,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf","2011-12-23 00:00:00",
13071,1,17029,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf","2014-04-07 00:00:00",
49550,1,17029,"SUPPL",140,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017029Orig1s140ltr.pdf","2017-08-28 00:00:00",
49553,2,17029,"SUPPL",140,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017029s140lbl.pdf","2017-08-28 00:00:00",
531,1,17031,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17031s034ltr.pdf","2004-07-21 00:00:00",
49435,2,17031,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf","2017-08-16 00:00:00",
49565,1,17031,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017031Orig1s035,s036ltr.pdf","2017-08-29 00:00:00",
49436,2,17031,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf","2017-08-16 00:00:00",
49564,1,17031,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017031Orig1s035,s036ltr.pdf","2017-08-29 00:00:00",
10950,2,17037,"SUPPL",154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf","2005-09-07 00:00:00",
13072,1,17037,"SUPPL",154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf","2005-09-07 00:00:00",
13073,1,17037,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf","2005-09-07 00:00:00",
33218,2,17037,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf","2005-09-07 00:00:00",
532,1,17037,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf","2005-09-07 00:00:00",
33219,2,17037,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf","2005-09-07 00:00:00",
10951,2,17037,"SUPPL",158,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf","2006-10-05 00:00:00",
13074,1,17037,"SUPPL",158,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017037s158LTR.pdf","2006-10-13 00:00:00",
533,1,17037,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017037s161ltr.pdf","2008-01-09 00:00:00",
33220,2,17037,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf","2007-12-21 00:00:00",
534,1,17037,"SUPPL",162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s162ltr.pdf","2009-02-19 00:00:00",
10952,2,17037,"SUPPL",165,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf","2009-10-16 00:00:00",
13075,1,17037,"SUPPL",165,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s165ltr.pdf","2009-11-09 00:00:00",
10953,2,17037,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf","2011-03-04 00:00:00",
13076,1,17037,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s168ltr.pdf","2011-02-28 00:00:00",
10954,2,17037,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf","2012-01-26 00:00:00",
13077,1,17037,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s169ltr.pdf","2011-12-29 00:00:00",
48334,2,17037,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017037s178lbl.pdf","2017-05-10 00:00:00",
48358,1,17037,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017037Orig1s178ltr.pdf","2017-05-12 00:00:00",
535,1,17057,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17057slr027ltr.pdf","2002-09-13 00:00:00",
10955,2,17058,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf","2006-12-14 00:00:00",
13078,1,17058,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017058s017ltr.pdf","2006-12-28 00:00:00",
536,1,17058,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017058s019ltr.pdf","2008-02-07 00:00:00",
33221,2,17058,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017058s019lbl.pdf","2008-02-14 00:00:00",
537,1,17058,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017058Orig1s021ltr.pdf","2013-09-20 00:00:00",
10956,2,17058,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf","2013-09-24 00:00:00",
46207,1,17058,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017058Orig1s022,s023ltr.pdf","2016-12-19 00:00:00",
46406,2,17058,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf","2016-12-21 00:00:00",
46208,1,17058,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017058Orig1s022,s023ltr.pdf","2016-12-19 00:00:00",
46407,2,17058,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf","2016-12-21 00:00:00",
52236,2,17058,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017058s025lbl.pdf","2018-02-01 00:00:00",
52285,1,17058,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017058Orig1s025ltr.pdf","2018-02-02 00:00:00",
538,1,17060,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017060s067ltr.pdf","2005-10-25 00:00:00",
13079,1,17067,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017067s057ltr.pdf","2011-04-19 00:00:00",
33222,2,17067,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017067s057lbl.pdf","2011-04-18 00:00:00",
44010,10,17078,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
539,1,17078,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017078s040LTR.pdf","2006-08-14 00:00:00",
10957,2,17078,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf","2006-08-11 00:00:00",
540,1,17078,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017078s042ltr.pdf","2007-05-07 00:00:00",
33223,2,17078,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf","2007-05-07 00:00:00",
13080,1,17078,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017078s044ltr.pdf","2008-05-28 00:00:00",
33224,2,17078,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf","2008-06-12 00:00:00",
541,1,17078,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s046ltr.pdf","2013-06-13 00:00:00",
10958,2,17078,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf","2013-06-18 00:00:00",
542,1,17078,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s047ltr.pdf","2013-12-10 00:00:00",
10959,2,17078,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf","2013-12-12 00:00:00",
10960,2,17078,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf","2015-04-20 00:00:00",
13081,1,17078,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017078Orig1s048ltr.pdf","2015-04-20 00:00:00",
46716,2,17078,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf","2017-01-06 00:00:00",
46774,8,17078,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf#page=9","2017-01-10 00:00:00",
46775,1,17078,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s049ltr.pdf","2017-01-10 00:00:00",
48481,2,17078,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf","2017-05-22 00:00:00",
48506,1,17078,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s050ltr.pdf","2017-05-24 00:00:00",
543,1,17084,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017084s016ltr.pdf","2008-09-03 00:00:00",
33225,2,17084,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017084s016lbl.pdf","2008-08-29 00:00:00",
10961,2,17084,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf","2009-05-25 00:00:00",
13082,1,17084,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017084s017ltr.pdf","2009-05-29 00:00:00",
13083,1,17087,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17087slr045ltr.pdf","2002-10-08 00:00:00",
544,1,17087,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017087s047ltr.pdf","2006-09-25 00:00:00",
10962,2,17087,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf","2006-09-21 00:00:00",
10963,2,17087,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf","2010-01-24 00:00:00",
13084,1,17087,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017087s048ltr.pdf","2010-01-28 00:00:00",
23102,8,17090,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf","2012-10-29 00:00:00",
23535,10,17090,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
545,1,17090,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17090slr069ltr.pdf","2004-03-28 00:00:00",
13085,1,17090,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17090s070ltr.pdf","2005-01-13 00:00:00",
33226,2,17090,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf","2005-01-13 00:00:00",
546,1,17090,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf","2007-07-24 00:00:00",
10964,2,17090,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf","2007-07-16 00:00:00",
547,1,17090,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf","2012-10-29 00:00:00",
10965,2,17090,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf","2012-10-26 00:00:00",
10966,2,17090,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf","2014-07-11 00:00:00",
13086,1,17090,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf","2014-07-11 00:00:00",
548,1,17090,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf","2014-07-29 00:00:00",
10967,2,17090,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf","2014-07-29 00:00:00",
48268,2,17100,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017100s044lbl.pdf","2017-05-08 00:00:00",
48298,1,17100,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017100Orig1s044ltr.pdf","2017-05-09 00:00:00",
54490,2,17100,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017100s045lbl.pdf","2018-06-11 00:00:00",
54548,1,17100,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017100Orig1s045ltr_Redacted.pdf","2018-06-14 00:00:00",
549,1,17105,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf","2002-02-07 00:00:00",
40737,3,17105,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf","2007-07-09 00:00:00",
13087,1,17105,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf","2002-02-07 00:00:00",
20070,3,17105,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf","2007-07-09 00:00:00",
550,1,17105,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17105slr070ltr.pdf","2003-03-26 00:00:00",
40738,3,17105,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017105_S070_Tranxene_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
551,1,17105,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017105s075ltr.pdf","2009-04-29 00:00:00",
10968,2,17105,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf","2009-04-28 00:00:00",
552,1,17105,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017105s076ltr.pdf","2010-06-15 00:00:00",
10969,2,17105,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf","2010-06-14 00:00:00",
13088,1,17105,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017105s077ltr.pdf","2011-07-21 00:00:00",
46232,2,17105,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf","2016-12-20 00:00:00",
46459,1,17105,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017105Orig1s079ltr.pdf","2016-12-22 00:00:00",
46626,8,17105,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf#page=10","2016-12-30 00:00:00",
13089,1,17106,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17106se5-028ltr.pdf","2003-06-25 00:00:00",
33227,2,17106,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf","2003-06-25 00:00:00",
13090,1,17106,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17106s032ltr.pdf","2004-09-21 00:00:00",
33228,2,17106,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf","2004-09-21 00:00:00",
553,1,17111,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf","2003-04-09 00:00:00",
13091,1,17111,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s062ltr.pdf","2008-03-17 00:00:00",
33229,2,17111,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf","2008-03-17 00:00:00",
554,1,17111,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s063ltr.pdf","2008-08-19 00:00:00",
33230,2,17111,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf","2008-08-29 00:00:00",
555,1,17111,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017111s066ltr.pdf","2009-07-23 00:00:00",
33231,2,17111,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf","2009-07-23 00:00:00",
10970,2,17111,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf","2010-12-04 00:00:00",
13092,1,17111,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017111s067ltr.pdf","2010-12-06 00:00:00",
47354,2,17111,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017111s068lbl.pdf","2017-02-27 00:00:00",
47398,1,17111,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017111Orig1s068ltr.pdf","2017-03-02 00:00:00",
23536,10,17116,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm","2006-11-27 00:00:00",
13093,1,17116,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17116s014ltr.pdf","2002-03-27 00:00:00",
556,1,17116,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf","2005-05-27 00:00:00",
10971,2,17116,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf","2005-05-27 00:00:00",
13094,1,17116,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf","2005-05-27 00:00:00",
33232,2,17116,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf","2005-05-27 00:00:00",
13095,1,17116,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf","2005-08-08 00:00:00",
13096,1,17116,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf","2005-08-08 00:00:00",
13097,1,17116,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017116s021ltr.pdf","2008-02-07 00:00:00",
33233,2,17116,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017116s021lbl.pdf","2008-02-14 00:00:00",
46212,1,17116,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017116Orig1s029ltr.pdf","2017-01-03 00:00:00",
46405,2,17116,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017116s029lbl.pdf","2016-12-21 00:00:00",
52251,2,17116,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf","2018-02-01 00:00:00",
52284,1,17116,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017116Orig1s032ltr.pdf","2018-02-02 00:00:00",
13098,1,17118,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17118slr017ltr.pdf","2003-09-29 00:00:00",
33234,2,17118,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf","2004-04-27 00:00:00",
40739,3,17118,"SUPPL",17,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017118_s017_Symmetrel_syrup.pdf","2011-01-04 00:00:00",
13099,1,17118,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017118s019ltr.pdf","2009-01-06 00:00:00",
33235,2,17118,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf","2009-01-06 00:00:00",
13100,1,17122,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-11-13 00:00:00",
23104,8,17122,"SUPPL",61,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf","2009-10-01 00:00:00",
33236,2,17122,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf","2009-10-01 00:00:00",
10972,2,17122,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf","2009-10-01 00:00:00",
13101,1,17122,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf","2009-10-26 00:00:00",
43593,8,17122,"SUPPL",62,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf","2009-10-01 00:00:00",
557,1,17243,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17243scs022ltr.pdf","2004-06-29 00:00:00",
558,1,17243,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17243s025ltr.pdf","2004-10-22 00:00:00",
10973,2,17243,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf","2004-10-22 00:00:00",
13102,1,17243,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017243s028ltr.pdf","2006-04-05 00:00:00",
13103,1,17243,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017243Orig1s043ltr.pdf","2014-02-19 00:00:00",
33237,2,17243,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf","2014-02-19 00:00:00",
559,1,17243,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017243Orig1s044ltr.pdf","2013-12-24 00:00:00",
33238,2,17243,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf","2014-01-13 00:00:00",
560,1,17243,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017243Orig1s046ltr.pdf","2015-05-05 00:00:00",
33239,2,17243,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf","2015-05-06 00:00:00",
13104,1,17279,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17279s8ltr.pdf","2002-01-22 00:00:00",
13105,1,17284,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17284slr009LTR.pdf","2003-10-29 00:00:00",
10974,2,17284,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf","2011-09-16 00:00:00",
13106,1,17284,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017284s012ltr.pdf","2011-09-16 00:00:00",
10975,2,17340,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13107,1,17340,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
561,1,17340,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33240,2,17340,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
562,1,17340,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33241,2,17340,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
563,1,17351,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17351slr027ltr.pdf","2002-07-08 00:00:00",
20071,3,17351,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-351s027_Cortifoam.cfm","2005-03-08 00:00:00",
13108,1,17351,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17351slr030ltr.pdf","2003-12-11 00:00:00",
20072,3,17351,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017351_s030_CortifoamTOC.cfm","2006-05-08 00:00:00",
13109,1,17354,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf","2003-05-30 00:00:00",
46003,2,17354,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017354s045lbl.pdf","2016-12-02 00:00:00",
49334,2,17354,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf","2017-08-11 00:00:00",
49392,1,17354,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036, 017354Orig1s051, 017875s037, 017355Orig1s053ltr.pdf","2017-08-15 00:00:00",
13110,1,17355,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf","2003-07-31 00:00:00",
49335,2,17355,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf","2017-08-11 00:00:00",
49394,1,17355,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036,017354Orig1s051,017875s037,017355Orig1s053ltr.pdf","2017-08-15 00:00:00",
564,1,17362,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017362s104_ltr.pdf","2007-01-16 00:00:00",
33242,2,17362,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf","2007-01-16 00:00:00",
55298,2,17362,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017362s111lbl.pdf","2018-08-24 00:00:00",
55323,1,17362,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017362Orig1s111ltr.pdf","2018-08-27 00:00:00",
13111,1,17373,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf","2006-01-19 00:00:00",
565,1,17376,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf","2005-08-03 00:00:00",
33243,2,17376,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf","2005-08-03 00:00:00",
13112,1,17376,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf","2008-03-13 00:00:00",
33244,2,17376,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf","2008-03-13 00:00:00",
566,1,17376,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf","2007-09-25 00:00:00",
33245,2,17376,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf","2007-09-11 00:00:00",
13113,1,17376,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017376Orig1s060ltr.pdf","2013-09-05 00:00:00",
33246,2,17376,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf","2013-09-09 00:00:00",
52237,2,17376,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017376s061lbl.pdf","2018-02-01 00:00:00",
52294,1,17376,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017376Orig1s061ltr.pdf","2018-02-02 00:00:00",
567,1,17377,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17377slr057ltr.pdf","2003-02-12 00:00:00",
33247,2,17377,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17377slr057_Bactrim_lbl.pdf","2003-02-12 00:00:00",
10976,2,17377,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf","2002-10-17 00:00:00",
13114,1,17377,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17377scf058ltr.pdf","2002-10-17 00:00:00",
568,1,17377,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017377s063ltr.pdf","2007-06-07 00:00:00",
33248,2,17377,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017377s063lbl.pdf","2007-06-07 00:00:00",
13115,1,17377,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s066ltr.pdf","2010-07-02 00:00:00",
13116,1,17377,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s067ltr.pdf","2010-07-29 00:00:00",
33249,2,17377,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017377s067lbl.pdf","2010-07-31 00:00:00",
10977,2,17377,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf","2013-07-17 00:00:00",
13117,1,17377,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf","2013-07-15 00:00:00",
569,1,17377,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017377Orig1s071ltr.pdf","2012-08-31 00:00:00",
33250,2,17377,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017377s071lbl.pdf","2012-08-31 00:00:00",
10978,2,17377,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf","2013-07-17 00:00:00",
13118,1,17377,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf","2013-07-15 00:00:00",
13119,1,17377,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017377Orig1s074ltr.pdf","2014-07-17 00:00:00",
33251,2,17377,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017377s074lbl.pdf","2014-07-17 00:00:00",
13120,1,17378,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
10979,2,17378,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf","2009-02-04 00:00:00",
13121,1,17378,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065ltr.pdf","2009-01-30 00:00:00",
13122,1,17378,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385Orig1s059ltr.pdf","2013-09-13 00:00:00",
33252,2,17378,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf","2013-09-17 00:00:00",
13123,1,17381,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17381slr041ltr.pdf","2004-02-03 00:00:00",
570,1,17381,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017381Orig1s050ltr.pdf","2013-03-06 00:00:00",
33253,2,17381,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf","2013-03-08 00:00:00",
46810,2,17381,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf","2017-01-13 00:00:00",
48137,1,17381,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017381Orig1s015ltr.pdf","2017-04-27 00:00:00",
13124,1,17385,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385Orig1s059ltr.pdf","2013-09-13 00:00:00",
33254,2,17385,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf","2013-09-17 00:00:00",
13125,1,17385,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017385Orig1s060ltr.pdf","2014-12-24 00:00:00",
33255,2,17385,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf","2015-01-09 00:00:00",
571,1,17385,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017385Orig1s062ltr.pdf","2016-03-22 00:00:00",
33256,2,17385,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf","2016-03-22 00:00:00",
54941,1,17385,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf","2018-07-23 00:00:00",
33257,2,17386,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf","2003-06-16 00:00:00",
572,1,17386,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf","2002-10-29 00:00:00",
13126,1,17386,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf","2003-08-25 00:00:00",
50646,2,17386,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017386s036lbl.pdf","2017-12-08 00:00:00",
45780,3,17386,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017386Orig1s039.pdf","2016-11-02 00:00:00",
45781,3,17386,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/017386Orig1s040.pdf","2016-11-02 00:00:00",
573,1,17391,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf","2003-07-24 00:00:00",
574,1,17391,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf","2005-07-29 00:00:00",
10980,2,17391,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf","2005-07-29 00:00:00",
575,1,17391,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf","2008-07-14 00:00:00",
10981,2,17391,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf","2008-07-10 00:00:00",
13127,1,17391,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf","2011-05-26 00:00:00",
33258,2,17391,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017391s015lbl.pdf","2011-05-25 00:00:00",
13128,1,17391,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf","2014-02-11 00:00:00",
33259,2,17391,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf","2014-02-07 00:00:00",
13129,1,17398,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17398scm014ltr.pdf","2003-10-22 00:00:00",
10982,2,17398,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf","2004-09-29 00:00:00",
13130,1,17398,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17398s015ltr.pdf","2004-09-29 00:00:00",
576,1,17407,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s033ltr.pdf","2010-01-06 00:00:00",
33260,2,17407,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf","2010-01-08 00:00:00",
577,1,17407,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017407s034ltr.pdf","2010-01-06 00:00:00",
10983,2,17407,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf","2009-11-13 00:00:00",
10984,2,17407,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf","2010-04-19 00:00:00",
13131,1,17407,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s036ltr.pdf","2010-04-09 00:00:00",
10985,2,17407,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf","2012-06-06 00:00:00",
13132,1,17407,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017407s037ltr.pdf","2012-06-05 00:00:00",
578,1,17422,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17422slr035ltr.pdf","2003-03-10 00:00:00",
579,1,17422,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017422s036ltr.pdf","2005-10-25 00:00:00",
13133,1,17422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017422s037ltr.pdf","2007-08-22 00:00:00",
33261,2,17422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf","2007-08-21 00:00:00",
40740,3,17422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/017422Orig1s037.pdf","2015-01-28 00:00:00",
580,1,17422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s038ltr.pdf","2011-03-16 00:00:00",
33262,2,17422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf","2011-03-14 00:00:00",
13134,1,17422,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s042ltr.pdf","2011-08-15 00:00:00",
33263,2,17422,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf","2011-08-12 00:00:00",
40741,3,17422,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017422Orig1s045.pdf","2015-08-21 00:00:00",
33264,2,17422,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf","2013-10-22 00:00:00",
40742,3,17422,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/017422Orig1s047.pdf","2015-08-21 00:00:00",
581,1,17422,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017422Orig1s050ltr.pdf","2016-05-02 00:00:00",
33265,2,17422,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf","2016-06-17 00:00:00",
47723,2,17422,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017422s055lbl.pdf","2017-03-27 00:00:00",
47759,1,17422,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017422Orig1s055ltr.pdf","2017-03-29 00:00:00",
582,1,17425,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf","2015-09-21 00:00:00",
10986,2,17425,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf","2015-09-21 00:00:00",
50114,1,17428,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017428Orig1s071,017866Orig1s052ltr.pdf","2017-10-19 00:00:00",
50150,2,17428,"SUPPL",71,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf","2017-10-23 00:00:00",
40743,3,17430,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm","2004-08-10 00:00:00",
20073,3,17430,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm","2004-08-10 00:00:00",
10987,2,17430,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf","2004-09-10 00:00:00",
13135,1,17430,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf","2004-09-10 00:00:00",
583,1,17430,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf","2004-09-10 00:00:00",
33266,2,17430,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf","2004-09-10 00:00:00",
584,1,17430,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf","2004-09-10 00:00:00",
10988,2,17430,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf","2004-09-10 00:00:00",
585,1,17430,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017430s032ltr.pdf","2007-08-07 00:00:00",
33267,2,17430,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017430s032lbl.pdf","2007-08-06 00:00:00",
586,1,17438,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
13136,1,17441,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17441S161ltr.pdf","2001-04-18 00:00:00",
33268,2,17441,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017441s171lbl.pdf","2009-09-17 00:00:00",
587,1,17442,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17442s29ltr.pdf","2001-06-12 00:00:00",
13137,1,17442,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s033ltr.pdf","2009-04-09 00:00:00",
33269,2,17442,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf","2009-04-16 00:00:00",
10989,2,17442,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf","2009-07-23 00:00:00",
13138,1,17442,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s035ltr.pdf","2009-07-15 00:00:00",
10990,2,17442,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf","2013-11-04 00:00:00",
13139,1,17442,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017442Orig1s041ltr.pdf","2013-11-07 00:00:00",
10991,2,17442,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf","2015-03-02 00:00:00",
13140,1,17442,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf","2015-03-02 00:00:00",
10992,2,17443,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf","2012-07-19 00:00:00",
13141,1,17443,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf","2012-07-18 00:00:00",
588,1,17443,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf","2012-07-18 00:00:00",
10993,2,17443,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf","2012-07-19 00:00:00",
10994,2,17443,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf","2012-07-19 00:00:00",
13142,1,17443,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf","2012-07-18 00:00:00",
589,1,17443,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf","2012-07-18 00:00:00",
33270,2,17443,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf","2012-07-19 00:00:00",
13143,1,17450,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17450scp052ltr.pdf","2002-08-07 00:00:00",
33271,2,17450,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17450s52lbl.pdf","2002-08-07 00:00:00",
590,1,17450,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017450s055ltr.pdf","2008-08-22 00:00:00",
50145,2,17450,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017450Orig1s055lbl.pdf","2017-10-23 00:00:00",
49515,2,17450,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017450Orig1s056lbl.pdf","2017-08-22 00:00:00",
591,1,17451,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-09-08 00:00:00",
10995,2,17451,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-09-08 00:00:00",
13144,1,17451,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065ltr.pdf","2009-01-30 00:00:00",
33272,2,17451,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf","2009-02-04 00:00:00",
13145,1,17453,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17453scm010ltr.pdf","2004-01-22 00:00:00",
592,1,17453,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017453s014ltr.pdf","2008-12-24 00:00:00",
33273,2,17453,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf","2009-01-02 00:00:00",
593,1,17453,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf","2015-09-21 00:00:00",
33274,2,17453,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017453s020lbl.pdf","2015-09-21 00:00:00",
23105,8,17463,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088647.pdf","2009-12-04 00:00:00",
10996,2,17463,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf","2006-01-25 00:00:00",
13146,1,17463,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017463s104ltr.pdf","2006-01-30 00:00:00",
594,1,17463,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017463s105ltr.pdf","2007-09-11 00:00:00",
33275,2,17463,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf","2007-09-11 00:00:00",
595,1,17468,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf","2003-05-29 00:00:00",
10997,2,17468,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf","2003-05-28 00:00:00",
13147,1,17469,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf","2003-07-31 00:00:00",
33276,2,17469,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf","2003-05-28 00:00:00",
13148,1,17469,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017469s035LTR.pdf","2006-05-18 00:00:00",
33277,2,17469,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf","2006-05-16 00:00:00",
33278,2,17469,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf","2006-05-16 00:00:00",
596,1,17469,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017469s040ltr.pdf","2007-10-15 00:00:00",
10998,2,17469,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf","2007-10-15 00:00:00",
13149,1,17473,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17473slr038ltr.pdf","2002-11-14 00:00:00",
597,1,17473,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17473slr039ltr.pdf","2003-11-05 00:00:00",
598,1,17473,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s041ltr.pdf","2009-05-06 00:00:00",
33279,2,17473,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s041lbl.pdf","2009-05-11 00:00:00",
13150,1,17473,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s043ltr.pdf","2009-07-23 00:00:00",
33280,2,17473,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s043lbl.pdf","2009-07-21 00:00:00",
10999,2,17473,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf","2010-12-04 00:00:00",
13151,1,17473,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017473s045ltr.pdf","2010-12-06 00:00:00",
11000,2,17473,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf","2011-09-30 00:00:00",
13152,1,17473,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017473s046ltr.pdf","2011-10-03 00:00:00",
40744,3,17473,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/017473Orig1s046.pdf","2012-01-27 00:00:00",
599,1,17476,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf","2004-12-02 00:00:00",
13153,1,17476,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf","2004-12-02 00:00:00",
13154,1,17478,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17478scs013ltr.pdf","2004-03-10 00:00:00",
600,1,17478,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017478s014ltr.pdf","2011-10-26 00:00:00",
11001,2,17478,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf","2011-10-25 00:00:00",
55123,2,17478,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf","2018-08-07 00:00:00",
55131,1,17478,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017478Orig1s016ltr.pdf","2018-08-07 00:00:00",
48716,2,17481,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017481s047lbl.pdf","2017-06-14 00:00:00",
48750,1,17481,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017481Orig1s047ltr.pdf","2017-06-16 00:00:00",
601,1,17484,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017484s061ltr.pdf","2005-06-08 00:00:00",
33281,2,17484,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017484s061lbl.pdf","2005-06-08 00:00:00",
602,1,17484,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33282,2,17484,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
54942,1,17484,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf","2018-07-23 00:00:00",
603,1,17493,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr065ltr.pdf","2003-01-03 00:00:00",
13155,1,17493,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr066ltr.pdf","2003-05-30 00:00:00",
604,1,17493,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493scs067ltr.pdf","2003-01-17 00:00:00",
13156,1,17498,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017498s027ltr.pdf","2008-10-29 00:00:00",
33283,2,17498,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf","2008-11-03 00:00:00",
13157,1,17498,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017498s029ltr.pdf","2009-11-19 00:00:00",
33284,2,17498,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf","2009-09-17 00:00:00",
13158,1,17498,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017498s030ltr.pdf","2011-02-04 00:00:00",
33285,2,17498,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf","2011-02-04 00:00:00",
13159,1,17498,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017498Orig1s031ltr.pdf","2013-10-16 00:00:00",
33286,2,17498,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf","2013-10-22 00:00:00",
605,1,17498,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017498Orig1s032ltr.pdf","2015-05-26 00:00:00",
33287,2,17498,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf","2015-05-27 00:00:00",
45133,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
45134,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
45135,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
45136,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
45137,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
45138,1,17512,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
606,1,17512,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
607,1,17512,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
11002,2,17512,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017512s108lbl.pdf","2009-01-02 00:00:00",
13160,1,17512,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017512s108ltr.pdf","2008-12-24 00:00:00",
608,1,17512,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf","2013-04-24 00:00:00",
11003,2,17512,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf","2013-04-23 00:00:00",
13161,1,17512,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf","2015-02-10 00:00:00",
33288,2,17512,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf","2015-02-10 00:00:00",
609,1,17512,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf","2015-07-31 00:00:00",
11004,2,17512,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf","2015-07-30 00:00:00",
13162,1,17512,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf","2015-07-31 00:00:00",
33289,2,17512,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf","2015-07-30 00:00:00",
610,1,17512,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf","2015-09-04 00:00:00",
11005,2,17512,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf","2015-09-04 00:00:00",
13163,1,17514,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17514slr058ltr.pdf","2004-04-29 00:00:00",
20074,3,17516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017516_OriginalApprovalPackage.pdf","2009-11-02 00:00:00",
44011,10,17516,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
611,1,17516,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17516slr020,16798slr050ltr.pdf","2003-10-09 00:00:00",
612,1,17516,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16798s053,17516s022ltr.pdf","2005-02-23 00:00:00",
613,1,17516,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
33290,2,17516,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf","2007-08-03 00:00:00",
11006,2,17516,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf","2014-07-15 00:00:00",
13164,1,17516,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516Orig1s025ltr.pdf","2014-07-15 00:00:00",
13165,1,17521,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf","2003-07-31 00:00:00",
40745,3,17521,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf","2007-09-24 00:00:00",
614,1,17521,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf","2003-07-31 00:00:00",
20075,3,17521,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf","2007-09-24 00:00:00",
615,1,17521,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf","2014-12-24 00:00:00",
11007,2,17521,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf","2015-01-09 00:00:00",
52981,1,17521,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017521Orig1s069ltr.pdf","2018-03-15 00:00:00",
53056,2,17521,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017521s069lbl.pdf","2018-03-19 00:00:00",
616,1,17522,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33291,2,17522,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
11008,2,17522,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13166,1,17522,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
11009,2,17522,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13167,1,17522,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
47331,2,17525,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf","2017-02-24 00:00:00",
47412,1,17525,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf","2017-03-02 00:00:00",
11010,2,17530,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf","2004-06-18 00:00:00",
13168,1,17530,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17529s009ltr.pdf","2004-06-18 00:00:00",
40746,3,17530,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017530_S018_TIGAN_AP.pdf","2007-07-09 00:00:00",
617,1,17530,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf","2005-08-31 00:00:00",
11011,2,17530,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf","2005-08-31 00:00:00",
13830,1,17530,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf","2005-08-31 00:00:00",
33292,2,17530,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf","2005-08-31 00:00:00",
618,1,17530,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf","2005-08-31 00:00:00",
11012,2,17530,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf","2005-08-31 00:00:00",
11013,2,17530,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf","2008-06-05 00:00:00",
13831,1,17530,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017530s024ltr.pdf","2008-04-22 00:00:00",
619,1,17531,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17531S010ltr.pdf","2002-04-30 00:00:00",
11014,2,17531,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf","2002-04-30 00:00:00",
20076,3,17531,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017531_S010_TIGAN_CAPSULE_AP.pdf","2007-07-06 00:00:00",
11015,2,17531,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf","2008-03-27 00:00:00",
13832,1,17531,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s012ltr.pdf","2008-03-26 00:00:00",
13833,1,17531,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s013ltr.pdf","2008-12-10 00:00:00",
33293,2,17531,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s013lbl.pdf","2008-12-08 00:00:00",
47564,1,17531,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017531Orig1s014ltr.pdf","2017-03-14 00:00:00",
47565,2,17531,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017531s014lbl.pdf","2017-03-14 00:00:00",
13834,1,17532,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf","2009-03-10 00:00:00",
33294,2,17532,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf","2009-03-17 00:00:00",
620,1,17532,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf","2009-03-10 00:00:00",
11016,2,17532,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf","2009-03-17 00:00:00",
621,1,17532,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s030ltr.pdf","2009-07-15 00:00:00",
11017,2,17532,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf","2009-07-23 00:00:00",
622,1,17532,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017532Orig1s034ltr.pdf","2013-10-16 00:00:00",
11018,2,17532,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf","2013-10-21 00:00:00",
46803,2,17532,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017532s038lbl.pdf","2017-01-11 00:00:00",
46879,1,17532,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017532Orig1s038ltr.pdf","2017-01-18 00:00:00",
623,1,17533,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17533S31ltr.pdf","2001-01-22 00:00:00",
20077,3,17533,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017533_S031_KLONOPIN_TABS_AP.pdf","2007-04-09 00:00:00",
624,1,17533,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17533s37ltr.pdf","2002-01-29 00:00:00",
40747,3,17533,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017533_S037_KLONOPIN_TABS_AP.pdf","2007-04-09 00:00:00",
625,1,17533,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017533s045,020813s005ltr.pdf","2009-05-01 00:00:00",
11019,2,17533,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf","2009-05-12 00:00:00",
626,1,17533,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf","2012-06-04 00:00:00",
33295,2,17533,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf","2012-06-04 00:00:00",
627,1,17533,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf","2010-09-21 00:00:00",
33296,2,17533,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf","2010-09-07 00:00:00",
13835,1,17533,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s052,020813s008ltr.pdf","2011-12-14 00:00:00",
628,1,17533,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813Orig1s009ltr.pdf","2013-11-06 00:00:00",
11020,2,17533,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf","2013-11-01 00:00:00",
13836,1,17533,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s055ltr.pdf","2016-03-29 00:00:00",
33297,2,17533,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf","2016-03-29 00:00:00",
46281,2,17533,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf","2016-12-20 00:00:00",
46460,1,17533,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s058,020813Orig1s010ltr.pdf","2016-12-22 00:00:00",
50187,2,17533,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf","2017-10-26 00:00:00",
50188,8,17533,"SUPPL",59,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf#page=19","2017-10-26 00:00:00",
50222,1,17533,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017533Orig1s059ltr.pdf","2017-10-30 00:00:00",
629,1,17536,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17536s18ltr.pdf","2001-10-03 00:00:00",
11021,2,17536,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf","2001-10-03 00:00:00",
40748,3,17536,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-536S018_Diprosone.cfm","2001-10-03 00:00:00",
13837,1,17536,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17536s18ltr.pdf","2001-10-03 00:00:00",
33298,2,17536,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf","2001-10-03 00:00:00",
40749,3,17536,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-536S018_Diprosone.cfm","2001-10-03 00:00:00",
47638,2,17538,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017538s019lbl.pdf","2017-03-22 00:00:00",
47681,1,17538,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017538Orig1s019ltr.pdf","2017-03-24 00:00:00",
44012,10,17543,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
13838,1,17555,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
630,1,17555,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
631,1,17555,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
13839,1,17555,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
632,1,17555,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
633,1,17555,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
13840,1,17555,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
634,1,17555,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
13841,1,17555,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf","2001-04-11 00:00:00",
635,1,17555,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
11022,2,17555,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf","2014-07-22 00:00:00",
13842,1,17555,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
33299,2,17555,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf","2014-07-22 00:00:00",
13843,1,17555,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017555s069ltr.pdf","2009-01-06 00:00:00",
33300,2,17555,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf","2009-01-06 00:00:00",
40750,3,17555,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/017555Orig1s069.pdf","2013-06-03 00:00:00",
11023,2,17555,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf","2011-02-04 00:00:00",
13844,1,17555,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf","2011-02-07 00:00:00",
11024,2,17555,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf","2014-07-22 00:00:00",
13845,1,17555,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
636,1,17556,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17556s034ltr.pdf","2004-10-04 00:00:00",
33301,2,17556,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf","2004-10-04 00:00:00",
11025,2,17556,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf","2009-06-22 00:00:00",
13846,1,17556,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017556s038ltr.pdf","2009-06-16 00:00:00",
11026,2,17557,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf","2011-12-23 00:00:00",
13847,1,17557,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf","2011-12-22 00:00:00",
637,1,17557,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf","2011-12-22 00:00:00",
33302,2,17557,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf","2011-12-23 00:00:00",
11027,2,17557,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf","2011-12-23 00:00:00",
13848,1,17557,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf","2011-12-22 00:00:00",
13849,1,17557,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf","2011-12-22 00:00:00",
33303,2,17557,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf","2011-12-23 00:00:00",
638,1,17557,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf","2011-12-22 00:00:00",
33304,2,17557,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf","2011-12-23 00:00:00",
20078,3,17558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017558_S000_RobinulTOC.cfm","2007-02-20 00:00:00",
13850,1,17558,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf","2004-11-08 00:00:00",
639,1,17558,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf","2004-11-08 00:00:00",
640,1,17558,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf","2003-07-06 00:00:00",
13851,1,17558,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf","2003-07-06 00:00:00",
641,1,17558,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf","2004-11-08 00:00:00",
13852,1,17558,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf","2004-11-08 00:00:00",
642,1,17558,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017558s053ltr.pdf","2005-05-27 00:00:00",
33305,2,17558,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf","2005-05-27 00:00:00",
54861,1,17558,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017558Orig1s062ltr.pdf","2018-07-09 00:00:00",
54911,2,17558,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf","2018-07-18 00:00:00",
40751,3,17559,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf","1998-11-09 00:00:00",
643,1,17559,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017559s040_ltr.pdf","2006-09-18 00:00:00",
644,1,17561,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17561slr013ltr.pdf","2003-07-06 00:00:00",
13853,1,17563,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017563Orig1s023,20222Orig1s005ltr.pdf","2014-05-23 00:00:00",
33306,2,17563,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf","2014-05-28 00:00:00",
53869,1,17563,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017563Orig1s024ltr.pdf","2018-04-27 00:00:00",
49322,2,17565,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf","2017-08-10 00:00:00",
49468,1,17565,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s084,017566Orig1s091,017743Orig1s088ltr.pdf","2017-08-21 00:00:00",
50008,2,17565,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf","2017-10-11 00:00:00",
50036,1,17565,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s085,017566Orig1s092,017743Orig1s089ltr.pdf","2017-10-12 00:00:00",
49323,2,17566,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf","2017-08-10 00:00:00",
49469,1,17566,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s084,017566Orig1s091,017743Orig1s088ltr.pdf","2017-08-21 00:00:00",
50009,2,17566,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf","2017-10-11 00:00:00",
50035,1,17566,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s085,017566Orig1s092,017743Orig1s089ltr.pdf","2017-10-12 00:00:00",
20079,3,17573,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17573s040_vanceril_approv_admindocs.pdf","2004-06-29 00:00:00",
11028,2,17576,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf","2008-07-23 00:00:00",
13854,1,17576,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017576s051ltr.pdf","2008-07-23 00:00:00",
33307,2,17577,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
40752,3,17577,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017577_s032&s033_DITROPAN TABS.pdf","2009-09-14 00:00:00",
11029,2,17577,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
13855,1,17577,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf","2003-05-29 00:00:00",
20080,3,17577,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017577_s032&s033_DITROPAN TABS.pdf","2009-09-14 00:00:00",
11030,2,17577,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf","2008-02-14 00:00:00",
13856,1,17577,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017577s034ltr.pdf","2008-02-13 00:00:00",
645,1,17577,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017577s035ltr.pdf","2009-07-16 00:00:00",
11031,2,17577,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf","2009-07-23 00:00:00",
11032,2,17577,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf","2011-08-08 00:00:00",
13857,1,17577,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s036ltr.pdf","2011-08-10 00:00:00",
11033,2,17577,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf","2011-12-20 00:00:00",
13858,1,17577,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s037ltr.pdf","2011-12-20 00:00:00",
646,1,17577,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017577s038ltr.pdf","2012-03-26 00:00:00",
11034,2,17577,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf","2012-03-23 00:00:00",
647,1,17579,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33308,2,17579,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
648,1,17579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33309,2,17579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
649,1,17579,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33310,2,17579,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
40753,3,17581,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017581_S004_NAPROSYN_AP.pdf","2007-04-11 00:00:00",
650,1,17581,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf","2003-05-29 00:00:00",
651,1,17581,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
11035,2,17581,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
13859,1,17581,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
33311,2,17581,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
11036,2,17581,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf","2006-03-14 00:00:00",
13860,1,17581,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf","2006-03-23 00:00:00",
11037,2,17581,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf","2006-01-25 00:00:00",
13861,1,17581,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf","2006-01-30 00:00:00",
13862,1,17581,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf","2007-04-25 00:00:00",
652,1,17581,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf","2007-09-25 00:00:00",
11038,2,17581,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf","2007-09-26 00:00:00",
11039,2,17581,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf","2008-07-29 00:00:00",
13863,1,17581,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf","2008-07-30 00:00:00",
653,1,17581,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf","2013-03-26 00:00:00",
33312,2,17581,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf","2013-03-26 00:00:00",
654,1,17581,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf","2016-05-11 00:00:00",
33313,2,17581,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf","2016-05-11 00:00:00",
47539,2,17581,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf","2017-03-13 00:00:00",
47540,8,17581,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22","2017-03-13 00:00:00",
47557,1,17581,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017581Orig1s113,018161Orig1s063,020067Orig1s020ltr.pdf","2017-03-14 00:00:00",
655,1,17588,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17588slr031ltr.pdf","2002-12-20 00:00:00",
656,1,17588,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17588slr033ltr.pdf","2003-03-10 00:00:00",
657,1,17588,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017588s034ltr.pdf","2009-05-06 00:00:00",
33314,2,17588,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017588s034lbl.pdf","2009-05-11 00:00:00",
658,1,17588,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017588Orig1s036ltr.pdf","2012-11-23 00:00:00",
11040,2,17588,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf","2012-11-28 00:00:00",
659,1,17588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017588s037ltr.pdf","2011-05-16 00:00:00",
33315,2,17588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017588s037lbl.pdf","2011-05-16 00:00:00",
11041,2,17588,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf","2013-08-21 00:00:00",
660,1,17588,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017588Orig1s040ltr.pdf","2014-05-22 00:00:00",
33316,2,17588,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017588s040lbl.pdf","2014-05-28 00:00:00",
661,1,17588,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s042ltr.pdf","2016-01-07 00:00:00",
11042,2,17588,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf","2016-01-07 00:00:00",
13864,1,17588,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s043ltr.pdf","2016-02-01 00:00:00",
33317,2,17588,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s043lbl.pdf","2016-02-02 00:00:00",
11043,2,17598,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf","2005-08-03 00:00:00",
13865,1,17598,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf","2005-08-03 00:00:00",
13866,1,17598,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf","2008-03-13 00:00:00",
33318,2,17598,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf","2008-03-13 00:00:00",
662,1,17598,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf","2007-09-25 00:00:00",
11044,2,17598,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf","2007-09-11 00:00:00",
663,1,17601,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17601slr020LTR.pdf","2002-11-04 00:00:00",
43596,8,17604,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf","2009-11-19 00:00:00",
11045,2,17604,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf","2006-01-20 00:00:00",
13867,1,17604,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017604s040ltr.pdf","2006-01-20 00:00:00",
664,1,17604,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017604s041ltr.pdf","2007-08-14 00:00:00",
11046,2,17604,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf","2007-08-14 00:00:00",
665,1,17604,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017604s043ltr.pdf","2009-07-23 00:00:00",
11047,2,17604,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf","2009-07-24 00:00:00",
11048,2,17604,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf","2016-05-11 00:00:00",
13868,1,17604,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017604Orig1s046ltr.pdf","2016-05-11 00:00:00",
40754,3,17612,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf","2003-02-05 00:00:00",
49315,2,17612,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf","2017-08-10 00:00:00",
49388,1,17612,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017612Orig1s043,018206Orig1s021ltr.pdf","2017-08-15 00:00:00",
13869,1,17624,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017624s034ltr.pdf","2006-09-18 00:00:00",
33319,2,17624,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017624s034lbl.pdf","2006-09-01 00:00:00",
666,1,17624,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017624s036ltr.pdf","2010-02-26 00:00:00",
11049,2,17624,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017624s036lbl.pdf","2010-03-03 00:00:00",
48190,1,17624,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017624Orig1s041ltr.pdf","2017-05-02 00:00:00",
48218,2,17624,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017624s041lbl.pdf","2017-05-02 00:00:00",
43597,8,17628,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf","2009-12-04 00:00:00",
11050,2,17628,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf","2006-02-22 00:00:00",
13870,1,17628,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf","2006-02-22 00:00:00",
667,1,17628,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017628s068ltr.pdf","2008-01-24 00:00:00",
33320,2,17628,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf","2008-01-24 00:00:00",
13871,1,17630,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017630s013ltr.pdf","2005-06-21 00:00:00",
13872,1,17634,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17634slr059ltr.pdf","2004-06-02 00:00:00",
668,1,17634,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017634s064ltr.pdf","2005-05-25 00:00:00",
33321,2,17634,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf","2005-05-25 00:00:00",
669,1,17634,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33322,2,17634,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
13873,1,17634,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017634Orig1s069ltr.pdf","2014-12-24 00:00:00",
33323,2,17634,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf","2015-01-09 00:00:00",
48594,1,17634,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf","2017-05-31 00:00:00",
48607,2,17634,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf","2017-05-31 00:00:00",
48595,1,17634,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf","2017-05-31 00:00:00",
48608,2,17634,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf","2017-05-31 00:00:00",
670,1,17643,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf","2004-04-20 00:00:00",
671,1,17643,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf","2007-05-01 00:00:00",
33324,2,17643,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf","2007-04-25 00:00:00",
46015,2,17643,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2016/017643s076.pdf","2016-12-05 00:00:00",
46059,1,17643,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf","2016-12-06 00:00:00",
55003,1,17643,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf","2018-07-26 00:00:00",
55032,2,17643,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf","2018-07-27 00:00:00",
13874,1,17646,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17646s049ltr.pdf","2002-07-30 00:00:00",
13875,1,17648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17648scs061ltr.pdf","2002-11-26 00:00:00",
13876,1,17648,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17648slr058ltr.pdf","2003-01-10 00:00:00",
672,1,17648,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017648s064ltr.pdf","2005-05-25 00:00:00",
33325,2,17648,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017648s064lbl.pdf","2005-05-25 00:00:00",
673,1,17648,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33326,2,17648,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
20081,3,17651,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017651_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-20 00:00:00",
13877,1,17651,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017651s042ltr.pdf","2008-01-09 00:00:00",
674,1,17651,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017651s046ltr.pdf","2009-04-03 00:00:00",
33327,2,17651,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf","2009-04-03 00:00:00",
11051,2,17651,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf","2010-06-24 00:00:00",
13878,1,17651,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf","2010-06-14 00:00:00",
675,1,17651,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf","2011-07-05 00:00:00",
676,1,17651,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf","2011-12-29 00:00:00",
33328,2,17651,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf","2011-12-23 00:00:00",
677,1,17651,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf","2014-04-07 00:00:00",
47332,2,17658,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf","2017-02-24 00:00:00",
47410,1,17658,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf","2017-03-02 00:00:00",
678,1,17670,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17670slr043ltr.pdf","2004-04-20 00:00:00",
679,1,17673,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr051ltr.pdf","2003-06-22 00:00:00",
13879,1,17673,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
680,1,17673,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673scs067ltr.pdf","2003-04-15 00:00:00",
13880,1,17673,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17673scp069ltr.pdf","2004-03-16 00:00:00",
681,1,17681,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf","2004-06-15 00:00:00",
33329,2,17681,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf","2004-06-15 00:00:00",
682,1,17681,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf","2005-11-30 00:00:00",
33330,2,17681,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf","2005-11-30 00:00:00",
50581,1,17681,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017681Orig1s018ltr.pdf","2017-12-01 00:00:00",
50592,2,17681,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017681s018lbl.pdf","2017-12-04 00:00:00",
683,1,17683,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf","2011-04-01 00:00:00",
33331,2,17683,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf","2011-03-29 00:00:00",
45822,2,17690,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017690s005lbl.pdf","2016-11-07 00:00:00",
45834,1,17690,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017690Orig1s005,017694Orig1s052ltr.pdf","2016-11-08 00:00:00",
684,1,17691,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17691s19ltr.pdf","2001-10-03 00:00:00",
20082,3,17691,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-691S019_Diprosone.cfm","2001-10-03 00:00:00",
33332,2,17691,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf","2001-10-03 00:00:00",
685,1,17691,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17691s19ltr.pdf","2001-10-03 00:00:00",
20083,3,17691,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-691S019_Diprosone.cfm","2001-10-03 00:00:00",
33333,2,17691,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf","2001-10-03 00:00:00",
686,1,17692,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s018ltr.pdf","2007-02-12 00:00:00",
33334,2,17692,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf","2007-02-21 00:00:00",
13881,1,17692,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s020ltr.pdf","2008-01-09 00:00:00",
687,1,17692,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017692s021ltr.pdf","2011-04-19 00:00:00",
33335,2,17692,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf","2011-04-18 00:00:00",
44439,14,17693,"SUPPL",25,"Package Insert","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017693s025PI.pdf","2013-12-17 00:00:00",
13882,1,17693,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017693Orig1s026ltr.pdf","2014-10-15 00:00:00",
33336,2,17693,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf","2014-10-15 00:00:00",
688,1,17693,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017693Orig1s029ltr.pdf","2015-08-11 00:00:00",
11052,2,17693,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf","2015-09-09 00:00:00",
13883,1,17694,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017694s050ltr.pdf","2005-10-25 00:00:00",
33337,2,17694,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf","2005-10-25 00:00:00",
45823,2,17694,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017694s052lbl.pdf","2016-11-07 00:00:00",
45835,1,17694,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017690Orig1s005,017694Orig1s052ltr.pdf","2016-11-08 00:00:00",
689,1,17697,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf","2004-06-07 00:00:00",
20084,3,17697,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s012.pdf","2012-11-09 00:00:00",
13884,1,17697,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf","2004-06-07 00:00:00",
20085,3,17697,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s013.pdf","2012-11-09 00:00:00",
690,1,17697,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf","2004-06-07 00:00:00",
20086,3,17697,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s014.pdf","2012-11-09 00:00:00",
691,1,17697,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf","2004-06-07 00:00:00",
40755,3,17697,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s015.pdf","2012-11-09 00:00:00",
13885,1,17697,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017697s017ltr.pdf","2005-04-28 00:00:00",
54301,3,17697,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017697Orig1s027.pdf","2018-05-22 00:00:00",
52551,1,17697,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017697Orig1s031ltr.pdf","2018-02-09 00:00:00",
52628,2,17697,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s031lbl.pdf","2018-02-14 00:00:00",
54303,3,17697,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017697Orig1s031.pdf","2018-05-22 00:00:00",
53143,1,17697,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017697Orig1s032ltr.pdf","2018-03-22 00:00:00",
53145,2,17697,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s032lbl.pdf","2018-03-22 00:00:00",
44013,10,17703,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm","2011-12-20 00:00:00",
40756,3,17703,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-017703a_s011.pdf","2003-06-17 00:00:00",
20087,3,17703,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-017703a_s012.pdf","2003-06-17 00:00:00",
40757,3,17703,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/017703a_s014.pdf","1998-05-13 00:00:00",
692,1,17703,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr018ltr.pdf","2003-11-25 00:00:00",
33338,2,17703,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf","2005-10-19 00:00:00",
13886,1,17707,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17707s010ltr.pdf","2004-09-27 00:00:00",
13887,1,17714,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17714s21ltr.pdf","2002-03-20 00:00:00",
11053,2,17735,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf","2013-10-04 00:00:00",
13888,1,17735,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
693,1,17735,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
33339,2,17735,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf","2012-07-13 00:00:00",
13889,1,17735,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
694,1,17735,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
13890,1,17735,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
13891,1,17735,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf","2015-11-04 00:00:00",
33340,2,17735,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf","2015-11-04 00:00:00",
49319,2,17735,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf","2017-08-10 00:00:00",
49471,1,17735,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf","2017-08-21 00:00:00",
11054,2,17741,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr021lbl.pdf","2003-06-08 00:00:00",
13892,1,17741,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17741slr021ltr.pdf","2003-06-22 00:00:00",
695,1,17741,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17741slr022ltr.pdf","2003-12-22 00:00:00",
11055,2,17741,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr022_florone_lbl.pdf","2003-12-29 00:00:00",
50225,1,17741,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf","2017-10-30 00:00:00",
50232,2,17741,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017741s024lbl.pdf","2017-10-30 00:00:00",
49324,2,17743,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf","2017-08-10 00:00:00",
49470,1,17743,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s084,017566Orig1s091,017743Orig1s088ltr.pdf","2017-08-21 00:00:00",
50010,2,17743,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf","2017-10-11 00:00:00",
50034,1,17743,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s085,017566Orig1s092,017743Orig1s089ltr.pdf","2017-10-12 00:00:00",
47746,2,17744,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017744s026lbl.pdf","2017-03-29 00:00:00",
47747,1,17744,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017744Orig1s026ltr.pdf","2017-03-29 00:00:00",
696,1,17760,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17760s9ltr.pdf","2001-07-13 00:00:00",
11056,2,17760,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf","2003-06-16 00:00:00",
697,1,17760,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017760s015ltr.pdf","2007-09-25 00:00:00",
11057,2,17760,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf","2013-02-14 00:00:00",
13893,1,17760,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017760Orig1s017ltr.pdf","2013-02-13 00:00:00",
11058,2,17765,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf","2003-12-16 00:00:00",
13894,1,17765,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17765scp024ltr.pdf","2003-12-16 00:00:00",
13895,1,17766,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17766s028ltr.pdf","2002-06-12 00:00:00",
11059,2,17766,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17766scs029_nephramine_lbl.pdf","2004-05-07 00:00:00",
13896,1,17766,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17766scs029ltr.pdf","2004-05-07 00:00:00",
13897,1,17766,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017766s030LTR.pdf","2006-05-05 00:00:00",
33341,2,17766,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017766s030lbl.pdf","2006-05-05 00:00:00",
13898,1,17768,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017768s039ltr.pdf","2012-05-29 00:00:00",
698,1,17768,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017768Orig1s041ltr.pdf","2014-07-01 00:00:00",
33342,2,17768,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf","2014-07-31 00:00:00",
11060,2,17768,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf","2015-12-15 00:00:00",
50115,1,17768,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017768Orig1s044ltr.pdf","2017-10-19 00:00:00",
50144,2,17768,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017768Orig1s044lbl.pdf","2017-10-23 00:00:00",
13899,1,17771,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017771Orig1s035ltr.pdf","2014-02-13 00:00:00",
33343,2,17771,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf","2014-02-12 00:00:00",
11061,2,17781,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf","2001-10-03 00:00:00",
13900,1,17781,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf","2001-10-03 00:00:00",
40758,3,17781,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-781S015_Diprosone.cfm","2001-10-03 00:00:00",
699,1,17781,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf","2001-10-03 00:00:00",
20088,3,17781,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-781S015_Diprosone.cfm","2001-10-03 00:00:00",
33344,2,17781,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf","2001-10-03 00:00:00",
13901,1,17783,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf","2008-10-29 00:00:00",
33345,2,17783,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf","2008-11-07 00:00:00",
700,1,17783,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf","2009-11-19 00:00:00",
11062,2,17783,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf","2009-09-17 00:00:00",
701,1,17783,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf","2011-02-09 00:00:00",
33346,2,17783,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf","2011-02-07 00:00:00",
702,1,17783,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf","2013-10-16 00:00:00",
33347,2,17783,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf","2013-10-22 00:00:00",
45098,2,17783,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf","2016-08-22 00:00:00",
45144,1,17783,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017783Orig1s026ltr.pdf","2016-08-18 00:00:00",
703,1,17789,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr051ltr.pdf","2003-06-22 00:00:00",
704,1,17789,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
705,1,17794,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017794s035_LTR.pdf","2007-04-25 00:00:00",
11063,2,17794,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf","2007-04-20 00:00:00",
46238,2,17794,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf","2016-12-20 00:00:00",
46462,1,17794,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017794Orig1s044ltr.pdf","2016-12-22 00:00:00",
46629,8,17794,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf#page=9","2016-12-30 00:00:00",
40759,3,17802,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf","2003-02-05 00:00:00",
47566,2,17802,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017802s018lbl.pdf","2017-03-15 00:00:00",
48683,2,17802,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s029lbl.pdf","2017-06-09 00:00:00",
48687,1,17802,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017802Orig1s029ltr.pdf","2017-06-09 00:00:00",
49310,2,17802,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s032lbl.pdf","2017-08-10 00:00:00",
49390,1,17802,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017802Orig1s032ltr.pdf","2017-08-15 00:00:00",
53251,2,17802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017802s033lbl.pdf","2018-03-23 00:00:00",
53487,1,17802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017802Orig1s033ltr.pdf","2018-03-28 00:00:00",
13902,1,17806,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017806s025ltr.pdf","2011-08-26 00:00:00",
33348,2,17806,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017806s025lbl.pdf","2011-08-26 00:00:00",
44014,10,17808,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm388640.htm","2014-03-12 00:00:00",
40760,3,17808,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/017808a_s014.pdf","1997-07-14 00:00:00",
706,1,17808,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17808slr024ltr.pdf","2003-06-08 00:00:00",
33349,2,17808,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf","2009-12-10 00:00:00",
11064,2,17808,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf","2012-04-20 00:00:00",
13903,1,17808,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017808s034ltr.pdf","2012-04-23 00:00:00",
707,1,17808,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017808Orig1s035ltr.pdf","2014-03-13 00:00:00",
11065,2,17808,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf","2014-03-13 00:00:00",
708,1,17808,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017808Orig1s036ltr.pdf","2015-02-03 00:00:00",
11066,2,17808,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf","2015-02-03 00:00:00",
49718,2,17808,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017808s037lbl.pdf","2017-09-12 00:00:00",
49752,1,17808,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017808Orig1s037ltr.pdf","2017-09-15 00:00:00",
48914,2,17810,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017810s019lbl.pdf","2017-07-06 00:00:00",
48918,1,17810,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017810Orig1s019ltr.pdf","2017-07-06 00:00:00",
13904,1,17812,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
13905,1,17812,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
13906,1,17812,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
13907,1,17812,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
709,1,17812,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
710,1,17812,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17812s21ltr.pdf","2001-06-14 00:00:00",
711,1,17812,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf","2003-01-31 00:00:00",
45709,1,17812,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf","2016-10-28 00:00:00",
45760,2,17812,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf","2016-11-01 00:00:00",
13908,1,17812,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf","2011-10-25 00:00:00",
33350,2,17812,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf","2011-10-25 00:00:00",
712,1,17814,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf","2005-03-29 00:00:00",
11067,2,17814,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf","2006-01-27 00:00:00",
13909,1,17814,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf","2007-02-02 00:00:00",
33351,2,17814,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf","2007-02-02 00:00:00",
713,1,17814,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf","2016-05-11 00:00:00",
11068,2,17814,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf","2016-05-11 00:00:00",
13910,1,17814,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf","2016-05-11 00:00:00",
33352,2,17814,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf","2016-05-11 00:00:00",
20089,3,17820,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17820-s036_doubtrex.pdf","1998-07-29 00:00:00",
714,1,17820,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17820slr037ltr.pdf","2002-07-23 00:00:00",
20090,3,17820,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-820_Dobutrex.cfm","2002-07-23 00:00:00",
13911,1,17821,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17821se8-045ltr.pdf","2004-06-04 00:00:00",
33353,2,17821,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017821s045lbl.pdf","2003-03-05 00:00:00",
40761,3,17821,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017821_S045_FLEXERIL.pdf","2008-04-02 00:00:00",
13912,1,17821,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017821Orig1s051ltr.pdf","2013-04-16 00:00:00",
33354,2,17821,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017821s051lbl.pdf","2013-04-16 00:00:00",
13913,1,17823,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17823s023ltr.pdf","2004-10-04 00:00:00",
33355,2,17823,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf","2004-10-04 00:00:00",
715,1,17824,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17824s024ltr.pdf","2004-10-04 00:00:00",
11069,2,17824,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf","2004-10-04 00:00:00",
716,1,17830,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
11070,2,17830,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
11071,2,17830,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
13914,1,17830,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
717,1,17830,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
33356,2,17830,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
13915,1,17830,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
33357,2,17830,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
11072,2,17830,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
13916,1,17830,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
718,1,17830,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf","2014-02-25 00:00:00",
11073,2,17830,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf","2014-02-25 00:00:00",
23537,10,17831,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
13917,1,17831,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17831s52ltr.pdf","2002-03-15 00:00:00",
719,1,17831,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17831slr053ltr.pdf","2004-02-27 00:00:00",
20091,3,17831,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/017831_S053_DIDRONEL_AP.pdf","2007-07-06 00:00:00",
33358,2,17831,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17831slr053_didronel_lbl.pdf","2004-04-05 00:00:00",
11074,2,17831,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017831s054lbl.pdf","2006-01-10 00:00:00",
13918,1,17831,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017831s054ltr.pdf","2006-01-20 00:00:00",
13919,1,17831,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017831s055ltr.pdf","2010-01-06 00:00:00",
33359,2,17831,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017831s055lbl.pdf","2010-01-04 00:00:00",
13920,1,17831,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017831Orig1s056ltr.pdf","2013-04-24 00:00:00",
33360,2,17831,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017831s056lbl.pdf","2013-04-23 00:00:00",
720,1,17831,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s057ltr.pdf","2015-03-19 00:00:00",
33361,2,17831,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s057lbl.pdf","2015-03-19 00:00:00",
11075,2,17831,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017831s058lbl.pdf","2015-04-10 00:00:00",
13921,1,17831,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017831Orig1s058ltr.pdf","2015-04-13 00:00:00",
721,1,17836,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17836scs008ltr.pdf","2004-06-10 00:00:00",
13922,1,17849,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr019ltr.pdf","2003-12-23 00:00:00",
20092,3,17853,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf","1998-11-06 00:00:00",
23108,8,17854,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf","2011-12-20 00:00:00",
20093,3,17854,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf","2001-06-18 00:00:00",
13923,1,17854,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr040ltr.pdf","2003-05-29 00:00:00",
13924,1,17854,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf","2002-11-25 00:00:00",
13925,1,17854,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr044ltr.pdf","2003-05-29 00:00:00",
13926,1,17854,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr045ltr.pdf","2003-05-29 00:00:00",
13927,1,17854,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17854s047ltr.pdf","2004-07-28 00:00:00",
33362,2,17854,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf","2004-07-28 00:00:00",
722,1,17854,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf","2009-07-06 00:00:00",
11076,2,17854,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf","2009-09-22 00:00:00",
40762,3,17854,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/017854_s051_reglan_tablets.pdf","2011-01-04 00:00:00",
723,1,17854,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf","2009-10-26 00:00:00",
11077,2,17854,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf","2009-10-08 00:00:00",
13928,1,17854,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf","2010-11-22 00:00:00",
33363,2,17854,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf","2010-11-26 00:00:00",
13929,1,17854,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s056ltr.pdf","2011-08-05 00:00:00",
11078,2,17854,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf","2011-09-23 00:00:00",
13930,1,17854,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s058ltr.pdf","2011-09-26 00:00:00",
49582,2,17854,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017854s062lbl.pdf","2017-08-30 00:00:00",
49633,1,17854,"SUPPL",62,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017854Orig1s062ltr.pdf","2017-08-30 00:00:00",
11079,2,17856,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf","2004-05-04 00:00:00",
13931,1,17856,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf","2004-04-29 00:00:00",
724,1,17858,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17858slr024ltr.pdf","2002-09-13 00:00:00",
11080,2,17858,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858s034lbl.pdf","2011-07-27 00:00:00",
13932,1,17858,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017858s034ltr.pdf","2011-07-26 00:00:00",
725,1,17858,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017858Orig1s035ltr.pdf","2012-08-16 00:00:00",
11081,2,17858,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858s035lbl.pdf","2012-08-15 00:00:00",
20094,3,17858,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/017858Orig1s035MedR.pdf","2012-09-12 00:00:00",
40763,3,17862,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf","2001-06-18 00:00:00",
13933,1,17862,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf","2002-11-25 00:00:00",
726,1,17862,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf","2004-04-29 00:00:00",
13934,1,17862,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf","2004-04-29 00:00:00",
727,1,17862,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017862s061ltr.pdf","2009-07-06 00:00:00",
11082,2,17862,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf","2009-07-09 00:00:00",
13935,1,17862,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017862s063ltr.pdf","2010-11-22 00:00:00",
33364,2,17862,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf","2010-11-26 00:00:00",
43599,8,17862,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf","2010-11-26 00:00:00",
13936,1,17863,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17863s040ltr.pdf","2002-07-03 00:00:00",
13937,1,17863,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17863slr042ltr.pdf","2004-03-28 00:00:00",
13938,1,17863,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17863slr043ltr.pdf","2002-09-03 00:00:00",
13939,1,17863,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17863slr045ltr.pdf","2003-08-14 00:00:00",
728,1,17865,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr038ltr.pdf","2002-07-17 00:00:00",
729,1,17865,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr040ltr.pdf","2002-09-03 00:00:00",
730,1,17865,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr041ltr.pdf","2002-09-03 00:00:00",
731,1,17865,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017865s045ltr.pdf","2006-03-01 00:00:00",
50113,1,17866,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017428Orig1s071,017866Orig1s052ltr.pdf","2017-10-19 00:00:00",
50151,2,17866,"SUPPL",52,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf","2017-10-23 00:00:00",
13940,1,17871,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17871slr011ltr.pdf","2003-06-08 00:00:00",
11083,2,17874,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf","2003-04-10 00:00:00",
13941,1,17874,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf","2001-07-26 00:00:00",
40764,3,17874,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf","2007-07-09 00:00:00",
732,1,17874,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf","2001-07-26 00:00:00",
11084,2,17874,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf","2003-04-11 00:00:00",
20095,3,17874,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf","2007-07-09 00:00:00",
13942,1,17874,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17874s032ltr.pdf","2002-03-22 00:00:00",
733,1,17874,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017874s035_ltr.pdf","2007-01-16 00:00:00",
11085,2,17874,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf","2013-05-30 00:00:00",
13943,1,17874,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017874Orig1s038ltr.pdf","2013-05-02 00:00:00",
54541,2,17874,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017874Orig1s042lbl.pdf","2018-06-12 00:00:00",
54542,1,17874,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017874Orig1s042ltr.pdf","2018-06-12 00:00:00",
734,1,17875,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf","2003-05-30 00:00:00",
49336,2,17875,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf","2017-08-11 00:00:00",
49393,1,17875,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036,017354Orig1s051,017875s037,017355Orig1s053ltr.pdf","2017-08-15 00:00:00",
735,1,17876,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf","2003-05-30 00:00:00",
49337,2,17876,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf","2017-08-11 00:00:00",
49391,1,17876,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036,017354Orig1s051,017875s037,017355Orig1s053ltr.pdf","2017-08-15 00:00:00",
736,1,17881,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17881scm004ltr.pdf","2002-07-23 00:00:00",
13944,1,17881,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017881s009ltr.pdf","2008-10-21 00:00:00",
737,1,17881,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017881s010ltr.pdf","2009-06-16 00:00:00",
11086,2,17881,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf","2009-06-10 00:00:00",
738,1,17881,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017881s016ltr.pdf","2011-09-28 00:00:00",
11087,2,17881,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf","2011-09-29 00:00:00",
739,1,17881,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017881Orig1s025ltr.pdf","2016-06-10 00:00:00",
50157,2,17881,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf","2017-10-24 00:00:00",
23538,10,17892,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
13945,1,17892,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17892slr034ltr.pdf","2003-07-06 00:00:00",
20096,3,17892,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017892_s034_HalcionTOC.cfm","2006-05-08 00:00:00",
740,1,17892,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017892s038ltr.pdf","2008-02-14 00:00:00",
11088,2,17892,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf","2008-02-14 00:00:00",
13946,1,17892,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017892Orig1s047ltr.pdf","2014-09-23 00:00:00",
33365,2,17892,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf","2014-09-22 00:00:00",
46315,2,17892,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf","2016-12-20 00:00:00",
46463,1,17892,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017892Orig1s049ltr.pdf","2016-12-22 00:00:00",
46630,8,17892,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf#page=13","2016-12-30 00:00:00",
43601,8,17911,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf","2009-11-16 00:00:00",
741,1,17911,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s065ltr.pdf","2006-10-13 00:00:00",
33366,2,17911,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf","2006-10-11 00:00:00",
742,1,17911,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s068ltr.pdf","2006-01-30 00:00:00",
11089,2,17911,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf","2006-01-25 00:00:00",
743,1,17911,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017911s070ltr.pdf","2007-08-27 00:00:00",
11090,2,17911,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf","2007-08-27 00:00:00",
13947,1,17911,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017911s072ltr.pdf","2009-04-03 00:00:00",
33367,2,17911,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf","2009-04-03 00:00:00",
11091,2,17911,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf","2010-06-07 00:00:00",
13948,1,17911,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s073ltr.pdf","2010-06-10 00:00:00",
744,1,17911,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s074ltr.pdf","2010-12-28 00:00:00",
33368,2,17911,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf","2010-12-26 00:00:00",
13949,1,17919,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
33369,2,17919,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf","2013-10-04 00:00:00",
11092,2,17919,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf","2012-07-13 00:00:00",
13950,1,17919,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
13951,1,17919,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
13952,1,17919,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
745,1,17919,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
746,1,17919,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf","2015-11-04 00:00:00",
11093,2,17919,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf","2015-11-04 00:00:00",
49320,2,17919,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf","2017-08-10 00:00:00",
49472,2,17919,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf","2017-08-21 00:00:00",
13953,1,17920,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017920s094ltr.pdf","2005-12-16 00:00:00",
747,1,17920,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017920s095_ltr.pdf","2006-07-21 00:00:00",
44015,10,17922,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2007-12-04 00:00:00",
748,1,17922,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf","2003-11-25 00:00:00",
13954,1,17922,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-17 00:00:00",
33370,2,17922,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-16 00:00:00",
11094,2,17922,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf","2007-11-07 00:00:00",
13955,1,17922,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf","2007-11-08 00:00:00",
749,1,17922,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf","2015-11-09 00:00:00",
33371,2,17922,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf","2015-11-19 00:00:00",
750,1,17923,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF","2001-03-15 00:00:00",
13956,1,17931,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17931s25ltr.pdf","2002-02-11 00:00:00",
751,1,17936,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17931s25ltr.pdf","2002-02-11 00:00:00",
752,1,17938,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf","2001-05-22 00:00:00",
753,1,17943,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17943slr016ltr.pdf","2002-08-26 00:00:00",
33372,2,17943,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17943s16lbl.pdf","2002-08-26 00:00:00",
754,1,17943,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017943s017ltr.pdf","2006-01-20 00:00:00",
13957,1,17944,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17944slr018ltr.pdf","2003-11-25 00:00:00",
49313,2,17948,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf","2017-08-10 00:00:00",
49398,1,17948,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018926Orig1s011,017948Orig1s044ltr.pdf","2017-08-15 00:00:00",
53254,3,17948,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/017948s045,018926s012lbl.pdf","2018-03-23 00:00:00",
53488,1,17948,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf","2018-03-28 00:00:00",
13958,1,17950,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17950slr021ltr.pdf","2003-03-25 00:00:00",
33373,2,17950,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.pdf","2003-03-25 00:00:00",
11095,2,17955,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13959,1,17955,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
11096,2,17955,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
13960,1,17955,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
755,1,17955,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33374,2,17955,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
756,1,17957,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17957slr032ltr.pdf","2003-05-29 00:00:00",
757,1,17957,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17957s039ltr.pdf","2005-01-13 00:00:00",
11097,2,17962,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf","2005-11-17 00:00:00",
13961,1,17962,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf","2005-11-17 00:00:00",
20097,3,17962,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm","2006-05-08 00:00:00",
13962,1,17962,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf","2005-11-17 00:00:00",
33375,2,17962,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf","2005-11-17 00:00:00",
40765,3,17962,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm","2006-05-08 00:00:00",
13963,1,17962,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf","2012-01-06 00:00:00",
33376,2,17962,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf","2012-01-06 00:00:00",
11098,2,17962,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf","2012-01-06 00:00:00",
13964,1,17962,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf","2012-01-06 00:00:00",
13965,1,17963,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf","2003-09-25 00:00:00",
758,1,17963,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf","2006-09-18 00:00:00",
13966,1,17963,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf","2008-01-09 00:00:00",
759,1,17963,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf","2008-07-30 00:00:00",
33377,2,17963,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf","2008-07-29 00:00:00",
760,1,17963,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf","2010-01-06 00:00:00",
33378,2,17963,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf","2009-11-23 00:00:00",
33379,2,17963,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf","2011-03-21 00:00:00",
761,1,17963,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017963Orig1s067ltr.pdf","2012-12-26 00:00:00",
11099,2,17963,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf","2013-01-11 00:00:00",
13967,1,17963,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017963Orig1s068ltr.pdf","2013-03-15 00:00:00",
43602,8,17970,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf","2009-11-19 00:00:00",
40766,3,17970,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017970_S018_Nolvadex.pdf","2009-09-14 00:00:00",
11101,2,17970,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf","2002-05-16 00:00:00",
13968,1,17970,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf","2002-05-16 00:00:00",
11102,2,17970,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf","1998-10-29 00:00:00",
13969,1,17970,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s39.pdf","1998-10-29 00:00:00",
40767,3,17970,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm","1998-10-29 00:00:00",
762,1,17970,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/17970s40.pdf","1998-10-29 00:00:00",
20098,3,17970,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17970S39S40.cfm","1998-10-29 00:00:00",
33380,2,17970,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/17970.pdf","1998-10-29 00:00:00",
763,1,17970,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf","2002-05-16 00:00:00",
33381,2,17970,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf","2002-05-16 00:00:00",
13970,1,17970,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/17970S46LTR.PDF","2000-06-29 00:00:00",
33382,2,17970,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/17970S46LBL.PDF","2000-06-29 00:00:00",
40768,3,17970,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/17-970S046_Nolvadex.cfm","2000-06-29 00:00:00",
764,1,17970,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17970slr048ltr.pdf","2003-06-22 00:00:00",
11103,2,17970,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17970slr048_nolvadex_lbl.pdf","2003-06-22 00:00:00",
765,1,17970,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17970s037ltr.pdf","2002-05-16 00:00:00",
20099,3,17970,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm","2003-07-05 00:00:00",
33383,2,17970,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17970s37s44s49lbl.pdf","2002-05-16 00:00:00",
11104,2,17970,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21109lbl,17970s50lbl.pdf","2002-08-30 00:00:00",
13971,1,17970,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21109and17970slr050ltr.pdf","2002-08-30 00:00:00",
40769,3,17970,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21109_Nolvadex.cfm","2003-03-07 00:00:00",
13972,1,17970,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_Approv.pdf","2004-06-10 00:00:00",
20100,3,17970,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex.cfm","2003-07-05 00:00:00",
33384,2,17970,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/17-970S049FA_Nolvadex_prntlbl.pdf","2004-06-10 00:00:00",
766,1,17970,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17970s052ltr.pdf","2004-12-30 00:00:00",
11105,2,17970,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17970s052lbl.pdf","2004-12-30 00:00:00",
53729,3,17970,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/017970Orig1s052.pdf","2018-04-18 00:00:00",
767,1,17970,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17970s053ltr.pdf","2005-03-23 00:00:00",
33385,2,17970,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf","2005-03-23 00:00:00",
768,1,17970,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017970s054ltr.pdf","2006-03-23 00:00:00",
33386,2,17970,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017970s054lbl.pdf","2006-03-14 00:00:00",
11106,2,17971,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf","2004-06-03 00:00:00",
13973,1,17971,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf","2004-06-03 00:00:00",
769,1,17989,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017989Orig1s019ltr.pdf","2013-12-13 00:00:00",
11107,2,17989,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017989s019lbl.pdf","2013-12-17 00:00:00",
770,1,17994,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17994slr022ltr.pdf","2003-06-08 00:00:00",
11108,2,17994,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17994slr022_psorcon_lbl.pdf","2003-06-08 00:00:00",
50192,2,17994,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017994s026lbl.pdf","2017-10-26 00:00:00",
50226,1,17994,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf","2017-10-30 00:00:00",
13974,1,18008,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf","2003-05-29 00:00:00",
771,1,18008,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf","2004-06-07 00:00:00",
11109,2,18008,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
13975,1,18008,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
772,1,18008,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf","2007-05-01 00:00:00",
33387,2,18008,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf","2007-04-25 00:00:00",
773,1,18008,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf","2013-09-12 00:00:00",
33388,2,18008,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf","2013-09-11 00:00:00",
43603,8,18012,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf","2009-11-20 00:00:00",
44016,10,18012,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
33389,2,18012,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf","2003-04-11 00:00:00",
40770,3,18012,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018012_s024_PAMELOR CAPSULES.pdf","2009-09-14 00:00:00",
774,1,18012,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf","2005-01-13 00:00:00",
11110,2,18012,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf","2005-01-13 00:00:00",
775,1,18012,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf","2007-07-24 00:00:00",
33390,2,18012,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf","2007-07-16 00:00:00",
776,1,18012,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf","2012-10-29 00:00:00",
11111,2,18012,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf","2012-10-26 00:00:00",
777,1,18012,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf","2014-07-11 00:00:00",
11112,2,18012,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf","2014-07-11 00:00:00",
13976,1,18012,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf","2014-07-29 00:00:00",
33391,2,18012,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf","2014-07-29 00:00:00",
23111,8,18013,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf","2009-11-20 00:00:00",
23539,10,18013,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
20101,3,18013,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018013_s053_PAMELOR CAPSULES.pdf","2009-09-14 00:00:00",
11113,2,18013,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf","2005-01-13 00:00:00",
13977,1,18013,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf","2005-01-13 00:00:00",
778,1,18013,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf","2007-07-24 00:00:00",
33392,2,18013,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf","2007-07-16 00:00:00",
13978,1,18013,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf","2012-10-29 00:00:00",
33393,2,18013,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf","2012-10-26 00:00:00",
11114,2,18013,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf","2014-07-11 00:00:00",
13979,1,18013,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf","2014-07-11 00:00:00",
779,1,18013,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf","2014-07-29 00:00:00",
11115,2,18013,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf","2014-07-29 00:00:00",
780,1,18016,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
781,1,18016,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18016scp053ltr.pdf","2003-07-28 00:00:00",
11116,2,18016,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf","2005-05-25 00:00:00",
13980,1,18016,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018016s056ltr.pdf","2005-05-25 00:00:00",
782,1,18016,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
11117,2,18016,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
783,1,18016,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf","2013-09-13 00:00:00",
11118,2,18016,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf","2013-09-17 00:00:00",
784,1,18016,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf","2014-12-30 00:00:00",
11119,2,18016,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf","2015-01-08 00:00:00",
785,1,18017,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18017slr036ltr.pdf","2003-03-10 00:00:00",
20102,3,18017,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18-017s036_Blocadren.cfm","2003-07-05 00:00:00",
13981,1,18017,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18017s037ltr.pdf","2002-03-27 00:00:00",
40771,3,18017,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-017S037.pdf","2002-05-30 00:00:00",
44017,10,18021,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
786,1,18024,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18024slr036ltr.pdf","2003-05-30 00:00:00",
40772,3,18024,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018024_S036_NUBAIN_INJECTION.pdf","2007-07-18 00:00:00",
13982,1,18024,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018024s040ltr.pdf","2005-08-31 00:00:00",
20103,3,18024,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018024_S040_NUBAIN.pdf","2007-08-06 00:00:00",
33394,2,18024,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018024s040lbl.pdf","2005-08-31 00:00:00",
46213,1,18024,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018024Orig1s041ltr.pdf","2016-12-19 00:00:00",
46404,2,18024,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018024s041lbl.pdf","2016-12-21 00:00:00",
787,1,18027,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf","2002-10-07 00:00:00",
33395,2,18027,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf","2002-10-07 00:00:00",
13983,1,18027,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf","2002-10-07 00:00:00",
33396,2,18027,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf","2002-10-07 00:00:00",
11120,2,18027,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf","2002-10-07 00:00:00",
13984,1,18027,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf","2002-10-07 00:00:00",
788,1,18027,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s051ltr.pdf","2006-04-13 00:00:00",
789,1,18027,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s055LTR.pdf","2006-10-05 00:00:00",
40773,3,18027,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018027_s055_lithobid_LBL.pdf","2008-04-02 00:00:00",
790,1,18027,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018027s056ltr.pdf","2011-10-24 00:00:00",
11121,2,18027,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf","2011-10-25 00:00:00",
791,1,18027,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018027Orig1s059ltr.pdf","2016-06-01 00:00:00",
33397,2,18027,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf","2016-06-01 00:00:00",
53996,1,18027,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018027Orig1s064ltr.pdf","2018-05-03 00:00:00",
54010,2,18027,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s064lbl.pdf","2018-05-03 00:00:00",
44018,10,18029,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
792,1,18029,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf","2004-05-27 00:00:00",
793,1,18029,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf","2004-05-27 00:00:00",
794,1,18029,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf","2002-01-11 00:00:00",
13985,1,18029,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
33398,2,18029,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
795,1,18029,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
11122,2,18029,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
796,1,18029,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf","2007-05-01 00:00:00",
33399,2,18029,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf","2007-05-01 00:00:00",
797,1,18029,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf","2010-11-18 00:00:00",
33400,2,18029,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf","2010-11-17 00:00:00",
798,1,18029,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf","2010-12-15 00:00:00",
11123,2,18029,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf","2010-12-10 00:00:00",
11124,2,18029,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf","2013-06-11 00:00:00",
13986,1,18029,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf","2013-06-11 00:00:00",
13987,1,18029,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf","2013-12-16 00:00:00",
33401,2,18029,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf","2013-12-17 00:00:00",
799,1,18029,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf","2015-04-21 00:00:00",
11125,2,18029,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf","2015-04-21 00:00:00",
46706,2,18029,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf","2017-01-06 00:00:00",
46825,8,18029,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf#page=14","2017-01-13 00:00:00",
46826,1,18029,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf","2017-01-13 00:00:00",
800,1,18031,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18031slr032ltr.pdf","2004-06-10 00:00:00",
13988,1,18031,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018031s033ltr.pdf","2007-01-08 00:00:00",
801,1,18031,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf","2007-03-06 00:00:00",
11126,2,18031,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf","2008-01-08 00:00:00",
13989,1,18031,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018031s035ltr.pdf","2008-01-09 00:00:00",
11127,2,18031,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf","2010-03-05 00:00:00",
13990,1,18031,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018031s036ltr.pdf","2010-03-08 00:00:00",
13991,1,18031,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf","2011-03-23 00:00:00",
33402,2,18031,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf","2011-03-21 00:00:00",
802,1,18031,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf","2011-03-23 00:00:00",
11128,2,18031,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf","2011-03-21 00:00:00",
20104,3,18035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-035_Technescan%20MDP.pdf","2002-08-14 00:00:00",
803,1,18035,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18035scm017ltr.pdf","2002-07-03 00:00:00",
804,1,18035,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18035scr018ltr.pdf","2004-03-02 00:00:00",
805,1,18035,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018035s024ltr.pdf","2009-07-13 00:00:00",
33403,2,18035,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf","2009-07-09 00:00:00",
13992,1,18035,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018035s029ltr.pdf","2010-10-26 00:00:00",
33404,2,18035,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf","2010-10-25 00:00:00",
11129,2,18035,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf","2011-09-29 00:00:00",
13993,1,18035,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018035s032ltr.pdf","2011-09-28 00:00:00",
806,1,18037,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf","2003-05-29 00:00:00",
13994,1,18037,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf","2004-06-07 00:00:00",
807,1,18037,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33405,2,18037,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
11130,2,18037,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf","2007-04-25 00:00:00",
13995,1,18037,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf","2007-05-01 00:00:00",
808,1,18037,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf","2013-09-12 00:00:00",
11131,2,18037,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf","2013-09-11 00:00:00",
47333,2,18039,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf","2017-02-24 00:00:00",
47411,1,18039,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf","2017-03-02 00:00:00",
20105,3,18044,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf","1998-05-06 00:00:00",
40774,3,18044,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf","1998-05-06 00:00:00",
40775,3,18044,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf","1998-05-06 00:00:00",
13996,1,18044,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18044s25ltr.pdf","2004-06-16 00:00:00",
13997,1,18044,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf","2002-02-01 00:00:00",
809,1,18044,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf","2004-07-08 00:00:00",
810,1,18044,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018044s038ltr.pdf","2010-03-03 00:00:00",
811,1,18045,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18045s16ltr.pdf","2002-01-18 00:00:00",
812,1,18045,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18045slr021ltr.pdf","2003-10-29 00:00:00",
11132,2,18045,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf","2003-10-31 00:00:00",
813,1,18045,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018045s023ltr.pdf","2008-07-14 00:00:00",
11133,2,18045,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf","2008-07-10 00:00:00",
814,1,18052,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018052s032ltr.pdf","2010-04-14 00:00:00",
33406,2,18052,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf","2015-01-12 00:00:00",
11134,2,18053,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf","2015-07-13 00:00:00",
13998,1,18053,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018053Orig1s055ltr.pdf","2015-07-13 00:00:00",
815,1,18057,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18057slr076ltr.pdf","2002-11-08 00:00:00",
816,1,18057,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018057s079ltr.pdf","2010-09-07 00:00:00",
11135,2,18057,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf","2010-09-07 00:00:00",
11136,2,18057,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf","2011-08-30 00:00:00",
13999,1,18057,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s080ltr.pdf","2011-08-31 00:00:00",
14000,1,18057,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s081ltr.pdf","2012-01-03 00:00:00",
33407,2,18057,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf","2012-01-11 00:00:00",
11137,2,18057,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf","2015-03-02 00:00:00",
14001,1,18057,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018057Orig1s083ltr.pdf","2015-02-27 00:00:00",
20106,3,18060,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-060S055.pdf","2003-09-11 00:00:00",
817,1,18060,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018060s063ltr.pdf","2010-05-03 00:00:00",
14002,1,18060,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018060s065ltr.pdf","2011-11-03 00:00:00",
11138,2,18060,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf","2014-04-16 00:00:00",
14003,1,18060,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018060Orig1s066ltr.pdf","2014-03-27 00:00:00",
14004,1,18061,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18061slr029ltr.pdf","2003-03-10 00:00:00",
11139,2,18063,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf","2008-02-14 00:00:00",
14005,1,18063,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018063s060ltr.pdf","2008-02-07 00:00:00",
818,1,18063,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018063s062ltr.pdf","2011-06-07 00:00:00",
33408,2,18063,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf","2011-06-27 00:00:00",
14006,1,18063,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018063Orig1s063ltr.pdf","2013-07-16 00:00:00",
33409,2,18063,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf","2013-07-15 00:00:00",
14007,1,18066,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf","2002-05-30 00:00:00",
14008,1,18066,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf","2002-05-30 00:00:00",
14009,1,18066,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018066Orig1s020ltr.pdf","2013-09-13 00:00:00",
33410,2,18066,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018066Orig1s020lbl.pdf","2013-09-24 00:00:00",
11140,2,18067,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf","2002-08-01 00:00:00",
14010,1,18067,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18067slr029ltr.pdf","2002-08-01 00:00:00",
819,1,18074,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018074s034ltr.pdf","2012-02-14 00:00:00",
33411,2,18074,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf","2012-02-24 00:00:00",
23540,10,18081,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
820,1,18081,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
14011,1,18081,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s042ltr.pdf","2006-01-20 00:00:00",
33412,2,18081,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
14012,1,18081,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
33413,2,18081,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
821,1,18081,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33414,2,18081,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
822,1,18081,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032ltr.pdf","2009-05-01 00:00:00",
14013,1,18081,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33415,2,18081,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
11141,2,18081,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf","2014-06-23 00:00:00",
14014,1,18081,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
11142,2,18081,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
14015,1,18081,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
823,1,18081,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11143,2,18081,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
14016,1,18081,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
33416,2,18081,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.pdf","2013-03-04 00:00:00",
11144,2,18081,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s056lbl.pdf","2013-09-17 00:00:00",
14017,1,18081,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
33417,2,18081,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.pdf","2013-07-02 00:00:00",
11145,2,18081,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf","2014-12-03 00:00:00",
14018,1,18081,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
11146,2,18081,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf","2015-01-08 00:00:00",
14019,1,18081,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
824,1,18081,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
11147,2,18081,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
14020,1,18081,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
33418,2,18081,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf","2014-08-22 00:00:00",
14021,1,18081,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
33419,2,18081,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf","2015-03-17 00:00:00",
14022,1,18081,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
33420,2,18081,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf","2015-10-06 00:00:00",
825,1,18081,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
33421,2,18081,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf","2016-02-23 00:00:00",
45810,1,18081,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45840,2,18081,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s065_018082s048lbl.pdf","2016-11-08 00:00:00",
47479,2,18081,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018081s066,018082s049lbl.pdf","2017-03-07 00:00:00",
47489,8,18081,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s036lbl.pdf#page=45","2017-03-08 00:00:00",
47509,1,18081,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49985,1,18081,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
49998,2,18081,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018081s067,018082s050lbl.pdf","2017-10-10 00:00:00",
54065,1,18081,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54085,2,18081,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068 018082Orig1s051lbl.pdf","2018-05-10 00:00:00",
44019,10,18082,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
826,1,18082,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
827,1,18082,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018082s026ltr.pdf","2006-01-20 00:00:00",
33422,2,18082,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
14023,1,18082,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
33423,2,18082,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
11148,2,18082,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
14024,1,18082,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
14025,1,18082,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032ltr.pdf","2009-05-01 00:00:00",
33424,2,18082,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018081s047,018082s032lbl.pdf","2009-05-12 00:00:00",
828,1,18082,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11149,2,18082,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
829,1,18082,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
33425,2,18082,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf","2014-06-23 00:00:00",
830,1,18082,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33426,2,18082,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
14026,1,18082,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33427,2,18082,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf","2011-10-12 00:00:00",
14027,1,18082,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
33428,2,18082,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.pdf","2013-03-04 00:00:00",
831,1,18082,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
11150,2,18082,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081S056lbl.pdf","2013-09-17 00:00:00",
33429,2,18082,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.pdf","2013-07-02 00:00:00",
14028,1,18082,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
33430,2,18082,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf","2014-12-03 00:00:00",
832,1,18082,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
33431,2,18082,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf","2015-01-08 00:00:00",
833,1,18082,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
11151,2,18082,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
11152,2,18082,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf","2014-08-22 00:00:00",
14029,1,18082,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
834,1,18082,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
11153,2,18082,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf","2015-03-17 00:00:00",
835,1,18082,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
11154,2,18082,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf","2015-10-06 00:00:00",
11155,2,18082,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf","2016-02-23 00:00:00",
14030,1,18082,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
45811,1,18082,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45841,2,18082,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s065_018082s048lbl.pdf","2016-11-08 00:00:00",
47480,2,18082,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018081s066,018082s049lbl.pdf","2017-03-07 00:00:00",
47490,8,18082,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s036lbl.pdf#page=45","2017-03-08 00:00:00",
47508,1,18082,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49984,1,18082,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
49999,2,18082,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018081s067,018082s050lbl.pdf","2017-10-10 00:00:00",
54066,1,18082,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54086,2,18082,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068 018082Orig1s051lbl.pdf","2018-05-10 00:00:00",
43604,8,18084,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf","2009-12-04 00:00:00",
836,1,18084,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf","2006-02-22 00:00:00",
11156,2,18084,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf","2006-02-22 00:00:00",
11157,2,18084,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf","2008-01-24 00:00:00",
14031,1,18084,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018084s052ltr.pdf","2008-01-24 00:00:00",
40776,3,18086,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-086S047.pdf","2003-09-11 00:00:00",
40777,3,18086,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-086S052.pdf","2003-09-11 00:00:00",
837,1,18086,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086S54ltr.pdf","2004-06-28 00:00:00",
11158,2,18086,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf","2001-04-12 00:00:00",
14032,1,18086,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086s058.pdf","2002-04-29 00:00:00",
33432,2,18086,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf","2002-04-29 00:00:00",
11159,2,18086,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf","2003-12-29 00:00:00",
14910,1,18086,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18086scs060ltr.pdf","2003-12-24 00:00:00",
20107,3,18086,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018086_s060_TimopticTOC.cfm","2006-05-08 00:00:00",
11160,2,18086,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf","2006-05-01 00:00:00",
14911,1,18086,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf","2006-05-01 00:00:00",
838,1,18086,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf","2006-05-01 00:00:00",
33433,2,18086,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf","2006-05-01 00:00:00",
14912,1,18086,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018086s075ltr.pdf","2011-10-03 00:00:00",
33434,2,18086,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf","2011-09-30 00:00:00",
45016,2,18086,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf","2016-08-09 00:00:00",
45018,1,18086,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018086Orig1s076ltr.pdf","2016-08-09 00:00:00",
49762,2,18090,"SUPPL",75,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/018090s075lbl.pdf","2017-09-18 00:00:00",
49829,2,18090,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018090sS116lbl.pdf","2017-09-21 00:00:00",
49833,1,18090,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018090Orig1s116ltr.pdf","2017-09-22 00:00:00",
839,1,18101,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf","2003-11-25 00:00:00",
11161,2,18101,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf","2004-04-27 00:00:00",
40778,3,18101,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm","2006-05-08 00:00:00",
840,1,18101,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf","2007-03-07 00:00:00",
11162,2,18101,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf","2007-03-07 00:00:00",
841,1,18101,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf","2008-09-26 00:00:00",
11163,2,18101,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf","2008-10-03 00:00:00",
842,1,18101,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf","2009-02-03 00:00:00",
33435,2,18101,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf","2009-02-04 00:00:00",
843,1,18107,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018107s011ltr.pdf","2008-11-28 00:00:00",
14913,1,18110,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018110s012ltr.pdf","2005-05-17 00:00:00",
20108,3,18117,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18117s029_azmacort_approv_prntlbl_medr_admindocs_corres.pdf","2004-05-27 00:00:00",
14914,1,18117,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018117s030ltr.pdf","2007-04-20 00:00:00",
33436,2,18117,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018117s030lbl.pdf","2007-04-20 00:00:00",
844,1,18117,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr032ltr.pdf","2003-09-25 00:00:00",
11164,2,18117,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.pdf","2003-09-25 00:00:00",
845,1,18117,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr033ltr.pdf","2003-12-23 00:00:00",
11165,2,18117,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.pdf","2003-12-29 00:00:00",
846,1,18117,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr034ltr.pdf","2004-01-09 00:00:00",
33437,2,18117,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr034_azmacort_lbl.pdf","2004-01-15 00:00:00",
847,1,18117,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018117s037_ltr.pdf","2006-09-18 00:00:00",
848,1,18117,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018117s042ltr.pdf","2008-03-17 00:00:00",
11166,2,18117,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf","2008-03-17 00:00:00",
20109,3,18118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018118_lanoxicaps_toc.cfm","2003-08-05 00:00:00",
40779,3,18118,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/9330-s020_lanoxin.pdf","2001-09-14 00:00:00",
14915,1,18123,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18123scs014ltr.pdf","2002-07-19 00:00:00",
14916,1,18124,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf","2005-04-28 00:00:00",
33438,2,18124,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf","2005-04-28 00:00:00",
849,1,18132,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826Orig1s045ltr.pdf","2014-05-19 00:00:00",
33439,2,18132,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf","2014-05-15 00:00:00",
20110,3,18140,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018140ap_s003.pdf","1997-10-05 00:00:00",
40780,3,18140,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018140_S027_ATIVAN_INJECTION_AP.pdf","2007-04-09 00:00:00",
850,1,18140,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018140s028ltr.pdf","2006-12-28 00:00:00",
11167,2,18140,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf","2006-12-04 00:00:00",
14917,1,18140,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018140Orig1s040ltr.pdf","2016-05-31 00:00:00",
47209,2,18140,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018140s040lbl.pdf","2017-02-15 00:00:00",
48194,1,18140,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf","2017-05-02 00:00:00",
48223,2,18140,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf","2017-05-02 00:00:00",
48195,1,18140,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf","2017-05-02 00:00:00",
48224,2,18140,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf","2017-05-02 00:00:00",
851,1,18141,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018141s029_ltr.pdf","2007-09-07 00:00:00",
33440,2,18141,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf","2007-09-06 00:00:00",
14918,1,18147,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18147slr028ltr.pdf","2004-06-04 00:00:00",
11168,2,18147,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf","2006-01-25 00:00:00",
14919,1,18147,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018147s029ltr.pdf","2006-01-30 00:00:00",
14920,1,18147,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018147s030_ltr.pdf","2007-07-10 00:00:00",
33441,2,18147,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf","2007-07-06 00:00:00",
852,1,18147,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018147s032ltr.pdf","2010-09-07 00:00:00",
11169,2,18147,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf","2010-08-28 00:00:00",
43606,8,18147,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032MedGuide.pdf","2010-08-28 00:00:00",
11170,2,18147,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf","2015-03-04 00:00:00",
14921,1,18147,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf","2015-03-02 00:00:00",
14922,1,18147,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf","2015-03-02 00:00:00",
33442,2,18147,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf","2015-03-04 00:00:00",
853,1,18147,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf","2015-03-02 00:00:00",
11171,2,18147,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf","2015-03-04 00:00:00",
14923,1,18147,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf","2015-03-02 00:00:00",
33443,2,18147,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf","2015-03-04 00:00:00",
854,1,18147,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf","2015-03-02 00:00:00",
11172,2,18147,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf","2015-03-04 00:00:00",
855,1,18147,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018147Orig1s044ltr.pdf","2016-05-11 00:00:00",
33444,2,18147,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf","2016-05-11 00:00:00",
20111,3,18148,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18148s023_nasalide.pdf","1999-02-25 00:00:00",
14924,1,18148,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf","2002-05-09 00:00:00",
14925,1,18148,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf","2002-05-09 00:00:00",
14926,1,18150,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150s019ltr.pdf","2004-07-28 00:00:00",
33445,2,18150,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.pdf","2004-07-28 00:00:00",
40781,3,18150,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018150_S019_Thallous Chloride T1-201_APPROVAL_PACKAGE.pdf","2006-10-26 00:00:00",
14927,1,18150,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150scs020ltr.pdf","2004-04-20 00:00:00",
856,1,18150,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018150s025ltr.pdf","2011-06-27 00:00:00",
33446,2,18150,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf","2011-06-29 00:00:00",
857,1,18150,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018150s026ltr.pdf","2012-01-18 00:00:00",
33447,2,18150,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf","2012-01-26 00:00:00",
858,1,18150,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018150Orig1s027ltr.pdf","2016-07-14 00:00:00",
47804,2,18150,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018150s027lbl.pdf","2017-03-31 00:00:00",
14928,1,18152,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
14929,1,18152,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
859,1,18152,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
860,1,18152,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
14930,1,18152,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
14931,1,18152,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf","2002-05-08 00:00:00",
14932,1,18152,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860slr073,17971slr019,18152slr017ltr.pdf","2004-06-03 00:00:00",
14933,1,18152,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf","2004-03-16 00:00:00",
33448,2,18152,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf","2004-04-05 00:00:00",
861,1,18154,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18154slr023ltr.pdf","2002-07-09 00:00:00",
11173,2,18154,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","2015-01-14 00:00:00",
14934,1,18154,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018154Orig1s026ltr.pdf","2015-01-15 00:00:00",
44020,10,18163,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
862,1,18163,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18163s053ltr.pdf","2002-06-03 00:00:00",
11174,2,18163,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf","2010-11-12 00:00:00",
14935,1,18163,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018163s054ltr.pdf","2010-11-12 00:00:00",
14936,1,18163,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18163s057ltr.pdf","2004-11-08 00:00:00",
863,1,18163,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf","2008-02-27 00:00:00",
33449,2,18163,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf","2008-02-26 00:00:00",
11175,2,18163,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf","2008-02-26 00:00:00",
14937,1,18163,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf","2008-02-27 00:00:00",
46313,2,18163,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf","2016-12-20 00:00:00",
46464,1,18163,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018163Orig1s064ltr.pdf","2016-12-22 00:00:00",
46631,8,18163,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf#page=13","2016-12-30 00:00:00",
44021,10,18164,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2005-07-28 00:00:00",
864,1,18164,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf","2003-05-29 00:00:00",
865,1,18164,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
33450,2,18164,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
866,1,18164,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
33451,2,18164,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
867,1,18164,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf","2006-03-23 00:00:00",
33452,2,18164,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf","2006-03-14 00:00:00",
14938,1,18164,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf","2006-01-30 00:00:00",
33453,2,18164,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf","2006-01-25 00:00:00",
14939,1,18164,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf","2007-04-25 00:00:00",
868,1,18164,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf","2007-09-25 00:00:00",
33454,2,18164,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf","2007-09-26 00:00:00",
869,1,18164,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf","2008-07-30 00:00:00",
11176,2,18164,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf","2008-07-29 00:00:00",
11177,2,18164,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf","2013-03-26 00:00:00",
14940,1,18164,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf","2013-03-26 00:00:00",
11178,2,18164,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf","2016-05-11 00:00:00",
14941,1,18164,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf","2016-05-11 00:00:00",
47537,2,18164,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf","2017-03-13 00:00:00",
47538,8,18164,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22","2017-03-13 00:00:00",
47560,1,18164,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017581Orig1s113,018164Orig1s063,020067Orig1s020ltr.pdf","2017-03-14 00:00:00",
11179,2,18185,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf","2016-05-11 00:00:00",
14942,1,18185,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf","2016-05-11 00:00:00",
23116,8,18185,"SUPPL",55,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501640.pdf","2016-05-18 00:00:00",
870,1,18185,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf","2016-05-11 00:00:00",
11180,2,18185,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf","2016-05-11 00:00:00",
871,1,18200,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18200s24ltr.pdf","2002-03-21 00:00:00",
33455,2,18200,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf","2002-03-21 00:00:00",
40782,3,18200,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200s024_Midamor.cfm","2002-05-30 00:00:00",
14943,1,18200,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18200slr026,18201slr040ltr.pdf","2003-03-10 00:00:00",
11181,2,18201,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf","2002-03-21 00:00:00",
14944,1,18201,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18200s24ltr.pdf","2002-03-21 00:00:00",
20112,3,18201,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200s024_Midamor.cfm","2002-05-30 00:00:00",
14945,1,18201,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18200slr026,18201slr040ltr.pdf","2003-03-10 00:00:00",
872,1,18202,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18202slr021ltr.pdf","2003-05-30 00:00:00",
11182,2,18202,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf","2003-05-13 00:00:00",
50102,1,18206,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018206Orig1s020ltr.pdf","2017-10-19 00:00:00",
50181,2,18206,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018206s020lbl.pdf","2017-10-25 00:00:00",
49314,2,18206,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017612s043,018206s021lbl.pdf","2017-08-10 00:00:00",
49389,1,18206,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017612Orig1s043,018206Orig1s021ltr.pdf","2017-08-15 00:00:00",
23541,10,18207,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
873,1,18207,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18207slr029ltr.pdf","2004-03-19 00:00:00",
874,1,18207,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18207s030ltr.pdf","2005-01-13 00:00:00",
33456,2,18207,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18207s030lbl.pdf","2005-01-13 00:00:00",
14946,1,18207,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018207Orig1s031ltr.pdf","2014-07-21 00:00:00",
48892,2,18207,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf","2017-07-03 00:00:00",
48893,8,18207,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13","2017-07-03 00:00:00",
48907,1,18207,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018207Orig1s032ltr.pdf","2017-07-05 00:00:00",
11183,2,18211,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
20113,3,18211,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf","2009-09-14 00:00:00",
875,1,18211,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf","2003-05-29 00:00:00",
33457,2,18211,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
40783,3,18211,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf","2009-09-14 00:00:00",
14947,1,18211,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018211s017ltr.pdf","2008-02-13 00:00:00",
33458,2,18211,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf","2008-02-14 00:00:00",
14948,1,18225,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf","2002-10-29 00:00:00",
33459,2,18225,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf","2002-10-29 00:00:00",
40784,3,18225,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm","2003-03-07 00:00:00",
876,1,18225,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf","2002-10-29 00:00:00",
11184,2,18225,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf","2002-10-29 00:00:00",
20114,3,18225,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm","2003-03-07 00:00:00",
14949,1,18225,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18225slr022ltr.pdf","2003-06-08 00:00:00",
877,1,18225,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018225s024ltr.pdf","2010-01-26 00:00:00",
11185,2,18225,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf","2010-01-24 00:00:00",
48252,2,18225,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf","2017-05-05 00:00:00",
48316,1,18225,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018225Orig1s026ltr.pdf","2017-05-09 00:00:00",
55159,1,18225,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018225Orig1s028ltr.pdf","2018-08-10 00:00:00",
55275,2,18225,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf","2018-08-23 00:00:00",
14950,1,18226,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf","2002-10-29 00:00:00",
33460,2,18226,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf","2002-10-29 00:00:00",
40785,3,18226,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm","2003-03-07 00:00:00",
878,1,18226,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf","2002-10-29 00:00:00",
20115,3,18226,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm","2003-03-07 00:00:00",
33461,2,18226,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf","2002-10-29 00:00:00",
20116,3,18227,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018227_s012_AmidateTOC.cfm","2006-05-10 00:00:00",
48191,1,18227,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018227Orig1s032ltr.pdf","2017-05-02 00:00:00",
48219,2,18227,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018227s032lbl.pdf","2017-05-02 00:00:00",
14951,1,18233,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18233scs062ltr.pdf","2003-01-24 00:00:00",
879,1,18233,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18233s063ltr.pdf","2005-01-26 00:00:00",
880,1,18233,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018233s068ltr.pdf","2007-11-08 00:00:00",
11186,2,18234,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18234s020lbl.pdf","2004-10-04 00:00:00",
14952,1,18234,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18234s020ltr.pdf","2004-10-04 00:00:00",
40786,3,18238,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s011_MICRO-K.pdf","2009-01-12 00:00:00",
40787,3,18238,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s013_MICROK.pdf","2009-01-12 00:00:00",
14953,1,18238,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18238slr031ltr.pdf","2003-08-25 00:00:00",
53979,2,18238,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018238s046lbl.pdf","2018-05-02 00:00:00",
53987,1,18238,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018238Orig1s046ltr.pdf","2018-05-03 00:00:00",
33462,2,18239,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18239s25lbl.pdf","2003-04-14 00:00:00",
40788,3,18240,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf","2001-06-04 00:00:00",
20117,3,18240,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf","2001-06-04 00:00:00",
14954,1,18240,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr027ltr.pdf","2003-01-09 00:00:00",
14955,1,18240,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf","2003-11-13 00:00:00",
881,1,18240,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18240s029ltr.pdf","2005-02-11 00:00:00",
14956,1,18240,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018240s030ltr.pdf","2008-05-05 00:00:00",
882,1,18240,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018240s031ltr.pdf","2011-08-18 00:00:00",
11187,2,18240,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf","2011-08-24 00:00:00",
14957,1,18240,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018240Orig1s032ltr.pdf","2012-11-05 00:00:00",
33463,2,18240,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf","2012-11-06 00:00:00",
20118,3,18248,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf","2007-07-09 00:00:00",
20119,3,18248,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf","2007-07-09 00:00:00",
14958,1,18248,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018248s034_ltr.pdf","2007-07-30 00:00:00",
40789,3,18261,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18261-s011_pitocin.pdf","1997-07-29 00:00:00",
14959,1,18261,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18261s21ltr.pdf","2002-01-10 00:00:00",
20120,3,18261,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018261_s021_PITOCIN_LBL.pdf","2008-04-04 00:00:00",
14960,1,18261,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18261slr023ltr.pdf","2003-03-26 00:00:00",
40790,3,18261,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018261_s023_PITOCIN_LBL.pdf","2008-04-04 00:00:00",
14961,1,18261,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018261s028ltr.pdf","2007-07-31 00:00:00",
33464,2,18261,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf","2007-07-30 00:00:00",
883,1,18261,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018261Orig1s031ltr.pdf","2014-10-03 00:00:00",
33465,2,18261,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf","2014-10-03 00:00:00",
11188,2,18264,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf","2008-11-07 00:00:00",
14962,1,18264,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018264s025ltr.pdf","2008-10-27 00:00:00",
20121,3,18276,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018276ap.pdf","1997-11-20 00:00:00",
40791,3,18276,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018276_S035_Xanax Tablets_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
884,1,18276,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18276slr038,039,21434slr001ltr.pdf","2004-04-07 00:00:00",
40792,3,18276,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018276_S038_Xanax Tablets_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
14963,1,18276,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18276slr038,039,21434slr001ltr.pdf","2004-04-07 00:00:00",
40793,3,18276,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018276_S039_Xanax Tablets_APPROVAL PACKAGES.pdf","2006-10-25 00:00:00",
885,1,18276,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s044,021434s006ltr.pdf","2011-06-03 00:00:00",
33466,2,18276,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf","2011-06-07 00:00:00",
886,1,18276,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s045,021434s007ltr.pdf","2011-08-26 00:00:00",
11189,2,18276,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf","2011-08-24 00:00:00",
46243,2,18276,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf","2016-12-20 00:00:00",
46465,1,18276,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018276Orig1s052,021434Orig1s016ltr.pdf","2016-12-22 00:00:00",
46632,8,18276,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf#page=24","2016-12-30 00:00:00",
14964,1,18279,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18279s027ltr.pdf","2004-12-30 00:00:00",
887,1,18279,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018279s029ltr.pdf","2012-02-17 00:00:00",
11190,2,18279,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf","2013-11-26 00:00:00",
11191,2,18279,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf","2014-07-03 00:00:00",
53988,1,18279,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018279Orig1s037ltr.pdf","2018-05-03 00:00:00",
54050,2,18279,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018279Orig1s037lbl.pdf","2018-05-08 00:00:00",
20122,3,18281,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/018927_S031_TEGRETOL_AP.PDF","2007-07-06 00:00:00",
888,1,18281,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF","2001-03-07 00:00:00",
33467,2,18281,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF","2001-03-07 00:00:00",
40794,3,18281,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018281_S039_TEGRETOL_AP.PDF","2007-07-06 00:00:00",
11192,2,18281,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf","2007-08-17 00:00:00",
14965,1,18281,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf","2007-08-17 00:00:00",
889,1,18281,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf","2015-09-01 00:00:00",
33468,2,18281,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf","2015-09-03 00:00:00",
11193,2,18281,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf","2007-12-12 00:00:00",
14966,1,18281,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf","2008-01-09 00:00:00",
14967,1,18281,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf","2014-09-17 00:00:00",
33469,2,18281,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf","2014-09-19 00:00:00",
11194,2,18281,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf","2009-05-12 00:00:00",
14968,1,18281,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf","2009-05-01 00:00:00",
14969,1,18281,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
33470,2,18281,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
890,1,18281,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
11195,2,18281,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
11196,2,18281,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf","2014-01-17 00:00:00",
14970,1,18281,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf","2014-01-17 00:00:00",
11197,2,18281,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf","2013-03-08 00:00:00",
14971,1,18281,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf","2013-03-08 00:00:00",
11198,2,18281,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf","2012-12-13 00:00:00",
14972,1,18281,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf","2012-12-13 00:00:00",
53149,1,18281,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf","2018-03-22 00:00:00",
53419,2,18281,"SUPPL",58,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf","2018-03-26 00:00:00",
53451,8,18281,"SUPPL",58,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19","2018-03-27 00:00:00",
891,1,18285,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018285s034ltr.pdf","2007-11-08 00:00:00",
11199,2,18285,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf","2007-11-07 00:00:00",
14973,1,18299,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18299s014ltr.pdf","2002-02-20 00:00:00",
892,1,18300,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18300scm014ltr.pdf","2004-01-15 00:00:00",
14974,1,18300,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18300scm015ltr.pdf","2004-01-15 00:00:00",
893,1,18300,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018300s018ltr.pdf","2012-05-29 00:00:00",
53782,1,18300,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018300Orig1s019ltr.pdf","2018-04-23 00:00:00",
53791,2,18300,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018300Orig1s019lbl.pdf","2018-04-23 00:00:00",
14975,1,18303,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18303slr025ltr.pdf","2003-11-25 00:00:00",
894,1,18303,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018303s029_ltr.pdf","2006-09-18 00:00:00",
11200,2,18303,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf","2008-01-08 00:00:00",
14976,1,18303,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s032ltr.pdf","2008-01-09 00:00:00",
895,1,18303,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s033ltr.pdf","2008-08-13 00:00:00",
33471,2,18303,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf","2008-07-29 00:00:00",
896,1,18303,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018303s034ltr.pdf","2010-01-06 00:00:00",
33472,2,18303,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf","2009-09-17 00:00:00",
11201,2,18303,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf","2011-03-21 00:00:00",
33473,2,18303,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf","2011-03-21 00:00:00",
897,1,18304,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf","2015-07-14 00:00:00",
33474,2,18304,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf","2015-07-13 00:00:00",
11202,2,18304,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf","2015-07-13 00:00:00",
14977,1,18304,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf","2015-07-14 00:00:00",
898,1,18309,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf","2004-04-29 00:00:00",
33475,2,18309,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf","2004-05-04 00:00:00",
11203,2,18310,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf","2007-11-07 00:00:00",
14978,1,18310,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018310s011ltr.pdf","2007-11-08 00:00:00",
47818,1,18321,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018321Orig1s022ltr.pdf","2017-04-03 00:00:00",
47854,2,18321,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf","2017-04-04 00:00:00",
11204,2,18327,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf","2016-03-14 00:00:00",
43608,8,18332,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088612.pdf","2009-11-19 00:00:00",
14979,1,18332,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf","2005-03-29 00:00:00",
33476,2,18332,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf","2006-01-27 00:00:00",
899,1,18332,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf","2007-02-02 00:00:00",
11205,2,18332,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf","2007-02-02 00:00:00",
33477,2,18332,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018332s032lbl.pdf","2009-04-03 00:00:00",
14980,1,18332,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf","2016-05-12 00:00:00",
33478,2,18332,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf","2016-05-11 00:00:00",
900,1,18332,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf","2016-05-12 00:00:00",
33479,2,18332,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf","2016-05-11 00:00:00",
11206,2,18333,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf","2007-05-01 00:00:00",
14981,1,18333,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018333s032ltr.pdf","2007-05-01 00:00:00",
11207,2,18333,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf","2013-03-08 00:00:00",
14982,1,18333,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf","2013-03-05 00:00:00",
40795,3,18337,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018337Orig1s013.pdf","2012-03-30 00:00:00",
14983,1,18337,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018337s024ltr.pdf","2007-11-08 00:00:00",
14984,1,18337,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018337s025ltr.pdf","2008-07-01 00:00:00",
14985,1,18337,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018337s028ltr.pdf","2010-04-08 00:00:00",
11208,2,18337,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf","2014-01-28 00:00:00",
14986,1,18337,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018337Orig1s032ltr.pdf","2014-01-17 00:00:00",
11209,2,18337,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf","2015-08-13 00:00:00",
14987,1,18337,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018337Orig1s034ltr.pdf","2015-08-13 00:00:00",
14988,1,18340,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18340slr021ltr.pdf","2003-12-02 00:00:00",
44022,10,18343,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
901,1,18343,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18343slr075ltr.pdf","2004-05-07 00:00:00",
14989,1,18343,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018343s081ltr.pdf","2008-09-29 00:00:00",
14990,1,18343,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s082ltr.pdf","2011-05-24 00:00:00",
33480,2,18343,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf","2011-05-23 00:00:00",
902,1,18343,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s083ltr.pdf","2011-12-15 00:00:00",
33481,2,18343,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf","2011-12-14 00:00:00",
903,1,18343,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018343Orig1s084ltr.pdf","2012-08-29 00:00:00",
11210,2,18343,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf","2012-08-28 00:00:00",
904,1,18343,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018343Orig1s085ltr.pdf","2014-12-30 00:00:00",
33482,2,18343,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf","2015-01-09 00:00:00",
14991,1,18343,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018343Orig1s086ltr.pdf","2015-06-22 00:00:00",
33483,2,18343,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf","2015-06-22 00:00:00",
49217,1,18343,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018343Orig1s087ltr.pdf","2017-08-02 00:00:00",
49226,2,18343,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018343s087lbl.pdf","2017-08-03 00:00:00",
14992,1,18344,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018344s026_018345s027ltr.pdf","2006-01-20 00:00:00",
33484,2,18344,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018344s026,018345s027lbl.pdf","2006-01-13 00:00:00",
14993,1,18345,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018344s026_018345s027ltr.pdf","2006-01-20 00:00:00",
33485,2,18345,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018344s026,018345s027lbl.pdf","2006-01-13 00:00:00",
905,1,18347,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18347slr025ltr.pdf","2003-10-16 00:00:00",
11211,2,18347,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18347slr025_lente_lbl.pdf","2003-10-16 00:00:00",
14994,1,18353,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018353Orig1s026ltr.pdf","2013-08-20 00:00:00",
33486,2,18353,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf","2013-08-21 00:00:00",
906,1,18353,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018353Orig1s027ltr.pdf","2015-07-14 00:00:00",
33487,2,18353,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf","2015-07-16 00:00:00",
47471,2,18374,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018374s025lbl.pdf","2017-03-06 00:00:00",
47503,1,18374,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018374Orig1s025ltr.pdf","2017-03-08 00:00:00",
52564,2,18374,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018374s026lbl.pdf","2018-02-12 00:00:00",
52631,1,18374,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018374Orig1s026ltr.pdf","2018-02-14 00:00:00",
40796,3,18381,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018381ap.pdf","1997-04-16 00:00:00",
20123,3,18383,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018383ap.pdf","1997-04-16 00:00:00",
907,1,18388,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018388Orig1s084ltr.pdf","2014-01-17 00:00:00",
33488,2,18388,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf","2014-01-16 00:00:00",
14995,1,18401,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18401s014ltr.pdf","2002-03-08 00:00:00",
20124,3,18401,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018401_s014_BuprenexTOC.cfm","2006-05-10 00:00:00",
14996,1,18401,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18401slr015ltr.pdf","2003-06-22 00:00:00",
40797,3,18401,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018401_S015_Buprenex Injectable_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
46214,1,18401,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018401Orig1s022ltr.pdf","2016-12-19 00:00:00",
908,1,18405,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018405s023_ltr.pdf","2007-07-10 00:00:00",
11212,2,18405,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf","2007-07-06 00:00:00",
909,1,18415,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018415Orig1s026ltr.pdf","2014-10-03 00:00:00",
910,1,18421,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
14997,1,18421,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
911,1,18421,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
14998,1,18421,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
912,1,18421,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf","2001-11-26 00:00:00",
913,1,18421,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf","2003-01-31 00:00:00",
45710,1,18421,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf","2016-10-28 00:00:00",
45759,2,18421,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf","2016-11-01 00:00:00",
914,1,18421,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf","2011-10-25 00:00:00",
11213,2,18421,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf","2011-10-25 00:00:00",
915,1,18422,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf","2004-06-08 00:00:00",
33489,2,18422,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf","2003-04-14 00:00:00",
11214,2,18422,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf","2003-04-14 00:00:00",
14999,1,18422,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf","2004-06-08 00:00:00",
15000,1,18422,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf","2003-01-15 00:00:00",
916,1,18422,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18422slr045ltr.pdf","2004-04-07 00:00:00",
917,1,18422,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018422s048ltr.pdf","2009-07-17 00:00:00",
11215,2,18422,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf","2009-07-17 00:00:00",
918,1,18422,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018422s050ltr.pdf","2010-09-29 00:00:00",
11216,2,18422,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf","2010-09-27 00:00:00",
11217,2,18422,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf","2013-11-01 00:00:00",
15001,1,18422,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018422Orig1s053ltr.pdf","2013-11-06 00:00:00",
919,1,18422,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018422Orig1s054ltr.pdf","2014-11-07 00:00:00",
11218,2,18422,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf","2014-11-07 00:00:00",
920,1,18422,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018422Orig1s055ltr.pdf","2016-04-08 00:00:00",
33490,2,18422,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf","2016-04-07 00:00:00",
48064,2,18422,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018422s056lbl.pdf","2017-04-19 00:00:00",
48067,1,18422,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018422Orig1s056ltr.pdf","2017-04-19 00:00:00",
53819,2,18422,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018422s058lbl.pdf","2018-04-26 00:00:00",
53870,1,18422,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018422Orig1s058ltr.pdf","2018-04-27 00:00:00",
15002,1,18429,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
921,1,18429,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18429slr021ltr.pdf","2003-06-22 00:00:00",
40799,3,18439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018439_01.pdf","1998-05-07 00:00:00",
15003,1,18445,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018445s057ltr.pdf","2006-01-30 00:00:00",
33491,2,18445,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018445s057lbl.pdf","2006-01-25 00:00:00",
922,1,18445,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018445s058ltr.pdf","2007-03-23 00:00:00",
11219,2,18445,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf","2007-03-23 00:00:00",
15004,1,18449,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf","2004-04-20 00:00:00",
11220,2,18449,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf","2007-04-25 00:00:00",
15005,1,18449,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf","2007-05-01 00:00:00",
46016,2,18449,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018449s043lbl.pdf","2016-12-05 00:00:00",
46060,1,18449,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf","2016-12-06 00:00:00",
55004,1,18449,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf","2018-07-26 00:00:00",
55033,2,18449,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf","2018-07-27 00:00:00",
923,1,18452,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf","2008-03-13 00:00:00",
11221,2,18452,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf","2008-03-13 00:00:00",
15006,1,18458,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18458slr012ltr.pdf","2003-07-28 00:00:00",
924,1,18458,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018458s013ltr.pdf","2008-08-12 00:00:00",
15007,1,18458,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s014ltr.pdf","2011-03-08 00:00:00",
33492,2,18458,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf","2011-03-07 00:00:00",
925,1,18458,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s016ltr.pdf","2011-06-28 00:00:00",
11222,2,18458,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf","2011-06-29 00:00:00",
11223,2,18461,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf","2002-01-23 00:00:00",
15008,1,18461,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18461s50ltr.pdf","2002-01-23 00:00:00",
40800,3,18461,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf","2002-09-10 00:00:00",
926,1,18461,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18461slr052ltr.pdf","2003-12-16 00:00:00",
15009,1,18461,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s055ltr.pdf","2012-02-29 00:00:00",
15010,1,18461,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s056ltr.pdf","2012-03-12 00:00:00",
33493,2,18461,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf","2012-03-05 00:00:00",
47133,2,18461,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018461s058lbl.pdf","2017-02-08 00:00:00",
47243,1,18461,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018461Orig1s058ltr.pdf","2017-02-16 00:00:00",
20125,3,18467,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm","2003-08-05 00:00:00",
40801,3,18467,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm","2003-08-05 00:00:00",
927,1,18469,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf","2003-07-28 00:00:00",
15011,1,18469,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf","2003-07-28 00:00:00",
928,1,18469,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf","2004-05-27 00:00:00",
33494,2,18469,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf","2004-05-27 00:00:00",
15012,1,18469,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf","2004-05-27 00:00:00",
33495,2,18469,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf","2004-05-27 00:00:00",
929,1,18469,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf","2004-12-30 00:00:00",
33496,2,18469,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf","2004-12-30 00:00:00",
930,1,18469,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf","2004-12-30 00:00:00",
11224,2,18469,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf","2004-12-30 00:00:00",
11225,2,18469,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf","2015-05-14 00:00:00",
15013,1,18469,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf","2015-12-22 00:00:00",
33497,2,18469,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf","2015-11-12 00:00:00",
931,1,18469,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf","2015-12-22 00:00:00",
11226,2,18469,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf","2015-11-12 00:00:00",
932,1,18469,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018469Orig1s056ltr.pdf","2016-04-28 00:00:00",
11227,2,18469,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf","2016-06-17 00:00:00",
15014,1,18473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf","2004-06-29 00:00:00",
15015,1,18473,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf","2003-07-06 00:00:00",
15016,1,18482,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18482s43ltr.pdf","2002-02-22 00:00:00",
15017,1,18482,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018482s049ltr.pdf","2011-09-29 00:00:00",
33498,2,18482,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf","2011-09-30 00:00:00",
11228,2,18482,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf","2013-07-30 00:00:00",
15018,1,18482,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018482Orig1s051ltr.pdf","2013-07-29 00:00:00",
933,1,18482,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018482Orig1s052ltr.pdf","2015-01-12 00:00:00",
33499,2,18482,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf","2015-01-29 00:00:00",
53888,2,18485,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/018485s009lbl.pdf","2018-05-01 00:00:00",
934,1,18487,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018487s040ltr.pdf","2010-03-03 00:00:00",
11229,2,18487,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf","2016-03-14 00:00:00",
15019,1,18487,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018487Orig1s043ltr.pdf","2016-03-10 00:00:00",
11230,2,18489,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf","2015-05-14 00:00:00",
935,1,18498,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18498slr008ltr.pdf","2002-09-03 00:00:00",
33500,2,18498,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf","2002-09-03 00:00:00",
20126,3,18506,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml","2007-03-02 00:00:00",
40802,3,18506,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml","2007-03-02 00:00:00",
15020,1,18506,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr024ltr.pdf","2002-11-01 00:00:00",
936,1,18506,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr025ltr.pdf","2002-12-12 00:00:00",
937,1,18511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018511s019ltr.pdf","2011-09-28 00:00:00",
33501,2,18511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf","2011-09-29 00:00:00",
51022,2,18511,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf","2018-01-10 00:00:00",
50938,2,18511,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf","2017-12-28 00:00:00",
50977,1,18511,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018511Orig1s028ltr.pdf","2017-12-29 00:00:00",
54161,20,18511,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/232_18511S28 draximage clinical prea.pdf","1900-01-01 00:00:00",
54162,17,18511,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/231_18511S28 draximage statistical prea.pdf","1900-01-01 00:00:00",
938,1,18513,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018513s012ltr.pdf","2010-05-24 00:00:00",
15021,1,18514,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18514s008ltr.pdf","2002-05-22 00:00:00",
15022,1,18514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018514s009ltr.pdf","2005-12-15 00:00:00",
15023,1,18514,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018514Orig1s013ltr.pdf","2014-10-31 00:00:00",
33502,2,18514,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf","2014-11-04 00:00:00",
15024,1,18519,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18519slr014ltr.pdf","2002-07-17 00:00:00",
43609,8,18533,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf","2013-07-25 00:00:00",
44023,10,18533,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm362415.htm","2014-02-07 00:00:00",
939,1,18533,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018533Orig1s040ltr.pdf","2013-07-29 00:00:00",
33503,2,18533,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf","2013-07-25 00:00:00",
11231,2,18533,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf","2014-03-05 00:00:00",
15025,1,18533,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018533Orig1s041ltr.pdf","2014-02-27 00:00:00",
11232,2,18538,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf","2009-10-08 00:00:00",
15026,1,18538,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018538s028ltr.pdf","2009-11-09 00:00:00",
40803,3,18553,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf","2009-09-14 00:00:00",
40804,3,18553,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf","2009-09-14 00:00:00",
20127,3,18553,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf","2009-09-14 00:00:00",
40805,3,18553,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf","2009-09-14 00:00:00",
20128,3,18553,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf","2009-09-14 00:00:00",
940,1,18553,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf","2004-06-10 00:00:00",
15027,1,18553,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf","2007-01-08 00:00:00",
941,1,18553,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf","2007-03-06 00:00:00",
15028,1,18553,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf","2007-11-08 00:00:00",
942,1,18553,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf","2011-03-23 00:00:00",
11233,2,18553,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf","2011-03-21 00:00:00",
943,1,18554,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S21LTR.PDF","2001-03-23 00:00:00",
40806,3,18554,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S021.pdf","2005-01-28 00:00:00",
944,1,18554,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S22LTR.PDF","2001-03-30 00:00:00",
40807,3,18554,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S022.pdf","2005-01-28 00:00:00",
33504,2,18554,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf","2003-04-14 00:00:00",
11234,2,18557,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf","2004-04-05 00:00:00",
15029,1,18557,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18557slr015ltr.pdf","2004-03-02 00:00:00",
40808,3,18557,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018557_S015_Fandsidar_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
15030,1,18557,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18557slr016ltr.pdf","2003-05-29 00:00:00",
45711,1,18558,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf","2016-10-28 00:00:00",
45758,2,18558,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf","2016-11-01 00:00:00",
945,1,18561,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf","2016-02-24 00:00:00",
33505,2,18561,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf","2016-02-23 00:00:00",
54206,1,18561,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf","2018-05-16 00:00:00",
54238,2,18561,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf","2018-05-17 00:00:00",
946,1,18562,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf","2016-02-24 00:00:00",
11235,2,18562,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf","2016-02-23 00:00:00",
54208,1,18562,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf","2018-05-16 00:00:00",
54239,2,18562,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf","2018-05-17 00:00:00",
947,1,18563,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf","2016-02-24 00:00:00",
11236,2,18563,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf","2016-02-23 00:00:00",
54207,1,18563,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf","2018-05-16 00:00:00",
54240,2,18563,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf","2018-05-17 00:00:00",
11237,2,18564,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf","2016-02-23 00:00:00",
15031,1,18564,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf","2016-02-24 00:00:00",
54210,1,18564,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf","2018-05-16 00:00:00",
54241,2,18564,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf","2018-05-17 00:00:00",
948,1,18565,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18565slr010ltr.pdf","2003-07-06 00:00:00",
15032,1,18565,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18565slr012ltr.pdf","2004-06-01 00:00:00",
33506,2,18565,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf","2009-05-19 00:00:00",
949,1,18565,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018565s014ltr.pdf","2005-06-08 00:00:00",
11238,2,18565,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf","2005-06-08 00:00:00",
950,1,18565,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018565s020ltr.pdf","2010-10-05 00:00:00",
11239,2,18565,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf","2010-10-12 00:00:00",
46220,1,18565,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Infumorph.pdf","2016-12-19 00:00:00",
46403,2,18565,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf","2016-12-21 00:00:00",
46489,1,18565,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Duramorph.pdf","2016-12-22 00:00:00",
46509,2,18565,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf","2016-12-23 00:00:00",
45529,1,18569,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018569Orig1s063ltr.pdf","2016-10-12 00:00:00",
15033,1,18571,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr019ltr.pdf","2003-12-23 00:00:00",
11240,2,18579,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf","2011-08-16 00:00:00",
951,1,18582,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18582scs031ltr.pdf","2004-01-09 00:00:00",
33507,2,18582,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18582scs031_procalAmine_lbl.pdf","2004-01-15 00:00:00",
15034,1,18584,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18584slr026ltr.pdf","2002-12-16 00:00:00",
33508,2,18584,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf","2003-04-14 00:00:00",
15035,1,18586,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18586slr004ltr.pdf","2004-04-29 00:00:00",
33509,2,18586,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18586slr004_topicort_lbl.pdf","2004-05-04 00:00:00",
952,1,18594,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018594s007ltr.pdf","2010-05-21 00:00:00",
11241,2,18594,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf","2010-05-28 00:00:00",
11242,2,18594,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf","2014-12-19 00:00:00",
15036,1,18594,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018594Orig1s008ltr.pdf","2014-12-11 00:00:00",
15037,1,18596,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18596slr030ltr.pdf","2004-03-02 00:00:00",
33510,2,18596,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf","2004-04-05 00:00:00",
953,1,18602,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018602s063ltr.pdf","2010-11-30 00:00:00",
11243,2,18602,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf","2010-11-22 00:00:00",
33511,2,18602,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf","2014-11-25 00:00:00",
45911,1,18602,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018602Orig1s067ltr.pdf","2016-11-22 00:00:00",
45943,2,18602,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018602s067lbl.pdf","2016-11-21 00:00:00",
15038,1,18603,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18603s19ltr.pdf","1998-06-02 00:00:00",
33512,2,18603,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf","1998-06-02 00:00:00",
954,1,18603,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf","2002-01-29 00:00:00",
15039,1,18603,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf","2002-01-29 00:00:00",
955,1,18603,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf","2002-01-29 00:00:00",
956,1,18603,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18603slr027ltr.pdf","2004-05-27 00:00:00",
33513,2,18603,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf","2004-05-27 00:00:00",
20129,3,18604,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018604S014.pdf","1997-01-08 00:00:00",
33514,2,18604,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf","2012-06-22 00:00:00",
33515,2,18604,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf","2012-06-22 00:00:00",
957,1,18604,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/018604Orig1s019ltr.pdf","2013-06-07 00:00:00",
958,1,18608,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18608slr031ltr.pdf","2002-12-16 00:00:00",
11244,2,18609,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf","2003-04-14 00:00:00",
40809,3,18609,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s033_Haparin_Sodium.pdf","2008-04-02 00:00:00",
33516,2,18609,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf","2003-04-14 00:00:00",
40810,3,18609,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018609_s035_Heparin_Sodium.pdf","2008-04-02 00:00:00",
959,1,18609,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018609s042ltr.pdf","2012-02-29 00:00:00",
960,1,18609,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018609s044ltr.pdf","2010-08-20 00:00:00",
11245,2,18609,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf","2010-08-28 00:00:00",
20130,3,18612,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018612s022_020066s004_Nicorette.cfm","2005-05-02 00:00:00",
961,1,18612,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf","1998-12-23 00:00:00",
20131,3,18612,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm","1998-12-23 00:00:00",
33517,2,18612,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf","1998-12-23 00:00:00",
962,1,18612,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf","2002-08-09 00:00:00",
15040,1,18612,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf034ltr.pdf","2004-04-29 00:00:00",
20132,3,18612,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018612_S034_NICORETTE_GUM_AP.pdf","2007-07-06 00:00:00",
15041,1,18612,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612slr035ltr.pdf","2004-06-24 00:00:00",
963,1,18612,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf037ltr.pdf","2004-06-23 00:00:00",
964,1,18612,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf","2005-12-13 00:00:00",
11246,2,18612,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf","2005-12-13 00:00:00",
965,1,18612,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf","2006-05-05 00:00:00",
15042,1,18612,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf","2007-07-05 00:00:00",
33518,2,18612,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf","2007-06-27 00:00:00",
966,1,18612,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf","2008-06-16 00:00:00",
20133,3,18612,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/018612Orig1s050.pdf","2012-03-27 00:00:00",
15043,1,18612,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf","2009-05-08 00:00:00",
967,1,18612,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf","2011-05-19 00:00:00",
968,1,18612,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s057ltr.pdf","2011-09-29 00:00:00",
969,1,18612,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf","2012-02-03 00:00:00",
970,1,18612,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf","2012-02-17 00:00:00",
33519,2,18612,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf","2012-03-28 00:00:00",
971,1,18612,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf","2012-07-18 00:00:00",
33520,2,18612,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf","2014-01-16 00:00:00",
15044,1,18612,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf","2013-10-31 00:00:00",
33521,2,18612,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf","2013-11-07 00:00:00",
972,1,18612,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf","2014-06-12 00:00:00",
11247,2,18612,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf","2014-08-05 00:00:00",
15045,1,18612,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf","2014-06-12 00:00:00",
33522,2,18612,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf","2014-08-05 00:00:00",
11248,2,18612,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf","2014-11-07 00:00:00",
15046,1,18612,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf","2014-11-03 00:00:00",
15047,1,18612,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf","2015-10-02 00:00:00",
33523,2,18612,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf","2015-11-02 00:00:00",
49988,2,18612,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf","2017-10-10 00:00:00",
50747,1,18612,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf","2017-12-18 00:00:00",
54550,1,18612,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020066Orig1s061,018612Orig1s080ltr.pdf","2018-06-14 00:00:00",
54650,2,18612,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf","2018-06-21 00:00:00",
20134,3,18613,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf","1999-04-30 00:00:00",
20135,3,18613,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf","1999-04-30 00:00:00",
11249,2,18613,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf","2003-04-04 00:00:00",
15048,1,18613,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18613slr011ltr.pdf","2003-04-16 00:00:00",
973,1,18613,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018613s017ltr.pdf","2011-12-14 00:00:00",
11250,2,18613,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf","2011-12-14 00:00:00",
20136,3,18623,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018623ap.pdf","1997-04-16 00:00:00",
54943,1,18629,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf","2018-07-23 00:00:00",
20137,3,18631,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018631_s030ap.pdf","1997-04-29 00:00:00",
974,1,18631,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18631slr033ltr.pdf","2003-10-09 00:00:00",
975,1,18631,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018631s034ltr.pdf","2005-04-12 00:00:00",
33524,2,18631,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf","2005-04-12 00:00:00",
976,1,18631,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018631Orig1s036ltr.pdf","2014-04-18 00:00:00",
977,1,18631,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018631s039ltr.pdf","2012-07-09 00:00:00",
33525,2,18631,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf","2012-07-10 00:00:00",
15049,1,18631,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018631Orig1s040ltr.pdf","2015-02-17 00:00:00",
33526,2,18631,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf","2015-03-27 00:00:00",
11251,2,18631,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf","2016-02-17 00:00:00",
15050,1,18631,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018631Orig1s041ltr.pdf","2016-01-20 00:00:00",
15051,1,18632,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018632Orig1s051ltr.pdf","2016-05-31 00:00:00",
33527,2,18632,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf","2016-06-01 00:00:00",
978,1,18634,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18634slr007ltr.pdf","2003-06-08 00:00:00",
44024,10,18644,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
40811,3,18644,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf","2003-06-17 00:00:00",
20138,3,18644,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf","2003-06-17 00:00:00",
40812,3,18644,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf","2003-06-17 00:00:00",
979,1,18644,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf","2002-10-02 00:00:00",
15052,1,18644,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s018,023LTR.pdf","2002-06-20 00:00:00",
15053,1,18644,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf","2002-10-02 00:00:00",
15054,1,18644,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s25ltr.pdf","2002-02-12 00:00:00",
15055,1,18644,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf","2002-10-22 00:00:00",
980,1,18644,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf","2004-06-01 00:00:00",
40813,3,18644,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm","2007-06-29 00:00:00",
981,1,18644,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf","2005-01-13 00:00:00",
11252,2,18644,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf","2005-01-13 00:00:00",
15056,1,18644,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf","2006-03-03 00:00:00",
982,1,18644,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf","2006-07-13 00:00:00",
11253,2,18644,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf","2006-07-05 00:00:00",
983,1,18644,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf","2006-07-13 00:00:00",
33528,2,18644,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf","2006-07-05 00:00:00",
40814,3,18644,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018644Orig1s034.pdf","2012-06-26 00:00:00",
984,1,18644,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf","2007-02-02 00:00:00",
15057,1,18644,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf","2007-08-07 00:00:00",
33529,2,18644,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s036lbl.pdf","2007-08-03 00:00:00",
11254,2,18644,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf","2010-05-28 00:00:00",
15058,1,18644,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045ltr.pdf","2010-05-27 00:00:00",
985,1,18644,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf","2009-07-07 00:00:00",
11255,2,18644,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf","2009-07-06 00:00:00",
15059,1,18644,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf","2009-07-07 00:00:00",
33530,2,18644,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf","2009-07-06 00:00:00",
15060,1,18644,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048ltr.pdf","2010-03-03 00:00:00",
15061,1,18644,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf","2011-05-19 00:00:00",
33531,2,18644,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf","2011-05-23 00:00:00",
11256,2,18644,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf","2011-07-25 00:00:00",
15062,1,18644,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf","2011-07-28 00:00:00",
15063,1,18644,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358Orig1s051ltr.pdf","2012-08-03 00:00:00",
986,1,18644,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358Origs052ltr.pdf","2013-03-21 00:00:00",
33532,2,18644,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf","2013-03-26 00:00:00",
11257,2,18644,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf","2013-12-24 00:00:00",
15064,1,18644,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf","2013-12-26 00:00:00",
20139,3,18644,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s046.pdf","2014-07-07 00:00:00",
987,1,18644,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf","2013-12-26 00:00:00",
20140,3,18644,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s047.pdf","2014-07-07 00:00:00",
33533,2,18644,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf","2013-12-24 00:00:00",
988,1,18644,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf","2014-12-17 00:00:00",
33534,2,18644,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf","2014-12-17 00:00:00",
15065,1,18644,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf","2014-07-21 00:00:00",
33535,2,18644,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s049lbl.pdf","2014-07-22 00:00:00",
15066,1,18644,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf","2016-04-27 00:00:00",
33536,2,18644,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf","2016-04-27 00:00:00",
48354,2,18644,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s051lbl.pdf","2017-05-10 00:00:00",
48359,1,18644,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s051,020358Orig1s058ltr.pdf","2017-05-12 00:00:00",
48263,2,18644,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s052lbl.pdf","2017-05-08 00:00:00",
48303,1,18644,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s052,020358Orig1s059ltr.pdf","2017-05-09 00:00:00",
49456,2,18644,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s053lbl.pdf","2017-08-18 00:00:00",
49457,8,18644,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s053lbl.pdf#page=30","2017-08-18 00:00:00",
49479,1,18644,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s053,020358Orig1s060ltr.pdf","2017-08-21 00:00:00",
20141,3,18647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-647_corzide.pdf","2011-11-08 00:00:00",
15067,1,18647,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18647slr016ltr.pdf","2003-06-08 00:00:00",
15068,1,18647,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018647s020ltr.pdf","2008-08-07 00:00:00",
989,1,18647,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018647s024ltr.pdf","2011-06-09 00:00:00",
33537,2,18647,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf","2011-06-27 00:00:00",
990,1,18647,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018647Orig1s025ltr.pdf","2013-07-16 00:00:00",
33538,2,18647,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf","2013-07-15 00:00:00",
991,1,18649,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18649slr040ltr.pdf","2004-01-09 00:00:00",
33539,2,18649,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18649slr040_viaflex_lbl.pdf","2004-01-15 00:00:00",
992,1,18649,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018649s043ltr.pdf","2008-10-21 00:00:00",
20142,3,18651,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18651S011_Marinol.pdf","1999-08-05 00:00:00",
45040,2,18651,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/018651s013lbl.pdf","2000-09-22 00:00:00",
993,1,18651,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18651slr018ltr.pdf","2003-05-29 00:00:00",
11258,2,18651,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf","2003-05-06 00:00:00",
994,1,18651,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018651s021ltr.pdf","2005-04-28 00:00:00",
11259,2,18651,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf","2005-04-28 00:00:00",
15069,1,18651,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf","2006-06-28 00:00:00",
33540,2,18651,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf","2006-06-28 00:00:00",
995,1,18651,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf","2006-06-28 00:00:00",
11260,2,18651,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf","2006-06-28 00:00:00",
49585,2,18651,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf","2017-08-30 00:00:00",
49627,1,18651,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018651Orig1s029ltr.pdf","2017-08-30 00:00:00",
996,1,18652,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018652Orig1s010ltr.pdf","2014-10-31 00:00:00",
11261,2,18652,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf","2014-11-04 00:00:00",
20143,3,18654,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf","1997-11-20 00:00:00",
20144,3,18654,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf","1997-11-20 00:00:00",
40815,3,18654,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf","1997-11-20 00:00:00",
15070,1,18657,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf","2004-06-07 00:00:00",
33541,2,18657,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf","2004-06-07 00:00:00",
997,1,18657,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf","2004-06-07 00:00:00",
11262,2,18657,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf","2004-06-07 00:00:00",
15071,1,18657,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018657s028ltr.pdf","2012-05-30 00:00:00",
998,1,18657,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018657s029ltr.pdf","2009-11-19 00:00:00",
11263,2,18657,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf","2009-09-17 00:00:00",
999,1,18657,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018657s031ltr.pdf","2011-08-09 00:00:00",
11264,2,18657,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf","2011-08-12 00:00:00",
11265,2,18657,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf","2013-10-25 00:00:00",
15072,1,18657,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018657Orig1s032ltr.pdf","2013-10-25 00:00:00",
1000,1,18657,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018657Orig1s034ltr.pdf","2015-07-14 00:00:00",
33542,2,18657,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf","2015-07-16 00:00:00",
50619,1,18657,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018657s036ltr.pdf","2017-12-06 00:00:00",
50656,2,18657,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018657s036lbl.pdf","2017-12-12 00:00:00",
15073,1,18658,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18658S15LTR.PDF","2002-01-24 00:00:00",
1001,1,18658,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18658s017ltr.pdf","2004-11-16 00:00:00",
40816,3,18658,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018658_S017_DELSYM_AP.pdf","2007-04-09 00:00:00",
1002,1,18658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18658s018ltr.pdf","2005-03-10 00:00:00",
1003,1,18658,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018658s022ltr.pdf","2007-10-04 00:00:00",
33543,2,18658,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf","2007-10-04 00:00:00",
15074,1,18658,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018658s023ltr.pdf","2008-12-10 00:00:00",
15075,1,18658,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018658s026ltr.pdf","2009-11-12 00:00:00",
15076,1,18658,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s027ltr.pdf","2010-04-13 00:00:00",
1004,1,18658,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s028ltr.pdf","2010-11-15 00:00:00",
1005,1,18658,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018658s029ltr.pdf","2011-05-19 00:00:00",
11266,2,18658,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf","2014-08-05 00:00:00",
15077,1,18658,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018658Orig1s030ltr.pdf","2014-08-11 00:00:00",
44025,10,18662,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2005-07-28 00:00:00",
44440,14,18662,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
1006,1,18662,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s38ltr.pdf","2000-05-01 00:00:00",
40817,3,18662,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018662_S038_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
15078,1,18662,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s39ltr.pdf","2000-05-01 00:00:00",
1007,1,18662,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s40ltr.pdf","2000-05-01 00:00:00",
1008,1,18662,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf","2001-12-31 00:00:00",
11267,2,18662,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf","2001-12-31 00:00:00",
40818,3,18662,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018662_S042_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
1009,1,18662,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s043ltr.pdf","2002-05-02 00:00:00",
33544,2,18662,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf","2002-05-02 00:00:00",
1010,1,18662,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s44ltr.pdf","2001-10-30 00:00:00",
33545,2,18662,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf","2001-10-30 00:00:00",
15079,1,18662,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf","2001-12-31 00:00:00",
33546,2,18662,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf","2001-12-31 00:00:00",
15080,1,18662,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s046ltr.pdf","2002-02-15 00:00:00",
33547,2,18662,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf","2002-02-15 00:00:00",
15081,1,18662,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s47ltr.pdf","2002-04-12 00:00:00",
43560,6,18662,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s47Pi.pdf","2002-04-12 00:00:00",
1011,1,18662,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf","2003-08-27 00:00:00",
33548,2,18662,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf","2003-08-29 00:00:00",
40819,3,18662,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S048_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
1012,1,18662,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s051LTR.pdf","2002-06-20 00:00:00",
11268,2,18662,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf","2002-06-20 00:00:00",
1013,1,18662,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf","2004-05-25 00:00:00",
11269,2,18662,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf","2003-08-29 00:00:00",
40820,3,18662,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S052_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
40821,3,18662,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S053_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
11270,2,18662,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf","2004-08-25 00:00:00",
15082,1,18662,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18662s054ltr.pdf","2004-08-25 00:00:00",
40822,3,18662,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S054_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
20145,3,18662,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S055_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
11271,2,18662,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf","2005-08-12 00:00:00",
15083,1,18662,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018662s056ltr.pdf","2005-08-15 00:00:00",
40823,3,18662,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S056_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
20146,3,18662,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018662_S057_ACCUTANE_AP.pdf","2007-07-06 00:00:00",
1014,1,18662,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018662s058ltr.pdf","2007-10-10 00:00:00",
33549,2,18662,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf","2007-10-10 00:00:00",
15084,1,18662,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018662s059ltr.pdf","2008-11-21 00:00:00",
33550,2,18662,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf","2009-06-10 00:00:00",
1015,1,18662,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s060ltr.pdf","2010-02-05 00:00:00",
33551,2,18662,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf","2010-02-04 00:00:00",
1016,1,18662,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s061ltr.pdf","2010-10-26 00:00:00",
23122,8,18662,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf","2010-10-25 00:00:00",
45413,2,18667,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018667s036lbl.pdf","2016-09-29 00:00:00",
45530,1,18667,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018667Orig1s036ltr.pdf","2016-10-12 00:00:00",
20147,3,18668,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf","2003-02-05 00:00:00",
49326,2,18668,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018668s040lbl.pdf","2017-08-10 00:00:00",
49395,1,18668,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018668Orig1s040ltr.pdf","2017-08-15 00:00:00",
15085,1,18671,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018671s016ltr.pdf","2008-06-17 00:00:00",
33552,2,18671,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf","2008-06-18 00:00:00",
1017,1,18676,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18676scs022ltr.pdf","2004-05-03 00:00:00",
11272,2,18676,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf","2004-05-04 00:00:00",
1018,1,18677,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018677s011LTR.pdf","2006-05-18 00:00:00",
33553,2,18677,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf","2006-05-16 00:00:00",
15086,1,18677,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018677s013ltr.pdf","2008-12-10 00:00:00",
11273,2,18679,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf","2015-10-14 00:00:00",
11274,2,18679,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf","2016-06-17 00:00:00",
15087,1,18679,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018679Orig1s044ltr.pdf","2016-06-15 00:00:00",
20148,3,18680,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018680_original_approval.pdf","2011-02-15 00:00:00",
33554,2,18680,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18680s55lbl.pdf","2003-04-30 00:00:00",
1019,1,18680,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18680slr057ltr.pdf","2003-05-29 00:00:00",
11275,2,18680,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf","2005-09-08 00:00:00",
15088,1,18680,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018680s060ltr.pdf","2005-09-08 00:00:00",
1020,1,18680,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018680Orig1s066ltr.pdf","2013-06-13 00:00:00",
33555,2,18680,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018680s066lbl.pdf","2013-06-18 00:00:00",
11276,2,18681,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf","2014-09-03 00:00:00",
1021,1,18683,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18683s028ltr.pdf","2004-11-08 00:00:00",
1022,1,18683,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018683s030ltr.pdf","2005-04-28 00:00:00",
33556,2,18683,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018683s030lbl.pdf","2005-04-29 00:00:00",
15089,1,18683,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018683s034ltr.pdf","2010-06-02 00:00:00",
15090,1,18684,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18684slr020ltr.pdf","2003-05-29 00:00:00",
1023,1,18692,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18692slr007ltr.pdf","2003-06-22 00:00:00",
1024,1,18692,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018692s014ltr.pdf","2010-02-25 00:00:00",
11277,2,18692,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf","2010-02-25 00:00:00",
11278,2,18692,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf","2012-01-31 00:00:00",
15091,1,18692,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf","2012-02-01 00:00:00",
20149,3,18701,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018701_S046_HALDOL_TABLETS_AP.pdf","2007-07-06 00:00:00",
15092,1,18701,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf","2007-05-09 00:00:00",
33557,2,18701,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf","2007-05-07 00:00:00",
1025,1,18701,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf","2011-08-15 00:00:00",
11279,2,18701,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf","2011-08-16 00:00:00",
15093,1,18701,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf","2007-09-25 00:00:00",
15094,1,18701,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf","2008-05-14 00:00:00",
33558,2,18701,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf","2008-06-05 00:00:00",
1026,1,18701,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf","2008-08-19 00:00:00",
33559,2,18701,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf","2008-08-29 00:00:00",
1027,1,18701,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf","2009-08-04 00:00:00",
11280,2,18701,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf","2009-07-23 00:00:00",
1028,1,18701,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf","2010-12-06 00:00:00",
33560,2,18701,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf","2010-12-04 00:00:00",
15095,1,18701,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf","2011-03-07 00:00:00",
33561,2,18701,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf","2011-03-04 00:00:00",
1029,1,18701,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf","2013-05-07 00:00:00",
50629,1,18701,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018701s070ltr.pdf","2017-12-07 00:00:00",
50630,2,18701,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018701s070lbl.pdf","2017-12-07 00:00:00",
11281,2,18701,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf","2016-05-20 00:00:00",
15096,1,18701,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf","2016-05-20 00:00:00",
47356,2,18701,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/015923s096,018701s074lbl.pdf","2017-02-27 00:00:00",
47357,1,18701,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/015923Orig1s096,018701Orig1s074ltr.pdf","2017-03-02 00:00:00",
11282,2,18702,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf","2004-05-28 00:00:00",
15097,1,18702,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf","2004-05-28 00:00:00",
1030,1,18702,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf","2004-05-25 00:00:00",
33562,2,18702,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf","2004-05-25 00:00:00",
11283,2,18702,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf","2011-04-06 00:00:00",
15098,1,18702,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf","2011-04-11 00:00:00",
15099,1,18703,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac_approv.pdf","2004-07-01 00:00:00",
20150,3,18703,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac.cfm","2003-04-30 00:00:00",
1031,1,18703,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf","2002-01-07 00:00:00",
11284,2,18703,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf","2005-05-02 00:00:00",
15100,1,18703,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf","2005-05-02 00:00:00",
1032,1,18703,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf","2006-07-21 00:00:00",
11285,2,18703,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf","2009-03-27 00:00:00",
15101,1,18703,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf","2009-02-19 00:00:00",
1033,1,18703,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf","2009-11-12 00:00:00",
11286,2,18703,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf","2009-10-06 00:00:00",
1034,1,18704,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf","2003-09-25 00:00:00",
15102,1,18704,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf","2006-09-18 00:00:00",
1035,1,18704,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf","2008-01-09 00:00:00",
1036,1,18704,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf","2008-07-30 00:00:00",
33563,2,18704,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf","2008-07-29 00:00:00",
11287,2,18704,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf","2009-11-23 00:00:00",
15103,1,18704,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf","2010-01-06 00:00:00",
15104,1,18704,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018704Orig1s025ltr.pdf","2012-12-26 00:00:00",
33564,2,18704,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018704s025lbl.pdf","2013-01-02 00:00:00",
1037,1,18704,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018704Orig1s026ltr.pdf","2013-03-15 00:00:00",
33565,2,18704,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018704s026lbl.pdf","2013-03-15 00:00:00",
1038,1,18705,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18705scp012ltr.pdf","2002-11-05 00:00:00",
1039,1,18705,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18705s013ltr.pdf","2004-09-03 00:00:00",
1040,1,18705,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018705s015ltr.pdf","2006-02-22 00:00:00",
1041,1,18705,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018705s016LTR.pdf","2006-10-02 00:00:00",
11288,2,18705,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018705s017lbl.pdf","2008-10-09 00:00:00",
15105,1,18705,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018705s017ltr.pdf","2008-10-06 00:00:00",
15106,1,18705,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018705Orig1s019ltr.pdf","2015-01-26 00:00:00",
33566,2,18705,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018705s019lbl.pdf","2015-01-30 00:00:00",
55058,1,18705,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018705Orig1s025ltr.pdf","2018-07-30 00:00:00",
55078,2,18705,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018705s025lbl.pdf","2018-08-02 00:00:00",
15107,1,18707,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf","2003-04-16 00:00:00",
33567,2,18707,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf","2003-04-07 00:00:00",
1042,1,18707,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf","2011-04-11 00:00:00",
33568,2,18707,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018707s012lbl.pdf","2011-04-06 00:00:00",
23542,10,18708,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
15108,1,18708,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18708slr014ltr.pdf","2003-07-29 00:00:00",
15109,1,18708,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018708s017ltr.pdf","2007-11-08 00:00:00",
33569,2,18708,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf","2007-11-07 00:00:00",
33570,2,18708,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf","2010-04-20 00:00:00",
11289,2,18708,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf","2013-04-23 00:00:00",
11290,2,18708,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf","2013-04-23 00:00:00",
46316,2,18708,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf","2016-12-20 00:00:00",
46467,1,18708,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018708Orig1s023ltr.pdf","2016-12-22 00:00:00",
46642,8,18708,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf#page=12","2017-01-03 00:00:00",
1043,1,18709,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018709s033LTR.pdf","2006-05-21 00:00:00",
1044,1,18709,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018709s035ltr.pdf","2009-03-03 00:00:00",
20151,3,18713,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018713_S004_MYCELEX TROCHE_AP.pdf","2007-07-06 00:00:00",
40824,3,18713,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018713_S014_MYCELEX TROCHE_AP.pdf","2007-07-06 00:00:00",
20152,3,18713,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018713_S017_MYCELEX TROCHE_AP.pdf","2007-07-06 00:00:00",
11291,2,18713,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf","2002-12-15 00:00:00",
15110,1,18713,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18713slr019ltr.pdf","2002-12-15 00:00:00",
11292,2,18714,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf","2004-07-21 00:00:00",
15111,1,18714,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf","2004-07-21 00:00:00",
1045,1,18714,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf","2004-07-21 00:00:00",
33571,2,18714,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf","2004-07-21 00:00:00",
11293,2,18714,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf","2010-08-01 00:00:00",
15112,1,18714,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf","2010-08-20 00:00:00",
11294,2,18714,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf","2014-03-05 00:00:00",
15113,1,18714,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018714Orig1s013ltr.pdf","2014-02-27 00:00:00",
15114,1,18716,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18716scm023ltr.pdf","2003-05-29 00:00:00",
1046,1,18716,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018716s026ltr.pdf","2010-11-30 00:00:00",
33572,2,18716,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf","2010-11-22 00:00:00",
23543,10,18723,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
15115,1,18723,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
15116,1,18723,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018723s032ltr.pdf","2006-01-20 00:00:00",
33573,2,18723,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
15117,1,18723,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
33574,2,18723,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
11295,2,18723,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf","2011-10-12 00:00:00",
15118,1,18723,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
15119,1,18723,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018723s039ltr.pdf","2009-05-01 00:00:00",
33575,2,18723,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018723s039lbl.pdf","2009-05-12 00:00:00",
11296,2,18723,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf","2011-10-12 00:00:00",
15120,1,18723,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11297,2,18723,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s041lbl.pdf","2014-06-23 00:00:00",
15121,1,18723,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
11298,2,18723,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf46lbl.pdf","2011-10-12 00:00:00",
16008,1,18723,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11299,2,18723,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf","2011-10-12 00:00:00",
16009,1,18723,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
1047,1,18723,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11300,2,18723,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf","2011-10-12 00:00:00",
1048,1,18723,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
11301,2,18723,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s047lbl.pdf","2013-03-04 00:00:00",
11302,2,18723,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s048lbl.pdf","2013-09-17 00:00:00",
16010,1,18723,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
33576,2,18723,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s049lbl.pdf","2013-07-02 00:00:00",
11303,2,18723,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s050lbl.pdf","2014-12-03 00:00:00",
16011,1,18723,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
1049,1,18723,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
11304,2,18723,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s051lbl.pdf","2015-01-08 00:00:00",
16012,1,18723,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
33577,2,18723,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
11305,2,18723,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s053lbl.pdf","2014-08-22 00:00:00",
16013,1,18723,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
1050,1,18723,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
33578,2,18723,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf","2015-03-17 00:00:00",
1051,1,18723,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
33579,2,18723,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s055lbl.pdf","2015-10-06 00:00:00",
11306,2,18723,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018723s056lbl.pdf","2016-02-23 00:00:00",
16014,1,18723,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
45812,1,18723,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45845,2,18723,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018723s057lbl.pdf","2016-11-08 00:00:00",
47478,2,18723,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018723s058lbl.pdf","2017-03-07 00:00:00",
47507,1,18723,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49983,1,18723,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
50000,2,18723,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018723s059lbl.pdf","2017-10-10 00:00:00",
54067,1,18723,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54087,2,18723,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018723s060lbl.pdf","2018-05-10 00:00:00",
1052,1,18726,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf","2002-09-03 00:00:00",
33580,2,18726,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf","2002-09-03 00:00:00",
1053,1,18726,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf","2000-09-21 00:00:00",
33581,2,18726,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf","2002-09-03 00:00:00",
11307,2,18731,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf","2003-04-14 00:00:00",
11308,2,18731,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf","2001-07-19 00:00:00",
16015,1,18731,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf","2001-07-19 00:00:00",
20153,3,18731,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf","2004-04-14 00:00:00",
33582,2,18731,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf","2003-04-14 00:00:00",
1054,1,18731,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf","2002-02-07 00:00:00",
16016,1,18731,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf","2007-09-25 00:00:00",
33583,2,18731,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf","2007-09-26 00:00:00",
1055,1,18731,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf","2010-11-30 00:00:00",
11309,2,18731,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf","2010-11-22 00:00:00",
1056,1,18733,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18733slr012ltr.pdf","2003-03-10 00:00:00",
11310,2,18733,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf","2008-09-12 00:00:00",
16017,1,18733,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018733s015ltr.pdf","2011-03-02 00:00:00",
33584,2,18733,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf","2011-03-04 00:00:00",
16018,1,18735,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr043ltr.pdf","2002-07-08 00:00:00",
1057,1,18735,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf","2002-06-20 00:00:00",
16019,1,18735,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018735Orig1s054ltr.pdf","2012-08-03 00:00:00",
33585,2,18735,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf","2012-08-02 00:00:00",
16020,1,18735,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf","2015-07-09 00:00:00",
33586,2,18735,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf","2015-07-09 00:00:00",
47882,2,18735,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018735s057lbl.pdf","2017-04-06 00:00:00",
47969,1,18735,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018735Orig1s057,020327Orig1s012ltr.pdf","2017-04-12 00:00:00",
1058,1,18737,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18737slr003ltr.pdf","2003-06-08 00:00:00",
11311,2,18737,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf","2003-06-08 00:00:00",
11312,2,18738,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf","2003-06-08 00:00:00",
16021,1,18738,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18738slr007ltr.pdf","2003-06-08 00:00:00",
1059,1,18738,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018738s009ltr.pdf","2009-07-13 00:00:00",
11313,2,18738,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf","2009-07-09 00:00:00",
11314,2,18741,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf","2006-02-22 00:00:00",
16022,1,18741,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf","2005-10-14 00:00:00",
16023,1,18741,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf","2006-02-22 00:00:00",
33587,2,18741,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf","2005-10-14 00:00:00",
1060,1,18741,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s028LTR.pdf","2006-09-18 00:00:00",
33588,2,18741,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf","2006-08-29 00:00:00",
16024,1,18741,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf","2014-08-14 00:00:00",
33589,2,18741,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf","2014-08-15 00:00:00",
53568,2,18741,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf","2018-04-01 00:00:00",
53585,1,18741,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf","2018-04-01 00:00:00",
11315,2,18748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf","2003-03-28 00:00:00",
16025,1,18748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18748slr010ltr.pdf","2003-03-28 00:00:00",
33590,2,18748,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf","2003-04-15 00:00:00",
16026,1,18748,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf","2013-07-02 00:00:00",
33591,2,18748,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf","2013-07-11 00:00:00",
11316,2,18751,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf","2014-04-01 00:00:00",
16027,1,18751,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf","2014-04-02 00:00:00",
52281,2,18751,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf","2018-02-02 00:00:00",
54587,1,18751,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018751Orig1s025ltr.pdf","2018-06-14 00:00:00",
54608,2,18751,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018751s025lbl.pdf","2018-06-19 00:00:00",
20154,3,18754,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf","2003-09-11 00:00:00",
16028,1,18754,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18754slr026ltr.pdf","2003-08-26 00:00:00",
16029,1,18754,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf","2006-01-20 00:00:00",
20155,3,18760,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf","2001-06-04 00:00:00",
40825,3,18760,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf","2001-06-04 00:00:00",
16030,1,18760,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr024ltr.pdf","2003-01-31 00:00:00",
1061,1,18760,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr025ltr.pdf","2003-12-02 00:00:00",
16031,1,18760,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18760s026ltr.pdf","2005-02-11 00:00:00",
1062,1,18760,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018760s027ltr.pdf","2008-10-30 00:00:00",
33592,2,18760,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf","2008-11-07 00:00:00",
11317,2,18760,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf","2011-08-24 00:00:00",
16032,1,18760,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018760s028ltr.pdf","2011-08-18 00:00:00",
1063,1,18760,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018760Orig1s029ltr.pdf","2012-11-01 00:00:00",
11318,2,18760,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf","2012-11-02 00:00:00",
16033,1,18761,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18761s16ltr.pdf","2002-01-23 00:00:00",
1064,1,18763,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18763slr003ltr.pdf","2004-04-29 00:00:00",
11319,2,18763,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf","2004-05-04 00:00:00",
1065,1,18766,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018766s013ltr.pdf","2006-01-30 00:00:00",
11320,2,18766,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf","2006-01-25 00:00:00",
16034,1,18766,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018766s014ltr.pdf","2007-07-05 00:00:00",
16035,1,18766,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018766s015ltr.pdf","2010-09-07 00:00:00",
23124,8,18766,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf","2010-08-28 00:00:00",
33593,2,18766,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf","2010-08-28 00:00:00",
1066,1,18766,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018766Orig1s020ltr.pdf","2016-05-11 00:00:00",
11321,2,18766,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf","2016-05-11 00:00:00",
20156,3,18768,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18768S041_VePesid.pdf","1999-04-02 00:00:00",
11322,2,18768,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf","2012-08-03 00:00:00",
16036,1,18768,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf","2002-11-05 00:00:00",
20157,3,18768,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018768_S045_VEPESIDE.pdf","2007-07-06 00:00:00",
1067,1,18771,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18771s12ltr.pdf","2002-03-20 00:00:00",
33594,2,18771,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18771S12lbl.pdf","2002-03-20 00:00:00",
16037,1,18771,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018771s017ltr.pdf","2008-02-25 00:00:00",
33595,2,18771,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017lbl.pdf","2008-02-25 00:00:00",
1068,1,18776,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18776slr027ltr.pdf","2003-06-08 00:00:00",
16038,1,18776,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018776s030ltr.pdf","2010-11-29 00:00:00",
20158,3,18780,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018780_s037.pdf","2003-06-17 00:00:00",
1069,1,18780,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780slr066ltr.pdf","2003-05-29 00:00:00",
16039,1,18780,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf","2004-06-07 00:00:00",
33596,2,18780,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf","2003-03-05 00:00:00",
16040,1,18780,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf","2004-06-07 00:00:00",
33597,2,18780,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf","2003-03-05 00:00:00",
1070,1,18780,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm080ltr.pdf","2003-11-25 00:00:00",
11323,2,18780,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf","2003-12-01 00:00:00",
1071,1,18780,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf","2005-03-03 00:00:00",
11324,2,18780,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf","2005-03-03 00:00:00",
1072,1,18780,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
1073,1,18780,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf","2007-08-27 00:00:00",
11325,2,18780,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf","2007-08-23 00:00:00",
11326,2,18780,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf","2007-09-11 00:00:00",
16041,1,18780,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s114ltr.pdf","2007-09-11 00:00:00",
1074,1,18780,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s120ltr.pdf","2011-03-29 00:00:00",
11327,2,18780,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf","2011-04-01 00:00:00",
1075,1,18780,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s124ltr.pdf","2011-03-24 00:00:00",
11328,2,18780,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s124lbl.pdf","2011-03-28 00:00:00",
54375,2,18780,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s126s134lbl.pdf","2018-05-31 00:00:00",
54378,1,18780,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s126,s134ltr.pdf","2018-05-31 00:00:00",
16042,1,18780,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf","2010-06-15 00:00:00",
33598,2,18780,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf","2010-06-24 00:00:00",
16043,1,18780,"SUPPL",132,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018780Orig1s132ltr.pdf","2013-03-12 00:00:00",
33599,2,18780,"SUPPL",132,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf","2013-03-12 00:00:00",
1076,1,18780,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s133ltr.pdf","2011-11-02 00:00:00",
54374,2,18780,"SUPPL",134,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s126s134lbl.pdf","2018-05-31 00:00:00",
54379,1,18780,"SUPPL",134,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s126,s134ltr.pdf","2018-05-31 00:00:00",
1077,1,18780,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf","2015-12-30 00:00:00",
11329,2,18780,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf","2015-12-31 00:00:00",
11330,2,18780,"SUPPL",148,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf","2014-09-26 00:00:00",
16044,1,18780,"SUPPL",150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s150ltr.pdf","2015-04-01 00:00:00",
33600,2,18780,"SUPPL",150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf","2015-03-03 00:00:00",
16045,1,18780,"SUPPL",152,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf","2015-12-30 00:00:00",
33601,2,18780,"SUPPL",152,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf","2015-12-31 00:00:00",
1078,1,18780,"SUPPL",153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018780Orig1s153ltr.pdf","2016-07-12 00:00:00",
47639,2,18780,"SUPPL",153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf","2017-03-22 00:00:00",
20159,3,18781,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018781_s027_Humulin N.pdf","2009-09-16 00:00:00",
1079,1,18781,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18781slr054ltr.pdf","2002-11-05 00:00:00",
1080,1,18781,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf","2004-06-07 00:00:00",
11331,2,18781,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf","2003-03-05 00:00:00",
1081,1,18781,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf","2003-11-25 00:00:00",
16046,1,18781,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf","2003-11-25 00:00:00",
11332,2,18781,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781slr072_humulin_lbl.pdf","2003-07-08 00:00:00",
16047,1,18781,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr072ltr.pdf","2003-07-06 00:00:00",
1082,1,18781,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781scm074ltr.pdf","2003-11-25 00:00:00",
11333,2,18781,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf","2003-12-02 00:00:00",
1083,1,18781,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781slr076ltr.pdf","2004-04-29 00:00:00",
11334,2,18781,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf","2004-05-04 00:00:00",
1084,1,18781,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf","2004-09-07 00:00:00",
11335,2,18781,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf","2004-09-07 00:00:00",
1085,1,18781,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf","2005-03-03 00:00:00",
33602,2,18781,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf","2005-03-03 00:00:00",
1086,1,18781,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018781s025,060,065,085ltr.pdf","2005-11-18 00:00:00",
33603,2,18781,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf","2005-11-17 00:00:00",
16048,1,18781,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
11336,2,18781,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf","2007-08-23 00:00:00",
16049,1,18781,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf","2007-08-27 00:00:00",
11337,2,18781,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf","2009-03-17 00:00:00",
16050,1,18781,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf","2009-03-23 00:00:00",
1087,1,18781,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf","2010-06-15 00:00:00",
33604,2,18781,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf","2010-06-24 00:00:00",
16051,1,18781,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf","2013-11-12 00:00:00",
33605,2,18781,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf","2013-11-15 00:00:00",
11338,2,18781,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf","2014-10-02 00:00:00",
1088,1,18781,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s121ltr.pdf","2013-03-12 00:00:00",
33606,2,18781,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf","2013-03-12 00:00:00",
1089,1,18781,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf","2013-11-12 00:00:00",
11339,2,18781,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf","2013-11-15 00:00:00",
16052,1,18781,"SUPPL",144,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s144ltr.pdf","2013-12-13 00:00:00",
16053,1,18781,"SUPPL",145,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018781Orig1s145ltr.pdf","2014-01-17 00:00:00",
1090,1,18781,"SUPPL",154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s154ltr.pdf","2015-02-27 00:00:00",
11340,2,18781,"SUPPL",154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf","2015-05-08 00:00:00",
11341,2,18781,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s156lbl.pdf","2015-03-17 00:00:00",
16054,1,18781,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s156ltr.pdf","2015-03-13 00:00:00",
46732,2,18781,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018781s167lbl.pdf","2017-01-06 00:00:00",
46788,1,18781,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018781Orig1s167ltr.pdf","2017-01-11 00:00:00",
20160,3,18782,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf","2003-02-05 00:00:00",
1091,1,18782,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018782Orig1s036ltr.pdf","2013-06-04 00:00:00",
33607,2,18782,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018782s036lbl.pdf","2013-06-03 00:00:00",
49327,2,18782,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018782s038lbl.pdf","2017-08-10 00:00:00",
49396,1,18782,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018782Orig1s038ltr.pdf","2017-08-15 00:00:00",
1092,1,18796,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018796s014ltr.pdf","2008-04-22 00:00:00",
33608,2,18796,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018796s014lbl.pdf","2008-06-05 00:00:00",
16055,1,18800,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf","2003-02-19 00:00:00",
16056,1,18801,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18801scs023ltr.pdf","2004-04-20 00:00:00",
16057,1,18801,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018801s034ltr.pdf","2009-07-08 00:00:00",
11342,2,18814,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf","2010-08-28 00:00:00",
16058,1,18814,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018814s032ltr.pdf","2010-08-20 00:00:00",
16059,1,18817,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018817s021ltr.pdf","2009-07-17 00:00:00",
33609,2,18817,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf","2009-07-23 00:00:00",
1093,1,18817,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018817s022ltr.pdf","2010-04-19 00:00:00",
33610,2,18817,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf","2010-04-19 00:00:00",
1094,1,18817,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s024ltr.pdf","2011-07-05 00:00:00",
33611,2,18817,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf","2011-06-30 00:00:00",
1095,1,18817,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s027ltr.pdf","2011-11-07 00:00:00",
33612,2,18817,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf","2011-11-04 00:00:00",
16060,1,18817,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018817Orig1s031ltr.pdf","2013-10-28 00:00:00",
33613,2,18817,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf","2013-10-31 00:00:00",
45235,1,18817,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018817Orig1s032ltr.pdf","2016-08-24 00:00:00",
49760,2,18817,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018817s033lbl.pdf","2017-09-18 00:00:00",
49801,1,18817,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018817Orig1s033ltr.pdf","2017-09-19 00:00:00",
40826,3,18821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf","2001-06-18 00:00:00",
1096,1,18821,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf","2002-11-25 00:00:00",
49004,1,18823,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018823rig1s044ltr.pdf","2017-07-17 00:00:00",
49011,2,18823,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018823s044lbl.pdf","2017-07-18 00:00:00",
16061,1,18826,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18826S27ltr.pdf","2003-04-03 00:00:00",
40827,3,18826,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-826S027.pdf","2003-07-28 00:00:00",
1097,1,18826,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826Orig1s045ltr.pdf","2014-05-19 00:00:00",
33614,2,18826,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf","2014-05-15 00:00:00",
33615,2,18827,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf","2003-04-15 00:00:00",
16062,1,18827,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf","2003-07-31 00:00:00",
33616,2,18827,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf","2005-07-29 00:00:00",
1098,1,18827,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf","2003-04-15 00:00:00",
11343,2,18827,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf","2003-03-28 00:00:00",
1099,1,18827,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf","2008-01-29 00:00:00",
11344,2,18827,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf","2008-01-30 00:00:00",
1100,1,18827,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf","2009-05-13 00:00:00",
11345,2,18827,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf","2009-07-08 00:00:00",
1101,1,18827,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf","2014-04-22 00:00:00",
11346,2,18827,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf","2014-04-22 00:00:00",
54309,2,18827,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf","2018-05-22 00:00:00",
54325,1,18827,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf","2018-05-24 00:00:00",
20161,3,18828,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18828S010_Zovirax.pdf","2000-07-05 00:00:00",
33617,2,18828,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf","2003-04-15 00:00:00",
33618,2,18828,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf","2003-04-15 00:00:00",
11347,2,18828,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf","2004-05-27 00:00:00",
16063,1,18828,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf","2004-05-27 00:00:00",
16064,1,18828,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf","2005-12-15 00:00:00",
33619,2,18828,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf","2005-12-15 00:00:00",
1102,1,18828,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf","2008-08-13 00:00:00",
11348,2,18828,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf","2016-03-30 00:00:00",
16065,1,18829,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018829Orig1s022ltr.pdf","2016-05-11 00:00:00",
33620,2,18829,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf","2016-05-11 00:00:00",
50349,1,18830,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018830Orig1s024ltr.pdf","2017-11-09 00:00:00",
11349,2,18840,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018840s028lbl.pdf","2005-06-08 00:00:00",
16066,1,18840,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018840s028ltr.pdf","2005-06-08 00:00:00",
1103,1,18840,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33621,2,18840,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
1104,1,18841,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf","2002-01-25 00:00:00",
33622,2,18841,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf","2002-01-25 00:00:00",
11350,2,18841,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf","2002-01-25 00:00:00",
16067,1,18841,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf","2002-01-25 00:00:00",
16068,1,18841,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18841slr020ltr.pdf","2004-06-02 00:00:00",
33623,2,18841,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf","2003-04-17 00:00:00",
16069,1,18841,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018841s021ltr.pdf","2006-01-20 00:00:00",
33624,2,18841,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf","2006-01-20 00:00:00",
1105,1,18841,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018841s022ltr.pdf","2007-07-05 00:00:00",
11351,2,18841,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf","2014-05-07 00:00:00",
16070,1,18841,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018841Orig1s028ltr.pdf","2016-05-12 00:00:00",
23125,8,18841,"SUPPL",28,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501638.pdf","2016-05-18 00:00:00",
33625,2,18841,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf","2016-05-11 00:00:00",
1106,1,18849,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf","2006-01-19 00:00:00",
16071,1,18849,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018849Orig1s020ltr.pdf","2014-03-04 00:00:00",
1107,1,18851,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018851Orig1s025ltr.pdf","2016-05-12 00:00:00",
11352,2,18851,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf","2016-05-11 00:00:00",
11353,2,18858,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf","2016-05-11 00:00:00",
16072,1,18858,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf","2016-05-12 00:00:00",
16073,1,18858,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf","2016-05-12 00:00:00",
33626,2,18858,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf","2016-05-11 00:00:00",
1108,1,18869,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18869S10LTR.PDF","2000-08-22 00:00:00",
33627,2,18869,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf","2000-08-22 00:00:00",
16074,1,18869,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018869s014ltr.pdf","2006-01-30 00:00:00",
33628,2,18869,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf","2006-01-27 00:00:00",
1109,1,18873,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18873slr018ltr.pdf","2004-06-09 00:00:00",
1110,1,18874,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18874s16ltr.pdf","2003-07-30 00:00:00",
16075,1,18874,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018874s019_ltr.pdf","2007-07-05 00:00:00",
1111,1,18874,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018874s022ltr.pdf","2012-03-14 00:00:00",
11354,2,18874,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf","2012-03-27 00:00:00",
16076,1,18878,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf","2003-05-30 00:00:00",
1112,1,18878,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf","2003-05-30 00:00:00",
16077,1,18878,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018878s023ltr.pdf","2006-02-08 00:00:00",
33629,2,18878,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf","2006-02-07 00:00:00",
1113,1,18878,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018878s024ltr.pdf","2007-01-25 00:00:00",
11355,2,18878,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf","2007-01-16 00:00:00",
16078,1,18878,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018878s027ltr.pdf","2010-01-26 00:00:00",
33630,2,18878,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf","2010-01-20 00:00:00",
16079,1,18883,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs010ltr.pdf","2003-12-02 00:00:00",
1114,1,18883,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015ltr.pdf","2009-11-13 00:00:00",
16080,1,18883,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171Orig1s026ltr.pdf","2013-02-04 00:00:00",
33631,2,18883,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf","2013-02-01 00:00:00",
33632,2,18883,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf","2013-04-19 00:00:00",
1115,1,18883,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171Orig1s033ltr.pdf","2014-04-25 00:00:00",
33633,2,18883,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf","2014-04-28 00:00:00",
1116,1,18883,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171Orig1s039ltr.pdf","2015-01-09 00:00:00",
11356,2,18883,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf","2015-01-12 00:00:00",
1117,1,18887,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18887slr020ltr.pdf","2004-03-02 00:00:00",
33634,2,18887,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf","2004-04-05 00:00:00",
16081,1,18890,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018890Orig1s050ltr.pdf","2015-07-14 00:00:00",
33635,2,18890,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018890s050lbl.pdf","2015-07-16 00:00:00",
53606,2,18890,"SUPPL",52,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018890s052lbl.pdf","2018-04-04 00:00:00",
53627,1,18890,"SUPPL",52,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018890Orig1s052ltr.pdf","2018-04-05 00:00:00",
20162,3,18891,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.cfm","2003-08-05 00:00:00",
1118,1,18891,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18891s022ltr.pdf","2004-08-25 00:00:00",
16082,1,18891,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018891s024ltr.pdf","2006-04-14 00:00:00",
1119,1,18891,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018891s025ltr.pdf","2010-01-07 00:00:00",
11357,2,18891,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf","2009-11-13 00:00:00",
16083,1,18891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018891s027ltr.pdf","2010-05-03 00:00:00",
33636,2,18891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf","2010-05-07 00:00:00",
11358,2,18891,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf","2012-06-06 00:00:00",
16084,1,18891,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018891s028ltr.pdf","2012-06-07 00:00:00",
1120,1,18892,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18892s21ltr.pdf","2002-03-14 00:00:00",
1121,1,18893,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18893scs017ltr.pdf","2003-03-10 00:00:00",
33637,2,18893,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf","2014-09-03 00:00:00",
16085,1,18895,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18895scs013ltr.pdf","2003-05-29 00:00:00",
1122,1,18896,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18896scs012ltr.pdf","2002-12-24 00:00:00",
16086,1,18897,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18897s16ltr.pdf","2002-03-14 00:00:00",
1123,1,18900,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s031ltr.pdf","2015-12-10 00:00:00",
33638,2,18900,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s031lbl.pdf","2015-12-10 00:00:00",
1124,1,18900,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s032ltr.pdf","2015-07-14 00:00:00",
33639,2,18900,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s032lbl.pdf","2015-07-16 00:00:00",
53662,2,18900,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018900s035lbl.pdf","2018-04-12 00:00:00",
53687,1,18900,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018900Orig1s035ltr.pdf","2018-04-16 00:00:00",
16087,1,18902,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s027ltr.pdf","2016-03-10 00:00:00",
33640,2,18902,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf","2016-03-14 00:00:00",
45353,1,18902,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s028ltr.pdf","2016-09-21 00:00:00",
16088,1,18905,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018905Orig1s024ltr.pdf","2015-07-10 00:00:00",
33641,2,18905,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf","2015-07-09 00:00:00",
47874,2,18905,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018905s025lbl.pdf","2017-04-06 00:00:00",
47967,1,18905,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018905Orig1s025ltr.pdf","2017-04-12 00:00:00",
11359,2,18916,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf","2011-12-23 00:00:00",
16089,1,18916,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018916s057ltr.pdf","2011-12-29 00:00:00",
1125,1,18916,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018916Orig1s060ltr.pdf","2013-02-13 00:00:00",
33642,2,18916,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf","2013-02-14 00:00:00",
1126,1,18916,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf","2016-04-07 00:00:00",
33643,2,18916,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf","2016-04-12 00:00:00",
16090,1,18916,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf","2016-04-07 00:00:00",
33644,2,18916,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf","2016-04-12 00:00:00",
16091,1,18917,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018917s024_ltr.pdf","2007-09-11 00:00:00",
33645,2,18917,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf","2007-09-11 00:00:00",
11360,2,18917,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf","2014-03-17 00:00:00",
16092,1,18917,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018917s025ltr.pdf","2011-03-07 00:00:00",
1127,1,18920,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18920slr024ltr.pdf","2002-07-08 00:00:00",
33646,2,18920,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18920s024lbl.pdf","2002-07-08 00:00:00",
50370,1,18920,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018920Orig1s036ltr.pdf","2017-11-13 00:00:00",
50387,2,18920,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018920s036lbl.pdf","2017-11-13 00:00:00",
11361,2,18921,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018921s031lbl.pdf","2015-10-07 00:00:00",
16093,1,18921,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018921Orig1s031ltr.pdf","2015-10-01 00:00:00",
11362,2,18922,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf","2005-05-27 00:00:00",
16094,1,18922,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018922s021ltr.pdf","2005-05-27 00:00:00",
16095,1,18922,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009ltr.pdf","2006-01-20 00:00:00",
33647,2,18922,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf","2006-01-20 00:00:00",
16096,1,18922,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018922s023ltr.pdf","2007-10-15 00:00:00",
33648,2,18922,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018922s023lbl.pdf","2015-07-27 00:00:00",
16097,1,18925,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003ltr.pdf","2010-04-19 00:00:00",
33649,2,18925,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf","2010-04-19 00:00:00",
1128,1,18925,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018925s008ltr.pdf","2011-11-07 00:00:00",
11363,2,18925,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf","2011-11-04 00:00:00",
45912,1,18925,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018925Orig1s010ltr.pdf","2016-11-22 00:00:00",
45942,2,18925,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018925s010lbl.pdf","2016-11-21 00:00:00",
49312,2,18926,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf","2017-08-10 00:00:00",
49397,1,18926,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018926Orig1s011,017948Orig1s044ltr.pdf","2017-08-15 00:00:00",
53255,2,18926,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017948s045,018926s012lbl.pdf","2018-03-23 00:00:00",
53489,1,18926,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf","2018-03-28 00:00:00",
11364,2,18927,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF","2001-03-07 00:00:00",
16098,1,18927,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF","2001-03-07 00:00:00",
11365,2,18927,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf","2007-08-17 00:00:00",
16099,1,18927,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf","2007-08-17 00:00:00",
1129,1,18927,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf","2015-09-01 00:00:00",
33650,2,18927,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf","2015-09-03 00:00:00",
1130,1,18927,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf","2008-01-09 00:00:00",
33651,2,18927,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018927s039lbl.pdf","2007-12-12 00:00:00",
16100,1,18927,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf","2014-09-17 00:00:00",
33652,2,18927,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf","2014-09-19 00:00:00",
1131,1,18927,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
11366,2,18927,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
11367,2,18927,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
16101,1,18927,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
1132,1,18927,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016608s101,018927s043ltr.pdf","2009-05-01 00:00:00",
33653,2,18927,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf","2009-05-12 00:00:00",
1133,1,18927,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf","2014-01-17 00:00:00",
11368,2,18927,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf","2014-01-17 00:00:00",
16102,1,18927,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf","2013-03-08 00:00:00",
33654,2,18927,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf","2013-03-08 00:00:00",
16103,1,18927,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf","2011-11-10 00:00:00",
11369,2,18927,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf","2012-12-13 00:00:00",
16104,1,18927,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf","2012-12-13 00:00:00",
53148,1,18927,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf","2018-03-22 00:00:00",
53420,2,18927,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf","2018-03-26 00:00:00",
53452,8,18927,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19","2018-03-27 00:00:00",
50442,2,18931,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018931s049lbl.pdf","2017-11-17 00:00:00",
50447,1,18931,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018931Orig1s049ltr.pdf","2017-11-17 00:00:00",
1134,1,18932,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018932Orig1s017ltr.pdf","2013-10-04 00:00:00",
33655,2,18932,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf","2013-10-08 00:00:00",
23544,10,18936,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
40828,3,18936,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018936_S033_PROZAC.pdf","2007-12-06 00:00:00",
40829,3,18936,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18936S036_ProzacPulvules.pdf","2003-09-25 00:00:00",
40830,3,18936,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm","2004-08-09 00:00:00",
20163,3,18936,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936s054_Prozac.cfm","2004-08-09 00:00:00",
1135,1,18936,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18936S58LTR.PDF","2000-07-06 00:00:00",
11370,2,18936,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF","2000-07-06 00:00:00",
20164,3,18936,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm","2007-02-20 00:00:00",
33656,2,18936,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf","2002-07-29 00:00:00",
20165,3,18936,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm","2007-02-20 00:00:00",
20166,3,18936,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm","2007-02-20 00:00:00",
11371,2,18936,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf","2003-01-07 00:00:00",
16105,1,18936,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18936se5-064ltr.pdf","2003-01-07 00:00:00",
20167,3,18936,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18936s064_Prozac.cfm","2003-09-25 00:00:00",
16106,1,18936,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18936s067ltr.pdf","2002-06-12 00:00:00",
33657,2,18936,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf","2002-06-12 00:00:00",
1136,1,18936,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf","2004-08-25 00:00:00",
1137,1,18936,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18936s070ltr.pdf","2004-09-03 00:00:00",
16107,1,18936,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf","2005-12-05 00:00:00",
16108,1,18936,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf","2005-02-23 00:00:00",
1138,1,18936,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf","2005-12-05 00:00:00",
16109,1,18936,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf","2006-04-13 00:00:00",
1139,1,18936,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf","2009-03-24 00:00:00",
33658,2,18936,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf","2009-03-20 00:00:00",
33659,2,18936,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf","2006-09-21 00:00:00",
11372,2,18936,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf","2009-03-20 00:00:00",
16110,1,18936,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf","2009-03-24 00:00:00",
1140,1,18936,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf","2007-03-23 00:00:00",
40831,3,18936,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/018936Orig1s078.pdf","2015-11-05 00:00:00",
1141,1,18936,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
11373,2,18936,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf","2007-08-03 00:00:00",
11374,2,18936,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf","2007-08-03 00:00:00",
16111,1,18936,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
16112,1,18936,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf","2008-03-12 00:00:00",
33660,2,18936,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf","2008-03-13 00:00:00",
1142,1,18936,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf","2008-03-24 00:00:00",
11375,2,18936,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf","2008-03-24 00:00:00",
11376,2,18936,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf","2008-06-30 00:00:00",
16113,1,18936,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s086ltr.pdf","2008-07-01 00:00:00",
11377,2,18936,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf","2009-02-04 00:00:00",
16114,1,18936,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf","2009-02-03 00:00:00",
16115,1,18936,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s089ltr.pdf","2009-06-24 00:00:00",
33661,2,18936,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf","2009-06-24 00:00:00",
11378,2,18936,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf","2011-04-04 00:00:00",
16116,1,18936,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
1143,1,18936,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
20168,3,18936,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936Orig1s093.pdf","2013-10-21 00:00:00",
33662,2,18936,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf","2011-04-04 00:00:00",
1144,1,18936,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
33663,2,18936,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf","2011-04-04 00:00:00",
16117,1,18936,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf","2011-06-16 00:00:00",
33664,2,18936,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf","2011-06-16 00:00:00",
1145,1,18936,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf","2013-01-07 00:00:00",
20169,3,18936,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018936Orig1s097.pdf","2015-11-18 00:00:00",
33665,2,18936,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf","2013-01-07 00:00:00",
16118,1,18936,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf","2013-01-07 00:00:00",
33666,2,18936,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf","2013-01-07 00:00:00",
1146,1,18936,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
11379,2,18936,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf","2013-07-30 00:00:00",
16119,1,18936,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
33667,2,18936,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf","2013-07-30 00:00:00",
11380,2,18936,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf","2014-10-15 00:00:00",
16120,1,18936,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf","2014-10-15 00:00:00",
47719,2,18936,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf","2017-03-27 00:00:00",
47720,8,18936,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28","2017-03-27 00:00:00",
47757,1,18936,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf","2017-03-29 00:00:00",
16121,1,18936,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf","2014-07-24 00:00:00",
33668,2,18936,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf","2014-07-23 00:00:00",
16122,1,18936,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018936Orig1s106ltr.pdf","2015-11-25 00:00:00",
46698,2,18936,"SUPPL",108,"Label for Sarafem","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf","2017-01-06 00:00:00",
46818,1,18936,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf","2017-01-13 00:00:00",
23545,10,18938,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2007-12-04 00:00:00",
16123,1,18938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18938slr017ltr.pdf","2002-08-08 00:00:00",
40832,3,18938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018938_S017_DDAVP_AP.pdf","2007-07-09 00:00:00",
16124,1,18938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf","2003-11-25 00:00:00",
11381,2,18938,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-16 00:00:00",
16125,1,18938,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-17 00:00:00",
11382,2,18938,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf","2007-11-07 00:00:00",
16126,1,18938,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf","2007-11-08 00:00:00",
1147,1,18938,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf","2015-11-09 00:00:00",
11383,2,18938,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf","2015-11-19 00:00:00",
53222,2,18938,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf","2018-03-23 00:00:00",
53503,1,18938,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018938Orig1s035ltr.pdf","2018-03-29 00:00:00",
20170,3,18948,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018948a_s016_071492.pdf","1998-05-07 00:00:00",
1148,1,18948,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf","2002-04-15 00:00:00",
33669,2,18948,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf","2002-04-15 00:00:00",
16127,1,18948,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf","2007-04-09 00:00:00",
33670,2,18948,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf","2007-03-31 00:00:00",
1149,1,18948,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf","2015-06-02 00:00:00",
33671,2,18948,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf","2015-06-04 00:00:00",
53734,2,18948,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf","2018-04-19 00:00:00",
53759,1,18948,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018948Orig1s028,019257Orig1s014ltr.pdf","2018-04-20 00:00:00",
20171,3,18956,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018956-S28_Omnipaque_toc.cfm","2003-08-05 00:00:00",
1150,1,18956,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr039ltr.pdf","2002-12-23 00:00:00",
40833,3,18956,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18956a_s043_061595.pdf","1998-05-11 00:00:00",
16128,1,18956,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr049ltr.pdf","2002-12-23 00:00:00",
1151,1,18956,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956slr058ltr.pdf","2004-03-10 00:00:00",
1152,1,18956,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956s062ltr.pdf","2004-12-29 00:00:00",
16129,1,18956,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18956s065ltr.pdf","2005-03-30 00:00:00",
16130,1,18956,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018956s076ltr.pdf","2007-10-04 00:00:00",
1153,1,18956,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018956Orig1s095,020608Orig1s031ltr.pdf","2015-07-10 00:00:00",
33672,2,18956,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf","2015-07-09 00:00:00",
47896,2,18956,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018956s099lbl.pdf","2017-04-07 00:00:00",
47966,1,18956,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018956Orig1s099,020608s036s037ltr.pdf","2017-04-12 00:00:00",
53733,2,18956,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf","2018-04-19 00:00:00",
53761,1,18956,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018956Orig1s101ltr.pdf","2018-04-20 00:00:00",
16131,1,18959,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18959slr011,008ltr.pdf","2004-07-01 00:00:00",
16132,1,18959,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18959slr011,008ltr.pdf","2004-07-01 00:00:00",
16133,1,18960,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18960slr013ltr.pdf","2003-03-10 00:00:00",
1154,1,18961,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18961s012.pdf","2002-04-24 00:00:00",
11384,2,18961,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf","2002-04-24 00:00:00",
16134,1,18962,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18962slr007ltr.pdf","2004-03-02 00:00:00",
16135,1,18962,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18962slr011ltr.pdf","2002-12-06 00:00:00",
33673,2,18962,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf","2002-12-06 00:00:00",
16136,1,18965,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf","2003-05-29 00:00:00",
1155,1,18965,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
33674,2,18965,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
1156,1,18965,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
11385,2,18965,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
11386,2,18965,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf","2006-03-14 00:00:00",
16137,1,18965,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf","2006-03-23 00:00:00",
11387,2,18965,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf","2006-01-25 00:00:00",
16138,1,18965,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf","2006-01-30 00:00:00",
16139,1,18965,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf","2007-04-25 00:00:00",
1157,1,18965,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf","2007-09-25 00:00:00",
11388,2,18965,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf","2007-09-26 00:00:00",
1158,1,18965,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf","2008-07-30 00:00:00",
11389,2,18965,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf","2008-07-29 00:00:00",
11390,2,18965,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf","2013-03-26 00:00:00",
16140,1,18965,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf","2013-03-26 00:00:00",
11391,2,18965,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf","2016-05-11 00:00:00",
16141,1,18965,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf","2016-05-12 00:00:00",
1159,1,18965,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf","2016-05-12 00:00:00",
33675,2,18965,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf","2016-05-11 00:00:00",
47541,2,18965,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018965s025lbl.pdf","2017-03-13 00:00:00",
47542,8,18965,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018965s025lbl.pdf#page=21","2017-03-13 00:00:00",
47562,1,18965,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018965Orig1s025ltr.pdf","2017-03-14 00:00:00",
16142,1,18969,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18969scs012ltr.pdf","2003-03-26 00:00:00",
1160,1,18970,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18970scs013ltr.pdf","2003-04-18 00:00:00",
40834,3,18972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-972_Cardarone.cfm","2004-08-26 00:00:00",
44026,10,18972,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-29 00:00:00",
40835,3,18972,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf","1998-06-15 00:00:00",
16143,1,18972,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf","1999-01-05 00:00:00",
40836,3,18972,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm","1999-01-05 00:00:00",
40837,3,18972,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf","1998-06-15 00:00:00",
1161,1,18972,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf","1999-01-05 00:00:00",
20172,3,18972,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm","1999-01-05 00:00:00",
20173,3,18972,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf","1998-06-15 00:00:00",
20174,3,18972,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf","1999-10-08 00:00:00",
40838,3,18972,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf","1999-10-08 00:00:00",
1162,1,18972,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf","2004-05-27 00:00:00",
16144,1,18972,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_18972slr023ltr.pdf","2003-05-29 00:00:00",
1163,1,18972,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18972slr025ltr.pdf","2004-06-01 00:00:00",
16145,1,18972,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/018972s026ltr.pdf","2003-05-30 00:00:00",
1164,1,18972,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf","2004-05-27 00:00:00",
1165,1,18972,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s028ltr.pdf","2004-09-03 00:00:00",
16146,1,18972,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s029ltr.pdf","2004-11-08 00:00:00",
11392,2,18972,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf","2004-12-06 00:00:00",
16147,1,18972,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf","2004-12-06 00:00:00",
40839,3,18972,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone.cfm","2005-04-27 00:00:00",
16148,1,18972,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018972s031ltr.pdf","2005-08-31 00:00:00",
1166,1,18972,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s032ltr.pdf","2006-09-25 00:00:00",
16149,1,18972,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s033ltr.pdf","2006-09-18 00:00:00",
16150,1,18972,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s034ltr.pdf","2007-04-09 00:00:00",
1167,1,18972,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s035ltr.pdf","2007-10-04 00:00:00",
1168,1,18972,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s036LTR.pdf","2007-11-19 00:00:00",
1169,1,18972,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018972s037ltr.pdf","2008-10-21 00:00:00",
1170,1,18972,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s039ltr.pdf","2009-04-24 00:00:00",
11393,2,18972,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf","2009-04-28 00:00:00",
11394,2,18972,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf","2009-04-28 00:00:00",
16151,1,18972,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s39ltr.pdf","2009-04-24 00:00:00",
16152,1,18972,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s040ltr.pdf","2009-11-12 00:00:00",
1171,1,18972,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s041ltr.pdf","2010-01-07 00:00:00",
11395,2,18972,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf","2009-11-23 00:00:00",
1172,1,18972,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018972s042ltr.pdf","2010-12-15 00:00:00",
11396,2,18972,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf","2010-12-13 00:00:00",
16153,1,18972,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018972s044ltr.pdf","2011-11-16 00:00:00",
33676,2,18972,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf","2011-11-14 00:00:00",
11397,2,18972,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf","2015-04-01 00:00:00",
16154,1,18972,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018972Orig1s047ltr.pdf","2015-03-31 00:00:00",
1173,1,18972,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s048ltr.pdf","2014-01-23 00:00:00",
33677,2,18972,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf","2014-01-23 00:00:00",
1174,1,18972,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s050ltr.pdf","2014-12-24 00:00:00",
11398,2,18972,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf","2015-01-08 00:00:00",
1175,1,18972,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf","2016-04-26 00:00:00",
11399,2,18972,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf","2016-04-29 00:00:00",
45955,1,18972,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s052ltr.pdf","2016-11-23 00:00:00",
45988,2,18972,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s052lbl.pdf","2016-12-01 00:00:00",
47917,2,18972,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf","2017-04-10 00:00:00",
47918,8,18972,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf#page=22","2017-04-10 00:00:00",
47978,1,18972,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018972Orig1s053ltr.pdf","2017-04-12 00:00:00",
11400,2,18976,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018976s012lbl.pdf","2011-05-05 00:00:00",
49328,2,18977,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018977s041lbl.pdf","2017-08-10 00:00:00",
49399,1,18977,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018977Orig1s041ltr.pdf","2017-08-15 00:00:00",
1176,1,18983,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18983slr035ltr.pdf","2002-09-16 00:00:00",
1177,1,18983,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18983slr037ltr.pdf","2003-11-25 00:00:00",
16155,1,18983,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018983Orig1s047ltr.pdf","2013-08-22 00:00:00",
33678,2,18983,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf","2013-08-19 00:00:00",
1178,1,18985,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
33679,2,18985,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf","2013-10-04 00:00:00",
11401,2,18985,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf","2012-07-13 00:00:00",
16156,1,18985,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
16157,1,18985,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
16158,1,18985,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
1179,1,18985,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
1180,1,18985,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf","2015-11-04 00:00:00",
11402,2,18985,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf","2015-11-04 00:00:00",
49321,2,18985,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf","2017-08-10 00:00:00",
49473,1,18985,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf","2017-08-21 00:00:00",
40840,3,18986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/1983-018986ap.pdf","2003-06-17 00:00:00",
11403,2,18989,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf","2003-04-23 00:00:00",
11404,2,18989,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf","2004-05-26 00:00:00",
16159,1,18989,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf","2004-05-26 00:00:00",
11405,2,18989,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf","2003-09-30 00:00:00",
16160,1,18989,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf","2003-09-30 00:00:00",
1181,1,18989,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18989s058ltr.pdf","2004-07-21 00:00:00",
16161,1,18989,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s060ltr.pdf","2006-04-20 00:00:00",
1182,1,18989,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s061ltr.pdf","2006-04-07 00:00:00",
11406,2,18989,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf","2007-05-07 00:00:00",
16162,1,18989,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018989s067ltr.pdf","2007-05-07 00:00:00",
1183,1,18989,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018989s070ltr.pdf","2008-06-13 00:00:00",
16163,1,18989,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018989s073ltr.pdf","2009-05-26 00:00:00",
1184,1,18989,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018989s079ltr.pdf","2011-04-28 00:00:00",
33680,2,18989,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf","2012-03-27 00:00:00",
1185,1,18989,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018989s080ltr.pdf","2010-09-07 00:00:00",
1186,1,18989,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018989Orig1s084ltr.pdf","2015-12-18 00:00:00",
11407,2,18989,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf","2015-12-22 00:00:00",
49575,2,18989,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018989Orig1s088lbl.pdf","2017-08-29 00:00:00",
49622,1,18989,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018989Orig1s088ltr.pdf","2017-08-30 00:00:00",
1187,1,18991,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18991scs025,18997scs026ltr.pdf","2003-05-29 00:00:00",
16164,1,18997,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18991scs025,18997scs026ltr.pdf","2003-05-29 00:00:00",
20175,3,18998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_Vasotec.cfm","2005-04-27 00:00:00",
44027,10,18998,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
40841,3,18998,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S005_Vasotec_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
40842,3,18998,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S006_Vasotec_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
40843,3,18998,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S009_Vasotec_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
20176,3,18998,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S011_VASOTEC.pdf","2007-11-19 00:00:00",
20177,3,18998,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S013_VASOTEC.pdf","2007-11-19 00:00:00",
40844,3,18998,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S015_ VASOTEC_AP.pdf","2007-07-06 00:00:00",
20178,3,18998,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S016_VASOTEC.pdf","2007-11-19 00:00:00",
20179,3,18998,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S017_VASOTEC.pdf","2007-09-14 00:00:00",
20180,3,18998,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S018_VASOTEC_AP.pdf","2007-07-06 00:00:00",
20181,3,18998,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S020_VASOTEC_AP.pdf","2007-07-06 00:00:00",
20182,3,18998,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S021_VASOTEC.pdf","2007-07-20 00:00:00",
40845,3,18998,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S022_VASOTEC.pdf","2007-07-20 00:00:00",
40846,3,18998,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S023_VASOTEC.pdf","2007-07-20 00:00:00",
20183,3,18998,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S024_VASOTEC.pdf","2007-09-14 00:00:00",
40847,3,18998,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S025_VASOTEC.pdf","2007-09-14 00:00:00",
40848,3,18998,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S034_VASOTEC_AP.pdf","2007-07-06 00:00:00",
20184,3,18998,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s038_vasotec.pdf","2011-01-04 00:00:00",
40849,3,18998,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s039_vasotec.pdf","2011-01-04 00:00:00",
20185,3,18998,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s040_vasotec.pdf","2011-01-04 00:00:00",
40850,3,18998,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S041_VASOTEC_AP.pdf","2007-06-12 00:00:00",
40851,3,18998,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S042_VASOTEC_AP.pdf","2007-06-12 00:00:00",
40852,3,18998,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s043_vasotec.pdf","2011-02-15 00:00:00",
20186,3,18998,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s044_vasotec.pdf","2011-02-15 00:00:00",
20187,3,18998,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S045_VASOTEC_AP.pdf","2007-06-12 00:00:00",
20188,3,18998,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S046_VASOTEC_AP.pdf","2007-07-06 00:00:00",
20189,3,18998,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S050_VASOTEC_AP.pdf","2007-07-06 00:00:00",
40853,3,18998,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018998_S051_VASOTEC_AP.pdf","2007-04-09 00:00:00",
20190,3,18998,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/018998_S052_VASOTEC_AP.pdf","2007-04-09 00:00:00",
40854,3,18998,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf","1997-06-11 00:00:00",
20191,3,18998,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
1188,1,18998,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf","2001-11-27 00:00:00",
20192,3,18998,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm","2001-11-27 00:00:00",
33681,2,18998,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf","2001-11-27 00:00:00",
16165,1,18998,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_Approv.pdf","2001-02-13 00:00:00",
33682,2,18998,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf","2001-02-13 00:00:00",
40855,3,18998,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec.cfm","2001-02-13 00:00:00",
20193,3,18998,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S061_Vasotec_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
20194,3,18998,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S062_Vasotec_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
16166,1,18998,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18998scm063ltr.pdf","2002-08-30 00:00:00",
40856,3,18998,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S064_Vasotec_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
1189,1,18998,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf","2007-11-08 00:00:00",
1190,1,18998,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf","2008-09-29 00:00:00",
11408,2,18998,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf","2010-05-18 00:00:00",
1191,1,18998,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998s076ltr.pdf","2012-02-23 00:00:00",
33683,2,18998,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf","2012-02-22 00:00:00",
11409,2,18998,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf","2012-09-14 00:00:00",
16167,1,18998,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998Origs077ltr.pdf","2012-09-17 00:00:00",
1192,1,18998,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018998Orig1s079ltr.pdf","2014-12-30 00:00:00",
33684,2,18998,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf","2015-01-09 00:00:00",
1193,1,18998,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018998Orig1s080ltr.pdf","2015-08-27 00:00:00",
33685,2,18998,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf","2015-08-26 00:00:00",
49048,2,18998,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018998s082lbl.pdf","2017-07-25 00:00:00",
55354,2,18998,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018998s083lbl.pdf","2018-08-29 00:00:00",
40857,3,19002,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019002-S2_VASCOR TABLETS_toc.cfm","2003-08-05 00:00:00",
11410,2,19009,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19009s6lbl.pdf","2003-04-08 00:00:00",
23546,10,19010,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
20195,3,19010,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010_S006_Lupron Injection_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
40858,3,19010,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S023_Lupron Injection_APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
40859,3,19010,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S024_Lupron Injection_APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
1194,1,19010,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19010slr027ltr.pdf","2003-12-02 00:00:00",
1195,1,19010,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19010s028ltr.pdf","2004-10-22 00:00:00",
1196,1,19010,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
20196,3,19010,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019010_S031_Lupron Injection_APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
1197,1,19010,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019010s032ltr.pdf","2007-09-25 00:00:00",
1198,1,19010,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
11411,2,19010,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
1199,1,19010,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s035ltr.pdf","2011-03-24 00:00:00",
11412,2,19010,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf","2011-03-21 00:00:00",
16168,1,19010,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/019010s036,019732s037,020517Orig1s031ltr_C.pdf","2011-01-20 00:00:00",
33686,2,19010,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf","2011-01-20 00:00:00",
1200,1,19010,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019010Orig1s037ltr.pdf","2014-07-11 00:00:00",
11413,2,19010,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf","2014-07-11 00:00:00",
48466,2,19010,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf","2017-05-19 00:00:00",
48467,8,19010,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf#page=27","2017-05-19 00:00:00",
48497,1,19010,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s038ltr.pdf","2017-05-23 00:00:00",
53721,3,19010,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/019010Orig1s038.pdf","2018-04-18 00:00:00",
48954,2,19010,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s039lbl.pdf","2017-07-12 00:00:00",
48984,1,19010,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s039ltr.pdf","2017-07-14 00:00:00",
43617,8,19011,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370635.pdf","2013-10-03 00:00:00",
16169,1,19011,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19011slr015ltr.pdf","2002-09-19 00:00:00",
16170,1,19011,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019011Orig1s025ltr.pdf","2013-09-24 00:00:00",
33687,2,19011,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019011s025lbl.pdf","2013-09-23 00:00:00",
11414,2,19012,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf","2000-02-25 00:00:00",
16171,1,19012,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19012S16LTR.PDF","2000-02-25 00:00:00",
40860,3,19012,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016.cfm","2002-05-14 00:00:00",
33688,2,19012,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf","2003-04-16 00:00:00",
16172,1,19012,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf","2003-10-31 00:00:00",
1201,1,19012,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s037ltr.pdf","2006-02-22 00:00:00",
16173,1,19012,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s038ltr.pdf","2006-12-28 00:00:00",
1202,1,19012,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019012s040_CKD.pdf","2007-11-26 00:00:00",
1203,1,19012,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019012s043ltr.pdf","2009-05-01 00:00:00",
16174,1,19012,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019012s046ltr.pdf","2010-10-26 00:00:00",
33689,2,19012,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf","2012-03-27 00:00:00",
20197,3,19012,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/019012Orig1s052.pdf","2015-11-05 00:00:00",
40861,3,19012,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/019012Orig1s053.pdf","2015-11-05 00:00:00",
45096,2,19012,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf","2016-08-22 00:00:00",
45145,1,19012,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019012Orig1s055ltr.pdf","2016-08-18 00:00:00",
47576,2,19012,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf","2017-03-17 00:00:00",
47586,1,19012,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019012Orig1s056,s057ltr.pdf","2017-03-20 00:00:00",
47577,2,19012,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf","2017-03-17 00:00:00",
47587,1,19012,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019012Orig1s056,s057ltr.pdf","2017-03-20 00:00:00",
11415,2,19018,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf","2004-04-05 00:00:00",
16175,1,19018,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19018scs018ltr.pdf","2004-03-28 00:00:00",
1204,1,19022,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
1205,1,19022,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019022s021ltr.pdf","2005-06-14 00:00:00",
11416,2,19022,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf","2005-06-14 00:00:00",
11417,2,19022,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
16176,1,19022,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
1206,1,19022,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf","2014-12-30 00:00:00",
33690,2,19022,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf","2015-01-08 00:00:00",
55499,1,19022,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019022Orig1s031ltr.pdf","2018-09-18 00:00:00",
55511,2,19022,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019022s031lbl.pdf","2018-09-18 00:00:00",
1207,1,19024,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19024slr015ltr.pdf","2003-10-28 00:00:00",
16177,1,19028,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019028s015ltr.pdf","2010-10-04 00:00:00",
1208,1,19028,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019028Orig1s020ltr.pdf","2013-01-22 00:00:00",
11418,2,19028,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf","2013-01-22 00:00:00",
11419,2,19028,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf","2013-01-14 00:00:00",
1209,1,19032,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf","2002-03-12 00:00:00",
40862,3,19032,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm","2002-05-30 00:00:00",
16178,1,19032,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf","2002-03-12 00:00:00",
20198,3,19032,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm","2002-05-30 00:00:00",
16179,1,19032,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019032Orig1s021ltr.pdf","2013-07-05 00:00:00",
33691,2,19032,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019032s021lbl.pdf","2013-07-05 00:00:00",
11420,2,19034,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf","2006-06-12 00:00:00",
16180,1,19034,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019034s012LTR.pdf","2006-06-12 00:00:00",
1210,1,19034,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019034s018ltr.pdf","2009-05-06 00:00:00",
11421,2,19034,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf","2009-05-11 00:00:00",
1211,1,19034,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019034s021ltr.pdf","2011-07-06 00:00:00",
33692,2,19034,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf","2011-07-06 00:00:00",
46507,1,19034,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s025ltr.pdf","2016-12-23 00:00:00",
46221,1,19034,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s027ltr.pdf","2016-12-19 00:00:00",
46402,2,19034,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf","2016-12-21 00:00:00",
47246,2,19034,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf","2017-02-16 00:00:00",
1212,1,19038,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003ltr.pdf","2010-04-19 00:00:00",
11422,2,19038,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf","2010-04-19 00:00:00",
1213,1,19038,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019038s004ltr.pdf","2011-11-07 00:00:00",
11423,2,19038,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019038s004lbl.pdf","2011-11-04 00:00:00",
45234,1,19038,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019038Orig1s005ltr.pdf","2016-08-24 00:00:00",
1214,1,19039,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19039s002ltr.pdf","2002-02-27 00:00:00",
11424,2,19044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf","2014-11-18 00:00:00",
20199,3,19044,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s002_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40863,3,19044,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s003_indium in 111 oxyquinoline.pdf","2011-02-15 00:00:00",
40864,3,19044,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s005_indium-in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40865,3,19044,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s006-_indium-in-111-oxyquinoline.pdf","2011-02-15 00:00:00",
20200,3,19044,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s008_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40866,3,19044,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s009_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40867,3,19044,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
20201,3,19044,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
20202,3,19044,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40868,3,19044,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/019044Orig1s015.pdf","2012-03-27 00:00:00",
20203,3,19044,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019044_s016_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
40869,3,19044,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019044Orig1s017.pdf","2012-03-27 00:00:00",
1215,1,19044,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19044slr018ltr.pdf","2002-09-19 00:00:00",
40870,3,19044,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019044_s018_indium in-111 oxyquinoline.pdf","2011-02-15 00:00:00",
16181,1,19047,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf","2002-04-03 00:00:00",
1216,1,19047,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
11425,2,19047,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
11426,2,19049,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
16182,1,19049,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
1217,1,19049,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
11427,2,19049,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
1218,1,19049,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf","2002-06-10 00:00:00",
33693,2,19049,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf","2002-06-10 00:00:00",
11428,2,19050,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf","2007-06-07 00:00:00",
16183,1,19050,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019050s031ltr.pdf","2007-06-07 00:00:00",
1219,1,19050,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019050Orig1s032ltr.pdf","2014-03-21 00:00:00",
11429,2,19050,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf","2014-03-25 00:00:00",
46225,1,19050,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019050Orig1s034ltr.pdf","2016-12-20 00:00:00",
46401,2,19050,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf","2016-12-21 00:00:00",
1220,1,19057,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf","2002-01-23 00:00:00",
20204,3,19057,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-057-S015.pdf","2004-01-06 00:00:00",
1221,1,19057,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347Orig1s009 ltr.pdf","2006-02-08 00:00:00",
11430,2,19057,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf","2016-04-11 00:00:00",
11431,2,19057,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf","2009-07-23 00:00:00",
16184,1,19057,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019057s022ltr.pdf","2009-07-16 00:00:00",
40871,3,19058,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf","2001-06-04 00:00:00",
40872,3,19058,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf","2001-06-04 00:00:00",
1222,1,19058,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19058slr015ltr.pdf","2003-01-22 00:00:00",
16185,1,19058,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf","2003-11-13 00:00:00",
1223,1,19058,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19058s017ltr.pdf","2005-02-11 00:00:00",
11432,2,19071,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf","2010-01-08 00:00:00",
16186,1,19071,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019071s012ltr.pdf","2010-01-08 00:00:00",
11433,2,19079,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf","2006-11-09 00:00:00",
16187,1,19079,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019079s024LTR.pdf","2006-11-14 00:00:00",
45726,2,19079,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf","2016-10-31 00:00:00",
47467,1,19079,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019079Orig1s030ltr.pdf","2017-03-06 00:00:00",
44028,10,19080,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
1224,1,19080,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19080slr007ltr.pdf","2004-06-10 00:00:00",
11434,2,19081,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf","2004-06-01 00:00:00",
16188,1,19081,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf","2004-06-01 00:00:00",
40873,3,19081,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf","2008-08-01 00:00:00",
1225,1,19081,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf","2004-06-01 00:00:00",
33694,2,19081,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf","2004-06-01 00:00:00",
40874,3,19081,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf","2008-08-01 00:00:00",
11435,2,19081,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf","2004-12-30 00:00:00",
16189,1,19081,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081s040ltr.pdf","2004-12-30 00:00:00",
16190,1,19081,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019081s042ltr.pdf","2012-07-09 00:00:00",
33695,2,19081,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf","2012-07-13 00:00:00",
50272,2,19081,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf","2017-11-02 00:00:00",
50304,1,19081,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019081Orig1s043ltr.pdf","2017-11-06 00:00:00",
23547,10,19084,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm362415.htm","2014-02-07 00:00:00",
16191,1,19090,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection_approv.pdf","2004-07-01 00:00:00",
20205,3,19090,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection.cfm","2003-04-29 00:00:00",
16192,1,19090,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf","2002-01-07 00:00:00",
16193,1,19090,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf","2006-07-21 00:00:00",
1226,1,19090,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf","2009-02-19 00:00:00",
33696,2,19090,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf","2009-03-27 00:00:00",
16194,1,19090,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042ltr.pdf","2009-11-12 00:00:00",
33697,2,19090,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf","2009-10-06 00:00:00",
1227,1,19099,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19099s008ltr.pdf","2005-01-11 00:00:00",
46226,1,19101,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019101Orig1s045ltr.pdf","2016-12-20 00:00:00",
46400,2,19101,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf","2016-12-21 00:00:00",
44029,10,19111,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm","2008-03-13 00:00:00",
1228,1,19111,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19111slr011ltr.pdf","2003-11-25 00:00:00",
20206,3,19111,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019111_s011_TUSSIONEX KINETIC.pdf","2008-08-01 00:00:00",
11436,2,19111,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf","2008-03-13 00:00:00",
16195,1,19111,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019111s015ltr.pdf","2008-03-13 00:00:00",
16196,1,19111,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019111s016ltr.pdf","2011-06-09 00:00:00",
16197,1,19111,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019111Orig1s018ltr.pdf","2015-04-03 00:00:00",
33698,2,19111,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf","2015-04-02 00:00:00",
46870,2,19111,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019111s019lbl.pdf","2017-01-13 00:00:00",
46887,1,19111,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019111Orig1s019ltr.pdf","2017-01-24 00:00:00",
54752,2,19111,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf","2018-07-05 00:00:00",
54789,8,19111,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf#page=25","2018-07-06 00:00:00",
54848,1,19111,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019111Orig1s022ltr.pdf","2018-07-06 00:00:00",
46228,1,19115,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019115Orig1s030,s031ltr.pdf","2016-12-20 00:00:00",
46398,2,19115,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf","2016-12-21 00:00:00",
46229,1,19115,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019115Orig1s030,s031ltr.pdf","2016-12-20 00:00:00",
46399,2,19115,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf","2016-12-21 00:00:00",
1229,1,19116,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019116Orig1s009ltr.pdf","2014-10-31 00:00:00",
11437,2,19116,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf","2014-11-04 00:00:00",
40875,3,19123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf","2010-03-16 00:00:00",
1230,1,19123,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19123slr021ltr.pdf","2003-11-25 00:00:00",
16198,1,19123,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19123slr022ltr.pdf","2004-05-27 00:00:00",
16199,1,19123,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019123s024ltr.pdf","2006-04-20 00:00:00",
52716,2,19123,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf","2018-02-26 00:00:00",
53980,2,19123,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019123s036lbl.pdf","2018-05-02 00:00:00",
53989,1,19123,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019123Orig1s036ltr.pdf","2018-05-03 00:00:00",
20207,3,19125,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-125S028.pdf","2003-09-11 00:00:00",
16200,1,19125,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019125s034ltr.pdf","2005-05-18 00:00:00",
1231,1,19125,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019125Orig1s040ltr.pdf","2012-11-13 00:00:00",
16201,1,19125,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019125Orig1s042ltr.pdf","2014-10-22 00:00:00",
33699,2,19125,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf","2014-10-30 00:00:00",
49800,1,19125,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019125Orig1s044ltr.pdf","2017-09-19 00:00:00",
49827,2,19125,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf","2017-09-21 00:00:00",
16202,1,19127,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019127s013ltr.pdf","2009-06-23 00:00:00",
1232,1,19127,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019127Orig1s020ltr.pdf","2013-04-16 00:00:00",
49799,1,19127,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019127Orig1s022ltr.pdf","2017-09-19 00:00:00",
49826,2,19127,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019127Orig1s022lbl.pdf","2017-09-21 00:00:00",
1233,1,19129,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019129s043ltr.pdf","2011-03-24 00:00:00",
33700,2,19129,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf","2011-03-28 00:00:00",
20208,3,19151,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19151.pdf","1997-12-23 00:00:00",
1234,1,19151,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf","2002-12-05 00:00:00",
1235,1,19151,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf","2004-06-16 00:00:00",
1236,1,19151,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019151Orig1s012ltr.pdf","2013-03-22 00:00:00",
33701,2,19151,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf","2013-03-26 00:00:00",
16203,1,19152,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf","2002-11-26 00:00:00",
1237,1,19152,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019152s032ltr.pdf","2009-07-08 00:00:00",
11438,2,19152,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf","2009-07-09 00:00:00",
1238,1,19152,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019152s033ltr.pdf","2010-04-02 00:00:00",
11439,2,19152,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf","2010-04-04 00:00:00",
11440,2,19152,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf","2011-12-02 00:00:00",
16204,1,19152,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf","2011-12-05 00:00:00",
11441,2,19152,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf","2013-10-28 00:00:00",
16205,1,19152,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf","2013-10-28 00:00:00",
45233,1,19152,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019152Orig1s039ltr.pdf","2016-08-24 00:00:00",
47293,2,19152,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf","2017-02-23 00:00:00",
49761,2,19152,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf","2017-09-18 00:00:00",
49798,1,19152,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019152Orig1s041ltr.pdf","2017-09-19 00:00:00",
16206,1,19155,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf","2004-05-03 00:00:00",
20209,3,19155,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf","2007-07-06 00:00:00",
1239,1,19155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf","2004-05-03 00:00:00",
20210,3,19155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf","2007-07-06 00:00:00",
1240,1,19155,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019155s022ltr.pdf","2007-11-19 00:00:00",
11442,2,19155,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf","2007-11-19 00:00:00",
40876,3,19157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019157_PEDIAPRED_ORIGINAL_AP.pdf","2007-04-11 00:00:00",
16207,1,19157,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf","1998-12-17 00:00:00",
1241,1,19157,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf","1998-12-17 00:00:00",
1242,1,19157,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf","1998-12-17 00:00:00",
1243,1,19157,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf","1998-12-17 00:00:00",
40877,3,19157,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-157S016.pdf","2003-09-11 00:00:00",
1244,1,19157,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19157s018ltr.pdf","2004-12-08 00:00:00",
11443,2,19157,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf","2004-12-08 00:00:00",
20211,3,19157,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019157_018_PrediapredTOC.cfm","2006-05-08 00:00:00",
1245,1,19157,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019157Orig1s020ltr.pdf","2013-10-10 00:00:00",
33702,2,19157,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf","2013-10-17 00:00:00",
52431,2,19157,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019157s021lbl.pdf","2018-02-06 00:00:00",
52514,1,19157,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019157Orig1s021ltr.pdf","2018-02-08 00:00:00",
40878,3,19183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019183_biopharm.pdf","2011-02-15 00:00:00",
16208,1,19183,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf","2006-02-22 00:00:00",
11444,2,19183,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf","2007-05-01 00:00:00",
16209,1,19183,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf","2007-05-01 00:00:00",
11445,2,19183,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf","2010-12-26 00:00:00",
16210,1,19183,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf","2010-12-28 00:00:00",
1246,1,19183,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf","2013-03-05 00:00:00",
11446,2,19183,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf","2013-03-08 00:00:00",
49428,2,19183,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf","2017-08-16 00:00:00",
49489,1,19183,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019183Orig1s019ltr.pdf","2017-08-21 00:00:00",
11447,2,19190,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf","2016-04-07 00:00:00",
49309,2,19190,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019190s048lbl.pdf","2017-08-10 00:00:00",
49400,1,19190,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019190Orig1s048ltr.pdf","2017-08-15 00:00:00",
49311,2,19192,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019192s047lbl.pdf","2017-08-10 00:00:00",
49416,1,19192,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019192Orig1s047ltr.pdf","2017-08-15 00:00:00",
1247,1,19193,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019193s013ltr.pdf","2008-07-30 00:00:00",
11448,2,19193,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf","2008-08-13 00:00:00",
45223,2,19193,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019193s017lbl.pdf","2016-08-29 00:00:00",
20212,3,19194,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19194-S005_Syprine.pdf","2001-06-08 00:00:00",
23132,8,19201,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089822.pdf","2009-12-04 00:00:00",
1248,1,19201,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19201slr018ltr.pdf","2002-11-26 00:00:00",
20213,3,19201,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-201s018_Voltaren.cfm","2005-02-08 00:00:00",
16211,1,19201,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf","2006-01-30 00:00:00",
33703,2,19201,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf","2006-01-25 00:00:00",
1249,1,19201,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019201s036ltr.pdf","2007-07-16 00:00:00",
11449,2,19201,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf","2007-07-10 00:00:00",
16212,1,19201,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf","2009-02-27 00:00:00",
33704,2,19201,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf","2009-03-17 00:00:00",
11450,2,19201,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf","2011-03-04 00:00:00",
16213,1,19201,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf","2011-02-28 00:00:00",
1250,1,19201,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf","2011-02-28 00:00:00",
33705,2,19201,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf","2011-03-04 00:00:00",
1251,1,19201,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019201Orig1s046ltr.pdf","2016-05-12 00:00:00",
33706,2,19201,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf","2016-05-11 00:00:00",
11451,2,19211,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf","2008-11-07 00:00:00",
16214,1,19211,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019211s040ltr.pdf","2008-11-03 00:00:00",
1252,1,19211,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019211s042ltr.pdf","2009-04-01 00:00:00",
11452,2,19211,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf","2009-04-03 00:00:00",
1253,1,19216,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf","2006-01-20 00:00:00",
33707,2,19216,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf","2006-01-13 00:00:00",
11453,2,19216,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf","2006-01-13 00:00:00",
16215,1,19216,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf","2006-01-20 00:00:00",
16216,1,19216,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019216Orig1s025ltr.pdf","2013-02-13 00:00:00",
33708,2,19216,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf","2013-02-14 00:00:00",
1254,1,19217,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19217slr003ltr.pdf","2003-12-11 00:00:00",
11454,2,19219,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf","2003-04-15 00:00:00",
50912,1,19219,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019219Orig1s029ltr.pdf","2017-12-27 00:00:00",
50931,2,19219,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf","2017-12-27 00:00:00",
40879,3,19221,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019221_s023ap.pdf","1997-06-11 00:00:00",
20214,3,19221,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19221s024.pdf","1998-10-13 00:00:00",
40880,3,19221,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
1255,1,19221,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf","2001-11-27 00:00:00",
11455,2,19221,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf","2001-11-27 00:00:00",
40881,3,19221,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm","2001-11-27 00:00:00",
1256,1,19221,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf","2002-10-30 00:00:00",
1257,1,19221,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf","2007-11-08 00:00:00",
1258,1,19221,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf","2008-09-29 00:00:00",
1259,1,19221,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019221s041ltr.pdf","2011-03-16 00:00:00",
11456,2,19221,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf","2011-03-14 00:00:00",
17333,1,19221,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221s042ltr.pdf","2012-02-23 00:00:00",
33709,2,19221,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s042lbl.pdf","2012-02-22 00:00:00",
17334,1,19221,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221Orig1s043ltr.pdf","2012-09-17 00:00:00",
33710,2,19221,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s043lbl.pdf","2012-09-14 00:00:00",
1260,1,19221,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019221Orig1s044ltr.pdf","2014-12-30 00:00:00",
11457,2,19221,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf","2015-01-09 00:00:00",
11458,2,19221,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf","2015-08-26 00:00:00",
17335,1,19221,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019221Orig1s045ltr.pdf","2015-08-27 00:00:00",
49049,2,19221,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019221s047lbl.pdf","2017-07-25 00:00:00",
49071,1,19221,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019221Orig1s047ltr.pdf","2017-07-25 00:00:00",
1261,1,19257,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf","2002-04-15 00:00:00",
33711,2,19257,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf","2002-04-15 00:00:00",
1262,1,19257,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf","2007-04-09 00:00:00",
11459,2,19257,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf","2007-03-31 00:00:00",
11460,2,19257,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf","2015-06-04 00:00:00",
17336,1,19257,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf","2015-06-02 00:00:00",
53735,2,19257,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf","2018-04-19 00:00:00",
53760,1,19257,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018948Orig1s028,019257Orig1s014ltr.pdf","2018-04-20 00:00:00",
1263,1,19258,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19258s011ltr.pdf","2005-02-17 00:00:00",
1264,1,19258,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019258s014ltr.pdf","2006-04-07 00:00:00",
1265,1,19258,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019258s016ltr.pdf","2010-04-28 00:00:00",
17337,1,19258,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019258s019ltr.pdf","2012-05-21 00:00:00",
17338,1,19258,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019258Orig1s021ltr.pdf","2015-08-10 00:00:00",
17339,1,19258,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019258Orig1s023ltr.pdf","2016-01-15 00:00:00",
33712,2,19258,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019258Orig1s023lbl.pdf","2016-01-15 00:00:00",
51030,1,19258,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019258Orig1s026ltr.pdf","2018-01-11 00:00:00",
51077,2,19258,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019258s026lbl.pdf","2018-01-17 00:00:00",
1266,1,19259,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19259slr009ltr.pdf","2003-06-08 00:00:00",
11461,2,19259,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19259slr009_psorcon_lbl.pdf","2003-06-08 00:00:00",
50193,2,19259,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019259s012lbl.pdf","2017-10-26 00:00:00",
50227,1,19259,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf","2017-10-30 00:00:00",
11462,2,19260,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019260s007lbl.pdf","2003-04-28 00:00:00",
17340,1,19260,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19260slr007ltr.pdf","2003-05-29 00:00:00",
50194,2,19260,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019260s009lbl.pdf","2017-10-26 00:00:00",
50228,1,19260,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf","2017-10-30 00:00:00",
11463,2,19261,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19261s8lbl.pdf","2003-04-15 00:00:00",
40882,3,19268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019268Orig1s000.pdf","2011-12-16 00:00:00",
44030,10,19268,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111315.htm","2005-07-29 00:00:00",
11464,2,19268,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf","2002-04-17 00:00:00",
17341,1,19268,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19268s037ltr.pdf","2002-04-17 00:00:00",
17342,1,19268,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr039ltr.pdf","2003-08-14 00:00:00",
17343,1,19268,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr040ltr.pdf","2003-08-14 00:00:00",
1267,1,19268,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019268s041ltr.pdf","2009-11-12 00:00:00",
33713,2,19268,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf","2009-10-06 00:00:00",
11465,2,19268,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf","2012-11-26 00:00:00",
17344,1,19268,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019268Orig1s047ltr.pdf","2012-11-21 00:00:00",
46222,2,19268,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019268Orig1s049lbl.pdf","2016-12-19 00:00:00",
46223,1,19268,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019268Orig1s049ltr.pdf","2016-12-19 00:00:00",
52774,2,19268,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf","2018-03-01 00:00:00",
52779,1,19268,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019268Orig1s051ltr.pdf","2018-03-01 00:00:00",
1268,1,19270,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019270s031ltr.pdf","2006-02-22 00:00:00",
33714,2,19270,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf","2006-02-22 00:00:00",
11466,2,19279,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/019279s010lbl.pdf","2015-08-11 00:00:00",
17345,1,19280,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf","1999-09-09 00:00:00",
20215,3,19280,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf","1999-09-09 00:00:00",
1269,1,19281,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf","1999-09-09 00:00:00",
40883,3,19281,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf","2001-06-18 00:00:00",
1270,1,19281,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19281S13LTR.PDF","2001-03-27 00:00:00",
17346,1,19281,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019281s025ltr.pdf","2008-12-24 00:00:00",
33715,2,19281,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019281s025lbl.pdf","2009-01-02 00:00:00",
17347,1,19281,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019281s027ltr.pdf","2009-01-30 00:00:00",
17348,1,19281,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019281s030ltr.pdf","2011-02-02 00:00:00",
33716,2,19281,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf","2011-01-31 00:00:00",
1271,1,19281,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019281Orig1s031ltr.pdf","2013-05-14 00:00:00",
11467,2,19281,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf","2013-05-14 00:00:00",
33717,2,19281,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019281s033lbl.pdf","2015-04-14 00:00:00",
50473,2,19281,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019281s041lbl.pdf","2017-11-22 00:00:00",
50495,1,19281,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019281Orig1s041ltr.pdf","2017-11-27 00:00:00",
11468,2,19292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf","2015-07-09 00:00:00",
17349,1,19292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019292Orig1s010ltr.pdf","2015-07-10 00:00:00",
47875,2,19292,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019292s011lbl.pdf","2017-04-06 00:00:00",
47964,1,19292,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019292ig1s011ltr.pdf","2017-04-12 00:00:00",
23548,10,19297,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm","2008-07-29 00:00:00",
40884,3,19297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019297_S000_ORIGINAL_APPROVAL_PKG.pdf","2008-04-04 00:00:00",
40885,3,19297,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019297_s014ap.pdf","1997-11-20 00:00:00",
40886,3,19297,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19297-S021_Novantrone.pdf","2000-02-04 00:00:00",
1272,1,19297,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19297s24ltr.pdf","2002-02-20 00:00:00",
1273,1,19297,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf","2003-01-13 00:00:00",
17350,1,19297,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf","2003-01-13 00:00:00",
1274,1,19297,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf","2003-01-13 00:00:00",
1275,1,19297,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019297s028ltr.pdf","2005-04-28 00:00:00",
11469,2,19297,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf","2005-04-28 00:00:00",
1276,1,19297,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019297s029LTR.pdf","2007-04-20 00:00:00",
17351,1,19297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf","2009-02-13 00:00:00",
33718,2,19297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf","2009-02-12 00:00:00",
1277,1,19297,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf","2009-02-13 00:00:00",
11470,2,19297,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf","2009-02-12 00:00:00",
17352,1,19297,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf","2010-06-16 00:00:00",
33719,2,19297,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf","2010-06-24 00:00:00",
1278,1,19297,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf","2010-06-16 00:00:00",
11471,2,19297,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf","2010-06-24 00:00:00",
11472,2,19297,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf","2012-03-27 00:00:00",
17353,1,19297,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019297s035ltr.pdf","2012-03-26 00:00:00",
43618,8,19297,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf","2012-03-27 00:00:00",
20216,3,19304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019304a_s001.pdf","1998-10-26 00:00:00",
40887,3,19304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019304_s000.pdf","2010-03-16 00:00:00",
1279,1,19304,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19304S5LTR.PDF","2000-04-24 00:00:00",
33720,2,19304,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor_prntlbl.pdf","2000-04-11 00:00:00",
40888,3,19304,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor.cfm","2001-06-08 00:00:00",
17354,1,19308,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf","2003-05-29 00:00:00",
1280,1,19308,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf","2004-06-07 00:00:00",
11473,2,19308,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
17355,1,19308,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
1281,1,19308,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf","2007-05-01 00:00:00",
33721,2,19308,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf","2007-04-25 00:00:00",
17356,1,19308,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf","2013-09-12 00:00:00",
33722,2,19308,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf","2013-09-11 00:00:00",
44031,10,19309,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
40889,3,19309,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s005_vasotec IV injection.pdf","2011-02-15 00:00:00",
20217,3,19309,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s008_vasotec iv injection.pdf","2011-02-15 00:00:00",
20218,3,19309,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S011_VASOTEC I.V.INJECTION.pdf","2007-07-24 00:00:00",
20219,3,19309,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019309_S012_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
40890,3,19309,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S013_VASOTEC I.V. INJECTION.pdf","2007-07-24 00:00:00",
40891,3,19309,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf","2006-10-26 00:00:00",
20220,3,19309,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S015_Vasotec I.V. Injection_Approval Package.pdf","2006-10-26 00:00:00",
40892,3,19309,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S016_VASOTEC I.V. INJECTION.pdf","2007-07-24 00:00:00",
20221,3,19309,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf","2006-10-26 00:00:00",
20222,3,19309,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S018_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
40893,3,19309,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S019_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
40894,3,19309,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf","1997-06-11 00:00:00",
20223,3,19309,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
1282,1,19309,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf","2004-06-29 00:00:00",
11474,2,19309,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf","2004-06-29 00:00:00",
40895,3,19309,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm","2001-11-27 00:00:00",
17357,1,19309,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf","2002-10-30 00:00:00",
17358,1,19316,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019316s011ltr.pdf","2006-12-28 00:00:00",
33723,2,19316,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019316s011lbl.pdf","2006-12-14 00:00:00",
1283,1,19316,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019316Orig1s018ltr.pdf","2013-05-30 00:00:00",
11475,2,19316,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf","2013-06-04 00:00:00",
52825,2,19316,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019316s024lbl.pdf","2018-03-06 00:00:00",
52914,1,19316,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019316Orig1s024ltr.pdf","2018-03-12 00:00:00",
40896,3,19322,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019322-S15_TemovateCream_toc.cfm","2003-08-05 00:00:00",
1284,1,19322,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19322slr018,19323slr019ltr.pdf","2003-04-18 00:00:00",
11476,2,19322,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf","2003-04-07 00:00:00",
20224,3,19323,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019323-S16_Temovate Ointment 0.05%_toc.cfm","2003-08-05 00:00:00",
1285,1,19323,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19322slr018,19323slr019ltr.pdf","2003-04-18 00:00:00",
11477,2,19323,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf","2003-04-07 00:00:00",
1286,1,19334,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf","2009-01-06 00:00:00",
33724,2,19334,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf","2009-01-06 00:00:00",
1287,1,19334,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf","2009-01-06 00:00:00",
33725,2,19334,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf","2009-01-06 00:00:00",
1288,1,19339,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019339s034ltr.pdf","2008-10-21 00:00:00",
17359,1,19339,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf","2009-07-31 00:00:00",
17360,1,19339,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019339s047ltr.pdf","2011-12-29 00:00:00",
33726,2,19339,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf","2011-12-23 00:00:00",
11478,2,19339,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf","2014-03-19 00:00:00",
17361,1,19339,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019339Orig1s054ltr.pdf","2014-03-18 00:00:00",
1289,1,19345,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf","2016-02-24 00:00:00",
33727,2,19345,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf","2016-02-23 00:00:00",
54209,1,19345,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf","2018-05-16 00:00:00",
54242,2,19345,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf","2018-05-17 00:00:00",
1290,1,19353,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019353Orig1s019ltr.pdf","2015-07-27 00:00:00",
11479,2,19353,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf","2015-07-30 00:00:00",
46231,1,19353,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019353Orig1s021ltr.pdf","2016-12-20 00:00:00",
46397,2,19353,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf","2016-12-21 00:00:00",
1291,1,19356,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019356s007ltr.pdf","2007-10-04 00:00:00",
53981,2,19356,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf","2018-05-02 00:00:00",
53994,1,19356,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019356Orig1s008,019599Orig1s014,204286Orig1s003ltr.pdf","2018-05-03 00:00:00",
1292,1,19357,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19357s14ltr.pdf","2002-02-05 00:00:00",
17362,1,19367,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19367slr015ltr.pdf","2003-01-03 00:00:00",
11480,2,19367,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf","2005-06-08 00:00:00",
17363,1,19367,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019367s021ltr.pdf","2005-06-08 00:00:00",
1293,1,19367,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf","2005-08-31 00:00:00",
33728,2,19367,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf","2005-08-31 00:00:00",
1294,1,19367,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf","2011-10-24 00:00:00",
11481,2,19367,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf","2011-11-04 00:00:00",
50640,2,19367,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019367s030lbl.pdf","2017-12-07 00:00:00",
50641,1,19367,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019367s030ltr.pdf","2017-12-07 00:00:00",
17364,1,19374,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
17365,1,19377,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19377scm036ltr.pdf","2003-05-29 00:00:00",
33729,2,19377,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19377scm036_humulin_lbl.pdf","2003-05-29 00:00:00",
1295,1,19377,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019377s046_019571s037ltr.pdf","2006-01-20 00:00:00",
11482,2,19377,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019377s046,019571s037lbl.pdf","2006-01-10 00:00:00",
20225,3,19383,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf","1998-11-06 00:00:00",
23133,8,19384,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf","2013-08-16 00:00:00",
23961,14,19384,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf","2011-03-15 00:00:00",
20226,3,19384,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S024_NOROXIN.pdf","2008-04-04 00:00:00",
40897,3,19384,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S027_NOROXIN.pdf","2008-04-04 00:00:00",
40898,3,19384,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S029_NOROXIN.pdf","2008-04-04 00:00:00",
20227,3,19384,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S030_NOROXIN.pdf","2008-04-04 00:00:00",
40899,3,19384,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S031_NOROXIN.pdf","2008-04-04 00:00:00",
20228,3,19384,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S032_NOROXIN.pdf","2008-04-04 00:00:00",
40900,3,19384,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S034_NOROXIN.pdf","2008-04-04 00:00:00",
20229,3,19384,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S035_NOROXIN.pdf","2008-04-04 00:00:00",
40901,3,19384,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S036_NOROXIN.pdf","2008-04-04 00:00:00",
1296,1,19384,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf","2001-04-23 00:00:00",
17366,1,19384,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf","2001-04-23 00:00:00",
17367,1,19384,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf","2001-04-23 00:00:00",
1297,1,19384,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf","2004-07-28 00:00:00",
11483,2,19384,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf","2004-07-28 00:00:00",
1298,1,19384,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf","2004-07-28 00:00:00",
11484,2,19384,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf","2004-07-28 00:00:00",
1299,1,19384,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf","2004-07-28 00:00:00",
33730,2,19384,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf","2004-07-28 00:00:00",
11485,2,19384,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf","2006-05-18 00:00:00",
17368,1,19384,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s045LTR.pdf","2006-05-21 00:00:00",
11486,2,19384,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf","2006-09-25 00:00:00",
17369,1,19384,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s046LTR.pdf","2006-09-27 00:00:00",
1300,1,19384,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019384s048lbl.pdf","2007-03-15 00:00:00",
17370,1,19384,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s049ltr.pdf","2008-09-26 00:00:00",
33731,2,19384,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf","2008-10-03 00:00:00",
1301,1,19384,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s052ltr.pdf","2008-10-07 00:00:00",
11487,2,19384,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf","2008-10-09 00:00:00",
17371,1,19384,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s053ltr.pdf","2009-02-13 00:00:00",
11488,2,19384,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf","2009-05-11 00:00:00",
17372,1,19384,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s054ltr.pdf","2009-05-04 00:00:00",
1302,1,19384,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
17373,1,19384,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s056ltr.pdf","2011-03-03 00:00:00",
33732,2,19384,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf","2011-03-04 00:00:00",
1303,1,19384,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s058ltr.pdf","2011-09-13 00:00:00",
17374,1,19384,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s059ltr.pdf","2011-05-31 00:00:00",
11489,2,19384,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf","2011-11-04 00:00:00",
17375,1,19384,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s060ltr.pdf","2011-10-20 00:00:00",
11490,2,19384,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf","2011-09-20 00:00:00",
17376,1,19384,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s061ltr.pdf","2011-09-21 00:00:00",
1304,1,19384,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s062ltr.pdf","2012-02-13 00:00:00",
11491,2,19384,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf","2012-02-10 00:00:00",
11492,2,19384,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf","2012-06-18 00:00:00",
17377,1,19384,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s063ltr.pdf","2012-06-18 00:00:00",
1305,1,19384,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s065ltr.pdf","2013-03-29 00:00:00",
11493,2,19384,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf","2013-04-01 00:00:00",
1306,1,19384,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s066ltr.pdf","2013-08-16 00:00:00",
11494,2,19384,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf","2013-08-15 00:00:00",
1307,1,19384,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019384Orig1s067ltr.pdf","2016-07-26 00:00:00",
11495,2,19384,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf","2016-07-26 00:00:00",
44032,10,19385,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143341.htm","2007-03-29 00:00:00",
1308,1,19385,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19385slr028ltr.pdf","2002-08-29 00:00:00",
11496,2,19385,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf","2003-10-10 00:00:00",
17378,1,19385,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf","2003-10-09 00:00:00",
1309,1,19385,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf","2003-10-09 00:00:00",
11497,2,19385,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf","2003-10-10 00:00:00",
20230,3,19385,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S031_PERMAX.pdf","2009-01-12 00:00:00",
17379,1,19385,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf","2003-10-09 00:00:00",
20231,3,19385,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S035_PERMAX.pdf","2009-01-12 00:00:00",
33733,2,19385,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf","2003-10-10 00:00:00",
40902,3,19386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-386_ Brevibloc.cfm","2004-10-04 00:00:00",
40903,3,19386,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf","2007-12-06 00:00:00",
40904,3,19386,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf","2007-12-06 00:00:00",
40905,3,19386,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf","2007-12-06 00:00:00",
20232,3,19386,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S005_BREVIBLOC.pdf","2007-12-06 00:00:00",
20233,3,19386,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf","2007-12-06 00:00:00",
40906,3,19386,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S007_BREVIBLOC.pdf","2007-12-06 00:00:00",
20234,3,19386,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S009_BREVIBLOC_INJECTION.pdf","2008-02-19 00:00:00",
20235,3,19386,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S010_BREVIBLOC_INJECTION.pdf","2008-02-19 00:00:00",
20236,3,19386,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S011_BREVIBLOC.pdf","2008-02-19 00:00:00",
20237,3,19386,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S012_BREVIBLOC.pdf","2008-02-19 00:00:00",
20238,3,19386,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019386_S015_BREVIBLOC_INJECTION.pdf","2007-09-14 00:00:00",
20239,3,19386,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S017_BREVIBLOC_INJECTION.pdf","2007-09-14 00:00:00",
40907,3,19386,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S018_BREVIBLOC_INJECTION.pdf","2007-09-14 00:00:00",
17380,1,19386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf","2003-01-27 00:00:00",
1310,1,19386,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf","2003-01-27 00:00:00",
1311,1,19386,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf021ltr.pdf","2003-03-10 00:00:00",
40908,3,19386,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-386s021.cfm","2003-07-08 00:00:00",
17381,1,19386,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scm022ltr.pdf","2003-05-30 00:00:00",
40909,3,19386,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019386_S022_Brevibloc.pdf","2007-07-06 00:00:00",
1312,1,19386,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf024ltr.pdf","2003-08-26 00:00:00",
17382,1,19386,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019386s039ltr.pdf","2007-11-08 00:00:00",
33734,2,19386,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf","2007-11-07 00:00:00",
11498,2,19386,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf","2012-12-13 00:00:00",
17383,1,19386,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019386Orig1s043ltr.pdf","2012-12-13 00:00:00",
17384,1,19389,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr021ltr.pdf","2002-12-19 00:00:00",
33735,2,19389,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19389s23lbl.pdf","2003-04-15 00:00:00",
17385,1,19389,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr025ltr.pdf","2002-12-16 00:00:00",
1313,1,19389,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019389s027ltr.pdf","2005-11-01 00:00:00",
33736,2,19389,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019389s027lbl.pdf","2005-11-01 00:00:00",
17386,1,19398,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
33737,2,19404,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s14lbl.pdf","2003-04-15 00:00:00",
33738,2,19404,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s17lbl.pdf","2003-04-15 00:00:00",
1314,1,19404,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19404scp020ltr.pdf","2004-06-10 00:00:00",
11499,2,19404,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19404scp020_ocufen_lbl.pdf","2003-08-28 00:00:00",
1315,1,19404,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019404Orig1s026ltr.pdf","2012-07-30 00:00:00",
33739,2,19404,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019404s026lbl.pdf","2012-07-26 00:00:00",
17387,1,19407,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19407slr010ltr.pdf","2002-08-23 00:00:00",
44033,10,19414,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287453.htm","2012-01-12 00:00:00",
1316,1,19414,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf","2001-04-11 00:00:00",
1317,1,19414,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf","2009-07-23 00:00:00",
11500,2,19414,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf","2009-07-23 00:00:00",
11501,2,19414,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf","2010-07-31 00:00:00",
17388,1,19414,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf","2010-07-30 00:00:00",
1318,1,19414,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf","2012-02-10 00:00:00",
11502,2,19414,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf","2012-02-09 00:00:00",
17389,1,19422,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19422se8-032ltr.pdf","2003-12-23 00:00:00",
40910,3,19422,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019422_S032_ChlorhexidineTOC.cfm","2007-07-09 00:00:00",
1319,1,19422,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019422s033ltr.pdf","2004-12-30 00:00:00",
1320,1,19422,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s036ltr.pdf","2009-02-27 00:00:00",
1321,1,19422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s037ltr.pdf","2009-02-27 00:00:00",
1322,1,19422,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019422Orig1s043ltr.pdf","2012-12-18 00:00:00",
33740,2,19422,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf","2014-01-14 00:00:00",
49785,1,19422,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019422Orig1s047ltr.pdf","2017-09-19 00:00:00",
17390,1,19425,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019425s021ltr.pdf","2010-11-30 00:00:00",
33741,2,19425,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf","2010-11-22 00:00:00",
17391,1,19429,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19429slr006ltr.pdf","2002-08-26 00:00:00",
11503,2,19429,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf","2008-04-28 00:00:00",
17392,1,19429,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019429s023ltr.pdf","2008-04-28 00:00:00",
44441,14,19429,"SUPPL",23,"Corrected Approval Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019429s023ltr2.pdf","2008-04-28 00:00:00",
17393,1,19429,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019429Orig1s035ltr.pdf","2013-05-13 00:00:00",
33742,2,19429,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf","2013-05-14 00:00:00",
46233,1,19429,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019429Orig1s039ltr.pdf","2016-12-20 00:00:00",
46396,2,19429,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf","2016-12-21 00:00:00",
49589,2,19429,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf","2017-08-30 00:00:00",
49590,8,19429,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf#page=36","2017-08-30 00:00:00",
49629,1,19429,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019429Orig1s040ltr.pdf","2017-08-30 00:00:00",
55646,1,19429,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf","2018-09-28 00:00:00",
55830,2,19429,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf","2018-10-05 00:00:00",
55832,8,19429,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf#page=42","2018-10-05 00:00:00",
55647,1,19429,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf","2018-09-28 00:00:00",
55831,2,19429,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf","2018-10-05 00:00:00",
55833,8,19429,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf#page=42","2018-10-05 00:00:00",
52646,3,19430,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019430Orig1s001.pdf","2018-02-14 00:00:00",
33743,2,19430,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf","2003-04-15 00:00:00",
50605,3,19430,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/019430Orig1s015.pdf","2017-12-06 00:00:00",
17394,1,19430,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf","2003-12-22 00:00:00",
11504,2,19430,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf","2008-10-03 00:00:00",
17395,1,19430,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf","2008-10-01 00:00:00",
17396,1,19430,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf","2009-05-26 00:00:00",
11505,2,19430,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf","2012-08-20 00:00:00",
17397,1,19430,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf","2012-08-22 00:00:00",
40911,3,19430,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s054.pdf","2014-01-15 00:00:00",
40912,3,19430,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s055.pdf","2014-01-16 00:00:00",
20240,3,19430,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s056.pdf","2014-01-16 00:00:00",
1323,1,19430,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf","2014-07-21 00:00:00",
33744,2,19430,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf","2014-07-30 00:00:00",
17398,1,19430,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf","2014-05-01 00:00:00",
33745,2,19430,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf","2014-05-02 00:00:00",
17399,1,19430,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf","2016-05-20 00:00:00",
33746,2,19430,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf","2016-05-20 00:00:00",
47089,3,19430,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/019430Orig1s061pkg.pdf","2017-02-02 00:00:00",
48199,1,19430,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019430Orig1s067ltr.pdf","2017-05-02 00:00:00",
48229,2,19430,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019430s067lbl.pdf","2017-05-03 00:00:00",
55293,2,19430,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019430s074lbl.pdf","2018-08-24 00:00:00",
55309,1,19430,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019430Orig1s074Ltr.pdf","2018-08-24 00:00:00",
17400,1,19436,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr014ltr.pdf","2003-04-18 00:00:00",
17401,1,19436,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf","2007-05-07 00:00:00",
17402,1,19436,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf","2007-11-08 00:00:00",
17403,1,19437,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19437slr014ltr.pdf","2003-07-06 00:00:00",
17404,1,19437,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
17405,1,19438,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
1324,1,19439,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019439s022ltr.pdf","2008-06-16 00:00:00",
50949,2,19439,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf","2018-01-02 00:00:00",
17406,1,19445,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf","1998-11-23 00:00:00",
20241,3,19445,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19445-s4-s6.cfm","1998-11-23 00:00:00",
1325,1,19445,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf","1998-11-23 00:00:00",
20242,3,19445,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19445-s4-s6.cfm","1998-11-23 00:00:00",
1326,1,19452,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19452s15ltr.pdf","1999-08-18 00:00:00",
20243,3,19452,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19452S15_DermaSmooth.cfm","1999-08-18 00:00:00",
33747,2,19452,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19425s15lbl.pdf","1999-08-18 00:00:00",
1327,1,19452,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf","2005-11-18 00:00:00",
11506,2,19452,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf","2005-11-17 00:00:00",
1328,1,19452,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19452s17ltr.pdf","2001-10-10 00:00:00",
11507,2,19452,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf","2001-10-10 00:00:00",
20244,3,19452,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-452S017_DermaSmoothe.cfm","2001-10-10 00:00:00",
1329,1,19452,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19452scp018ltr.pdf","2003-05-29 00:00:00",
33748,2,19452,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19452scp018_dermasmoothe_lbl.pdf","2003-05-29 00:00:00",
1330,1,19452,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf","2005-11-18 00:00:00",
33749,2,19452,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf","2005-11-17 00:00:00",
17407,1,19452,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf","2005-11-18 00:00:00",
33750,2,19452,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf","2005-11-17 00:00:00",
51066,2,19452,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019452s024lbl.pdf","2017-12-07 00:00:00",
17408,1,19453,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19453slr014ltr.pdf","2003-04-14 00:00:00",
11508,2,19462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf","2003-04-30 00:00:00",
20245,3,19462,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf","1999-03-18 00:00:00",
33751,2,19462,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf","2003-04-24 00:00:00",
11509,2,19462,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf","2002-06-06 00:00:00",
17409,1,19462,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf","2002-06-06 00:00:00",
20246,3,19462,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf","2007-07-09 00:00:00",
1331,1,19462,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf","2001-03-14 00:00:00",
11510,2,19462,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf","2007-11-07 00:00:00",
17410,1,19462,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf","2007-11-08 00:00:00",
1332,1,19462,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf","2010-03-25 00:00:00",
33752,2,19462,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf","2010-03-26 00:00:00",
1333,1,19462,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019462s037ltr.pdf","2011-06-03 00:00:00",
33753,2,19462,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf","2011-06-07 00:00:00",
17411,1,19462,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf","2014-02-10 00:00:00",
33754,2,19462,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf","2014-02-06 00:00:00",
54662,2,19462,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf","2018-06-21 00:00:00",
54697,1,19462,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019462Orig1s039ltr.pdf","2018-06-27 00:00:00",
20247,3,19463,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-463S019.pdf","2003-09-11 00:00:00",
33755,2,19463,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf","2003-04-15 00:00:00",
1334,1,19463,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19463slr026ltr.pdf","2003-12-24 00:00:00",
20248,3,19463,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019463_s026_TimopticTOC.cfm","2006-05-08 00:00:00",
33756,2,19463,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf","2003-12-29 00:00:00",
1335,1,19463,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019463s027LTR.pdf","2006-06-08 00:00:00",
33757,2,19463,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf","2006-06-06 00:00:00",
17412,1,19463,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019463s028ltr.pdf","2011-10-03 00:00:00",
33758,2,19463,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf","2011-09-30 00:00:00",
47893,2,19463,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019463s031lbl.pdf","2017-04-07 00:00:00",
47975,1,19463,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019463Orig1s031ltr.pdf","2017-04-12 00:00:00",
17413,1,19465,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf","2016-06-14 00:00:00",
45428,2,19465,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019465s055lbl.pdf","2016-09-29 00:00:00",
45482,1,19465,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s055ltr.pdf","2016-09-30 00:00:00",
1336,1,19466,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf","2016-06-14 00:00:00",
1337,1,19479,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf","2016-06-14 00:00:00",
1338,1,19480,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf","2016-06-14 00:00:00",
45429,2,19480,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019480s046lbl.pdf","2016-09-30 00:00:00",
45483,1,19480,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019480Orig1s046ltr.pdf","2016-09-30 00:00:00",
17414,1,19481,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019481s007ltr.pdf","2007-05-09 00:00:00",
17415,1,19481,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019481Orig1s013ltr.pdf","2015-11-04 00:00:00",
33759,2,19481,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019481s013lbl.pdf","2015-11-04 00:00:00",
17416,1,19482,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf","2002-02-04 00:00:00",
17417,1,19487,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf","2004-06-16 00:00:00",
20249,3,19487,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S021_IMODIUM A-D LIQUID.pdf","2008-04-04 00:00:00",
1339,1,19487,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487scf022ltr.pdf","2004-07-14 00:00:00",
20250,3,19487,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S022_IMODIUM_A-D LIQUID.pdf","2008-07-31 00:00:00",
1340,1,19487,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019487s023ltr.pdf","2005-06-09 00:00:00",
40913,3,19487,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019487_s023_IMODIUM A-D LIQUID.pdf","2008-07-30 00:00:00",
11511,2,19487,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf","2015-03-24 00:00:00",
17418,1,19487,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019487Orig1s027ltr.pdf","2015-03-19 00:00:00",
1341,1,19487,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019487Orig1s028ltr.pdf","2016-04-07 00:00:00",
11512,2,19487,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf","2016-04-11 00:00:00",
48020,2,19487,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019487Orig1s032lbl.pdf","2017-04-14 00:00:00",
48028,1,19487,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019487Orig1s032ltr.pdf","2017-04-14 00:00:00",
45069,1,19488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019488Orig1s010ltr.pdf","2016-08-26 00:00:00",
45116,2,19488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019488s010lbl.pdf","2016-08-26 00:00:00",
1342,1,19492,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf","2004-05-27 00:00:00",
1343,1,19500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19500slr010ltr.pdf","2003-06-22 00:00:00",
11513,2,19500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf","2003-06-22 00:00:00",
1344,1,19500,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019500Orig1s013ltr.pdf","2016-07-12 00:00:00",
47023,2,19500,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019500s013lbl.pdf","2017-01-30 00:00:00",
1345,1,19501,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf","2005-06-23 00:00:00",
33760,2,19501,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf","2005-06-23 00:00:00",
17419,1,19501,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19501scs024ltr.pdf","2004-06-30 00:00:00",
1346,1,19501,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf","2005-06-23 00:00:00",
33761,2,19501,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf","2005-06-23 00:00:00",
40914,3,19501,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019501s025.pdf","2011-09-22 00:00:00",
1347,1,19501,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019501Orig1s029ltr.pdf","2015-04-29 00:00:00",
11514,2,19501,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf","2015-04-29 00:00:00",
1348,1,19507,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019507s006ltr.pdf","2008-08-13 00:00:00",
17420,1,19507,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019507s007ltr.pdf","2009-05-14 00:00:00",
33762,2,19507,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019507s007lbl.pdf","2009-07-08 00:00:00",
1349,1,19507,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019507s008ltr.pdf","2011-08-18 00:00:00",
33763,2,19507,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019507s008lbl.pdf","2011-08-24 00:00:00",
17421,1,19508,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19508S30LTR.PDF","2001-03-02 00:00:00",
1350,1,19508,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019508s033rev2.pdf","2006-01-06 00:00:00",
11515,2,19508,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf","2006-01-05 00:00:00",
1351,1,19508,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019508s034ltr.pdf","2006-01-30 00:00:00",
33764,2,19510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19510lbl.pdf","2003-04-30 00:00:00",
40915,3,19510,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf","1999-03-18 00:00:00",
11516,2,19510,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf","2002-06-06 00:00:00",
17422,1,19510,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf","2002-06-06 00:00:00",
20251,3,19510,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019510_s028_Pepcid Injection.pdf","2009-01-12 00:00:00",
1352,1,19510,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF","2001-03-14 00:00:00",
33765,2,19510,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF","2001-03-14 00:00:00",
17423,1,19510,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf","2007-11-08 00:00:00",
33766,2,19510,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf","2007-11-07 00:00:00",
23962,14,19516,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
43619,8,19516,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf","2012-07-11 00:00:00",
1353,1,19516,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516scp019ltr.pdf","2004-06-09 00:00:00",
17424,1,19516,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516slr021ltr.pdf","2003-08-14 00:00:00",
1354,1,19516,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019516s030ltr.pdf","2007-05-29 00:00:00",
1355,1,19516,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019516s034ltr.pdf","2010-05-14 00:00:00",
33767,2,19516,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf","2010-05-17 00:00:00",
17425,1,19516,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s036ltr.pdf","2012-07-11 00:00:00",
33768,2,19516,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf","2012-07-12 00:00:00",
1356,1,19516,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s037ltr.pdf","2012-07-11 00:00:00",
33769,2,19516,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf","2012-07-13 00:00:00",
17426,1,19516,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019516Orig1s038ltr.pdf","2013-04-16 00:00:00",
17427,1,19516,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s042ltr.pdf","2014-04-17 00:00:00",
33770,2,19516,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf","2014-04-16 00:00:00",
1357,1,19516,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf","2014-10-30 00:00:00",
33771,2,19516,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf","2014-10-30 00:00:00",
1358,1,19516,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s044ltr.pdf","2014-08-20 00:00:00",
17428,1,19516,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019516Orig1s046ltr.pdf","2015-06-29 00:00:00",
1359,1,19516,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s047ltr.pdf","2016-04-22 00:00:00",
46236,1,19516,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s049ltr.pdf","2016-12-20 00:00:00",
46395,2,19516,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf","2016-12-21 00:00:00",
45459,1,19516,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s050ltr.pdf","2016-10-04 00:00:00",
48580,1,19516,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019516Orig1s052ltr.pdf","2017-05-31 00:00:00",
55650,1,19516,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019516Orig1s053s054ltr.pdf","2018-09-28 00:00:00",
55834,2,19516,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf","2018-10-05 00:00:00",
55836,8,19516,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28","2018-10-05 00:00:00",
55651,1,19516,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019516Orig1s053s054ltr.pdf","2018-09-28 00:00:00",
55835,2,19516,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf","2018-10-05 00:00:00",
55837,2,19516,"SUPPL",54,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28","2018-10-05 00:00:00",
17429,1,19520,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19520S18LTR.PDF","2000-04-12 00:00:00",
1360,1,19525,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19525S010ltr.pdf","2005-03-11 00:00:00",
33772,2,19525,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf","2005-03-11 00:00:00",
40916,3,19527,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf","1999-03-18 00:00:00",
1361,1,19527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf","2002-06-06 00:00:00",
20252,3,19527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf","2007-07-09 00:00:00",
33773,2,19527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf","2002-06-06 00:00:00",
1362,1,19527,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19527s027ltr.pdf","2004-12-02 00:00:00",
33774,2,19527,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf","2004-12-03 00:00:00",
1363,1,19527,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019527s028ltr.pdf","2007-11-08 00:00:00",
33775,2,19527,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf","2007-11-07 00:00:00",
33776,2,19531,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf","2014-12-05 00:00:00",
20253,3,19532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019532_Mycrox_toc.cfm","2003-08-05 00:00:00",
11517,2,19532,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf","2003-04-30 00:00:00",
17430,1,19532,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf","2002-10-29 00:00:00",
1364,1,19532,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf","2003-08-25 00:00:00",
40917,3,19537,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm","2004-09-29 00:00:00",
40918,3,19537,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm","2004-10-08 00:00:00",
40919,3,19537,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019537_S025_CIPRO.pdf","2008-04-04 00:00:00",
20254,3,19537,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S030_CIPRO.pdf","2008-08-11 00:00:00",
40920,3,19537,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S031_CIPRO.pdf","2008-08-11 00:00:00",
40921,3,19537,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019537_S032_Cipro Tablets.pdf","2007-07-09 00:00:00",
40922,3,19537,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S033_CIPRO.pdf","2008-08-11 00:00:00",
20255,3,19537,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019537_S035_Cipro Tablets.pdf","2007-07-09 00:00:00",
1365,1,19537,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf","2000-08-30 00:00:00",
33777,2,19537,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf","2000-08-30 00:00:00",
40923,3,19537,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm","2000-08-30 00:00:00",
11518,2,19537,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf","2002-04-17 00:00:00",
17431,1,19537,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf","2002-04-17 00:00:00",
40924,3,19537,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S041_CIPRO.pdf","2008-04-04 00:00:00",
40925,3,19537,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019537_S042_Cipro Tablets.pdf","2007-07-09 00:00:00",
17432,1,19537,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537scp043ltr.pdf","2002-12-16 00:00:00",
40926,3,19537,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S043_CIPPRO.pdf","2007-11-19 00:00:00",
40927,3,19537,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S044_CIPRO.pdf","2008-04-04 00:00:00",
20256,3,19537,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S045_CIPRO.pdf","2008-04-04 00:00:00",
1366,1,19537,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
33778,2,19537,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
40928,3,19537,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S048_CIPRO.pdf","2007-11-19 00:00:00",
1367,1,19537,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf","2004-03-28 00:00:00",
33779,2,19537,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf","2004-04-05 00:00:00",
40929,3,19537,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm","2008-04-04 00:00:00",
51816,20,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_Cipro-MedRev.pdf","1900-01-01 00:00:00",
51817,23,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_WR_orig.pdf","1900-01-01 00:00:00",
51818,25,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_WR_amend.pdf","1900-01-01 00:00:00",
51819,26,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_WR_amend2.pdf","1900-01-01 00:00:00",
51820,18,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_Cipro-ClinPharmRev.pdf","1900-01-01 00:00:00",
51821,17,19537,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019537s049_ciprofloxacin_Cipro-StatsRev.pdf","1900-01-01 00:00:00",
11519,2,19537,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
17433,1,19537,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
40930,3,19537,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S050_CIPRO.pdf","2007-11-19 00:00:00",
1368,1,19537,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
33780,2,19537,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
40931,3,19537,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S051_CIPRO.pdf","2007-11-19 00:00:00",
17434,1,19537,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf","2005-01-11 00:00:00",
33781,2,19537,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf","2005-01-11 00:00:00",
11520,2,19537,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf","2004-07-21 00:00:00",
17435,1,19537,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf","2004-07-21 00:00:00",
40932,3,19537,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S053_CIPRO.pdf","2008-04-04 00:00:00",
1369,1,19537,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf","2004-07-21 00:00:00",
33782,2,19537,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf","2004-07-21 00:00:00",
40933,3,19537,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S054_CIPRO.pdf","2008-04-04 00:00:00",
17436,1,19537,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019ltr.pdf","2005-05-20 00:00:00",
33783,2,19537,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf","2005-05-20 00:00:00",
1370,1,19537,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf","2005-11-18 00:00:00",
20257,3,19537,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019537_S060_Cipro Tablets.pdf","2007-07-09 00:00:00",
33784,2,19537,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf","2005-11-17 00:00:00",
17437,1,19537,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf","2006-06-28 00:00:00",
11521,2,19537,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019537s65lbl.pdf","2007-06-27 00:00:00",
17438,1,19537,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf","2007-07-05 00:00:00",
11522,2,19537,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf","2008-01-23 00:00:00",
17439,1,19537,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025ltr.pdf","2008-01-22 00:00:00",
1371,1,19537,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s068,019847s042ltr.pdf","2008-10-07 00:00:00",
11523,2,19537,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf","2008-10-09 00:00:00",
40934,3,19537,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019537Orig1s068.pdf","2012-09-17 00:00:00",
1372,1,19537,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf","2009-02-18 00:00:00",
11524,2,19537,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf","2009-02-20 00:00:00",
17440,1,19537,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf","2009-05-07 00:00:00",
20258,3,19537,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019537Orig1s070.pdf","2012-09-17 00:00:00",
33785,2,19537,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf","2009-05-11 00:00:00",
1373,1,19537,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf","2009-06-30 00:00:00",
17441,1,19537,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030ltr.pdf","2009-04-10 00:00:00",
33786,2,19537,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf","2009-04-16 00:00:00",
1374,1,19537,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s074,020780s032ltr.pdf","2011-11-21 00:00:00",
33787,2,19537,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf","2011-11-16 00:00:00",
11525,2,19537,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf","2011-03-04 00:00:00",
17442,1,19537,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf","2011-03-02 00:00:00",
17443,1,19537,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036ltr.pdf","2011-06-14 00:00:00",
33788,2,19537,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf","2011-06-14 00:00:00",
1375,1,19537,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf","2011-08-08 00:00:00",
17444,1,19537,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf","2011-10-20 00:00:00",
33789,2,19537,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf","2011-11-04 00:00:00",
11526,2,19537,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf","2013-02-01 00:00:00",
17445,1,19537,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780Orig1s039ltr.pdf","2013-01-31 00:00:00",
1376,1,19537,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s082,020780Orig1s040ltr.pdf","2013-08-16 00:00:00",
11527,2,19537,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf","2013-08-15 00:00:00",
1377,1,19537,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf","2015-02-12 00:00:00",
33790,2,19537,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf","2015-03-02 00:00:00",
45289,1,19537,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537Orig1s085,020780Orig1s042ltr.pdf","2016-09-19 00:00:00",
45385,2,19537,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf","2016-09-19 00:00:00",
17446,1,19537,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf","2016-07-26 00:00:00",
33791,2,19537,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf","2016-07-26 00:00:00",
49097,2,19537,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf","2017-07-27 00:00:00",
49098,8,19537,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf#page=41","2017-07-27 00:00:00",
49103,1,19537,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019537Orig1s087,020780Orig1s044ltr.pdf","2017-07-28 00:00:00",
17447,1,19543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf","2002-07-17 00:00:00",
33792,2,19543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf","2002-07-17 00:00:00",
1378,1,19543,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf","2002-07-17 00:00:00",
33793,2,19543,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf","2002-07-17 00:00:00",
17448,1,19543,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19543slr014ltr.pdf","2004-06-03 00:00:00",
33794,2,19543,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543slr014_Elocon_lbl.pdf","2002-12-15 00:00:00",
1379,1,19543,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019543Orig1s024ltr.pdf","2013-04-01 00:00:00",
33795,2,19543,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019543s024lbl.pdf","2013-04-01 00:00:00",
54308,2,19543,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019543s028lbl.pdf","2018-05-22 00:00:00",
54324,1,19543,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf","2018-05-24 00:00:00",
40935,3,19546,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-546_Isradipine.cfm","2002-09-10 00:00:00",
1380,1,19546,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019546s031,020336s013ltr.pdf","2005-05-20 00:00:00",
17449,1,19555,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf","2001-10-03 00:00:00",
20259,3,19555,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm","2001-10-03 00:00:00",
33796,2,19555,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf","2001-10-03 00:00:00",
17450,1,19555,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf","2001-10-03 00:00:00",
20260,3,19555,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm","2001-10-03 00:00:00",
33797,2,19555,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf","2001-10-03 00:00:00",
17451,1,19555,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019555s026ltr.pdf","2006-09-18 00:00:00",
33798,2,19555,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf","2006-08-28 00:00:00",
11528,2,19555,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf","2014-08-15 00:00:00",
17452,1,19555,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf","2014-08-14 00:00:00",
53569,2,19555,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019555s034lbl.pdf","2018-04-01 00:00:00",
53586,1,19555,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf","2018-04-01 00:00:00",
20261,3,19557,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19557S023_VePesid.pdf","1999-04-02 00:00:00",
11529,2,19557,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf","2012-08-03 00:00:00",
17453,1,19557,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf","2002-11-05 00:00:00",
40936,3,19557,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019557_S028_VEPESIDE.pdf","2007-07-06 00:00:00",
1381,1,19558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf","2004-06-14 00:00:00",
11530,2,19558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf","2004-06-14 00:00:00",
44034,10,19558,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
20262,3,19558,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
17454,1,19558,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr040ltr.pdf","2004-05-07 00:00:00",
1382,1,19558,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf","2003-06-08 00:00:00",
11531,2,19558,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf","2003-06-08 00:00:00",
20263,3,19558,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm","2005-04-17 00:00:00",
17455,1,19558,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf","2004-03-03 00:00:00",
1383,1,19558,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019558s046ltr.pdf","2005-10-11 00:00:00",
17456,1,19558,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf","2006-06-20 00:00:00",
1384,1,19558,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf","2006-10-23 00:00:00",
1385,1,19558,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf","2007-02-12 00:00:00",
17457,1,19558,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf","2008-10-14 00:00:00",
1386,1,19558,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf","2008-10-14 00:00:00",
1387,1,19558,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
11532,2,19558,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf","2011-11-21 00:00:00",
17458,1,19558,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf","2011-11-21 00:00:00",
1388,1,19558,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf","2012-06-08 00:00:00",
11533,2,19558,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf","2012-06-11 00:00:00",
1389,1,19558,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019558Orig1s056ltr.pdf","2013-02-28 00:00:00",
11534,2,19558,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf","2013-03-01 00:00:00",
1390,1,19558,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s057ltr.pdf","2015-07-13 00:00:00",
11535,2,19558,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf","2015-07-13 00:00:00",
17459,1,19558,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s059ltr.pdf","2015-09-01 00:00:00",
33799,2,19558,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf","2015-09-03 00:00:00",
45556,1,19558,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019558Orig1s060ltr.pdf","2016-10-19 00:00:00",
45625,2,19558,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf","2016-10-17 00:00:00",
49813,2,19558,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019558s061lbl.pdf","2017-09-20 00:00:00",
49844,1,19558,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019558Orig1s061ltr.pdf","2017-09-22 00:00:00",
40937,3,19561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-561_MicroKLS.pdf","2002-09-13 00:00:00",
1391,1,19561,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019561s004ltr.pdf","2005-08-24 00:00:00",
1392,1,19568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19568scf008ltr.pdf","2004-07-06 00:00:00",
11536,2,19568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.pdf","2004-07-07 00:00:00",
1393,1,19568,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019568s014ltr.pdf","2010-12-10 00:00:00",
11537,2,19568,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf","2010-12-06 00:00:00",
1394,1,19571,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19571scm029ltr.pdf","2003-05-29 00:00:00",
11538,2,19571,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19571scm029_humulin_lbl.pdf","2003-05-29 00:00:00",
17460,1,19571,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019377s046_019571s037ltr.pdf","2006-01-20 00:00:00",
33800,2,19571,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019377s046,019571s037lbl.pdf","2006-01-10 00:00:00",
1395,1,19574,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19574slr010ltr.pdf","2004-06-07 00:00:00",
53825,2,19574,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019574s016lbl.pdf","2018-04-27 00:00:00",
11539,2,19579,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
17461,1,19579,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
1396,1,19579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
33801,2,19579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
17462,1,19579,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr020ltr.pdf","2003-09-30 00:00:00",
11540,2,19579,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf","2004-07-01 00:00:00",
17463,1,19579,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf","2004-06-30 00:00:00",
1397,1,19579,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf","2013-10-01 00:00:00",
33802,2,19579,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf","2013-09-27 00:00:00",
11541,2,19579,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf","2014-07-24 00:00:00",
17464,1,19579,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf","2014-07-25 00:00:00",
1398,1,19583,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019583s023ltr.pdf","2005-08-15 00:00:00",
11542,2,19583,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf","2005-08-15 00:00:00",
1399,1,19583,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019583s025ltr.pdf","2006-01-30 00:00:00",
33803,2,19583,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019583s025lbl.pdf","2006-01-25 00:00:00",
11543,2,19591,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf","2002-10-04 00:00:00",
43622,8,19591,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088616.pdf","2009-09-25 00:00:00",
17465,1,19591,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf","2003-01-10 00:00:00",
33804,2,19591,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf","2003-01-10 00:00:00",
1400,1,19591,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf","2003-01-10 00:00:00",
33805,2,19591,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf","2003-01-10 00:00:00",
17466,1,19591,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr019ltr.pdf","2003-07-10 00:00:00",
33806,2,19591,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591s19lbl_Lariam.pdf","2003-07-09 00:00:00",
11544,2,19591,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf","2003-09-08 00:00:00",
1401,1,19591,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr022ltr.pdf","2003-09-08 00:00:00",
11545,2,19591,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf","2003-09-08 00:00:00",
11546,2,19591,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf","2008-06-05 00:00:00",
17467,1,19591,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s023ltr.pdf","2008-05-14 00:00:00",
1402,1,19591,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf","2008-09-26 00:00:00",
33807,2,19591,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf","2008-10-03 00:00:00",
17468,1,19591,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf","2008-09-26 00:00:00",
33808,2,19591,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf","2008-10-03 00:00:00",
11547,2,19591,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf","2009-09-17 00:00:00",
17469,1,19591,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf","2009-11-19 00:00:00",
11548,2,19591,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf","2009-07-24 00:00:00",
17470,1,19591,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s027ltr.pdf","2009-06-30 00:00:00",
11549,2,19591,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf","2009-09-17 00:00:00",
17471,1,19591,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf","2009-11-19 00:00:00",
17472,1,19591,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019591s030ltr.pdf","2011-05-04 00:00:00",
11550,2,19593,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf","1999-10-29 00:00:00",
17473,1,19593,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacivinjection_approv.pdf","2003-04-30 00:00:00",
20264,3,19593,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacinjection.cfm","2003-04-30 00:00:00",
1403,1,19593,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf","2002-01-07 00:00:00",
17474,1,19593,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf","2006-07-21 00:00:00",
11551,2,19593,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf","2009-03-27 00:00:00",
17475,1,19593,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf","2009-02-19 00:00:00",
1404,1,19593,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042ltr.pdf","2009-11-12 00:00:00",
11552,2,19593,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf","2009-10-06 00:00:00",
1405,1,19594,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19594slr021ltr.pdf","2002-08-14 00:00:00",
51025,2,19594,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019594s21lbl.pdf","2018-01-11 00:00:00",
44035,10,19596,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
20265,3,19596,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf","2011-02-04 00:00:00",
40938,3,19596,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf","2011-02-04 00:00:00",
1406,1,19596,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19596s033ltr.pdf","2005-01-26 00:00:00",
11553,2,19596,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf","2005-01-26 00:00:00",
17476,1,19596,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf","2010-08-31 00:00:00",
33809,2,19596,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf","2010-09-07 00:00:00",
1407,1,19596,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019596s039ltr.pdf","2006-09-15 00:00:00",
1408,1,19596,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019596s043, 021037s018ltr.pdf","2007-09-06 00:00:00",
33810,2,19596,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf","2007-09-06 00:00:00",
11554,2,19596,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf","2009-05-25 00:00:00",
17477,1,19596,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf","2009-05-29 00:00:00",
1409,1,19596,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf","2010-12-22 00:00:00",
11555,2,19596,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf","2010-12-20 00:00:00",
1410,1,19596,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf","2012-04-02 00:00:00",
33811,2,19596,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019596s051lbl.pdf","2012-03-29 00:00:00",
1411,1,19596,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037Orig1s029ltr.pdf","2013-10-18 00:00:00",
11556,2,19596,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf","2013-10-22 00:00:00",
1412,1,19596,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf","2014-06-12 00:00:00",
47811,2,19596,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057lbl.pdf","2017-03-31 00:00:00",
53851,2,19596,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s063lbl.pdf","2018-04-27 00:00:00",
53890,1,19596,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s063,021037Orig1s036_replacement ltr.pdf","2018-06-20 00:00:00",
54985,2,19596,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf","2018-07-26 00:00:00",
55012,1,19596,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s064s065Ltr.pdf","2018-07-26 00:00:00",
54986,2,19596,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf","2018-07-26 00:00:00",
55013,1,19596,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s064s065Ltr.pdf","2018-07-26 00:00:00",
55030,8,19596,"SUPPL",65,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12","2018-07-27 00:00:00",
40939,3,19599,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019599Orig1s007.pdf","2015-11-05 00:00:00",
1413,1,19599,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019599s010ltr.pdf","2009-01-30 00:00:00",
11557,2,19599,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf","2012-01-23 00:00:00",
17478,1,19599,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019599s011ltr.pdf","2012-01-18 00:00:00",
11558,2,19599,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf","2014-10-15 00:00:00",
17479,1,19599,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019599Orig1s012ltr.pdf","2014-10-14 00:00:00",
45890,2,19599,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf","2016-11-14 00:00:00",
45892,1,19599,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019599Orig1s013ltr.pdf","2016-11-15 00:00:00",
51404,20,19599,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/32_19599%20naftifine%20clinical%20prea.pdf","1900-01-01 00:00:00",
51406,18,19599,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/33_19599 naftifine clinpharm prea.pdf","1900-01-01 00:00:00",
51407,17,19599,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/34_19599 naftifine statistical prea.pdf","1900-01-01 00:00:00",
53982,2,19599,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf","2018-05-02 00:00:00",
53993,1,19599,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019356Orig1s008,019599Orig1s014,204286Orig1s003ltr.pdf","2018-05-03 00:00:00",
1414,1,19600,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19600slr006,009ltr.pdf","2003-04-15 00:00:00",
11559,2,19600,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf","2003-03-26 00:00:00",
1415,1,19600,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19600slr006,009ltr.pdf","2003-04-15 00:00:00",
11560,2,19600,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf","2003-03-28 00:00:00",
1416,1,19614,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf","2010-04-09 00:00:00",
17480,1,19614,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf","2010-04-02 00:00:00",
33812,2,19614,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf","2010-04-04 00:00:00",
11561,2,19614,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf","2011-11-14 00:00:00",
17481,1,19614,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019614s049ltr.pdf","2011-11-16 00:00:00",
1417,1,19614,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019614Orig1s050ltr.pdf","2014-10-10 00:00:00",
11562,2,19614,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf","2014-10-15 00:00:00",
45913,1,19614,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019614Orig1s053ltr.pdf","2016-11-22 00:00:00",
45941,2,19614,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf","2016-11-21 00:00:00",
17482,1,19615,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19615S12ltr.pdf","2001-04-17 00:00:00",
20266,3,19615,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19615S012_Dopamine.pdf","2001-04-17 00:00:00",
17483,1,19615,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019615s014ltr.pdf","2007-07-05 00:00:00",
17484,1,19615,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19615s017LTR.pdf","2002-06-20 00:00:00",
17485,1,19615,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s020ltr.pdf","2012-03-15 00:00:00",
1418,1,19615,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s021ltr.pdf","2012-06-18 00:00:00",
11563,2,19615,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.pdf","2012-06-18 00:00:00",
49055,2,19615,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019615s024lbl.pdf","2017-07-25 00:00:00",
49079,1,19615,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019615Orig1s024ltr.pdf","2017-07-25 00:00:00",
17486,1,19616,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf","2002-08-21 00:00:00",
1419,1,19616,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf","2002-08-21 00:00:00",
17487,1,19616,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf","2002-08-21 00:00:00",
1420,1,19617,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019617s010ltr.pdf","2010-02-22 00:00:00",
11564,2,19617,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf","2010-02-16 00:00:00",
48916,2,19617,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf","2017-07-06 00:00:00",
48919,1,19617,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019617Orig1s017ltr.pdf","2017-07-06 00:00:00",
1421,1,19618,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019618s016.pdf","2006-01-06 00:00:00",
11565,2,19618,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf","2015-05-26 00:00:00",
17488,1,19618,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019618s018ltr.pdf","2008-06-24 00:00:00",
49122,1,19618,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019618Orig1s023ltr.pdf","2017-07-28 00:00:00",
49137,2,19618,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf","2017-07-28 00:00:00",
1422,1,19625,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf","2002-07-17 00:00:00",
11566,2,19625,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf","2002-07-17 00:00:00",
1423,1,19625,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf","2002-07-17 00:00:00",
11567,2,19625,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf","2002-07-17 00:00:00",
1424,1,19625,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019625Orig1s024ltr.pdf","2013-04-24 00:00:00",
33813,2,19625,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019625s024lbl.pdf","2013-04-23 00:00:00",
54306,2,19625,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019625s026lbl.pdf","2018-05-22 00:00:00",
54323,1,19625,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf","2018-05-24 00:00:00",
17489,1,19626,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19626scs019ltr.pdf","2004-03-02 00:00:00",
33814,2,19626,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.pdf","2004-04-05 00:00:00",
33815,2,19626,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf","2015-02-20 00:00:00",
23549,10,19627,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm","2007-06-18 00:00:00",
40940,3,19627,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019627_S002_Diprivan.pdf","2009-01-12 00:00:00",
20267,3,19627,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019627_S027_Diprivan_APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
1425,1,19627,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf","2001-02-23 00:00:00",
11568,2,19627,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf","2001-02-23 00:00:00",
20268,3,19627,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019627_S035_DiprivanTOC.cfm","2007-07-09 00:00:00",
11569,2,19627,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf","2007-02-21 00:00:00",
17490,1,19627,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019627s045ltr.pdf","2007-02-12 00:00:00",
20269,3,19627,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019627_S045_DIPRIVAN.pdf","2009-01-12 00:00:00",
11570,2,19627,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf","2008-04-23 00:00:00",
17491,1,19627,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019627s046ltr.pdf","2008-04-16 00:00:00",
11571,2,19627,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf","2014-01-28 00:00:00",
17492,1,19627,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019627Orig1s060ltr.pdf","2013-09-17 00:00:00",
40941,3,19627,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019627Orig1s060.pdf","2013-09-24 00:00:00",
33816,2,19627,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf","2014-06-10 00:00:00",
48192,1,19627,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019627Orig1s066ltr.pdf","2017-05-02 00:00:00",
48220,2,19627,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf","2017-05-02 00:00:00",
1426,1,19630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19630s023ltr.pdf","2004-09-29 00:00:00",
11572,2,19630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19630s023lbl.pdf","2004-09-29 00:00:00",
17493,1,19630,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016ltr.pdf","2005-09-08 00:00:00",
17494,1,19631,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19631s023ltr.pdf","2004-09-29 00:00:00",
33817,2,19631,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf","2004-09-29 00:00:00",
11573,2,19634,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf","2004-10-04 00:00:00",
17495,1,19634,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19634s021ltr.pdf","2004-10-04 00:00:00",
1427,1,19634,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019634s033ltr.pdf","2013-02-15 00:00:00",
33818,2,19634,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf","2013-02-14 00:00:00",
11574,2,19635,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf","2014-09-09 00:00:00",
17496,1,19638,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019638s005ltr.pdf","2010-11-30 00:00:00",
40942,3,19640,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf","1997-03-11 00:00:00",
20270,3,19640,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf","1997-03-11 00:00:00",
20271,3,19640,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640_s020_HUMATROPE 5.pdf","2008-08-11 00:00:00",
40943,3,19640,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019640_s022_HUMATROPE.pdf","2009-01-12 00:00:00",
1428,1,19640,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640s025ltr.pdf","2002-06-10 00:00:00",
17497,1,19640,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640slr031ltr.pdf","2002-12-04 00:00:00",
1429,1,19640,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640slr032ltr.pdf","2003-03-26 00:00:00",
40944,3,19640,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S032_HUMATROPE_AP.pdf","2007-07-06 00:00:00",
17498,1,19640,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640se1-033ltr.pdf","2004-06-07 00:00:00",
20272,3,19640,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S033_HUMATROPE_AP.pdf","2007-04-09 00:00:00",
33819,2,19640,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf","2003-08-14 00:00:00",
1430,1,19640,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19640s040rev2.pdf","2004-09-29 00:00:00",
11575,2,19640,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf","2004-09-29 00:00:00",
1431,1,19640,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019640s045ltr.pdf","2005-10-25 00:00:00",
11576,2,19640,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf","2005-10-25 00:00:00",
17499,1,19640,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s046ltr.pdf","2006-07-03 00:00:00",
1432,1,19640,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf","2006-10-27 00:00:00",
33820,2,19640,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf","2006-10-27 00:00:00",
1433,1,19640,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf","2006-10-27 00:00:00",
11577,2,19640,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf","2006-10-27 00:00:00",
1434,1,19640,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s058ltr.pdf","2006-11-06 00:00:00",
33821,2,19640,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf","2006-11-06 00:00:00",
1435,1,19640,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s068ltr.pdf","2009-03-17 00:00:00",
11578,2,19640,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf","2009-03-17 00:00:00",
1436,1,19640,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s070ltr.pdf","2009-01-14 00:00:00",
1437,1,19640,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019640s078ltr.pdf","2010-07-30 00:00:00",
11579,2,19640,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf","2010-07-31 00:00:00",
11580,2,19640,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf","2011-03-04 00:00:00",
17500,1,19640,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s084ltr.pdf","2011-02-28 00:00:00",
1438,1,19640,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s086ltr.pdf","2011-08-26 00:00:00",
11581,2,19640,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf","2011-08-22 00:00:00",
1439,1,19640,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019640Orig1s092ltr.pdf","2014-07-31 00:00:00",
33822,2,19640,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf","2014-07-31 00:00:00",
46149,1,19640,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019640Orig1s104ltr.pdf","2016-12-14 00:00:00",
46183,2,19640,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019640s104lbl.pdf","2016-12-14 00:00:00",
11582,2,19641,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
17501,1,19641,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
17502,1,19641,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
33823,2,19641,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
1440,1,19641,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf","2004-06-30 00:00:00",
11583,2,19641,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf","2004-07-01 00:00:00",
1441,1,19641,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf","2013-10-01 00:00:00",
11584,2,19641,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf","2013-09-27 00:00:00",
1442,1,19641,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf","2014-07-25 00:00:00",
33824,2,19641,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf","2014-07-24 00:00:00",
20273,3,19643,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019643_S017_MEVACOR_TABLETS_AP.pdf","2007-07-06 00:00:00",
40945,3,19643,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s050.pdf","1997-08-12 00:00:00",
20274,3,19643,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf","1997-06-25 00:00:00",
40946,3,19643,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf","1997-06-25 00:00:00",
17503,1,19643,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor_appltr.pdf","1999-03-11 00:00:00",
40947,3,19643,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor.cfm","2000-05-17 00:00:00",
1443,1,19643,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s061_LTR.pdf","2007-04-25 00:00:00",
11585,2,19643,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf","2007-04-20 00:00:00",
40948,3,19643,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf","2001-08-17 00:00:00",
11586,2,19643,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf","2003-04-16 00:00:00",
20275,3,19643,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf","2001-08-17 00:00:00",
17504,1,19643,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643s067ltr.pdf","2002-02-14 00:00:00",
33825,2,19643,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf","2002-02-14 00:00:00",
33826,2,19643,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf","2003-04-17 00:00:00",
1444,1,19643,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643slr071ltr.pdf","2002-09-20 00:00:00",
33827,2,19643,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf","2002-09-20 00:00:00",
20276,3,19643,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019643_S073_MEVACOR_TABLETS_AP.pdf","2007-07-06 00:00:00",
11587,2,19643,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf","2005-04-12 00:00:00",
17505,1,19643,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19643s075ltr.pdf","2005-04-12 00:00:00",
1445,1,19643,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s076ltr.pdf","2005-11-18 00:00:00",
11588,2,19643,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf","2005-11-08 00:00:00",
17506,1,19643,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s077ltr.pdf","2005-06-14 00:00:00",
33828,2,19643,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf","2005-06-14 00:00:00",
17507,1,19643,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s078ltr.pdf","2007-06-04 00:00:00",
33829,2,19643,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf","2007-06-04 00:00:00",
1446,1,19643,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s079ltr.pdf","2008-01-09 00:00:00",
17508,1,19643,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019643s080ltr.pdf","2009-03-11 00:00:00",
33830,2,19643,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf","2009-03-17 00:00:00",
1447,1,19643,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019643s081ltr.pdf","2010-07-02 00:00:00",
33831,2,19643,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf","2010-07-06 00:00:00",
17509,1,19643,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
1448,1,19643,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019643s084ltr.pdf","2011-02-07 00:00:00",
11589,2,19643,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf","2011-02-04 00:00:00",
11590,2,19643,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf","2012-02-28 00:00:00",
17510,1,19643,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643s085ltr.pdf","2012-02-28 00:00:00",
23963,14,19643,"SUPPL",85,"Tracked Changes Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085-trackedchangeslbl.pdf","2012-02-28 00:00:00",
40949,3,19643,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019643s085.pdf","2012-03-30 00:00:00",
17511,1,19643,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf","2012-11-05 00:00:00",
33832,2,19643,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf","2012-11-06 00:00:00",
1449,1,19643,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf","2012-11-05 00:00:00",
11591,2,19643,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf","2012-11-06 00:00:00",
1450,1,19643,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019643Orig1s088ltr.pdf","2014-02-28 00:00:00",
33833,2,19643,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf","2014-03-04 00:00:00",
23137,8,19645,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089165.pdf","2009-12-04 00:00:00",
17512,1,19645,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s016ltr.pdf","2007-01-25 00:00:00",
33834,2,19645,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf","2007-01-24 00:00:00",
1451,1,19645,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s017ltr.pdf","2007-11-19 00:00:00",
11592,2,19645,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf","2007-11-19 00:00:00",
1452,1,19645,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019645s018ltr.pdf","2008-12-19 00:00:00",
1453,1,19645,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019645Orig1s019ltr.pdf","2013-03-28 00:00:00",
11593,2,19645,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf","2013-04-01 00:00:00",
1454,1,19649,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf","2001-04-11 00:00:00",
11594,2,19649,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf","2004-06-04 00:00:00",
17513,1,19649,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019649s010;019650s007ltr.pdf","2007-03-23 00:00:00",
33835,2,19649,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf","2007-03-15 00:00:00",
17514,1,19649,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s012,019650s009ltr.pdf","2008-01-09 00:00:00",
1455,1,19649,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s014ltr.pdf","2008-11-25 00:00:00",
33836,2,19649,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019649s014lbl.pdf","2009-01-21 00:00:00",
11595,2,19649,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf","2010-04-07 00:00:00",
17515,1,19649,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019649s015ltr.pdf","2010-04-08 00:00:00",
11596,2,19650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf","2004-06-04 00:00:00",
17516,1,19650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf","2004-06-04 00:00:00",
1456,1,19650,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf","2001-04-11 00:00:00",
33837,2,19650,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf","2001-04-11 00:00:00",
1457,1,19650,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019649s010;019650s007ltr.pdf","2007-03-23 00:00:00",
11597,2,19650,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf","2007-03-15 00:00:00",
17517,1,19650,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s012,019650s009ltr.pdf","2008-01-09 00:00:00",
20277,3,19651,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/asacol_19651s5.cfm","2003-06-18 00:00:00",
1458,1,19651,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019651s016LTR.pdf","2007-04-20 00:00:00",
17518,1,19651,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019651s020ltr.pdf","2009-11-12 00:00:00",
33838,2,19651,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf","2009-10-06 00:00:00",
1459,1,19651,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019651s023ltr.pdf","2010-05-28 00:00:00",
11598,2,19651,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf","2010-05-28 00:00:00",
1460,1,19651,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019651Orig1s024ltr.pdf","2013-10-21 00:00:00",
11599,2,19651,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf","2013-10-22 00:00:00",
11600,2,19651,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf","2015-05-29 00:00:00",
17519,1,19651,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019651Orig1s025ltr.pdf","2015-05-28 00:00:00",
49123,1,19651,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf","2017-07-28 00:00:00",
49138,2,19651,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019651s027lbl.pdf","2017-07-28 00:00:00",
40950,3,19653,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s016_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
40951,3,19653,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019653_s017_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40952,3,19653,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s018_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20278,3,19653,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s020_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40953,3,19653,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s021_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40954,3,19653,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s022_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20279,3,19653,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s023_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40955,3,19653,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019653_s024_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
40956,3,19653,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s027_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20280,3,19653,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s030_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
40957,3,19653,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s031_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20281,3,19653,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s032_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
20282,3,19653,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s033_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40958,3,19653,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019653_s035_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
11601,2,19653,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf","2007-05-07 00:00:00",
17520,1,19653,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034ltr.pdf","2007-05-09 00:00:00",
17521,1,19653,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041ltr.pdf","2008-06-03 00:00:00",
11602,2,19653,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf","2013-10-04 00:00:00",
17522,1,19653,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
1461,1,19653,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
11603,2,19653,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf","2012-07-13 00:00:00",
1462,1,19653,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
1463,1,19653,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
1464,1,19653,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
1465,1,19653,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf","2015-05-04 00:00:00",
11604,2,19653,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf","2015-05-04 00:00:00",
49317,2,19653,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019653s058,019697s054lbl.pdf","2017-08-10 00:00:00",
49417,1,19653,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019653Orig1s058,19697Orig1s054ltr.pdf","2017-08-15 00:00:00",
1466,1,19655,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF","2001-03-30 00:00:00",
33839,2,19655,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf","2001-03-30 00:00:00",
40959,3,19655,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm","2005-04-19 00:00:00",
11605,2,19655,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf","2003-06-16 00:00:00",
1467,1,19655,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf","2002-02-21 00:00:00",
17523,1,19655,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf","2002-12-18 00:00:00",
33840,2,19655,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf","2003-04-04 00:00:00",
17524,1,19655,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20528slr011ltr.pdf","2003-10-17 00:00:00",
33841,2,19655,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf","2003-10-17 00:00:00",
11606,2,19655,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf","2006-05-16 00:00:00",
17525,1,19655,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf","2006-05-18 00:00:00",
17526,1,19655,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s043ltr.pdf","2006-11-22 00:00:00",
33842,2,19655,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s043lbl.pdf","2006-11-16 00:00:00",
11607,2,19655,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf","2008-09-25 00:00:00",
17527,1,19655,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf","2008-09-23 00:00:00",
17528,1,19655,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018ltr.pdf","2010-01-06 00:00:00",
33843,2,19655,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf","2009-11-23 00:00:00",
1468,1,19655,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf","2010-05-21 00:00:00",
11608,2,19655,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf","2010-05-18 00:00:00",
1469,1,19655,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf","2011-12-01 00:00:00",
11609,2,19655,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf","2011-11-25 00:00:00",
17529,1,19655,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf","2012-06-04 00:00:00",
33844,2,19655,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf","2012-06-06 00:00:00",
17530,1,19655,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf","2014-12-31 00:00:00",
33845,2,19655,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf","2015-01-08 00:00:00",
47365,2,19655,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf","2017-02-28 00:00:00",
47438,1,19655,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s055,019910Orig1s042,019951Orig1s033ltr.pdf","2017-03-03 00:00:00",
48005,2,19655,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf","2017-04-13 00:00:00",
48021,1,19655,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s056,019910Orig1s043,019951Orig1s034ltr.pdf","2017-04-14 00:00:00",
50526,2,19655,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf","2017-11-29 00:00:00",
50553,1,19655,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s057,019910Orig1s044,019951Orig1s035ltr.pdf","2017-12-01 00:00:00",
55424,2,19655,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf","2018-09-11 00:00:00",
55435,1,19655,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019655Orig1s058,019910Orig1s045,019951Orig1s036ltr.pdf","2018-09-12 00:00:00",
20283,3,19658,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19658-S005_Claritin.pdf","2001-05-25 00:00:00",
40960,3,19658,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml","2007-03-02 00:00:00",
40961,3,19658,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml","2007-03-02 00:00:00",
17531,1,19658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf","2002-11-27 00:00:00",
20284,3,19658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm","2004-12-07 00:00:00",
1470,1,19658,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf","2003-11-25 00:00:00",
1471,1,19658,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658slr021ltr.pdf","2003-07-06 00:00:00",
17532,1,19658,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019658s026_rc.pdf","2008-01-09 00:00:00",
33846,2,19658,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf","2013-09-18 00:00:00",
1472,1,19658,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019658Orig1s044ltr.pdf","2015-12-22 00:00:00",
11610,2,19658,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf","2015-12-22 00:00:00",
45032,1,19658,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s045ltr.pdf","2016-08-09 00:00:00",
45054,2,19658,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf","2016-08-22 00:00:00",
46171,1,19658,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s046ltr.pdf","2016-12-15 00:00:00",
46205,2,19658,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf","2016-12-19 00:00:00",
48169,2,19658,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019658Orig1s048lbl.pdf","2017-05-01 00:00:00",
48209,1,19658,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019658Orig1s048ltr.pdf","2017-05-02 00:00:00",
54410,1,19658,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s051ltr.pdf","2018-06-01 00:00:00",
54414,2,19658,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s051lbl.pdf","2018-06-01 00:00:00",
54409,1,19658,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s052ltr.pdf","2018-06-01 00:00:00",
54413,2,19658,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s052lbl.pdf","2018-06-01 00:00:00",
54862,2,19658,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s053lbl.pdf","2018-07-06 00:00:00",
1473,1,19660,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19660slr017ltr.pdf","2004-03-02 00:00:00",
11611,2,19661,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf","2006-02-02 00:00:00",
17533,1,19661,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019661s030ltr.pdf","2006-02-02 00:00:00",
48908,1,19661,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019661Orig1s036ltr.pdf","2017-07-05 00:00:00",
48909,2,19661,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019661s036lbl.pdf","2017-07-05 00:00:00",
55122,2,19661,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf","2018-08-07 00:00:00",
40962,3,19667,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019667-s04.pdf","1999-02-19 00:00:00",
17534,1,19667,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf","2002-07-24 00:00:00",
1474,1,19667,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf","2002-07-24 00:00:00",
17535,1,19667,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm042ltr.pdf","2003-02-10 00:00:00",
1475,1,19667,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm044ltr.pdf","2003-01-17 00:00:00",
11612,2,19667,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf","2003-01-17 00:00:00",
1476,1,19667,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019667s050ltr.pdf","2005-09-08 00:00:00",
33847,2,19667,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf","2005-09-08 00:00:00",
1477,1,19667,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653Orig1s058,19697Orig1s054ltr.pdf","2008-08-28 00:00:00",
11613,2,19667,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf","2008-08-29 00:00:00",
1478,1,19667,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf","2010-02-05 00:00:00",
33848,2,19667,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf","2010-02-04 00:00:00",
1479,1,19667,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019667Orig1s059ltr.pdf","2014-02-11 00:00:00",
17536,1,19667,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019667s061ltr.pdf","2012-03-27 00:00:00",
33849,2,19667,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf","2012-03-27 00:00:00",
11614,2,19667,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf","2015-03-12 00:00:00",
17537,1,19667,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019667Orig1s062ltr.pdf","2015-02-24 00:00:00",
17538,1,19668,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19668slr012ltr.pdf","2003-06-22 00:00:00",
1480,1,19668,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19668s15ltr.pdf","2002-01-23 00:00:00",
1481,1,19668,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019668s017ltr.pdf","2006-03-03 00:00:00",
17539,1,19668,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf","2009-07-17 00:00:00",
33850,2,19668,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf","2009-07-23 00:00:00",
11615,2,19668,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf","2015-08-24 00:00:00",
17540,1,19668,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019668s022ltr.pdf","2010-03-10 00:00:00",
11616,2,19668,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf","2013-11-08 00:00:00",
17541,1,19668,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019668Orig1s026ltr.pdf","2013-11-07 00:00:00",
1482,1,19668,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019668Orig1s028ltr.pdf","2016-06-10 00:00:00",
11617,2,19668,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf","2016-06-13 00:00:00",
40963,3,19670,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml","2007-03-02 00:00:00",
20285,3,19670,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019670_s009_Claritin-DTOC.cfml","2007-03-02 00:00:00",
40964,3,19670,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml","2007-03-02 00:00:00",
40965,3,19670,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml","2007-03-02 00:00:00",
40966,3,19670,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s014_Claritin-DTOC.cfml","2007-03-02 00:00:00",
40967,3,19670,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml","2007-03-02 00:00:00",
20286,3,19670,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019670_S017_Claritin-DTOC.cfml","2007-03-02 00:00:00",
17542,1,19670,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf","2002-11-27 00:00:00",
40968,3,19670,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm","2004-12-07 00:00:00",
11618,2,19670,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf","2004-08-02 00:00:00",
17543,1,19670,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf","2004-08-02 00:00:00",
1483,1,19670,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019670s020ltr.pdf","2009-04-27 00:00:00",
40969,3,19670,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019670Orig1s020.pdf","2011-12-16 00:00:00",
1484,1,19670,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf","2010-02-17 00:00:00",
1485,1,19670,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf","2015-11-27 00:00:00",
11619,2,19670,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf","2015-12-11 00:00:00",
55090,1,19670,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019670Orig1s034,020470Orig1s047ltr.pdf","2018-08-03 00:00:00",
55113,2,19670,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf","2018-08-03 00:00:00",
40970,3,19675,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019675a_clinpharm_rev.pdf","1998-02-04 00:00:00",
1486,1,19675,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup_approv.pdf","2003-04-30 00:00:00",
20287,3,19675,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup.cfm","2003-04-30 00:00:00",
17544,1,19675,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf","2002-01-07 00:00:00",
17545,1,19675,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19675scs030ltr.pdf","2004-05-07 00:00:00",
1487,1,19675,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf","2005-05-02 00:00:00",
11620,2,19675,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf","2005-05-02 00:00:00",
17546,1,19675,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf","2006-07-21 00:00:00",
1488,1,19675,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf","2009-02-19 00:00:00",
11621,2,19675,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf","2009-03-27 00:00:00",
11622,2,19675,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf","2009-10-06 00:00:00",
19081,1,19675,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf","2009-11-12 00:00:00",
19082,1,19676,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin_approv.pdf","2004-06-10 00:00:00",
40971,3,19676,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin.cfm","2003-04-29 00:00:00",
1489,1,19676,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19676S16LTR.PDF","2000-04-13 00:00:00",
33851,2,19676,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf","2004-06-10 00:00:00",
40972,3,19676,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676s016_Nutropin.cfm","2003-07-08 00:00:00",
19083,1,19676,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf","2005-06-29 00:00:00",
23964,14,19676,"SUPPL",20,"Additional App Ltr","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf","2005-07-22 00:00:00",
33852,2,19676,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf","2005-06-29 00:00:00",
44442,14,19676,"SUPPL",20,"Additional Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf","2005-07-26 00:00:00",
1490,1,19676,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf","2005-06-29 00:00:00",
11623,2,19676,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf","2005-06-29 00:00:00",
44443,14,19676,"SUPPL",21,"Additional App Ltr","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf","2005-07-22 00:00:00",
44444,14,19676,"SUPPL",21,"Additional Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf","2005-07-26 00:00:00",
1491,1,19676,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019676s026ltr.pdf","2006-03-01 00:00:00",
33853,2,19676,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf","2006-02-28 00:00:00",
19084,1,19676,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf","2007-02-23 00:00:00",
33854,2,19676,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf","2007-02-21 00:00:00",
19085,1,19676,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf","2012-04-12 00:00:00",
33855,2,19676,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf","2012-04-17 00:00:00",
46150,1,19676,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf","2016-12-14 00:00:00",
46179,2,19676,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf","2016-12-14 00:00:00",
1492,1,19677,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005ltr.pdf","2005-12-15 00:00:00",
11624,2,19677,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf","2005-12-15 00:00:00",
11625,2,19677,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf","2009-04-03 00:00:00",
19086,1,19677,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019677s006ltr.pdf","2009-04-03 00:00:00",
19087,1,19678,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005ltr.pdf","2005-12-15 00:00:00",
33856,2,19678,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf","2005-12-15 00:00:00",
23550,10,19680,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
1493,1,19680,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
1494,1,19680,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s019ltr.pdf","2006-01-20 00:00:00",
11626,2,19680,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
1495,1,19680,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s021ltr.pdf","2006-12-28 00:00:00",
33857,2,19680,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019680s021lbl.pdf","2006-12-26 00:00:00",
1496,1,19680,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
11627,2,19680,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
19088,1,19680,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33858,2,19680,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf","2011-10-12 00:00:00",
1497,1,19680,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019680s026ltr.pdf","2009-05-01 00:00:00",
11628,2,19680,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf","2009-05-07 00:00:00",
1498,1,19680,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11629,2,19680,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf","2011-10-12 00:00:00",
11630,2,19680,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf","2014-06-23 00:00:00",
19089,1,19680,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
1499,1,19680,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
11631,2,19680,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf","2011-10-12 00:00:00",
19090,1,19680,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
33859,2,19680,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf","2011-10-12 00:00:00",
19091,1,19680,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019680Orig1s033ltr.pdf","2014-06-23 00:00:00",
33860,2,19680,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s033lbl.pdf","2014-06-23 00:00:00",
11632,2,19680,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf","2013-03-04 00:00:00",
19092,1,19680,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
1500,1,19680,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
33861,2,19680,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s035lbl.pdf","2013-09-17 00:00:00",
11633,2,19680,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf","2013-07-02 00:00:00",
19093,1,19680,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
33862,2,19680,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s037lbl.pdf","2014-12-03 00:00:00",
19094,1,19680,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
33863,2,19680,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s038lbl.pdf","2015-01-08 00:00:00",
1501,1,19680,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
11634,2,19680,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
19095,1,19680,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
33864,2,19680,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s040lbl.pdf","2014-08-22 00:00:00",
1502,1,19680,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
33865,2,19680,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf","2015-03-17 00:00:00",
1503,1,19680,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
33866,2,19680,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s042lbledt.pdf","2015-10-06 00:00:00",
19096,1,19680,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
33867,2,19680,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s043lbl.pdf","2016-02-23 00:00:00",
45813,1,19680,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45842,2,19680,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s044lbl.pdf","2016-11-08 00:00:00",
47481,2,19680,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s045lbl.pdf","2017-03-07 00:00:00",
47506,1,19680,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49982,1,19680,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
50001,2,19680,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s046lbl.pdf","2017-10-10 00:00:00",
54068,1,19680,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54088,2,19680,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019680s047lbl.pdf","2018-05-10 00:00:00",
54089,8,19680,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019680s047lbl.pdf#page=39","2018-05-10 00:00:00",
19097,1,19681,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf","2004-05-27 00:00:00",
19098,1,19681,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf","2004-05-27 00:00:00",
1504,1,19681,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19681scs020ltr.pdf","2004-05-27 00:00:00",
1505,1,19682,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19682slr015,018ltr.pdf","2004-05-27 00:00:00",
1506,1,19682,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19682slr015,018ltr.pdf","2004-05-27 00:00:00",
1507,1,19682,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19682scs020ltr.pdf","2004-05-27 00:00:00",
1508,1,19683,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19683scs021ltr.pdf","2004-05-27 00:00:00",
1509,1,19683,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019683s027ltr.pdf","2005-10-11 00:00:00",
11635,2,19683,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019683s027lbl.pdf","2005-10-10 00:00:00",
20288,3,19684,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf","1997-01-08 00:00:00",
1510,1,19684,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019684s023ltr.pdf","2010-10-07 00:00:00",
33868,2,19684,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf","2010-10-04 00:00:00",
19099,1,19684,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019684s024ltr.pdf","2011-10-03 00:00:00",
33869,2,19684,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf","2011-09-30 00:00:00",
1511,1,19684,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019684Orig1s026ltr.pdf","2013-07-29 00:00:00",
33870,2,19684,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf","2013-07-30 00:00:00",
19100,1,19684,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019684Orig1s027ltr.pdf","2014-05-08 00:00:00",
33871,2,19684,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf","2014-05-12 00:00:00",
11636,2,19684,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf","2015-01-14 00:00:00",
19101,1,19684,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019684Orig1s029ltr.pdf","2015-01-12 00:00:00",
53108,20,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-MedRev.pdf","1900-01-01 00:00:00",
53109,18,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-ClinPharmRev.pdf","1900-01-01 00:00:00",
53110,17,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-StatRev.pdf","1900-01-01 00:00:00",
53111,23,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_11-12-02_HFD510_orig.pdf","1900-01-01 00:00:00",
53112,25,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_1-15-03_HFD510_amend.pdf","1900-01-01 00:00:00",
53113,26,19697,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_8-15-03_HFD510_amend2.pdf","1900-01-01 00:00:00",
40973,3,19697,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/01969_s002_Orthotricyclen.pdf","2009-01-12 00:00:00",
40974,3,19697,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019697_s004_ORTHOTRICYCLEN.pdf","2009-01-12 00:00:00",
20289,3,19697,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s005_ORTHOTRICYCLEN.pdf","2009-01-12 00:00:00",
40975,3,19697,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s009_ORTHOTRICYCLEN.pdf","2009-01-12 00:00:00",
40976,3,19697,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s010_ORTHOTRICYCLEN.pdf","2009-01-12 00:00:00",
40977,3,19697,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s011_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20290,3,19697,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s013_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
20291,3,19697,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s015_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40978,3,19697,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s016_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
40979,3,19697,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s018_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20292,3,19697,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s019_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
20293,3,19697,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s021_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
40980,3,19697,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s024_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20294,3,19697,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s025_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20295,3,19697,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s027_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
20296,3,19697,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s028_ORTHO CYCLEN.pdf","2009-01-12 00:00:00",
40981,3,19697,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s029_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
20297,3,19697,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s030_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
20298,3,19697,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019697_s032_ORTHOCYCLEN.pdf","2009-01-12 00:00:00",
1512,1,19697,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034ltr.pdf","2007-05-09 00:00:00",
33872,2,19697,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf","2007-05-07 00:00:00",
19102,1,19697,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041ltr.pdf","2008-06-03 00:00:00",
11637,2,19697,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046, 019697Orig1s042lbl.pdf","2013-11-20 00:00:00",
19103,1,19697,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
1513,1,19697,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
11638,2,19697,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf","2012-07-13 00:00:00",
1514,1,19697,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
19104,1,19697,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
33873,2,19697,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf","2013-10-04 00:00:00",
1515,1,19697,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
19105,1,19697,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf","2015-05-04 00:00:00",
33874,2,19697,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf","2015-05-04 00:00:00",
49318,2,19697,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019653s058,019697s054lbl.pdf","2017-08-10 00:00:00",
49418,1,19697,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019653Orig1s058,19697Orig1s054ltr.pdf","2017-08-15 00:00:00",
19106,1,19699,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19699s013ltr.pdf","2004-09-29 00:00:00",
33875,2,19699,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19699s013lbl.pdf","2004-09-29 00:00:00",
11639,2,19700,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf","2003-06-16 00:00:00",
19107,1,19700,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19700s019ltr.pdf","2002-02-08 00:00:00",
20299,3,19700,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019700_S019_ACULAR.pdf","2009-01-12 00:00:00",
33876,2,19700,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf","2002-02-08 00:00:00",
11640,2,19700,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf","2005-03-11 00:00:00",
19108,1,19700,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf","2005-03-11 00:00:00",
1516,1,19700,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf","2005-03-11 00:00:00",
33877,2,19700,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf","2005-03-11 00:00:00",
1517,1,19700,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019700s028ltr.pdf","2012-06-18 00:00:00",
11641,2,19700,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf","2012-06-18 00:00:00",
11642,2,19708,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf","2004-09-29 00:00:00",
19109,1,19708,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19708s013ltr.pdf","2004-09-29 00:00:00",
19110,1,19708,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016ltr.pdf","2005-09-08 00:00:00",
20300,3,19710,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019710a_so21_052397.pdf","1997-05-23 00:00:00",
19111,1,19710,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s032ltr.pdf","2008-04-28 00:00:00",
1518,1,19710,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s034ltr.pdf","2008-04-30 00:00:00",
45076,2,19710,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf","2016-08-17 00:00:00",
45131,1,19710,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf","2016-08-12 00:00:00",
1519,1,19710,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf","2015-07-10 00:00:00",
11643,2,19710,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf","2015-07-09 00:00:00",
48135,2,19710,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf","2017-04-27 00:00:00",
48211,1,19710,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s054,020923Orig1s019ltr.pdf","2017-05-02 00:00:00",
47877,2,19710,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s055lbl.pdf","2017-04-06 00:00:00",
47963,1,19710,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf","2017-04-12 00:00:00",
1520,1,19715,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715s18ltr.pdf","2002-01-18 00:00:00",
1521,1,19715,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715scs021ltr.pdf","2002-08-09 00:00:00",
1522,1,19715,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019715s025ltr.pdf","2007-07-16 00:00:00",
1523,1,19715,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019715s027ltr.pdf","2009-11-12 00:00:00",
33878,2,19715,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf","2009-08-13 00:00:00",
1524,1,19716,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf","2005-10-14 00:00:00",
33879,2,19716,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf","2005-10-14 00:00:00",
1525,1,19716,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf","2006-04-25 00:00:00",
11644,2,19716,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf","2006-08-28 00:00:00",
19112,1,19716,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf","2006-09-18 00:00:00",
11645,2,19716,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf","2014-08-15 00:00:00",
19113,1,19716,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf","2014-08-14 00:00:00",
53570,2,19716,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf","2018-04-01 00:00:00",
53587,1,19716,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf","2018-04-01 00:00:00",
19114,1,19717,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr030ltr.pdf","2002-11-01 00:00:00",
11646,2,19717,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf","2003-03-05 00:00:00",
19115,1,19717,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf","2004-06-07 00:00:00",
1526,1,19717,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-717S035.pdf","2002-02-05 00:00:00",
1527,1,19717,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr041ltr.pdf","2002-10-03 00:00:00",
11647,2,19717,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19717s41lbl.pdf","2002-10-03 00:00:00",
1528,1,19717,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr050ltr.pdf","2003-11-25 00:00:00",
11648,2,19717,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr050_humilin_lbl.pdf","2003-12-02 00:00:00",
11649,2,19717,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr052_humulin_lbl.pdf","2003-07-08 00:00:00",
19116,1,19717,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr052ltr.pdf","2003-07-06 00:00:00",
1529,1,19717,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717scm054ltr.pdf","2003-12-02 00:00:00",
33880,2,19717,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717scm054_humulin_lbl.pdf","2003-12-02 00:00:00",
19117,1,19717,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717slr058ltr.pdf","2004-04-29 00:00:00",
33881,2,19717,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717slr058_humulin_lbl.pdf","2004-05-04 00:00:00",
1530,1,19717,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717s060ltr.pdf","2004-11-16 00:00:00",
11650,2,19717,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717s060lbl.pdf","2004-11-16 00:00:00",
1531,1,19717,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
1532,1,19717,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf","2007-08-27 00:00:00",
11651,2,19717,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf","2007-08-23 00:00:00",
1533,1,19717,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf","2009-03-23 00:00:00",
1534,1,19717,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf","2010-06-15 00:00:00",
33882,2,19717,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019717s094lbl.pdf","2010-06-24 00:00:00",
1535,1,19717,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf","2013-11-13 00:00:00",
33883,2,19717,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf","2013-11-15 00:00:00",
1536,1,19717,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s099ltr.pdf","2013-03-12 00:00:00",
33884,2,19717,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf","2013-03-12 00:00:00",
1537,1,19717,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf","2013-11-13 00:00:00",
33885,2,19717,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf","2013-11-15 00:00:00",
19118,1,19717,"SUPPL",123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s123ltr.pdf","2013-12-13 00:00:00",
1538,1,19717,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019717Orig1s124ltr.pdf","2014-01-17 00:00:00",
1539,1,19717,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s133ltr.pdf","2015-02-27 00:00:00",
33886,2,19717,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf","2015-03-02 00:00:00",
19119,1,19717,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s135ltr.pdf","2015-03-13 00:00:00",
33887,2,19717,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s135lbl.pdf","2015-03-17 00:00:00",
46733,2,19717,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019717s146lbl.pdf","2017-01-06 00:00:00",
46787,1,19717,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019717Orig1s146ltr.pdf","2017-01-11 00:00:00",
1540,1,19722,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19722s004ltr.pdf","2002-06-14 00:00:00",
40982,3,19722,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019722_S004_NASCOBAL GEL.pdf","2007-07-24 00:00:00",
1541,1,19722,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19722slr006ltr.pdf","2004-06-09 00:00:00",
11652,2,19722,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf","2003-08-28 00:00:00",
23551,10,19726,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
20301,3,19726,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19726S018_Zoladex.cfm","1997-06-27 00:00:00",
20302,3,19726,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf","1998-04-09 00:00:00",
19120,1,19726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf","1998-07-27 00:00:00",
33888,2,19726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf","1998-07-27 00:00:00",
40983,3,19726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.cfm","1998-07-27 00:00:00",
19121,1,19726,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s34ltr.pdf","2002-02-05 00:00:00",
40984,3,19726,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf","2002-02-05 00:00:00",
19122,1,19726,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf","2002-02-28 00:00:00",
19123,1,19726,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf","2004-06-25 00:00:00",
1542,1,19726,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf","2005-10-25 00:00:00",
1543,1,19726,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf","2010-01-07 00:00:00",
11653,2,19726,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf","2009-09-17 00:00:00",
1544,1,19726,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf","2010-01-07 00:00:00",
11654,2,19726,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf","2009-09-17 00:00:00",
19124,1,19726,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf","2010-01-07 00:00:00",
33889,2,19726,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf","2009-09-17 00:00:00",
1545,1,19726,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf","2011-01-20 00:00:00",
11655,2,19726,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf","2011-01-20 00:00:00",
11656,2,19726,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf","2013-06-17 00:00:00",
19125,1,19726,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf","2013-06-20 00:00:00",
1546,1,19726,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf","2013-06-20 00:00:00",
33890,2,19726,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf","2013-06-17 00:00:00",
1547,1,19726,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf","2014-10-09 00:00:00",
33891,2,19726,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf","2014-10-09 00:00:00",
1548,1,19726,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf","2015-02-17 00:00:00",
11657,2,19726,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf","2015-02-13 00:00:00",
40985,3,19729,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19729_Cyclocort.pdf","2001-05-25 00:00:00",
23552,10,19732,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
20303,3,19732,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S007_Lupron Depot_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
20304,3,19732,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S009_Lupron Depot_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
1549,1,19732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_APPROV.PDF","2003-05-30 00:00:00",
11658,2,19732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_PRNTLBL.PDF","2003-05-30 00:00:00",
20305,3,19732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019732s012_lupron.cfm","2003-05-30 00:00:00",
20306,3,19732,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019732_S016_Lupron Depot_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
19126,1,19732,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf","2003-09-25 00:00:00",
19127,1,19732,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf","2004-01-14 00:00:00",
1550,1,19732,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
40986,3,19732,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S027_Lupron Depot_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
19128,1,19732,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
40987,3,19732,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S029_Lupron Depot_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
11659,2,19732,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
19129,1,19732,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
1551,1,19732,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
33892,2,19732,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
11660,2,19732,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
19130,1,19732,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
1552,1,19732,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf","2011-01-20 00:00:00",
11661,2,19732,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf","2011-01-20 00:00:00",
11662,2,19732,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf","2012-02-22 00:00:00",
19131,1,19732,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019732s038ltr.pdf","2012-02-23 00:00:00",
1553,1,19732,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf","2013-07-12 00:00:00",
33893,2,19732,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf","2013-07-11 00:00:00",
1554,1,19732,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf","2014-07-01 00:00:00",
11663,2,19732,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf","2014-07-01 00:00:00",
1555,1,19732,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf","2016-06-08 00:00:00",
11664,2,19732,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf","2016-06-13 00:00:00",
19132,1,19734,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019734s009ltr.pdf","2007-07-05 00:00:00",
1556,1,19734,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s013ltr.pdf","2008-08-05 00:00:00",
1557,1,19734,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s014ltr.pdf","2008-11-13 00:00:00",
19133,1,19734,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019734s015ltr.pdf","2010-01-15 00:00:00",
33894,2,19734,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf","2010-01-20 00:00:00",
1558,1,19734,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019734s017ltr.pdf","2011-02-09 00:00:00",
33895,2,19734,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf","2011-02-07 00:00:00",
1559,1,19734,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019734Orig1s023ltr.pdf","2014-07-24 00:00:00",
11665,2,19734,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf","2014-07-24 00:00:00",
45068,1,19734,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019734Orig1s027ltr.pdf","2016-08-26 00:00:00",
45172,2,19734,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf","2016-08-26 00:00:00",
55048,1,19734,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019734Orig1s030Ltr.pdf","2018-07-30 00:00:00",
40988,3,19735,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s001_FloxinTOC.cfm","2006-05-10 00:00:00",
20307,3,19735,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s004_FloxinTOC.cfm","2006-05-10 00:00:00",
20308,3,19735,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s007_FloxinTOC.cfm","2006-05-10 00:00:00",
20309,3,19735,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s008_FloxinTOC.cfm","2006-05-10 00:00:00",
40989,3,19735,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s016_FloxinTOC.cfm","2006-05-10 00:00:00",
20310,3,19735,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S018_Floxin.pdf","2008-04-04 00:00:00",
40990,3,19735,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S019_Floxin.pdf","2008-04-04 00:00:00",
20311,3,19735,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S022_FLOXIN.pdf","2008-04-04 00:00:00",
40991,3,19735,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S023_FLOXIN.pdf","2008-04-04 00:00:00",
19134,1,19735,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735slr051ltr.pdf","2004-03-10 00:00:00",
33896,2,19735,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735slr051_floxin_lbl.pdf","2004-04-05 00:00:00",
19135,1,19735,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf","2004-09-17 00:00:00",
20312,3,19735,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S052_Floxin.pdf","2009-09-16 00:00:00",
33897,2,19735,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf","2004-09-17 00:00:00",
19136,1,19735,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf","2004-09-17 00:00:00",
33898,2,19735,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf","2004-09-17 00:00:00",
40992,3,19735,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S053_floxin.pdf","2009-09-16 00:00:00",
11666,2,19735,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf","2006-01-27 00:00:00",
19137,1,19735,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s054ltr.pdf","2006-01-30 00:00:00",
1560,1,19735,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s055LTR.pdf","2006-06-20 00:00:00",
33899,2,19735,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s055lbl.pdf","2006-06-20 00:00:00",
1561,1,19735,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s056ltr.pdf","2007-05-29 00:00:00",
11667,2,19735,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf","2007-05-29 00:00:00",
19138,1,19735,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s057ltr.pdf","2007-07-05 00:00:00",
33900,2,19735,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s057lbl.pdf","2007-06-27 00:00:00",
1562,1,19735,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s058ltr..pdf","2008-01-09 00:00:00",
33901,2,19735,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s058lbl.pdf","2007-12-14 00:00:00",
1563,1,19735,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019735s059ltr.pdf","2008-10-07 00:00:00",
33902,2,19735,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019735s059lbl.pdf","2008-10-09 00:00:00",
1564,1,19735,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019735s060ltr.pdf","2009-02-13 00:00:00",
1565,1,19735,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019735s061ltr.pdf","2011-03-03 00:00:00",
33903,2,19735,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061lbl.pdf","2011-03-04 00:00:00",
43624,8,19735,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf","2011-03-04 00:00:00",
19139,1,19737,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19737s007ltr.pdf","2002-06-03 00:00:00",
11668,2,19757,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf","2003-06-16 00:00:00",
23553,10,19758,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
44445,14,19758,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
20313,3,19758,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019758_S035_CLOZARIL_TABS.pdf","2008-02-19 00:00:00",
11669,2,19758,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf","2003-06-16 00:00:00",
19140,1,19758,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s45ltr.pdf","2002-01-14 00:00:00",
33904,2,19758,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf","2002-01-14 00:00:00",
1566,1,19758,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758se1-047ltr.pdf","2004-06-01 00:00:00",
20314,3,19758,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019758Orig1s047.pdf","2012-03-14 00:00:00",
33905,2,19758,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-047_Clozaril_lbl.pdf","2003-04-04 00:00:00",
19141,1,19758,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s048ltr.pdf","2002-07-05 00:00:00",
1567,1,19758,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19758slr051ltr.pdf","2003-12-24 00:00:00",
19142,1,19758,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s053ltr.pdf","2008-11-06 00:00:00",
1568,1,19758,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s054ltr.pdf","2005-05-17 00:00:00",
11670,2,19758,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf","2005-05-17 00:00:00",
1569,1,19758,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s056ltr.pdf","2005-06-29 00:00:00",
11671,2,19758,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf","2005-06-29 00:00:00",
19143,1,19758,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s057ltr.pdf","2005-12-13 00:00:00",
19144,1,19758,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s058ltr.pdf","2008-07-01 00:00:00",
1570,1,19758,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s059ltr.pdf","2008-08-19 00:00:00",
11672,2,19758,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf","2015-09-16 00:00:00",
19145,1,19758,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf","2015-09-16 00:00:00",
11673,2,19758,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf","2010-01-20 00:00:00",
19146,1,19758,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s062ltr.pdf","2010-01-26 00:00:00",
11674,2,19758,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf","2011-10-25 00:00:00",
19147,1,19758,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019758s063ltr.pdf","2011-10-24 00:00:00",
19148,1,19758,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s065ltr.pdf","2010-12-06 00:00:00",
33906,2,19758,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf","2010-12-04 00:00:00",
19149,1,19758,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf","2013-03-25 00:00:00",
33907,2,19758,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf","2013-03-26 00:00:00",
1571,1,19758,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf","2013-03-25 00:00:00",
11675,2,19758,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf","2013-03-26 00:00:00",
19150,1,19758,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s069ltr.pdf","2013-07-22 00:00:00",
33908,2,19758,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf","2013-07-23 00:00:00",
19151,1,19758,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf","2013-03-25 00:00:00",
33909,2,19758,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf","2013-03-26 00:00:00",
33910,2,19758,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf","2013-07-23 00:00:00",
1572,1,19758,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s072ltr.pdf","2014-10-01 00:00:00",
33911,2,19758,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf","2014-09-30 00:00:00",
1573,1,19758,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s073ltr.pdf","2014-12-23 00:00:00",
11676,2,19758,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf","2015-01-09 00:00:00",
1574,1,19758,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s074ltr.pdf","2015-09-22 00:00:00",
33912,2,19758,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf","2015-09-23 00:00:00",
11677,2,19758,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf","2015-09-16 00:00:00",
19152,1,19758,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf","2015-09-16 00:00:00",
19153,1,19758,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s078ltr.pdf","2015-10-13 00:00:00",
33913,2,19758,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf","2015-10-22 00:00:00",
46486,1,19758,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019758Orig1s80ltr.pdf","2016-12-22 00:00:00",
46496,2,19758,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019758s080lbl.pdf","2016-12-21 00:00:00",
46997,2,19758,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s081lbl.pdf","2017-01-26 00:00:00",
47017,1,19758,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019758Orig1s081ltr.pdf","2017-01-30 00:00:00",
47351,2,19758,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf","2017-02-27 00:00:00",
47390,1,19758,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019758Orig1s084ltr.pdf","2017-03-02 00:00:00",
1575,1,19759,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf","2016-06-14 00:00:00",
46012,2,19759,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019759s047lbl.pdf","2016-12-05 00:00:00",
46053,1,19759,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019759Orig1s047ltr.pdf","2016-12-06 00:00:00",
19154,1,19763,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019763s016ltr.pdf","2011-03-25 00:00:00",
33914,2,19763,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019763s016lbl.pdf","2011-03-28 00:00:00",
19155,1,19763,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019763s017ltr.pdf","2012-03-05 00:00:00",
33915,2,19763,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019763s017lbl.pdf","2012-03-06 00:00:00",
1576,1,19763,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019763Orig1s019ltr.pdf","2014-09-02 00:00:00",
33916,2,19763,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019763s019lbl.pdf","2014-09-03 00:00:00",
55079,2,19763,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019763s020lbl.pdf","2018-08-02 00:00:00",
55092,1,19763,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019763Orig1s020ltr.pdf","2018-08-03 00:00:00",
20315,3,19764,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019764_s011_SAIZEN INJECTION.pdf","2009-01-12 00:00:00",
11678,2,19764,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf","2004-11-15 00:00:00",
19156,1,19764,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764s020ltr.pdf","2004-11-15 00:00:00",
1577,1,19764,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19764slr023ltr.pdf","2003-07-08 00:00:00",
33917,2,19764,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf","2003-07-08 00:00:00",
1578,1,19764,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf","2004-07-14 00:00:00",
33918,2,19764,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf","2004-07-14 00:00:00",
11679,2,19764,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf","2007-01-18 00:00:00",
19157,1,19764,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s030ltr.pdf","2007-01-25 00:00:00",
11680,2,19764,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf","2007-03-07 00:00:00",
19158,1,19764,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s034ltr.pdf","2007-03-15 00:00:00",
11681,2,19764,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf","2007-11-07 00:00:00",
19159,1,19764,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s035ltr.pdf","2007-11-08 00:00:00",
19160,1,19764,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s037ltr.pdf","2007-08-27 00:00:00",
33919,2,19764,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf","2007-08-23 00:00:00",
1579,1,19764,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s039ltr.pdf","2007-08-30 00:00:00",
11682,2,19764,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf","2007-08-30 00:00:00",
19161,1,19764,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf","2012-04-05 00:00:00",
33920,2,19764,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf","2012-04-06 00:00:00",
1580,1,19764,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019764Orig1s072ltr.pdf","2014-06-18 00:00:00",
33921,2,19764,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf","2014-06-17 00:00:00",
46883,2,19764,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s079lbl.pdf","2017-01-17 00:00:00",
47288,2,19764,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s079lbl.pdf","2017-02-22 00:00:00",
46152,1,19764,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019764Orig1s083ltr.pdf","2016-12-14 00:00:00",
46188,2,19764,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s083lbl.pdf","2016-12-14 00:00:00",
48320,2,19764,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf","2017-05-09 00:00:00",
48339,1,19764,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019764Orig1s086ltr.pdf","2017-05-10 00:00:00",
44036,10,19766,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2008-01-25 00:00:00",
44446,14,19766,"ORIG",1,"Patent Request","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_Zocor_Patent_Request.pdf","2007-07-09 00:00:00",
20316,3,19766,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s008_ZOCOR_TABLETS.pdf","2008-04-04 00:00:00",
20317,3,19766,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s012_ZOCOR_TABLETS.pdf","2008-04-04 00:00:00",
40993,3,19766,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s014_ZOCOR_TABLETS.pdf","2008-04-04 00:00:00",
20318,3,19766,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_S016_ZOCOR_TABLETS.pdf","2008-02-19 00:00:00",
40994,3,19766,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766a_s018.pdf","1997-05-19 00:00:00",
20319,3,19766,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S022_ZOCOR_TABLETS.pdf","2008-02-19 00:00:00",
20320,3,19766,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S023_ZOCOR_TABLETS.pdf","2008-02-19 00:00:00",
20321,3,19766,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S025_ZOCOR_TABLETS.pdf","2008-02-19 00:00:00",
19162,1,19766,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf","1998-07-10 00:00:00",
40995,3,19766,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm","1998-07-10 00:00:00",
19163,1,19766,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf","1998-03-31 00:00:00",
20322,3,19766,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766s027_Zocor.cfm","1998-03-31 00:00:00",
19164,1,19766,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf","1998-07-10 00:00:00",
20323,3,19766,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm","1998-07-10 00:00:00",
20324,3,19766,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766a_s029.pdf","1998-06-29 00:00:00",
40996,3,19766,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766_S030_ZOCOR_TABLETS.pdf","2008-02-19 00:00:00",
20325,3,19766,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s031_ZOCOR_TABLETS.pdf","2008-04-04 00:00:00",
19165,1,19766,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf","1999-08-05 00:00:00",
20326,3,19766,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_S033_ZOCOR_TABLET.pdf","2008-02-19 00:00:00",
40997,3,19766,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf","1999-11-22 00:00:00",
20327,3,19766,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s035_ZOCOR TABLETS.pdf","2008-04-04 00:00:00",
20328,3,19766,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf","1999-11-22 00:00:00",
19166,1,19766,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF","2000-04-27 00:00:00",
20329,3,19766,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor.cfm","2000-04-27 00:00:00",
33922,2,19766,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf","2000-04-27 00:00:00",
40998,3,19766,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_s041_ZOCOR_TABLETS.pdf","2008-08-04 00:00:00",
20330,3,19766,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S043_ZOCOR_TABLETS.pdf","2007-11-19 00:00:00",
20331,3,19766,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S044_ZOCOR_TABLET.pdf","2007-11-19 00:00:00",
40999,3,19766,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S045_ZOCOR.pdf","2008-02-19 00:00:00",
41000,3,19766,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S047_ZOCOR.pdf","2008-02-19 00:00:00",
41001,3,19766,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S048_ZOCOR.pdf","2008-02-19 00:00:00",
41002,3,19766,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S049_ZOCOR.pdf","2008-02-19 00:00:00",
41003,3,19766,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S050_ZOCOR.pdf","2008-02-19 00:00:00",
19167,1,19766,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf","2002-05-06 00:00:00",
33923,2,19766,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf","2002-05-06 00:00:00",
19168,1,19766,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf","2002-03-21 00:00:00",
20332,3,19766,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-766s052_Zocor.cfm","2002-03-21 00:00:00",
33924,2,19766,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf","2002-03-21 00:00:00",
11683,2,19766,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf","2003-06-16 00:00:00",
41004,3,19766,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S053_ZOCOR.pdf","2008-02-19 00:00:00",
20333,3,19766,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S054_ZOCOR.pdf","2008-02-19 00:00:00",
20334,3,19766,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S055_ZOCOR.pdf","2008-02-19 00:00:00",
19169,1,19766,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-056ltr.pdf","2002-10-18 00:00:00",
33925,2,19766,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf","2002-10-18 00:00:00",
11684,2,19766,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf","2003-04-17 00:00:00",
19170,1,19766,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-058ltr.pdf","2003-05-29 00:00:00",
41005,3,19766,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019766_S058_ZOCOR_TABS_AP.pdf","2007-04-09 00:00:00",
11685,2,19766,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf","2003-09-25 00:00:00",
19171,1,19766,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf","2003-09-29 00:00:00",
1581,1,19766,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf","2003-09-29 00:00:00",
11686,2,19766,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf","2003-09-25 00:00:00",
11687,2,19766,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf","2004-04-05 00:00:00",
19172,1,19766,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf","2004-02-25 00:00:00",
41006,3,19766,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf","2007-07-06 00:00:00",
11688,2,19766,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf","2004-04-05 00:00:00",
19173,1,19766,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf","2004-02-25 00:00:00",
20335,3,19766,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf","2007-07-06 00:00:00",
1582,1,19766,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf","2005-09-08 00:00:00",
11689,2,19766,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf","2005-09-08 00:00:00",
19174,1,19766,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf","2005-05-20 00:00:00",
33926,2,19766,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf","2005-05-20 00:00:00",
1583,1,19766,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf","2007-06-04 00:00:00",
33927,2,19766,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf","2007-06-04 00:00:00",
11690,2,19766,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf","2007-12-03 00:00:00",
19175,1,19766,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf","2007-12-03 00:00:00",
11691,2,19766,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf","2008-06-19 00:00:00",
19176,1,19766,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf","2008-06-13 00:00:00",
19177,1,19766,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf","2011-06-08 00:00:00",
33928,2,19766,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf","2011-06-08 00:00:00",
41007,3,19766,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766s077.pdf","2011-08-15 00:00:00",
1584,1,19766,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf","2010-03-08 00:00:00",
11692,2,19766,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf","2010-03-02 00:00:00",
19178,1,19766,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
11693,2,19766,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf","2010-04-19 00:00:00",
19179,1,19766,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf","2010-04-13 00:00:00",
1585,1,19766,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf","2010-11-08 00:00:00",
33929,2,19766,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf","2010-11-04 00:00:00",
19180,1,19766,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf","2011-06-08 00:00:00",
33930,2,19766,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf","2011-06-08 00:00:00",
1586,1,19766,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf","2011-10-12 00:00:00",
33931,2,19766,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf","2011-10-12 00:00:00",
41008,3,19766,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf","2012-06-06 00:00:00",
11694,2,19766,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf","2012-03-01 00:00:00",
19181,1,19766,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf","2012-02-29 00:00:00",
19182,1,19766,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf","2012-11-05 00:00:00",
33932,2,19766,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf","2012-11-02 00:00:00",
1587,1,19766,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf","2012-11-05 00:00:00",
11695,2,19766,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf","2012-11-02 00:00:00",
1588,1,19766,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf","2013-10-28 00:00:00",
11696,2,19766,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf","2013-10-31 00:00:00",
1589,1,19766,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf","2014-02-28 00:00:00",
11697,2,19766,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf","2014-03-04 00:00:00",
1590,1,19766,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf","2015-02-03 00:00:00",
11698,2,19766,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf","2015-02-03 00:00:00",
52775,2,19766,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf","2018-03-01 00:00:00",
52778,1,19766,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019766Orig1s098ltr.pdf","2018-03-01 00:00:00",
33933,2,19771,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf","2003-06-10 00:00:00",
1591,1,19771,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19771slr022ltr.pdf","2003-10-22 00:00:00",
19183,1,19771,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s026ltr.pdf","2006-04-20 00:00:00",
1592,1,19771,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s028ltr.pdf","2006-03-01 00:00:00",
19184,1,19771,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019771s031ltr.pdf","2008-06-23 00:00:00",
1593,1,19771,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019771s032ltr.pdf","2009-05-26 00:00:00",
19185,1,19771,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019771s036ltr.pdf","2010-09-07 00:00:00",
47665,1,19771,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019771Orig1s040ltr.pdf","2017-03-24 00:00:00",
47701,2,19771,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019771Orig1s040lbl.pdf","2017-03-24 00:00:00",
11699,2,19774,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19774s009lbl.pdf","2005-03-18 00:00:00",
19186,1,19774,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19774s009ltr.pdf","2005-03-18 00:00:00",
41009,3,19774,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019774_s009_TEV TROPIN.pdf","2008-07-30 00:00:00",
1594,1,19774,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019774s014ltr.pdf","2007-02-23 00:00:00",
33934,2,19774,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019774s014lbl.pdf","2007-02-21 00:00:00",
1595,1,19774,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019774s016ltr.pdf","2009-06-30 00:00:00",
11700,2,19774,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019774s019lbl.pdf","2010-04-13 00:00:00",
19187,1,19774,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019774s019ltr.pdf","2010-04-15 00:00:00",
19188,1,19774,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019774s023ltr.pdf","2011-07-21 00:00:00",
33935,2,19774,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019774s023lbl.pdf","2011-07-20 00:00:00",
19189,1,19774,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s026ltr.pdf","2015-03-06 00:00:00",
33936,2,19774,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s026lbl.pdf","2015-03-05 00:00:00",
1596,1,19774,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s027ltr.pdf","2014-06-19 00:00:00",
33937,2,19774,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s027lbl.pdf","2014-06-23 00:00:00",
19190,1,19774,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s028ltr.pdf","2014-10-30 00:00:00",
33938,2,19774,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s028lbl.pdf","2014-11-04 00:00:00",
52268,2,19774,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf","2018-02-02 00:00:00",
52274,1,19774,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf","2018-02-02 00:00:00",
11701,2,19774,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s031lbl.pdf","2015-06-15 00:00:00",
19191,1,19774,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s031ltr.pdf","2015-06-15 00:00:00",
45471,1,19774,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019774Orig1s036ltr.pdf","2016-10-04 00:00:00",
45584,2,19774,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s036lbl.pdf","2016-10-06 00:00:00",
46805,2,19774,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019774s037lbl.pdf","2017-01-11 00:00:00",
46857,1,19774,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019774Orig1s037ltr.pdf","2017-01-17 00:00:00",
46153,1,19774,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019774Orig1s038ltr.pdf","2016-12-14 00:00:00",
46186,2,19774,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s038lbl.pdf","2016-12-14 00:00:00",
52269,2,19774,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf","2018-02-02 00:00:00",
52275,1,19774,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf","2018-02-02 00:00:00",
52270,2,19774,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf","2018-02-02 00:00:00",
52276,1,19774,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf","2018-02-02 00:00:00",
52271,2,19774,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf","2018-02-02 00:00:00",
52277,1,19774,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf","2018-02-02 00:00:00",
54922,2,19774,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf","2018-07-20 00:00:00",
54934,1,19774,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf","2018-07-20 00:00:00",
54923,2,19774,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf","2018-07-20 00:00:00",
54935,1,19774,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf","2018-07-20 00:00:00",
54924,2,19774,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf","2018-07-20 00:00:00",
54936,1,19774,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf","2018-07-20 00:00:00",
54925,2,19774,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf","2018-07-20 00:00:00",
54937,1,19774,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf","2018-07-20 00:00:00",
23554,10,19777,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
41010,3,19777,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S1_Zestril.pdf","2001-09-18 00:00:00",
20336,3,19777,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S2_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41011,3,19777,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S3_Zestril.pdf","2001-09-18 00:00:00",
20337,3,19777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S4_Zestril.pdf","2001-09-18 00:00:00",
20338,3,19777,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S6_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
20339,3,19777,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S8_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41012,3,19777,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S9_Zestril.pdf","2001-09-18 00:00:00",
41013,3,19777,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S11_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41014,3,19777,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S12_Zestril_toc.cfm","2003-08-05 00:00:00",
20340,3,19777,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S13_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41015,3,19777,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S15_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41016,3,19777,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S17_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
20341,3,19777,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf","2001-09-18 00:00:00",
20342,3,19777,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S24_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
41017,3,19777,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S26_ZestrilTablets_toc.cfm","2003-08-05 00:00:00",
20343,3,19777,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S27_ZestrilTablets_toc.cfm","2003-08-08 00:00:00",
41018,3,19777,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S30_ZestrilTablets_toc.cfm","2003-08-08 00:00:00",
41019,3,19777,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S31_ZestrilTablets_toc.cfm","2003-08-08 00:00:00",
20344,3,19777,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019777ap.pdf","1997-01-08 00:00:00",
41020,3,19777,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s033_zestril.pdf","1998-05-01 00:00:00",
20345,3,19777,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s034_zestril.pdf","1998-11-06 00:00:00",
41021,3,19777,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19777-s035_Zestril.pdf","1999-01-20 00:00:00",
1597,1,19777,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19777S37LTR.PDF","2000-02-07 00:00:00",
20346,3,19777,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19777s037.pdf","2005-12-16 00:00:00",
19192,1,19777,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf","2003-07-06 00:00:00",
20347,3,19777,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm","2004-09-08 00:00:00",
33939,2,19777,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf","2003-07-08 00:00:00",
19193,1,19777,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19777slr043ltr.pdf","2004-04-07 00:00:00",
19194,1,19777,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf","2003-07-06 00:00:00",
20348,3,19777,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm","2004-09-08 00:00:00",
33940,2,19777,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf","2004-01-02 00:00:00",
1598,1,19777,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019777s049ltr.pdf","2005-05-25 00:00:00",
19195,1,19777,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf","2006-06-20 00:00:00",
1599,1,19777,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf","2007-07-24 00:00:00",
1600,1,19777,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf","2007-10-10 00:00:00",
1601,1,19777,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s054ltr.pdf","2009-05-26 00:00:00",
11702,2,19777,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf","2009-05-25 00:00:00",
11703,2,19777,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf","2009-11-19 00:00:00",
19196,1,19777,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s056ltr.pdf","2010-01-07 00:00:00",
1602,1,19777,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s057ltr.pdf","2014-06-27 00:00:00",
33941,2,19777,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s057lbl.pdf","2014-06-30 00:00:00",
1603,1,19777,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019777s058ltr.pdf","2011-08-09 00:00:00",
33942,2,19777,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019777s058lbl.pdf","2011-08-12 00:00:00",
1604,1,19777,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s059ltr.pdf","2012-05-04 00:00:00",
11704,2,19777,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf","2012-05-07 00:00:00",
11705,2,19777,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf","2012-03-29 00:00:00",
19197,1,19777,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s060ltr.pdf","2012-04-02 00:00:00",
11706,2,19777,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf","2012-11-02 00:00:00",
19198,1,19777,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s061ltr.pdf","2012-11-05 00:00:00",
1605,1,19777,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s062ltr.pdf","2012-08-16 00:00:00",
33943,2,19777,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s062lbl.pdf","2012-08-15 00:00:00",
11707,2,19777,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf","2013-11-21 00:00:00",
19199,1,19777,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019777Orig1s063ltr.pdf","2013-11-07 00:00:00",
11708,2,19777,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf","2015-01-09 00:00:00",
19200,1,19777,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s064ltr.pdf","2014-12-30 00:00:00",
11709,2,19777,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf","2015-08-26 00:00:00",
19201,1,19777,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019777Orig1s073ltr.pdf","2015-08-27 00:00:00",
1606,1,19777,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019777Orig1s074ltr.pdf","2016-04-22 00:00:00",
33944,2,19777,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019777s074lbl.pdf","2016-04-29 00:00:00",
49046,2,19777,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019777s076lbl.pdf","2017-07-25 00:00:00",
49069,1,19777,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019777Orig1s076ltr.pdf","2017-07-25 00:00:00",
19202,1,19778,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_appltrs.pdf","1998-10-28 00:00:00",
20349,3,19778,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028.cfm","1998-10-28 00:00:00",
33945,2,19778,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_prntlbl.pdf","1998-10-28 00:00:00",
41022,3,19778,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
19203,1,19778,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778slr032ltr.pdf","2002-11-08 00:00:00",
1607,1,19778,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778s034ltr.pdf","2002-07-02 00:00:00",
41023,3,19778,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19778-S-034_Prinzide_review.pdf","2004-04-21 00:00:00",
19204,1,19778,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf","2004-03-03 00:00:00",
1608,1,19778,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019778s036ltr.pdf","2005-10-11 00:00:00",
19205,1,19778,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf","2006-06-20 00:00:00",
19206,1,19778,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf","2006-10-23 00:00:00",
1609,1,19778,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf","2007-02-12 00:00:00",
1610,1,19778,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf","2008-10-14 00:00:00",
1611,1,19778,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf","2008-10-14 00:00:00",
19207,1,19778,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
11710,2,19778,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf","2011-02-11 00:00:00",
19208,1,19778,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf","2011-11-21 00:00:00",
33946,2,19778,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778Orig1s046_REPLACEMENT.pdf","2011-11-21 00:00:00",
19209,1,19778,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019778s047ltr.pdf","2011-08-31 00:00:00",
33947,2,19778,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s047lbl.pdf","2011-08-30 00:00:00",
19210,1,19778,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf","2012-06-08 00:00:00",
33948,2,19778,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019778s048lbl.pdf","2012-06-11 00:00:00",
11711,2,19778,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf","2013-03-01 00:00:00",
19211,1,19778,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019778Orig1s049ltr.pdf","2013-02-28 00:00:00",
11712,2,19779,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf","2002-03-22 00:00:00",
19212,1,19779,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19779s14ltr.pdf","2002-03-22 00:00:00",
1612,1,19779,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19779SLR015ltr.pdf","2003-06-08 00:00:00",
19213,1,19779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19779s018,019ltr.pdf","2004-12-30 00:00:00",
33949,2,19779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf","2004-12-30 00:00:00",
1613,1,19779,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19779s018,019ltr.pdf","2004-12-30 00:00:00",
11713,2,19779,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf","2004-12-30 00:00:00",
47891,2,19779,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019779s023lbl.pdf","2017-04-07 00:00:00",
47974,1,19779,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019779Orig1s023ltr.pdf","2017-04-12 00:00:00",
52792,2,19779,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019779s025lbl.pdf","2018-03-02 00:00:00",
52811,1,19779,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019779Orig1s025ltr.pdf","2018-03-05 00:00:00",
1614,1,19781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19781ltr.pdf","1998-05-14 00:00:00",
11714,2,19781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf","1998-05-14 00:00:00",
20350,3,19781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19781.cfm","1998-05-14 00:00:00",
19214,1,19781,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf","2004-03-10 00:00:00",
1615,1,19781,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf","2009-07-07 00:00:00",
33950,2,19781,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf","2009-07-06 00:00:00",
11715,2,19781,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf","2011-11-04 00:00:00",
19215,1,19781,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf","2011-11-03 00:00:00",
11716,2,19785,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf","2008-06-18 00:00:00",
19216,1,19785,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf","2008-06-18 00:00:00",
44633,21,19785,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/019785se5-018_SumR.pdf","2008-07-17 00:00:00",
52356,23,19785,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019785s000_technetiumTc99m_Cardiolite(amended)_7-27-07_160_WR.pdf","2008-01-11 00:00:00",
52888,18,19785,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019785s018_Technetium_Clinpharm_BPCA.pdf","2008-01-11 00:00:00",
52889,17,19785,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019785s018_Technetium_Statistical_BPCA.pdf","2008-01-11 00:00:00",
20351,3,19787,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S2_Norvasc Tablets_toc.cfm","2003-08-05 00:00:00",
41024,3,19787,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S3_Norvasc_toc.cfm","2003-08-05 00:00:00",
20352,3,19787,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S4_Norvasc Tablets_toc.cfm","2003-08-05 00:00:00",
41025,3,19787,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S5_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
41026,3,19787,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S6_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
41027,3,19787,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-787s007_Amlodipine.cfm","2002-04-30 00:00:00",
41028,3,19787,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S8_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
20353,3,19787,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S9_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
41029,3,19787,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S10_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
20354,3,19787,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S11_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
41030,3,19787,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S12_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
20355,3,19787,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf","1997-01-08 00:00:00",
41031,3,19787,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S14_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
20356,3,19787,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S15_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
41032,3,19787,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019787-S16_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
1616,1,19787,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF","2000-07-12 00:00:00",
20357,3,19787,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf","2000-07-12 00:00:00",
41033,3,19787,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787-s018_Norvasc.pdf","1999-06-04 00:00:00",
1617,1,19787,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787S019_NORVASC_APPROV.PDF","2004-06-10 00:00:00",
20358,3,19787,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019787-S19_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm","2003-08-05 00:00:00",
1618,1,19787,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF","2000-07-12 00:00:00",
41034,3,19787,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf","2000-07-12 00:00:00",
20359,3,19787,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787s021_norvasc.pdf","2000-02-01 00:00:00",
20360,3,19787,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787s022_Norvasc.pdf","1999-12-15 00:00:00",
19217,1,19787,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr027ltr.pdf","2003-12-08 00:00:00",
1619,1,19787,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19787se5-030ltr.pdf","2004-01-09 00:00:00",
41035,3,19787,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019787_S30_NorvascTOC.cfm","2007-03-02 00:00:00",
1620,1,19787,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr031ltr.pdf","2003-08-28 00:00:00",
19218,1,19787,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19787s032ltr.pdf","2002-05-28 00:00:00",
1621,1,19787,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s037ltr.pdf","2005-07-15 00:00:00",
33951,2,19787,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s037lbl.pdf","2005-07-15 00:00:00",
19219,1,19787,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s038ltr.pdf","2005-10-20 00:00:00",
33952,2,19787,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf","2005-09-30 00:00:00",
1622,1,19787,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019787s042ltr.pdf","2007-11-08 00:00:00",
11717,2,19787,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf","2007-11-07 00:00:00",
19220,1,19787,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019787s045ltr.pdf","2010-02-22 00:00:00",
33953,2,19787,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019787s045lbl.pdf","2010-02-23 00:00:00",
1623,1,19787,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s047ltr.pdf","2011-05-11 00:00:00",
33954,2,19787,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf","2011-05-09 00:00:00",
11718,2,19787,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf","2011-10-31 00:00:00",
19221,1,19787,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s052ltr.pdf","2011-11-02 00:00:00",
11719,2,19787,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf","2013-01-07 00:00:00",
19222,1,19787,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf","2013-01-08 00:00:00",
11720,2,19787,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf","2013-01-07 00:00:00",
19223,1,19787,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf","2013-01-08 00:00:00",
11721,2,19787,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf","2015-04-09 00:00:00",
19224,1,19787,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019787Orig1s059ltr.pdf","2015-03-25 00:00:00",
47800,2,19787,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s061lbl.pdf","2017-03-31 00:00:00",
47825,1,19787,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019787Orig1s061ltr.pdf","2017-04-03 00:00:00",
50296,1,19787,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019787Orig1s062ltr.pdf","2017-11-06 00:00:00",
50438,2,19787,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s062lbl.pdf","2017-11-17 00:00:00",
19225,1,19790,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019790Orig1s011ltr.pdf","2014-10-27 00:00:00",
33955,2,19790,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf","2014-11-18 00:00:00",
23555,10,19794,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2011-12-20 00:00:00",
1624,1,19796,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf","2002-07-17 00:00:00",
33956,2,19796,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf","2002-07-17 00:00:00",
11722,2,19796,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf","2002-07-17 00:00:00",
19226,1,19796,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf","2002-07-17 00:00:00",
1625,1,19796,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019796s020ltr.pdf","2005-09-15 00:00:00",
33957,2,19796,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf","2005-09-15 00:00:00",
1626,1,19796,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019796Orig1s026ltr.pdf","2013-04-01 00:00:00",
11723,2,19796,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf","2013-04-01 00:00:00",
54307,2,19796,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019796s029lbl.pdf","2018-05-22 00:00:00",
54322,1,19796,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf","2018-05-24 00:00:00",
43625,8,19797,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf","2013-10-03 00:00:00",
1627,1,19797,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19797scf013ltr.pdf","2004-06-18 00:00:00",
11724,2,19797,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf","2013-09-23 00:00:00",
19227,1,19797,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019797Orig1s022ltr.pdf","2013-09-24 00:00:00",
1628,1,19805,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf","2012-01-03 00:00:00",
11725,2,19805,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf","2011-12-23 00:00:00",
19228,1,19805,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf","2014-03-18 00:00:00",
33958,2,19805,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf","2014-03-19 00:00:00",
1629,1,19806,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19806slr008ltr.pdf","2004-02-27 00:00:00",
53649,2,19806,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf","2018-04-11 00:00:00",
53654,1,19806,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019806Orig1s013ltr.pdf","2018-04-12 00:00:00",
1630,1,19807,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019807s001ltr.pdf","2011-03-24 00:00:00",
33959,2,19807,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s001lbl.pdf","2011-03-28 00:00:00",
11726,2,19807,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019807s002lbl.pdf","2011-08-24 00:00:00",
19229,1,19807,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019807s002ltr.pdf","2011-08-24 00:00:00",
23139,8,19810,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf","2012-10-03 00:00:00",
23556,10,19810,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
19230,1,19810,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf","2004-03-02 00:00:00",
20361,3,19810,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf","2007-07-20 00:00:00",
33960,2,19810,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf","2004-04-05 00:00:00",
41036,3,19810,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019810_S008_OMEPRAZOLE_AP.pdf","2007-07-09 00:00:00",
20362,3,19810,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019810ap.pdf","1997-11-04 00:00:00",
20363,3,19810,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm","1998-01-15 00:00:00",
20364,3,19810,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm","1998-01-07 00:00:00",
20365,3,19810,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm","1998-07-10 00:00:00",
20366,3,19810,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19810-S57_Prilosec.pdf","1999-02-03 00:00:00",
1631,1,19810,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf","2004-03-02 00:00:00",
20367,3,19810,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf","2007-07-20 00:00:00",
33961,2,19810,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf","2004-04-05 00:00:00",
1632,1,19810,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810s061ltr.pdf","2002-02-14 00:00:00",
41037,3,19810,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19810-S062_Prilosec.pdf","2000-02-23 00:00:00",
19231,1,19810,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf","2003-10-16 00:00:00",
33962,2,19810,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf","2003-10-16 00:00:00",
19232,1,19810,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810se5074ltr.pdf","2002-07-12 00:00:00",
33963,2,19810,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19810s074lbl.pdf","2002-07-12 00:00:00",
19233,1,19810,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19180slr076ltr.pdf","2002-12-16 00:00:00",
19234,1,19810,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf","2003-10-16 00:00:00",
33964,2,19810,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf","2003-10-16 00:00:00",
1633,1,19810,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19810s082ltr.pdf","2005-03-10 00:00:00",
33965,2,19810,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19810s082lbl.pdf","2005-03-10 00:00:00",
19235,1,19810,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s083ltr.pdf","2006-01-30 00:00:00",
33966,2,19810,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s083lbl.pdf","2006-01-27 00:00:00",
19236,1,19810,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s084LTR.pdf","2006-09-27 00:00:00",
33967,2,19810,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s084lbl.pdf","2006-09-26 00:00:00",
11727,2,19810,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf","2007-05-01 00:00:00",
19237,1,19810,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019810s085ltr.pdf","2007-05-01 00:00:00",
11728,2,19810,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf","2008-12-04 00:00:00",
19238,1,19810,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf","2008-12-04 00:00:00",
19239,1,19810,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf","2010-03-08 00:00:00",
33968,2,19810,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf","2010-03-05 00:00:00",
1634,1,19810,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf","2010-09-08 00:00:00",
33969,2,19810,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf","2010-09-10 00:00:00",
11729,2,19810,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf","2011-07-06 00:00:00",
19240,1,19810,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf","2011-07-06 00:00:00",
11730,2,19810,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf","2011-01-24 00:00:00",
19241,1,19810,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf","2011-01-25 00:00:00",
11731,2,19810,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf","2011-05-25 00:00:00",
19242,1,19810,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf","2011-05-25 00:00:00",
1635,1,19810,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf","2012-01-24 00:00:00",
33970,2,19810,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf","2012-02-06 00:00:00",
1636,1,19810,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf","2012-10-11 00:00:00",
33971,2,19810,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf","2012-10-12 00:00:00",
11732,2,19810,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf","2012-10-01 00:00:00",
19243,1,19810,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf","2012-10-02 00:00:00",
11733,2,19810,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf","2013-05-21 00:00:00",
19244,1,19810,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf","2013-05-16 00:00:00",
19245,1,19810,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf","2014-04-14 00:00:00",
33972,2,19810,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf","2014-04-01 00:00:00",
1637,1,19810,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf","2014-02-27 00:00:00",
33973,2,19810,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf","2014-02-27 00:00:00",
11734,2,19810,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf","2014-12-29 00:00:00",
19246,1,19810,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf","2014-12-24 00:00:00",
46476,1,19810,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s102,022056Orig1s019ltr.pdf","2016-12-22 00:00:00",
46492,2,19810,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf","2016-12-21 00:00:00",
55457,8,19810,"SUPPL",102,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf","2018-09-12 00:00:00",
45656,1,19810,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf","2016-10-26 00:00:00",
45716,2,19810,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf","2016-10-31 00:00:00",
55458,8,19810,"SUPPL",103,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34","2018-09-12 00:00:00",
20368,3,19813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019813_ORIGINAL APPROVAL_PACKAGE.pdf","2008-02-19 00:00:00",
23557,10,19813,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114961.htm","2005-07-29 00:00:00",
23965,14,19813,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
51851,20,19813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813s036_fentanyl-Duragesic MedRev.pdf","1900-01-01 00:00:00",
51852,23,19813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813_fentanyl_Duragesic_WR_orig.pdf","1900-01-01 00:00:00",
51853,25,19813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813_fentanyl_Duragesic_WR(amended)_11-30-99.pdf","1900-01-01 00:00:00",
51854,26,19813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813_fentanyl_Duragesic_WR(amended)_2-22-01.pdf","1900-01-01 00:00:00",
51855,18,19813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813s036_fentanyl-Duragesic-ClinPharmRev.pdf","1900-01-01 00:00:00",
20369,3,19813,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S018_Duragesic.pdf","2007-07-09 00:00:00",
20370,3,19813,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S019_Duragesic.pdf","2007-07-09 00:00:00",
41038,3,19813,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S020_Duragesic.pdf","2007-07-09 00:00:00",
41039,3,19813,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S021_Duragesic.pdf","2007-07-09 00:00:00",
1638,1,19813,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf","2001-04-11 00:00:00",
20371,3,19813,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S023_DURAGESIC.pdf","2009-01-12 00:00:00",
41040,3,19813,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S025_DURAGESIC.pdf","2009-01-12 00:00:00",
20372,3,19813,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S026_DURAGESIC.pdf","2009-01-12 00:00:00",
19247,1,19813,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf","2001-04-11 00:00:00",
20373,3,19813,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S030_DURAGESIC.pdf","2009-01-12 00:00:00",
1639,1,19813,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019813s033ltr.pdf","2008-02-14 00:00:00",
20374,3,19813,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019813Orig1s033.pdf","2012-09-17 00:00:00",
33974,2,19813,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf","2008-02-14 00:00:00",
1640,1,19813,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19813se1-036ltr.pdf","2003-06-08 00:00:00",
33975,2,19813,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19813se1-036_duragesic_lbl.pdf","2003-06-08 00:00:00",
41041,3,19813,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019813_S036_DURAGESIC.pdf","2009-01-12 00:00:00",
1641,1,19813,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19813s039ltr.pdf","2005-02-08 00:00:00",
33976,2,19813,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19813s039lbl.pdf","2005-02-08 00:00:00",
41042,3,19813,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019813_S039_DURAGESIC.pdf","2009-01-12 00:00:00",
20375,3,19813,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019813Orig1s044.pdf","2012-10-12 00:00:00",
33977,2,19813,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf","2010-04-01 00:00:00",
19248,1,19813,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s051ltr.pdf","2012-07-11 00:00:00",
19249,1,19813,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s052ltr.pdf","2012-07-11 00:00:00",
33978,2,19813,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019813s052lbl.pdf","2012-07-12 00:00:00",
19250,1,19813,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s056ltr.pdf","2013-04-16 00:00:00",
11735,2,19813,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pdf","2013-09-24 00:00:00",
19251,1,19813,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s060ltr.pdf","2013-10-09 00:00:00",
1642,1,19813,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s063ltr.pdf","2014-04-17 00:00:00",
33979,2,19813,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019813s063lbl.pdf","2014-04-16 00:00:00",
19252,1,19813,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s065ltr.pdf","2014-08-20 00:00:00",
19253,1,19813,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019813Orig1s066ltr.pdf","2015-07-02 00:00:00",
19254,1,19813,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s067ltr.pdf","2016-04-22 00:00:00",
47185,1,19813,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s068ltr.pdf","2017-02-13 00:00:00",
46237,1,19813,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s069ltr.pdf","2016-12-20 00:00:00",
46394,2,19813,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019813s069lbl.pdf","2016-12-21 00:00:00",
47097,1,19813,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s070ltr.pdf","2017-02-03 00:00:00",
45460,1,19813,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s071ltr.pdf","2016-10-04 00:00:00",
51914,2,19813,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf","2018-01-26 00:00:00",
51917,8,19813,"SUPPL",72,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48","2018-01-26 00:00:00",
51915,2,19813,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf","2018-01-26 00:00:00",
51916,8,19813,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48","2018-01-26 00:00:00",
48570,1,19813,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s074ltr.pdf","2017-05-30 00:00:00",
55654,1,19813,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019813Orig1s075s076Orig1s000ltr.pdf","2018-09-28 00:00:00",
55842,2,19813,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf","2018-10-05 00:00:00",
55844,8,19813,"SUPPL",75,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51","2018-10-05 00:00:00",
55655,1,19813,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019813Orig1s075s076Orig1s000ltr.pdf","2018-09-28 00:00:00",
55843,2,19813,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf","2018-10-05 00:00:00",
55845,8,19813,"SUPPL",76,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51","2018-10-05 00:00:00",
33980,2,19814,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf","2003-06-10 00:00:00",
11736,2,19814,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf","2003-06-10 00:00:00",
1643,1,19815,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19815s5ltr.pdf","2002-03-20 00:00:00",
41043,3,19815,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-815s005_Midodrine.cfm","2002-03-20 00:00:00",
19255,1,19815,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19815s007ltr.pdf","2004-07-28 00:00:00",
47135,2,19815,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019815s010lbl.pdf","2017-02-08 00:00:00",
47236,1,19815,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019815Orig1s010ltr.pdf","2017-02-16 00:00:00",
20376,3,19816,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf","2003-09-11 00:00:00",
1644,1,19816,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf","2006-01-20 00:00:00",
11737,2,19816,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.pdf","2006-01-20 00:00:00",
19256,1,19816,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019816s011ltr.pdf","2007-08-02 00:00:00",
33982,2,19816,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019816s011lbl.pdf","2007-08-02 00:00:00",
19257,1,19818,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf","2007-11-08 00:00:00",
33983,2,19818,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf","2007-11-07 00:00:00",
1645,1,19818,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf","2008-09-29 00:00:00",
11738,2,19818,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf","2008-10-03 00:00:00",
11739,2,19818,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf","2014-06-10 00:00:00",
19258,1,19818,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf","2014-06-11 00:00:00",
20377,3,19821,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19821-S001_Soritane.pdf","1997-06-05 00:00:00",
11740,2,19821,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf","2003-04-28 00:00:00",
19259,1,19821,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf","2003-05-29 00:00:00",
41044,3,19821,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf","2007-07-06 00:00:00",
1646,1,19821,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf","2003-05-29 00:00:00",
20378,3,19821,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf","2007-07-06 00:00:00",
33984,2,19821,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf","2003-04-28 00:00:00",
19260,1,19821,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821scp010ltr.pdf","2004-03-24 00:00:00",
33985,2,19821,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821scp010_soriatane_lbl.pdf","2004-04-05 00:00:00",
1647,1,19821,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s011ltr.pdf","2004-10-15 00:00:00",
33986,2,19821,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821s011lbl.pdf","2004-10-15 00:00:00",
1648,1,19821,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s012ltr.pdf","2004-11-08 00:00:00",
19261,1,19821,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf","2007-10-22 00:00:00",
33987,2,19821,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf","2007-10-22 00:00:00",
1649,1,19821,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf","2007-10-22 00:00:00",
11741,2,19821,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf","2007-10-22 00:00:00",
19262,1,19821,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019821s017ltr.pdf","2010-02-16 00:00:00",
1650,1,19821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019821s018ltr.pdf","2011-11-28 00:00:00",
33988,2,19821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018lbl.pdf","2011-11-29 00:00:00",
43628,8,19821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf","2011-11-29 00:00:00",
1651,1,19821,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s022ltr.pdf","2014-02-20 00:00:00",
11742,2,19821,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf","2014-02-19 00:00:00",
19263,1,19821,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s023ltr.pdf","2014-02-04 00:00:00",
33989,2,19821,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s023lbl.pdf","2014-01-31 00:00:00",
11743,2,19821,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf","2014-05-15 00:00:00",
19264,1,19821,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s024ltr.pdf","2014-05-19 00:00:00",
1652,1,19821,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019821Orig1s027ltr.pdf","2015-05-22 00:00:00",
11744,2,19821,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf","2015-05-21 00:00:00",
49873,2,19821,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019821s028lbl.pdf","2017-09-28 00:00:00",
49886,1,19821,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019821Orig1s028ltr.pdf","2017-09-29 00:00:00",
19265,1,19822,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19822slr006ltr.pdf","2003-01-09 00:00:00",
33990,2,19822,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-Scrub_lbl.pdf","2003-01-09 00:00:00",
1653,1,19822,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019822Orig1s007ltr.pdf","2013-01-10 00:00:00",
11745,2,19822,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf","2014-01-14 00:00:00",
54192,1,19822,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019822Orig1s008ltr.pdf","2018-05-15 00:00:00",
54315,2,19822,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019822Orig1s008lbl.pdf","2018-05-23 00:00:00",
19266,1,19824,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr008ltr.pdf","2003-03-28 00:00:00",
33991,2,19824,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf","2003-03-28 00:00:00",
1654,1,19824,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr009ltr.pdf","2003-03-28 00:00:00",
11746,2,19824,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf","2003-03-28 00:00:00",
1655,1,19824,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf","2013-07-02 00:00:00",
33992,2,19824,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf","2013-07-11 00:00:00",
1656,1,19826,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s020ltr.pdf","2008-04-10 00:00:00",
19267,1,19826,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s021ltr.pdf","2008-10-21 00:00:00",
19268,1,19826,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019826s023ltr.pdf","2012-02-27 00:00:00",
33993,2,19826,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019826s023lbl.pdf","2012-02-22 00:00:00",
19269,1,19828,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19828slr009,20209slr005ltr.pdf","2004-01-29 00:00:00",
33994,2,19828,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf","2004-02-02 00:00:00",
19270,1,19829,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019829s019ltr.pdf","2005-06-21 00:00:00",
1657,1,19829,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019829Orig1s026ltr.pdf","2013-08-06 00:00:00",
33995,2,19829,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf","2013-08-05 00:00:00",
55535,2,19829,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf","2018-09-20 00:00:00",
55735,1,19829,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019829Orig1s034ltr.pdf","2018-10-01 00:00:00",
19271,1,19830,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19830slr008ltr.pdf","2004-06-25 00:00:00",
1658,1,19830,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019830Orig1s018ltr.pdf","2013-02-04 00:00:00",
33996,2,19830,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf","2013-02-06 00:00:00",
1659,1,19832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19832ltr.pdf","1998-06-05 00:00:00",
33997,2,19832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19832lbl.pdf","1998-06-05 00:00:00",
41045,3,19832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19832.cfm","1999-01-06 00:00:00",
19272,1,19832,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf","2001-07-12 00:00:00",
19273,1,19832,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19832s2s3ltr.pdf","2001-07-12 00:00:00",
41046,3,19833,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-833S011.pdf","2003-09-11 00:00:00",
41047,3,19834,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834S002_plendil_toc.cfm","2003-08-07 00:00:00",
41048,3,19834,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834_S004_PLENDIL.pdf","2008-04-02 00:00:00",
41049,3,19834,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s005_PLENDIL.pdf","2008-08-11 00:00:00",
20379,3,19834,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s006_PLENDIL.pdf","2008-08-11 00:00:00",
41050,3,19834,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_s007_PLENDIL.pdf","2008-08-08 00:00:00",
1660,1,19834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_APPROV.PDF","2004-06-14 00:00:00",
11747,2,19834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_PRNTLBL.PDF","2004-06-14 00:00:00",
20380,3,19834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834S009_plendil_toc.cfm","2003-08-07 00:00:00",
20381,3,19834,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019834_s012_PLENDIL.pdf","2008-08-11 00:00:00",
41051,3,19834,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834_s013.pdf","2008-08-08 00:00:00",
20382,3,19834,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019834_s014_PLENDIL.pdf","2008-08-04 00:00:00",
20383,3,19834,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_016_PLENDIL.pdf","2008-08-08 00:00:00",
1661,1,19834,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19834S017ltr.pdf","2002-05-22 00:00:00",
11748,2,19834,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf","2002-05-22 00:00:00",
20384,3,19834,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_017_PLENDIL.pdf","2008-08-04 00:00:00",
20385,3,19834,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S019_PLENDIL.pdf","2008-08-04 00:00:00",
41052,3,19834,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S020_PLENDIL.pdf","2008-04-02 00:00:00",
11749,2,19834,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pdf","2004-06-10 00:00:00",
19274,1,19834,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19834slr022ltr.pdf","2004-06-10 00:00:00",
41053,3,19834,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019834_S022_PLENDIL.pdf","2008-04-02 00:00:00",
19275,1,19834,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019834Orig1s025ltr.pdf","2012-11-05 00:00:00",
33998,2,19834,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf","2012-11-02 00:00:00",
1662,1,19835,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19835s005ltr.pdf","1998-05-15 00:00:00",
41054,3,19835,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf","1998-05-15 00:00:00",
1663,1,19835,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19835se5-015,20346se5-008LTR.pdf","2002-10-21 00:00:00",
20386,3,19835,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019835_S015_ZYRTEC TABLETS.pdf","2009-01-12 00:00:00",
33999,2,19835,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf","2002-10-21 00:00:00",
1664,1,19835,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf","2004-03-24 00:00:00",
34000,2,19835,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf","2004-04-05 00:00:00",
41055,3,19835,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019835_S016_ZYRTEC SYRUP_.pdf","2009-01-12 00:00:00",
1665,1,19835,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019835s020ltr.pdf","2006-04-07 00:00:00",
1666,1,19835,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019835s022_CKD.pdf","2007-11-26 00:00:00",
41056,3,19835,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm","2008-05-21 00:00:00",
1667,1,19835,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019835s025ltr.pdf","2008-11-28 00:00:00",
19276,1,19835,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019835s028ltr.pdf","2010-03-04 00:00:00",
1668,1,19835,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s029ltr.pdf","2012-01-30 00:00:00",
1669,1,19835,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s030ltr.pdf","2012-03-15 00:00:00",
1670,1,19835,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835Orig1s032ltr.pdf","2012-09-11 00:00:00",
11750,2,19835,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf","2012-12-12 00:00:00",
23558,10,19839,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053351.htm","2005-07-29 00:00:00",
41057,3,19839,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839_s011ap.pdf","1997-07-08 00:00:00",
41058,3,19839,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf","1997-10-10 00:00:00",
20387,3,19839,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf","1997-10-10 00:00:00",
11751,2,19839,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf","1999-12-07 00:00:00",
19277,1,19839,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_Approv.pdf","1999-12-07 00:00:00",
20388,3,19839,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft.cfm","1999-12-07 00:00:00",
1671,1,19839,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf","2003-07-31 00:00:00",
34001,2,19839,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf","2003-04-25 00:00:00",
1672,1,19839,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf","2001-08-17 00:00:00",
20389,3,19839,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm","2001-08-17 00:00:00",
34002,2,19839,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf","2001-08-17 00:00:00",
19278,1,19839,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf","2002-09-20 00:00:00",
1673,1,19839,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf","2002-05-16 00:00:00",
34003,2,19839,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf","2002-05-16 00:00:00",
1674,1,19839,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf","2002-09-18 00:00:00",
11752,2,19839,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf","2003-09-25 00:00:00",
19279,1,19839,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf","2003-09-25 00:00:00",
20390,3,19839,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm","2007-03-02 00:00:00",
52189,20,19839,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019839s044, 020990s010_sertraline_Zoloft-MedRev_PREA.pdf","1900-01-01 00:00:00",
52190,17,19839,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019839s044_sertraline_Zoloft_StatsRev_PREA.pdf","1900-01-01 00:00:00",
52191,23,19839,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019839_sertraline_Zoloft_WR_PREA.pdf","1900-01-01 00:00:00",
52192,25,19839,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019839_sertraline_Zoloft_WR_amend_PREA.pdf","1900-01-01 00:00:00",
1675,1,19839,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf","2004-07-01 00:00:00",
11753,2,19839,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf","2003-03-05 00:00:00",
1676,1,19839,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf","2004-08-25 00:00:00",
34004,2,19839,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf","2004-08-25 00:00:00",
1677,1,19839,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf","2004-08-25 00:00:00",
11754,2,19839,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf","2004-08-25 00:00:00",
1678,1,19839,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf","2005-02-23 00:00:00",
11755,2,19839,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf","2005-07-14 00:00:00",
19280,1,19839,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf","2005-02-23 00:00:00",
34005,2,19839,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf","2005-07-14 00:00:00",
1679,1,19839,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf","2005-07-29 00:00:00",
1680,1,19839,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf","2006-05-16 00:00:00",
1681,1,19839,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf","2006-09-15 00:00:00",
34006,2,19839,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf","2006-09-15 00:00:00",
1682,1,19839,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
1683,1,19839,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf","2006-09-15 00:00:00",
11756,2,19839,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf","2006-09-15 00:00:00",
19281,1,19839,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
34007,2,19839,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf","2007-08-03 00:00:00",
1684,1,19839,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
34008,2,19839,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf","2007-08-03 00:00:00",
1685,1,19839,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf","2007-10-10 00:00:00",
34009,2,19839,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf","2007-10-10 00:00:00",
11757,2,19839,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf","2008-03-07 00:00:00",
19282,1,19839,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf","2008-03-07 00:00:00",
11758,2,19839,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf","2009-02-04 00:00:00",
19283,1,19839,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf","2009-02-03 00:00:00",
19284,1,19839,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
34010,2,19839,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
1686,1,19839,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf","2012-12-21 00:00:00",
34011,2,19839,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf","2012-12-28 00:00:00",
46532,2,19839,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46547,1,19839,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
11759,2,19839,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
19285,1,19839,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
1687,1,19839,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
11760,2,19839,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
19286,1,19839,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf","2013-02-04 00:00:00",
34012,2,19839,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf","2013-02-06 00:00:00",
1688,1,19839,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf","2014-07-08 00:00:00",
11761,2,19839,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf","2014-07-08 00:00:00",
1689,1,19839,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf","2012-12-21 00:00:00",
34013,2,19839,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf","2012-12-28 00:00:00",
1690,1,19839,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf","2014-07-08 00:00:00",
11762,2,19839,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf","2014-07-08 00:00:00",
11763,2,19839,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf","2014-09-19 00:00:00",
19287,1,19839,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf","2014-09-16 00:00:00",
46533,2,19839,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46548,1,19839,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
46534,2,19839,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46549,1,19839,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
48729,2,19839,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s088,020990s046lbl.pdf","2017-06-16 00:00:00",
48748,1,19839,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s088,020990Orig1s046ltr.pdf","2017-06-16 00:00:00",
50663,2,19839,"SUPPL",91,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf","2017-12-12 00:00:00",
50720,1,19839,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf","2017-12-18 00:00:00",
50662,2,19839,"SUPPL",93,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf","2017-12-12 00:00:00",
50664,8,19839,"SUPPL",93,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf#page=27","2017-12-12 00:00:00",
50721,1,19839,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf","2017-12-18 00:00:00",
11764,2,19841,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf","2004-03-16 00:00:00",
19288,1,19841,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111mal021902L.htm","2004-03-16 00:00:00",
20391,3,19842,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm","2006-05-08 00:00:00",
11765,2,19842,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf","2006-01-25 00:00:00",
19289,1,19842,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019842s019ltr.pdf","2006-01-30 00:00:00",
19290,1,19842,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019842s020ltr.pdf","2007-09-11 00:00:00",
34014,2,19842,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf","2007-09-11 00:00:00",
11766,2,19845,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19845slr017_betopic_lblo.pdf","2003-05-29 00:00:00",
19291,1,19845,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19845slr017ltr.pdf","2003-06-08 00:00:00",
19741,1,19845,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019845s020ltr.pdf","2007-06-14 00:00:00",
34015,2,19845,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019845s020lbl.pdf","2007-06-12 00:00:00",
51784,23,19845,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019845s020, 020963s010_betaxolol-Orig_WR.pdf","1900-01-01 00:00:00",
53081,20,19845,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019845s020, 020963s010_betaxolol-MedRev.pdf","1900-01-01 00:00:00",
53082,20,19845,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019845s020, 020963s010_betaxolol-MedRev2.pdf","1900-01-01 00:00:00",
11767,2,19845,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019845s021lbl.pdf","2008-06-12 00:00:00",
19742,1,19845,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019845s021ltr.pdf","2008-05-14 00:00:00",
47080,1,19845,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019845Orig1s025ltr.pdf","2017-01-31 00:00:00",
47102,2,19845,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019845s025lbl.pdf","2017-02-06 00:00:00",
47087,2,19845,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019845s025lbl.pdf","2017-02-01 00:00:00",
43629,8,19847,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf","2011-03-15 00:00:00",
41059,3,19847,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019847_S012_CIPRO.pdf","2008-08-11 00:00:00",
20392,3,19847,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019847_S022_CIPRO.pdf","2008-08-08 00:00:00",
1691,1,19847,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf","2000-08-30 00:00:00",
20393,3,19847,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm","2000-08-30 00:00:00",
34016,2,19847,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf","2000-08-30 00:00:00",
1692,1,19847,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf","2002-04-17 00:00:00",
20394,3,19847,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019847_S026_CIPRO.pdf","2008-08-04 00:00:00",
34017,2,19847,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf","2002-04-17 00:00:00",
1693,1,19847,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf","2004-03-28 00:00:00",
11768,2,19847,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf","2004-04-05 00:00:00",
41060,3,19847,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm","2008-07-31 00:00:00",
19743,1,19847,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
20395,3,19847,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S028_CIPRO.pdf","2008-07-31 00:00:00",
34018,2,19847,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
1694,1,19847,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
11769,2,19847,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
20396,3,19847,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S029_CIPRO.pdf","2008-07-31 00:00:00",
1695,1,19847,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf","2005-01-11 00:00:00",
11770,2,19847,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf","2005-01-11 00:00:00",
19744,1,19847,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
34019,2,19847,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
41061,3,19847,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S031_CIPRO.pdf","2008-07-31 00:00:00",
19745,1,19847,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038ltr.pdf","2005-05-20 00:00:00",
34020,2,19847,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf","2005-05-20 00:00:00",
1696,1,19847,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf","2005-11-18 00:00:00",
11771,2,19847,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf","2005-11-17 00:00:00",
20397,3,19847,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019847_S036_Cipro.pdf","2007-07-09 00:00:00",
19746,1,19847,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf","2006-06-28 00:00:00",
19747,1,19847,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf","2007-07-05 00:00:00",
34021,2,19847,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019847s39lbl.pdf","2007-06-27 00:00:00",
19748,1,19847,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019847s041ltr.pdf","2008-01-24 00:00:00",
34022,2,19847,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf","2008-01-23 00:00:00",
1697,1,19847,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s068,019847s042ltr.pdf","2008-10-07 00:00:00",
34023,2,19847,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf","2008-10-09 00:00:00",
1698,1,19847,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf","2009-02-18 00:00:00",
11772,2,19847,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf","2009-02-20 00:00:00",
1699,1,19847,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf","2009-05-07 00:00:00",
34024,2,19847,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf","2009-05-11 00:00:00",
1700,1,19847,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf","2009-06-30 00:00:00",
19749,1,19847,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053ltr.pdf","2011-11-21 00:00:00",
34025,2,19847,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf","2011-11-16 00:00:00",
11773,2,19847,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf","2011-03-04 00:00:00",
19750,1,19847,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf","2011-03-02 00:00:00",
11774,2,19847,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf","2011-08-16 00:00:00",
19751,1,19847,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057ltr.pdf","2011-08-15 00:00:00",
1701,1,19847,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf","2011-08-08 00:00:00",
11775,2,19847,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf","2011-11-04 00:00:00",
19752,1,19847,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf","2011-10-20 00:00:00",
1702,1,19847,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s053,019857Orig1s060ltr.pdf","2013-01-31 00:00:00",
34026,2,19847,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf","2013-02-01 00:00:00",
19753,1,19847,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s054ltr.pdf","2013-08-16 00:00:00",
34027,2,19847,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s054lbl.pdf","2013-08-15 00:00:00",
1703,1,19847,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf","2015-02-12 00:00:00",
11776,2,19847,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf","2015-03-02 00:00:00",
1704,1,19847,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019847Orig1s056,019857Orig1s064ltr.pdf","2015-03-20 00:00:00",
11777,2,19847,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf","2015-03-20 00:00:00",
1705,1,19847,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf","2016-07-26 00:00:00",
34028,2,19847,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019847s057lbl.pdf","2016-07-26 00:00:00",
49162,2,19847,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019847s058lbl.pdf","2017-07-31 00:00:00",
49192,1,19847,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019847Orig1s058ltr.pdf","2017-08-02 00:00:00",
20398,3,19849,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019849_S011_REV-EYES.pdf","2008-08-04 00:00:00",
41062,3,19849,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019849_S012_REV-EYES.pdf","2008-08-04 00:00:00",
44037,10,19851,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
51779,23,19851,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019851_benazepril_Lotensin_WR_Orig.pdf","1900-01-01 00:00:00",
51780,25,19851,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019851_benazepril_Lotensin_WR amend.pdf","1900-01-01 00:00:00",
51781,20,19851,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019851s028_benazepril_Lotensin_MedReview.pdf","1900-01-01 00:00:00",
51782,18,19851,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019851s028_benazepril_Lotensin_ClinPharmReview.pdf","1900-01-01 00:00:00",
51783,17,19851,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019851s028_benazepril_Lotensin_StatReview.pdf","1900-01-01 00:00:00",
1706,1,19851,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19851se5-028ltr.pdf","2004-03-03 00:00:00",
11778,2,19851,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf","2004-04-05 00:00:00",
1707,1,19851,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf","2003-11-05 00:00:00",
1708,1,19851,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf","2007-02-12 00:00:00",
1709,1,19851,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf","2008-06-02 00:00:00",
19754,1,19851,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf","2009-01-26 00:00:00",
1710,1,19851,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s038ltr.pdf","2010-01-07 00:00:00",
34029,2,19851,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf","2009-11-16 00:00:00",
1711,1,19851,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019851s040ltr.pdf","2011-06-16 00:00:00",
11779,2,19851,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf","2011-06-16 00:00:00",
19755,1,19851,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851Orig1s042ltr.pdf","2012-05-21 00:00:00",
34030,2,19851,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf","2012-05-22 00:00:00",
19756,1,19851,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf","2012-02-06 00:00:00",
34031,2,19851,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf","2012-01-23 00:00:00",
34032,2,19851,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf","2012-09-25 00:00:00",
1712,1,19851,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf","2015-07-23 00:00:00",
11780,2,19851,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf","2015-07-24 00:00:00",
19757,1,19851,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019851Orig1s046ltr.pdf","2014-12-15 00:00:00",
34033,2,19851,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf","2014-12-16 00:00:00",
19758,1,19851,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s047ltr.pdf","2015-01-27 00:00:00",
34034,2,19851,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf","2015-01-30 00:00:00",
19759,1,19851,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf","2015-07-23 00:00:00",
34035,2,19851,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf","2015-07-24 00:00:00",
49252,2,19851,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019851s052lbl.pdf","2017-08-07 00:00:00",
49266,1,19851,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019851Orig1s052ltr.pdf","2017-08-07 00:00:00",
19760,1,19853,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf","2003-11-25 00:00:00",
1713,1,19853,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf","2003-11-25 00:00:00",
1714,1,19853,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf","2004-10-29 00:00:00",
11781,2,19853,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf","2004-11-01 00:00:00",
52731,3,19853,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1s012.pdf","2018-02-27 00:00:00",
19761,1,19853,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr013ltr.pdf","2003-06-08 00:00:00",
34036,2,19853,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf","2003-06-08 00:00:00",
11782,2,19853,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf","2004-11-01 00:00:00",
19762,1,19853,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf","2004-10-29 00:00:00",
52732,3,19853,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1S014.pdf","2018-02-27 00:00:00",
19763,1,19856,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
34037,2,19856,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf","2014-07-22 00:00:00",
19764,1,19856,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
34038,2,19856,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf","2014-07-22 00:00:00",
11783,2,19856,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf","2009-01-06 00:00:00",
19765,1,19856,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019856s025ltr.pdf","2009-01-06 00:00:00",
1715,1,19856,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf","2011-02-07 00:00:00",
34039,2,19856,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf","2011-02-04 00:00:00",
1716,1,19856,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf","2014-07-23 00:00:00",
11784,2,19856,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf","2014-07-22 00:00:00",
41063,3,19857,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019857_S013_CIPRO.pdf","2008-08-11 00:00:00",
11785,2,19857,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf","2000-08-30 00:00:00",
19766,1,19857,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf","2000-08-30 00:00:00",
41064,3,19857,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm","2000-08-30 00:00:00",
1717,1,19857,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf","2002-04-17 00:00:00",
20399,3,19857,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019857_S028_CIPRO.pdf","2008-08-04 00:00:00",
34040,2,19857,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf","2002-04-17 00:00:00",
1718,1,19857,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf","2004-03-28 00:00:00",
11786,2,19857,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf","2004-04-05 00:00:00",
41065,3,19857,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm","2008-07-31 00:00:00",
1719,1,19857,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
34041,2,19857,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
41066,3,19857,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S033_CIPRO.pdf","2008-07-31 00:00:00",
11787,2,19857,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
19767,1,19857,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
41067,3,19857,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S034_CIPRO.pdf","2008-07-31 00:00:00",
1720,1,19857,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf","2005-01-11 00:00:00",
34042,2,19857,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf","2005-01-11 00:00:00",
1721,1,19857,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf","2004-07-21 00:00:00",
11788,2,19857,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf","2004-07-21 00:00:00",
41068,3,19857,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S036_CIPRO.pdf","2008-07-31 00:00:00",
1722,1,19857,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038ltr.pdf","2005-05-20 00:00:00",
34043,2,19857,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf","2005-05-20 00:00:00",
19768,1,19857,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf","2005-11-18 00:00:00",
34044,2,19857,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf","2005-11-17 00:00:00",
41069,3,19857,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019857_S041_Cipro.pdf","2007-07-09 00:00:00",
1723,1,19857,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf","2006-06-28 00:00:00",
11789,2,19857,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf","2007-06-27 00:00:00",
19769,1,19857,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf","2007-07-05 00:00:00",
19770,1,19857,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s048ltr.pdf","2008-01-24 00:00:00",
34045,2,19857,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf","2008-01-23 00:00:00",
34046,2,19857,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf","2008-10-09 00:00:00",
1724,1,19857,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf","2009-02-18 00:00:00",
11790,2,19857,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf","2009-02-20 00:00:00",
1725,1,19857,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019857s051ltr.pdf","2009-05-07 00:00:00",
34047,2,19857,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf","2009-05-11 00:00:00",
1726,1,19857,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf","2009-06-30 00:00:00",
19771,1,19857,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053ltr.pdf","2011-11-21 00:00:00",
34048,2,19857,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf","2011-11-16 00:00:00",
11791,2,19857,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf","2011-03-04 00:00:00",
19772,1,19857,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf","2011-03-02 00:00:00",
11792,2,19857,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf","2011-08-16 00:00:00",
19773,1,19857,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057ltr.pdf","2011-08-15 00:00:00",
1727,1,19857,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf","2011-08-08 00:00:00",
34049,2,19857,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf","2011-08-12 00:00:00",
11793,2,19857,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf","2011-11-04 00:00:00",
19774,1,19857,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf","2011-10-20 00:00:00",
1728,1,19857,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s053,019857Orig1s060ltr.pdf","2013-01-31 00:00:00",
34050,2,19857,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf","2013-02-01 00:00:00",
11794,2,19857,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf","2013-08-15 00:00:00",
19775,1,19857,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019857Orig1s062ltr.pdf","2013-08-16 00:00:00",
1729,1,19857,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf","2015-02-12 00:00:00",
34051,2,19857,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf","2015-03-02 00:00:00",
19776,1,19857,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019847Orig1s056,019857Orig1s064ltr.pdf","2015-03-20 00:00:00",
34052,2,19857,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf","2015-03-20 00:00:00",
11795,2,19857,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf","2016-07-26 00:00:00",
19777,1,19857,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf","2016-07-26 00:00:00",
49107,1,19857,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019857Orig1s066ltr.pdf","2017-07-28 00:00:00",
49424,2,19857,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019857s066lbl.pdf","2017-08-16 00:00:00",
49425,8,19857,"SUPPL",66,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019857s066lbl.pdf#page=33","2017-08-16 00:00:00",
20400,3,19858,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019858_S011_CIPRO.pdf","2008-08-11 00:00:00",
11796,2,19858,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf","2000-08-30 00:00:00",
19778,1,19858,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf","2000-08-30 00:00:00",
20401,3,19858,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm","2000-08-30 00:00:00",
1730,1,19858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf","2002-04-17 00:00:00",
20402,3,19858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019858_S022_CIPRO.pdf","2008-08-04 00:00:00",
34053,2,19858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf","2002-04-17 00:00:00",
1731,1,19860,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19860S18ltr.pdf","2001-04-11 00:00:00",
19779,1,19860,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf","2004-06-16 00:00:00",
41070,3,19860,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019860_S020_IMODIUM_CHEWABLE_TABLETS.pdf","2008-07-31 00:00:00",
1732,1,19860,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019860s029ltr.pdf","2012-05-08 00:00:00",
48012,2,19860,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032lbl.pdf","2017-04-13 00:00:00",
48030,2,19860,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032ltr.pdf","2017-04-14 00:00:00",
1733,1,19862,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111med021902L.htm","2004-03-16 00:00:00",
11797,2,19862,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf","2004-03-16 00:00:00",
1734,1,19862,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/in111med042403L.pdf","2004-03-16 00:00:00",
34054,2,19862,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf","2004-03-16 00:00:00",
41071,3,19863,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf","2008-02-19 00:00:00",
20403,3,19863,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S002_Geref.pdf","2008-02-19 00:00:00",
11798,2,19865,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf","2001-10-01 00:00:00",
19780,1,19865,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_Approv.pdf","2001-10-01 00:00:00",
41072,3,19865,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865s10_Betapace.cfm","2002-06-19 00:00:00",
19781,1,19865,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s019ltr.pdf","2011-02-09 00:00:00",
34055,2,19865,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf","2011-02-04 00:00:00",
19782,1,19865,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s020ltr.pdf","2011-08-18 00:00:00",
34056,2,19865,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf","2011-08-24 00:00:00",
11799,2,19865,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf","2016-05-11 00:00:00",
19783,1,19865,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019865Orig1s021ltr.pdf","2016-05-17 00:00:00",
41073,3,19872,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019872Orig1s006.pdf","2012-04-13 00:00:00",
20404,3,19872,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019872Orig1s009.pdf","2012-06-28 00:00:00",
11800,2,19872,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf","2003-06-08 00:00:00",
19784,1,19872,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr012ltr.pdf","2003-06-08 00:00:00",
1735,1,19872,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr013ltr.pdf","2003-06-08 00:00:00",
34057,2,19872,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf","2003-06-08 00:00:00",
19785,1,19872,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr014ltr.pdf","2003-06-08 00:00:00",
34058,2,19872,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf","2003-06-08 00:00:00",
1736,1,19872,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872scs016ltr.pdf","2003-08-14 00:00:00",
19786,1,19872,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872scp017ltr.pdf","2004-03-30 00:00:00",
1737,1,19872,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872slr018ltr.pdf","2004-04-20 00:00:00",
1738,1,19872,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872s021ltr.pdf","2004-11-08 00:00:00",
20405,3,19872,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019872Orig1_s029.pdf","2012-01-27 00:00:00",
1739,1,19872,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019872s031ltr.pdf","2009-06-23 00:00:00",
11801,2,19872,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf","2009-06-29 00:00:00",
1740,1,19872,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s033ltr.pdf","2010-05-12 00:00:00",
1741,1,19872,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s034ltr.pdf","2010-05-17 00:00:00",
1742,1,19872,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019872s36ltr.pdf","2012-01-03 00:00:00",
34059,2,19872,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf","2014-01-09 00:00:00",
19787,1,19872,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s037ltr.pdf","2013-03-28 00:00:00",
34060,2,19872,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf","2014-01-09 00:00:00",
1743,1,19872,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s039ltr.pdf","2013-12-26 00:00:00",
11802,2,19872,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf","2014-01-09 00:00:00",
1744,1,19872,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s040ltr.pdf","2014-03-07 00:00:00",
11803,2,19872,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf","2014-03-27 00:00:00",
1745,1,19872,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s041ltr.pdf","2014-12-15 00:00:00",
11804,2,19872,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf","2014-12-15 00:00:00",
1746,1,19872,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s042ltr.pdf","2014-12-30 00:00:00",
34061,2,19872,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf","2015-01-05 00:00:00",
45180,2,19872,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf","2016-08-26 00:00:00",
41074,3,19880,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19880S009_Paraplatin.pdf","1998-01-06 00:00:00",
1747,1,19880,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19880s11ltr.pdf","2002-02-14 00:00:00",
19788,1,19880,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019880s020ltr.pdf","2010-11-12 00:00:00",
1748,1,19881,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr002ltr.pdf","2003-05-30 00:00:00",
11805,2,19881,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf","2003-05-06 00:00:00",
1749,1,19881,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr009ltr.pdf","2003-08-06 00:00:00",
34062,2,19881,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.pdf","2003-08-06 00:00:00",
19789,1,19884,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf","2003-01-30 00:00:00",
1750,1,19884,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf","2003-01-30 00:00:00",
1751,1,19884,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf","2014-03-19 00:00:00",
11806,2,19884,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf","2014-03-19 00:00:00",
44038,10,19885,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
1752,1,19885,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19885S18ltr.pdf","2001-04-17 00:00:00",
19790,1,19885,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19885slr019ltr.pdf","2003-07-30 00:00:00",
1753,1,19885,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf","2003-11-05 00:00:00",
1754,1,19885,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019885s028ltr.pdf","2009-11-12 00:00:00",
11807,2,19885,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf","2009-10-01 00:00:00",
1755,1,19885,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019885s033ltr.pdf","2011-10-18 00:00:00",
11808,2,19885,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf","2011-10-20 00:00:00",
1756,1,19885,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf","2012-01-23 00:00:00",
34063,2,19885,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf","2012-01-23 00:00:00",
11809,2,19885,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf","2012-09-25 00:00:00",
1757,1,19885,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s037ltr.pdf","2013-04-11 00:00:00",
34064,2,19885,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf","2013-04-16 00:00:00",
1758,1,19885,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s038ltr.pdf","2013-09-24 00:00:00",
11810,2,19885,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf","2013-09-23 00:00:00",
1759,1,19885,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s039ltr.pdf","2013-10-28 00:00:00",
11811,2,19885,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf","2013-10-31 00:00:00",
19791,1,19885,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019885Orig1s040ltr.pdf","2014-05-06 00:00:00",
34065,2,19885,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf","2014-05-06 00:00:00",
1760,1,19885,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019885Orig1s041ltr.pdf","2015-09-14 00:00:00",
11812,2,19885,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf","2015-09-14 00:00:00",
47194,1,19885,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s042ltr.pdf","2017-02-14 00:00:00",
47216,2,19885,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf","2017-02-15 00:00:00",
48134,2,19885,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf","2017-04-27 00:00:00",
48212,1,19885,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s043ltr.pdf","2017-05-02 00:00:00",
1761,1,19886,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19886s13ltr.pdf","1998-12-24 00:00:00",
20406,3,19886,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019886S013%20.cfm","1999-07-21 00:00:00",
1762,1,19886,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019886s022ltr.pdf","2006-04-13 00:00:00",
34066,2,19886,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf","2006-04-13 00:00:00",
1763,1,19886,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf","2011-01-07 00:00:00",
11813,2,19886,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf","2011-01-11 00:00:00",
19792,1,19886,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf","2011-01-07 00:00:00",
34067,2,19886,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf","2011-01-11 00:00:00",
1764,1,19886,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019886s030ltr.pdf","2012-01-17 00:00:00",
34068,2,19886,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf","2012-01-12 00:00:00",
11814,2,19886,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf","2015-08-10 00:00:00",
19793,1,19886,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019886Orig1s032ltr.pdf","2015-08-11 00:00:00",
48477,2,19886,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf","2017-05-22 00:00:00",
48480,8,19886,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf#page=28","2017-05-22 00:00:00",
48495,1,19886,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019886Orig1s033s035ltr.pdf","2017-05-23 00:00:00",
48478,2,19886,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf","2017-05-22 00:00:00",
48479,8,19886,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf#page=28","2017-05-22 00:00:00",
48496,1,19886,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019886Orig1s033s035ltr.pdf","2017-05-23 00:00:00",
19794,1,19887,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019887s014ltr.pdf","2011-02-14 00:00:00",
34069,2,19887,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019887s014lbl.pdf","2011-02-09 00:00:00",
41075,3,19888,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf","2001-09-18 00:00:00",
41076,3,19888,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019888s020_zestoretic_toc.cfm","2003-08-08 00:00:00",
1765,1,19888,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19888slr035ltr.pdf","2003-05-29 00:00:00",
1766,1,19888,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019888s040ltr.pdf","2005-05-25 00:00:00",
1767,1,19888,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf","2006-06-20 00:00:00",
1768,1,19888,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf","2007-07-24 00:00:00",
1769,1,19888,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf","2007-10-10 00:00:00",
1770,1,19888,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s045ltr.pdf","2009-05-26 00:00:00",
34070,2,19888,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf","2009-05-25 00:00:00",
1771,1,19888,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s047ltr.pdf","2010-01-07 00:00:00",
11815,2,19888,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf","2009-11-19 00:00:00",
1772,1,19888,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf","2011-03-16 00:00:00",
34071,2,19888,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf","2011-03-11 00:00:00",
1773,1,19888,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s050ltr.pdf","2011-08-05 00:00:00",
34072,2,19888,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf","2011-08-05 00:00:00",
1774,1,19888,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s051ltr.pdf","2012-05-04 00:00:00",
34073,2,19888,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf","2012-05-07 00:00:00",
1775,1,19888,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s052ltr.pdf","2012-04-02 00:00:00",
34074,2,19888,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf","2012-03-29 00:00:00",
1776,1,19888,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s053ltr.pdf","2012-11-05 00:00:00",
11816,2,19888,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf","2012-11-02 00:00:00",
1777,1,19888,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s054ltr.pdf","2012-08-16 00:00:00",
34075,2,19888,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf","2012-08-15 00:00:00",
11817,2,19888,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf","2013-11-08 00:00:00",
19795,1,19888,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019888Orig1s055ltr.pdf","2013-11-08 00:00:00",
1778,1,19888,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019888Orig1s056ltr.pdf","2014-12-30 00:00:00",
11818,2,19888,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf","2015-01-09 00:00:00",
11819,2,19888,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf","2015-08-26 00:00:00",
19796,1,19888,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019888Orig1s065ltr.pdf","2015-08-27 00:00:00",
49047,2,19888,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019888s067lbl.pdf","2017-07-25 00:00:00",
49070,1,19888,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019888Orig1s067ltr.pdf","2017-07-25 00:00:00",
19797,1,19890,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19890s17ltr.pdf","2002-01-14 00:00:00",
34076,2,19890,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19890s17lbl.pdf","2002-01-14 00:00:00",
11820,2,19891,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf","2006-06-12 00:00:00",
19798,1,19891,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019891s008, 019892s009LTR.pdf","2006-06-12 00:00:00",
46239,1,19891,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019891Orig1s024,019892Orig1s029ltr.pdf","2016-12-20 00:00:00",
46392,2,19891,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf","2016-12-21 00:00:00",
55602,2,19891,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf","2018-09-24 00:00:00",
55656,1,19891,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf","2018-09-28 00:00:00",
55603,2,19891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf","2018-09-24 00:00:00",
55657,1,19891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf","2018-09-28 00:00:00",
1779,1,19892,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19891slr002,19892slr002ltr.pdf","2004-06-02 00:00:00",
11821,2,19892,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf","2006-06-12 00:00:00",
19799,1,19892,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019891s008, 019892s009LTR.pdf","2006-06-12 00:00:00",
1780,1,19892,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019892s015ltr.pdf","2007-11-19 00:00:00",
11822,2,19892,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf","2007-11-19 00:00:00",
46240,1,19892,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019891Orig1s024,019892Orig1s029ltr.pdf","2016-12-20 00:00:00",
46393,2,19892,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf","2016-12-21 00:00:00",
55604,2,19892,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf","2018-09-24 00:00:00",
55607,8,19892,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf#page=27","2018-09-24 00:00:00",
55658,1,19892,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf","2018-09-28 00:00:00",
55605,2,19892,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf","2018-09-24 00:00:00",
55608,8,19892,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf#page=27","2018-09-24 00:00:00",
55659,1,19892,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf","2018-09-28 00:00:00",
41077,3,19898,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019898_S016_PRAVACOL_TABLETS.pdf","2007-11-19 00:00:00",
41078,3,19898,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019898a_s017_041597.pdf","1997-04-15 00:00:00",
41079,3,19898,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S018_Pravachol.pdf","1998-03-27 00:00:00",
20407,3,19898,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S020_Pravachol.pdf","1998-03-11 00:00:00",
20408,3,19898,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S023_PRAVACHOL_TABLETS.pdf","2008-02-19 00:00:00",
41080,3,19898,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S024_PRAVACHOL_TABLETS.pdf","2008-02-19 00:00:00",
20409,3,19898,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S025_PRAVACHOL_TABLETS.pdf","2008-02-19 00:00:00",
19800,1,19898,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF","2000-01-18 00:00:00",
1781,1,19898,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF","2000-01-18 00:00:00",
1782,1,19898,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF","2000-01-18 00:00:00",
1783,1,19898,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF","2000-01-18 00:00:00",
19801,1,19898,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S31LTR.PDF","2000-06-09 00:00:00",
41081,3,19898,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_S031_PRAVACHOL_TABLETS_AP.pdf","2007-04-11 00:00:00",
1784,1,19898,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/19898S32LTR.PDF","2000-02-10 00:00:00",
41082,3,19898,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898s032_Pravastatin.cfm","2000-02-10 00:00:00",
1785,1,19898,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF","1999-10-14 00:00:00",
41083,3,19898,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf","1999-10-14 00:00:00",
1786,1,19898,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF","1999-10-14 00:00:00",
20410,3,19898,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf","1999-10-14 00:00:00",
41084,3,19898,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898S34.PDF","1999-10-14 00:00:00",
41085,3,19898,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_s036_PRAVACHOL_TABLETS.pdf","2008-08-08 00:00:00",
20411,3,19898,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s037_PRAVACHOL_TABLETS.pdf","2008-08-04 00:00:00",
41086,3,19898,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s041_PRAVACHOL_TABLETS.pdf","2008-08-04 00:00:00",
19802,1,19898,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19898S42ltr.pdf","2001-06-15 00:00:00",
34077,2,19898,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf","2001-06-15 00:00:00",
41087,3,19898,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s043_PRAVACHOL TABS.pdf","2008-08-04 00:00:00",
20412,3,19898,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s044_PRAVACHOL TABS.pdf","2008-08-04 00:00:00",
19803,1,19898,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898s46ltr.pdf","2001-12-18 00:00:00",
34078,2,19898,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf","2001-12-18 00:00:00",
41088,3,19898,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S049_PRAVACOL_TABLETS.pdf","2007-11-19 00:00:00",
11823,2,19898,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf","2002-07-12 00:00:00",
19804,1,19898,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898slr050ltr.pdf","2002-07-12 00:00:00",
20413,3,19898,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_s050_PRAVACHOL TABS.pdf","2008-08-04 00:00:00",
41089,3,19898,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S051_PRAVACOL_TABLETS.pdf","2007-11-19 00:00:00",
1787,1,19898,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898se5-052ltr.pdf","2002-10-29 00:00:00",
34079,2,19898,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf","2002-10-29 00:00:00",
11824,2,19898,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf","2003-09-25 00:00:00",
19805,1,19898,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19898slr054ltr.pdf","2003-09-25 00:00:00",
41090,3,19898,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019898_s054_PRAVACHOL TABS.pdf","2008-08-01 00:00:00",
11825,2,19898,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf","2005-07-15 00:00:00",
19806,1,19898,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019898s058ltr.pdf","2005-07-15 00:00:00",
11826,2,19898,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf","2007-03-07 00:00:00",
19807,1,19898,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019898s060ltr.pdf","2007-03-07 00:00:00",
11827,2,19898,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf","2011-05-23 00:00:00",
19808,1,19898,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019898s061ltr.pdf","2011-05-20 00:00:00",
20414,3,19898,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019898Orig1s061.pdf","2013-08-07 00:00:00",
11828,2,19898,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf","2012-02-28 00:00:00",
19809,1,19898,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898s062ltr.pdf","2012-02-28 00:00:00",
20415,3,19898,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019898s062.pdf","2012-03-30 00:00:00",
19810,1,19898,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf","2012-11-05 00:00:00",
34080,2,19898,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf","2012-11-06 00:00:00",
19811,1,19898,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf","2012-11-05 00:00:00",
34081,2,19898,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf","2012-11-06 00:00:00",
1788,1,19898,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019898Orig1s066ltr.pdf","2016-07-07 00:00:00",
11829,2,19898,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf","2016-07-08 00:00:00",
19812,1,19899,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf","2002-09-03 00:00:00",
19813,1,19899,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf","2002-09-03 00:00:00",
1789,1,19899,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf","2002-09-03 00:00:00",
19814,1,19899,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19899slr015ltr.pdf","2004-06-09 00:00:00",
34082,2,19899,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf","2003-08-06 00:00:00",
19815,1,19899,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019899s018ltr.pdf","2006-03-01 00:00:00",
48390,2,19899,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf","2017-05-17 00:00:00",
48396,1,19899,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019899Orig1s019ltr.pdf","2017-05-17 00:00:00",
44039,10,19901,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
20416,3,19901,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19901s025_Altace.pdf","1998-12-16 00:00:00",
20417,3,19901,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019901_s028_Altace.cfm","2005-04-15 00:00:00",
1790,1,19901,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901slr034ltr.pdf","2002-08-02 00:00:00",
19816,1,19901,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901scm035ltr.pdf","2002-07-10 00:00:00",
1791,1,19901,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf","2004-10-22 00:00:00",
1792,1,19901,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf","2004-10-22 00:00:00",
1793,1,19901,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s043ltr.pdf","2004-10-22 00:00:00",
19817,1,19901,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s046ltr.pdf","2004-11-16 00:00:00",
20418,3,19901,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019901_s046_altace.pdf","2011-02-15 00:00:00",
19818,1,19901,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s052,022021s001ltr.pdf","2009-03-06 00:00:00",
19819,1,19901,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s054,022021s005ltr.pdf","2009-02-18 00:00:00",
11830,2,19901,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf","2010-10-25 00:00:00",
19820,1,19901,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019901s055ltr.pdf","2010-10-25 00:00:00",
11831,2,19901,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf","2011-09-02 00:00:00",
19821,1,19901,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019901s058ltr.pdf","2011-08-26 00:00:00",
1794,1,19901,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019901s059ltr.pdf","2012-04-16 00:00:00",
11832,2,19901,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf","2012-04-20 00:00:00",
19822,1,19901,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s060ltr.pdf","2013-09-24 00:00:00",
34083,2,19901,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf","2013-09-23 00:00:00",
1795,1,19901,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s062ltr.pdf","2013-11-06 00:00:00",
34084,2,19901,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf","2013-11-04 00:00:00",
11833,2,19901,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf","2013-10-31 00:00:00",
19823,1,19901,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s063ltr.pdf","2013-10-28 00:00:00",
1796,1,19901,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019901Orig1s064ltr.pdf","2014-05-06 00:00:00",
34085,2,19901,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf","2014-05-06 00:00:00",
19824,1,19901,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019901Orig1s065ltr.pdf","2015-09-14 00:00:00",
34086,2,19901,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf","2015-09-14 00:00:00",
48127,2,19901,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019901s067lbl.pdf","2017-04-27 00:00:00",
48204,1,19901,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/19901Orig1s067ltr.pdf","2017-05-02 00:00:00",
1797,1,19904,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019904s012ltr.pdf","2012-03-16 00:00:00",
46762,2,19904,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019904s014lbl.pdf","2017-01-06 00:00:00",
46840,1,19904,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019904Orig1s014ltr.pdf","2017-01-13 00:00:00",
23559,10,19906,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
34087,2,19906,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf","2003-06-10 00:00:00",
41091,3,19906,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019906_S022_ANAFRANIL_AP.pdf","2007-06-12 00:00:00",
19825,1,19906,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19906s030ltr.pdf","2004-09-07 00:00:00",
1798,1,19906,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019906s032ltr.pdf","2005-01-13 00:00:00",
11834,2,19906,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf","2005-01-13 00:00:00",
11835,2,19906,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf","2007-07-16 00:00:00",
19826,1,19906,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf","2007-07-24 00:00:00",
1799,1,19906,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf","2012-10-29 00:00:00",
11836,2,19906,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf","2012-10-26 00:00:00",
1800,1,19906,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf","2014-07-11 00:00:00",
11837,2,19906,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf","2014-07-11 00:00:00",
11838,2,19906,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf","2014-07-29 00:00:00",
19827,1,19906,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf","2014-07-29 00:00:00",
48533,1,19906,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019906Orig1s040ltr.pdf","2017-05-25 00:00:00",
48546,2,19906,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf","2017-05-26 00:00:00",
48548,8,19906,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf#page=27","2017-05-26 00:00:00",
55322,1,19906,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019906Orig1s041Ltr.pdf","2018-08-27 00:00:00",
19828,1,19907,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019907s025ltr.pdf","2006-12-04 00:00:00",
20419,3,19908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S000_AmbienTOC.cfm","2005-07-13 00:00:00",
23560,10,19908,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
41092,3,19908,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S002_AMBIEN_AP.pdf","2007-07-09 00:00:00",
55601,1,19908,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf","2018-09-24 00:00:00",
11839,2,19908,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf","2007-03-31 00:00:00",
19829,1,19908,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s022ltr.pdf","2007-04-09 00:00:00",
52154,20,19908,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019908s022_zolpidem_Ambien_MedRev_PREA.pdf","1900-01-01 00:00:00",
52155,18,19908,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019908s022_zolpidem_Ambien_ClinPharmRev_PREA.pdf","1900-01-01 00:00:00",
52156,23,19908,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019908s022_zolpidem_Ambien_ClinPharmRev_PREA.pdf","1900-01-01 00:00:00",
55739,1,19908,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf","2018-10-01 00:00:00",
1801,1,19908,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf","2007-10-22 00:00:00",
1802,1,19908,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019908s024, s027ltr.pdf","2008-05-09 00:00:00",
11840,2,19908,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf","2008-05-28 00:00:00",
48861,3,19908,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019908Orig1s027.pdf","2017-06-29 00:00:00",
19830,1,19908,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019908s029ltr.pdf","2010-04-19 00:00:00",
34088,2,19908,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf","2010-04-19 00:00:00",
11841,2,19908,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf","2013-04-23 00:00:00",
19831,1,19908,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf","2013-04-24 00:00:00",
20420,3,19908,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf","2013-09-30 00:00:00",
19832,1,19908,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf","2013-04-24 00:00:00",
20421,3,19908,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf","2013-09-30 00:00:00",
34089,2,19908,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf","2013-04-23 00:00:00",
19833,1,19908,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf","2014-10-09 00:00:00",
34090,2,19908,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf","2014-10-09 00:00:00",
45042,2,19908,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf","2016-08-24 00:00:00",
45043,1,19908,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf","2016-08-24 00:00:00",
46022,2,19908,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf","2016-12-05 00:00:00",
46051,1,19908,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf","2016-12-06 00:00:00",
46081,8,19908,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf#page=22","2016-12-06 00:00:00",
47473,2,19908,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf","2017-03-06 00:00:00",
47500,1,19908,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf","2017-03-08 00:00:00",
55500,1,19908,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf","2018-09-18 00:00:00",
55512,2,19908,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf","2018-09-18 00:00:00",
41093,3,19909,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19909S003_Zovirax.pdf","2000-07-06 00:00:00",
34091,2,19909,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf","2003-06-10 00:00:00",
11842,2,19909,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf","2003-06-10 00:00:00",
11843,2,19909,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf","2004-05-27 00:00:00",
19834,1,19909,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf","2004-05-27 00:00:00",
19835,1,19909,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf","2005-12-15 00:00:00",
34092,2,19909,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf","2005-12-15 00:00:00",
19836,1,19909,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf","2008-08-13 00:00:00",
53438,20,19910,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019910s033_Zidovudine (RETROVIR)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53439,18,19910,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19910 zidovudine clinpharm prea.pdf","1900-01-01 00:00:00",
19837,1,19910,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF","2001-03-30 00:00:00",
20422,3,19910,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm","2005-04-19 00:00:00",
34093,2,19910,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf","2001-03-30 00:00:00",
11844,2,19910,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf","2003-06-10 00:00:00",
19838,1,19910,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf","2002-02-21 00:00:00",
19839,1,19910,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf","2002-12-18 00:00:00",
34094,2,19910,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf","2003-04-04 00:00:00",
1803,1,19910,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20528slr011ltr.pdf","2003-10-17 00:00:00",
11845,2,19910,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf","2003-10-17 00:00:00",
1804,1,19910,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf","2006-05-18 00:00:00",
11846,2,19910,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf","2006-05-16 00:00:00",
11847,2,19910,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf","2006-11-16 00:00:00",
19840,1,19910,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019910s032ltr.pdf","2006-11-22 00:00:00",
1805,1,19910,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf","2008-09-23 00:00:00",
34095,2,19910,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf","2008-09-23 00:00:00",
54136,20,19910,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019910s033_Zidovudine (RETROVIR)_Clinical_PREA.pdf","1900-01-01 00:00:00",
54137,18,19910,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019910s033_Zidovudine (RETROVIR)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
1806,1,19910,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019910s035ltr.pdf","2010-01-07 00:00:00",
11848,2,19910,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf","2009-11-19 00:00:00",
1807,1,19910,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf","2010-05-21 00:00:00",
11849,2,19910,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf","2010-05-18 00:00:00",
19841,1,19910,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf","2011-12-01 00:00:00",
34096,2,19910,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf","2011-11-25 00:00:00",
1808,1,19910,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf","2012-06-04 00:00:00",
34097,2,19910,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf","2012-06-06 00:00:00",
1809,1,19910,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf","2014-12-31 00:00:00",
34098,2,19910,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf","2015-01-08 00:00:00",
47364,2,19910,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf","2017-02-28 00:00:00",
47439,1,19910,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s055,019910Orig1s042,019951Orig1s033ltr.pdf","2017-03-03 00:00:00",
48006,2,19910,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf","2017-04-13 00:00:00",
48022,1,19910,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s056,019910Orig1s043,019951Orig1s034ltr.pdf","2017-04-14 00:00:00",
50527,2,19910,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf","2017-11-29 00:00:00",
50552,1,19910,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s057,019910Orig1s044,019951Orig1s035ltr.pdf","2017-12-01 00:00:00",
55425,2,19910,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf","2018-09-11 00:00:00",
55436,1,19910,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019655Orig1s058,019910Orig1s045,019951Orig1s036ltr.pdf","2018-09-12 00:00:00",
23561,10,19915,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
19842,1,19915,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19915slr032ltr.pdf","2002-08-29 00:00:00",
41094,3,19915,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-915S032.pdf","2003-07-08 00:00:00",
1810,1,19915,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915se5-037ltr.pdf","2003-06-08 00:00:00",
34099,2,19915,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19915se5-037_monopril_lbl.pdf","2003-06-08 00:00:00",
51960,20,19915,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019915Orig1s037MedR2 merged.pdf","1900-01-01 00:00:00",
51961,23,19915,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019915s000_fosinopril_Monopril_WR_orig.pdf","1900-01-01 00:00:00",
51962,25,19915,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019915s000_fosinopril_Monopril_WR_amend.pdf","1900-01-01 00:00:00",
51963,17,19915,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019915s037_fosinopril_Monopril_StatR_PREA.pdf","1900-01-01 00:00:00",
19843,1,19915,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr006ltr.pdf","2003-11-05 00:00:00",
1811,1,19915,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008ltr.pdf","2009-02-13 00:00:00",
11850,2,19916,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf","2006-11-06 00:00:00",
19844,1,19916,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019916s004ltr.pdf","2006-11-06 00:00:00",
46244,1,19916,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf","2016-12-20 00:00:00",
46387,2,19916,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf","2016-12-21 00:00:00",
46245,1,19916,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf","2016-12-20 00:00:00",
46388,2,19916,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf","2016-12-21 00:00:00",
46246,1,19917,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf","2016-12-20 00:00:00",
46390,2,19917,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf","2016-12-21 00:00:00",
46247,1,19917,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf","2016-12-20 00:00:00",
46391,2,19917,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf","2016-12-21 00:00:00",
20423,3,19918,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019918ap.pdf","1997-12-11 00:00:00",
1812,1,19918,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19918s9ltr.pdf","2002-01-17 00:00:00",
41095,3,19919,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019919a_s002.pdf","1997-08-08 00:00:00",
53114,20,19921,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019921s018_ofloxacin_Ocuflox_MedR2.pdf","1900-01-01 00:00:00",
53115,20,19921,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19981S018 ocuflox clinical bpca_rev1rev2kc_redone 6.23.15_Redacted.pdf","1900-01-01 00:00:00",
53116,23,19921,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019921_ofloxacin_Ocuflox_10-22-99_WR.pdf","1900-01-01 00:00:00",
20424,3,19921,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019921_S008_Ocuflox_Approval_Package.pdf","2006-10-26 00:00:00",
45903,2,19921,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019921s021lbl.pdf","2016-11-16 00:00:00",
45904,1,19921,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019921Orig1s021ltr.pdf","2016-11-17 00:00:00",
41096,3,19922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019922_toc.cfm","2010-01-26 00:00:00",
1813,1,19922,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19922se5-005ltr.pdf","2004-04-07 00:00:00",
34100,2,19922,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf","2004-04-05 00:00:00",
1814,1,19922,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019922Orig1s016ltr.pdf","2015-12-18 00:00:00",
34101,2,19922,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf","2015-12-18 00:00:00",
23562,10,19927,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm362415.htm","2014-02-07 00:00:00",
34102,2,19927,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019927s028lbl.pdf","2009-09-17 00:00:00",
11851,2,19927,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf","2012-12-05 00:00:00",
19845,1,19927,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019927Orig1s031ltr.pdf","2012-12-05 00:00:00",
11852,2,19927,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf","2013-10-31 00:00:00",
19846,1,19927,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019927Orig1s032ltr.pdf","2013-10-30 00:00:00",
20425,3,19928,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019928Orig1s001.pdf","2012-01-27 00:00:00",
1815,1,19928,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19928slr002ltr.pdf","2003-05-29 00:00:00",
41097,3,19931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019931ap.pdf","1997-11-17 00:00:00",
1816,1,19931,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19931slr008ltr.pdf","2004-06-07 00:00:00",
11853,2,19931,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf","2004-06-07 00:00:00",
19847,1,19931,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019931s019ltr.pdf","2010-07-08 00:00:00",
34103,2,19931,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf","2010-07-06 00:00:00",
19848,1,19937,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf","2005-07-21 00:00:00",
11854,2,19937,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf","2009-11-19 00:00:00",
19849,1,19937,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019937s024ltr.pdf","2010-01-07 00:00:00",
20426,3,19938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938a_s019.pdf","1997-04-10 00:00:00",
41098,3,19938,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938ap.pdf","1997-11-20 00:00:00",
1818,1,19938,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf","2002-03-11 00:00:00",
11856,2,19938,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf","2002-03-11 00:00:00",
19850,1,19938,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf","2002-04-11 00:00:00",
34104,2,19938,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf","2002-04-11 00:00:00",
11857,2,19938,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf","2002-04-15 00:00:00",
19851,1,19938,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf","2002-04-15 00:00:00",
1819,1,19938,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019938s037ltr.pdf","2005-11-22 00:00:00",
34105,2,19938,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf","2005-11-22 00:00:00",
11858,2,19938,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf","2005-10-25 00:00:00",
1820,1,19938,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf","2009-06-18 00:00:00",
34106,2,19938,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf","2009-06-22 00:00:00",
1821,1,19938,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pd","2009-07-24 00:00:00",
34107,2,19938,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf","2009-07-23 00:00:00",
19852,1,19938,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019938s066ltr.pdf","2012-02-29 00:00:00",
34108,2,19938,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf","2012-02-27 00:00:00",
1822,1,19938,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
1823,1,19938,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf","2011-01-04 00:00:00",
1824,1,19938,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
11859,2,19938,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf","2013-03-12 00:00:00",
19853,1,19938,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s071ltr.pdf","2013-03-12 00:00:00",
11860,2,19938,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf","2013-02-08 00:00:00",
19854,1,19938,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s072ltr.pdf","2013-02-08 00:00:00",
11861,2,19938,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf","2016-01-12 00:00:00",
19855,1,19938,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019938Orig1s074ltr.pdf","2016-01-11 00:00:00",
54419,2,19938,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019938s076lbl.pdf","2018-06-04 00:00:00",
54433,1,19938,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019938Orig1s076ltr.pdf","2018-06-04 00:00:00",
20427,3,19941,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019941_S002_EMLA_CREAM.pdf","2007-12-06 00:00:00",
20428,3,19941,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf","1998-02-04 00:00:00",
20429,3,19941,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf","1998-02-04 00:00:00",
41099,3,19941,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf","1998-02-04 00:00:00",
19856,1,19941,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19941s10ltr.pdf","1999-03-11 00:00:00",
19857,1,19941,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19941S11LTR.PDF","2000-01-28 00:00:00",
34109,2,19941,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF","2000-01-28 00:00:00",
41100,3,19941,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-941S011.pdf","2004-03-24 00:00:00",
41101,3,19941,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019941_S012_EMLA_CREAM.pdf","2007-12-06 00:00:00",
19858,1,19941,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19941scp014,015ltr.pdf","2004-06-03 00:00:00",
1825,1,19941,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019941s017ltr.pdf","2006-01-19 00:00:00",
34110,2,19941,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf","2006-01-05 00:00:00",
41102,3,19941,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019941_S017_EMLA_CREAM.pdf","2007-12-06 00:00:00",
1826,1,19941,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019941s018LTR.pdf","2006-05-01 00:00:00",
12081,2,19941,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf","2006-05-01 00:00:00",
41103,3,19942,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019942_ORIGINAL_APPROVAL_PACKAGE.pdf","2008-02-19 00:00:00",
1827,1,19942,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf","2004-04-20 00:00:00",
46061,1,19942,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf","2016-12-06 00:00:00",
55005,1,19942,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf","2018-07-26 00:00:00",
20430,3,19943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_LupronTOC.cfm","2007-07-09 00:00:00",
44040,10,19943,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
41104,3,19943,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_S003_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
41105,3,19943,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019943_S010_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
19859,1,19943,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf","2004-01-22 00:00:00",
19860,1,19943,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf","2004-01-14 00:00:00",
1828,1,19943,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
20431,3,19943,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S022_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
1829,1,19943,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
41106,3,19943,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S024_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
1830,1,19943,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf","2007-11-08 00:00:00",
19861,1,19943,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf","2009-06-08 00:00:00",
34111,2,19943,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf","2009-06-04 00:00:00",
12082,2,19943,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf","2010-10-29 00:00:00",
19862,1,19943,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf","2010-11-02 00:00:00",
1831,1,19943,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf","2012-04-02 00:00:00",
34112,2,19943,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf","2012-03-28 00:00:00",
19863,1,19943,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf","2011-06-16 00:00:00",
34113,2,19943,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf","2011-06-16 00:00:00",
1832,1,19943,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf","2012-01-25 00:00:00",
34114,2,19943,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s033lbl.pdf","2012-01-23 00:00:00",
1833,1,19943,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf","2013-10-31 00:00:00",
34115,2,19943,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.pdf","2013-11-05 00:00:00",
19864,1,19946,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019946s007ltr.pdf","2010-11-30 00:00:00",
34116,2,19946,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019946s007lbl.pdf","2010-11-22 00:00:00",
19865,1,19949,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34117,2,19949,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
19866,1,19949,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34118,2,19949,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
19867,1,19949,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19949slr033,19950slr033,20090slr015ltr.pdf","2002-08-07 00:00:00",
34119,2,19949,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf","2002-08-07 00:00:00",
19868,1,19949,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34120,2,19949,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
1834,1,19949,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf","2004-03-28 00:00:00",
12083,2,19949,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf","2004-04-05 00:00:00",
19869,1,19949,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf","2008-04-04 00:00:00",
34121,2,19949,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf","2008-04-16 00:00:00",
12084,2,19949,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf","2010-08-10 00:00:00",
19870,1,19949,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf","2010-08-10 00:00:00",
19871,1,19949,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf","2011-06-08 00:00:00",
34122,2,19949,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s051lbl.pdf","2011-06-06 00:00:00",
1835,1,19949,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf","2011-04-29 00:00:00",
12085,2,19949,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf","2011-04-29 00:00:00",
19872,1,19949,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf","2011-11-21 00:00:00",
34123,2,19949,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf","2011-11-21 00:00:00",
1836,1,19949,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf","2013-09-17 00:00:00",
12086,2,19949,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf","2013-09-17 00:00:00",
1837,1,19949,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf","2014-03-25 00:00:00",
12087,2,19949,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf","2014-03-25 00:00:00",
19873,1,19949,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1s060,020090orig1s044ltr.pdf","2014-10-31 00:00:00",
34124,2,19949,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf","2014-11-04 00:00:00",
52924,2,19949,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s064,020090s046lbl.pdf","2018-03-13 00:00:00",
52993,1,19949,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s064,020090Orig1s046ltr.pdf","2018-03-15 00:00:00",
50235,2,19949,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019949s067,020090s048lbl.pdf","2017-10-30 00:00:00",
50241,1,19949,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019949Orig1s067,020090Orig1s048ltr.pdf","2017-10-31 00:00:00",
51466,2,19949,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s068,020090s049lbl.pdf","2018-01-23 00:00:00",
51873,1,19949,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s068,020090Orig1s049ltr.pdf","2018-01-26 00:00:00",
19874,1,19950,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34125,2,19950,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
19875,1,19950,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34126,2,19950,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
1838,1,19950,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
12088,2,19950,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
12089,2,19950,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf","2004-04-05 00:00:00",
19876,1,19950,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf","2004-03-28 00:00:00",
19877,1,19950,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf","2008-04-04 00:00:00",
34127,2,19950,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf","2008-04-16 00:00:00",
12090,2,19950,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf","2010-08-10 00:00:00",
19878,1,19950,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf","2010-08-10 00:00:00",
12091,2,19950,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf","2011-06-06 00:00:00",
19879,1,19950,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf","2011-06-08 00:00:00",
1839,1,19950,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf","2011-04-29 00:00:00",
12092,2,19950,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf","2011-04-29 00:00:00",
1840,1,19950,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf","2011-11-21 00:00:00",
34128,2,19950,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf","2011-11-21 00:00:00",
19880,1,19950,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf","2013-09-17 00:00:00",
34129,2,19950,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf","2013-09-17 00:00:00",
1841,1,19950,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf","2014-03-25 00:00:00",
34130,2,19950,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf","2014-03-25 00:00:00",
12093,2,19951,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf","2003-06-10 00:00:00",
1842,1,19951,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19951s17ltr.pdf","2002-02-21 00:00:00",
1843,1,19951,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr018ltr.pdf","2004-06-16 00:00:00",
12094,2,19951,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.pdf","2003-08-06 00:00:00",
1844,1,19951,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr019ltr.pdf","2003-08-15 00:00:00",
34131,2,19951,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr019_retrovir_lbl.pdf","2003-08-14 00:00:00",
1845,1,19951,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s023LTR.pdf","2006-07-13 00:00:00",
34132,2,19951,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019951s023lbl.pdf","2006-07-13 00:00:00",
1846,1,19951,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s024ltr.pdf","2006-11-22 00:00:00",
1847,1,19951,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019951s029ltr.pdf","2011-11-28 00:00:00",
34133,2,19951,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019951s029lbl.pdf","2011-11-25 00:00:00",
19881,1,19951,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019951s030ltr.pdf","2012-06-05 00:00:00",
34134,2,19951,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019951s030lbl.pdf","2012-06-06 00:00:00",
12095,2,19951,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf","2015-01-08 00:00:00",
19882,1,19951,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf","2014-12-31 00:00:00",
47363,2,19951,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s055,019910s042,019951s033lbl.pdf","2017-02-28 00:00:00",
47440,1,19951,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s055,019910Orig1s042,019951Orig1s033ltr.pdf","2017-03-03 00:00:00",
48007,2,19951,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s056,019910s043,019951s034lbl.pdf","2017-04-13 00:00:00",
48023,1,19951,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s056,019910Orig1s043,019951Orig1s034ltr.pdf","2017-04-14 00:00:00",
50528,2,19951,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019655s057,019910s044,019951s035lbl.pdf","2017-11-29 00:00:00",
50551,1,19951,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019655Orig1s057,019910Orig1s044,019951Orig1s035ltr.pdf","2017-12-01 00:00:00",
55426,2,19951,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019655s058,019910s045,019951s036lbl.pdf","2018-09-11 00:00:00",
55437,1,19951,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019655Orig1s058,019910Orig1s045,019951Orig1s036ltr.pdf","2018-09-12 00:00:00",
1848,1,19952,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19952slr012ltr.pdf","2004-04-20 00:00:00",
34135,2,19952,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019952s021lbl.pdf","2009-03-17 00:00:00",
19883,1,19952,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019952s026ltr.pdf","2011-12-29 00:00:00",
34136,2,19952,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019952s026lbl.pdf","2011-12-23 00:00:00",
1849,1,19952,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s030ltr.pdf","2013-01-11 00:00:00",
34137,2,19952,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s030lbl.pdf","2013-01-11 00:00:00",
19884,1,19952,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019952Orig1s031ltr.pdf","2013-09-04 00:00:00",
34138,2,19952,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s031lbl.pdf","2013-09-09 00:00:00",
12096,2,19952,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019952s033lbl.pdf","2016-06-01 00:00:00",
19885,1,19952,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019952Orig1s033ltr.pdf","2016-05-27 00:00:00",
1850,1,19953,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf","2004-04-20 00:00:00",
1851,1,19953,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf","2009-03-03 00:00:00",
34139,2,19953,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf","2009-03-17 00:00:00",
19886,1,19953,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf","2011-12-29 00:00:00",
34140,2,19953,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf","2011-12-23 00:00:00",
19887,1,19953,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf","2013-01-14 00:00:00",
34141,2,19953,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf","2013-01-11 00:00:00",
19888,1,19953,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf","2013-09-04 00:00:00",
34142,2,19953,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf","2013-09-09 00:00:00",
12097,2,19953,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf","2016-05-17 00:00:00",
19889,1,19953,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf","2016-05-16 00:00:00",
23563,10,19955,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2007-12-04 00:00:00",
19890,1,19955,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf","2003-11-25 00:00:00",
12098,2,19955,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-16 00:00:00",
19891,1,19955,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf","2005-11-17 00:00:00",
19892,1,19955,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf","2007-11-08 00:00:00",
34143,2,19955,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf","2007-11-07 00:00:00",
12099,2,19957,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf","2003-06-10 00:00:00",
34144,2,19957,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf","2003-06-10 00:00:00",
1852,1,19957,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf","2003-04-08 00:00:00",
12100,2,19957,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf","2004-06-02 00:00:00",
19893,1,19957,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf","2015-02-19 00:00:00",
34145,2,19957,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf","2015-02-20 00:00:00",
1853,1,19958,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf","1999-06-17 00:00:00",
34146,2,19958,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf","1999-06-17 00:00:00",
41107,3,19958,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19958S8_Cutivate.cfm","1999-06-17 00:00:00",
1854,1,19958,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf","1999-06-17 00:00:00",
34147,2,19958,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf","1999-06-17 00:00:00",
1855,1,19958,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf","2002-04-16 00:00:00",
34148,2,19958,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf","2002-04-16 00:00:00",
19894,1,19958,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf","2010-09-08 00:00:00",
34149,2,19958,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf","2010-09-07 00:00:00",
20432,3,19959,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019959ap.pdf","1997-04-16 00:00:00",
1856,1,19959,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf","2002-03-11 00:00:00",
34150,2,19959,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf","2002-03-11 00:00:00",
12101,2,19959,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf","2002-04-11 00:00:00",
19895,1,19959,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf","2002-04-11 00:00:00",
12102,2,19959,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf","2002-04-15 00:00:00",
19896,1,19959,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf","2002-04-15 00:00:00",
34151,2,19959,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19959s36lbl.pdf","2003-04-17 00:00:00",
1857,1,19959,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf","2009-06-18 00:00:00",
34152,2,19959,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf","2009-06-22 00:00:00",
1858,1,19959,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf","2009-07-24 00:00:00",
12103,2,19959,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf","2009-07-23 00:00:00",
1859,1,19959,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
1860,1,19959,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf","2011-01-04 00:00:00",
1861,1,19959,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
1862,1,19959,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019959Orig1s073ltr.pdf","2013-03-12 00:00:00",
12104,2,19959,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019959s073lbl.pdf","2013-03-12 00:00:00",
54420,2,19959,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019959s074s079lbl.pdf","2018-06-04 00:00:00",
54432,1,19959,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019959Orig1s074,019959Orig1s079ltr.pdf","2018-06-04 00:00:00",
1863,1,19959,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019959Orig1s075ltr.pdf","2015-02-27 00:00:00",
34153,2,19959,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019959s075lbl.pdf","2015-03-03 00:00:00",
12105,2,19959,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019959s077lbl.pdf","2016-02-17 00:00:00",
19897,1,19959,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019959Orig1s077ltr.pdf","2016-01-11 00:00:00",
54421,2,19959,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019959s074s079lbl.pdf","2018-06-04 00:00:00",
54431,1,19959,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019959Orig1s074,019959Orig1s079ltr.pdf","2018-06-04 00:00:00",
19898,1,19961,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19961slr009ltr.pdf","2003-09-29 00:00:00",
20433,3,19961,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019961_S009_GANITE.pdf","2007-08-06 00:00:00",
20434,3,19962,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-001_Toprol_XL.pdf","2005-07-15 00:00:00",
20435,3,19962,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-002_Toprol_XL.pdf","2005-07-15 00:00:00",
41108,3,19962,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-003_Toprol_XL.pdf","2005-07-15 00:00:00",
41109,3,19962,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-004_Toprol_XL.pdf","2005-07-15 00:00:00",
12106,2,19962,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf","2000-07-10 00:00:00",
19899,1,19962,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_Approv.pdf","2000-07-10 00:00:00",
41110,3,19962,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol.cfm","2000-07-20 00:00:00",
19900,1,19962,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962s22ltr.pdf","2002-03-05 00:00:00",
41111,3,19962,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-962S022.pdf","2002-05-30 00:00:00",
1864,1,19962,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962slr024ltr.pdf","2003-01-30 00:00:00",
1865,1,19962,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s027ltr.pdf","2005-02-17 00:00:00",
34154,2,19962,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf","2005-02-17 00:00:00",
19901,1,19962,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s028ltr.pdf","2005-04-12 00:00:00",
19902,1,19962,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s031LTR.pdf","2006-05-05 00:00:00",
19903,1,19962,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s032LTR.pdf","2006-08-04 00:00:00",
34155,2,19962,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf","2006-08-04 00:00:00",
1866,1,19962,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s033ltr.pdf","2007-07-24 00:00:00",
34156,2,19962,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf","2007-07-24 00:00:00",
52037,20,19962,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019962s033_metoprolol_ToprolXL-MedRev.pdf","1900-01-01 00:00:00",
52038,23,19962,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019962_metoprolol_ToprolXL_WR reissued.pdf","1900-01-01 00:00:00",
52039,18,19962,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019962s033_metoprolol_ToprolXL-ClinPharmRev.pdf","1900-01-01 00:00:00",
52041,61,19962,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019962s033_metoprolol_ToprolXL-ClinPharmRev addendum.pdf","1900-01-01 00:00:00",
19904,1,19962,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s034ltr.pdf","2007-03-23 00:00:00",
12107,2,19962,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf","2008-02-25 00:00:00",
19905,1,19962,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019962s036ltr.pdf","2008-02-19 00:00:00",
1867,1,19962,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019962s038ltr.pdf","2009-03-02 00:00:00",
34157,2,19962,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf","2009-03-02 00:00:00",
12108,2,19962,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf","2010-03-26 00:00:00",
19906,1,19962,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s041ltr.pdf","2010-03-24 00:00:00",
12109,2,19962,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf","2010-01-20 00:00:00",
19907,1,19962,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s042ltr.pdf","2010-01-26 00:00:00",
1868,1,19962,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019962Orig1s043ltr.pdf","2012-11-05 00:00:00",
34158,2,19962,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf","2012-11-02 00:00:00",
19908,1,19962,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019962Orig1s044ltr.pdf","2014-05-08 00:00:00",
34159,2,19962,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf","2014-05-12 00:00:00",
1869,1,19963,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF","2000-08-01 00:00:00",
34160,2,19963,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF","2000-08-01 00:00:00",
1870,1,19963,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF","2000-08-01 00:00:00",
34161,2,19963,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF","2000-08-01 00:00:00",
1871,1,19964,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
12110,2,19964,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
1872,1,19964,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf","2003-03-25 00:00:00",
34162,2,19964,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf","2003-03-20 00:00:00",
1873,1,19964,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr020ltr.pdf","2003-09-30 00:00:00",
12111,2,19964,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf","2004-07-01 00:00:00",
19909,1,19964,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf","2004-06-30 00:00:00",
1874,1,19964,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf","2013-10-01 00:00:00",
34163,2,19964,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf","2013-09-27 00:00:00",
1875,1,19964,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf","2014-07-25 00:00:00",
34164,2,19964,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf","2014-07-24 00:00:00",
41112,3,19965,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019965ap.pdf","1997-04-16 00:00:00",
12112,2,19965,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19965slr024_novolin_lbl.pdf","2003-08-15 00:00:00",
19910,1,19965,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19965slr024ltr.pdf","2003-08-15 00:00:00",
1876,1,19966,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19966slr008ltr.pdf","2003-04-18 00:00:00",
12113,2,19966,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019966s008lbl.pdf","2003-04-07 00:00:00",
19911,1,19967,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19967slr004ltr.pdf","2003-04-18 00:00:00",
34165,2,19967,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019967s004lbl.pdf","2003-04-07 00:00:00",
41113,3,19967,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019967_S004_ULTRAVATE CREAM.pdf","2007-08-06 00:00:00",
1877,1,19967,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19967s010ltr.pdf","2004-09-17 00:00:00",
34166,2,19967,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19967s010lbl.pdf","2004-09-17 00:00:00",
19912,1,19967,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf","2012-04-04 00:00:00",
34167,2,19967,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019967s015lbl.pdf","2012-04-02 00:00:00",
12114,2,19968,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf","2004-09-17 00:00:00",
19913,1,19968,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19968s007ltr.pdf","2004-09-17 00:00:00",
1878,1,19968,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf","2012-04-04 00:00:00",
34168,2,19968,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf","2012-04-02 00:00:00",
1879,1,19970,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019970Orig1s015ltr.pdf","2014-10-03 00:00:00",
34169,2,19970,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019970s015lbl.pdf","2014-10-03 00:00:00",
45109,2,19970,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019970s018lbl.pdf","2016-08-23 00:00:00",
45155,1,19970,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019970Orig1s018ltr.pdf","2016-08-22 00:00:00",
20436,3,19971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019971ap.pdf","1997-12-02 00:00:00",
19914,1,19976,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19976slr005ltr.pdf","2002-11-04 00:00:00",
1880,1,19976,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf","2004-03-02 00:00:00",
19915,1,19977,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf","2001-07-13 00:00:00",
19916,1,19977,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf","2002-02-14 00:00:00",
1881,1,19979,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19979S18ltr.pdf","2001-04-18 00:00:00",
20437,3,19979,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-879S018_Ticlid.cfm","2001-12-18 00:00:00",
34170,2,19979,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf","2001-04-18 00:00:00",
20438,3,19979,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19979-s019_ticlid.pdf","2001-06-04 00:00:00",
20439,3,19982,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982_Zebeta.cfm","2001-08-01 00:00:00",
20440,3,19982,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S1_Zebeta.pdf","2001-08-01 00:00:00",
41114,3,19982,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf","2002-08-01 00:00:00",
20441,3,19982,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19982-S4_Zebeta.pdf","1997-01-14 00:00:00",
20442,3,19982,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S5_Zebeta.pdf","1998-06-23 00:00:00",
20443,3,19982,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S6_Zebeta.pdf","1998-02-19 00:00:00",
19917,1,19982,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf","2004-07-01 00:00:00",
19918,1,19982,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf","2007-09-26 00:00:00",
34171,2,19982,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019982s014lbl.pdf","2010-08-12 00:00:00",
12115,2,19982,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf","2011-02-04 00:00:00",
19919,1,19982,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019982s016ltr.pdf","2011-02-10 00:00:00",
1882,1,19983,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf","1998-12-23 00:00:00",
41115,3,19983,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm","1998-12-23 00:00:00",
1883,1,19983,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf","1998-12-23 00:00:00",
20444,3,19983,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm","1998-12-23 00:00:00",
1884,1,19983,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983s16ltr.pdf","2002-01-18 00:00:00",
12116,2,19983,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf","2002-01-18 00:00:00",
1885,1,19983,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983slr017ltr.pdf","2002-10-04 00:00:00",
41116,3,19991,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019991ap.pdf","1997-04-16 00:00:00",
34172,2,19991,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s31lbl.pdf","2003-04-17 00:00:00",
1886,1,19991,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf","2002-03-11 00:00:00",
34173,2,19991,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf","2002-03-11 00:00:00",
1887,1,19991,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf","2002-04-11 00:00:00",
12117,2,19991,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf","2002-04-11 00:00:00",
1888,1,19991,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf","2002-04-15 00:00:00",
12118,2,19991,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf","2002-04-15 00:00:00",
12119,2,19991,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s37lbl.pdf","2003-04-17 00:00:00",
12120,2,19991,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf","2009-06-22 00:00:00",
19920,1,19991,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf","2009-06-18 00:00:00",
19921,1,19991,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf","2009-07-24 00:00:00",
34174,2,19991,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf","2009-07-23 00:00:00",
1889,1,19991,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
1890,1,19991,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf","2011-01-04 00:00:00",
19922,1,19991,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
1891,1,19991,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019991Orig1s074ltr.pdf","2013-03-12 00:00:00",
12121,2,19991,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019991s074lbl.pdf","2013-03-12 00:00:00",
54423,2,19991,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019991s075s079lbl.pdf","2018-06-04 00:00:00",
54430,1,19991,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019991Orig1s075,019991Orig1s079ltr.pdf","2018-06-04 00:00:00",
12122,2,19991,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019991s077lbl.pdf","2016-01-12 00:00:00",
19923,1,19991,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019991Orig1s077ltr.pdf","2016-01-11 00:00:00",
54422,2,19991,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019991s075s079lbl.pdf","2018-06-04 00:00:00",
54429,1,19991,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019991Orig1s075,019991Orig1s079ltr.pdf","2018-06-04 00:00:00",
1892,1,19992,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19992s019ltr.pdf","2004-08-25 00:00:00",
34175,2,19992,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf","2004-08-25 00:00:00",
1893,1,19992,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019992s020ltr.pdf","2006-02-08 00:00:00",
12123,2,19992,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf","2006-02-08 00:00:00",
47637,2,19992,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf","2017-03-22 00:00:00",
47682,1,19992,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019992Orig1s026ltr.pdf","2017-03-24 00:00:00",
1894,1,19998,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019998s013ltr.pdf","2007-07-16 00:00:00",
34176,2,19998,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf","2007-07-16 00:00:00",
19924,1,19998,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019998s017ltr.pdf","2010-10-19 00:00:00",
55783,2,19998,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf","2018-10-02 00:00:00",
46191,2,19999,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf","2016-12-16 00:00:00",
46248,1,19999,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019999Orig1s021,s022ltr.pdf","2016-12-20 00:00:00",
46192,2,19999,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019999s021s022lbl.pdf","2016-12-16 00:00:00",
46249,1,19999,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019999Orig1s021,s022ltr.pdf","2016-12-20 00:00:00",
19925,1,20001,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020001Orig1s012ltr.pdf","2015-12-18 00:00:00",
45067,1,20005,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020005Orig1s014ltr.pdf","2016-08-26 00:00:00",
45171,2,20005,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf","2016-08-29 00:00:00",
23967,14,20007,"ORIG",1,"Other Important Information from FDA","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm","2011-12-20 00:00:00",
23968,14,20007,"ORIG",1,"Pediatric Written Request","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020007_Zofran_Pediatric_Written_Request.pdf","2007-07-09 00:00:00",
20445,3,20007,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm","1997-10-31 00:00:00",
41117,3,20007,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020007_s030_Zofran_Injection.pdf","2009-01-12 00:00:00",
12124,2,20007,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf","2004-12-03 00:00:00",
19926,1,20007,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf","2004-12-02 00:00:00",
1895,1,20007,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20007s035ltr.pdf","2005-03-30 00:00:00",
12125,2,20007,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf","2005-03-30 00:00:00",
52917,20,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007s35_ondansetron_Zofran-MedRev.pdf","1900-01-01 00:00:00",
52918,17,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007s35_ondansetron_Zofran-StatsRev.pdf","1900-01-01 00:00:00",
52919,18,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007s35_ondansetron_Zofran-ClinPharmRev.pdf","1900-01-01 00:00:00",
52920,25,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007_ondansetron_Zofran_6-26-01_HFD180_orig.pdf","1900-01-01 00:00:00",
52921,26,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007_ondansetron_Zofran_9-3-04_HFD180_amend2.pdf","1900-01-01 00:00:00",
53117,23,20007,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020007_ondansetron_Zofran_6-26-01_HFD180_orig.pdf","1900-01-01 00:00:00",
12126,2,20007,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf","2006-01-05 00:00:00",
20446,3,20007,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020007_s037_Zofran Inj.pdf","2009-09-16 00:00:00",
19927,1,20007,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf","2006-09-18 00:00:00",
34177,2,20007,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf","2006-08-23 00:00:00",
1896,1,20007,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf","2010-09-28 00:00:00",
12127,2,20007,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf","2010-09-29 00:00:00",
19928,1,20007,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf","2011-07-13 00:00:00",
1897,1,20007,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf","2011-09-16 00:00:00",
12128,2,20007,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf","2011-09-16 00:00:00",
1898,1,20007,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020007Orig1s043ltr.pdf","2012-11-16 00:00:00",
12129,2,20007,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf","2012-11-15 00:00:00",
19929,1,20007,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf","2013-12-13 00:00:00",
34178,2,20007,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020007s044lbl.pdf","2013-12-11 00:00:00",
12130,2,20007,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf","2014-09-22 00:00:00",
19930,1,20007,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020007Orig1s046ltr.pdf","2014-09-23 00:00:00",
47512,2,20007,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020007s047lbl.pdf","2017-03-09 00:00:00",
47546,1,20007,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20007Orig1s047ltr.pdf","2017-03-14 00:00:00",
1899,1,20010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20010ltr.pdf","2000-12-08 00:00:00",
34179,2,20010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20010lbl.pdf","2000-12-08 00:00:00",
41118,3,20010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20010_Lotrisone.cfm","2004-09-08 00:00:00",
1900,1,20010,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20010slr003ltr.pdf","2002-12-17 00:00:00",
12131,2,20010,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.pdf","2003-04-04 00:00:00",
1901,1,20010,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20010slr005ltr.pdf","2003-04-15 00:00:00",
12132,2,20010,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.pdf","2003-03-28 00:00:00",
19931,1,20010,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020010s011LTR.pdf","2006-04-25 00:00:00",
1902,1,20010,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s015ltr.pdf","2008-02-21 00:00:00",
12133,2,20010,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf","2008-01-30 00:00:00",
1903,1,20010,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s020ltr.pdf","2008-12-24 00:00:00",
19932,1,20010,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020010s021ltr.pdf","2009-05-13 00:00:00",
34180,2,20010,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020010s021lbl.pdf","2009-05-13 00:00:00",
44041,10,20011,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
19933,1,20011,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF","1998-04-09 00:00:00",
20447,3,20011,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm","2001-08-06 00:00:00",
1904,1,20011,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20011s21ltr.pdf","2001-09-21 00:00:00",
12134,2,20011,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf","2001-09-21 00:00:00",
41119,3,20011,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-011S021_Lupron.cfm","2001-11-14 00:00:00",
1905,1,20011,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf","2004-01-22 00:00:00",
19934,1,20011,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf","2004-01-14 00:00:00",
1906,1,20011,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
1907,1,20011,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
19935,1,20011,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf","2007-11-08 00:00:00",
1908,1,20011,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf","2009-06-08 00:00:00",
12135,2,20011,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf","2009-06-04 00:00:00",
19936,1,20011,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf","2010-11-02 00:00:00",
34181,2,20011,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf","2010-10-29 00:00:00",
19937,1,20011,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf","2012-04-02 00:00:00",
34182,2,20011,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf","2012-03-28 00:00:00",
1909,1,20011,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf","2011-06-16 00:00:00",
12136,2,20011,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf","2011-06-16 00:00:00",
12137,2,20011,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf","2012-01-23 00:00:00",
19938,1,20011,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf","2012-01-25 00:00:00",
12138,2,20011,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf","2013-11-05 00:00:00",
19939,1,20011,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf","2013-10-31 00:00:00",
12139,2,20013,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf","2003-04-17 00:00:00",
1910,1,20013,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20013slr014ltr.pdf","2004-03-10 00:00:00",
12140,2,20013,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf","2004-04-05 00:00:00",
1911,1,20013,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20013s015ltr.pdf","2005-03-18 00:00:00",
34183,2,20013,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf","2005-03-18 00:00:00",
1912,1,20014,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020014s022LTR.pdf","2006-08-04 00:00:00",
20448,3,20021,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S001_EFIDAC 24_AP.pdf","2007-05-09 00:00:00",
20449,3,20021,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S002_EFIDAC 24_AP.pdf","2007-05-09 00:00:00",
41120,3,20021,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S003_EFIDAC 24_AP.pdf","2007-05-09 00:00:00",
20450,3,20021,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020021_S004_EFIDAC_AP.pdf","2007-07-06 00:00:00",
41121,3,20021,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S005_SUDAFED_AP.pdf","2007-07-06 00:00:00",
20451,3,20021,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S006_SUDAFED_AP.pdf","2007-07-06 00:00:00",
1913,1,20027,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20027s019ltr.pdf","2004-12-30 00:00:00",
44042,10,20031,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm","2005-08-16 00:00:00",
53121,23,20031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020031, 020710_paroxetine_Paxil_WR_orig.pdf","1900-01-01 00:00:00",
53122,25,20031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020031, 020710_paroxetine_Paxil_WR_amend.pdf","1900-01-01 00:00:00",
53123,20,20031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020031s037_paroxetine_Paxil-MedRev.pdf","1900-01-01 00:00:00",
53124,18,20031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020031s037_paroxetine_Paxil-ClinPharmRev.pdf","1900-01-01 00:00:00",
1914,1,20031,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20031s23ltr.pdf","1999-05-11 00:00:00",
34184,2,20031,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s23lbl.pdf","2003-04-24 00:00:00",
41122,3,20031,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S025_PAXIL_AP.pdf","2007-07-09 00:00:00",
12141,2,20031,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf","2001-04-13 00:00:00",
19940,1,20031,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031S26ltr.pdf","2001-04-13 00:00:00",
20452,3,20031,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S026_Paxil.cfm","2004-06-29 00:00:00",
20453,3,20031,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S027_PAXIL_AP.pdf","2007-07-09 00:00:00",
20454,3,20031,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S028_PAXIL_AP.pdf","2007-07-09 00:00:00",
19941,1,20031,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031s29ltr.pdf","2001-12-14 00:00:00",
20455,3,20031,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S029.pdf","2004-09-15 00:00:00",
34185,2,20031,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s29lbl.pdf","2001-12-14 00:00:00",
41123,3,20031,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S030_PAXIL_AP.pdf","2007-07-09 00:00:00",
41124,3,20031,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020031_S031_PAXIL_AP.pdf","2007-07-09 00:00:00",
19942,1,20031,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20031se8-035ltr.pdf","2002-10-02 00:00:00",
19943,1,20031,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf","2004-04-20 00:00:00",
19944,1,20031,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf","2004-04-20 00:00:00",
1915,1,20031,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf","2005-07-15 00:00:00",
1916,1,20031,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr019ltr.pdf","2004-05-27 00:00:00",
12142,2,20031,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf","2005-01-13 00:00:00",
19945,1,20031,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr.pdf","2005-01-13 00:00:00",
19946,1,20031,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046ltr.pdf","2006-03-23 00:00:00",
1917,1,20031,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf","2006-02-08 00:00:00",
19947,1,20031,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-25 00:00:00",
19948,1,20031,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf","2006-02-08 00:00:00",
19949,1,20031,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf","2006-02-08 00:00:00",
41125,3,20031,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020031Orig1s052.pdf","2014-01-16 00:00:00",
1918,1,20031,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf","2007-08-07 00:00:00",
12143,2,20031,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf","2007-08-03 00:00:00",
19950,1,20031,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-25 00:00:00",
19951,1,20031,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-25 00:00:00",
1919,1,20031,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
34186,2,20031,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf","2011-07-12 00:00:00",
1920,1,20031,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf","2009-11-19 00:00:00",
12144,2,20031,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf","2009-11-05 00:00:00",
12145,2,20031,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf","2008-11-07 00:00:00",
21054,1,20031,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf","2008-11-03 00:00:00",
21055,1,20031,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf","2009-02-03 00:00:00",
34187,2,20031,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf","2009-02-04 00:00:00",
1921,1,20031,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
12146,2,20031,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
1922,1,20031,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf","2010-11-02 00:00:00",
34188,2,20031,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf","2010-10-28 00:00:00",
1923,1,20031,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
12147,2,20031,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
1924,1,20031,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
34189,2,20031,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf","2011-07-12 00:00:00",
1925,1,20031,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf","2012-12-21 00:00:00",
34190,2,20031,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf","2012-12-31 00:00:00",
21056,1,20031,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf","2012-04-12 00:00:00",
34191,2,20031,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf","2012-04-17 00:00:00",
21057,1,20031,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
34192,2,20031,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
1926,1,20031,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf","2014-07-23 00:00:00",
12148,2,20031,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf","2014-07-29 00:00:00",
46694,2,20031,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf","2017-01-06 00:00:00",
46811,1,20031,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf","2017-01-13 00:00:00",
46812,8,20031,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43","2017-01-13 00:00:00",
21058,1,20032,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020032s026ltr.pdf","2005-05-02 00:00:00",
1927,1,20032,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020032s035ltr.pdf","2009-02-13 00:00:00",
21059,1,20032,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020032s036ltr.pdf","2009-01-14 00:00:00",
21060,1,20033,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf","2003-11-05 00:00:00",
21061,1,20033,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf","2007-02-12 00:00:00",
1928,1,20033,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf","2008-06-02 00:00:00",
21062,1,20033,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf","2009-01-26 00:00:00",
1929,1,20033,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020033s038ltr.pdf","2010-01-19 00:00:00",
34193,2,20033,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf","2009-11-12 00:00:00",
1930,1,20033,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s040ltr.pdf","2011-03-21 00:00:00",
12149,2,20033,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf","2011-03-21 00:00:00",
1931,1,20033,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s041ltr.pdf","2011-06-16 00:00:00",
12150,2,20033,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf","2011-06-16 00:00:00",
1932,1,20033,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033s043ltr.pdf","2012-02-17 00:00:00",
34194,2,20033,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf","2012-02-17 00:00:00",
12151,2,20033,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf","2012-01-23 00:00:00",
21063,1,20033,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf","2012-02-06 00:00:00",
1933,1,20033,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033Orig1s046ltr.pdf","2012-07-30 00:00:00",
34195,2,20033,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf","2012-07-30 00:00:00",
34196,2,20033,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf","2012-09-25 00:00:00",
1934,1,20033,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020033Orig1s050ltr.pdf","2014-12-15 00:00:00",
34197,2,20033,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf","2014-12-16 00:00:00",
1935,1,20033,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020033Orig1s052ltr.pdf","2015-08-27 00:00:00",
34198,2,20033,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf","2015-08-26 00:00:00",
49253,2,20033,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020033s061lbl.pdf","2017-08-07 00:00:00",
49265,1,20033,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020033Orig1s061ltr.pdf","2017-08-07 00:00:00",
55160,1,20033,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020033Orig1s062ltr.pdf","2018-08-10 00:00:00",
55413,2,20033,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020033s0062lbl.pdf","2018-09-10 00:00:00",
20456,3,20036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020036_aredia_toc.cfm","2004-01-06 00:00:00",
20457,3,20036,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf","2004-01-06 00:00:00",
21064,1,20036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036_apvl_ltr.pdf","2003-12-02 00:00:00",
23564,10,20036,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
34199,2,20036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf","2003-12-02 00:00:00",
41126,3,20036,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf","2004-01-06 00:00:00",
41127,3,20036,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s003_ltr_lbl.pdf","2004-01-06 00:00:00",
1936,1,20036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036s004_ltr.pdf","2004-09-10 00:00:00",
20458,3,20036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s004_pkg.pdf","2004-01-06 00:00:00",
34200,2,20036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf","2003-04-30 00:00:00",
41128,3,20036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf","2004-01-06 00:00:00",
1937,1,20036,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia_appltr.pdf","1998-09-22 00:00:00",
41129,3,20036,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia.cfm","1998-09-22 00:00:00",
1938,1,20036,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016_Aredia_appltr.pdf","1998-09-22 00:00:00",
41130,3,20036,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016.cfm","1998-09-22 00:00:00",
20459,3,20036,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020036_S020_AREDIA.pdf","2008-02-19 00:00:00",
21065,1,20036,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20036slr020ltr.pdf","2003-10-16 00:00:00",
12152,2,20036,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf","2001-08-20 00:00:00",
20460,3,20036,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-036S024_Aredia.pdf","2004-05-27 00:00:00",
21066,1,20036,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20036s24ltr.pdf","2001-08-20 00:00:00",
1939,1,20036,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20036se8026ltr.pdf","2002-07-12 00:00:00",
20461,3,20036,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020036_S028_AREDIA.pdf","2007-08-06 00:00:00",
21067,1,20036,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr028ltr.pdf","2004-01-09 00:00:00",
1940,1,20036,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr029ltr.pdf","2004-03-28 00:00:00",
1941,1,20036,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20036s030ltr.pdf","2005-02-03 00:00:00",
12153,2,20036,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf","2005-02-03 00:00:00",
41131,3,20036,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020036_s030_Aredia.pdf","2009-01-12 00:00:00",
1942,1,20036,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s031ltr.pdf","2005-10-14 00:00:00",
12154,2,20036,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf","2005-10-14 00:00:00",
1943,1,20036,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s032ltr.pdf","2005-11-18 00:00:00",
12155,2,20036,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf","2005-11-18 00:00:00",
12156,2,20036,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf","2007-12-14 00:00:00",
21068,1,20036,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020036s034ltr.pdf","2008-01-09 00:00:00",
12157,2,20036,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf","2009-01-02 00:00:00",
21069,1,20036,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020036s035ltr.pdf","2008-12-18 00:00:00",
1944,1,20036,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020036s039ltr.pdf","2011-04-04 00:00:00",
34201,2,20036,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf","2011-04-11 00:00:00",
12158,2,20036,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf","2012-06-06 00:00:00",
21070,1,20036,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020036s041ltr.pdf","2012-06-07 00:00:00",
12159,2,20037,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf","2007-09-06 00:00:00",
21071,1,20037,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020037s014ltr.pdf","2007-09-06 00:00:00",
21072,1,20037,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020037s023ltr.pdf","2011-04-13 00:00:00",
34202,2,20037,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf","2011-04-11 00:00:00",
1945,1,20037,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020037Orig1s031ltr.pdf","2012-09-14 00:00:00",
34203,2,20037,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf","2012-09-14 00:00:00",
51946,20,20038,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020038_fludarabine_Fludara-MedRev.pdf","1900-01-01 00:00:00",
51947,23,20038,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020038_fludarabine_Fludara_11-9-01_HFD150_orig.pdf","1900-01-01 00:00:00",
34204,2,20038,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20038s19lbl.pdf","2003-04-21 00:00:00",
1946,1,20038,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20038se8-028ltr.pdf","2003-08-14 00:00:00",
34205,2,20038,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20038se8-028_fludara_lbl.pdf","2003-08-14 00:00:00",
12160,2,20038,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf","2007-12-27 00:00:00",
21073,1,20038,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020038s031ltr.pdf","2008-01-09 00:00:00",
1947,1,20038,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020038s032ltr.pdf","2009-02-13 00:00:00",
34206,2,20038,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf","2009-02-12 00:00:00",
1948,1,20038,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020038s033ltr.pdf","2010-08-02 00:00:00",
34207,2,20038,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020038s033lbl.pdf","2010-07-31 00:00:00",
21074,1,20041,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20041slr011ltr.pdf","2002-08-21 00:00:00",
21075,1,20041,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20041scs013ltr.pdf","2004-05-27 00:00:00",
1949,1,20047,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf","2014-12-24 00:00:00",
12161,2,20047,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf","2015-01-09 00:00:00",
41132,3,20049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020049a_052292_biopharmrev.pdf","1998-02-18 00:00:00",
12162,2,20049,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf","1999-09-10 00:00:00",
21076,1,20049,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_approv.pdf","1999-09-10 00:00:00",
41133,3,20049,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20046S006_Pentasa.cfm","1999-09-10 00:00:00",
1950,1,20049,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf","2004-07-14 00:00:00",
41134,3,20049,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020049_S015_PENTASA.pdf","2007-11-19 00:00:00",
1951,1,20049,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020049s017ltr.pdf","2006-07-03 00:00:00",
21077,1,20049,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020049s019ltr.pdf","2007-07-05 00:00:00",
21078,1,20049,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s025ltr.pdf","2013-07-26 00:00:00",
34208,2,20049,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf","2013-07-30 00:00:00",
12163,2,20049,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf","2013-12-17 00:00:00",
21079,1,20049,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s026ltr.pdf","2013-12-17 00:00:00",
21080,1,20049,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020049Orig1s027ltr.pdf","2015-08-10 00:00:00",
34209,2,20049,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf","2015-08-07 00:00:00",
41135,3,20049,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020049Orig1s027.pdf","2015-11-18 00:00:00",
49533,2,20049,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s028lbl.pdf","2017-08-24 00:00:00",
49539,1,20049,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s028ltr.pdf","2017-08-25 00:00:00",
49126,1,20049,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf","2017-07-28 00:00:00",
49142,2,20049,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s030lbl.pdf","2017-07-31 00:00:00",
54318,2,20049,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020049s031lbl.pdf","2018-05-24 00:00:00",
54380,1,20049,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020049Origs031ltr.pdf","2018-05-31 00:00:00",
20462,3,20051,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020051S003ap.pdf","1997-01-10 00:00:00",
1952,1,20051,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020051s013ltr.pdf","2008-11-03 00:00:00",
34210,2,20051,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020051s013lbl.pdf","2008-11-07 00:00:00",
1953,1,20051,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020051s016ltr.pdf","2009-11-19 00:00:00",
34211,2,20051,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020051s016lbl.pdf","2009-09-17 00:00:00",
1954,1,20051,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020051s017ltr.pdf","2011-02-09 00:00:00",
34212,2,20051,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020051s017lbl.pdf","2011-02-07 00:00:00",
21081,1,20051,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020051Orig1s020ltr.pdf","2013-10-16 00:00:00",
34213,2,20051,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020051s020lbl.pdf","2013-10-22 00:00:00",
1955,1,20051,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020051Orig1s021ltr.pdf","2015-05-26 00:00:00",
34214,2,20051,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020051s021lbl.pdf","2015-05-27 00:00:00",
49524,2,20051,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020051s022lbl.pdf","2017-08-24 00:00:00",
49581,1,20051,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020051Orig1s022ltr.pdf","2017-08-29 00:00:00",
21082,1,20057,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020057s034ltr.pdf","2006-02-22 00:00:00",
34215,2,20057,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020057s034lbl.pdf","2006-02-22 00:00:00",
41136,3,20058,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020058Orig1s009.pdf","2016-07-27 00:00:00",
20463,3,20058,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020058Orig1s010.pdf","2016-07-27 00:00:00",
23565,10,20059,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm234178.htm","2013-12-27 00:00:00",
1956,1,20059,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20059s7ltr.pdf","2001-08-31 00:00:00",
34216,2,20059,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf","2003-04-30 00:00:00",
41137,3,20059,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-059S007_Adenoscan.pdf","2004-05-25 00:00:00",
21083,1,20059,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf","2005-07-21 00:00:00",
21084,1,20059,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020059s014ltr.pdf","2010-01-19 00:00:00",
34217,2,20059,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf","2009-11-19 00:00:00",
12164,2,20059,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf","2014-01-07 00:00:00",
21085,1,20059,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s016ltr.pdf","2014-01-07 00:00:00",
21086,1,20059,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf","2014-08-21 00:00:00",
34218,2,20059,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf","2014-08-22 00:00:00",
1957,1,20059,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf","2014-08-21 00:00:00",
34219,2,20059,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf","2014-08-22 00:00:00",
41138,3,20062,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20062-s027_cardizem.pdf","2001-07-13 00:00:00",
1958,1,20062,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020062s040ltr.pdf","2010-11-30 00:00:00",
12165,2,20062,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf","2010-11-22 00:00:00",
45087,2,20062,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s042lbl.pdf","2016-06-22 00:00:00",
48412,3,20062,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020062Orig1s042.pdf","2017-05-17 00:00:00",
45914,1,20062,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020062Orig1s043ltr.pdf","2016-11-22 00:00:00",
45940,2,20062,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s043lbl.pdf","2016-11-21 00:00:00",
21087,1,20064,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr013ltr.pdf","2003-02-04 00:00:00",
1959,1,20064,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr014ltr.pdf","2003-11-05 00:00:00",
34220,2,20064,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf","2003-11-05 00:00:00",
1960,1,20064,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020064s017ltr.pdf","2007-07-05 00:00:00",
1961,1,20064,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020064s019ltr.pdf","2009-03-06 00:00:00",
34221,2,20064,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf","2009-03-17 00:00:00",
1962,1,20064,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf","2011-06-09 00:00:00",
21088,1,20064,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020064Orig1s021ltr.pdf","2013-09-11 00:00:00",
34222,2,20064,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020064s021lbl.pdf","2013-09-09 00:00:00",
1963,1,20065,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020065s010ltr.pdf","2005-04-28 00:00:00",
1964,1,20065,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020065s017ltr.pdf","2007-08-02 00:00:00",
12166,2,20065,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf","2007-08-02 00:00:00",
20464,3,20066,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm","1998-12-23 00:00:00",
21089,1,20066,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf","1998-12-13 00:00:00",
34223,2,20066,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf","1998-12-23 00:00:00",
1965,1,20066,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_Approv.pdf","2000-09-25 00:00:00",
12167,2,20066,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf","2000-09-25 00:00:00",
20465,3,20066,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066s10_Nicorette.cfm","2000-09-25 00:00:00",
1966,1,20066,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf","2002-08-09 00:00:00",
1967,1,20066,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf016ltr.pdf","2004-04-29 00:00:00",
20466,3,20066,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020066_S016_NICORETTE_GUM_AP.pdf","2007-04-11 00:00:00",
21090,1,20066,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066slr017ltr.pdf","2004-06-24 00:00:00",
21091,1,20066,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf019ltr.pdf","2004-06-23 00:00:00",
1968,1,20066,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf","2005-12-13 00:00:00",
34224,2,20066,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf","2005-12-13 00:00:00",
21092,1,20066,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf","2006-05-05 00:00:00",
21093,1,20066,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf","2007-07-05 00:00:00",
34225,2,20066,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf","2007-06-27 00:00:00",
1969,1,20066,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf","2008-06-16 00:00:00",
20467,3,20066,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020066Orig1s031.pdf","2012-03-27 00:00:00",
1970,1,20066,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf","2009-05-08 00:00:00",
21094,1,20066,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf","2011-05-19 00:00:00",
21095,1,20066,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020066s038ltr.pdf","2011-09-29 00:00:00",
21096,1,20066,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf","2012-02-03 00:00:00",
12168,2,20066,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf","2012-03-28 00:00:00",
21097,1,20066,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf","2012-02-17 00:00:00",
12169,2,20066,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf","2014-01-16 00:00:00",
21098,1,20066,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf","2012-07-18 00:00:00",
1971,1,20066,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf","2013-10-31 00:00:00",
12170,2,20066,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf","2013-11-07 00:00:00",
21099,1,20066,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf","2014-06-12 00:00:00",
34226,2,20066,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf","2014-08-05 00:00:00",
1972,1,20066,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf","2014-06-12 00:00:00",
12171,2,20066,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf","2014-08-05 00:00:00",
1973,1,20066,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf","2014-11-03 00:00:00",
34227,2,20066,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf","2014-11-07 00:00:00",
1974,1,20066,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf","2015-10-02 00:00:00",
34228,2,20066,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020066s057lbl.pdf","2015-11-02 00:00:00",
49989,2,20066,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf","2017-10-10 00:00:00",
50745,1,20066,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf","2017-12-18 00:00:00",
50746,1,20066,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020066Orig1s060,018612Orig1s079ltr.pdf","2017-12-18 00:00:00",
54549,1,20066,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020066Orig1s061,018612Orig1s080ltr.pdf","2018-06-14 00:00:00",
54651,2,20066,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf","2018-06-21 00:00:00",
1975,1,20067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
12172,2,20067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
1976,1,20067,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20067slr005ltr.pdf","2003-06-08 00:00:00",
21100,1,20067,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf","2004-11-16 00:00:00",
34229,2,20067,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf","2004-11-16 00:00:00",
1977,1,20067,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010ltr.pdf","2006-03-23 00:00:00",
34230,2,20067,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf","2006-03-14 00:00:00",
1978,1,20067,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf","2006-01-30 00:00:00",
12173,2,20067,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf","2006-01-25 00:00:00",
1979,1,20067,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf","2007-04-25 00:00:00",
1980,1,20067,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf","2007-09-25 00:00:00",
12174,2,20067,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf","2007-09-26 00:00:00",
12175,2,20067,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf","2008-07-29 00:00:00",
21101,1,20067,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf","2008-07-30 00:00:00",
1981,1,20067,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf","2013-03-26 00:00:00",
12176,2,20067,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf","2013-03-26 00:00:00",
1982,1,20067,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf","2016-05-11 00:00:00",
34231,2,20067,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf","2016-05-11 00:00:00",
47535,2,20067,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf","2017-03-13 00:00:00",
47536,8,20067,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22","2017-03-13 00:00:00",
47561,1,20067,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017581Orig1s113,018164Orig1s063,020067Orig1s020ltr.pdf","2017-03-14 00:00:00",
21102,1,20068,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf","2006-05-18 00:00:00",
34232,2,20068,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf","2006-05-16 00:00:00",
34233,2,20068,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf","2007-12-03 00:00:00",
34234,2,20068,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf","2012-04-06 00:00:00",
12177,2,20068,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf","2015-05-05 00:00:00",
21103,1,20068,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf","2014-11-12 00:00:00",
45889,2,20068,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020068s022lbl.pdf","2016-11-14 00:00:00",
45893,1,20068,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020068Orig1s022ltr.pdf","2016-11-15 00:00:00",
47336,2,20068,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020068s023lbl.pdf","2017-02-27 00:00:00",
47432,1,20068,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020068Orig1s023ltr.pdf","2017-03-02 00:00:00",
41139,3,20070,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf","1997-10-10 00:00:00",
41140,3,20070,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf","1997-10-10 00:00:00",
1983,1,20070,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf","2003-06-22 00:00:00",
21104,1,20070,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf","2003-06-22 00:00:00",
21105,1,20071,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20071s014ltr.pdf","2004-08-11 00:00:00",
12178,2,20071,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf","2007-06-12 00:00:00",
21106,1,20071,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020071s017ltr.pdf","2007-06-14 00:00:00",
54628,1,20071,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020071Orig1s023ltr.pdf","2018-06-20 00:00:00",
54670,2,20071,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020071s023lbl.pdf","2018-06-21 00:00:00",
49325,2,20071,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf","2017-08-10 00:00:00",
49419,1,20071,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020071Orig1s025ltr.pdf","2017-08-15 00:00:00",
1984,1,20073,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20073slr011ltr.pdf","2004-03-10 00:00:00",
34235,2,20073,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf","2004-03-05 00:00:00",
1985,1,20073,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020073s016ltr.pdf","2007-10-10 00:00:00",
12179,2,20073,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf","2007-10-10 00:00:00",
1986,1,20075,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf","2002-03-06 00:00:00",
21107,1,20075,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf","2002-03-06 00:00:00",
1987,1,20075,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075scp017ltr.pdf","2002-11-20 00:00:00",
21108,1,20075,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scm019ltr.pdf","2003-01-17 00:00:00",
1988,1,20075,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scp020ltr.pdf","2003-05-30 00:00:00",
21109,1,20075,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s021ltr.pdf","2011-03-29 00:00:00",
34236,2,20075,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf","2011-03-29 00:00:00",
1989,1,20075,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s024ltr.pdf","2011-11-16 00:00:00",
12180,2,20075,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf","2011-11-16 00:00:00",
34237,2,20075,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf","2013-03-08 00:00:00",
21110,1,20075,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020075Orig1s028ltr.pdf","2013-11-20 00:00:00",
34238,2,20075,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf","2013-11-22 00:00:00",
1990,1,20075,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020075Orig1s031ltr.pdf","2014-11-21 00:00:00",
45461,1,20075,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020075Orig1s032ltr.pdf","2016-10-04 00:00:00",
45597,2,20075,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf","2016-10-06 00:00:00",
21111,1,20076,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20076S11LTR.PDF","1999-11-12 00:00:00",
1991,1,20076,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr020ltr.pdf","2002-07-12 00:00:00",
34239,2,20076,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s20lbl.pdf","2002-07-12 00:00:00",
12181,2,20076,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf","2002-07-15 00:00:00",
21112,1,20076,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr021ltr.pdf","2002-07-15 00:00:00",
21113,1,20076,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr024ltr.pdf","2004-03-03 00:00:00",
21114,1,20076,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr025ltr.pdf","2004-01-22 00:00:00",
21115,1,20076,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076s027ltr.pdf","2004-10-29 00:00:00",
1992,1,20076,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020076s028ltr.pdf","2005-11-30 00:00:00",
21116,1,20076,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020076s029ltr.pdf","2006-05-16 00:00:00",
12182,2,20076,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf","2014-07-29 00:00:00",
21117,1,20076,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020076Orig1s036ltr.pdf","2014-07-28 00:00:00",
12183,2,20076,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf","2016-06-17 00:00:00",
21118,1,20076,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s041ltr.pdf","2016-05-16 00:00:00",
1993,1,20076,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s042ltr.pdf","2016-07-07 00:00:00",
12184,2,20076,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf","2016-07-08 00:00:00",
12185,2,20076,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf","2016-07-18 00:00:00",
21119,1,20076,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s043ltr.pdf","2016-07-07 00:00:00",
49081,1,20076,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020076Orig1s045ltr.pdf","2017-07-25 00:00:00",
49085,2,20076,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020076Orig1s045lbl.pdf","2017-07-26 00:00:00",
54847,1,20076,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020076Orig1s049ltr.pdf","2018-07-06 00:00:00",
54863,2,20076,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020076Orig1s049lbl.pdf","2018-07-06 00:00:00",
44043,10,20080,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
41141,3,20080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020080ap.pdf","1997-11-20 00:00:00",
21120,1,20080,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20080slr029ltr.pdf","2004-06-07 00:00:00",
20468,3,20080,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020080_S030_IMITREX TABLETS, NASAL SPRAY INJ.pdf","2007-07-24 00:00:00",
21121,1,20080,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf","2003-08-15 00:00:00",
12186,2,20080,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf","2006-02-07 00:00:00",
21122,1,20080,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020080s036ltr.pdf","2006-02-08 00:00:00",
1994,1,20080,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020080s038ltr.pdf","2010-07-28 00:00:00",
34240,2,20080,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020080s038lbl.pdf","2010-07-31 00:00:00",
21123,1,20080,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf","2012-10-04 00:00:00",
34241,2,20080,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf","2012-10-04 00:00:00",
1995,1,20080,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf","2012-10-04 00:00:00",
12187,2,20080,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf","2012-10-04 00:00:00",
1996,1,20080,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf","2012-10-04 00:00:00",
12188,2,20080,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf","2012-10-04 00:00:00",
21124,1,20080,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf","2012-10-04 00:00:00",
34242,2,20080,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf","2012-10-04 00:00:00",
1997,1,20080,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s048ltr.pdf","2015-06-12 00:00:00",
12189,2,20080,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf","2015-06-12 00:00:00",
21125,1,20080,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s049ltr.pdf","2015-11-20 00:00:00",
34243,2,20080,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s049lbl.pdf","2015-11-25 00:00:00",
50699,2,20080,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020080s050lbl.pdf","2017-12-15 00:00:00",
50705,1,20080,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf","2017-12-15 00:00:00",
54919,2,20080,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020080s052lbl.pdf","2018-07-19 00:00:00",
54950,1,20080,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020080Orig1s052ltr.pdf","2018-07-23 00:00:00",
34244,2,20083,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20083s25lbl.pdf","2003-04-24 00:00:00",
12190,2,20083,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf","2002-07-17 00:00:00",
21126,1,20083,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf","2002-07-17 00:00:00",
12191,2,20083,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf","2002-04-11 00:00:00",
21127,1,20083,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083s29ltr.pdf","2002-04-11 00:00:00",
12192,2,20083,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf","2002-07-17 00:00:00",
21128,1,20083,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf","2002-07-17 00:00:00",
21129,1,20083,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20083slr033ltr.pdf","2003-11-25 00:00:00",
34245,2,20083,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20083slr033_sporanox_lbl.pdf","2003-12-02 00:00:00",
1998,1,20083,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf","2004-07-21 00:00:00",
34246,2,20083,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf","2004-07-21 00:00:00",
1999,1,20083,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf","2004-07-21 00:00:00",
12193,2,20083,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf","2004-07-21 00:00:00",
2000,1,20083,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf","2009-03-10 00:00:00",
12194,2,20083,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf","2009-03-17 00:00:00",
21130,1,20083,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf","2009-03-10 00:00:00",
34247,2,20083,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf","2009-03-17 00:00:00",
21131,1,20083,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf","2009-03-10 00:00:00",
34248,2,20083,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf","2009-03-17 00:00:00",
2001,1,20083,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf","2010-08-03 00:00:00",
12195,2,20083,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf","2010-07-31 00:00:00",
2002,1,20083,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf","2012-04-23 00:00:00",
12196,2,20083,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf","2012-04-20 00:00:00",
21132,1,20083,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf","2012-04-23 00:00:00",
34249,2,20083,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf","2012-04-20 00:00:00",
12197,2,20083,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf","2012-04-20 00:00:00",
21133,1,20083,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf","2012-04-23 00:00:00",
2003,1,20083,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf","2014-06-11 00:00:00",
12198,2,20083,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf","2014-06-10 00:00:00",
21134,1,20083,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf","2015-04-17 00:00:00",
34250,2,20083,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf","2015-04-17 00:00:00",
47659,2,20083,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s060lbl.pdf","2017-03-23 00:00:00",
47696,1,20083,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s060,020657Orig1s035ltr.pdf","2017-03-24 00:00:00",
49991,2,20083,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s061,020657s036lbl.pdf","2017-10-10 00:00:00",
50033,1,20083,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s061,020657Orig1s036ltr.pdf","2017-10-12 00:00:00",
54062,2,20083,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020083s062lbl.pdf","2018-05-10 00:00:00",
54077,1,20083,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20083Orig1s062ltr.pdf","2018-05-10 00:00:00",
2004,1,20088,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20088s16ltr.pdf","2002-01-15 00:00:00",
2005,1,20088,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020088s017ltr.pdf","2005-07-21 00:00:00",
2006,1,20088,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20088slr018ltr.pdf","2004-01-09 00:00:00",
20469,3,20089,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020089s002_zovirax_toc.cfm","2003-08-08 00:00:00",
34251,2,20089,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf","2003-04-21 00:00:00",
12199,2,20089,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf","2003-04-21 00:00:00",
12200,2,20089,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf","2004-05-27 00:00:00",
21135,1,20089,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf","2004-05-27 00:00:00",
2007,1,20089,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf","2005-12-15 00:00:00",
34252,2,20089,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf","2005-12-15 00:00:00",
21136,1,20089,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf","2008-08-13 00:00:00",
2008,1,20090,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
12201,2,20090,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
21137,1,20090,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34253,2,20090,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
2009,1,20090,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19949slr033,19950slr033,20090slr015ltr.pdf","2002-08-07 00:00:00",
12202,2,20090,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf","2002-08-07 00:00:00",
21138,1,20090,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf","2004-10-08 00:00:00",
34254,2,20090,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf","2004-10-08 00:00:00",
12203,2,20090,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf","2004-04-05 00:00:00",
21139,1,20090,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf","2004-03-28 00:00:00",
2010,1,20090,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf","2008-04-04 00:00:00",
12204,2,20090,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf","2008-04-16 00:00:00",
12205,2,20090,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf","2010-08-10 00:00:00",
21140,1,20090,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf","2010-08-10 00:00:00",
12206,2,20090,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf","2011-06-06 00:00:00",
21141,1,20090,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf","2011-06-08 00:00:00",
2011,1,20090,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf","2011-04-29 00:00:00",
34255,2,20090,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf","2011-04-29 00:00:00",
12207,2,20090,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf","2011-11-21 00:00:00",
21142,1,20090,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf","2011-11-21 00:00:00",
21143,1,20090,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf","2013-09-17 00:00:00",
34256,2,20090,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf","2013-09-17 00:00:00",
2012,1,20090,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf","2014-03-25 00:00:00",
12208,2,20090,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf","2014-03-25 00:00:00",
2013,1,20090,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1s060,020090orig1s044ltr.pdf","2014-10-31 00:00:00",
12209,2,20090,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf","2014-11-04 00:00:00",
52925,2,20090,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s064,020090s046lbl.pdf","2018-03-13 00:00:00",
52994,1,20090,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s064,020090Orig1s046ltr.pdf","2018-03-15 00:00:00",
50234,2,20090,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019949s067,020090s048lbl.pdf","2017-10-30 00:00:00",
50242,1,20090,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019949Orig1s067,020090Orig1s048ltr.pdf","2017-10-31 00:00:00",
51467,2,20090,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s068,020090s049lbl.pdf","2018-01-23 00:00:00",
51872,1,20090,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s068,020090Orig1s049ltr.pdf","2018-01-26 00:00:00",
51898,1,20090,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s068,020090Orig1s049ltr.pdf","2018-01-26 00:00:00",
2014,1,20092,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20092slr015ltr.pdf","2003-12-16 00:00:00",
21144,1,20092,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020092s016ltr.pdf","2010-06-15 00:00:00",
34257,2,20092,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020092s016lbl.pdf","2010-06-24 00:00:00",
21145,1,20092,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020092s017ltr.pdf","2011-06-09 00:00:00",
34258,2,20092,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020092s017lbl.pdf","2011-06-27 00:00:00",
20470,3,20095,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm","2003-04-29 00:00:00",
21146,1,20095,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules_approv.pdf","2004-07-01 00:00:00",
41142,3,20095,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules.cfm","2003-04-29 00:00:00",
21147,1,20095,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf","2002-01-07 00:00:00",
21148,1,20098,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf","2004-06-09 00:00:00",
34259,2,20098,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf","2004-06-09 00:00:00",
41143,3,20098,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron.cfm","2000-07-03 00:00:00",
2015,1,20098,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20098s013ltr.pdf","2002-06-04 00:00:00",
2016,1,20098,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020098s017ltr.pdf","2010-11-30 00:00:00",
34260,2,20098,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020098s017lbl.pdf","2010-11-22 00:00:00",
12210,2,20098,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf","2015-02-03 00:00:00",
55026,2,20098,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020098s019lbl.pdf","2018-07-27 00:00:00",
55044,1,20098,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020098Orig1s019Ltr.pdf","2018-07-30 00:00:00",
21149,1,20100,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20100scm021ltr.pdf","2003-11-25 00:00:00",
21150,1,20100,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
12211,2,20100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf","2007-08-23 00:00:00",
21151,1,20100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf","2007-08-27 00:00:00",
44044,10,20101,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
20471,3,20101,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm","2004-08-09 00:00:00",
21152,1,20101,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20101scm029ltr.pdf","2004-06-01 00:00:00",
21153,1,20101,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf","2004-08-25 00:00:00",
21154,1,20101,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf","2005-12-05 00:00:00",
2017,1,20101,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf","2005-02-23 00:00:00",
21155,1,20101,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf","2006-04-13 00:00:00",
12212,2,20101,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf","2006-09-21 00:00:00",
21156,1,20101,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf","2007-03-23 00:00:00",
12213,2,20101,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf","2007-08-03 00:00:00",
21157,1,20101,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
21158,1,20101,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf","2008-03-12 00:00:00",
34261,2,20101,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf","2008-03-13 00:00:00",
2018,1,20101,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf","2008-03-24 00:00:00",
12214,2,20101,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf","2008-03-24 00:00:00",
21159,1,20101,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf","2009-02-03 00:00:00",
34262,2,20101,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf","2009-02-04 00:00:00",
23566,10,20103,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm","2011-12-20 00:00:00",
34263,2,20103,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf","2006-01-05 00:00:00",
20472,3,20103,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm","1999-08-27 00:00:00",
21160,1,20103,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran_appltr.pdf","2004-07-01 00:00:00",
41144,3,20103,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm","1999-08-27 00:00:00",
20473,3,20103,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020103_S017_ZOFRAN.pdf","2007-09-14 00:00:00",
2019,1,20103,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF","2000-12-13 00:00:00",
12215,2,20103,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF","2000-12-13 00:00:00",
2020,1,20103,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20103slr021,20781slr003ltr.pdf","2004-07-01 00:00:00",
2021,1,20103,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf","2004-12-02 00:00:00",
34264,2,20103,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf","2004-12-03 00:00:00",
21161,1,20103,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20103s024ltr.pdf","2005-02-23 00:00:00",
34265,2,20103,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20103s024lbl.pdf","2005-02-23 00:00:00",
41145,3,20103,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s024_Zofran Tabs.pdf","2009-09-16 00:00:00",
20474,3,20103,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s025_Zofran  Inj.pdf","2009-09-16 00:00:00",
21162,1,20103,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf","2006-01-06 00:00:00",
34266,2,20103,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf","2006-01-05 00:00:00",
12216,2,20103,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf","2006-08-23 00:00:00",
21163,1,20103,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf","2006-09-18 00:00:00",
2022,1,20103,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf","2010-09-27 00:00:00",
12217,2,20103,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf","2010-09-29 00:00:00",
12218,2,20103,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf","2011-09-16 00:00:00",
21164,1,20103,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf","2011-09-16 00:00:00",
2023,1,20103,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf","2013-12-13 00:00:00",
34267,2,20103,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf","2013-12-11 00:00:00",
45484,1,20103,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf","2016-09-30 00:00:00",
12219,2,20103,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf","2014-09-22 00:00:00",
21165,1,20103,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf","2014-09-23 00:00:00",
45875,2,20103,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf","2016-11-10 00:00:00",
45878,1,20103,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s035,020605Orig1s019,020781Orig1s019ltr.pdf","2016-11-10 00:00:00",
49962,2,20103,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf","2017-10-06 00:00:00",
49976,1,20103,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020103Orig1s036,020605Orig1s020,020781Orig1s020ltr.pdf","2017-10-06 00:00:00",
21166,1,20105,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20105s002ltr.pdf","2002-05-20 00:00:00",
34268,2,20105,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20105s2lbl.pdf","2002-05-20 00:00:00",
2024,1,20111,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020111Orig1s007ltr.pdf","2013-05-10 00:00:00",
12220,2,20111,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020111Orig1s007lbl.pdf","2013-09-24 00:00:00",
50463,2,20111,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020111Orig1s009lbl.pdf","2017-11-20 00:00:00",
50464,1,20111,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020111Orig1s009ltr.pdf","2017-11-20 00:00:00",
21167,1,20114,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S5LTR.PDF","2000-05-30 00:00:00",
2025,1,20114,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S06ltr.pdf","2000-09-15 00:00:00",
20475,3,20114,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin.cfm","2004-05-27 00:00:00",
21168,1,20114,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020114s017ltr.pdf","2007-08-14 00:00:00",
2026,1,20114,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020114s023ltr.pdf","2012-01-23 00:00:00",
34269,2,20114,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf","2012-01-24 00:00:00",
21169,1,20114,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020114Orig1s026ltr.pdf","2014-10-24 00:00:00",
34270,2,20114,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf","2014-11-13 00:00:00",
55433,2,20114,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020114s028lbl.pdf","2018-09-12 00:00:00",
54058,3,20118,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20118Orig1s007.pdf","2018-05-08 00:00:00",
54057,3,20118,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20118Orig1s008.pdf","2018-05-08 00:00:00",
12221,2,20118,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf","2006-05-16 00:00:00",
21170,1,20118,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s010ltr.pdf","2006-05-16 00:00:00",
2027,1,20118,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s011LTR.pdf","2006-08-21 00:00:00",
34271,2,20118,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s011lbl.pdf","2006-08-18 00:00:00",
12222,2,20118,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf","2006-12-26 00:00:00",
21171,1,20118,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s012ltr.pdf","2006-12-28 00:00:00",
51830,20,20118,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/desflurane_Suprane-MedRev-20118s012.pdf","1900-01-01 00:00:00",
51831,23,20118,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020118_desflurane_Suprane_12-31-01_HFD170_orig.pdf","1900-01-01 00:00:00",
51832,25,20118,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020118_desflurane_Suprane_6-20-03_HFD170_amend.pdf","1900-01-01 00:00:00",
51833,26,20118,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020118_desflurane_Suprane_3-6-06_HFD170_amend2.pdf","1900-01-01 00:00:00",
12223,2,20118,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf","2009-04-23 00:00:00",
21172,1,20118,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020118s016ltr.pdf","2009-04-20 00:00:00",
12224,2,20118,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf","2010-04-05 00:00:00",
21173,1,20118,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020118s017ltr.pdf","2010-04-08 00:00:00",
2028,1,20118,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020118Orig1s018ltr.pdf","2013-09-24 00:00:00",
34272,2,20118,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020118s018lbl.pdf","2013-09-23 00:00:00",
2029,1,20118,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020118Orig1s020ltr.pdf","2015-02-27 00:00:00",
34273,2,20118,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020118s020lbl.pdf","2015-03-02 00:00:00",
45830,1,20118,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020118Orig1s021ltr.pdf","2016-11-08 00:00:00",
45849,2,20118,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020118s021lbl.pdf","2016-11-08 00:00:00",
48193,1,20118,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020118Orig1s024ltr.pdf","2017-05-02 00:00:00",
48221,2,20118,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020118s024lbl.pdf","2017-05-02 00:00:00",
21174,1,20119,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20119slr004ltr.pdf","2002-10-02 00:00:00",
21175,1,20119,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020119s009ltr.pdf","2009-02-13 00:00:00",
2030,1,20119,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010s011ltr.pdf","2011-10-24 00:00:00",
34274,2,20119,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf","2011-10-25 00:00:00",
12225,2,20119,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf","2011-10-25 00:00:00",
21176,1,20119,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020119s010,s011ltr.pdf","2011-10-24 00:00:00",
21177,1,20119,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020119Orig1s013ltr.pdf","2015-03-05 00:00:00",
34275,2,20119,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020119s013lbl.pdf","2015-03-05 00:00:00",
2031,1,20120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20120ltr.pdf","2000-02-04 00:00:00",
12226,2,20120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20120lbl.pdf","2000-02-04 00:00:00",
20476,3,20120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-120_Tri-Nasal.cfm","2002-11-20 00:00:00",
2032,1,20120,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020120s002ltr.pdf","2009-01-09 00:00:00",
12227,2,20120,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf","2009-01-07 00:00:00",
53088,18,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-ClinPharmRev-BPCA.pdf","1900-01-01 00:00:00",
53089,18,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_clinpharm review2_BPCA.pdf","1900-01-01 00:00:00",
53090,60,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_DD summary review_BPCA.pdf","1900-01-01 00:00:00",
53091,20,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-MedRev-BPCA.pdf","1900-01-01 00:00:00",
53092,17,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-StatsRev-BPCA.pdf","1900-01-01 00:00:00",
53093,20,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_TL Summary review_BPCA.pdf","1900-01-01 00:00:00",
53094,23,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020548s000_fluticasone propionate_WR.pdf","1900-01-01 00:00:00",
53095,25,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020548s000_fluticasone propionate_WR_Amend.pdf","1900-01-01 00:00:00",
53096,26,20121,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020548s000_fluticasone propionate_WR_Amend2.pdf","1900-01-01 00:00:00",
41146,3,20121,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20121.pdf","2010-05-25 00:00:00",
2033,1,20121,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20121s9ltr.pdf","1998-12-11 00:00:00",
12228,2,20121,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf","1998-12-11 00:00:00",
41147,3,20121,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121S009_Flonase.cfm","1998-12-11 00:00:00",
2034,1,20121,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf","2002-05-09 00:00:00",
21178,1,20121,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf","2002-05-09 00:00:00",
2035,1,20121,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf","2002-05-09 00:00:00",
2036,1,20121,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20121s023ltr.pdf","2002-05-23 00:00:00",
2037,1,20121,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20121se8-028ltr.pdf","2003-05-30 00:00:00",
34276,2,20121,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020121s028lbl.pdf","2003-05-06 00:00:00",
12229,2,20121,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf","2004-04-05 00:00:00",
21179,1,20121,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf","2004-04-07 00:00:00",
12230,2,20121,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf","2015-01-30 00:00:00",
21180,1,20121,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020121Orig1s044ltr.pdf","2015-01-26 00:00:00",
23567,10,20123,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
20477,3,20123,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020123_s015.pdf","1997-10-03 00:00:00",
2038,1,20123,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s018ltr.pdf","2002-07-08 00:00:00",
21181,1,20123,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s021ltr.pdf","2002-05-17 00:00:00",
21182,1,20123,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s022ltr.pdf","2002-06-28 00:00:00",
21183,1,20123,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123scm023ltr.pdf","2003-07-31 00:00:00",
21184,1,20123,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s034_ltr.pdf","2007-09-07 00:00:00",
34277,2,20123,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s034lbl.pdf","2007-09-06 00:00:00",
12231,2,20123,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf","2007-12-27 00:00:00",
21185,1,20123,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s035ltr.pdf","2008-01-09 00:00:00",
2039,1,20123,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf","2010-12-22 00:00:00",
12232,2,20123,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf","2010-12-20 00:00:00",
2040,1,20123,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039, 022066Orig1s004ltr.pdf","2013-08-29 00:00:00",
12233,2,20123,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf","2013-08-28 00:00:00",
2041,1,20123,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf","2014-11-18 00:00:00",
34278,2,20123,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf","2014-11-20 00:00:00",
53860,2,20123,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf","2018-04-27 00:00:00",
53861,8,20123,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1","2018-04-27 00:00:00",
53892,1,20123,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s046,022066Orig1s008Ltr.pdf","2018-05-01 00:00:00",
46279,2,20124,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020124s032lbl.pdf","2016-12-20 00:00:00",
46468,1,20124,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020124Orig1s032ltr.pdf","2016-12-22 00:00:00",
21186,1,20125,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20125ltr.pdf","1999-12-28 00:00:00",
34279,2,20125,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20125lbl.pdf","1999-12-28 00:00:00",
41148,3,20125,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20125_Accuretic.cfm","2001-05-31 00:00:00",
2042,1,20125,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf","2003-11-05 00:00:00",
2043,1,20125,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020125s007ltr.pdf","2009-11-12 00:00:00",
12234,2,20125,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf","2009-10-01 00:00:00",
2044,1,20125,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s010ltr.pdf","2011-03-24 00:00:00",
12235,2,20125,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf","2011-03-22 00:00:00",
21187,1,20125,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s011ltr.pdf","2011-10-18 00:00:00",
34280,2,20125,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s011lbl.pdf","2011-10-20 00:00:00",
2045,1,20125,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf","2012-01-23 00:00:00",
34281,2,20125,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s012lbl.pdf","2012-01-23 00:00:00",
2046,1,20125,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020125Orig1s014ltr.pdf","2012-09-24 00:00:00",
34282,2,20125,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s014lbl.pdf","2012-09-25 00:00:00",
21188,1,20125,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s015ltr.pdf","2013-09-24 00:00:00",
34283,2,20125,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s015lbl.pdf","2013-09-23 00:00:00",
2047,1,20125,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s016ltr_replacement.pdf","2014-01-21 00:00:00",
34284,2,20125,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s016lbl.pdf","2014-01-22 00:00:00",
21189,1,20125,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s017ltr.pdf","2013-10-28 00:00:00",
34285,2,20125,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s017lbl.pdf","2013-10-31 00:00:00",
12236,2,20125,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf","2014-05-06 00:00:00",
21190,1,20125,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s018ltr.pdf","2014-05-06 00:00:00",
2048,1,20125,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020125Orig1s019ltr.pdf","2015-02-06 00:00:00",
34286,2,20125,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s019lbl.pdf","2015-02-06 00:00:00",
12237,2,20125,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf","2015-09-14 00:00:00",
48128,2,20125,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020125s022lbl.pdf","2017-04-27 00:00:00",
48205,1,20125,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020125Orig1s022ltr.pdf","2017-05-02 00:00:00",
2049,1,20126,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20126slr006ltr.pdf","2004-07-01 00:00:00",
12238,2,20126,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf","2003-04-04 00:00:00",
41149,3,20130,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20130-s003_Estrostep.pdf","1999-05-07 00:00:00",
12239,2,20130,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf","2003-04-25 00:00:00",
2050,1,20130,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20130s009ltr.pdf","2002-06-14 00:00:00",
49305,2,20130,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf","2017-08-09 00:00:00",
49420,1,20130,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s017ltr.pdf","2017-08-15 00:00:00",
50012,2,20130,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf","2017-10-11 00:00:00",
50031,1,20130,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s018ltr.pdf","2017-10-12 00:00:00",
44045,10,20131,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
2051,1,20131,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf","2002-09-30 00:00:00",
21191,1,20131,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf","2002-09-30 00:00:00",
12240,2,20131,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf","2007-09-06 00:00:00",
21192,1,20131,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf","2007-09-06 00:00:00",
21193,1,20131,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf","2010-12-22 00:00:00",
34287,2,20131,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020131s024lbl.pdf","2010-12-20 00:00:00",
2052,1,20131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf","2013-08-16 00:00:00",
12241,2,20131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf","2013-08-15 00:00:00",
49771,2,20131,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020131s027lbl.pdf","2017-09-18 00:00:00",
49784,1,20131,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020131Orig1s027ltr.pdf","2017-09-19 00:00:00",
53847,2,20131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf","2018-04-27 00:00:00",
53848,8,20131,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf#page=1","2018-04-27 00:00:00",
53894,1,20131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020131Orig1s028,021489Orig1s006Ltr.pdf","2018-05-01 00:00:00",
23568,10,20132,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
21194,1,20132,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf","2010-08-16 00:00:00",
34288,2,20132,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf","2010-08-19 00:00:00",
20478,3,20132,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_S014_IMITREX TABLETS, NASAL SPRAY INJ.pdf","2007-07-24 00:00:00",
21195,1,20132,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf","2003-08-15 00:00:00",
20479,3,20132,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_s015_ImitrexTOC.cfm","2006-05-08 00:00:00",
2053,1,20132,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20132slr018ltr.pdf","2004-06-23 00:00:00",
2054,1,20132,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf","2010-08-16 00:00:00",
12242,2,20132,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf","2010-08-19 00:00:00",
21196,1,20132,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf","2010-08-16 00:00:00",
34289,2,20132,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf","2010-08-19 00:00:00",
2055,1,20132,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf","2010-08-16 00:00:00",
34290,2,20132,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf","2010-08-19 00:00:00",
21197,1,20132,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf","2012-03-05 00:00:00",
21198,1,20132,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf","2012-03-05 00:00:00",
34291,2,20132,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf","2012-03-06 00:00:00",
21199,1,20132,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf","2013-11-27 00:00:00",
34292,2,20132,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf","2013-11-26 00:00:00",
50697,2,20132,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020132s029lbl.pdf","2017-12-15 00:00:00",
50706,1,20132,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf","2017-12-15 00:00:00",
2056,1,20134,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020134Orig1s012ltr.pdf","2013-12-24 00:00:00",
34293,2,20134,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020134s012lbl.pdf","2013-12-23 00:00:00",
2057,1,20135,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf","2002-02-04 00:00:00",
41150,3,20135,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm","2006-05-08 00:00:00",
41151,3,20136,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020136ap_s08_s09.pdf","1997-10-09 00:00:00",
12243,2,20136,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf","2010-01-29 00:00:00",
21200,1,20136,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020136s023ltr.pdf","2010-02-01 00:00:00",
2058,1,20136,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020136Orig1s024ltr.pdf","2012-08-15 00:00:00",
12244,2,20136,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf","2012-08-15 00:00:00",
47109,2,20136,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020136s027lbl.pdf","2017-02-06 00:00:00",
47124,1,20136,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020136Orig1s027ltr.pdf","2017-02-07 00:00:00",
21201,1,20137,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf","2002-06-20 00:00:00",
41152,3,20137,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020136ap_s08_s09.pdf","1997-10-09 00:00:00",
2059,1,20140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s000ltrCorrected.pdf","2008-03-12 00:00:00",
2060,1,20140,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s001ltr.pdf","2008-07-15 00:00:00",
12245,2,20140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf","2008-03-13 00:00:00",
12246,2,20140,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf","2008-07-15 00:00:00",
24174,21,20140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140s000SumR.pdf","2010-03-11 00:00:00",
41153,3,20140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140_levoleucovorin_toc.cfm","2010-03-11 00:00:00",
2061,1,20140,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020140s002ltr.pdf","2011-05-04 00:00:00",
12247,2,20140,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf","2011-05-02 00:00:00",
23148,8,20142,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf","2009-11-16 00:00:00",
21202,1,20142,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf","2006-01-30 00:00:00",
34294,2,20142,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020142s017lbl.pdf","2006-01-25 00:00:00",
2062,1,20142,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020142s019ltr.pdf","2009-03-03 00:00:00",
34295,2,20142,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020142s019lbl.pdf","2009-03-17 00:00:00",
12248,2,20142,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf","2011-03-04 00:00:00",
21203,1,20142,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf","2011-02-28 00:00:00",
12249,2,20142,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf","2011-03-04 00:00:00",
21204,1,20142,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf","2011-02-28 00:00:00",
2063,1,20142,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020142Orig1s027ltr.pdf","2016-05-12 00:00:00",
34296,2,20142,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf","2016-05-11 00:00:00",
41154,3,20145,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s006_nitro-dur_toc.cfm","2003-08-07 00:00:00",
41155,3,20145,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s007_nitro-dur_toc.cfm","2003-08-07 00:00:00",
2064,1,20145,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20145slr015ltr.pdf","2004-06-25 00:00:00",
21205,1,20145,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20145scs016ltr.pdf","2002-10-18 00:00:00",
21206,1,20145,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20145s021ltr.pdf","2005-04-12 00:00:00",
21207,1,20145,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020145Orig1s027ltr.pdf","2014-10-03 00:00:00",
34297,2,20145,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020145s027lbl.pdf","2014-10-03 00:00:00",
21208,1,20147,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20147S06LTR.PDF","2000-04-12 00:00:00",
41156,3,20148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/97/020148_migranal_toc.cfm","2010-05-25 00:00:00",
2065,1,20148,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf","2002-07-31 00:00:00",
12250,2,20148,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf","2002-07-31 00:00:00",
21209,1,20148,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf","2002-07-31 00:00:00",
34298,2,20148,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf","2002-07-31 00:00:00",
23569,10,20151,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm","2005-04-15 00:00:00",
41157,3,20151,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
2066,1,20151,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf","2003-07-30 00:00:00",
12251,2,20151,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.pdf","2003-04-24 00:00:00",
20480,3,20151,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm","2007-07-06 00:00:00",
2067,1,20151,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf","2003-07-30 00:00:00",
34299,2,20151,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf","2004-06-02 00:00:00",
41158,3,20151,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm","2007-07-06 00:00:00",
41159,3,20151,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
20481,3,20151,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
41160,3,20151,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
41161,3,20151,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
20482,3,20151,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
2068,1,20151,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf","2004-05-07 00:00:00",
52222,20,20151,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20151Orig1s024, 20699Orig1s030_venlafaxine_Effexor-ClinicalR.pdf","1900-01-01 00:00:00",
52223,18,20151,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20151Orig1s024, 20699Orig1s030_venlafaxine_Effexor-ClinPharmR.pdf","1900-01-01 00:00:00",
52225,23,20151,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020151Orig1s000, 020699Orig1s000_venlafaxine_Effexor_12-18-01_HFD120_orig.pdf","1900-01-01 00:00:00",
53535,25,20151,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020151Orig1s000, 020699Orig1s000_venlafaxine_Effexor_12-18-01_HFD120_orig.pdf","1900-01-01 00:00:00",
53536,26,20151,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020151Orig1s000, 020699Orig1s000_venlafaxine_Effexor_12-18-01_HFD120_amend.pdf","1900-01-01 00:00:00",
20483,3,20151,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-05 00:00:00",
21210,1,20151,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf","2004-03-24 00:00:00",
20484,3,20151,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S028_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
21211,1,20151,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
34300,2,20151,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
2069,1,20151,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf","2004-04-20 00:00:00",
2070,1,20151,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
12252,2,20151,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
20485,3,20151,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S030_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
2071,1,20151,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf","2012-12-19 00:00:00",
34301,2,20151,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf","2012-12-13 00:00:00",
2072,1,20151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
12253,2,20151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
20486,3,20151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S032_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
12254,2,20151,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf","2007-08-02 00:00:00",
2073,1,20151,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf","2006-03-01 00:00:00",
21212,1,20151,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf","2005-02-23 00:00:00",
21213,1,20151,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf","2006-01-20 00:00:00",
2074,1,20151,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf","2006-01-20 00:00:00",
2075,1,20151,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s041ltr.pdf","2008-02-05 00:00:00",
2076,1,20151,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf","2007-02-12 00:00:00",
34302,2,20151,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf","2007-02-21 00:00:00",
21214,1,20151,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf","2006-09-20 00:00:00",
34303,2,20151,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf","2006-09-15 00:00:00",
2077,1,20151,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf","2006-10-23 00:00:00",
34304,2,20151,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf","2006-10-23 00:00:00",
21215,1,20151,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf","2007-08-02 00:00:00",
34305,2,20151,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf","2007-08-02 00:00:00",
2078,1,20151,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf","2007-09-25 00:00:00",
34306,2,20151,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf","2007-09-26 00:00:00",
2079,1,20151,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf","2007-09-25 00:00:00",
34307,2,20151,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf","2007-09-26 00:00:00",
21216,1,20151,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf","2008-05-28 00:00:00",
34308,2,20151,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf","2008-11-20 00:00:00",
21217,1,20151,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s052ltr.pdf","2008-02-14 00:00:00",
34309,2,20151,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf","2008-02-14 00:00:00",
2080,1,20151,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf","2010-01-19 00:00:00",
34310,2,20151,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf","2009-11-13 00:00:00",
2081,1,20151,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf","2009-02-03 00:00:00",
12255,2,20151,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf","2009-02-04 00:00:00",
2082,1,20151,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf","2012-12-19 00:00:00",
12256,2,20151,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf","2012-12-13 00:00:00",
21218,1,20151,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf","2010-01-14 00:00:00",
34311,2,20151,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf","2010-01-08 00:00:00",
2083,1,20151,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf","2010-01-14 00:00:00",
12257,2,20151,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf","2010-01-08 00:00:00",
2084,1,20151,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf","2012-12-19 00:00:00",
12258,2,20151,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf","2012-12-13 00:00:00",
2085,1,20151,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf","2012-05-09 00:00:00",
12259,2,20151,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf","2012-05-07 00:00:00",
2086,1,20151,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf","2012-12-19 00:00:00",
34312,2,20151,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf","2012-12-13 00:00:00",
46125,8,20151,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf#page=34","2016-12-09 00:00:00",
44046,10,20152,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
52058,20,20152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020152s032_nefazodone_Serzone_Clinical_BPCA.pdf","1900-01-01 00:00:00",
52059,23,20152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020152s000_nefazodone_Serzone_WR.pdf","1900-01-01 00:00:00",
52060,18,20152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020152s032_nefazodone_Serzone_ClinPharm_BPCA.pdf","1900-01-01 00:00:00",
41162,3,20152,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020152_S006_SERZONE_AP.pdf","2007-07-06 00:00:00",
20487,3,20152,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm","2007-05-09 00:00:00",
41163,3,20152,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm","2007-05-09 00:00:00",
2087,1,20152,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20152sltr.pdf","1998-03-31 00:00:00",
21219,1,20152,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152S26LTR.PDF","2001-03-21 00:00:00",
41164,3,20152,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-152s026_Nefazodone.cfm","2005-01-06 00:00:00",
21220,1,20152,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152s28ltr.pdf","2001-12-04 00:00:00",
41165,3,20152,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020152_S028_SERZONE_AP.pdf","2007-07-06 00:00:00",
2088,1,20152,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s29ltr.pdf","2002-01-08 00:00:00",
2089,1,20152,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20152slr031ltr.pdf","2003-05-30 00:00:00",
20488,3,20152,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020152_s031_SERZONETOC.cfm","2007-05-09 00:00:00",
2090,1,20152,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s033LTR.pdf","2002-06-20 00:00:00",
2091,1,20152,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20152slr034ltr.pdf","2004-06-01 00:00:00",
2092,1,20152,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20152s035ltr.pdf","2005-01-13 00:00:00",
12260,2,20152,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf","2005-01-13 00:00:00",
23570,10,20154,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm","2010-08-09 00:00:00",
41166,3,20154,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S004_VIDEX.pdf","2007-08-06 00:00:00",
20489,3,20154,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S009_VIDEX.pdf","2007-08-06 00:00:00",
41167,3,20154,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020154_S020_VIDEX.pdf","2007-08-06 00:00:00",
41168,3,20154,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm","2005-01-06 00:00:00",
2093,1,20154,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF","1999-10-29 00:00:00",
20490,3,20154,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm","2004-08-09 00:00:00",
34313,2,20154,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF","1999-10-29 00:00:00",
12261,2,20154,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF","1999-10-29 00:00:00",
21221,1,20154,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF","1999-10-29 00:00:00",
41169,3,20154,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm","2004-08-09 00:00:00",
20491,3,20154,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
41170,3,20154,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
34314,2,20154,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s35lbl.pdf","2003-04-21 00:00:00",
34315,2,20154,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s36lbl.pdf","2003-04-21 00:00:00",
2094,1,20154,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf","2002-04-01 00:00:00",
12262,2,20154,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf","2002-04-01 00:00:00",
2095,1,20154,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2002-09-25 00:00:00",
34316,2,20154,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2002-09-25 00:00:00",
41171,3,20154,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
12263,2,20154,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2002-09-25 00:00:00",
20492,3,20154,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
21222,1,20154,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2002-09-25 00:00:00",
2096,1,20154,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf","2003-03-10 00:00:00",
12264,2,20154,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf","2003-03-06 00:00:00",
12265,2,20154,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf","2004-01-22 00:00:00",
21223,1,20154,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf","2004-01-22 00:00:00",
12266,2,20154,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf","2006-08-21 00:00:00",
20493,3,20154,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020154_S049_VIDEX.pdf","2007-11-19 00:00:00",
21224,1,20154,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf","2006-09-18 00:00:00",
12267,2,20154,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf","2006-12-04 00:00:00",
21225,1,20154,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf","2006-12-28 00:00:00",
44047,10,20155,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm","2010-08-09 00:00:00",
20494,3,20155,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020155_S007_VIDEX.pdf","2007-08-06 00:00:00",
41172,3,20155,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020155_S007_VIDEX.pdf","2007-08-06 00:00:00",
20495,3,20155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm","2005-01-06 00:00:00",
21226,1,20155,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF","1999-10-29 00:00:00",
34317,2,20155,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF","1999-10-29 00:00:00",
41173,3,20155,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm","2004-08-09 00:00:00",
20496,3,20155,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
41174,3,20155,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
34318,2,20155,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s26lbl.pdf","2003-04-21 00:00:00",
12268,2,20155,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s27lbl.pdf","2003-04-21 00:00:00",
2097,1,20155,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf","2002-04-01 00:00:00",
12269,2,20155,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf","2002-04-01 00:00:00",
12270,2,20155,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2002-09-25 00:00:00",
21227,1,20155,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2002-09-25 00:00:00",
41175,3,20155,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
2098,1,20155,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2004-06-30 00:00:00",
34319,2,20155,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2004-06-30 00:00:00",
41176,3,20155,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
12271,2,20155,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf","2003-03-07 00:00:00",
21228,1,20155,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf","2003-03-10 00:00:00",
2099,1,20155,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf","2004-01-22 00:00:00",
34320,2,20155,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf","2004-01-22 00:00:00",
2100,1,20155,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf","2006-09-18 00:00:00",
12272,2,20155,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf","2006-08-21 00:00:00",
41177,3,20155,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020155_S038_VIDEX.pdf","2007-11-19 00:00:00",
21229,1,20155,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf","2006-12-28 00:00:00",
34321,2,20155,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf","2006-12-04 00:00:00",
44048,10,20156,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm","2010-08-09 00:00:00",
20497,3,20156,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020156_S007_VIDEX.pdf","2007-08-06 00:00:00",
20498,3,20156,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020156_S016_VIDEX.pdf","2007-08-06 00:00:00",
41178,3,20156,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm","2005-01-06 00:00:00",
2101,1,20156,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF","1999-10-29 00:00:00",
20499,3,20156,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm","2004-08-09 00:00:00",
34322,2,20156,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF","1999-10-21 00:00:00",
41179,3,20156,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
20500,3,20156,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm","2005-04-19 00:00:00",
12273,2,20156,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf","2003-04-21 00:00:00",
34323,2,20156,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s28lbl.pdf","2003-04-21 00:00:00",
12274,2,20156,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf","2002-04-01 00:00:00",
21230,1,20156,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf","2002-04-01 00:00:00",
12275,2,20156,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2002-09-25 00:00:00",
20501,3,20156,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
21231,1,20156,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2002-09-25 00:00:00",
2102,1,20156,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf","2002-09-25 00:00:00",
12276,2,20156,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf","2002-09-25 00:00:00",
41180,3,20156,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm","2005-04-27 00:00:00",
2103,1,20156,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf","2003-03-10 00:00:00",
34324,2,20156,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf","2003-03-07 00:00:00",
2104,1,20156,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf","2004-01-22 00:00:00",
12277,2,20156,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf","2004-01-22 00:00:00",
12278,2,20156,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf","2006-08-21 00:00:00",
21232,1,20156,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf","2006-09-18 00:00:00",
41181,3,20156,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020156_S039_VIDEX.pdf","2007-11-19 00:00:00",
2105,1,20156,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf","2006-12-28 00:00:00",
12279,2,20156,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf","2006-12-04 00:00:00",
2106,1,20156,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020156s044ltr.pdf","2009-06-17 00:00:00",
12280,2,20156,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf","2009-06-22 00:00:00",
2107,1,20156,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf","2010-02-01 00:00:00",
12281,2,20156,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf","2010-01-29 00:00:00",
2108,1,20156,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024ltr.pdf","2011-05-12 00:00:00",
21233,1,20156,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s048ltr.pdf","2011-11-22 00:00:00",
34325,2,20156,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048lbl.pdf","2011-11-22 00:00:00",
2109,1,20156,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020156Orig1s051ltr.pdf","2014-08-12 00:00:00",
12282,2,20156,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf","2014-08-12 00:00:00",
51921,2,20156,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf","2018-01-26 00:00:00",
51922,8,20156,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf#page=32","2018-01-26 00:00:00",
52105,1,20156,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020156Orig1s053ltr.pdf","2018-01-30 00:00:00",
2110,1,20162,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020162Orig1s010ltr.pdf","2015-09-04 00:00:00",
12283,2,20162,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf","2015-09-04 00:00:00",
21234,1,20163,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
2111,1,20163,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
21235,1,20163,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf","2013-04-24 00:00:00",
34326,2,20163,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf","2013-04-23 00:00:00",
2112,1,20163,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf","2015-02-10 00:00:00",
12284,2,20163,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf","2015-02-10 00:00:00",
2113,1,20163,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf","2015-09-04 00:00:00",
34327,2,20163,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf","2015-09-04 00:00:00",
45073,2,20163,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf","2016-08-17 00:00:00",
45139,1,20163,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
20502,3,20164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-164_review.pdf","2004-07-15 00:00:00",
21236,1,20164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-164ltr.pdf","2004-02-25 00:00:00",
34328,2,20164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-164_lbl.pdf","2004-04-05 00:00:00",
44049,10,20164,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm373741.htm","2013-11-07 00:00:00",
20503,3,20164,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S004_LOVENOX_INJECTION.pdf","2008-08-11 00:00:00",
20504,3,20164,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S005_LOVENOX INJ.pdf","2008-08-11 00:00:00",
41182,3,20164,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S009_LOVENOX INJ.pdf","2008-08-11 00:00:00",
2114,1,20164,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox_approv.pdf","2004-06-08 00:00:00",
41183,3,20164,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox.cfm","2003-04-29 00:00:00",
41184,3,20164,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020164_S011_LOVENOX.pdf","2008-08-08 00:00:00",
20505,3,20164,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S012_LOVENOX_INJECTION.pdf","2008-08-11 00:00:00",
20506,3,20164,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020164_S013_LOVENOX_INJECTION.pdf","2008-08-11 00:00:00",
2115,1,20164,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20164s15ltr.pdf","1998-12-31 00:00:00",
34329,2,20164,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20164s15lbl.pdf","1998-12-31 00:00:00",
41185,3,20164,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S15_Lovenox.cfm","2000-07-03 00:00:00",
41186,3,20164,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S019_LOVENOX.pdf","2008-08-08 00:00:00",
2116,1,20164,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S20LTR.PDF","2000-08-04 00:00:00",
20507,3,20164,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S021_LOVENOX.pdf","2008-08-08 00:00:00",
20508,3,20164,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S022_LOVENOX.pdf","2008-08-08 00:00:00",
20509,3,20164,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S023_LOVENOX_INJECTION.pdf","2008-08-08 00:00:00",
41187,3,20164,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S024_LOVENOX.pdf","2008-08-08 00:00:00",
41188,3,20164,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S026_LOVENOX.pdf","2008-08-08 00:00:00",
41189,3,20164,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S030_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
41190,3,20164,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S032_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
2117,1,20164,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S34ltr.pdf","2000-09-27 00:00:00",
2118,1,20164,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf","2000-11-17 00:00:00",
34330,2,20164,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf","2000-11-17 00:00:00",
12285,2,20164,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf","2000-11-17 00:00:00",
21237,1,20164,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf","2000-11-17 00:00:00",
41191,3,20164,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S038_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
41192,3,20164,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S039_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
21238,1,20164,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf","2002-01-09 00:00:00",
41193,3,20164,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf","2008-08-04 00:00:00",
41194,3,20164,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S041_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
41195,3,20164,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S042_LOVENOX_INJECTION.pdf","2008-08-04 00:00:00",
20510,3,20164,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S043_LOVENOX_INJECTION.pdf","2008-08-01 00:00:00",
21239,1,20164,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164scm043ltr.pdf","2003-01-23 00:00:00",
41196,3,20164,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S044_LOVENOX INJ.pdf","2008-08-04 00:00:00",
21240,1,20164,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf","2002-01-09 00:00:00",
41197,3,20164,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf","2008-08-04 00:00:00",
2119,1,20164,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf","2002-01-09 00:00:00",
20511,3,20164,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf","2008-08-04 00:00:00",
2120,1,20164,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr048ltr.pdf","2003-12-23 00:00:00",
2121,1,20164,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr050ltr.pdf","2003-07-08 00:00:00",
41198,3,20164,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S050_LOVENOX INJ.pdf","2008-08-01 00:00:00",
2122,1,20164,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr051ltr.pdf","2003-07-06 00:00:00",
20512,3,20164,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S051_LOVENOX INJ.pdf","2008-08-01 00:00:00",
21241,1,20164,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s053ltr.pdf","2004-10-26 00:00:00",
12286,2,20164,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf","2004-07-28 00:00:00",
20513,3,20164,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S055_Lovenox_Approval_Package.pdf","2006-10-26 00:00:00",
21242,1,20164,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s055ltr.pdf","2004-07-28 00:00:00",
20514,3,20164,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S056_LOVENOX INJ.pdf","2008-08-01 00:00:00",
21243,1,20164,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr056ltr.pdf","2004-04-20 00:00:00",
2123,1,20164,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr057ltr.pdf","2004-05-26 00:00:00",
41199,3,20164,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S057_LOVENOX INJECION_AP.pdf","2007-07-09 00:00:00",
21244,1,20164,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr058ltr.pdf","2004-04-29 00:00:00",
41200,3,20164,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S058_LOVENOX INJECTION_AP.pdf","2007-07-09 00:00:00",
2124,1,20164,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20164s063ltr.pdf","2005-03-10 00:00:00",
2125,1,20164,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020164s070ltr.pdf","2007-01-16 00:00:00",
34331,2,20164,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf","2007-01-16 00:00:00",
12287,2,20164,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf","2007-05-29 00:00:00",
20515,3,20164,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022138_020164_lovenox_enoxaparin_sodium_toc.cfm","2009-03-24 00:00:00",
21245,1,20164,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022138s000,020164s075ltr.pdf","2007-05-29 00:00:00",
12288,2,20164,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020164s080lbl.pdf","2008-07-22 00:00:00",
21246,1,20164,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020164s080ltr.pdf","2008-07-18 00:00:00",
21247,1,20164,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s083ltr.pdf","2009-07-31 00:00:00",
34332,2,20164,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf","2009-07-30 00:00:00",
12289,2,20164,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s085lbl.pdf","2009-12-30 00:00:00",
21248,1,20164,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s085ltr.pdf","2009-12-31 00:00:00",
2126,1,20164,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s092ltr.pdf","2011-04-15 00:00:00",
34333,2,20164,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s092lbl.pdf","2011-04-19 00:00:00",
2127,1,20164,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s093ltr.pdf","2011-04-22 00:00:00",
12290,2,20164,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf","2011-04-21 00:00:00",
2128,1,20164,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s100ltr.pdf","2013-06-07 00:00:00",
34334,2,20164,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s100lbl.pdf","2013-06-11 00:00:00",
21249,1,20164,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s102ltr.pdf","2013-10-25 00:00:00",
34335,2,20164,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s102lbl.pdf","2013-10-31 00:00:00",
50238,1,20164,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020164Orig1s110ltr.pdf","2017-10-31 00:00:00",
50280,2,20164,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020164s110lbl.pdf","2017-11-03 00:00:00",
2129,1,20165,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20165slr020ltr.pdf","2002-08-13 00:00:00",
20516,3,20165,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020165_S020_NICODERM CQ.pdf","2007-11-19 00:00:00",
2130,1,20165,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020165s023ltr.pdf","2006-09-20 00:00:00",
34336,2,20165,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020165s023lbl.pdf","2006-09-18 00:00:00",
12291,2,20165,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf","2007-04-19 00:00:00",
21250,1,20165,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020165s024ltr.pdf","2007-04-20 00:00:00",
21251,1,20165,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020165Orig1s028ltr.pdf","2012-09-24 00:00:00",
12292,2,20165,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf","2014-05-06 00:00:00",
21252,1,20165,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020165Orig1s029ltr.pdf","2014-05-01 00:00:00",
21253,1,20165,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020165Orig1s031ltr.pdf","2013-11-06 00:00:00",
34337,2,20165,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020165Orig1s031lbl.pdf","2013-11-19 00:00:00",
2131,1,20165,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s034ltr.pdf","2015-02-05 00:00:00",
12293,2,20165,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf","2015-02-17 00:00:00",
21254,1,20165,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s035ltr.pdf","2015-08-10 00:00:00",
34338,2,20165,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s035lbl.pdf","2015-08-10 00:00:00",
2132,1,20165,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s036ltr.pdf","2015-10-13 00:00:00",
12294,2,20165,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf","2015-11-25 00:00:00",
12295,2,20165,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20165Orig1s038lbl.pdf","2016-05-06 00:00:00",
21255,1,20165,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020165Orig1s038ltr.pdf","2016-05-06 00:00:00",
53720,3,20167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/0201675Orig1s000.pdf","2018-04-18 00:00:00",
41201,3,20168,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020168_S016&020656_S005_NUTROPIN FOR INJ.pdf","2007-08-06 00:00:00",
46151,1,20168,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf","2016-12-14 00:00:00",
46178,2,20168,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf","2016-12-14 00:00:00",
2133,1,20169,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20169s003ltr.pdf","2004-07-28 00:00:00",
48448,2,20169,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020169s008lbl.pdf","2017-05-18 00:00:00",
48455,1,20169,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020169Orig1s008ltr.pdf","2017-05-19 00:00:00",
21256,1,20171,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs010ltr.pdf","2003-12-02 00:00:00",
2134,1,20171,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015ltr.pdf","2009-11-13 00:00:00",
2135,1,20171,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171Orig1s026ltr.pdf","2013-02-04 00:00:00",
12296,2,20171,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf","2013-02-01 00:00:00",
34339,2,20171,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf","2013-04-19 00:00:00",
2136,1,20171,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171Orig1s033ltr.pdf","2014-04-25 00:00:00",
34340,2,20171,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf","2014-04-28 00:00:00",
2137,1,20171,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171Orig1s039ltr.pdf","2015-01-09 00:00:00",
12297,2,20171,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf","2015-01-12 00:00:00",
21257,1,20178,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020178Orig1s013ltr.pdf","2015-11-24 00:00:00",
34341,2,20178,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020178s013lbl.pdf","2015-11-25 00:00:00",
44050,10,20180,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm","2011-12-20 00:00:00",
41202,3,20180,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020180_s010_ProscarTOC.cfm","2006-05-10 00:00:00",
20517,3,20180,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020180s011_proscar_toc.cfm","2003-08-07 00:00:00",
20518,3,20180,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S013_PROSCAR.PDF","1997-05-12 00:00:00",
20519,3,20180,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020180_s014_ProscarTOC.cfm","2006-05-10 00:00:00",
20520,3,20180,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF","1998-03-20 00:00:00",
41203,3,20180,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF","1998-03-20 00:00:00",
20521,3,20180,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S017_PROSCAR.PDF","1997-12-19 00:00:00",
41204,3,20180,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020180_s018_PROSCAR 5MG.pdf","2008-08-08 00:00:00",
41205,3,20180,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s019_PROSCAR 5MG.pdf","2008-08-04 00:00:00",
20522,3,20180,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S020_PROSCAR_TABS_AP.pdf","2007-07-06 00:00:00",
21258,1,20180,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr020ltr.pdf","2003-09-30 00:00:00",
20523,3,20180,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s022_PROSCAR 5MG.pdf","2008-08-04 00:00:00",
41206,3,20180,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S023_PROSCAR TABLETS.pdf","2007-07-24 00:00:00",
20524,3,20180,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S024_PROSCAR TABLETS.pdf","2007-07-24 00:00:00",
21259,1,20180,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr025ltr.pdf","2003-07-06 00:00:00",
41207,3,20180,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S025_PROSCAR_TABS_AP.pdf","2007-07-06 00:00:00",
2138,1,20180,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180se8-026ltr.pdf","2004-04-20 00:00:00",
12298,2,20180,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf","2004-04-14 00:00:00",
41208,3,20180,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S026_PROSCAR TABLETS.pdf","2007-07-24 00:00:00",
20525,3,20180,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_s027_ProscarTOC.cfm","2006-05-08 00:00:00",
21260,1,20180,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr027ltr.pdf","2003-09-25 00:00:00",
34342,2,20180,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20180slr027_proscar_lbl.pdf","2003-09-25 00:00:00",
2139,1,20180,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180slr029ltr.pdf","2004-04-29 00:00:00",
34343,2,20180,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20180slr029_proscar_lbl.pdf","2004-05-04 00:00:00",
41209,3,20180,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S029_PROSCAR TABLETS.pdf","2007-07-24 00:00:00",
21261,1,20180,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s033ltr.pdf","2010-03-29 00:00:00",
34344,2,20180,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s033lbl.pdf","2010-03-26 00:00:00",
21262,1,20180,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
2140,1,20180,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s037ltr.pdf","2010-10-07 00:00:00",
12299,2,20180,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf","2010-10-04 00:00:00",
2141,1,20180,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020180s039ltr.pdf","2011-06-10 00:00:00",
34345,2,20180,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020180s039lbl.pdf","2011-06-10 00:00:00",
21263,1,20180,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf","2012-04-12 00:00:00",
34346,2,20180,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf","2012-04-11 00:00:00",
2142,1,20180,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf","2012-04-12 00:00:00",
12300,2,20180,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf","2012-04-11 00:00:00",
21264,1,20180,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf","2012-04-12 00:00:00",
34347,2,20180,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf","2012-04-11 00:00:00",
2143,1,20180,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020180Orig1s043ltr.pdf","2013-01-22 00:00:00",
34348,2,20180,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020180s043lbl.pdf","2013-01-22 00:00:00",
2144,1,20180,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020180Orig1s044ltr.pdf","2014-03-13 00:00:00",
12301,2,20180,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf","2014-03-13 00:00:00",
2145,1,20181,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20181scs001ltr.pdf","2004-06-08 00:00:00",
20526,3,20181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020181_s000_Liposyn.cfm","2005-05-23 00:00:00",
2146,1,20182,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF","1999-12-15 00:00:00",
12302,2,20182,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf","1999-12-15 00:00:00",
20527,3,20182,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182S6_Carnitor.cfm","1999-12-15 00:00:00",
12303,2,20182,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf","2002-04-15 00:00:00",
24541,1,20182,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf","2002-04-15 00:00:00",
24542,1,20182,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf","2015-06-02 00:00:00",
34349,2,20182,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf","2015-06-04 00:00:00",
53736,2,20182,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf","2018-04-19 00:00:00",
53762,1,20182,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20182Orig1s015ltr.pdf","2018-04-20 00:00:00",
2147,1,20183,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
24543,1,20183,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf","2005-08-11 00:00:00",
20528,3,20183,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020183_S015_VIDEX.pdf","2007-11-19 00:00:00",
12304,2,20183,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf","2013-04-23 00:00:00",
24544,1,20183,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf","2013-04-24 00:00:00",
2148,1,20183,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf","2015-02-10 00:00:00",
34350,2,20183,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf","2015-02-10 00:00:00",
2149,1,20183,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf","2015-09-04 00:00:00",
12305,2,20183,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf","2015-09-04 00:00:00",
45072,2,20183,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf","2016-08-17 00:00:00",
45140,1,20183,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf","2016-08-16 00:00:00",
23571,10,20184,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
20529,3,20184,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020184ap.pdf","1997-01-08 00:00:00",
20530,3,20184,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020184_S009_ACEON.pdf","2008-04-02 00:00:00",
24545,1,20184,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20184slr009ltr.pdf","2003-11-25 00:00:00",
12306,2,20184,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020184s011lbl.pdf","2005-08-31 00:00:00",
24546,1,20184,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020184s011ltr.pdf","2005-08-31 00:00:00",
24547,1,20184,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf","2008-09-04 00:00:00",
2150,1,20184,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf","2008-09-04 00:00:00",
2151,1,20184,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020184s015ltr.pdf","2010-12-28 00:00:00",
34351,2,20184,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020184s015lbl.pdf","2010-12-23 00:00:00",
12307,2,20184,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020184s017lbl.pdf","2011-09-02 00:00:00",
24548,1,20184,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020184s017ltr.pdf","2011-08-26 00:00:00",
2152,1,20184,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020184s019ltr.pdf","2012-04-13 00:00:00",
12308,2,20184,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf","2012-04-17 00:00:00",
24549,1,20184,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020184Orig1s020ltr_replace.pdf","2013-02-28 00:00:00",
34352,2,20184,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020184s020lblupdated.pdf","2013-03-01 00:00:00",
24550,1,20184,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020184Orig1s022ltr.pdf","2015-04-02 00:00:00",
34353,2,20184,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020184s022lbl.pdf","2015-04-01 00:00:00",
49916,2,20184,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020184s023lbl.pdf","2017-10-03 00:00:00",
49933,1,20184,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020184s023ltr.pdf","2017-10-03 00:00:00",
41210,3,20186,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf","2001-08-01 00:00:00",
24551,1,20186,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf","2004-07-01 00:00:00",
12309,2,20186,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020186s023lbl.pdf","2010-08-12 00:00:00",
24552,1,20186,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf","2007-09-26 00:00:00",
24553,1,20186,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020186s026ltr.pdf","2010-01-19 00:00:00",
34354,2,20186,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020186s026lbl.pdf","2009-11-19 00:00:00",
34355,2,20186,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020186s027s028lbl.pdf","2011-05-05 00:00:00",
24142,16,20189,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
2153,1,20189,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20189slr018ltr.pdf","2002-11-19 00:00:00",
12310,2,20189,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf","2009-05-13 00:00:00",
24554,1,20189,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020189s022ltr.pdf","2009-05-01 00:00:00",
24555,1,20189,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020189s023ltr.pdf","2011-07-07 00:00:00",
34356,2,20189,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf","2011-07-07 00:00:00",
12311,2,20189,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf","2012-09-06 00:00:00",
24556,1,20189,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020189Orig1s027ltr.pdf","2012-09-05 00:00:00",
43641,8,20189,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf","2012-09-06 00:00:00",
24557,1,20191,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20191slr018ltr.pdf","2003-07-06 00:00:00",
34357,2,20191,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf","2003-07-08 00:00:00",
20531,3,20192,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S003.pdf","2011-02-04 00:00:00",
20532,3,20192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S005_LAMISIL_CREAM.pdf","2008-02-19 00:00:00",
20533,3,20192,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S006_LAMISIL_CREAM.pdf","2008-02-19 00:00:00",
20534,3,20192,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S011_LAMISIL.pdf","2008-02-19 00:00:00",
20535,3,20192,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S012_LAMISIL.pdf","2008-02-19 00:00:00",
20536,3,20192,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S013_LAMISIL_CREAM.pdf","2008-02-19 00:00:00",
41211,3,20192,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020192_S014_LAMISIL_CREAM.pdf","2008-02-19 00:00:00",
41212,3,20193,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020193Orig1s002.pdf","2012-05-09 00:00:00",
24558,1,20193,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20193s003ltr.pdf","2004-08-25 00:00:00",
34358,2,20193,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20193s003lbl.pdf","2004-08-25 00:00:00",
2154,1,20193,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020193s004ltr.pdf","2006-09-25 00:00:00",
34359,2,20193,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020193s004lbl.pdf","2006-09-21 00:00:00",
24559,1,20193,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s007ltr.pdf","2008-07-29 00:00:00",
34360,2,20193,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s007lbl.pdf","2008-07-29 00:00:00",
2155,1,20193,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s009ltr.pdf","2008-12-23 00:00:00",
12312,2,20193,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf","2009-01-02 00:00:00",
41213,3,20195,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020195s002_fentanyl.pdf","1999-08-02 00:00:00",
2156,1,20198,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20198s017ltr.pdf","2005-04-06 00:00:00",
12313,2,20198,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf","2005-04-06 00:00:00",
2157,1,20198,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020198s022ltr.pdf","2010-03-08 00:00:00",
34361,2,20198,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf","2010-03-05 00:00:00",
2158,1,20198,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020198s023ltr.pdf","2011-03-02 00:00:00",
34362,2,20198,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf","2011-02-28 00:00:00",
2159,1,20199,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199s014ltr.pdf","2002-07-03 00:00:00",
12314,2,20199,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s014lbl.pdf","2002-07-03 00:00:00",
24560,1,20199,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199slr015ltr.pdf","2002-08-14 00:00:00",
34363,2,20199,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s15lbl.pdf","2002-08-14 00:00:00",
24561,1,20199,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf","2002-09-12 00:00:00",
34364,2,20199,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf","2002-09-12 00:00:00",
24562,1,20201,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20201S13ltr.pdf","2001-04-11 00:00:00",
12315,2,20201,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020201s036lbl.pdf","2016-06-01 00:00:00",
24563,1,20201,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020201Orig1s036ltr.pdf","2016-06-01 00:00:00",
23572,10,20204,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2005-07-28 00:00:00",
24564,1,20204,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20204S7LTR.PDF","2001-03-06 00:00:00",
2160,1,20204,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204s8ltr.pdf","2002-03-19 00:00:00",
2161,1,20204,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204scm016ltr.pdf","2002-08-30 00:00:00",
24565,1,20204,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20204slr019ltr.pdf","2004-03-24 00:00:00",
2162,1,20204,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020204s021ltr.pdf","2005-05-05 00:00:00",
12316,2,20204,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf","2005-05-05 00:00:00",
2163,1,20204,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf","2006-01-20 00:00:00",
2164,1,20204,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020204s031ltr.pdf","2008-11-26 00:00:00",
24566,1,20204,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020204s032ltr.pdf","2009-04-21 00:00:00",
24567,1,20204,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020204s035ltr.pdf","2010-11-08 00:00:00",
2165,1,20204,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s036ltr.pdf","2011-02-24 00:00:00",
24568,1,20204,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s037ltr.pdf","2011-04-11 00:00:00",
2166,1,20204,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s038ltr.pdf","2013-02-08 00:00:00",
34365,2,20204,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf","2014-01-14 00:00:00",
24569,1,20204,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204Orig1s039ltr.pdf","2012-03-19 00:00:00",
24570,1,20204,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204s40ltr.pdf","2012-03-19 00:00:00",
24571,1,20204,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s042ltr.pdf","2013-01-07 00:00:00",
24572,1,20204,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s044ltr.pdf","2013-04-23 00:00:00",
34366,2,20204,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf","2013-11-21 00:00:00",
12317,2,20204,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf","2016-06-17 00:00:00",
49535,2,20204,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s051lbl.pdf","2017-08-24 00:00:00",
49541,1,20204,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s051ltr.pdf","2017-08-25 00:00:00",
49797,1,20204,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s052ltr.pdf","2017-09-19 00:00:00",
49825,2,20204,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s052lbl.pdf","2017-09-21 00:00:00",
53499,2,20204,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s053lbl.pdf","2018-03-28 00:00:00",
53510,1,20204,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s053ltr.pdf","2018-03-29 00:00:00",
53578,1,20204,"SUPPL",54,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s054ltr.pdf","2018-04-01 00:00:00",
53588,2,20204,"SUPPL",54,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s054lbl.pdf","2018-04-01 00:00:00",
54588,1,20204,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s055ltr.pdf","2018-06-14 00:00:00",
54622,2,20204,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s055lbl.pdf","2018-06-20 00:00:00",
54596,1,20204,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s056ltr.pdf","2018-06-14 00:00:00",
54623,2,20204,"SUPPL",56,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s056lbl.pdf","2018-06-20 00:00:00",
55007,1,20204,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s057Ltr.pdf","2018-07-26 00:00:00",
55112,2,20204,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s057Lbl.pdf","2018-08-03 00:00:00",
55366,1,20204,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s058ltr.pdf","2018-08-30 00:00:00",
55367,2,20204,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204s058lbl.pdf","2018-08-30 00:00:00",
55737,1,20204,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s059ltr.pdf","2018-10-01 00:00:00",
2167,1,20207,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf","2002-01-07 00:00:00",
12318,2,20207,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf","2004-02-06 00:00:00",
24573,1,20207,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20207slr007ltr.pdf","2003-05-29 00:00:00",
24574,1,20207,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020207s012ltr.pdf","2005-06-15 00:00:00",
24575,1,20207,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf","2011-06-14 00:00:00",
34367,2,20207,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf","2011-06-14 00:00:00",
24576,1,20207,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020207s017ltr.pdf","2011-05-04 00:00:00",
34368,2,20207,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf","2011-05-02 00:00:00",
24577,1,20209,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19828slr009,20209slr005ltr.pdf","2004-01-29 00:00:00",
34369,2,20209,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf","2004-02-02 00:00:00",
41214,3,20210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020210_S000_CisaprideTOC.cfm","2007-05-09 00:00:00",
52756,8,20210,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Propulsid.pdf","2018-02-28 00:00:00",
41215,3,20210,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20210-S030_Propulsid.pdf","2000-03-06 00:00:00",
41216,3,20210,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20767-S011_Propulsid.pdf","2000-03-06 00:00:00",
2168,1,20212,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf","2002-10-31 00:00:00",
34370,2,20212,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf","2002-10-31 00:00:00",
12319,2,20212,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf","2002-10-31 00:00:00",
24578,1,20212,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf","2002-10-31 00:00:00",
24579,1,20212,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf","2002-10-31 00:00:00",
34371,2,20212,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf","2002-10-31 00:00:00",
2169,1,20212,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020212s008ltr.pdf","2005-05-25 00:00:00",
34372,2,20212,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020212s008lbl.pdf","2005-05-25 00:00:00",
24580,1,20212,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020212s013ltr.pdf","2012-07-09 00:00:00",
34373,2,20212,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020212s013lbl.pdf","2012-07-13 00:00:00",
12320,2,20212,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020212s017lbl.pdf","2014-04-29 00:00:00",
24581,1,20212,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020212Orig1s017ltr.pdf","2014-04-21 00:00:00",
2170,1,20213,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020213s010LTR.pdf","2006-06-06 00:00:00",
34374,2,20213,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020213s010lbl.pdf","2006-05-31 00:00:00",
24582,1,20214,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214slr016ltr.pdf","2004-03-03 00:00:00",
24583,1,20214,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20214slr017ltr.pdf","2003-06-08 00:00:00",
24584,1,20214,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214s021ltr.pdf","2004-08-25 00:00:00",
12321,2,20214,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020214s030lbl.pdf","2008-08-29 00:00:00",
24585,1,20214,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020214s030ltr.pdf","2008-08-29 00:00:00",
52325,23,20214,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020214_Rocuronium_ Amend_6.pdf","2008-04-03 00:00:00",
52986,20,20214,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020214s030_Rocuronium_Clinical_BPCA.pdf","1900-01-01 00:00:00",
52987,18,20214,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020214s030_Rocuronium_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
2171,1,20214,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020214s034ltr.pdf","2010-11-30 00:00:00",
34375,2,20214,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020214s034lbl.pdf","2010-11-22 00:00:00",
2172,1,20214,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020214Orig1s036ltr.pdf","2015-01-08 00:00:00",
34376,2,20214,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020214s036lbl.pdf","2015-01-08 00:00:00",
55025,2,20214,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020214s038lbl.pdf","2018-07-27 00:00:00",
55041,1,20214,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020214Orig1s038Ltr.pdf","2018-07-30 00:00:00",
2173,1,20215,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020215Orig1s024ltr.pdf","2014-10-03 00:00:00",
34377,2,20215,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf","2014-10-03 00:00:00",
41217,3,20216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_original_approval.pdf","2011-02-15 00:00:00",
20537,3,20216,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s018_premarin vaginal cream.pdf","2011-01-07 00:00:00",
20538,3,20216,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s030_premarin vaginal cream.pdf","2011-01-07 00:00:00",
20539,3,20216,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020216_s033_premarin_vaginal_cream.pdf","2011-02-15 00:00:00",
24586,1,20216,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20216slr052ltr.pdf","2004-04-29 00:00:00",
34378,2,20216,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020216s052lbl.pdf","2004-04-23 00:00:00",
24587,1,20216,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf","2005-01-21 00:00:00",
34379,2,20216,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020216s053lbl.pdf","2005-01-21 00:00:00",
2174,1,20216,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf","2005-09-07 00:00:00",
12322,2,20216,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf","2005-09-07 00:00:00",
2175,1,20216,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf","2006-08-04 00:00:00",
34380,2,20216,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf","2006-07-27 00:00:00",
2176,1,20216,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s059ltr.pdf","2008-03-05 00:00:00",
34381,2,20216,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s059lbl.pdf","2008-03-05 00:00:00",
2177,1,20216,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020216s060ltr.pdf","2008-11-13 00:00:00",
12323,2,20216,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf","2008-11-12 00:00:00",
24588,1,20216,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020216s067ltr.pdf","2011-04-25 00:00:00",
34382,2,20216,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020216s067lbl.pdf","2011-04-26 00:00:00",
12324,2,20216,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf","2012-02-17 00:00:00",
24589,1,20216,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf","2012-02-15 00:00:00",
2178,1,20216,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf","2012-02-15 00:00:00",
34383,2,20216,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf","2012-02-17 00:00:00",
12325,2,20216,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf","2012-02-17 00:00:00",
24590,1,20216,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf","2012-02-15 00:00:00",
2179,1,20216,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020216Orig1s081ltr.pdf","2015-12-30 00:00:00",
34384,2,20216,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020216s081lbl.pdf","2015-12-31 00:00:00",
50282,2,20216,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf","2017-11-03 00:00:00",
50303,1,20216,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020216Orig1s083ltr.pdf","2017-11-06 00:00:00",
2180,1,20220,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20220slr008ltr.pdf","2003-05-29 00:00:00",
24591,1,20220,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20220scp018ltr.pdf","2004-03-16 00:00:00",
34385,2,20220,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf","2004-04-05 00:00:00",
2181,1,20220,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020220s022ltr.pdf","2005-08-15 00:00:00",
24592,1,20220,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020220s027ltr.pdf","2007-09-06 00:00:00",
34386,2,20220,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf","2007-09-04 00:00:00",
12326,2,20220,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf","2010-01-08 00:00:00",
24593,1,20220,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s033,021425s017ltr.pdf","2010-01-05 00:00:00",
24594,1,20220,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf","2010-01-20 00:00:00",
2182,1,20220,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020220s036ltr.pdf","2012-05-04 00:00:00",
12327,2,20220,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf","2012-05-07 00:00:00",
2183,1,20220,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf","2015-07-10 00:00:00",
12328,2,20220,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf","2015-07-09 00:00:00",
47885,2,20220,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s042lbl.pdf","2017-04-07 00:00:00",
47960,2,20220,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220Orig1s042,021425Orig1s026ltr.pdf","2017-04-12 00:00:00",
49149,2,20220,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s043lbl.pdf","2017-07-31 00:00:00",
49181,1,20220,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s043ltr.pdf","2017-08-02 00:00:00",
53599,1,20220,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020220s045ltr.pdf","2018-04-04 00:00:00",
53600,2,20220,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s045lbl.pdf","2018-04-04 00:00:00",
53823,2,20220,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s046lbl.pdf","2018-04-26 00:00:00",
53866,1,20220,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020220Orig1s046ltr.pdf","2018-04-27 00:00:00",
2184,1,20221,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf","1999-06-24 00:00:00",
20540,3,20221,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20221-S012_Ethyol.cfm","1999-06-24 00:00:00",
34387,2,20221,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf","1999-06-24 00:00:00",
2185,1,20221,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf","2002-02-20 00:00:00",
24595,1,20221,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf","2003-04-15 00:00:00",
34388,2,20221,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf","2003-03-28 00:00:00",
24596,1,20221,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf","2006-04-05 00:00:00",
12329,2,20221,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf","2008-11-12 00:00:00",
24597,1,20221,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf","2008-11-13 00:00:00",
46217,2,20221,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020221s032lbl.pdf","2016-12-19 00:00:00",
46219,1,20221,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020221Orig1s032ltr.pdf","2016-12-19 00:00:00",
48557,2,20221,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020221s033lbl.pdf","2017-05-30 00:00:00",
48561,1,20221,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020221Orig1s033ltr.pdf","2017-05-30 00:00:00",
12330,2,20222,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf","2014-05-28 00:00:00",
24598,1,20222,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017563Orig1s023,20222Orig1s005ltr.pdf","2014-05-23 00:00:00",
48534,2,20222,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf","2017-05-25 00:00:00",
48550,1,20222,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020222Orig1s006ltr.pdf","2017-05-26 00:00:00",
24599,1,20225,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20225slr008ltr.pdf","2004-06-07 00:00:00",
20541,3,20228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020228_LBL_ATROVENT.pdf","2008-04-02 00:00:00",
48233,1,20229,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf","2002-08-20 00:00:00",
48234,1,20229,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf","2002-08-20 00:00:00",
48235,1,20229,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr021ltr.pdf","2002-08-22 00:00:00",
48232,1,20229,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020229s030ltr.pdf","2006-07-03 00:00:00",
48230,2,20229,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf","2012-08-03 00:00:00",
48231,1,20229,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020229Orig1s034ltr.pdf","2012-08-03 00:00:00",
20542,3,20231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020231_total_toc.cfm","2008-09-25 00:00:00",
34389,2,20231,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20231s21lbl.pdf","2003-04-22 00:00:00",
2187,1,20231,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231s023ltr.pdf","2002-04-30 00:00:00",
34390,2,20231,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20231s23.pdf","2002-04-30 00:00:00",
2188,1,20231,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scp026ltr.pdf","2002-12-06 00:00:00",
2189,1,20231,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scf027ltr.pdf","2002-12-06 00:00:00",
2190,1,20231,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scf028ltr.pdf","2003-10-16 00:00:00",
2191,1,20231,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp029ltr.pdf","2003-04-18 00:00:00",
2192,1,20231,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp032ltr.pdf","2003-12-02 00:00:00",
2193,1,20231,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20231scf033ltr.pdf","2004-04-20 00:00:00",
2194,1,20231,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20231s037ltr.pdf","2005-02-03 00:00:00",
24604,1,20231,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s041ltr.pdf","2005-08-08 00:00:00",
34391,2,20231,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020231s041lbl.pdf","2005-08-08 00:00:00",
2195,1,20231,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s042ltr.pdf","2005-11-17 00:00:00",
24605,1,20231,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s043LTR.pdf","2006-04-25 00:00:00",
2196,1,20231,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s046ltr.pdf","2006-09-20 00:00:00",
2197,1,20231,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s047ltr.pdf","2007-03-23 00:00:00",
24606,1,20231,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s050ltr.pdf","2007-03-23 00:00:00",
34392,2,20231,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s050lbl.pdf","2007-03-23 00:00:00",
24607,1,20231,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s052ltr.pdf","2007-11-19 00:00:00",
24608,1,20231,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s053ltr.pdf","2007-11-19 00:00:00",
2198,1,20231,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s055ltr.pdf","2007-09-25 00:00:00",
34393,2,20231,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s055lbl.pdf","2007-09-11 00:00:00",
24609,1,20231,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s056ltr.pdf","2007-09-25 00:00:00",
2199,1,20231,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s057ltr.pdf","2007-10-22 00:00:00",
24610,1,20231,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020231s058ltr.pdf","2010-09-20 00:00:00",
2200,1,20231,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s060ltr.pdf","2008-01-09 00:00:00",
24611,1,20231,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020231s064ltr.pdf","2009-02-23 00:00:00",
2201,1,20231,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020231Orig1s072,s073ltr.pdf","2014-06-17 00:00:00",
12332,2,20231,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf","2014-08-05 00:00:00",
12333,2,20231,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf","2014-08-05 00:00:00",
24612,1,20231,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020231Orig1s072,s073ltr.pdf","2014-06-17 00:00:00",
2202,1,20231,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020231Orig1s075ltr.pdf","2016-03-29 00:00:00",
12334,2,20231,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020231Orig1s075lbl.pdf","2016-04-11 00:00:00",
2203,1,20232,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf","2008-03-24 00:00:00",
34394,2,20232,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf","2008-03-24 00:00:00",
24613,1,20232,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020232s033ltr.pdf","2011-06-28 00:00:00",
34395,2,20232,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf","2011-06-29 00:00:00",
2204,1,20232,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf","2013-05-13 00:00:00",
12335,2,20232,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf","2013-05-14 00:00:00",
2205,1,20232,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf","2013-10-22 00:00:00",
34396,2,20232,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf","2013-10-22 00:00:00",
46250,1,20232,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020232Orig1s040ltr.pdf","2016-12-20 00:00:00",
46384,2,20232,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf","2016-12-21 00:00:00",
49593,2,20232,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf","2017-08-30 00:00:00",
49594,8,20232,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf#page=39","2017-08-30 00:00:00",
49630,1,20232,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020232Orig1s041ltr.pdf","2017-08-30 00:00:00",
55670,1,20232,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf","2018-09-28 00:00:00",
55846,2,20232,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf","2018-10-05 00:00:00",
55671,1,20232,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf","2018-09-28 00:00:00",
55847,2,20232,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf","2018-10-05 00:00:00",
20543,3,20233,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020233s003_rhinocort_toc.cfm","2003-08-07 00:00:00",
12336,2,20234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf","2004-12-08 00:00:00",
24614,1,20234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/020234ltr.pdf","2004-12-08 00:00:00",
41218,3,20234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020234_complete_Approval_pkg.pdf","2004-12-08 00:00:00",
2206,1,20234,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF","2001-03-07 00:00:00",
34397,2,20234,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF","2001-03-07 00:00:00",
41219,3,20234,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020234_S017_TEGRETOL_AP.pdf","2007-07-06 00:00:00",
12337,2,20234,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf","2007-08-17 00:00:00",
24615,1,20234,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf","2007-08-17 00:00:00",
12338,2,20234,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf","2015-09-03 00:00:00",
24616,1,20234,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf","2015-09-01 00:00:00",
2207,1,20234,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf","2008-01-09 00:00:00",
12339,2,20234,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf","2007-12-12 00:00:00",
24617,1,20234,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf","2014-09-17 00:00:00",
34398,2,20234,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf","2014-09-19 00:00:00",
2208,1,20234,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
12340,2,20234,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
24618,1,20234,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf","2009-05-01 00:00:00",
34399,2,20234,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf","2009-05-12 00:00:00",
12341,2,20234,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf","2011-03-07 00:00:00",
24619,1,20234,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf","2011-03-07 00:00:00",
2209,1,20234,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf","2014-01-17 00:00:00",
34400,2,20234,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf","2014-01-17 00:00:00",
2210,1,20234,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf","2013-03-08 00:00:00",
34401,2,20234,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf","2013-03-08 00:00:00",
24620,1,20234,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf","2011-11-10 00:00:00",
2211,1,20234,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf","2012-12-13 00:00:00",
12342,2,20234,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf","2012-12-13 00:00:00",
53147,1,20234,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf","2018-03-22 00:00:00",
53422,2,20234,"SUPPL",47,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf","2018-03-26 00:00:00",
53453,8,20234,"SUPPL",47,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19","2018-03-27 00:00:00",
24621,1,20235,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf","1998-09-29 00:00:00",
34402,2,20235,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20235s11lbl.pdf","1998-09-29 00:00:00",
41220,3,20235,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020235S011.pdf","1998-09-29 00:00:00",
12343,2,20235,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf","2000-10-12 00:00:00",
24622,1,20235,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf","2000-10-12 00:00:00",
41221,3,20235,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm","2004-05-06 00:00:00",
2212,1,20235,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf","2002-01-30 00:00:00",
2213,1,20235,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf","2004-06-10 00:00:00",
2214,1,20235,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf","2005-02-23 00:00:00",
12344,2,20235,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf","2005-02-23 00:00:00",
2215,1,20235,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf","2006-05-05 00:00:00",
12345,2,20235,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf","2011-03-04 00:00:00",
24623,1,20235,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf","2011-03-07 00:00:00",
2216,1,20235,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028ltr.pdf","2009-05-01 00:00:00",
34403,2,20235,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf","2009-04-28 00:00:00",
12346,2,20235,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf","2010-10-11 00:00:00",
24624,1,20235,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf","2010-10-13 00:00:00",
2217,1,20235,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf","2011-08-12 00:00:00",
34404,2,20235,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf","2011-08-11 00:00:00",
24625,1,20235,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
34405,2,20235,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
2218,1,20235,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
34406,2,20235,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
12347,2,20235,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
24626,1,20235,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
2219,1,20235,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf","2014-08-20 00:00:00",
34407,2,20235,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf","2014-08-20 00:00:00",
2220,1,20235,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf","2015-09-17 00:00:00",
12348,2,20235,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf","2015-09-23 00:00:00",
24627,1,20235,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf","2015-05-11 00:00:00",
34408,2,20235,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf","2015-04-27 00:00:00",
47710,2,20235,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf","2017-03-27 00:00:00",
47711,8,20235,"SUPPL",62,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32","2017-03-27 00:00:00",
47754,1,20235,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020235Orig1s062,020882Orig1s045,021129Orig1s044ltr.pdf","2017-03-29 00:00:00",
50105,1,20235,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf","2017-10-19 00:00:00",
50123,2,20235,"SUPPL",64,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf","2017-10-20 00:00:00",
44051,10,20236,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2005-11-30 00:00:00",
52186,20,20236,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20236s035_salmeterol_Serevent-MedRev-BPCA.pdf","1900-01-01 00:00:00",
52187,17,20236,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20236s035_salmeterol_Serevent-StatsRev-BPCA.pdf","1900-01-01 00:00:00",
52188,23,20236,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020236_salmeterol_WR.pdf","1900-01-01 00:00:00",
41222,3,20236,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020236_S010_SERVENT_INHALATION_AEROSOL.pdf","2009-09-16 00:00:00",
20544,3,20236,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020236s017_serevent_toc.cfm","2003-08-07 00:00:00",
12349,2,20236,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20236slr028_serevent_lbl.pdf","2003-08-14 00:00:00",
20545,3,20236,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020236_s028_SEREVENT_INHALATION.pdf","2008-08-01 00:00:00",
24628,1,20236,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20236slr028ltr.pdf","2003-08-14 00:00:00",
24629,1,20236,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf","2004-10-04 00:00:00",
34409,2,20236,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf","2004-10-04 00:00:00",
24630,1,20237,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf","2004-06-07 00:00:00",
2221,1,20237,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf","2004-06-07 00:00:00",
2222,1,20237,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen_appltr.pdf","1998-02-11 00:00:00",
20546,3,20237,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20237s007_Salagen.cfm","1998-02-11 00:00:00",
24631,1,20237,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf","2002-06-10 00:00:00",
34410,2,20237,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf","2002-06-10 00:00:00",
2223,1,20237,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20237s008ltr.pdf","2002-06-10 00:00:00",
12350,2,20237,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf","2002-06-10 00:00:00",
12351,2,20237,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf","2003-04-28 00:00:00",
20547,3,20237,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020237_S012_SALAGEN_AP.pdf","2007-07-06 00:00:00",
24632,1,20237,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20237scs012ltr.pdf","2003-05-29 00:00:00",
2224,1,20238,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020238s013ltr.pdf","2005-05-17 00:00:00",
12352,2,20238,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf","2005-05-17 00:00:00",
20548,3,20238,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020238_s013_TAGAMET HB.pdf","2008-07-30 00:00:00",
24633,1,20238,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020238s015LTR.pdf","2006-10-05 00:00:00",
2225,1,20238,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020238s017ltr.pdf","2008-02-13 00:00:00",
54109,20,20239,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20239_ granisetron_ clinical_ prea.pdf","1900-01-01 00:00:00",
54110,18,20239,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20239_ granisetron_ clinpharm_ prea.pdf","1900-01-01 00:00:00",
54111,17,20239,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20239_ granisetron_ statistical_ prea.pdf","1900-01-01 00:00:00",
20549,3,20239,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020239_s007_KYTRIL INJ.pdf","2008-08-11 00:00:00",
24634,1,20239,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20239se1-008ltr.pdf","2002-08-16 00:00:00",
34411,2,20239,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21239s8lbl.pdf","2002-08-16 00:00:00",
2226,1,20239,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s015ltr.pdf","2004-08-25 00:00:00",
12353,2,20239,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf","2004-08-25 00:00:00",
41223,3,20239,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s015_KYTRIL INJECTION.pdf","2009-01-12 00:00:00",
20550,3,20239,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s016_KYTRIL.pdf","2009-09-16 00:00:00",
24635,1,20239,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf","2004-09-21 00:00:00",
24636,1,20239,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf","2004-09-21 00:00:00",
41224,3,20239,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s017_KYTRIL.pdf","2009-09-16 00:00:00",
2227,1,20239,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020239s018ltr.pdf","2005-11-30 00:00:00",
12354,2,20239,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf","2005-11-30 00:00:00",
20551,3,20239,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s018_Kytril Inj.pdf","2009-09-16 00:00:00",
2228,1,20239,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf","2009-11-12 00:00:00",
12355,2,20239,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf","2009-10-14 00:00:00",
2229,1,20239,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020239s023ltr.pdf","2011-09-19 00:00:00",
12356,2,20239,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf","2011-05-02 00:00:00",
12357,2,20241,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s2lbl.pdf","1998-08-24 00:00:00",
24637,1,20241,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s2ltr.pdf","1998-08-24 00:00:00",
41225,3,20241,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm","1999-05-20 00:00:00",
2230,1,20241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf","1998-12-14 00:00:00",
20552,3,20241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm","1999-06-30 00:00:00",
34412,2,20241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf","1998-12-14 00:00:00",
34413,2,20241,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf","2003-03-06 00:00:00",
12358,2,20241,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2006-09-26 00:00:00",
24638,1,20241,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2006-09-27 00:00:00",
34414,2,20241,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf","2006-09-25 00:00:00",
34415,2,20241,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf","2001-05-25 00:00:00",
41226,3,20241,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020241_S011.pdf","2005-12-08 00:00:00",
2231,1,20241,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-016,20764se8-009ltr.pdf","2004-01-22 00:00:00",
24639,1,20241,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf","2003-07-06 00:00:00",
34416,2,20241,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf","2003-07-08 00:00:00",
41227,3,20241,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020241_S017_020764_S011TOC.cfm","2007-05-29 00:00:00",
24640,1,20241,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241slr018ltr.pdf","2003-04-18 00:00:00",
2232,1,20241,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
12359,2,20241,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
24641,1,20241,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
34417,2,20241,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
2233,1,20241,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
12360,2,20241,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
2234,1,20241,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
12361,2,20241,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
41228,3,20241,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020764_s020_Lamictal-optimized.pdf","2013-09-06 00:00:00",
12362,2,20241,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
24642,1,20241,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
24643,1,20241,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s036,020764s029ltr.pdf","2009-05-13 00:00:00",
34418,2,20241,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf","2009-07-08 00:00:00",
24644,1,20241,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf","2009-05-04 00:00:00",
34419,2,20241,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf","2009-05-12 00:00:00",
12363,2,20241,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf","2009-05-12 00:00:00",
24645,1,20241,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf","2009-05-04 00:00:00",
2235,1,20241,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf","2013-12-26 00:00:00",
34420,2,20241,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf","2013-12-23 00:00:00",
24646,1,20241,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
34421,2,20241,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
12364,2,20241,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
24647,1,20241,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
2236,1,20241,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
34422,2,20241,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
2237,1,20241,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
12365,2,20241,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
24648,1,20241,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf","2011-08-08 00:00:00",
34423,2,20241,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf","2011-08-05 00:00:00",
2238,1,20241,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf","2011-06-02 00:00:00",
24649,1,20241,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf","2011-12-02 00:00:00",
34424,2,20241,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf","2011-12-02 00:00:00",
24650,1,20241,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf","2012-08-02 00:00:00",
34425,2,20241,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf","2012-08-02 00:00:00",
2239,1,20241,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
12366,2,20241,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
24651,1,20241,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf","2014-06-12 00:00:00",
34426,2,20241,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf","2014-06-30 00:00:00",
12367,2,20241,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf","2015-05-21 00:00:00",
24652,1,20241,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf","2015-05-20 00:00:00",
54959,1,20241,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf","2018-07-24 00:00:00",
54979,2,20241,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf","2018-07-26 00:00:00",
54980,8,20241,"SUPPL",56,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64","2018-07-26 00:00:00",
54753,2,20241,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s057lbl.pdf","2018-07-05 00:00:00",
54846,1,20241,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf","2018-07-06 00:00:00",
24653,1,20243,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20243S21ltr.pdf","2000-09-28 00:00:00",
41229,3,20243,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-243S021.pdf","2004-06-08 00:00:00",
12368,2,20246,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf","2005-11-01 00:00:00",
24654,1,20246,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020246s013ltr.pdf","2005-11-01 00:00:00",
2240,1,20246,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20246scs019ltr.pdf","2003-06-08 00:00:00",
12369,2,20246,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-provera_lbl.pdf","2003-06-08 00:00:00",
2241,1,20246,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20246s025ltr.pdf","2004-12-02 00:00:00",
12370,2,20246,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf","2004-12-03 00:00:00",
48863,3,20246,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020246Orig1s025.pdf","2017-06-29 00:00:00",
12371,2,20246,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf","2011-08-05 00:00:00",
24655,1,20246,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020246s035ltr.pdf","2011-08-01 00:00:00",
2242,1,20246,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020246s036ltr.pdf","2010-10-19 00:00:00",
34427,2,20246,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf","2010-10-19 00:00:00",
41230,3,20246,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s048.pdf","2014-08-05 00:00:00",
20553,3,20246,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s049.pdf","2014-08-05 00:00:00",
20554,3,20246,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s050.pdf","2014-08-05 00:00:00",
20555,3,20246,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/20246Orig1s052.pdf","2014-08-05 00:00:00",
2243,1,20246,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s053ltr.pdf","2015-02-02 00:00:00",
12372,2,20246,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf","2015-02-03 00:00:00",
24656,1,20246,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf","2015-01-26 00:00:00",
34428,2,20246,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf","2015-01-29 00:00:00",
46290,2,20246,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020246s058lbl.pdf","2016-12-20 00:00:00",
46451,1,20246,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020246Orig1s058ltr.pdf","2016-12-21 00:00:00",
47591,1,20246,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020246Orig1s063ltr.pdf","2017-03-20 00:00:00",
46017,2,20248,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020248s020lbl.pdf","2016-12-05 00:00:00",
46062,1,20248,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf","2016-12-06 00:00:00",
55006,1,20248,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf","2018-07-26 00:00:00",
20556,3,20249,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf","1999-03-18 00:00:00",
12373,2,20249,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf","2002-06-06 00:00:00",
24657,1,20249,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf","2002-06-06 00:00:00",
41231,3,20249,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020249_s011_PEPCID INJECTION.pdf","2009-01-12 00:00:00",
2244,1,20249,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF","2001-03-14 00:00:00",
34429,2,20249,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF","2001-03-14 00:00:00",
24658,1,20249,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf","2007-11-08 00:00:00",
34430,2,20249,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf","2007-11-07 00:00:00",
2245,1,20250,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf","2002-08-01 00:00:00",
12374,2,20250,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf","2002-08-01 00:00:00",
24659,1,20250,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf","2002-08-01 00:00:00",
34431,2,20250,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf","2002-08-01 00:00:00",
20557,3,20251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm","2003-04-29 00:00:00",
24660,1,20251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv.pdf","2004-07-01 00:00:00",
24661,1,20251,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf","2002-01-07 00:00:00",
2246,1,20251,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20251scf015ltr.pdf","2004-04-07 00:00:00",
34432,2,20251,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20251scf015_zantac_lbl.pdf","2004-05-03 00:00:00",
2247,1,20251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf","2005-05-02 00:00:00",
34433,2,20251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf","2005-05-02 00:00:00",
2248,1,20251,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf","2006-07-21 00:00:00",
2249,1,20251,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf","2009-02-19 00:00:00",
34434,2,20251,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf","2009-03-27 00:00:00",
12375,2,20251,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf","2009-10-06 00:00:00",
24662,1,20251,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf","2009-11-12 00:00:00",
2250,1,20254,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf","2006-01-30 00:00:00",
34435,2,20254,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf","2006-01-25 00:00:00",
41232,3,20254,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020254Orig1s016.pdf","2015-11-05 00:00:00",
24663,1,20254,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf","2009-02-27 00:00:00",
34436,2,20254,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf","2009-03-17 00:00:00",
24664,1,20254,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf","2011-02-28 00:00:00",
34437,2,20254,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf","2011-03-04 00:00:00",
2251,1,20254,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf","2011-02-28 00:00:00",
12376,2,20254,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf","2011-03-04 00:00:00",
24665,1,20254,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf","2016-05-12 00:00:00",
34438,2,20254,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf","2016-05-11 00:00:00",
43643,8,20254,"SUPPL",28,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501669.pdf","2016-05-18 00:00:00",
20558,3,20255,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20255-s006_dobutamine.pdf","2000-06-14 00:00:00",
2252,1,20255,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf","2003-07-28 00:00:00",
24666,1,20255,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf","2003-07-28 00:00:00",
2253,1,20255,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020255s014ltr.pdf","2012-03-12 00:00:00",
12377,2,20255,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf","2013-04-19 00:00:00",
24667,1,20255,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020255Orig1s016ltr.pdf","2013-04-23 00:00:00",
12378,2,20258,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf","2004-06-18 00:00:00",
24668,1,20258,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20258slr019ltr.pdf","2004-06-08 00:00:00",
47892,2,20258,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf","2017-04-07 00:00:00",
47976,1,20258,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020258Orig1s026ltr.pdf","2017-04-12 00:00:00",
52791,2,20258,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020258s030lbl.pdf","2018-03-01 00:00:00",
52812,1,20258,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020258 Orig1s030ltr.pdf","2018-03-05 00:00:00",
41233,3,20261,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_s002_Lescol Capsules.pdf","2009-09-16 00:00:00",
20559,3,20261,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S003_LESCOL_AP.pdf","2007-07-06 00:00:00",
41234,3,20261,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S004_LESCOL_AP.pdf","2007-07-06 00:00:00",
41235,3,20261,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S007_LESCOL_CAPSULES.pdf","2008-02-19 00:00:00",
20560,3,20261,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S009_LESCOL_CAPSULES.pdf","2008-02-19 00:00:00",
20561,3,20261,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020261_S010_LESCOL.pdf","2007-09-14 00:00:00",
41236,3,20261,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S011_LESCOL_CAPSULES.pdf","2008-04-02 00:00:00",
20562,3,20261,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S013_LESCOL.pdf","2007-09-26 00:00:00",
20563,3,20261,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S014_LESCOL.pdf","2007-09-26 00:00:00",
20564,3,20261,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S016_LESCOL_TABLETS.pdf","2008-02-19 00:00:00",
20565,3,20261,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S016_LESCOL_TABLETS.pdf","2008-02-19 00:00:00",
20566,3,20261,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S017_LESCOL_TABLETS.pdf","2008-02-19 00:00:00",
24669,1,20261,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf","1999-03-08 00:00:00",
41237,3,20261,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm","1999-05-08 00:00:00",
41238,3,20261,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S019_LESCOL_CAPSULES.pdf","2008-04-02 00:00:00",
20567,3,20261,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S020_LESCOL_CAPSULES.pdf","2008-02-19 00:00:00",
20568,3,20261,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S021_LESCOL_CAPSULES.pdf","2008-02-19 00:00:00",
2254,1,20261,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf","1999-03-08 00:00:00",
41239,3,20261,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm","1999-03-08 00:00:00",
2255,1,20261,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S24ltr.pdf","2000-10-23 00:00:00",
34439,2,20261,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20261S24lbl.pdf","2000-10-23 00:00:00",
2256,1,20261,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S25ltr.pdf","2000-12-18 00:00:00",
12379,2,20261,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf","2004-06-08 00:00:00",
20569,3,20261,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm","2004-06-08 00:00:00",
24670,1,20261,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Approv.pdf","2004-06-08 00:00:00",
20570,3,20261,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020261_s029_LESCOL_CAPSULES.pdf","2008-08-04 00:00:00",
34440,2,20261,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20261s30lbl.pdf","2003-04-22 00:00:00",
41240,3,20261,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s031_LESCOL_CAPSULES.pdf","2008-08-04 00:00:00",
2257,1,20261,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf","2002-09-06 00:00:00",
12380,2,20261,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf","2002-09-06 00:00:00",
20571,3,20261,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s032_LESCOL_CAPSULES.pdf","2008-08-04 00:00:00",
2258,1,20261,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf","2003-06-08 00:00:00",
20572,3,20261,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020261_S033_LESCOL_CAPS_AP.pdf","2007-04-09 00:00:00",
34441,2,20261,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf","2003-06-08 00:00:00",
12381,2,20261,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf","2005-01-11 00:00:00",
24671,1,20261,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf","2005-01-11 00:00:00",
41241,3,20261,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020261_s034_Lescol Capsules.pdf","2009-09-16 00:00:00",
24672,1,20261,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf","2006-04-13 00:00:00",
34442,2,20261,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf","2006-04-12 00:00:00",
2259,1,20261,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf","2006-04-13 00:00:00",
12382,2,20261,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf","2006-04-12 00:00:00",
51957,20,20261,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020261s036_fluvastatin_Lescol-MedRev_PREA.pdf","1900-01-01 00:00:00",
51958,23,20261,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020261, 021192_fluvastatin_Lescol_WR.pdf","1900-01-01 00:00:00",
51959,17,20261,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020261s036_fluvastatin_Lescol-StatsRev_PREA.pdf","1900-01-01 00:00:00",
12383,2,20261,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf","2006-04-05 00:00:00",
24673,1,20261,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf","2006-04-05 00:00:00",
2260,1,20261,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf","2007-06-14 00:00:00",
12384,2,20261,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf","2007-06-14 00:00:00",
2261,1,20261,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf","2011-06-28 00:00:00",
34443,2,20261,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf","2011-06-28 00:00:00",
12385,2,20261,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf","2012-02-28 00:00:00",
24674,1,20261,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf","2012-02-28 00:00:00",
41242,3,20261,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020261s046.pdf","2012-03-30 00:00:00",
44447,14,20261,"SUPPL",46,"Tracked Changes Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261S046-trackedchangeslbl.pdf","2012-02-28 00:00:00",
2262,1,20261,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf","2012-11-05 00:00:00",
34444,2,20261,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf","2012-11-06 00:00:00",
49272,2,20261,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020261s052,021192s026lbl.pdf","2017-08-08 00:00:00",
49281,1,20261,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020261Orig1s052,021192Orig1s026ltr.pdf","2017-08-08 00:00:00",
20573,3,20262,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf","1999-01-08 00:00:00",
41243,3,20262,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf","1999-01-08 00:00:00",
41244,3,20262,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf","1999-01-08 00:00:00",
12386,2,20262,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf","1998-06-30 00:00:00",
24675,1,20262,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262s24ltr.pdf","1998-06-30 00:00:00",
41245,3,20262,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20262s024.cfm","1999-09-09 00:00:00",
12387,2,20262,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf","1998-04-09 00:00:00",
24676,1,20262,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf","1998-04-09 00:00:00",
41246,3,20262,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm","2000-06-15 00:00:00",
2263,1,20262,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf","1998-04-09 00:00:00",
20574,3,20262,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm","2000-06-15 00:00:00",
34445,2,20262,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf","1998-04-09 00:00:00",
12388,2,20262,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf","1998-04-09 00:00:00",
24677,1,20262,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf","1998-04-09 00:00:00",
41247,3,20262,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm","2000-06-15 00:00:00",
41248,3,20262,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf","2000-07-06 00:00:00",
12389,2,20262,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF","1999-10-25 00:00:00",
24678,1,20262,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20262S33LTR.PDF","1999-10-25 00:00:00",
24679,1,20262,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262slr035ltr.pdf","2002-08-29 00:00:00",
24680,1,20262,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20262S36LTR.PDF","2000-06-20 00:00:00",
34446,2,20262,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20262S36LBL.PDF","2000-06-20 00:00:00",
41249,3,20262,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020262s036,037,038_Taxol.pdf","2005-12-16 00:00:00",
24681,1,20262,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf","2002-03-04 00:00:00",
41250,3,20262,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf","2005-12-16 00:00:00",
20575,3,20262,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf","2005-12-16 00:00:00",
24682,1,20262,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf","2002-03-04 00:00:00",
2264,1,20262,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20262slr041ltr.pdf","2003-03-26 00:00:00",
12390,2,20262,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf","2010-08-28 00:00:00",
24683,1,20262,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020262s048ltr.pdf","2010-09-07 00:00:00",
53723,3,20262,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020262Orig1s048.pdf","2018-04-18 00:00:00",
24684,1,20262,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020262s049ltr.pdf","2011-05-04 00:00:00",
34447,2,20262,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf","2011-05-02 00:00:00",
12391,2,20262,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf","2015-03-05 00:00:00",
24685,1,20262,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020262Orig1s051ltr.pdf","2015-03-04 00:00:00",
44052,10,20263,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
41251,3,20263,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
41252,3,20263,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
20576,3,20263,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron Depot_APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
2265,1,20263,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf","2002-09-24 00:00:00",
24686,1,20263,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf","2003-10-31 00:00:00",
24687,1,20263,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf","2003-12-24 00:00:00",
12392,2,20263,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf","2004-04-05 00:00:00",
24688,1,20263,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf","2004-03-10 00:00:00",
12393,2,20263,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf","2005-11-17 00:00:00",
24689,1,20263,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf","2005-11-18 00:00:00",
2266,1,20263,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf","2006-02-22 00:00:00",
34448,2,20263,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf","2006-02-22 00:00:00",
41253,3,20263,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron Depot Ped_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
2267,1,20263,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf","2008-08-05 00:00:00",
12394,2,20263,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf","2009-06-29 00:00:00",
24690,1,20263,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf","2009-06-30 00:00:00",
24691,1,20263,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf","2010-09-02 00:00:00",
34449,2,20263,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf","2010-08-30 00:00:00",
24692,1,20263,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf","2011-08-17 00:00:00",
34450,2,20263,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf","2011-08-15 00:00:00",
24693,1,20263,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf","2011-10-12 00:00:00",
34451,2,20263,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf","2011-10-12 00:00:00",
2268,1,20263,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf","2013-05-16 00:00:00",
34452,2,20263,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf","2013-05-21 00:00:00",
48475,2,20263,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf","2017-05-22 00:00:00",
48476,8,20263,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf#page=20","2017-05-22 00:00:00",
48494,1,20263,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020263Orig1s042ltr.pdf","2017-05-23 00:00:00",
53722,3,20263,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/020263Orig1s042.pdf","2018-04-18 00:00:00",
41254,3,20264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020264Orig1s000.pdf","2011-12-14 00:00:00",
2269,1,20264,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20264s9ltr.pdf","2002-04-09 00:00:00",
2270,1,20264,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20264slr011ltr.pdf","2003-05-30 00:00:00",
2271,1,20264,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020264s017ltr.pdf","2012-04-11 00:00:00",
34453,2,20264,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020264s017lbl.pdf","2012-04-09 00:00:00",
20577,3,20267,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020267Orig1s009.pdf","2013-04-18 00:00:00",
24694,1,20267,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20267s009ltr.pdf","2004-09-03 00:00:00",
2272,1,20267,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020267s010ltr.pdf","2006-01-20 00:00:00",
24695,1,20267,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020267s012ltr.pdf","2008-06-23 00:00:00",
24696,1,20267,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020267s013ltr.pdf","2009-05-29 00:00:00",
47826,1,20267,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020267Orig1s015ltr.pdf","2017-04-03 00:00:00",
47861,2,20267,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020267Orig1s015lbl.pdf","2017-04-05 00:00:00",
41255,3,20272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020272_safety_review.pdf","2011-02-15 00:00:00",
44053,10,20272,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-20 00:00:00",
51643,60,20272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20272 risperidone clinicalDD prea_clinical 5.pdf","1900-01-01 00:00:00",
51644,57,20272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20272 risperidone clinical CDTL prea_clinical 4.pdf","1900-01-01 00:00:00",
51645,20,20272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20272 risperidone clinical-1 prea.pdf","1900-01-01 00:00:00",
51646,20,20272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20272 risperidone clinical2 prea.pdf","1900-01-01 00:00:00",
51647,17,20272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20272 risperidone statistical prea.pdf","1900-01-01 00:00:00",
20578,3,20272,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf","2007-07-20 00:00:00",
41256,3,20272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf","2007-07-20 00:00:00",
23969,14,20272,"SUPPL",7,"Clinical Pharmacology & Biopharmaceutics Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.htm","2004-11-03 00:00:00",
41257,3,20272,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf","1997-10-17 00:00:00",
24697,1,20272,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf","2002-03-03 00:00:00",
41258,3,20272,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020272_s008_RISPERDALE TABLETS.pdf","2009-01-12 00:00:00",
2273,1,20272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf","2004-06-16 00:00:00",
12395,2,20272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf","2004-06-16 00:00:00",
2274,1,20272,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf","2002-11-19 00:00:00",
24698,1,20272,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf","2003-11-28 00:00:00",
12396,2,20272,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
20579,3,20272,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf","2009-09-16 00:00:00",
24699,1,20272,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
2275,1,20272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
34454,2,20272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
41259,3,20272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf","2009-09-16 00:00:00",
20580,3,20272,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_S033_RISPERDAL_TABLETS.pdf","2008-02-19 00:00:00",
24700,1,20272,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf","2004-06-16 00:00:00",
2276,1,20272,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf","2003-11-25 00:00:00",
12397,2,20272,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
24701,1,20272,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
41260,3,20272,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
12398,2,20272,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
24702,1,20272,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
41261,3,20272,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
12399,2,20272,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf","2005-08-19 00:00:00",
24703,1,20272,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf","2005-08-19 00:00:00",
12400,2,20272,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
24704,1,20272,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
41262,3,20272,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
52161,20,20272,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020272s046_risperidone_Risperdal-MedRev.pdf","1900-01-01 00:00:00",
52162,18,20272,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020272s046_risperidone_Risperdal-ClinPharmRev.pdf","1900-01-01 00:00:00",
52163,18,20272,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020272s046_Risperidone Risperdal-ClinPharm2.pdf","1900-01-01 00:00:00",
52164,17,20272,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020272s046_Risperidone Risperdal-Stat Review.pdf","1900-01-01 00:00:00",
52165,23,20272,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020272_risperidone_Risperdal_11-25-02_HFD120_orig_WR.pdf","1900-01-01 00:00:00",
2277,1,20272,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
12401,2,20272,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
20581,3,20272,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
2278,1,20272,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf","2008-08-19 00:00:00",
2279,1,20272,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
12402,2,20272,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf","2010-08-30 00:00:00",
2280,1,20272,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf","2009-08-06 00:00:00",
12403,2,20272,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf","2009-08-06 00:00:00",
12404,2,20272,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf","2010-08-30 00:00:00",
24705,1,20272,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
12405,2,20272,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf","2011-08-25 00:00:00",
24706,1,20272,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf","2011-08-26 00:00:00",
24707,1,20272,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
34455,2,20272,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
24708,1,20272,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
34456,2,20272,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf","2010-08-30 00:00:00",
2281,1,20272,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
34457,2,20272,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf","2010-08-30 00:00:00",
2282,1,20272,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf","2010-12-06 00:00:00",
12406,2,20272,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf","2010-12-04 00:00:00",
12407,2,20272,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf","2011-06-16 00:00:00",
24709,1,20272,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf","2011-06-17 00:00:00",
12408,2,20272,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf","2012-08-03 00:00:00",
24710,1,20272,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf","2012-08-03 00:00:00",
24711,1,20272,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
34458,2,20272,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
24712,1,20272,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf","2012-03-13 00:00:00",
24713,1,20272,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf","2014-05-09 00:00:00",
34459,2,20272,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf","2014-04-29 00:00:00",
24714,1,20272,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
34460,2,20272,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf","2016-03-03 00:00:00",
47320,2,20272,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf","2017-02-24 00:00:00",
47420,1,20272,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf","2017-03-02 00:00:00",
55050,1,20272,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf","2018-07-30 00:00:00",
55144,2,20272,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf","2018-08-09 00:00:00",
2283,1,20273,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20273s4ltr.pdf","1999-07-07 00:00:00",
20582,3,20273,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20273S004_Dovonex.pdf","1999-07-07 00:00:00",
24715,1,20273,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020273s008ltr.pdf","2005-05-02 00:00:00",
34461,2,20273,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf","2005-05-02 00:00:00",
41263,3,20273,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020273_s008_DOVONEX.pdf","2009-01-12 00:00:00",
2284,1,20273,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf","2007-10-04 00:00:00",
12409,2,20273,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf","2007-10-04 00:00:00",
2285,1,20273,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf","2015-03-13 00:00:00",
12410,2,20273,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf","2015-03-17 00:00:00",
2286,1,20279,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020279s009ltr.pdf","2010-12-10 00:00:00",
12411,2,20279,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020279s009lbl.pdf","2010-12-06 00:00:00",
41264,3,20280,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020280s008.pdf","2011-02-04 00:00:00",
2287,1,20280,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF","2000-06-20 00:00:00",
24716,1,20280,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20280s31ltr.pdf","2001-07-25 00:00:00",
34462,2,20280,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf","2001-07-25 00:00:00",
41265,3,20280,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-280S031_Genotropin.cfm","2001-07-25 00:00:00",
24717,1,20280,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scm038ltr.pdf","2003-04-15 00:00:00",
2288,1,20280,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scs040ltr.pdf","2003-06-08 00:00:00",
12412,2,20280,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf","2003-05-29 00:00:00",
2289,1,20280,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280slr044ltr.pdf","2003-11-25 00:00:00",
20583,3,20280,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020280_s049_genotropin_medr.pdf","2006-04-01 00:00:00",
24718,1,20280,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020280s049LTR.pdf","2006-05-01 00:00:00",
34463,2,20280,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf","2006-05-01 00:00:00",
12413,2,20280,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf","2007-07-24 00:00:00",
24719,1,20280,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf","2007-07-24 00:00:00",
24720,1,20280,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s057ltr.pdf","2007-03-15 00:00:00",
34464,2,20280,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf","2007-03-15 00:00:00",
2290,1,20280,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s060ltr.pdf","2008-06-13 00:00:00",
12414,2,20280,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf","2008-06-18 00:00:00",
24175,21,20280,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf","2008-07-16 00:00:00",
24721,1,20280,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s061ltr.pdf","2009-01-06 00:00:00",
34465,2,20280,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf","2009-01-06 00:00:00",
2291,1,20280,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s064ltr.pdf","2009-05-26 00:00:00",
12415,2,20280,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf","2009-05-25 00:00:00",
24722,1,20280,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s066ltr.pdf","2008-12-19 00:00:00",
34466,2,20280,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf","2009-01-02 00:00:00",
24723,1,20280,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020280s068ltr.pdf","2010-02-16 00:00:00",
34467,2,20280,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf","2010-02-16 00:00:00",
2292,1,20280,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020280s071ltr.pdf","2011-05-19 00:00:00",
34468,2,20280,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf","2011-05-23 00:00:00",
12416,2,20280,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf","2012-02-06 00:00:00",
24724,1,20280,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020280s072ltr.pdf","2012-02-08 00:00:00",
12417,2,20280,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf","2014-09-30 00:00:00",
24725,1,20280,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020280Orig1s077ltr.pdf","2014-09-29 00:00:00",
12418,2,20280,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf","2015-06-24 00:00:00",
24726,1,20280,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020280Orig1s078ltr.pdf","2015-06-24 00:00:00",
45243,2,20280,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf","2016-09-06 00:00:00",
45274,1,20280,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s079ltr.pdf","2016-09-08 00:00:00",
46154,1,20280,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s088ltr.pdf","2016-12-14 00:00:00",
46181,2,20280,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s088lbl.pdf","2016-12-14 00:00:00",
20584,3,20281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s014_ultram_toc.cfm","2003-08-07 00:00:00",
24727,1,20281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S014_ULTRAM_APPROV.PDF","2004-06-29 00:00:00",
20585,3,20281,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s015_ultram_toc.cfm","2003-08-07 00:00:00",
24728,1,20281,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S015_ULTRAM_APPROV.PDF","2004-06-29 00:00:00",
24729,1,20281,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20281S16LTR.PDF","1999-12-23 00:00:00",
34469,2,20281,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20281S16LBL.PDF","1999-12-23 00:00:00",
34470,2,20281,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20281s29lbl.pdf","2003-04-22 00:00:00",
2293,1,20281,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr001ltr.pdf","2004-04-20 00:00:00",
34471,2,20281,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf","2004-05-03 00:00:00",
24730,1,20281,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf","2009-11-12 00:00:00",
34472,2,20281,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf","2009-10-06 00:00:00",
12419,2,20281,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf","2009-10-06 00:00:00",
24731,1,20281,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf","2009-11-12 00:00:00",
46251,1,20281,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020281Orig1s036,s038ltr.pdf","2016-12-20 00:00:00",
46385,2,20281,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf","2016-12-21 00:00:00",
46252,1,20281,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020281Orig1s036,s038ltr.pdf","2016-12-20 00:00:00",
46386,2,20281,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf","2016-12-21 00:00:00",
49595,2,20281,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s039lbl.pdf","2017-08-30 00:00:00",
49596,8,20281,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s039lbl.pdf#page=44","2017-08-30 00:00:00",
49625,1,20281,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020281Orig1s039ltr.pdf","2017-08-30 00:00:00",
55678,1,20281,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020281Orig1s042s043ltr.pdf","2018-10-01 00:00:00",
55874,2,20281,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf","2018-10-11 00:00:00",
55876,8,20281,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf#page=45","2018-10-11 00:00:00",
55679,1,20281,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020281Orig1s042s043ltr.pdf","2018-10-01 00:00:00",
55875,2,20281,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf","2018-10-11 00:00:00",
55877,8,20281,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf#page=45","2018-10-11 00:00:00",
24732,1,20286,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr006ltr.pdf","2003-11-05 00:00:00",
2294,1,20286,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008ltr.pdf","2009-02-13 00:00:00",
20586,3,20287,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287_s002_FRAGMIN INJECTION.pdf","2008-08-11 00:00:00",
20587,3,20287,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287a_s005edt.pdf","1998-02-04 00:00:00",
2295,1,20287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20287s8ltr.pdf","1999-03-30 00:00:00",
20588,3,20287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S008_Fragmin.cfm","1999-03-30 00:00:00",
34473,2,20287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20287s8lbl.pdf","1999-03-30 00:00:00",
24733,1,20287,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_appltr.pdf","1999-05-25 00:00:00",
34474,2,20287,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_prntlbl.pdf","1999-05-25 00:00:00",
41266,3,20287,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin.cfm","1999-05-25 00:00:00",
2296,1,20287,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr011ltr.pdf","2003-03-10 00:00:00",
20589,3,20287,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287_S015_FRAGMIN_AP.pdf","2007-07-06 00:00:00",
20590,3,20287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020287_S017_FRAGMIN_AP.pdf","2007-07-06 00:00:00",
2297,1,20287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20287S18LTR.PDF","2000-08-03 00:00:00",
34475,2,20287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20287S18LBL.PDF","2000-08-03 00:00:00",
24734,1,20287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf","2002-04-04 00:00:00",
2298,1,20287,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf","2002-04-04 00:00:00",
24735,1,20287,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf","2002-04-04 00:00:00",
2299,1,20287,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr027LTR.pdf","2002-11-01 00:00:00",
24736,1,20287,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr029ltr.pdf","2002-11-19 00:00:00",
2300,1,20287,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr031ltr.pdf","2003-07-06 00:00:00",
41267,3,20287,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s031_FRAGMIN INJECTION.pdf","2008-08-01 00:00:00",
24737,1,20287,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287se1-032ltr.pdf","2003-12-16 00:00:00",
34476,2,20287,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20287se1-032_fragmin_lbl.pdf","2003-12-16 00:00:00",
41268,3,20287,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s032_FRAGMIN INJECTION.pdf","2008-08-01 00:00:00",
2301,1,20287,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20287slr034ltr.pdf","2004-04-29 00:00:00",
41269,3,20287,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020287_s034_FRAGMIN INJECTION.pdf","2008-07-31 00:00:00",
2302,1,20287,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020287s035ltr.pdf","2007-05-07 00:00:00",
34477,2,20287,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020287s035lbl.pdf","2007-05-07 00:00:00",
41270,3,20287,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020287Orig1s035.pdf","2012-03-27 00:00:00",
24738,1,20287,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020287s049ltr.pdf","2010-01-05 00:00:00",
34478,2,20287,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020287s049lbl.pdf","2009-12-30 00:00:00",
24739,1,20287,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020287s050ltr.pdf","2010-10-26 00:00:00",
34479,2,20287,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf","2010-10-25 00:00:00",
12420,2,20287,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf","2015-01-30 00:00:00",
24740,1,20287,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s062ltr.pdf","2015-01-27 00:00:00",
24741,1,20287,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s063ltr.pdf","2015-10-01 00:00:00",
34480,2,20287,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s063lbl.pdf","2015-10-07 00:00:00",
44987,1,20287,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020287Orig1s067ltr.pdf","2016-08-04 00:00:00",
44997,2,20287,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020287s067lbl.pdf","2016-08-04 00:00:00",
48370,2,20287,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020287s069lbl.pdf","2017-05-12 00:00:00",
48406,1,20287,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020287Orig1s069ltr.pdf","2017-05-17 00:00:00",
24742,1,20291,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020291s020LTR.pdf","2006-06-02 00:00:00",
34481,2,20291,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf","2006-06-02 00:00:00",
24743,1,20291,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020291s023ltr.pdf","2008-11-13 00:00:00",
34482,2,20291,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf","2008-11-12 00:00:00",
2303,1,20291,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s026ltr.pdf","2009-05-13 00:00:00",
12421,2,20291,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf","2009-05-11 00:00:00",
24744,1,20291,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s027ltr.pdf","2009-06-08 00:00:00",
34483,2,20291,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf","2009-06-04 00:00:00",
24745,1,20291,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020291s029ltr.pdf","2011-04-06 00:00:00",
34484,2,20291,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf","2011-04-01 00:00:00",
24746,1,20291,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s030ltr.pdf","2012-09-20 00:00:00",
24747,1,20291,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s031ltr.pdf","2012-08-22 00:00:00",
34485,2,20291,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf","2012-08-20 00:00:00",
41271,3,20292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020292.pdf","2010-03-03 00:00:00",
41272,3,20297,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20297s4_Coreg.pdf","1999-09-08 00:00:00",
2304,1,20297,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_Approv.pdf","2001-11-01 00:00:00",
34486,2,20297,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf","2001-11-01 00:00:00",
41273,3,20297,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg.cfm","2001-11-01 00:00:00",
2305,1,20297,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297se1-009ltr.pdf","2003-03-28 00:00:00",
41274,3,20297,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-297s009_Coreg.cfm","2003-07-08 00:00:00",
24748,1,20297,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297slr011ltr.pdf","2003-09-30 00:00:00",
2306,1,20297,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s013ltr.pdf","2005-05-02 00:00:00",
12422,2,20297,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf","2005-05-02 00:00:00",
2307,1,20297,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s017ltr.pdf","2005-08-19 00:00:00",
2308,1,20297,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s018ltr.pdf","2006-09-18 00:00:00",
12423,2,20297,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf","2006-08-29 00:00:00",
2309,1,20297,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s020_ltr.pdf","2006-09-18 00:00:00",
24134,15,20297,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s020pi.pdf","2006-09-12 00:00:00",
2310,1,20297,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s021ltr.pdf","2006-12-28 00:00:00",
2311,1,20297,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020297s022ltr.pdf","2007-03-06 00:00:00",
12424,2,20297,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf","2007-02-26 00:00:00",
51798,23,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297carvedilol_Coreg_12-23-98_orig WR.pdf","1900-01-01 00:00:00",
51799,25,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297_carvedilol_Coreg(amended)_5-7-99_amend1.pdf","1900-01-01 00:00:00",
51800,26,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297_carvedilol_Coreg(amended)_11-2-99_amend2.pdf","1900-01-01 00:00:00",
51801,27,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297_carvedilol_Coreg(amended)_10-3-00_amend3.pdf","1900-01-01 00:00:00",
51802,28,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297_carvedilol_(amended)_5-28-03_amend4.pdf","1900-01-01 00:00:00",
51803,29,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297_carvedilol_(amended)_1-7-04_amend5.pdf","1900-01-01 00:00:00",
51805,20,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297s022_carvedilol_Coreg-MedRev.pdf","1900-01-01 00:00:00",
51806,17,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297s022_carvedilol_Coreg-StatsRev.pdf","1900-01-01 00:00:00",
53085,18,20297,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020297s022_carvedilol_Coreg-ClinPharmRev.pdf","1900-01-01 00:00:00",
24749,1,20297,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s028ltr.pdf","2008-07-23 00:00:00",
34487,2,20297,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf","2008-07-23 00:00:00",
2312,1,20297,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020297s029ltr.pdf","2009-06-26 00:00:00",
34488,2,20297,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf","2009-06-29 00:00:00",
24750,1,20297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s030ltr.pdf","2008-12-24 00:00:00",
34489,2,20297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf","2009-01-06 00:00:00",
2313,1,20297,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf","2011-02-02 00:00:00",
12425,2,20297,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf","2011-01-31 00:00:00",
24751,1,20297,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf","2011-01-07 00:00:00",
34490,2,20297,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf","2011-01-10 00:00:00",
2314,1,20297,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf","2011-01-07 00:00:00",
34491,2,20297,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf","2011-01-10 00:00:00",
24752,1,20297,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf","2011-07-07 00:00:00",
34492,2,20297,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf","2011-07-12 00:00:00",
24753,1,20297,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020297Orig1s037ltr.pdf","2015-10-06 00:00:00",
34493,2,20297,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf","2015-10-08 00:00:00",
49746,2,20297,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf","2017-09-15 00:00:00",
49783,1,20297,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020297Orig1s038ltr.pdf","2017-09-19 00:00:00",
12426,2,20298,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf","2016-04-04 00:00:00",
12427,2,20301,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf","2013-10-04 00:00:00",
24754,1,20301,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf","2013-10-04 00:00:00",
2315,1,20301,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
12428,2,20301,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf","2012-07-13 00:00:00",
2316,1,20301,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf","2013-10-04 00:00:00",
2317,1,20301,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf","2013-10-04 00:00:00",
24755,1,20301,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf","2013-10-04 00:00:00",
2318,1,20301,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020301Orig1s036ltr.pdf","2015-12-02 00:00:00",
12429,2,20301,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf","2015-12-02 00:00:00",
49298,2,20301,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020301s037lbl.pdf","2017-08-09 00:00:00",
49421,1,20301,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020301Orig1s037ltr.pdf","2017-08-15 00:00:00",
44054,10,20303,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm","2009-06-02 00:00:00",
44055,10,20304,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142720.htm","2006-02-27 00:00:00",
12430,2,20304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf","1998-08-28 00:00:00",
20591,3,20304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020304s004.cfm","1999-07-02 00:00:00",
24756,1,20304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf","1998-08-28 00:00:00",
12431,2,20304,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf","2006-02-07 00:00:00",
2319,1,20304,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020304s022ltr.pdf","2006-12-28 00:00:00",
12432,2,20304,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf","2006-12-15 00:00:00",
41275,3,20305,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020305a_s001.pdf","1997-10-06 00:00:00",
24757,1,20305,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20103s4ltr.pdf","1999-07-27 00:00:00",
41276,3,20305,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020305S004_Kytril.cfm","1999-07-27 00:00:00",
2320,1,20305,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005ltr.pdf","2005-11-30 00:00:00",
20592,3,20305,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020305_s010_Kytril Tabs.pdf","2009-09-16 00:00:00",
34494,2,20305,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf","2005-11-30 00:00:00",
2321,1,20305,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf","2009-11-12 00:00:00",
12433,2,20305,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf","2009-10-14 00:00:00",
12434,2,20306,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlbl.pdf","2004-03-10 00:00:00",
20593,3,20306,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306s005Fludeoxyglucose.cfm","2004-03-10 00:00:00",
24758,1,20306,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_APPROV.PDF","2004-03-10 00:00:00",
41277,3,20309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020309_original_approval.pdf","2011-02-15 00:00:00",
24759,1,20309,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020309s015ltr.pdf","2007-02-12 00:00:00",
24760,1,20309,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020309Orig1s028ltr.pdf","2013-05-30 00:00:00",
34495,2,20309,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020309s028lbl.pdf","2013-06-04 00:00:00",
20594,3,20310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20310_Nizoral.cfm","1997-10-10 00:00:00",
23574,10,20310,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm362415.htm","2014-02-07 00:00:00",
24761,1,20310,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020310s019ltr.pdf","2010-09-21 00:00:00",
23575,10,20312,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
41278,3,20312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-312_Moexipril_Univasc.pdf","2002-09-13 00:00:00",
2322,1,20312,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20312S16ltr.pdf","2001-04-11 00:00:00",
2323,1,20312,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf","2003-11-25 00:00:00",
12435,2,20312,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf","2010-01-29 00:00:00",
24762,1,20312,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020312s031ltr.pdf","2010-01-15 00:00:00",
12436,2,20312,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf","2011-09-02 00:00:00",
24763,1,20312,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020312s033ltr.pdf","2011-08-26 00:00:00",
2324,1,20312,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf","2012-01-23 00:00:00",
12437,2,20312,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf","2012-01-23 00:00:00",
12438,2,20312,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf","2012-09-18 00:00:00",
24764,1,20312,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312Orig1s035ltr.pdf","2012-09-18 00:00:00",
23576,10,20313,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm388640.htm","2014-03-12 00:00:00",
24765,1,20313,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020313s021ltr.pdf","2006-01-20 00:00:00",
2325,1,20313,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20313scs023ltr.pdf","2003-08-28 00:00:00",
20595,3,20313,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020313_S023_MIACALCIN_AP.pdf","2007-07-06 00:00:00",
34496,2,20313,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020313s029lbl.pdf","2009-12-10 00:00:00",
24766,1,20313,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020313s033ltr.pdf","2012-04-23 00:00:00",
34497,2,20313,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020313s033lbl.pdf","2012-04-20 00:00:00",
12439,2,20313,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf","2014-03-13 00:00:00",
24767,1,20313,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020313Orig1s034ltr.pdf","2014-03-13 00:00:00",
49728,2,20313,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020313s036lbl.pdf","2017-09-13 00:00:00",
49758,1,20313,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020313Orig1s036ltr.pdf","2017-09-15 00:00:00",
24768,1,20315,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20315S6LTR.PDF","2001-03-30 00:00:00",
2326,1,20316,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20316slr016ltr.pdf","2002-01-06 00:00:00",
2327,1,20316,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020316s021LTR.pdf","2006-11-14 00:00:00",
2328,1,20316,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020316Orig1s028ltr.pdf","2015-07-23 00:00:00",
12440,2,20316,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf","2015-07-23 00:00:00",
47873,2,20316,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf","2017-04-06 00:00:00",
47961,1,20316,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020316Orig1s029ltr.pdf","2017-04-12 00:00:00",
24769,1,20323,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf","2004-02-02 00:00:00",
34498,2,20323,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf","2004-02-03 00:00:00",
20596,3,20323,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-323S021_Vivelle.cfm","2004-03-28 00:00:00",
24770,1,20323,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S21LTR.PDF","2000-02-29 00:00:00",
34499,2,20323,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF","2000-02-28 00:00:00",
12441,2,20323,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf","2000-08-16 00:00:00",
20597,3,20323,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm","2004-04-13 00:00:00",
24771,1,20323,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf","2000-08-16 00:00:00",
24772,1,20323,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf","2004-02-02 00:00:00",
34500,2,20323,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf","2004-02-03 00:00:00",
24773,1,20323,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf","2004-02-02 00:00:00",
34501,2,20323,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf","2004-02-03 00:00:00",
24774,1,20323,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323s033ltr.pdf","2004-08-10 00:00:00",
34502,2,20323,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf","2004-08-10 00:00:00",
50286,2,20323,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf","2017-11-03 00:00:00",
50302,1,20323,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020323Orig1s036ltr.pdf","2017-11-06 00:00:00",
2329,1,20325,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s3ltr.pdf","2002-03-01 00:00:00",
2330,1,20325,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s13ltr.pdf","2002-03-01 00:00:00",
12442,2,20325,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf","2003-09-30 00:00:00",
24775,1,20325,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20325se2-015ltr.pdf","2003-09-30 00:00:00",
41279,3,20325,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020325s015TOC.cfm","2007-05-29 00:00:00",
2331,1,20325,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf","2004-10-29 00:00:00",
24776,1,20325,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020325s019LTR.pdf","2006-06-12 00:00:00",
12443,2,20325,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf","2016-04-11 00:00:00",
2332,1,20325,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020325Orig1s030ltr.pdf","2016-06-09 00:00:00",
12444,2,20325,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf","2016-06-13 00:00:00",
12445,2,20326,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf","2002-06-26 00:00:00",
24777,1,20326,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20326s011,013ltr.pdf","2002-06-26 00:00:00",
24778,1,20326,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20326s011,013ltr.pdf","2002-06-26 00:00:00",
34503,2,20326,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf","2002-06-26 00:00:00",
2333,1,20326,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020326s015ltr.pdf","2005-11-18 00:00:00",
12446,2,20326,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf","2005-11-17 00:00:00",
24779,1,20327,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20327slr002ltr.pdf","2003-07-23 00:00:00",
24780,1,20327,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf","2003-12-11 00:00:00",
12447,2,20327,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf","2012-08-02 00:00:00",
24781,1,20327,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020327Orig1s007ltr.pdf","2012-08-03 00:00:00",
24782,1,20327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020327Orig1s008ltr.pdf","2014-06-24 00:00:00",
34504,2,20327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf","2014-06-23 00:00:00",
2334,1,20327,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf","2015-07-09 00:00:00",
34505,2,20327,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf","2015-07-09 00:00:00",
24783,1,20327,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020327Orig1s011ltr.pdf","2016-01-25 00:00:00",
34506,2,20327,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf","2016-01-26 00:00:00",
47881,2,20327,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020327s012lbl.pdf","2017-04-06 00:00:00",
47968,1,20327,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018735Orig1s057,020327Orig1s012ltr.pdf","2017-04-12 00:00:00",
52688,2,20327,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020327s014lbl.pdf","2018-02-22 00:00:00",
52726,1,20327,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020327Orig1s014ltr.pdf","2018-02-26 00:00:00",
12448,2,20329,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20329s2lbl.pdf","2002-04-01 00:00:00",
24784,1,20329,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20329s002ltr.pdf","2002-04-01 00:00:00",
41280,3,20329,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020329_S003_Glucotrol XL_APPROVAL PACKAGES.pdf","2006-10-25 00:00:00",
24785,1,20329,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20329slr015ltr.pdf","2003-09-29 00:00:00",
41281,3,20329,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020329_S015_GLUCOTROL XP_AP.pdf","2007-07-09 00:00:00",
2335,1,20329,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020329s022ltr.pdf","2008-10-29 00:00:00",
12449,2,20329,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020329s22lbl.pdf","2008-11-07 00:00:00",
34507,2,20329,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020329s024lbl.pdf","2009-09-17 00:00:00",
2336,1,20329,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020329s025ltr.pdf","2011-02-09 00:00:00",
12450,2,20329,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020329s025lbl.pdf","2011-02-07 00:00:00",
12451,2,20329,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020329s028lbl.pdf","2013-10-22 00:00:00",
24786,1,20329,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020329Orig1s028ltr.pdf","2013-10-16 00:00:00",
2337,1,20329,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020329Orig1s029ltr.pdf","2015-10-06 00:00:00",
12452,2,20329,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020329s029lbl.pdf","2015-10-08 00:00:00",
49446,2,20329,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020329s030lbl.pdf","2017-08-17 00:00:00",
49569,1,20329,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020329Orig1s030ltr.pdf","2017-08-29 00:00:00",
55170,2,20329,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020329s032lbl.pdf","2018-08-13 00:00:00",
55200,1,20329,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020329Orig1s032ltr.pdf","2018-08-17 00:00:00",
41282,3,20330,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-330S011.pdf","2003-09-11 00:00:00",
2338,1,20330,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20330slr017ltr.pdf","2003-12-24 00:00:00",
34508,2,20330,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20330slr017_timoptic_lbl.pdf","2003-12-29 00:00:00",
41283,3,20330,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020330_s017_TimopticTOC.cfm","2006-05-08 00:00:00",
2339,1,20330,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf","2004-08-12 00:00:00",
34509,2,20330,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf","2004-08-12 00:00:00",
2340,1,20330,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf","2004-08-12 00:00:00",
12453,2,20330,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf","2004-08-12 00:00:00",
24787,1,20330,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022, s024LTR.pdf","2006-05-01 00:00:00",
34510,2,20330,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf","2006-05-01 00:00:00",
2341,1,20330,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022, s024LTR.pdf","2006-05-01 00:00:00",
34511,2,20330,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf","2006-05-01 00:00:00",
24788,1,20330,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020330s027ltr.pdf","2011-10-04 00:00:00",
34512,2,20330,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020330s027lbl.pdf","2011-09-30 00:00:00",
2342,1,20330,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020330Orig1s029ltr.pdf","2015-10-13 00:00:00",
12454,2,20330,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020330s029lbl.pdf","2015-10-15 00:00:00",
54906,2,20330,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020330s032lbl.pdf","2018-07-17 00:00:00",
54930,1,20330,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020330Orig1s032ltr.pdf","2018-07-20 00:00:00",
51766,23,20333,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_WR_orig.pdf","1900-01-01 00:00:00",
51767,25,20333,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_amend 1.pdf","1900-01-01 00:00:00",
51768,26,20333,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_amend 2.pdf","1900-01-01 00:00:00",
51769,20,20333,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333s008_anagrelide_Agrylin_MedR.pdf","1900-01-01 00:00:00",
51770,18,20333,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333s008_anagrelide_Agrylin_ClinPharmR.pdf","1900-01-01 00:00:00",
2343,1,20333,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20333S2ltr.pdf","1998-12-16 00:00:00",
12455,2,20333,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf","1998-12-16 00:00:00",
20598,3,20333,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20333-S002_Agrylin.pdf","1998-12-16 00:00:00",
2344,1,20333,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf","2004-12-10 00:00:00",
34513,2,20333,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf","2004-12-10 00:00:00",
12456,2,20333,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf","2004-12-10 00:00:00",
24789,1,20333,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf","2004-12-10 00:00:00",
2345,1,20333,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf","2004-12-30 00:00:00",
12457,2,20333,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf","2004-12-30 00:00:00",
12458,2,20333,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf","2008-06-19 00:00:00",
24790,1,20333,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf","2008-06-20 00:00:00",
41284,3,20333,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020333Orig1s013.pdf","2015-08-21 00:00:00",
24791,1,20333,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf","2009-07-17 00:00:00",
34514,2,20333,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf","2009-07-23 00:00:00",
2346,1,20333,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf","2010-07-02 00:00:00",
34515,2,20333,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf","2010-07-06 00:00:00",
12459,2,20333,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf","2011-01-31 00:00:00",
24792,1,20333,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf","2011-02-04 00:00:00",
2347,1,20333,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf","2011-11-28 00:00:00",
12460,2,20333,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf","2011-11-30 00:00:00",
24793,1,20333,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf","2013-07-19 00:00:00",
34516,2,20333,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf","2013-07-23 00:00:00",
2348,1,20333,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf","2014-02-11 00:00:00",
34517,2,20333,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf","2014-02-10 00:00:00",
12461,2,20333,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf","2014-11-04 00:00:00",
24794,1,20333,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf","2014-11-03 00:00:00",
12462,2,20333,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf","2015-07-16 00:00:00",
24795,1,20333,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf","2015-07-15 00:00:00",
53252,2,20333,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s024lbl.pdf","2018-03-23 00:00:00",
53490,1,20333,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020333Orig1s024ltr.pdf","2018-03-28 00:00:00",
2349,1,20334,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20334slr001ltr.pdf","2003-05-29 00:00:00",
34518,2,20334,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020334s001lbl.pdf","2003-04-28 00:00:00",
12463,2,20334,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf","2004-04-05 00:00:00",
24796,1,20334,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20334slr003ltr.pdf","2004-03-24 00:00:00",
24797,1,20334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf","2010-08-24 00:00:00",
34519,2,20334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020334s004lbl.pdf","2010-08-20 00:00:00",
2350,1,20334,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020334Orig1s008ltr.pdf","2013-08-20 00:00:00",
34520,2,20334,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020334s008lbl.pdf","2013-08-21 00:00:00",
2351,1,20334,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020334Orig1s009ltr.pdf","2015-07-14 00:00:00",
34521,2,20334,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020334s009lbl.pdf","2015-07-16 00:00:00",
53604,2,20334,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf","2018-04-04 00:00:00",
53624,1,20334,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012623Orig1s067,020334Orig1s010,020868Orig1s012ltr.pdf","2018-04-05 00:00:00",
2352,1,20336,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019546s031,020336s013ltr.pdf","2005-05-20 00:00:00",
20599,3,20337,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020337s001_temovate_toc.cfm","2003-08-07 00:00:00",
12464,2,20337,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020337s005lbl.pdf","2003-04-07 00:00:00",
24798,1,20337,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20337slr005ltr.pdf","2003-04-18 00:00:00",
41285,3,20340,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020340s003_temovate_toc.cfm","2003-08-07 00:00:00",
2353,1,20340,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20340slr006ltr.pdf","2003-04-18 00:00:00",
34522,2,20340,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020340s006lbl.pdf","2003-04-07 00:00:00",
24799,1,20340,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020340Orig1s007ltr.pdf","2012-11-16 00:00:00",
34523,2,20340,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020340s007lbl.pdf","2012-11-16 00:00:00",
2354,1,20343,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr014ltr.pdf","2003-04-18 00:00:00",
2355,1,20343,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf","2007-05-07 00:00:00",
2356,1,20343,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf","2007-11-08 00:00:00",
2357,1,20346,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20346s002ltr.pdf","1998-05-15 00:00:00",
41286,3,20346,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf","1998-05-15 00:00:00",
20600,3,20346,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S008_ZYRTEC TABLETS.pdf","2009-01-12 00:00:00",
24800,1,20346,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19835se5-015,20346se5-008LTR.pdf","2002-10-21 00:00:00",
34524,2,20346,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf","2002-10-21 00:00:00",
2358,1,20346,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf","2004-03-24 00:00:00",
34525,2,20346,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf","2004-04-05 00:00:00",
41287,3,20346,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S011_ZYRTEC SYRUP.pdf","2009-01-12 00:00:00",
24801,1,20347,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf","2002-01-23 00:00:00",
41288,3,20347,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-347-S006.pdf","2004-01-06 00:00:00",
2359,1,20347,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347Orig1s009 ltr.pdf","2006-02-08 00:00:00",
34526,2,20347,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf","2016-04-11 00:00:00",
2360,1,20351,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20351scm010ltr.pdf","2004-06-30 00:00:00",
24802,1,20351,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351scp011ltr.pdf","2003-09-25 00:00:00",
2361,1,20351,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351slr013ltr.pdf","2003-12-23 00:00:00",
34527,2,20351,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf","2003-12-29 00:00:00",
24803,1,20351,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351scp016ltr.pdf","2004-03-28 00:00:00",
24804,1,20351,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351s018ltr.pdf","2005-01-11 00:00:00",
24805,1,20351,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s020ltr.pdf","2005-04-28 00:00:00",
24806,1,20351,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s021ltr.pdf","2005-08-31 00:00:00",
2362,1,20351,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf","2015-07-10 00:00:00",
34528,2,20351,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf","2015-07-09 00:00:00",
47894,2,20351,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s044lbl.pdf","2017-04-07 00:00:00",
47958,1,20351,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf","2017-04-12 00:00:00",
51195,57,20351,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/169_20351S44 iodixanol CDTL clinical prea.pdf","1900-01-01 00:00:00",
51196,20,20351,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/170_20351S44 iodixanol clinical prea.pdf","1900-01-01 00:00:00",
51198,17,20351,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/172_20351S44 iohexol statistical prea.pdf","1900-01-01 00:00:00",
51199,18,20351,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/171_20351S44 iodixanol clinpharm prea.pdf","1900-01-01 00:00:00",
47899,2,20351,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s045lbl.pdf","2017-04-07 00:00:00",
47944,1,20351,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf","2017-04-12 00:00:00",
20601,3,20353,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020353s001_naprelan_toc.cfm","2003-08-08 00:00:00",
43644,8,20353,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280324.pdf","2011-11-17 00:00:00",
24807,1,20353,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020353s016ltr.pdf","2006-01-20 00:00:00",
34529,2,20353,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf","2006-01-20 00:00:00",
24808,1,20353,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020353s019ltr.pdf","2007-06-04 00:00:00",
2363,1,20353,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020353s023ltr.pdf","2009-08-10 00:00:00",
34530,2,20353,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf","2009-11-06 00:00:00",
24809,1,20353,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020353s028ltr.pdf","2011-11-10 00:00:00",
34531,2,20353,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf","2011-11-09 00:00:00",
2364,1,20353,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf","2016-05-12 00:00:00",
34532,2,20353,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf","2016-05-11 00:00:00",
2365,1,20353,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf","2016-05-12 00:00:00",
12465,2,20353,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf","2016-05-11 00:00:00",
49724,2,20353,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf","2017-09-13 00:00:00",
23577,10,20355,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2007-12-04 00:00:00",
24810,1,20355,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20355slr004ltr.pdf","2002-08-21 00:00:00",
12466,2,20355,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf","2007-11-07 00:00:00",
24811,1,20355,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020355s007ltr.pdf","2007-11-08 00:00:00",
2366,1,20355,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020355s013ltr.pdf","2011-09-21 00:00:00",
34533,2,20355,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020355s013lbl.pdf","2011-09-20 00:00:00",
2367,1,20355,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s017ltr.pdf","2013-05-28 00:00:00",
12467,2,20355,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf","2013-06-04 00:00:00",
24812,1,20355,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s020ltr.pdf","2013-06-12 00:00:00",
34534,2,20355,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s020lbl.pdf","2013-06-10 00:00:00",
48749,1,20356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/020356Orig1s027ltr.pdf","2017-06-16 00:00:00",
41289,3,20356,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf","2001-06-04 00:00:00",
20602,3,20356,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf","2001-06-04 00:00:00",
20603,3,20356,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020356Orig1s019.pdf","2012-02-28 00:00:00",
24813,1,20356,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020356s019ltr_CKD.pdf","2008-01-09 00:00:00",
48713,2,20356,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020356s027lbl.pdf","2017-06-14 00:00:00",
41290,3,20357,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020357a_s006.pdf","1997-11-06 00:00:00",
2368,1,20357,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20357s10ltr.pdf","1998-10-22 00:00:00",
41291,3,20357,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020357s010.cfm","1998-10-22 00:00:00",
20604,3,20357,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20357S17.PDF","1999-09-22 00:00:00",
2369,1,20357,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20357S19LTR.PDF","2000-12-15 00:00:00",
34535,2,20357,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf","2000-02-15 00:00:00",
41292,3,20357,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357s19_glucophage.cfm","2000-12-15 00:00:00",
24814,1,20357,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf","2001-04-23 00:00:00",
41293,3,20357,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020357_S020_GLUCOPHAGE_AP.pdf","2007-04-11 00:00:00",
24815,1,20357,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf","2002-01-08 00:00:00",
2370,1,20357,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf","2004-03-24 00:00:00",
24816,1,20357,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf","2004-03-24 00:00:00",
24817,1,20357,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf","2006-11-06 00:00:00",
34536,2,20357,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf","2006-11-06 00:00:00",
2371,1,20357,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf","2008-08-28 00:00:00",
34537,2,20357,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf","2008-08-29 00:00:00",
54381,1,20357,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020357Orig1s034, 021202Orig1s018ltr.pdf","2018-05-31 00:00:00",
54395,2,20357,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf","2018-05-31 00:00:00",
47933,2,20357,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf","2017-04-11 00:00:00",
47947,1,20357,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf","2017-04-12 00:00:00",
47934,2,20357,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf","2017-04-11 00:00:00",
47948,1,20357,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf","2017-04-12 00:00:00",
20605,3,20358,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf","1997-12-16 00:00:00",
23578,10,20358,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
41294,3,20358,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf","1997-12-16 00:00:00",
2372,1,20358,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf","2002-10-02 00:00:00",
20606,3,20358,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-358S019_Bupropion.pdf","2001-06-11 00:00:00",
24818,1,20358,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20358s19ltr.pdf","2001-06-11 00:00:00",
34538,2,20358,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20358s19lbl.pdf","2001-06-11 00:00:00",
20607,3,20358,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf","2011-12-09 00:00:00",
41295,3,20358,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf","2011-12-09 00:00:00",
41296,3,20358,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf","2011-12-09 00:00:00",
2373,1,20358,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s018,023LTR.pdf","2002-06-20 00:00:00",
24819,1,20358,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf","2002-10-02 00:00:00",
41297,3,20358,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358Orig1s025.pdf","2011-12-09 00:00:00",
12468,2,20358,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf","2002-06-14 00:00:00",
20608,3,20358,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358_S027_WELLBUTRIN_TABS_AP.pdf","2007-04-09 00:00:00",
24820,1,20358,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358s027ltr.pdf","2002-06-14 00:00:00",
24821,1,20358,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358scm028ltr.pdf","2002-07-12 00:00:00",
2374,1,20358,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf","2002-10-22 00:00:00",
24822,1,20358,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20358slr030ltr.pdf","2004-04-29 00:00:00",
2375,1,20358,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf","2004-06-01 00:00:00",
20609,3,20358,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm","2007-06-29 00:00:00",
12469,2,20358,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf","2005-01-13 00:00:00",
24823,1,20358,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf","2005-01-13 00:00:00",
2376,1,20358,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf","2006-03-03 00:00:00",
2377,1,20358,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf","2006-07-13 00:00:00",
34539,2,20358,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf","2006-07-05 00:00:00",
2378,1,20358,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf","2011-05-19 00:00:00",
34540,2,20358,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf","2011-05-23 00:00:00",
2379,1,20358,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf","2006-07-13 00:00:00",
34541,2,20358,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf","2006-07-05 00:00:00",
41298,3,20358,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020358Orig1s040.pdf","2012-06-26 00:00:00",
24824,1,20358,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf","2007-02-02 00:00:00",
34542,2,20358,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s035,020358s042lbl.pdf","2007-02-02 00:00:00",
12470,2,20358,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf","2007-08-03 00:00:00",
24825,1,20358,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf","2007-08-07 00:00:00",
24826,1,20358,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045ltr.pdf","2010-05-27 00:00:00",
34543,2,20358,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf","2010-05-28 00:00:00",
12471,2,20358,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf","2009-07-06 00:00:00",
24827,1,20358,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf","2009-07-07 00:00:00",
2380,1,20358,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf","2009-07-07 00:00:00",
12472,2,20358,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf","2009-07-06 00:00:00",
2381,1,20358,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048ltr.pdf","2010-03-03 00:00:00",
24828,1,20358,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf","2011-05-19 00:00:00",
34544,2,20358,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf","2011-05-23 00:00:00",
24829,1,20358,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf","2011-07-28 00:00:00",
34545,2,20358,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s050lbl.pdf","2011-07-25 00:00:00",
2382,1,20358,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358Orig1s051ltr.pdf","2012-08-03 00:00:00",
2383,1,20358,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358Origs052ltr.pdf","2013-03-21 00:00:00",
34546,2,20358,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf","2013-03-26 00:00:00",
12473,2,20358,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf","2013-12-24 00:00:00",
24830,1,20358,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf","2013-12-26 00:00:00",
41299,3,20358,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s053.pdf","2014-07-07 00:00:00",
2384,1,20358,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf","2013-12-26 00:00:00",
20610,3,20358,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s054.pdf","2014-07-07 00:00:00",
34547,2,20358,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf","2013-12-24 00:00:00",
12474,2,20358,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf","2014-12-17 00:00:00",
24831,1,20358,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf","2014-12-17 00:00:00",
2385,1,20358,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf","2014-07-21 00:00:00",
12475,2,20358,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf","2014-07-22 00:00:00",
24832,1,20358,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf","2016-04-27 00:00:00",
34548,2,20358,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf","2016-04-27 00:00:00",
48352,2,20358,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s058lbl.pdf","2017-05-10 00:00:00",
48360,1,20358,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s051,020358Orig1s058ltr.pdf","2017-05-12 00:00:00",
48265,2,20358,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s059lbl.pdf","2017-05-08 00:00:00",
48304,1,20358,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s052,020358Orig1s059ltr.pdf","2017-05-09 00:00:00",
49458,2,20358,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s060lbl.pdf","2017-08-18 00:00:00",
49459,8,20358,"SUPPL",60,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s060lbl.pdf#page=34","2017-08-18 00:00:00",
49480,1,20358,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s053,020358Orig1s060ltr.pdf","2017-08-21 00:00:00",
24833,1,20363,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf","1998-06-12 00:00:00",
2386,1,20363,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf","1998-06-12 00:00:00",
2387,1,20363,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf","1998-06-12 00:00:00",
12476,2,20363,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF","2001-03-29 00:00:00",
24834,1,20363,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF","2001-03-29 00:00:00",
41300,3,20363,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-363S-019_review.pdf","2004-04-14 00:00:00",
24835,1,20363,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s026ltr.pdf","2006-03-01 00:00:00",
34549,2,20363,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s026lbl.pdf","2006-02-28 00:00:00",
12477,2,20363,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf","2006-08-04 00:00:00",
24836,1,20363,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf","2006-08-04 00:00:00",
2388,1,20363,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf","2006-08-04 00:00:00",
34550,2,20363,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf","2006-08-04 00:00:00",
24837,1,20363,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020363s034ltr.pdf","2008-12-24 00:00:00",
34551,2,20363,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020363s034lbl.pdf","2009-01-02 00:00:00",
12478,2,20363,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf","2010-01-12 00:00:00",
24838,1,20363,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020363s036ltr.pdf","2009-12-31 00:00:00",
51150,23,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Original_WR.pdf","2009-09-21 00:00:00",
51609,25,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_1.pdf","2009-09-21 00:00:00",
51610,26,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_2.pdf","2009-09-21 00:00:00",
51611,27,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_3.pdf","2009-09-21 00:00:00",
52927,18,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_Famciclovir_Clinpharm_BPCA.pdf","2009-09-29 00:00:00",
52928,20,20363,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_Famciclovir_Clinical_BPCA.pdf","1900-01-01 00:00:00",
12479,2,20363,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf","2011-01-31 00:00:00",
24839,1,20363,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020363s037ltr.pdf","2011-02-04 00:00:00",
2389,1,20363,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf","2012-02-13 00:00:00",
12480,2,20363,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf","2012-02-10 00:00:00",
24840,1,20363,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf","2012-02-13 00:00:00",
34552,2,20363,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf","2012-02-10 00:00:00",
2390,1,20363,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020363Orig1s042ltr.pdf","2013-04-25 00:00:00",
12481,2,20363,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf","2013-04-30 00:00:00",
45318,2,20363,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020363s047lbl.pdf","2016-09-16 00:00:00",
45345,1,20363,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020363Orig1s047ltr.pdf","2016-09-20 00:00:00",
41301,3,20364,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20364S007_Latrel.pdf","1997-03-14 00:00:00",
24841,1,20364,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_Approv.pdf","1999-06-16 00:00:00",
34553,2,20364,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_prntlbl.pdf","1999-06-16 00:00:00",
41302,3,20364,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364S008_Lotrel.cfm","2001-08-21 00:00:00",
2391,1,20364,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20364slr014ltr.pdf","2003-09-09 00:00:00",
12482,2,20364,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-S016_Lotrel_lbl.pdf","2002-06-20 00:00:00",
20611,3,20364,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020364-s016_Lotrel.cfm","2002-11-22 00:00:00",
24842,1,20364,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20364s016LTR.pdf","2002-06-20 00:00:00",
12483,2,20364,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf","2006-04-12 00:00:00",
24843,1,20364,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020364s023ltr.pdf","2006-04-13 00:00:00",
12484,2,20364,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf","2004-07-07 00:00:00",
24844,1,20364,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364slr024ltr.pdf","2004-07-06 00:00:00",
2392,1,20364,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364s028ltr.pdf","2004-08-12 00:00:00",
2393,1,20364,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s036ltr.pdf","2007-03-06 00:00:00",
12485,2,20364,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf","2007-09-04 00:00:00",
24845,1,20364,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s039ltr.pdf","2007-09-06 00:00:00",
12486,2,20364,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf","2009-10-30 00:00:00",
24846,1,20364,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s046ltr.pdf","2009-11-19 00:00:00",
24847,1,20364,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020364s047ltr.pdf","2010-04-02 00:00:00",
34554,2,20364,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020364s047lbl.pdf","2010-04-04 00:00:00",
2394,1,20364,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s048ltr.pdf","2010-01-05 00:00:00",
34555,2,20364,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s048lbl.pdf","2010-01-04 00:00:00",
12487,2,20364,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf","2011-01-05 00:00:00",
24848,1,20364,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s050ltr.pdf","2011-01-07 00:00:00",
24849,1,20364,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s052ltr.pdf","2011-06-29 00:00:00",
34556,2,20364,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s052lbl.pdf","2011-07-07 00:00:00",
2395,1,20364,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s054ltr.pdf","2011-10-31 00:00:00",
12488,2,20364,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf","2011-11-01 00:00:00",
24850,1,20364,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364s055ltr.pdf","2012-01-23 00:00:00",
34557,2,20364,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s055lbl.pdf","2012-01-23 00:00:00",
2396,1,20364,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf","2012-10-10 00:00:00",
34558,2,20364,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf","2012-10-09 00:00:00",
12489,2,20364,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf","2012-10-09 00:00:00",
24851,1,20364,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf","2012-10-10 00:00:00",
24852,1,20364,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020364Orig1s058ltr.pdf","2014-12-30 00:00:00",
34559,2,20364,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020364s058lbl.pdf","2015-01-05 00:00:00",
12490,2,20364,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf","2015-04-24 00:00:00",
24853,1,20364,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s060ltr.pdf","2015-04-23 00:00:00",
24854,1,20364,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s061ltr.pdf","2015-05-19 00:00:00",
34560,2,20364,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s061lbl.pdf","2015-05-21 00:00:00",
49050,2,20364,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020364s065lbl.pdf","2017-07-25 00:00:00",
49072,1,20364,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020364Orig1s065ltr.pdf","2017-07-25 00:00:00",
2397,1,20367,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367s053ltr.pdf","2002-06-14 00:00:00",
34561,2,20367,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367s53lbl.pdf","2002-06-14 00:00:00",
2398,1,20367,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367slr055ltr.pdf","2003-07-31 00:00:00",
12491,2,20367,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.pdf","2002-11-13 00:00:00",
2399,1,20367,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20367s066ltr.pdf","2005-03-10 00:00:00",
34562,2,20367,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20367s066lbl.pdf","2005-03-10 00:00:00",
2400,1,20369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20369ltr.pdf","1998-03-30 00:00:00",
12492,2,20369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf","1998-03-30 00:00:00",
41303,3,20369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020369_ciloxan.cfm","2003-05-15 00:00:00",
2401,1,20369,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf","2003-08-28 00:00:00",
34563,2,20369,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf","2003-10-07 00:00:00",
12493,2,20369,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf","2003-10-07 00:00:00",
24855,1,20369,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf","2003-08-28 00:00:00",
2402,1,20369,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf","2004-07-21 00:00:00",
34564,2,20369,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf","2004-07-21 00:00:00",
12494,2,20369,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf","2004-07-21 00:00:00",
24856,1,20369,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf","2004-07-21 00:00:00",
47268,1,20369,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020369Orig1s022ltr.pdf","2017-02-21 00:00:00",
47269,2,20369,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf","2017-02-21 00:00:00",
2403,1,20372,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_Approv.pdf","2001-11-03 00:00:00",
20612,3,20372,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview.cfm","2002-03-12 00:00:00",
34565,2,20372,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf","2001-11-03 00:00:00",
12495,2,20372,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf","2003-04-22 00:00:00",
24857,1,20372,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20372scm011ltr.pdf","2002-05-22 00:00:00",
2404,1,20372,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372se1-013ltr.pdf","2003-03-10 00:00:00",
20613,3,20372,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-372s013_Myoview.cfm","2003-07-08 00:00:00",
34566,2,20372,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf","2003-03-05 00:00:00",
2405,1,20372,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372slr015ltr.pdf","2003-11-26 00:00:00",
34567,2,20372,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf","2003-12-01 00:00:00",
12496,2,20372,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf","2005-07-15 00:00:00",
24858,1,20372,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020372s019ltr.pdf","2005-07-15 00:00:00",
24859,1,20372,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020372s022ltr.pdf","2009-03-05 00:00:00",
34568,2,20372,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf","2009-03-17 00:00:00",
48053,1,20372,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020372Orig1s028ltr.pdf","2017-04-18 00:00:00",
48061,2,20372,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020372s028lbl.pdf","2017-04-18 00:00:00",
41304,3,20375,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S1_Climara_toc.cfm","2003-08-08 00:00:00",
41305,3,20375,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S2_Climara_toc.cfm","2003-08-08 00:00:00",
20614,3,20375,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S3_Climara_toc.cfm","2003-08-08 00:00:00",
41306,3,20375,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S4_Climara_toc.cfm","2003-08-08 00:00:00",
41307,3,20375,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020375-S5_Climara_toc.cfm","2003-08-08 00:00:00",
20615,3,20375,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020375-S7_Climara_toc.cfm","2003-08-08 00:00:00",
41308,3,20375,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s8_climara.cfm","2003-05-15 00:00:00",
2406,1,20375,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_appltr.pdf","1998-03-23 00:00:00",
12497,2,20375,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf","1998-03-23 00:00:00",
20616,3,20375,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara.cfm","1998-03-23 00:00:00",
41309,3,20375,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s10_climara.cfm","2003-05-22 00:00:00",
2407,1,20375,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf","1999-03-05 00:00:00",
12498,2,20375,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf","1999-03-05 00:00:00",
20617,3,20375,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994.cfm","1999-03-05 00:00:00",
41310,3,20375,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s12_climara.cfm","2003-05-15 00:00:00",
41311,3,20375,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20375-s013_climara.pdf","1999-05-20 00:00:00",
2408,1,20375,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S14ltr.pdf","2001-04-11 00:00:00",
34569,2,20375,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf","2001-04-11 00:00:00",
2409,1,20375,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S16ltr.pdf","2001-04-05 00:00:00",
34570,2,20375,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf","2003-04-24 00:00:00",
41312,3,20375,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-375s016_Berlex.cfm","2004-09-21 00:00:00",
2410,1,20375,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20375slr020ltr.pdf","2004-02-02 00:00:00",
12499,2,20375,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf","2004-02-12 00:00:00",
2411,1,20375,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf","2005-03-23 00:00:00",
2412,1,20375,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020375s022ltr.pdf","2005-06-24 00:00:00",
12500,2,20375,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf","2005-06-24 00:00:00",
12501,2,20375,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf","2006-01-05 00:00:00",
24860,1,20375,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020375s023ltr.pdf","2006-01-06 00:00:00",
2413,1,20375,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020375s026ltr.pdf","2008-01-09 00:00:00",
34571,2,20375,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf","2008-01-08 00:00:00",
2414,1,20375,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s027ltr.pdf","2013-10-11 00:00:00",
34572,2,20375,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf","2013-10-17 00:00:00",
24861,1,20375,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s028ltr.pdf","2013-10-31 00:00:00",
50265,2,20375,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s034lbl.pdf","2017-11-02 00:00:00",
50301,1,20375,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020375Orig1s034ltr.pdf","2017-11-06 00:00:00",
50278,2,20375,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s035lbl.pdf","2017-11-02 00:00:00",
50315,1,20375,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020375Orig1s035ltr.pdf","2017-11-06 00:00:00",
20618,3,20377,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020377-S1_Cordarone_toc.cfm","2003-08-08 00:00:00",
23579,10,20377,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-29 00:00:00",
41313,3,20377,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020377-S2_Cordarone_toc.cfm","2003-08-08 00:00:00",
2415,1,20377,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf","2001-07-11 00:00:00",
24862,1,20377,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf","2001-07-11 00:00:00",
2416,1,20377,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf","2004-11-08 00:00:00",
24863,1,20377,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf","2004-11-08 00:00:00",
2417,1,20377,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf","2003-05-30 00:00:00",
24864,1,20377,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf","2003-05-30 00:00:00",
24865,1,20377,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr013ltr.pdf","2003-05-30 00:00:00",
24866,1,20377,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr014ltr.pdf","2003-05-30 00:00:00",
2418,1,20377,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf","2004-11-08 00:00:00",
24867,1,20377,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s016ltr.pdf","2004-09-03 00:00:00",
2419,1,20377,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s017ltr.pdf","2004-11-08 00:00:00",
2420,1,20377,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020377s018ltr.pdf","2005-09-22 00:00:00",
2421,1,20377,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020377s020ltr.pdf","2006-09-18 00:00:00",
2422,1,20378,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20378S6LTR.PDF","2000-05-24 00:00:00",
41314,3,20378,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf","2004-04-14 00:00:00",
2423,1,20378,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20378scf015ltr.pdf","2004-03-28 00:00:00",
34573,2,20378,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf","2004-04-05 00:00:00",
24868,1,20378,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf","2003-07-28 00:00:00",
24869,1,20378,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf","2003-07-28 00:00:00",
20619,3,20379,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20379-s009_caverject.pdf","1998-03-26 00:00:00",
2424,1,20379,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20379s11ltr.pdf","2002-01-15 00:00:00",
2425,1,20379,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf","2003-09-09 00:00:00",
24870,1,20379,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020379Orig1s028ltr.pdf","2014-06-17 00:00:00",
34574,2,20379,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020379s028lbl.pdf","2014-06-17 00:00:00",
2426,1,20379,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020379Orig1s030ltr.pdf","2016-05-06 00:00:00",
12502,2,20379,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020379s030lbl.pdf","2016-05-06 00:00:00",
50632,1,20379,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s031ltr.pdf","2017-12-07 00:00:00",
50642,2,20379,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s031lbl.pdf","2017-12-07 00:00:00",
50633,1,20379,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s032ltr.pdf","2017-12-07 00:00:00",
50643,2,20379,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s032lbl.pdf","2017-12-07 00:00:00",
50634,1,20379,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s034ltr.pdf","2017-12-07 00:00:00",
50635,2,20379,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s034lbl.pdf","2017-12-07 00:00:00",
47775,2,20380,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020380Orig1s010lbl.pdf","2017-03-30 00:00:00",
47776,1,20380,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020380Orig1s010ltr.pdf","2017-03-30 00:00:00",
49900,3,20380,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020380s10_toc.cfm","2017-10-02 00:00:00",
48505,1,20380,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020380Orig1s011ltr.pdf","2017-05-24 00:00:00",
48538,2,20380,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020380Orig1s011lbl.pdf","2017-05-25 00:00:00",
53497,2,20380,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020380Orig1s013lbl.pdf","2018-03-28 00:00:00",
53507,1,20380,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020380Orig1s013ltr.pdf","2018-03-29 00:00:00",
24872,1,20381,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381S6LTR.PDF","1999-10-28 00:00:00",
2428,1,20381,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf","1999-09-13 00:00:00",
24873,1,20381,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20381se1-013ltr.pdf","2004-06-10 00:00:00",
34577,2,20381,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf","2003-03-05 00:00:00",
2429,1,20381,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf","2005-06-10 00:00:00",
12503,2,20381,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf","2005-06-10 00:00:00",
2430,1,20381,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf","2005-09-15 00:00:00",
34578,2,20381,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf","2005-09-15 00:00:00",
24874,1,20381,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020381s025ltr.pdf","2006-04-12 00:00:00",
34579,2,20381,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf","2006-04-12 00:00:00",
2431,1,20381,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf","2007-04-09 00:00:00",
2432,1,20381,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf","2008-05-30 00:00:00",
2433,1,20381,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf","2008-01-09 00:00:00",
34580,2,20381,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf","2007-12-27 00:00:00",
2434,1,20381,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf","2009-04-01 00:00:00",
12504,2,20381,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf","2009-09-21 00:00:00",
24875,1,20381,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf","2009-11-12 00:00:00",
2435,1,20381,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf","2009-11-12 00:00:00",
34581,2,20381,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf","2009-09-21 00:00:00",
12505,2,20381,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf","2010-03-03 00:00:00",
24876,1,20381,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s042ltr.pdf","2010-03-03 00:00:00",
12506,2,20381,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf","2010-11-12 00:00:00",
24877,1,20381,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s043ltr.pdf","2010-11-12 00:00:00",
2436,1,20381,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf","2013-02-25 00:00:00",
34582,2,20381,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf","2013-02-26 00:00:00",
2437,1,20381,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf","2015-04-28 00:00:00",
34583,2,20381,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf","2015-04-27 00:00:00",
24878,1,20385,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20385slr005ltr.pdf","2002-09-08 00:00:00",
2438,1,20385,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr011ltr.pdf","2003-11-25 00:00:00",
2439,1,20385,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr.pdf","2004-07-21 00:00:00",
24879,1,20385,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020385s010ltr.pdf","2010-07-01 00:00:00",
34584,2,20385,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020385s010lbl.pdf","2010-07-01 00:00:00",
44056,10,20386,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
20620,3,20386,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf","1997-11-07 00:00:00",
41315,3,20386,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386-s008_cozaar.pdf","1998-10-13 00:00:00",
20621,3,20386,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386s015_Cozaar.pdf","1998-11-24 00:00:00",
41316,3,20386,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20386S017_Cozaar.pdf","1999-06-09 00:00:00",
41317,3,20386,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf","2000-01-28 00:00:00",
2440,1,20386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf","2004-03-16 00:00:00",
34585,2,20386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf","2004-05-06 00:00:00",
41318,3,20386,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm","2004-06-04 00:00:00",
41319,3,20386,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf","2001-06-06 00:00:00",
2441,1,20386,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-028ltr.pdf","2002-09-17 00:00:00",
12507,2,20386,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf","2002-09-17 00:00:00",
41320,3,20386,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-386s028_Cozaar.cfm","2004-06-02 00:00:00",
2442,1,20386,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf","2004-03-16 00:00:00",
20622,3,20386,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm","2005-02-02 00:00:00",
34586,2,20386,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf","2004-05-06 00:00:00",
2443,1,20386,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-032ltr.pdf","2003-03-28 00:00:00",
12508,2,20386,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf","2003-03-25 00:00:00",
41321,3,20386,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-386s032_Cozaar.cfm","2003-07-08 00:00:00",
12509,2,20386,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf","2005-04-13 00:00:00",
24880,1,20386,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf","2005-04-13 00:00:00",
2444,1,20386,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf","2005-04-13 00:00:00",
12510,2,20386,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf","2005-04-13 00:00:00",
2445,1,20386,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s042ltr.pdf","2006-04-07 00:00:00",
24135,15,20386,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf","2006-09-25 00:00:00",
24881,1,20386,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf","2006-09-25 00:00:00",
43561,6,20386,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf","2006-04-14 00:00:00",
2446,1,20386,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s045ltr.pdf","2006-09-18 00:00:00",
12511,2,20386,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf","2006-08-30 00:00:00",
24136,15,20386,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf","2006-09-25 00:00:00",
24882,1,20386,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf","2006-09-25 00:00:00",
24883,1,20386,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020386s049ltr.pdf","2009-06-16 00:00:00",
34587,2,20386,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf","2009-06-04 00:00:00",
24884,1,20386,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020386s052ltr.pdf","2010-09-27 00:00:00",
34588,2,20386,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf","2010-09-23 00:00:00",
24885,1,20386,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
2447,1,20386,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf","2015-12-15 00:00:00",
12512,2,20386,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf","2015-12-15 00:00:00",
2448,1,20386,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf","2011-11-21 00:00:00",
34589,2,20386,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf","2011-11-21 00:00:00",
2449,1,20386,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf","2012-10-03 00:00:00",
34590,2,20386,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf","2012-10-02 00:00:00",
2450,1,20386,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf","2013-03-29 00:00:00",
12513,2,20386,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf","2013-04-01 00:00:00",
2451,1,20386,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_replace.pdf","2014-01-21 00:00:00",
12514,2,20386,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf","2014-01-22 00:00:00",
2452,1,20386,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf","2014-10-01 00:00:00",
12515,2,20386,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf","2014-09-30 00:00:00",
41322,3,20387,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-387S003_Hyzaar.pdf","2002-04-30 00:00:00",
20623,3,20387,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf","1997-11-07 00:00:00",
20624,3,20387,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S006_Hyzaar.pdf","1998-08-24 00:00:00",
20625,3,20387,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S008_Hyzaar.pdf","1998-11-10 00:00:00",
20626,3,20387,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S010_Hyzaar.pdf","1998-08-25 00:00:00",
20627,3,20387,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20387s011_Hyzaar.pdf","1998-11-24 00:00:00",
41323,3,20387,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20387S012_Hyzaar.pdf","1999-06-09 00:00:00",
2453,1,20387,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf","2003-09-30 00:00:00",
12516,2,20387,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf","2003-10-10 00:00:00",
41324,3,20387,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm","2003-11-25 00:00:00",
41325,3,20387,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf","2001-01-28 00:00:00",
2454,1,20387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf","2003-09-30 00:00:00",
12517,2,20387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf","2003-10-10 00:00:00",
41326,3,20387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm","2003-11-25 00:00:00",
41327,3,20387,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf","2000-01-19 00:00:00",
24886,1,20387,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20387slr024ltr.pdf","2002-11-07 00:00:00",
12518,2,20387,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf","2003-10-09 00:00:00",
20628,3,20387,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm","2003-11-25 00:00:00",
24887,1,20387,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf","2003-09-30 00:00:00",
2455,1,20387,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s033ltr.pdf","2005-04-12 00:00:00",
12519,2,20387,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf","2005-04-12 00:00:00",
2456,1,20387,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf","2005-04-13 00:00:00",
12520,2,20387,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf","2005-04-13 00:00:00",
24888,1,20387,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf","2005-04-13 00:00:00",
34591,2,20387,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf","2005-04-13 00:00:00",
12521,2,20387,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf","2005-10-24 00:00:00",
24889,1,20387,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s037ltr.pdf","2005-10-25 00:00:00",
41328,3,20387,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020387_s037_hyzaar.pdf","2011-02-15 00:00:00",
2457,1,20387,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s038LTR.pdf","2006-04-25 00:00:00",
34592,2,20387,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s038lbl.pdf","2006-04-21 00:00:00",
24890,1,20387,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s040ltr.pdf","2007-01-08 00:00:00",
12522,2,20387,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf","2006-08-30 00:00:00",
24891,1,20387,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s041ltr.pdf","2006-09-18 00:00:00",
24892,1,20387,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020387s045ltr.pdf","2009-06-17 00:00:00",
34593,2,20387,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020387s045lbl.pdf","2009-06-22 00:00:00",
2458,1,20387,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020387Orig1s047ltr.pdf","2015-12-15 00:00:00",
34594,2,20387,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020387s047lbl.pdf","2015-12-15 00:00:00",
2459,1,20387,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020387s048ltr.pdf","2010-09-27 00:00:00",
12523,2,20387,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf","2010-09-23 00:00:00",
24893,1,20387,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
12524,2,20387,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf","2011-08-24 00:00:00",
24894,1,20387,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s052ltr.pdf","2011-08-18 00:00:00",
24895,1,20387,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf","2011-11-21 00:00:00",
34595,2,20387,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387Orig1s054Lbl_REPLACEMENT.pdf","2011-11-21 00:00:00",
12525,2,20387,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf","2011-08-30 00:00:00",
24896,1,20387,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s055ltr.pdf","2011-08-31 00:00:00",
2460,1,20387,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020387Orig1s056ltr.pdf","2012-10-03 00:00:00",
12526,2,20387,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf","2012-10-02 00:00:00",
2461,1,20387,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020387Orig1s057ltr.pdf","2013-03-29 00:00:00",
12527,2,20387,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf","2013-04-01 00:00:00",
12528,2,20387,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf","2014-01-22 00:00:00",
24897,1,20387,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s059_replace_ltr.pdf","2014-01-21 00:00:00",
2462,1,20387,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s060ltr.pdf","2014-10-01 00:00:00",
34596,2,20387,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s060lbl.pdf","2014-09-30 00:00:00",
20629,3,20388,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020388_S003_NAVELBINE INJECTION_AP.pdf","2007-04-11 00:00:00",
2463,1,20388,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_Approv.pdf","2000-06-08 00:00:00",
12529,2,20388,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf","2000-06-08 00:00:00",
20630,3,20388,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388s008_Navelbine.cfm","2000-06-08 00:00:00",
2464,1,20388,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20388s10ltr.pdf","2003-07-24 00:00:00",
34597,2,20388,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf","2003-04-22 00:00:00",
2465,1,20388,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20388se8-014ltr.pdf","2002-11-05 00:00:00",
12530,2,20388,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf","2002-11-05 00:00:00",
20631,3,20388,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020388_S014_NAVELBINE_INJECTION_AP.pdf","2007-07-06 00:00:00",
2466,1,20388,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020388Orig1s027ltr.pdf","2014-03-19 00:00:00",
34598,2,20388,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf","2014-03-19 00:00:00",
54711,1,20388,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020388Orig1s035ltr.pdf","2018-06-27 00:00:00",
54713,2,20388,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020388s035lbl.pdf","2018-06-28 00:00:00",
24898,1,20392,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20392S5ltr.pdf","2001-04-11 00:00:00",
2467,1,20392,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20392slr007ltr.pdf","2004-02-03 00:00:00",
12531,2,20392,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf","2007-06-07 00:00:00",
24899,1,20392,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020392s010ltr.pdf","2007-06-14 00:00:00",
2468,1,20393,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20393ltr.pdf","1998-04-01 00:00:00",
2469,1,20393,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf","2003-05-30 00:00:00",
12532,2,20393,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf","2003-06-08 00:00:00",
2470,1,20393,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020393s007,020394s008ltr.pdf","2007-12-03 00:00:00",
12533,2,20393,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf","2007-12-03 00:00:00",
2471,1,20393,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020393s011ltr.pdf","2011-02-07 00:00:00",
2472,1,20394,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20394s01ltr.pdf","1998-11-09 00:00:00",
41329,3,20394,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20394-S001_Atrovent.pdf","1998-11-09 00:00:00",
23970,14,20394,"SUPPL",4,"Approval PAckage","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394Orig1s004.pdf","2011-12-16 00:00:00",
41330,3,20394,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394 Orig1s004.pdf","2000-10-27 00:00:00",
24900,1,20394,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf","2003-05-30 00:00:00",
34599,2,20394,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf","2004-09-20 00:00:00",
24901,1,20394,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020394s008ltr.pdf","2008-10-21 00:00:00",
2473,1,20394,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020394s012ltr.pdf","2011-02-24 00:00:00",
41331,3,20397,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020397_S004_ZANAFLEX TABLETS_AP.pdf","2007-07-09 00:00:00",
24902,1,20397,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20397slr014ltr.pdf","2002-11-27 00:00:00",
2474,1,20397,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf","2006-08-04 00:00:00",
12534,2,20397,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf","2006-08-04 00:00:00",
24903,1,20397,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020397Orig1s023ltr.pdf","2013-03-21 00:00:00",
12535,2,20397,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf","2013-11-08 00:00:00",
24904,1,20397,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s011,020397Orig1s026ltr.pdf","2013-11-08 00:00:00",
41332,3,20398,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20210-S030_Propulsid.pdf","2000-03-06 00:00:00",
41333,3,20398,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20767-S011_Propulsid.pdf","2000-03-06 00:00:00",
2475,1,20400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400_appltrs.pdf","1998-01-29 00:00:00",
41334,3,20400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400.cfm","1998-01-29 00:00:00",
24905,1,20400,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020400s005ltr.pdf","2011-08-12 00:00:00",
34600,2,20400,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020400s005lbl.pdf","2011-08-11 00:00:00",
41335,3,20401,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020401ap.pdf","1998-01-30 00:00:00",
41336,3,20401,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-401S013_Tiazac.pdf","2001-12-04 00:00:00",
20632,3,20401,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20401-s019_tiazac.pdf","2001-06-06 00:00:00",
2476,1,20401,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020401s034ltr.pdf","2007-07-05 00:00:00",
24906,1,20401,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020401s036ltr.pdf","2010-11-30 00:00:00",
34601,2,20401,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020401s036lbl.pdf","2010-11-22 00:00:00",
45915,1,20401,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020401Orig1s042ltr.pdf","2016-11-22 00:00:00",
45939,2,20401,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020401s042lbl.pdf","2016-11-21 00:00:00",
12536,2,20402,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF","2000-03-16 00:00:00",
20633,3,20402,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-402-s005_Advil.cfm","2003-07-08 00:00:00",
24907,1,20402,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20402S5LTR.PDF","2000-03-16 00:00:00",
2477,1,20402,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20402slr011ltr.pdf","2004-02-27 00:00:00",
2478,1,20402,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s016LTR.pdf","2006-05-02 00:00:00",
2479,1,20402,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s018ltr.pdf","2006-02-22 00:00:00",
2480,1,20402,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020402s024ltr.pdf","2008-06-17 00:00:00",
24908,1,20402,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s025ltr.pdf","2009-05-26 00:00:00",
24909,1,20402,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s026ltr.pdf","2009-07-15 00:00:00",
2481,1,20402,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020402s027ltr.pdf","2011-04-22 00:00:00",
34602,2,20402,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020402Orig1s027lbl.pdf","2015-07-09 00:00:00",
2482,1,20402,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020402Orig1s040ltr.pdf","2015-12-18 00:00:00",
34603,2,20402,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020402Orig1s040lbl.pdf","2015-12-22 00:00:00",
49165,2,20402,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402s042lbl.pdf","2017-08-01 00:00:00",
49166,1,20402,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s042ltr.pdf","2017-08-01 00:00:00",
49360,2,20402,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402Orig1s043lbl.pdf","2017-08-15 00:00:00",
49422,1,20402,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s043ltr.pdf","2017-08-15 00:00:00",
50107,1,20402,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s044ltr.pdf","2017-10-19 00:00:00",
55097,1,20402,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s046Ltr.pdf","2018-08-03 00:00:00",
55115,2,20402,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s046lbl.pdf","2018-08-03 00:00:00",
55474,1,20402,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s047ltr.pdf","2018-09-13 00:00:00",
55479,2,20402,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s047lbl.pdf","2018-09-14 00:00:00",
41337,3,20403,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm","1997-10-31 00:00:00",
20634,3,20403,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020403_s009_ZOFRAN_INJECTION.pdf","2009-01-12 00:00:00",
12537,2,20403,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf","2004-12-03 00:00:00",
24910,1,20403,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf","2004-12-02 00:00:00",
12538,2,20403,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf","2006-01-05 00:00:00",
24911,1,20403,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020403s014rev2.pdf","2006-01-06 00:00:00",
41338,3,20403,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020403_s014_Zofran Inj.pdf","2009-09-16 00:00:00",
24912,1,20403,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf","2006-09-18 00:00:00",
34604,2,20403,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf","2006-08-23 00:00:00",
12539,2,20403,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf","2010-09-29 00:00:00",
24913,1,20403,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf","2010-09-28 00:00:00",
2483,1,20403,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf","2011-07-13 00:00:00",
34605,2,20403,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf","2011-07-12 00:00:00",
12540,2,20403,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf","2011-09-16 00:00:00",
24914,1,20403,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf","2011-09-16 00:00:00",
20635,3,20405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020405_lanoxin_toc.cfm","2010-03-03 00:00:00",
2484,1,20405,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020405s004ltr.pdf","2010-02-17 00:00:00",
34606,2,20405,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf","2010-02-16 00:00:00",
2485,1,20405,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020405Orig1s005ltr.pdf","2012-08-16 00:00:00",
34607,2,20405,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf","2012-08-15 00:00:00",
2486,1,20405,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020405s006ltr.pdf","2011-11-16 00:00:00",
34608,2,20405,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf","2011-11-14 00:00:00",
12541,2,20405,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf","2013-10-18 00:00:00",
24915,1,20405,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020405Orig1s007ltr.pdf","2013-10-21 00:00:00",
12542,2,20405,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf","2015-07-30 00:00:00",
24916,1,20405,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020405Orig1s011ltr.pdf","2015-07-29 00:00:00",
46020,2,20405,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf","2016-12-05 00:00:00",
46136,1,20405,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020405Orig1s013ltr.pdf","2016-12-13 00:00:00",
55301,1,20405,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020405Orig1s014ltr.pdf","2018-08-24 00:00:00",
55337,2,20405,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf","2018-08-28 00:00:00",
23580,10,20406,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
41339,3,20406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_prevacid_toc.cfm","2010-03-16 00:00:00",
20636,3,20406,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s004_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41340,3,20406,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s005_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20637,3,20406,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s006_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41341,3,20406,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s007_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41342,3,20406,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s009_PrevacidDelayedReleaseCaps.pdf","2009-09-16 00:00:00",
41343,3,20406,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.cfm","1998-03-12 00:00:00",
41344,3,20406,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406Orig1s017.pdf","2011-12-09 00:00:00",
20638,3,20406,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s018_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41345,3,20406,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s019_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20639,3,20406,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s020_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20640,3,20406,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406-s021.cfm","1998-07-20 00:00:00",
24917,1,20406,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf","1998-07-20 00:00:00",
2487,1,20406,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf","1998-07-20 00:00:00",
20641,3,20406,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_S022_PREVACID.pdf","1998-07-20 00:00:00",
20642,3,20406,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s023_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20643,3,20406,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s024_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41346,3,20406,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s025_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20644,3,20406,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s026_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41347,3,20406,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf","1999-01-14 00:00:00",
24918,1,20406,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20406s28ltr.pdf","1999-07-06 00:00:00",
41348,3,20406,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.cfm","1999-07-06 00:00:00",
41349,3,20406,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf","1999-02-22 00:00:00",
24919,1,20406,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20406S33ltr.pdf","2000-11-30 00:00:00",
34610,2,20406,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20406S33lbl.pdf","2000-11-30 00:00:00",
20645,3,20406,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20406-S034_Prevacid.pdf","2000-06-20 00:00:00",
41350,3,20406,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s035_Prevacid Caps.pdf","2009-09-16 00:00:00",
24920,1,20406,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20406S38ltr.pdf","2003-07-31 00:00:00",
34611,2,20406,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20406s38lbl.pdf","2003-04-24 00:00:00",
20646,3,20406,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s039_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20647,3,20406,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s041_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
41351,3,20406,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s043_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
20648,3,20406,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s044_Prevacid_Delayed_Release_Capsules.pdf","2009-09-16 00:00:00",
24921,1,20406,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf","2002-05-03 00:00:00",
34612,2,20406,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf","2002-05-03 00:00:00",
12543,2,20406,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s47lbl.pdf","2002-07-31 00:00:00",
24922,1,20406,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406se5-047LTR.pdf","2002-07-31 00:00:00",
20649,3,20406,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020406_S048_PREVACID.pdf","2007-11-19 00:00:00",
24923,1,20406,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf","2002-12-03 00:00:00",
2488,1,20406,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf","2002-08-30 00:00:00",
12544,2,20406,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf","2002-08-30 00:00:00",
41352,3,20406,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm","2005-06-23 00:00:00",
24924,1,20406,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf","2003-08-15 00:00:00",
2489,1,20406,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406slr056ltr.pdf","2004-06-16 00:00:00",
34613,2,20406,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20406slr056_prevacid_lbl.pdf","2004-06-16 00:00:00",
2490,1,20406,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf","2004-06-23 00:00:00",
12545,2,20406,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf","2004-12-21 00:00:00",
24925,1,20406,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf","2006-04-13 00:00:00",
34614,2,20406,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf","2006-04-13 00:00:00",
12546,2,20406,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf","2007-06-27 00:00:00",
24926,1,20406,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf","2007-07-05 00:00:00",
2491,1,20406,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf","2008-04-23 00:00:00",
2492,1,20406,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf","2008-10-29 00:00:00",
12547,2,20406,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf","2008-11-07 00:00:00",
52302,23,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_Lansoprazole_Tab_2_WR_8-26-99.pdf","2008-07-15 00:00:00",
52303,25,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406, 021281_Lansoprazole_Tab_3_Amend_12-31-01.pdf","2008-07-15 00:00:00",
52304,27,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_Lansoprazole_Tab_5_Amend_12-18-02.pdf","2008-07-15 00:00:00",
52305,28,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406, 021281_Lansoprozole_Tab_6_amend_9-6-05.pdf","2008-07-15 00:00:00",
52960,26,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_lansoprazole_Prevacid_6-18-02_HFD180_amend2.pdf","2008-07-15 00:00:00",
52961,20,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406s057_lansoprazole_Prevacid-Med&ClinPharmRev.pdf","2008-07-15 00:00:00",
52962,17,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406s057_lansoprazole_Prevacid-StatRev.pdf","2008-07-15 00:00:00",
52963,18,20406,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20406s057_lansoprazole_Prevacid-ClinpharmRev.pdf","2008-07-15 00:00:00",
2493,1,20406,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf","2009-11-12 00:00:00",
34615,2,20406,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf","2009-08-13 00:00:00",
2494,1,20406,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf","2010-05-17 00:00:00",
34616,2,20406,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf","2010-05-17 00:00:00",
2495,1,20406,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s074,021428s021ltr.pdf","2010-09-09 00:00:00",
12548,2,20406,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf","2010-09-10 00:00:00",
2496,1,20406,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf","2011-06-03 00:00:00",
34617,2,20406,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf","2011-06-07 00:00:00",
12549,2,20406,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf","2011-11-01 00:00:00",
24927,1,20406,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076ltr, 021428s023ltr.pdf","2011-10-31 00:00:00",
24928,1,20406,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf","2011-05-25 00:00:00",
34618,2,20406,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf","2011-05-26 00:00:00",
2497,1,20406,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf","2012-10-02 00:00:00",
12550,2,20406,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf","2012-10-01 00:00:00",
24929,1,20406,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf","2012-05-09 00:00:00",
34619,2,20406,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf","2012-05-07 00:00:00",
24930,1,20406,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf","2015-12-18 00:00:00",
34620,2,20406,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf","2015-12-17 00:00:00",
24931,1,20406,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf","2014-12-24 00:00:00",
34621,2,20406,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf","2014-12-29 00:00:00",
45664,1,20406,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf","2016-10-26 00:00:00",
45714,2,20406,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf","2016-10-31 00:00:00",
50100,1,20406,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020406Orig1s083,021428Orig1s031ltr.pdf","2017-10-19 00:00:00",
50182,2,20406,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf","2017-10-25 00:00:00",
53696,1,20406,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s084,021428Orig1s032ltr.pdf","2018-04-16 00:00:00",
53707,2,20406,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf","2018-04-17 00:00:00",
54512,2,20406,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf","2018-06-11 00:00:00",
54514,8,20406,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38","2018-06-11 00:00:00",
54574,1,20406,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf","2018-06-14 00:00:00",
54511,2,20406,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf","2018-06-11 00:00:00",
54513,8,20406,"SUPPL",88,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38","2018-06-11 00:00:00",
54575,1,20406,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf","2018-06-14 00:00:00",
2498,1,20408,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s23ltr.pdf","2002-04-12 00:00:00",
12551,2,20408,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf","2002-04-12 00:00:00",
2499,1,20408,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s25ltr.pdf","2002-04-09 00:00:00",
34622,2,20408,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408S25lbl.pdf","2002-04-09 00:00:00",
12552,2,20408,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-033_trusopt_lbl.pdf","2004-05-03 00:00:00",
20650,3,20408,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020408_S033_TRUSOPT.pdf","2008-07-31 00:00:00",
24932,1,20408,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20408se5-033ltr.pdf","2004-04-20 00:00:00",
51834,20,20408,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020408s033_dorzolamide_Trusopt-MedRev.pdf","1900-01-01 00:00:00",
51836,23,20408,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020408s033_dorzolamide_Trusopt_6-24-99_HFD550.pdf","1900-01-01 00:00:00",
51838,25,20408,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020408s033_dorzolamide_Trusopt_5-19-00_HFD550_amend.pdf","1900-01-01 00:00:00",
51840,26,20408,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020408s033_dorzolamide_Trusopt_2-12-02_HFD550_amend2.pdf","1900-01-01 00:00:00",
51841,17,20408,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020408s033_dorzolamide_Trusopt-StatsRev.pdf","1900-01-01 00:00:00",
24933,1,20408,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020408s039ltr.pdf","2006-01-19 00:00:00",
34623,2,20408,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020408s039lbl.pdf","2006-01-05 00:00:00",
24934,1,20408,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020408s045ltr.pdf","2008-10-24 00:00:00",
34624,2,20408,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020408s045lbl.pdf","2008-11-07 00:00:00",
2500,1,20408,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020408s047ltr.pdf","2010-06-22 00:00:00",
12553,2,20408,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf","2010-06-24 00:00:00",
12554,2,20408,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf","2014-02-06 00:00:00",
24935,1,20408,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020408Orig1s050ltr.pdf","2014-02-10 00:00:00",
24936,1,20409,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf","2002-05-09 00:00:00",
2501,1,20409,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20409S6LTR.PDF","2001-03-27 00:00:00",
2502,1,20409,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf","2002-05-09 00:00:00",
2503,1,20409,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020409s022ltr.pdf","2008-03-18 00:00:00",
24937,1,20411,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020411s023ltr.pdf","2006-12-04 00:00:00",
34625,2,20411,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020411s023lbl.pdf","2006-12-04 00:00:00",
12555,2,20411,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf","2010-05-28 00:00:00",
24938,1,20411,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020411s027ltr.pdf","2010-06-02 00:00:00",
34626,2,20412,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20412s15lbl.pdf","2003-04-22 00:00:00",
2504,1,20412,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s16ltr.pdf","2002-03-29 00:00:00",
12556,2,20412,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf","2002-03-29 00:00:00",
24939,1,20412,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf","2002-02-20 00:00:00",
24940,1,20412,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf","2002-02-20 00:00:00",
2505,1,20412,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20412slr023,20413slr014ltr.pdf","2004-06-07 00:00:00",
34627,2,20412,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf","2004-06-07 00:00:00",
34628,2,20412,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020412s024lbl.pdf","2007-02-05 00:00:00",
2506,1,20412,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf","2007-04-25 00:00:00",
2507,1,20412,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf","2007-06-14 00:00:00",
2508,1,20412,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029, 020413s020ltr.pdf","2008-04-16 00:00:00",
34629,2,20412,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf","2008-04-23 00:00:00",
2509,1,20412,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030, 020413s021ltr.pdf","2008-04-16 00:00:00",
12557,2,20412,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf","2008-04-23 00:00:00",
2510,1,20412,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032, 020413s023ltr.pdf","2008-12-18 00:00:00",
34630,2,20412,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf","2009-01-02 00:00:00",
24941,1,20412,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s033,020413s025ltr.pdf","2009-02-18 00:00:00",
34631,2,20412,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf","2009-02-20 00:00:00",
2511,1,20412,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s034,020413s026ltr.pdf","2009-07-15 00:00:00",
34632,2,20412,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf","2009-07-09 00:00:00",
2512,1,20412,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028ltr.pdf","2010-12-28 00:00:00",
12558,2,20412,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf","2010-12-23 00:00:00",
2513,1,20412,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s037,020413s029ltr.pdf","2011-05-16 00:00:00",
24942,1,20412,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s038,020413s030ltr.pdf","2011-11-22 00:00:00",
34633,2,20412,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf","2011-11-22 00:00:00",
50820,2,20412,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf","2017-12-21 00:00:00",
50823,8,20412,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf#page=28","2017-12-21 00:00:00",
50867,1,20412,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020412Orig1s040, 020413Orig1s032ltr.pdf","2017-12-27 00:00:00",
34634,2,20413,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20413s6lbl.pdf","2003-04-25 00:00:00",
2514,1,20413,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s16ltr.pdf","2002-03-29 00:00:00",
12559,2,20413,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf","2002-03-29 00:00:00",
24943,1,20413,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf","2002-02-20 00:00:00",
24944,1,20413,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf","2002-02-20 00:00:00",
2515,1,20413,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20412slr023,20413slr014ltr.pdf","2004-06-07 00:00:00",
34635,2,20413,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf","2004-06-07 00:00:00",
34636,2,20413,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020413s015lbl.pdf","2007-02-05 00:00:00",
2516,1,20413,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf","2007-04-25 00:00:00",
2517,1,20413,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf","2007-06-14 00:00:00",
2518,1,20413,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029, 020413s020ltr.pdf","2008-04-16 00:00:00",
12560,2,20413,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf","2008-04-23 00:00:00",
2519,1,20413,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030, 020413s021ltr.pdf","2008-04-16 00:00:00",
12561,2,20413,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf","2008-04-23 00:00:00",
2520,1,20413,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032, 020413s023ltr.pdf","2008-12-18 00:00:00",
12562,2,20413,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf","2009-01-02 00:00:00",
2521,1,20413,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s033,020413s025ltr.pdf","2009-02-18 00:00:00",
12563,2,20413,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf","2009-02-20 00:00:00",
24945,1,20413,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s034,020413s026ltr.pdf","2009-07-15 00:00:00",
34637,2,20413,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf","2009-07-09 00:00:00",
12564,2,20413,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf","2010-12-23 00:00:00",
24946,1,20413,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028ltr.pdf","2010-12-28 00:00:00",
24947,1,20413,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s037,020413s029ltr.pdf","2011-05-16 00:00:00",
2522,1,20413,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s038,020413s030ltr.pdf","2011-11-22 00:00:00",
12565,2,20413,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf","2011-11-22 00:00:00",
50821,2,20413,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf","2017-12-21 00:00:00",
50822,8,20413,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf#page=28","2017-12-21 00:00:00",
50868,1,20413,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020412Orig1s040, 020413Orig1s032ltr.pdf","2017-12-27 00:00:00",
24948,1,20414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20414ltr.pdf","2003-02-05 00:00:00",
34638,2,20414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20414_pyridostigminebromide_lbl.pdf","2003-02-05 00:00:00",
41353,3,20414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20414_pyridostigmine.cfm","2003-04-25 00:00:00",
45782,3,20414,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020414Orig1s002.pdf","2016-11-02 00:00:00",
45783,3,20414,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020414Orig1s003.pdf","2016-11-02 00:00:00",
45784,3,20414,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020414Orig1s004.pdf","2016-11-02 00:00:00",
44057,10,20415,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
41354,3,20415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-415s003_Remeron.cfm","2004-09-08 00:00:00",
24949,1,20415,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415s9ltr.pdf","2002-04-16 00:00:00",
2523,1,20415,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415slr015ltr.pdf","2002-10-02 00:00:00",
2524,1,20415,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf","2004-06-07 00:00:00",
2525,1,20415,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf","2005-01-13 00:00:00",
12566,2,20415,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf","2005-01-13 00:00:00",
2526,1,20415,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf","2007-08-02 00:00:00",
34639,2,20415,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf","2007-07-31 00:00:00",
24950,1,20415,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020415s022ltr.pdf","2011-12-29 00:00:00",
34640,2,20415,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020415s022lbl.pdf","2011-12-27 00:00:00",
12567,2,20415,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf","2010-05-28 00:00:00",
24951,1,20415,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf","2010-05-21 00:00:00",
2527,1,20415,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf","2010-05-21 00:00:00",
12568,2,20415,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf","2010-05-28 00:00:00",
2528,1,20415,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf","2012-11-01 00:00:00",
12569,2,20415,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf","2012-11-06 00:00:00",
23157,8,20415,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026mg.pdf","2012-11-06 00:00:00",
12570,2,20415,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf","2016-08-01 00:00:00",
12571,2,20415,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf","2014-07-30 00:00:00",
24952,1,20415,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf","2014-07-23 00:00:00",
2529,1,20415,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf","2015-12-31 00:00:00",
12572,2,20415,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf","2015-12-31 00:00:00",
20651,3,20418,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm","2006-05-08 00:00:00",
24953,1,20418,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf","2002-02-04 00:00:00",
20652,3,20420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020420_genESA_toc.cfm","2010-03-03 00:00:00",
24954,1,20427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020427s000ltr.pdf","2009-08-26 00:00:00",
34641,2,20427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020427s000lbl.pdf","2009-08-26 00:00:00",
41355,3,20427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020427s000TOC.cfm","2009-11-23 00:00:00",
44448,14,20427,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=48","2011-02-02 00:00:00",
51567,20,20427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_CLINICAL_BPCA.pdf","1900-01-01 00:00:00",
51568,18,20427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_CLINPHARM_BPCA.pdf","1900-01-01 00:00:00",
51569,17,20427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_STATISTICAL_BPCA.pdf","1900-01-01 00:00:00",
52388,23,20427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427_022006_vigabatrin_Original_WR.pdf","1900-01-01 00:00:00",
52390,25,20427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427_022006_vigabatrin_WR Amendment_1.pdf","1900-01-01 00:00:00",
24955,1,20427,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002ltr.pdf","2011-01-24 00:00:00",
34642,2,20427,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020427s002lbl.pdf","2011-01-25 00:00:00",
24956,1,20427,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf","2012-12-13 00:00:00",
34643,2,20427,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005lbl.pdf","2012-12-14 00:00:00",
2530,1,20427,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
12573,2,20427,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
2531,1,20427,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
34644,2,20427,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
12574,2,20427,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
24957,1,20427,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
24958,1,20427,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006Orig1s014ltr.pdf","2014-04-04 00:00:00",
34645,2,20427,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf","2014-04-04 00:00:00",
12575,2,20427,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf","2016-06-27 00:00:00",
24959,1,20427,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006Orig1s015ltr.pdf","2016-06-23 00:00:00",
24960,1,20427,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006Orig1s016ltr.pdf","2015-09-23 00:00:00",
34646,2,20427,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf","2015-09-23 00:00:00",
48197,1,20427,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s016,022006Orig1s018ltr.pdf","2017-05-02 00:00:00",
48226,2,20427,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf","2017-05-02 00:00:00",
50213,1,20427,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s017,022006Orig1s019ltr.pdf","2017-10-30 00:00:00",
55279,2,20427,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf","2018-08-23 00:00:00",
55282,8,20427,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26","2018-08-23 00:00:00",
55320,1,20427,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020427Orig1s018,022006Orig1s020ltr.pdf","2018-08-27 00:00:00",
20653,3,20428,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf","2000-06-12 00:00:00",
41356,3,20428,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf","2000-06-12 00:00:00",
34647,2,20428,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20428s13lbl.pdf","2003-04-30 00:00:00",
2532,1,20428,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20428slr016ltr.pdf","2003-06-22 00:00:00",
12576,2,20428,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf","2003-06-22 00:00:00",
24961,1,20429,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s007ltr.pdf","2004-09-03 00:00:00",
2533,1,20429,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s008ltr.pdf","2004-09-15 00:00:00",
20654,3,20430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020430_toc.cfm","2010-01-05 00:00:00",
2534,1,20430,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20430s3ltr.pdf","2001-07-13 00:00:00",
12577,2,20430,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran_prntlbl.pdf","2001-07-13 00:00:00",
41357,3,20430,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran.cfm","2001-07-13 00:00:00",
24962,1,20438,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/020438-S001_VESANOID_ltr.pdf","2000-02-14 00:00:00",
34648,2,20438,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020438-S001_VESANOID_lbl.pdf","2000-02-14 00:00:00",
41358,3,20438,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20438-S001_VESANOID_review.pdf","2004-04-14 00:00:00",
24963,1,20438,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20438s004ltr.pdf","2004-10-08 00:00:00",
34649,2,20438,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20438s004lbl.pdf","2004-10-08 00:00:00",
12578,2,20438,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf","2015-09-14 00:00:00",
24964,1,20438,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020438s006ltr.pdf","2008-07-08 00:00:00",
12579,2,20439,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf","2004-11-01 00:00:00",
24965,1,20439,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20439s011ltr.pdf","2004-10-29 00:00:00",
20655,3,20441,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020441_S001_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
24966,1,20441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20441s2.ltr.pdf","1998-10-08 00:00:00",
34650,2,20441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20441s2.lbl.pdf","1998-10-08 00:00:00",
41359,3,20441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20441-S002_Pulmicort.cfm","1998-10-08 00:00:00",
41360,3,20441,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S003_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
20656,3,20441,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S005_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
41361,3,20441,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S007_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
20657,3,20441,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S009_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
41362,3,20441,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S010_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
41363,3,20441,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S011_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
2535,1,20441,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20441s12ltr.pdf","2001-12-31 00:00:00",
41364,3,20441,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S012_Pulmicort Turbuhaler_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
20658,3,20441,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S013_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
20659,3,20441,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S014_PULMICORT_TURBUHALER.pdf","2007-11-19 00:00:00",
24967,1,20441,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr016ltr.pdf","2003-11-05 00:00:00",
34651,2,20441,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr016_pulmicort_lbl.pdf","2003-11-05 00:00:00",
41365,3,20441,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S016_PULMICORT_TURBUHALER_AP.pdf","2007-07-09 00:00:00",
24968,1,20441,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr017ltr.pdf","2003-12-22 00:00:00",
34652,2,20441,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr017_pulmicort_lbl.pdf","2003-12-29 00:00:00",
41366,3,20441,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S017_PULMICORT_TURBUHALER_AP.pdf","2007-07-06 00:00:00",
2536,1,20441,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf","2003-09-30 00:00:00",
20660,3,20441,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S018_PULMUICORT_TURBUHALER_AP.pdf","2007-04-11 00:00:00",
34653,2,20441,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf","2003-09-30 00:00:00",
12580,2,20441,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf","2007-08-21 00:00:00",
24969,1,20441,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020441s020ltr.pdf","2007-08-22 00:00:00",
24970,1,20444,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF","2000-04-14 00:00:00",
34654,2,20444,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF","2000-04-14 00:00:00",
41367,3,20444,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-444S003_Flolan.cfm","2000-04-14 00:00:00",
2537,1,20444,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf","2008-03-17 00:00:00",
12581,2,20444,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf","2008-03-17 00:00:00",
2538,1,20444,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf","2011-03-31 00:00:00",
34655,2,20444,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf","2011-04-01 00:00:00",
34656,2,20444,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf","2015-04-22 00:00:00",
54211,1,20444,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s022ltr.pdf","2018-05-16 00:00:00",
54244,2,20444,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf","2018-05-17 00:00:00",
41368,3,20448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020448_imodium-ad_toc.cfm","2003-08-08 00:00:00",
12582,2,20448,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf","2007-01-16 00:00:00",
24971,1,20448,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020448s004ltr.pdf","2007-01-16 00:00:00",
48011,2,20448,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020448Orig1s011lbl.pdf","2017-04-13 00:00:00",
48031,1,20448,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020448Orig1s011ltr.pdf","2017-04-14 00:00:00",
54104,20,20449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020449_docetaxel_clinical_BPCA.pdf","1900-01-01 00:00:00",
54105,18,20449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020449_docetaxel_clinpharm_BPCA.pdf","1900-01-01 00:00:00",
54106,17,20449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020449_docetaxel_statistical_BPCA.pdf","1900-01-01 00:00:00",
41369,3,20449,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20449S004_Taxotere.pdf","2000-07-11 00:00:00",
2539,1,20449,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf","1998-06-22 00:00:00",
24972,1,20449,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf","1998-06-22 00:00:00",
20661,3,20449,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20449-S011_Taxotere.cfm","2001-07-05 00:00:00",
24973,1,20449,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20449S11LTR.PDF","1999-12-23 00:00:00",
34657,2,20449,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF","1999-12-23 00:00:00",
24974,1,20449,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr016ltr.pdf","2003-05-29 00:00:00",
34658,2,20449,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf","2003-04-28 00:00:00",
2540,1,20449,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf","2003-01-30 00:00:00",
34659,2,20449,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf","2004-06-18 00:00:00",
2541,1,20449,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20449se1-018ltr.pdf","2002-11-27 00:00:00",
12583,2,20449,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf","2002-11-27 00:00:00",
41370,3,20449,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-449s018_Taxotere.cfm","2003-07-08 00:00:00",
12584,2,20449,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf","2004-06-18 00:00:00",
24975,1,20449,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf","2003-01-30 00:00:00",
24976,1,20449,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf","2003-01-30 00:00:00",
34660,2,20449,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf","2003-01-30 00:00:00",
12585,2,20449,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf","2004-05-19 00:00:00",
20662,3,20449,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s028_Taxotere.cfm","2005-04-15 00:00:00",
24977,1,20449,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449se1-028ltr.pdf","2004-05-26 00:00:00",
2542,1,20449,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449s029ltr.pdf","2004-08-25 00:00:00",
34661,2,20449,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf","2004-08-19 00:00:00",
41371,3,20449,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s029_Taxotere.cfm","2005-04-27 00:00:00",
2543,1,20449,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20449s031ltr.pdf","2005-01-11 00:00:00",
24978,1,20449,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s033ltr.pdf","2005-08-15 00:00:00",
34662,2,20449,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf","2005-08-15 00:00:00",
2544,1,20449,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s034ltr.pdf","2005-11-18 00:00:00",
2545,1,20449,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449S035ltr.pdf","2006-04-05 00:00:00",
12586,2,20449,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf","2006-04-05 00:00:00",
20663,3,20449,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449Orig1s035.pdf","2014-07-07 00:00:00",
24979,1,20449,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s036LTR.pdf","2006-06-08 00:00:00",
34663,2,20449,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf","2006-06-08 00:00:00",
44604,15,20449,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036PI.pdf","2006-06-08 00:00:00",
2546,1,20449,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s039ltr.pdf","2006-10-23 00:00:00",
12587,2,20449,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf","2006-10-18 00:00:00",
41372,3,20449,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449s039.pdf","2011-09-22 00:00:00",
24980,1,20449,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s043ltr.pdf","2010-06-08 00:00:00",
41373,3,20449,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s043.pdf","2014-07-07 00:00:00",
2547,1,20449,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf","2010-04-23 00:00:00",
12588,2,20449,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf","2010-05-03 00:00:00",
12589,2,20449,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf","2007-10-04 00:00:00",
24981,1,20449,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020449s045ltr.pdf","2007-10-04 00:00:00",
12590,2,20449,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf","2010-05-03 00:00:00",
24982,1,20449,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf","2010-04-23 00:00:00",
41374,3,20449,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s054.pdf","2012-10-15 00:00:00",
2548,1,20449,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s059ltr.pdf","2010-05-18 00:00:00",
34664,2,20449,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf","2010-05-17 00:00:00",
51516,23,20449,"SUPPL",59,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20449_docetaxel_Original_WR.pdf","2007-06-11 00:00:00",
12591,2,20449,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf","2015-04-14 00:00:00",
2549,1,20449,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s064ltr.pdf","2011-09-12 00:00:00",
12592,2,20449,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf","2011-09-16 00:00:00",
2550,1,20449,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s065ltr.pdf","2011-12-20 00:00:00",
34665,2,20449,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf","2011-12-20 00:00:00",
12593,2,20449,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf","2013-07-08 00:00:00",
24983,1,20449,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s069ltr.pdf","2013-06-27 00:00:00",
2551,1,20449,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s071ltr.pdf","2013-12-16 00:00:00",
12594,2,20449,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf","2013-12-17 00:00:00",
2552,1,20449,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020449Orig1s073ltr.pdf","2014-11-17 00:00:00",
12595,2,20449,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf","2014-11-20 00:00:00",
12596,2,20449,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf","2015-12-15 00:00:00",
20664,3,20449,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020449Orig1s075.pdf","2016-07-27 00:00:00",
24984,1,20449,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020449Orig1s075ltr.pdf","2015-12-15 00:00:00",
55855,2,20449,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020449s079lbl.pdf","2018-10-09 00:00:00",
41375,3,20450,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020450a_s001.pdf","2003-06-17 00:00:00",
47387,2,20450,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s003lbl.pdf","2017-03-02 00:00:00",
47396,1,20450,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s003ltr.pdf","2017-03-02 00:00:00",
51129,20,20450,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020450s003 fosphenytoin CDTL clinical bpca.pdf","1900-01-01 00:00:00",
51130,18,20450,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020450s003 fosphenytoin clinpharm bpca.pdf","1900-01-01 00:00:00",
51131,20,20450,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020450s003 fosphenytoin clinical bpca.pdf","1900-01-01 00:00:00",
34666,2,20450,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf","2003-04-25 00:00:00",
41376,3,20450,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s004TOC.cfm","2007-05-29 00:00:00",
12597,2,20450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf","2001-08-31 00:00:00",
20665,3,20450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s005TOC.cfm","2007-05-30 00:00:00",
12598,2,20450,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf","2011-11-16 00:00:00",
24985,1,20450,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf","2011-11-17 00:00:00",
2553,1,20450,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf","2011-11-17 00:00:00",
34667,2,20450,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf","2011-11-16 00:00:00",
12599,2,20450,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf","2011-11-16 00:00:00",
24986,1,20450,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf","2011-11-17 00:00:00",
2554,1,20450,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf","2011-11-17 00:00:00",
34668,2,20450,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf","2011-11-16 00:00:00",
24987,1,20450,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s020ltr.pdf","2013-03-08 00:00:00",
34669,2,20450,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450s020lbl.pdf","2013-03-08 00:00:00",
12600,2,20450,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf","2014-01-07 00:00:00",
24988,1,20450,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s023ltr.pdf","2014-01-07 00:00:00",
2555,1,20450,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s024ltr.pdf","2013-10-24 00:00:00",
34670,2,20450,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450Orig1s024lbl.pdf","2013-11-20 00:00:00",
12601,2,20450,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf","2014-06-17 00:00:00",
24989,1,20450,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s025ltr.pdf","2014-06-17 00:00:00",
24990,1,20450,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020450Orig1s028ltr.pdf","2015-06-10 00:00:00",
34671,2,20450,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020450s028lbl.pdf","2015-06-10 00:00:00",
2556,1,20450,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s029ltr.pdf","2016-03-04 00:00:00",
34672,2,20450,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s029lbl.pdf","2016-03-04 00:00:00",
34673,2,20450,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s031lbledt.pdf","2016-06-21 00:00:00",
45825,2,20450,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s033lbl.pdf","2016-11-07 00:00:00",
45833,1,20450,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s033ltr.pdf","2016-11-08 00:00:00",
47554,1,20450,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s036ltr.pdf","2017-03-14 00:00:00",
47570,2,20450,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450Orig1s036lbl.pdf","2017-03-16 00:00:00",
50258,2,20450,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf","2017-11-01 00:00:00",
50310,1,20450,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf","2017-11-06 00:00:00",
50257,2,20450,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf","2017-11-01 00:00:00",
50311,1,20450,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf","2017-11-06 00:00:00",
2557,1,20451,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451sap.pdf","1998-01-09 00:00:00",
2558,1,20451,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451s3ltr.pdf","1998-12-22 00:00:00",
12602,2,20451,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf","2003-08-14 00:00:00",
24991,1,20451,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf","2003-08-15 00:00:00",
41377,3,20451,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020415s012_021525_PhotofrinTOC.cfm","2006-07-25 00:00:00",
2559,1,20451,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020451s016ltr.pdf","2005-10-20 00:00:00",
2560,1,20451,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020451s019ltr.pdf","2008-09-09 00:00:00",
34674,2,20451,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020451s019lbl.pdf","2008-09-09 00:00:00",
2561,1,20451,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s020ltr.pdf","2011-04-06 00:00:00",
12603,2,20451,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf","2011-04-04 00:00:00",
24992,1,20451,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s023ltr.pdf","2011-07-05 00:00:00",
34675,2,20451,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf","2011-06-28 00:00:00",
2562,1,20452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20452ltr.pdf","2003-07-28 00:00:00",
2563,1,20452,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20452scs001ltr.pdf","2004-01-14 00:00:00",
12604,2,20452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452.pdf_Paraplatin_Prntlbl.pdf","2004-06-14 00:00:00",
12605,2,20452,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20452scs001_paraplatin_lbl.pdf","2004-01-15 00:00:00",
20666,3,20452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452_Paraplatin.cfm","2004-05-06 00:00:00",
12606,2,20452,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020452s005lbl.pdf","2015-11-02 00:00:00",
24993,1,20452,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020452s005ltr.pdf","2010-11-12 00:00:00",
46976,2,20453,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020453s007lbl.pdf","2017-01-25 00:00:00",
47014,1,20453,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020453Orig1s007ltr.pdf","2017-01-30 00:00:00",
24994,1,20457,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf","2002-02-21 00:00:00",
24995,1,20457,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf","2002-02-21 00:00:00",
24996,1,20457,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457slr006,20906slr002ltr.pdf","2002-11-05 00:00:00",
12607,2,20457,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf","2011-03-21 00:00:00",
24997,1,20457,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020457s013ltr.pdf","2011-03-21 00:00:00",
2564,1,20457,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020457Orig1s014ltr.pdf","2015-07-31 00:00:00",
34676,2,20457,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf","2015-08-04 00:00:00",
45894,1,20457,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020457Orig1s015ltr.pdf","2016-11-15 00:00:00",
45898,2,20457,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020457s015lbl.pdf","2016-11-16 00:00:00",
48539,2,20457,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020457s016lbl.pdf","2017-05-25 00:00:00",
20667,3,20458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020458ap.pdf","1997-01-28 00:00:00",
24998,1,20458,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20458s2ltr.pdf","2002-03-14 00:00:00",
2565,1,20459,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020459s006ltr.pdf","2006-04-13 00:00:00",
34677,2,20459,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020459s006lbl.pdf","2006-04-12 00:00:00",
41378,3,20460,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20460.pdf","1997-12-12 00:00:00",
2566,1,20463,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20463S2LTR.PDF","2001-03-27 00:00:00",
20668,3,20463,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-463S002_NasalCrom.cfm","2001-03-27 00:00:00",
24999,1,20463,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20463s008ltr.pdf","2004-07-21 00:00:00",
41379,3,20468,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020468_s001_NASACORT AQ.pdf","2008-08-11 00:00:00",
12608,2,20468,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf","2003-12-29 00:00:00",
25000,1,20468,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr011ltr.pdf","2003-12-22 00:00:00",
2567,1,20468,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr012ltr.pdf","2004-01-09 00:00:00",
34678,2,20468,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr012_nasacort_lbl.pdf","2004-01-15 00:00:00",
2568,1,20468,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20468slr013ltr.pdf","2004-03-10 00:00:00",
12609,2,20468,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf","2004-04-05 00:00:00",
2569,1,20468,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020468s024ltr.pdf","2008-09-23 00:00:00",
12610,2,20468,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf","2008-09-25 00:00:00",
53428,20,20468,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020468s024_Triamcinolone_Clinical_PREA.pdf","1900-01-01 00:00:00",
53429,18,20468,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020468s024_Triamcinolone_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53430,17,20468,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020468s024_Triamcinolone_Statistical_PREA.pdf","1900-01-01 00:00:00",
2570,1,20468,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf","2013-07-03 00:00:00",
12611,2,20468,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf","2013-07-03 00:00:00",
25001,1,20468,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf","2013-07-03 00:00:00",
34679,2,20468,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf","2013-07-03 00:00:00",
12612,2,20468,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf","2013-10-15 00:00:00",
25002,1,20468,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s035ltr.pdf","2013-10-11 00:00:00",
25003,1,20468,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020468Orig1s039ltr.pdf","2014-09-23 00:00:00",
34680,2,20468,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020468Orig1s039lbl.pdf","2014-09-23 00:00:00",
2571,1,20468,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020468Orig1s040ltr.pdf","2015-06-22 00:00:00",
12613,2,20468,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf","2015-06-22 00:00:00",
45531,1,20468,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020468Orig1s042ltr.pdf","2016-10-12 00:00:00",
45603,2,20468,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020468Orig1s042lbl.pdf","2016-10-11 00:00:00",
51430,2,20468,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s044lbl.pdf","2018-01-22 00:00:00",
51868,1,20468,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020468Orig1s044ltr.pdf","2018-01-26 00:00:00",
20669,3,20470,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml","2007-03-02 00:00:00",
41380,3,20470,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20470-S005_Claritin.pdf","1998-12-04 00:00:00",
41381,3,20470,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml","2007-03-02 00:00:00",
41382,3,20470,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml","2007-03-02 00:00:00",
25004,1,20470,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf","2002-11-27 00:00:00",
41383,3,20470,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm","2004-12-07 00:00:00",
25005,1,20470,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20470slr019ltr.pdf","2003-07-06 00:00:00",
12614,2,20470,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf","2004-08-02 00:00:00",
25006,1,20470,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf","2004-08-02 00:00:00",
2572,1,20470,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf","2004-07-21 00:00:00",
25007,1,20470,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf","2010-02-17 00:00:00",
25008,1,20470,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf","2015-11-27 00:00:00",
34681,2,20470,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf","2015-12-11 00:00:00",
55091,1,20470,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019670Orig1s034,020470Orig1s047ltr.pdf","2018-08-03 00:00:00",
55114,2,20470,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf","2018-08-03 00:00:00",
41384,3,20471,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020471_s007_Zyflo Filmtabs.pdf","2009-09-16 00:00:00",
20670,3,20471,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020471_s009_Zyflo_Filmtab.pdf","2009-09-16 00:00:00",
25009,1,20471,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20471slr009ltr.pdf","2004-07-01 00:00:00",
2573,1,20471,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020471s011ltr.pdf","2006-01-27 00:00:00",
12615,2,20471,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf","2005-09-30 00:00:00",
25010,1,20471,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005ltr.pdf","2009-11-12 00:00:00",
34682,2,20471,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf","2009-08-28 00:00:00",
12616,2,20471,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf","2012-06-18 00:00:00",
25011,1,20471,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020471s017ltr.pdf","2012-06-12 00:00:00",
20671,3,20472,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020472_s001_ESTRING 2 MG.pdf","2009-01-12 00:00:00",
41385,3,20472,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020472_s003_ESTRING 2 MG.pdf","2009-01-12 00:00:00",
20672,3,20472,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020472_s004_ESTRING 2 MG.pdf","2009-01-12 00:00:00",
25012,1,20472,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020472s007ltr.pdf","2008-08-27 00:00:00",
34683,2,20472,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020472s007lbl.pdf","2008-08-29 00:00:00",
2574,1,20472,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020472Orig1s011ltr.pdf","2014-08-14 00:00:00",
34684,2,20472,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020472s011lbl.pdf","2014-08-13 00:00:00",
2575,1,20472,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013ltr.pdf","2015-09-30 00:00:00",
12617,2,20472,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf","2015-12-10 00:00:00",
25013,1,20472,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013ltr.pdf","2015-09-30 00:00:00",
34685,2,20472,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf","2015-12-10 00:00:00",
50274,2,20472,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020472s016lbl.pdf","2017-11-02 00:00:00",
50300,1,20472,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020472Orig1s016ltr.pdf","2017-11-06 00:00:00",
2576,1,20474,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20474slr016ltr.pdf","2003-05-29 00:00:00",
12618,2,20474,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf","2003-05-29 00:00:00",
2577,1,20474,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020474s019ltr.pdf","2007-10-22 00:00:00",
34686,2,20474,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020474s019lbl.pdf","2007-10-22 00:00:00",
25014,1,20474,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020474s021ltr.pdf","2012-02-27 00:00:00",
34687,2,20474,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020474s021lbl.pdf","2012-02-24 00:00:00",
41386,3,20475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020475ap.pdf","1997-02-07 00:00:00",
2578,1,20475,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20475s008ltr.pdf","2002-05-10 00:00:00",
34688,2,20475,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf","2002-05-10 00:00:00",
12619,2,20475,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf","2014-01-31 00:00:00",
41387,3,20475,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020475Org1s021.pdf","2015-08-25 00:00:00",
20673,3,20476,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm","2006-05-08 00:00:00",
25015,1,20476,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf","2002-02-04 00:00:00",
2579,1,20478,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20478S6LTR.PDF","2001-03-30 00:00:00",
12620,2,20478,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20478S6LBL.PDF","2001-03-30 00:00:00",
20674,3,20478,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020478_S006_ULTANE_AP.pdf","2007-05-29 00:00:00",
25016,1,20478,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20478slr007ltr.pdf","2004-06-29 00:00:00",
41388,3,20478,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020478s007TOC.cfm","2007-05-30 00:00:00",
48413,3,20478,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020478Orig1S011.pdf","2017-05-17 00:00:00",
25017,1,20478,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20478slr012ltr.pdf","2003-07-06 00:00:00",
2580,1,20478,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020478s013ltr.pdf","2005-06-23 00:00:00",
34689,2,20478,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020478s013lbl.pdf","2005-06-23 00:00:00",
25018,1,20478,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020478s016ltr.pdf","2006-07-03 00:00:00",
34690,2,20478,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020478s016lbl.pdf","2006-06-28 00:00:00",
25019,1,20478,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020478s018ltr.pdf","2010-01-28 00:00:00",
34691,2,20478,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020478s018lbl.pdf","2010-01-24 00:00:00",
12621,2,20478,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf","2012-08-17 00:00:00",
25020,1,20478,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf","2012-08-17 00:00:00",
2581,1,20478,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf","2012-08-17 00:00:00",
12622,2,20478,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf","2012-08-17 00:00:00",
12623,2,20478,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf","2014-03-13 00:00:00",
25021,1,20478,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf","2014-03-13 00:00:00",
2582,1,20478,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf","2014-03-13 00:00:00",
34692,2,20478,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf","2014-03-13 00:00:00",
48414,2,20478,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020478Orig1S029.pdf","2017-05-17 00:00:00",
48415,3,20478,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020478Orig1S029.pdf","2017-05-17 00:00:00",
48222,2,20478,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020478s030lbl.pdf","2017-05-02 00:00:00",
2583,1,20479,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20479slr005ltr.pdf","2004-06-04 00:00:00",
20675,3,20482,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf","1998-09-29 00:00:00",
25022,1,20482,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf","1998-09-29 00:00:00",
2584,1,20482,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf","1998-09-29 00:00:00",
41389,3,20482,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf","1998-09-29 00:00:00",
2585,1,20482,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose_appltr.pdf","1999-08-16 00:00:00",
20676,3,20482,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose.cfm","1999-08-16 00:00:00",
25023,1,20482,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20482slr011ltr.pdf","2002-10-29 00:00:00",
2586,1,20482,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020482s015ltr.pdf","2005-08-03 00:00:00",
34693,2,20482,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020482s015lbl.pdf","2005-08-03 00:00:00",
2587,1,20482,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020482s023ltr.pdf","2008-08-25 00:00:00",
34694,2,20482,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020482s023lbl.pdf","2008-08-26 00:00:00",
25024,1,20482,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020482s024ltr.pdf","2011-03-25 00:00:00",
34695,2,20482,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020482s024lbl.pdf","2011-03-28 00:00:00",
2588,1,20482,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020482s025ltr.pdf","2012-03-02 00:00:00",
34696,2,20482,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020482s025lbl.pdf","2012-03-01 00:00:00",
2589,1,20482,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020482Orig1s027ltr.pdf","2015-03-11 00:00:00",
34697,2,20482,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020482s027lbl.pdf","2015-03-27 00:00:00",
2590,1,20484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20484ltr.pdf","2000-07-14 00:00:00",
12624,2,20484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf","2000-07-14 00:00:00",
20677,3,20484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-484_Innohep.cfm","2000-07-14 00:00:00",
25025,1,20484,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20484s2ltr.pdf","2002-02-05 00:00:00",
2591,1,20484,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20484slr003ltr.pdf","2004-06-07 00:00:00",
25026,1,20484,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020484s006LTR.pdf","2006-11-09 00:00:00",
2592,1,20484,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020484s011ltr.pdf","2008-12-30 00:00:00",
34698,2,20484,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020484s011lbl.pdf","2009-01-02 00:00:00",
12625,2,20484,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf","2009-12-30 00:00:00",
25027,1,20484,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020484s013ltr.pdf","2009-12-31 00:00:00",
12626,2,20484,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf","2010-10-12 00:00:00",
25028,1,20484,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020484s014ltr.pdf","2010-10-13 00:00:00",
12627,2,20485,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf","2002-06-14 00:00:00",
25029,1,20485,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20485s005ltr.pdf","2002-06-14 00:00:00",
25030,1,20485,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20485scm006ltr.pdf","2003-09-25 00:00:00",
34699,2,20485,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf","2003-09-25 00:00:00",
2593,1,20485,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20485s007ltr.pdf","2004-10-22 00:00:00",
12628,2,20485,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf","2014-01-14 00:00:00",
25031,1,20485,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020485Orig1s009ltr.pdf","2012-12-21 00:00:00",
45179,2,20485,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf","2016-08-26 00:00:00",
53431,20,20487,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020487s014s015_Valacyclovir_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53432,18,20487,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020487s014_Valacyclovir_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53433,18,20487,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020487S015_Valacyclovir_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
41390,3,20487,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-487s002_ValtrexTOC.cfm","2005-06-27 00:00:00",
41391,3,20487,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20-487s003_ValtrexTOC.cfm","2005-06-27 00:00:00",
20678,3,20487,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-487s004_ValtrexTOC.cfm","2005-06-27 00:00:00",
25032,1,20487,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20487s005ltr.pdf","2004-12-08 00:00:00",
34700,2,20487,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf","2004-12-08 00:00:00",
41392,3,20487,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-487s005_ValtrexTOC.cfm","2005-06-27 00:00:00",
12629,2,20487,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf","2005-11-30 00:00:00",
25033,1,20487,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020487s007rel2_ltr.pdf","2005-11-30 00:00:00",
2594,1,20487,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020487s013ltr.pdf","2008-01-09 00:00:00",
12630,2,20487,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf","2007-12-14 00:00:00",
25034,1,20487,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020487s014ltr.pdf","2008-09-09 00:00:00",
34701,2,20487,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf","2008-09-03 00:00:00",
25035,1,20487,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020487s016ltr.pdf","2010-04-22 00:00:00",
34702,2,20487,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf","2010-04-20 00:00:00",
41393,3,20488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020488_original_approval.pdf","1995-07-01 00:00:00",
25036,1,20488,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020488Orig1s019ltr.pdf","2013-06-05 00:00:00",
34703,2,20488,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020488s019lbl.pdf","2013-06-04 00:00:00",
41394,3,20489,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20489-S003_ANDRODERM.PDF","1997-05-02 00:00:00",
20679,3,20489,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020489_S007_ANDRODERM_AP.pdf","2007-07-06 00:00:00",
25037,1,20489,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489s7ltr.pdf","2002-01-15 00:00:00",
25038,1,20489,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489slr010ltr.pdf","2002-08-09 00:00:00",
2595,1,20489,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020489s013LTR.pdf","2006-05-22 00:00:00",
34704,2,20489,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf","2006-05-22 00:00:00",
12631,2,20489,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf","2011-10-25 00:00:00",
25039,1,20489,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020489s025ltr.pdf","2011-10-25 00:00:00",
25040,1,20489,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020489Orig1s027ltr.pdf","2012-05-02 00:00:00",
34705,2,20489,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf","2012-05-01 00:00:00",
2596,1,20489,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020489Orig1s031ltr.pdf","2014-06-23 00:00:00",
34706,2,20489,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf","2014-06-23 00:00:00",
12632,2,20489,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf","2015-05-13 00:00:00",
25041,1,20489,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020489Orig1s033ltr.pdf","2015-05-13 00:00:00",
45671,1,20489,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020489Orig1s034ltr.pdf","2016-10-27 00:00:00",
45752,2,20489,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020489s034lbl.pdf","2016-11-01 00:00:00",
12633,2,20490,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf","2001-12-20 00:00:00",
25042,1,20490,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf","2001-12-20 00:00:00",
41395,3,20490,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm","2004-05-27 00:00:00",
2597,1,20490,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020490Orig1s008ltr.pdf","2016-03-25 00:00:00",
34707,2,20490,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020490s008lbl.pdf","2016-03-28 00:00:00",
2598,1,20491,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s01ltr.pdf","1999-05-13 00:00:00",
20680,3,20491,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20491s001.cfm","1999-05-13 00:00:00",
34708,2,20491,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20491s01lbl.pdf","1999-05-13 00:00:00",
20681,3,20491,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s002_Corvert.pdf","1998-04-03 00:00:00",
2599,1,20491,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf","2001-04-20 00:00:00",
12634,2,20491,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf","2001-04-20 00:00:00",
20682,3,20491,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf","2001-04-20 00:00:00",
2600,1,20496,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf","1999-02-24 00:00:00",
20683,3,20496,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm","1999-02-24 00:00:00",
20684,3,20496,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf","2004-05-27 00:00:00",
2601,1,20496,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf","2002-04-15 00:00:00",
25043,1,20496,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf","2004-08-25 00:00:00",
25044,1,20496,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf","2005-12-06 00:00:00",
34709,2,20496,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf","2005-12-05 00:00:00",
51965,20,20496,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496s015_glimepiride_Amaryl_Clinical_BPCA.pdf","1900-01-01 00:00:00",
51966,23,20496,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496_glimepiride_Amaryl_WR.pdf","1900-01-01 00:00:00",
51967,17,20496,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496s015_glimepiride_Amaryl-Statistical_BPCA.pdf","1900-01-01 00:00:00",
2602,1,20496,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf","2005-09-22 00:00:00",
34710,2,20496,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf","2005-09-22 00:00:00",
25045,1,20496,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf","2009-02-13 00:00:00",
34711,2,20496,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf","2009-02-04 00:00:00",
2603,1,20496,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf","2009-02-13 00:00:00",
12635,2,20496,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf","2009-02-04 00:00:00",
25046,1,20496,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf","2009-06-16 00:00:00",
34712,2,20496,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf","2009-06-04 00:00:00",
25047,1,20496,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf","2012-02-08 00:00:00",
34713,2,20496,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf","2012-02-06 00:00:00",
12636,2,20496,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf","2013-08-09 00:00:00",
25048,1,20496,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf","2013-08-05 00:00:00",
12637,2,20496,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf","2013-10-22 00:00:00",
25049,1,20496,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf","2013-10-18 00:00:00",
46490,1,20496,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020496Orig1s028ltr.pdf","2016-12-22 00:00:00",
46494,2,20496,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf","2016-12-21 00:00:00",
2604,1,20497,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020497s006ltr.pdf","2011-03-24 00:00:00",
12638,2,20497,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf","2011-03-28 00:00:00",
48369,2,20497,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020497s009lbl.pdf","2017-05-15 00:00:00",
48405,1,20497,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020497Orig1s009ltr.pdf","2017-05-17 00:00:00",
12639,2,20498,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf","2005-05-17 00:00:00",
25050,1,20498,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020498s016ltr.pdf","2005-05-17 00:00:00",
12640,2,20498,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf","2006-03-14 00:00:00",
25051,1,20498,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020498s018ltr.pdf","2006-03-23 00:00:00",
25052,1,20498,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf","2009-03-16 00:00:00",
34714,2,20498,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf","2009-02-12 00:00:00",
2605,1,20498,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf","2009-03-16 00:00:00",
12641,2,20498,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf","2009-02-12 00:00:00",
2606,1,20498,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020498s022ltr.pdf","2010-09-20 00:00:00",
34715,2,20498,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf","2010-09-20 00:00:00",
25053,1,20498,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020498Orig1s025ltr.pdf","2015-03-02 00:00:00",
34716,2,20498,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf","2015-03-04 00:00:00",
47588,1,20498,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s027ltr.pdf","2017-03-20 00:00:00",
47658,2,20498,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s027lbl.pdf","2017-03-23 00:00:00",
50299,1,20498,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s028ltr.pdf","2017-11-06 00:00:00",
50647,2,20498,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf","2017-12-08 00:00:00",
41396,3,20499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020499_actron_toc.cfm","2003-08-08 00:00:00",
12642,2,20500,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF","2004-06-09 00:00:00",
25054,1,20500,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf","2004-06-09 00:00:00",
41397,3,20500,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020500S005.cfm","2004-06-09 00:00:00",
2607,1,20500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf","2008-05-09 00:00:00",
34717,2,20500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf","2008-05-12 00:00:00",
12643,2,20500,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf","2013-03-05 00:00:00",
25055,1,20500,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf","2013-03-04 00:00:00",
2608,1,20500,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf","2015-06-10 00:00:00",
12644,2,20500,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf","2015-06-10 00:00:00",
50070,2,20500,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf","2017-10-17 00:00:00",
50087,1,20500,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020500Orig1s016ltr.pdf","2017-10-18 00:00:00",
20685,3,20503,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20503-S004_Proventil.pdf","1998-09-23 00:00:00",
25056,1,20503,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20503s4ltr.pdf","1998-09-23 00:00:00",
34718,2,20503,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20503s4lbl.pdf","1998-09-23 00:00:00",
2609,1,20503,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20503s11ltr.pdf","1999-06-02 00:00:00",
41398,3,20503,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20503-S011_Proventil.pdf","1999-06-02 00:00:00",
25057,1,20503,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20503slr022ltr.pdf","2004-02-03 00:00:00",
2610,1,20503,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020503s039ltr.pdf","2009-11-12 00:00:00",
34719,2,20503,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020503s039lbl.pdf","2009-09-17 00:00:00",
2611,1,20503,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020503s046ltr.pdf","2012-06-07 00:00:00",
34720,2,20503,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020503s046lbl.pdf","2012-06-11 00:00:00",
41399,3,20503,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020503Orig1s047.pdf","2015-03-10 00:00:00",
49854,1,20503,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020503Orig1s054ltr.pdf","2017-09-25 00:00:00",
49856,2,20503,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020503s054lbl.pdf","2017-09-26 00:00:00",
25058,1,20504,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020504s018ltr.pdf","2011-03-21 00:00:00",
34721,2,20504,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020504s018lbl.pdf","2011-03-21 00:00:00",
20686,3,20505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020505s000_Topamax.cfm","2004-09-10 00:00:00",
25059,1,20505,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf","1999-07-23 00:00:00",
34722,2,20505,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf","1999-07-23 00:00:00",
41400,3,20505,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax.cfm","2000-07-03 00:00:00",
51494,20,20505,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505 topiramate clinical prea.pdf","1900-01-01 00:00:00",
51495,17,20505,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505 topiramate statistical prea.pdf","1900-01-01 00:00:00",
52376,23,20505,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505, 020814_Topiramate_Tab_2_WR_7-9-04.pdf","1900-01-01 00:00:00",
52377,25,20505,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505, 020814_Topiramate_Tab_3_amend_12-14-05.pdf","1900-01-01 00:00:00",
25060,1,20505,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf","2001-08-28 00:00:00",
34723,2,20505,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf","2001-08-28 00:00:00",
41401,3,20505,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-844s010_Topamax.cfm","2004-09-08 00:00:00",
25061,1,20505,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf","1999-10-01 00:00:00",
34724,2,20505,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf","1999-10-01 00:00:00",
41402,3,20505,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax.cfm","2000-07-03 00:00:00",
2612,1,20505,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2004-06-28 00:00:00",
34725,2,20505,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
2613,1,20505,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
34726,2,20505,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
25062,1,20505,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr012ltr.pdf","2003-06-08 00:00:00",
25063,1,20505,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr016ltr.pdf","2002-12-09 00:00:00",
2614,1,20505,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2003-12-19 00:00:00",
12645,2,20505,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
20687,3,20505,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020505Orig1s018.pdf","2012-02-28 00:00:00",
25064,1,20505,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf","2005-07-08 00:00:00",
34727,2,20505,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf","2005-07-05 00:00:00",
2615,1,20505,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2003-12-19 00:00:00",
34728,2,20505,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
2616,1,20505,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr017ltr.pdf","2003-06-22 00:00:00",
2617,1,20505,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf","2003-05-29 00:00:00",
2618,1,20505,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf","2004-08-12 00:00:00",
12646,2,20505,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf","2004-08-12 00:00:00",
2619,1,20505,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf","2003-05-29 00:00:00",
2620,1,20505,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf","2004-08-12 00:00:00",
12647,2,20505,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf","2004-08-12 00:00:00",
25065,1,20505,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf","2005-07-08 00:00:00",
34729,2,20505,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf","2005-07-05 00:00:00",
25066,1,20505,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029, 020844s024ltr.pdf","2006-10-23 00:00:00",
12648,2,20505,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
25067,1,20505,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
2621,1,20505,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
34730,2,20505,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
34731,2,20505,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf","2009-04-28 00:00:00",
25068,1,20505,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
34732,2,20505,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
53029,20,20505,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20505se5-037-20844se5-031_Toprimate_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53030,18,20505,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20505se5-037_20844se5-031_Toprimate_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
25069,1,20505,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf","2009-05-04 00:00:00",
34733,2,20505,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf","2009-05-12 00:00:00",
2622,1,20505,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf","2009-05-04 00:00:00",
12649,2,20505,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf","2009-05-12 00:00:00",
12650,2,20505,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf","2011-03-04 00:00:00",
25070,1,20505,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf","2011-03-08 00:00:00",
2623,1,20505,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr.pdf","2011-07-19 00:00:00",
12651,2,20505,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf","2011-07-18 00:00:00",
12652,2,20505,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf","2011-03-04 00:00:00",
25071,1,20505,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf","2011-03-08 00:00:00",
2624,1,20505,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844Orig1s041ltr.pdf","2012-11-01 00:00:00",
34734,2,20505,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020505s050lbl.pdf","2012-10-29 00:00:00",
25072,1,20505,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844Orig1s043ltr.pdf","2014-04-02 00:00:00",
34735,2,20505,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf","2014-04-01 00:00:00",
12653,2,20505,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf","2014-01-31 00:00:00",
25073,1,20505,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844Orig1s044ltr.pdf","2014-01-30 00:00:00",
2625,1,20505,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844Orig1s045ltr.pdf","2014-10-23 00:00:00",
34736,2,20505,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf","2014-10-23 00:00:00",
2626,1,20505,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844Orig1s046ltr.pdf","2014-12-19 00:00:00",
12654,2,20505,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf","2014-12-19 00:00:00",
48381,2,20505,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf","2017-05-16 00:00:00",
48409,1,20505,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020505Orig1s057,020844Orig1s048ltr.pdf","2017-05-17 00:00:00",
54647,1,20505,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020505Orig1s058,020844Orig1s049ltr.pdf","2018-06-21 00:00:00",
54689,2,20505,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058_020844_49lbl.pdf","2018-06-26 00:00:00",
54690,8,20505,"SUPPL",58,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058_020844_49lbl.pdf#page=50","2018-06-26 00:00:00",
41403,3,20507,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf","2001-06-22 00:00:00",
20688,3,20508,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20508S005_Lac-Hydrin.cfm","2001-12-11 00:00:00",
25074,1,20508,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20508S5ltr.pdf","2000-08-25 00:00:00",
34737,2,20508,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20508S5lbl.pdf","2000-08-25 00:00:00",
12655,2,20508,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf","2004-12-30 00:00:00",
25075,1,20508,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20508s006ltr.pdf","2004-12-22 00:00:00",
2627,1,20509,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20509ltr.pdf","1998-08-25 00:00:00",
34738,2,20509,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf","1998-08-25 00:00:00",
12656,2,20509,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf","2003-03-07 00:00:00",
25076,1,20509,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20509slr013ltr.pdf","2005-04-07 00:00:00",
2628,1,20509,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20509s021ltr.pdf","2002-05-01 00:00:00",
2629,1,20509,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20509se1-029ltr.pdf","2004-05-26 00:00:00",
12657,2,20509,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf","2004-05-19 00:00:00",
41404,3,20509,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020509_S029_GEMZAR_AP.pdf","2007-11-19 00:00:00",
25077,1,20509,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s032ltr.pdf","2005-04-28 00:00:00",
34739,2,20509,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf","2005-04-28 00:00:00",
2630,1,20509,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s033ltr.pdf","2005-04-28 00:00:00",
12658,2,20509,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf","2005-04-28 00:00:00",
20689,3,20509,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020509_S033_GEMZAR.pdf","2008-02-19 00:00:00",
51964,23,20509,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020509s033_gemcitabine_WR.pdf","1900-01-01 00:00:00",
2631,1,20509,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s037ltr.pdf","2006-04-07 00:00:00",
25078,1,20509,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s039_ltr.pdf","2006-07-21 00:00:00",
12659,2,20509,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf","2010-03-26 00:00:00",
25079,1,20509,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020509s064ltr.pdf","2010-03-24 00:00:00",
12660,2,20509,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf","2011-02-09 00:00:00",
34740,2,20509,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf","2013-05-08 00:00:00",
2632,1,20509,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s075ltr.pdf","2014-06-12 00:00:00",
12661,2,20509,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf","2015-10-13 00:00:00",
25080,1,20509,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s077ltr.pdf","2014-05-12 00:00:00",
34741,2,20509,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf","2014-05-12 00:00:00",
49735,2,20509,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020509s079lbl.pdf","2017-09-14 00:00:00",
49803,1,20509,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020509Orig1s079ltr.pdf","2017-09-19 00:00:00",
54666,2,20509,"SUPPL",80,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf","2018-06-21 00:00:00",
20690,3,20511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020511ap.pdf","1997-11-20 00:00:00",
2633,1,20511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20511s002ltr.pdf","2002-06-11 00:00:00",
12662,2,20511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf","2002-06-11 00:00:00",
2634,1,20516,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf","1999-09-13 00:00:00",
12663,2,20516,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf","1999-09-13 00:00:00",
20691,3,20516,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm","1999-09-13 00:00:00",
2635,1,20516,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf","2003-10-31 00:00:00",
2636,1,20516,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf","2003-12-23 00:00:00",
2637,1,20516,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf","2005-02-09 00:00:00",
2638,1,20516,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf","2005-12-15 00:00:00",
2639,1,20516,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf","2006-06-28 00:00:00",
2640,1,20516,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf","2009-05-06 00:00:00",
25081,1,20516,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf","2010-10-22 00:00:00",
25082,1,20516,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf","2011-12-08 00:00:00",
2641,1,20516,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf","2014-12-12 00:00:00",
34742,2,20516,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf","2014-12-19 00:00:00",
2642,1,20516,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf","2015-04-17 00:00:00",
12664,2,20516,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf","2015-04-21 00:00:00",
25083,1,20516,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf","2016-06-21 00:00:00",
34743,2,20516,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf","2016-06-22 00:00:00",
47569,2,20516,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf","2017-03-16 00:00:00",
47607,1,20516,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020516Orig1s035ltr.pdf","2017-03-20 00:00:00",
20692,3,20517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020517_S000_Lupron_Depot.PDF","2006-04-06 00:00:00",
23581,10,20517,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
41405,3,20517,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20517S001_Lupron.pdf","2006-03-30 00:00:00",
20693,3,20517,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020517_s002ap.pdf","1997-05-30 00:00:00",
20694,3,20517,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020517_S006_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
25084,1,20517,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf","2003-09-25 00:00:00",
2643,1,20517,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf","2004-01-14 00:00:00",
2644,1,20517,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
41406,3,20517,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S018_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
25085,1,20517,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
41407,3,20517,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S019_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
12665,2,20517,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
25086,1,20517,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
25087,1,20517,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf","2011-06-29 00:00:00",
34744,2,20517,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf","2011-06-28 00:00:00",
41408,3,20517,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf","2015-01-20 00:00:00",
2645,1,20517,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
34745,2,20517,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
12666,2,20517,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf","2010-05-07 00:00:00",
25088,1,20517,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf","2010-05-04 00:00:00",
2646,1,20517,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf","2011-06-29 00:00:00",
34746,2,20517,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf","2011-06-28 00:00:00",
41409,3,20517,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf","2015-01-20 00:00:00",
12667,2,20517,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf","2011-01-20 00:00:00",
25089,1,20517,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf","2011-01-20 00:00:00",
2647,1,20517,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf","2011-06-29 00:00:00",
12668,2,20517,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf","2011-06-28 00:00:00",
20695,3,20517,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf","2015-01-20 00:00:00",
2648,1,20517,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020517Origs033ltr.pdf","2012-07-20 00:00:00",
12669,2,20517,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf","2012-07-19 00:00:00",
2649,1,20517,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf","2013-07-12 00:00:00",
12670,2,20517,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf","2013-07-11 00:00:00",
25090,1,20517,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf","2014-07-01 00:00:00",
34747,2,20517,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf","2014-07-01 00:00:00",
12671,2,20517,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf","2016-06-13 00:00:00",
25091,1,20517,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf","2016-06-08 00:00:00",
20696,3,20518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm","2005-04-19 00:00:00",
25092,1,20518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF","2001-03-30 00:00:00",
34748,2,20518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf","2001-03-30 00:00:00",
34749,2,20518,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518s8lbl.pdf","2003-04-25 00:00:00",
2650,1,20518,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf","2002-02-21 00:00:00",
2651,1,20518,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf","2002-12-18 00:00:00",
34750,2,20518,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf","2003-04-04 00:00:00",
25093,1,20518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20518slr011ltr.pdf","2004-03-11 00:00:00",
34751,2,20518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20518slr011_retrovir_lbl.pdf","2004-03-11 00:00:00",
2652,1,20518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf","2006-05-18 00:00:00",
12672,2,20518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf","2006-05-16 00:00:00",
2653,1,20518,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020518s015ltr.pdf","2006-12-04 00:00:00",
34752,2,20518,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020518s015lbl.pdf","2006-11-22 00:00:00",
2654,1,20518,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf","2008-09-23 00:00:00",
12673,2,20518,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf","2008-09-25 00:00:00",
12674,2,20518,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf","2009-11-23 00:00:00",
25094,1,20518,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018ltr.pdf","2010-01-06 00:00:00",
25095,1,20518,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf","2010-05-21 00:00:00",
34753,2,20518,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020518s019lbl.pdf","2010-05-18 00:00:00",
25096,1,20518,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf","2011-12-01 00:00:00",
34754,2,20518,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf","2011-11-25 00:00:00",
25097,1,20518,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf","2012-06-04 00:00:00",
34755,2,20518,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf","2012-06-06 00:00:00",
25098,1,20518,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf","2014-12-31 00:00:00",
34756,2,20518,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf","2015-01-08 00:00:00",
2655,1,20519,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20519slr005ltr.pdf","2003-04-15 00:00:00",
34757,2,20519,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf","2003-03-28 00:00:00",
2656,1,20519,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf","2013-07-02 00:00:00",
12675,2,20519,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf","2013-07-11 00:00:00",
20697,3,20520,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20520s1_Zantac.pdf","1998-06-08 00:00:00",
2657,1,20520,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20520s015ltr.pdf","2005-03-03 00:00:00",
20698,3,20520,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020520_S015_ZANTAC.pdf","2008-02-19 00:00:00",
25099,1,20520,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s028ltr.pdf","2015-02-03 00:00:00",
34758,2,20520,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf","2015-02-17 00:00:00",
12676,2,20520,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf","2015-11-25 00:00:00",
25100,1,20520,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s030ltr.pdf","2015-11-23 00:00:00",
25101,1,20520,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020520Orig1s032ltr.pdf","2016-02-17 00:00:00",
34759,2,20520,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf","2016-02-23 00:00:00",
25102,1,20520,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf","2016-07-28 00:00:00",
45114,2,20520,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf","2016-08-23 00:00:00",
20699,3,20521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20521_Infasurf.cfm","1998-07-01 00:00:00",
25103,1,20521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf","1998-07-01 00:00:00",
34760,2,20521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf","1998-07-01 00:00:00",
2658,1,20521,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf","2004-06-07 00:00:00",
25104,1,20521,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf","2011-07-07 00:00:00",
34761,2,20521,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf","2011-07-06 00:00:00",
41410,3,20522,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522_s002ap.pdf","1997-03-24 00:00:00",
41411,3,20522,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522a_s004.pdf","1997-12-17 00:00:00",
20700,3,20522,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20522S9.PDF","2003-05-15 00:00:00",
25105,1,20522,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20522S9LTR.PDF","1999-12-01 00:00:00",
20701,3,20522,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020522_S011_NUTROPIN FOR INJ.pdf","2007-08-06 00:00:00",
2659,1,20522,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20522S13LTR.PDF","2000-04-13 00:00:00",
12677,2,20522,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf","2004-06-10 00:00:00",
41412,3,20522,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522s013_Somatropin.cfm","2003-07-08 00:00:00",
25106,1,20522,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20522s017.pdf","2002-04-22 00:00:00",
34762,2,20522,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf","2002-04-22 00:00:00",
2660,1,20522,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf","2005-06-29 00:00:00",
12678,2,20522,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf","2005-06-29 00:00:00",
44449,14,20522,"SUPPL",21,"Additional App Ltr","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf","2005-07-22 00:00:00",
44450,14,20522,"SUPPL",21,"Additional Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf","2005-07-26 00:00:00",
23971,14,20522,"SUPPL",22,"Additional App Ltr","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf","2005-07-22 00:00:00",
23972,14,20522,"SUPPL",22,"Additional Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf","2005-07-26 00:00:00",
25107,1,20522,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf","2005-06-29 00:00:00",
34763,2,20522,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf","2005-06-29 00:00:00",
25108,1,20522,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf","2008-01-09 00:00:00",
34764,2,20522,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf","2008-01-08 00:00:00",
25109,1,20522,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s027ltr.pdf","2005-11-22 00:00:00",
34765,2,20522,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf","2005-11-22 00:00:00",
25110,1,20522,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf","2007-02-23 00:00:00",
34766,2,20522,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf","2007-02-21 00:00:00",
12679,2,20522,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf","2008-01-08 00:00:00",
25111,1,20522,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf","2008-01-09 00:00:00",
25112,1,20522,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf","2008-01-09 00:00:00",
34767,2,20522,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf","2008-01-08 00:00:00",
2661,1,20522,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf","2012-04-12 00:00:00",
34768,2,20522,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf","2012-04-17 00:00:00",
2662,1,20522,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020522Orig1s051ltr.pdf","2014-06-18 00:00:00",
12680,2,20522,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf","2014-06-17 00:00:00",
46158,1,20522,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020522Orig1s061ltr.pdf","2016-12-19 00:00:00",
46180,2,20522,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020522s061lbl.pdf","2016-12-14 00:00:00",
2663,1,20524,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20524S5ltr.pdf","2001-06-06 00:00:00",
20702,3,20524,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-524S005_Mentax.cfm","2001-11-20 00:00:00",
34769,2,20524,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf","2001-06-06 00:00:00",
23582,10,20527,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm","2009-06-02 00:00:00",
20703,3,20527,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20527S004_Prempro.pdf","1997-07-31 00:00:00",
25113,1,20527,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20527r.pdf","1998-01-09 00:00:00",
41413,3,20527,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527se2006_prempro.cfm","1998-01-09 00:00:00",
20704,3,20527,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20527S013_Prempro.pdf","1998-05-12 00:00:00",
2664,1,20527,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527s017ltr.pdf","2003-03-18 00:00:00",
20705,3,20527,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527s017_prempro_toc.cfm","2003-09-11 00:00:00",
34770,2,20527,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020527s017lbl.pdf","2003-03-20 00:00:00",
25114,1,20527,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527s018ltr.pdf","2002-02-11 00:00:00",
25115,1,20527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf","2003-06-08 00:00:00",
34771,2,20527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf","2003-06-08 00:00:00",
41414,3,20527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s024_prempro.pdf","2011-01-07 00:00:00",
2665,1,20527,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf","2003-06-08 00:00:00",
20706,3,20527,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s026_prempro.pdf","2011-01-07 00:00:00",
34772,2,20527,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf","2003-06-08 00:00:00",
25116,1,20527,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20527slr029ltr.pdf","2002-11-27 00:00:00",
34773,2,20527,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20527slr029_prempro_lbl.pdf","2002-11-27 00:00:00",
2666,1,20527,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/020527slr030ltr.pdf","2003-01-07 00:00:00",
12681,2,20527,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf","2003-01-07 00:00:00",
2667,1,20527,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20527se1-024,slr026,slr031ltr.pdf","2003-06-08 00:00:00",
34774,2,20527,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf","2003-06-08 00:00:00",
41415,3,20527,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020527_s031_prempro.pdf","2011-01-07 00:00:00",
25117,1,20527,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf","2004-04-29 00:00:00",
34775,2,20527,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf","2004-04-23 00:00:00",
2668,1,20527,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20527slr034,035ltr.pdf","2004-04-29 00:00:00",
12682,2,20527,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf","2004-12-29 00:00:00",
12683,2,20527,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf","2005-07-07 00:00:00",
25118,1,20527,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020527s036ltr.pdf","2005-07-08 00:00:00",
2669,1,20527,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020527s037ltr.pdf","2006-08-04 00:00:00",
34776,2,20527,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020527s037lbl.pdf","2006-08-04 00:00:00",
2670,1,20527,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020527s043ltr.pdf","2008-03-05 00:00:00",
12684,2,20527,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf","2008-03-05 00:00:00",
25119,1,20527,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s045ltr.pdf","2010-01-06 00:00:00",
34777,2,20527,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s045lbl.pdf","2010-01-04 00:00:00",
12685,2,20527,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf","2009-06-05 00:00:00",
20707,3,20527,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020527Orig1s046.pdf","2013-01-24 00:00:00",
25120,1,20527,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020527s046ltr.pdf","2009-05-26 00:00:00",
2671,1,20527,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf","2012-02-07 00:00:00",
34778,2,20527,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf","2012-02-06 00:00:00",
12686,2,20527,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf","2012-02-06 00:00:00",
25121,1,20527,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf","2012-02-07 00:00:00",
2672,1,20527,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf","2012-02-07 00:00:00",
34779,2,20527,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf","2012-02-06 00:00:00",
2673,1,20527,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020527s051,s052,s054,s056ltr.pdf","2012-02-07 00:00:00",
34780,2,20527,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf","2012-02-06 00:00:00",
2674,1,20527,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020527Orig1s062ltr.pdf","2015-09-04 00:00:00",
34781,2,20527,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020527s062lbl.pdf","2015-09-04 00:00:00",
50284,2,20527,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020527s065lbl.pdf","2017-11-03 00:00:00",
50298,1,20527,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020527Orig1s065ltr.pdf","2017-11-06 00:00:00",
23583,10,20528,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-06-09 00:00:00",
41416,3,20528,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020528_s001ap.pdf","1997-07-02 00:00:00",
2675,1,20528,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20528slr008ltr.pdf","2004-03-03 00:00:00",
2676,1,20528,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020528s012ltr.pdf","2010-04-23 00:00:00",
34782,2,20528,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf","2010-05-03 00:00:00",
25122,1,20528,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020528s016ltr.pdf","2009-04-16 00:00:00",
34783,2,20528,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf","2009-04-16 00:00:00",
2677,1,20528,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s017ltr.pdf","2011-11-14 00:00:00",
2678,1,20528,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s018ltr.pdf","2012-01-30 00:00:00",
12687,2,20528,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf","2012-01-23 00:00:00",
25123,1,20528,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s019ltr.pdf","2011-09-16 00:00:00",
34784,2,20528,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf","2011-09-16 00:00:00",
12688,2,20528,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf","2012-03-06 00:00:00",
25124,1,20528,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf","2012-01-30 00:00:00",
25125,1,20528,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528Orig1s021ltr.pdf","2012-09-14 00:00:00",
34785,2,20528,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf","2012-09-14 00:00:00",
25126,1,20528,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020528Orig1s023ltr.pdf","2014-12-30 00:00:00",
34786,2,20528,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf","2015-01-09 00:00:00",
12689,2,20528,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf","2016-02-02 00:00:00",
25127,1,20528,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020528Orig1s024ltr.pdf","2016-02-01 00:00:00",
49237,2,20528,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020528s025lbl.pdf","2017-08-04 00:00:00",
49247,1,20528,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020528Orig1s025ltr.pdf","2017-08-04 00:00:00",
41417,3,20533,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-533s002_Naropin.cfm","2004-06-28 00:00:00",
2679,1,20533,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20533s012ltr.pdf","2004-08-12 00:00:00",
12690,2,20533,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf","2004-08-12 00:00:00",
25128,1,20533,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020533s014LTR.pdf","2006-08-11 00:00:00",
34787,2,20533,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020533s014lbl.pdf","2006-08-09 00:00:00",
25129,1,20533,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf","2010-02-25 00:00:00",
34788,2,20533,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf","2010-02-25 00:00:00",
2680,1,20533,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf","2010-02-25 00:00:00",
12691,2,20533,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf","2010-02-25 00:00:00",
2681,1,20533,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020533Orig1s026ltr.pdf","2014-10-30 00:00:00",
34789,2,20533,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s028lbl.pdf","2013-01-07 00:00:00",
34790,2,20533,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s029lbl.pdf","2012-11-15 00:00:00",
52705,1,20533,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020533Orig1s034ltr.pdf","2018-02-23 00:00:00",
25130,1,20536,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20536slr010ltr.pdf","2002-07-23 00:00:00",
2682,1,20538,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_appltr.pdf","1999-01-08 00:00:00",
12692,2,20538,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf","1999-01-08 00:00:00",
20708,3,20538,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538S6.cfm","1999-01-08 00:00:00",
2683,1,20538,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf","2002-05-03 00:00:00",
34791,2,20538,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf","2002-05-03 00:00:00",
2684,1,20538,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf","2002-05-03 00:00:00",
34792,2,20538,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf","2002-05-03 00:00:00",
2685,1,20538,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf","2002-05-03 00:00:00",
34793,2,20538,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf","2002-05-03 00:00:00",
41418,3,20538,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020538_s015_VivelleTOC.cfm","2006-05-16 00:00:00",
12693,2,20538,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf","2004-02-03 00:00:00",
25131,1,20538,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538slr019ltr.pdf","2004-02-02 00:00:00",
12694,2,20538,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf","2004-08-10 00:00:00",
25132,1,20538,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538s024ltr.pdf","2004-08-10 00:00:00",
25133,1,20538,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf","2013-05-21 00:00:00",
34794,2,20538,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf","2013-05-21 00:00:00",
2686,1,20538,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf","2013-05-21 00:00:00",
34795,2,20538,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf","2013-05-21 00:00:00",
12695,2,20538,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf","2013-05-21 00:00:00",
25134,1,20538,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf","2013-05-21 00:00:00",
2687,1,20538,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020538Orig1s032ltr.pdf","2014-08-01 00:00:00",
12696,2,20538,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf","2014-08-01 00:00:00",
50287,2,20538,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf","2017-11-03 00:00:00",
25135,1,20539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf","2001-05-03 00:00:00",
25136,1,20539,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf","2001-04-13 00:00:00",
2688,1,20539,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf","2004-02-02 00:00:00",
34796,2,20539,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf","2004-02-03 00:00:00",
2689,1,20539,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf","2010-12-06 00:00:00",
34797,2,20539,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf","2010-12-04 00:00:00",
2690,1,20539,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf","2011-03-31 00:00:00",
34798,2,20539,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf","2011-04-01 00:00:00",
25137,1,20539,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s020ltr.pdf","2011-11-08 00:00:00",
34799,2,20539,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf","2012-03-22 00:00:00",
2691,1,20539,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf","2012-04-27 00:00:00",
34800,2,20539,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf","2012-05-02 00:00:00",
2692,1,20539,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf","2013-06-18 00:00:00",
34801,2,20539,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf","2013-06-17 00:00:00",
12697,2,20539,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf","2013-10-25 00:00:00",
25138,1,20539,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf","2013-10-25 00:00:00",
45232,1,20539,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020539Orig1s026ltr.pdf","2016-08-23 00:00:00",
45402,2,20539,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf","2016-09-28 00:00:00",
46949,2,20539,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf","2017-01-24 00:00:00",
46956,1,20539,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020539Orig1s029,022071Orig1s013ltr.pdf","2017-01-24 00:00:00",
25139,1,20541,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541slr005,009ltr.pdf","2002-10-07 00:00:00",
2693,1,20541,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20541S06LTR.PDF","2000-09-01 00:00:00",
12698,2,20541,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf","2000-09-01 00:00:00",
41419,3,20541,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex.cfm","2004-05-27 00:00:00",
12699,2,20541,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf","2002-09-05 00:00:00",
25140,1,20541,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541se1-010ltr.pdf","2002-09-05 00:00:00",
41420,3,20541,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-541s010_Arimidex.cfm","2003-07-08 00:00:00",
2694,1,20541,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20541s015ltr.pdf","2004-09-03 00:00:00",
34802,2,20541,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf","2004-09-03 00:00:00",
2695,1,20541,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020541s016ltr.pdf","2005-09-22 00:00:00",
12700,2,20541,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf","2005-09-22 00:00:00",
25141,1,20541,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf","2008-12-18 00:00:00",
34803,2,20541,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf","2009-01-02 00:00:00",
53731,3,20541,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/20541Org1s020.pdf","2018-04-18 00:00:00",
12701,2,20541,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf","2009-01-02 00:00:00",
54291,3,20541,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s021.pdf","2018-05-22 00:00:00",
25142,1,20541,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf","2008-12-18 00:00:00",
34804,2,20541,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf","2009-01-02 00:00:00",
54292,3,20541,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s023.pdf","2018-05-22 00:00:00",
2696,1,20541,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf","2009-05-06 00:00:00",
12702,2,20541,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf","2009-05-11 00:00:00",
12703,2,20541,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf","2009-05-11 00:00:00",
25143,1,20541,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf","2009-05-06 00:00:00",
25144,1,20541,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020541s026ltr.pdf","2011-04-20 00:00:00",
34805,2,20541,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf","2011-04-18 00:00:00",
2697,1,20541,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020541Orig1s027ltr.pdf","2013-05-07 00:00:00",
12704,2,20541,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf","2013-05-09 00:00:00",
54293,3,20541,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s027.pdf","2018-05-22 00:00:00",
2698,1,20541,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020541Orig1s029ltr.pdf","2014-05-06 00:00:00",
12705,2,20541,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf","2014-05-06 00:00:00",
12706,2,20544,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20544se2-003_jadelle_lbl.pdf","2002-11-22 00:00:00",
25145,1,20544,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20544se2-003ltr.pdf","2002-11-22 00:00:00",
46482,1,20544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020544Orig1s010ltr.pdf","2016-12-22 00:00:00",
46961,2,20544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020544s010lbl.pdf","2017-01-24 00:00:00",
20709,3,20545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020545_procanbid_toc.cfm","2003-08-07 00:00:00",
20710,3,20545,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20545s007_Procanbid.cfm","2004-07-15 00:00:00",
25146,1,20545,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20545scm007.pdf","2002-07-11 00:00:00",
2699,1,20547,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20547s07ltr.pdf","1999-09-17 00:00:00",
20711,3,20547,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-547-S007_Accolate.cfm","2004-04-14 00:00:00",
20712,3,20547,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20547-s008_accolate.pdf","2004-05-25 00:00:00",
41421,3,20547,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20547-S011_Accolate.pdf","2004-05-25 00:00:00",
2700,1,20547,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20547s014ltr.pdf","2003-07-29 00:00:00",
25147,1,20547,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20547slr017ltr.pdf","2004-05-25 00:00:00",
34806,2,20547,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf","2004-04-05 00:00:00",
25148,1,20547,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020547s022ltr.pdf","2005-06-08 00:00:00",
34807,2,20547,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf","2005-06-08 00:00:00",
25149,1,20547,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020547s025ltr.pdf","2008-06-02 00:00:00",
2701,1,20547,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020547s027ltr.pdf","2009-11-19 00:00:00",
12707,2,20547,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf","2009-08-28 00:00:00",
12708,2,20547,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf","2010-07-19 00:00:00",
25150,1,20547,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s029ltr.pdf","2010-07-15 00:00:00",
2702,1,20547,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s030ltr.pdf","2010-10-19 00:00:00",
34808,2,20547,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf","2010-10-19 00:00:00",
12709,2,20547,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf","2011-08-08 00:00:00",
25151,1,20547,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020547s031ltr.pdf","2011-08-10 00:00:00",
25152,1,20547,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020547Orig1s033ltr.pdf","2013-11-18 00:00:00",
34809,2,20547,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf","2013-11-22 00:00:00",
51948,23,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020548s000_fluticasone propionate_WR.pdf","1900-01-01 00:00:00",
51950,26,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020548s000_fluticasone propionate_WR_Amend2.pdf","1900-01-01 00:00:00",
51951,20,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-MedRev-BPCA.pdf","1900-01-01 00:00:00",
51952,60,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_DD summary review_BPCA.pdf","1900-01-01 00:00:00",
51953,20,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_TL Summary review_BPCA.pdf","1900-01-01 00:00:00",
51954,18,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-ClinPharmRev-BPCA.pdf","1900-01-01 00:00:00",
51955,18,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_clinpharm review2_BPCA.pdf","1900-01-01 00:00:00",
51956,17,20548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20548s018_fluticasone propionate_Flovent-StatsRev-BPCA.pdf","1900-01-01 00:00:00",
20713,3,20548,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf","1998-12-22 00:00:00",
25153,1,20548,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr016,015ltr.pdf","2003-07-06 00:00:00",
34810,2,20548,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf","2003-07-08 00:00:00",
2703,1,20548,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr019LTR.pdf","2003-10-16 00:00:00",
12710,2,20548,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf","2003-10-16 00:00:00",
12711,2,20548,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf","2004-04-05 00:00:00",
25154,1,20548,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf","2004-04-07 00:00:00",
41422,3,20549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020549ap.pdf","1997-11-07 00:00:00",
41423,3,20549,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf","1998-12-22 00:00:00",
41424,3,20549,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20549-S006_Flovent.pdf","1999-07-19 00:00:00",
2704,1,20549,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr012ltr.pdf","2003-07-06 00:00:00",
34811,2,20549,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr012_flovent_lbl.pdf","2003-07-08 00:00:00",
12712,2,20549,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pdf","2003-10-16 00:00:00",
20714,3,20549,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf","2004-06-04 00:00:00",
25155,1,20549,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr014ltr.pdf","2003-10-16 00:00:00",
2705,1,20549,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf","2004-04-07 00:00:00",
34812,2,20549,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf","2004-04-05 00:00:00",
52378,23,20550,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020550_Valacyclovir_hydrochloride_WR.pdf","1900-01-01 00:00:00",
52379,25,20550,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020550_Valacyclovir_Hydrochloride_Caplets_WR.pdf","1900-01-01 00:00:00",
20715,3,20550,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020550ap.pdf","1997-09-26 00:00:00",
2706,1,20550,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-005ltr.pdf","2003-04-18 00:00:00",
12713,2,20550,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf","2003-04-01 00:00:00",
12714,2,20550,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf","2003-04-25 00:00:00",
12715,2,20550,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf","2003-04-25 00:00:00",
20716,3,20550,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir.cfm","2004-06-14 00:00:00",
25156,1,20550,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir%20hydrochloride_Approv.pdf","2004-06-29 00:00:00",
12716,2,20550,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf","2003-04-25 00:00:00",
2707,1,20550,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20550se1-016ltr.pdf","2002-09-09 00:00:00",
25157,1,20550,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-019ltr.pdf","2003-09-09 00:00:00",
34813,2,20550,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s019lbl.pdf","2003-08-29 00:00:00",
25158,1,20550,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550slr021ltr.pdf","2003-08-15 00:00:00",
25159,1,20551,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20551se8-009ltr.pdf","2003-07-28 00:00:00",
2708,1,20551,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20551s010ltr.pdf","2002-06-04 00:00:00",
25160,1,20551,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s017ltr.pdf","2010-06-08 00:00:00",
2709,1,20551,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s019ltr.pdf","2010-11-30 00:00:00",
34814,2,20551,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020551s019lbl.pdf","2010-11-22 00:00:00",
55019,2,20551,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020551s020,s26lbl.pdf","2018-07-27 00:00:00",
55039,1,20551,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020551Orig1s020s026Ltr.pdf","2018-07-30 00:00:00",
55020,2,20551,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020551s020,s26lbl.pdf","2018-07-27 00:00:00",
55040,1,20551,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020551Orig1s020s026Ltr.pdf","2018-07-30 00:00:00",
2710,1,20552,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20552slr002ltr.pdf","2004-06-02 00:00:00",
2711,1,20552,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020552s005ltr.pdf","2009-07-07 00:00:00",
12717,2,20552,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf","2009-06-30 00:00:00",
2712,1,20552,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020552s006ltr.pdf","2010-04-21 00:00:00",
34815,2,20552,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020552s006lbl.pdf","2010-04-30 00:00:00",
2713,1,20552,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020552s007ltr.pdf","2011-11-07 00:00:00",
12718,2,20552,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf","2011-11-04 00:00:00",
45231,1,20552,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020552Orig1s009ltr.pdf","2016-08-24 00:00:00",
49763,2,20552,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020552s010lbl.pdf","2017-09-18 00:00:00",
49782,1,20552,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020552Orig1s010ltr.pdf","2017-09-19 00:00:00",
25161,1,20554,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf","2005-05-02 00:00:00",
34816,2,20554,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf","2005-05-02 00:00:00",
2714,1,20554,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf","2007-10-04 00:00:00",
34817,2,20554,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf","2007-10-04 00:00:00",
2715,1,20554,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf","2015-03-13 00:00:00",
34818,2,20554,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf","2015-03-17 00:00:00",
2716,1,20555,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_Approv.pdf","1998-04-01 00:00:00",
20717,3,20555,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555S003_AxidAr.cfm","2004-05-27 00:00:00",
34819,2,20555,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf","1998-04-01 00:00:00",
12719,2,20555,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf","1998-04-01 00:00:00",
25162,1,20555,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_Approv.pdf","1998-04-01 00:00:00",
41425,3,20555,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555S003_AxidAr.cfm","2004-05-27 00:00:00",
2717,1,20555,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20555s006ltr.pdf","2004-10-29 00:00:00",
23163,8,20560,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf","2013-05-09 00:00:00",
44058,10,20560,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
51761,23,20560,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020560_alendronate - Fosamax Orig_WR.pdf","1900-01-01 00:00:00",
51762,40,20560,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020560_alendronate - Fosamax Amend_WR.pdf","1900-01-01 00:00:00",
51763,20,20560,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020560_alendronate - Fosamax NDA Medical Rev.pdf","1900-01-01 00:00:00",
51764,18,20560,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020560_alendronate - Fosamax NDA Clin Pharm Rev.pdf","1900-01-01 00:00:00",
51765,17,20560,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020560_alendronate - Fosamax NDA Stat Rev.pdf","1900-01-01 00:00:00",
20718,3,20560,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf","1997-04-25 00:00:00",
41426,3,20560,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf","1997-04-25 00:00:00",
25163,1,20560,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560s12ltr.pdf","1999-06-16 00:00:00",
34820,2,20560,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20560s12lbl.pdf","1999-06-16 00:00:00",
41427,3,20560,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S12_Fosamax.cfm","1999-06-16 00:00:00",
2718,1,20560,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_appltr.pdf","1999-06-08 00:00:00",
12720,2,20560,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf","1999-06-08 00:00:00",
20719,3,20560,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax.cfm","1999-06-08 00:00:00",
41428,3,20560,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S014_FOSAMAX TABLETS.pdf","2008-08-08 00:00:00",
2719,1,20560,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF","1999-11-24 00:00:00",
20720,3,20560,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S15_fosamax.cfm","2003-04-30 00:00:00",
41429,3,20560,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S016_FOSAMAX.pdf","2007-11-19 00:00:00",
2720,1,20560,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF","1999-11-24 00:00:00",
20721,3,20560,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S18_fosamax.cfm","2003-04-30 00:00:00",
41430,3,20560,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S019_FOSAMAX_TABLETS.pdf","2008-08-08 00:00:00",
20722,3,20560,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S020_FOSAMAX.pdf","2007-11-19 00:00:00",
2721,1,20560,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf","2000-10-20 00:00:00",
12721,2,20560,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf","2000-10-20 00:00:00",
25164,1,20560,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf","2000-10-20 00:00:00",
34821,2,20560,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf","2000-10-20 00:00:00",
25165,1,20560,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S23ltr.pdf","2000-09-29 00:00:00",
2722,1,20560,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf","2001-01-31 00:00:00",
34822,2,20560,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf","2001-01-31 00:00:00",
25166,1,20560,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf","2001-01-31 00:00:00",
34823,2,20560,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf","2001-01-31 00:00:00",
2723,1,20560,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560slr028ltr.pdf","2002-09-16 00:00:00",
20723,3,20560,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s028_FOSAMAX TABS.pdf","2008-08-01 00:00:00",
34824,2,20560,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s28lbl.pdf","2002-09-16 00:00:00",
41431,3,20560,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_S029_FOSAMAX.pdf","2007-11-19 00:00:00",
12722,2,20560,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf","2004-05-04 00:00:00",
25167,1,20560,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf","2004-04-29 00:00:00",
20724,3,20560,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s031_FOSAMAX_TABLETS.pdf","2008-08-01 00:00:00",
34825,2,20560,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s31lbl.pdf","2002-07-25 00:00:00",
20725,3,20560,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_s032_FOSAMAX_TABLETS.pdf","2008-08-04 00:00:00",
20726,3,20560,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s033_FOSAMAX TABS.pdf","2008-08-01 00:00:00",
25168,1,20560,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp033ltr.pdf","2002-08-13 00:00:00",
2724,1,20560,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp036ltr.pdf","2002-08-05 00:00:00",
20727,3,20560,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s036_FOSAMAX_TABLETS.pdf","2008-08-01 00:00:00",
34826,2,20560,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s36lbl.pdf","2002-08-05 00:00:00",
20728,3,20560,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020560_s037_FOSAMAX TABS.pdf","2008-08-01 00:00:00",
25169,1,20560,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr037ltr.pdf","2003-03-26 00:00:00",
25170,1,20560,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007ltr.pdf","2006-01-06 00:00:00",
34827,2,20560,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020560s038_021575s007lbl.pdf","2006-01-05 00:00:00",
25171,1,20560,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr040ltr.pdf","2003-09-29 00:00:00",
34828,2,20560,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20560slr040_fosamax_lbl.pdf","2003-09-25 00:00:00",
12723,2,20560,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf","2004-05-03 00:00:00",
25172,1,20560,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf","2004-04-20 00:00:00",
41432,3,20560,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_s041_FOSAMAX TABS.pdf","2008-07-31 00:00:00",
2725,1,20560,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf","2004-03-03 00:00:00",
12724,2,20560,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf","2004-04-05 00:00:00",
20729,3,20560,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf","2007-07-06 00:00:00",
12725,2,20560,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf","2004-12-08 00:00:00",
25173,1,20560,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf","2004-12-08 00:00:00",
2726,1,20560,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf","2004-12-08 00:00:00",
34829,2,20560,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf","2004-12-08 00:00:00",
2727,1,20560,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf","2005-11-08 00:00:00",
12726,2,20560,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf","2005-11-03 00:00:00",
25174,1,20560,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
34830,2,20560,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
2728,1,20560,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
12727,2,20560,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
12728,2,20560,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
25175,1,20560,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
25176,1,20560,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf","2008-10-09 00:00:00",
34831,2,20560,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf","2008-11-07 00:00:00",
2729,1,20560,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
34832,2,20560,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
2730,1,20560,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf","2012-02-08 00:00:00",
12729,2,20560,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf","2012-02-06 00:00:00",
25177,1,20560,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
34833,2,20560,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
25178,1,20560,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf","2011-01-28 00:00:00",
34834,2,20560,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf","2011-01-26 00:00:00",
25179,1,20560,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf","2011-07-06 00:00:00",
25180,1,20560,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s062ltr.pdf","2012-06-28 00:00:00",
34835,2,20560,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s062lbl.pdf","2012-06-28 00:00:00",
12730,2,20560,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf","2013-04-23 00:00:00",
25181,1,20560,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf","2013-04-23 00:00:00",
25182,1,20560,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf","2013-12-26 00:00:00",
34836,2,20560,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf","2013-12-24 00:00:00",
25183,1,20560,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf","2015-04-13 00:00:00",
34837,2,20560,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf","2015-04-10 00:00:00",
2731,1,20560,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf","2015-12-01 00:00:00",
34838,2,20560,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf","2015-12-01 00:00:00",
41433,3,20563,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf","1997-07-16 00:00:00",
41434,3,20563,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
2732,1,20563,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF","2000-04-04 00:00:00",
12731,2,20563,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF","2000-04-04 00:00:00",
2733,1,20563,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF","2000-04-04 00:00:00",
34839,2,20563,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF","2000-04-04 00:00:00",
12732,2,20563,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF","2000-04-04 00:00:00",
25184,1,20563,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF","2000-04-04 00:00:00",
2734,1,20563,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF","2000-04-04 00:00:00",
34840,2,20563,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF","2000-04-04 00:00:00",
12733,2,20563,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf","2003-03-11 00:00:00",
25185,1,20563,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf","2004-06-07 00:00:00",
2735,1,20563,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563se3-024ltr.pdf","2004-06-07 00:00:00",
12734,2,20563,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf","2004-06-07 00:00:00",
2736,1,20563,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf","2004-06-07 00:00:00",
12735,2,20563,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf","2003-03-05 00:00:00",
2737,1,20563,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr032ltr.pdf","2003-04-16 00:00:00",
34841,2,20563,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf","2003-04-03 00:00:00",
2738,1,20563,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr036ltr.pdf","2004-01-22 00:00:00",
34842,2,20563,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf","2004-01-22 00:00:00",
2739,1,20563,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr040ltr.pdf","2003-07-06 00:00:00",
34843,2,20563,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf","2003-07-08 00:00:00",
12736,2,20563,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf","2003-10-08 00:00:00",
25186,1,20563,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf","2003-10-09 00:00:00",
25187,1,20563,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm044ltr.pdf","2003-11-25 00:00:00",
34844,2,20563,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf","2004-06-07 00:00:00",
2740,1,20563,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr046ltr.pdf","2004-04-29 00:00:00",
12737,2,20563,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf","2004-05-04 00:00:00",
25188,1,20563,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020563s054ltr.pdf","2005-05-23 00:00:00",
34845,2,20563,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf","2005-05-23 00:00:00",
25189,1,20563,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
2741,1,20563,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf","2007-08-27 00:00:00",
34846,2,20563,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf","2007-08-23 00:00:00",
2742,1,20563,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf","2007-09-11 00:00:00",
12738,2,20563,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf","2007-09-11 00:00:00",
2743,1,20563,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s076ltr.pdf","2007-07-05 00:00:00",
12739,2,20563,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf","2007-06-27 00:00:00",
25190,1,20563,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf","2007-07-24 00:00:00",
34847,2,20563,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf","2007-07-24 00:00:00",
25191,1,20563,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf","2009-03-23 00:00:00",
34848,2,20563,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf","2009-03-17 00:00:00",
2744,1,20563,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf","2011-05-24 00:00:00",
34849,2,20563,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf","2011-05-23 00:00:00",
2745,1,20563,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf","2011-05-24 00:00:00",
12740,2,20563,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf","2011-05-23 00:00:00",
25192,1,20563,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s115ltr.pdf","2013-03-13 00:00:00",
34850,2,20563,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf","2013-03-11 00:00:00",
12741,2,20563,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf","2011-11-16 00:00:00",
12742,2,20563,"SUPPL",123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf","2012-10-15 00:00:00",
25193,1,20563,"SUPPL",123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf","2012-10-16 00:00:00",
12743,2,20563,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf","2015-04-07 00:00:00",
25194,1,20563,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf","2015-03-16 00:00:00",
2746,1,20563,"SUPPL",127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s127ltr.pdf","2013-01-31 00:00:00",
34851,2,20563,"SUPPL",127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf","2013-02-01 00:00:00",
2747,1,20563,"SUPPL",157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s157ltr.pdf","2015-02-27 00:00:00",
34852,2,20563,"SUPPL",157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf","2015-03-02 00:00:00",
12744,2,20563,"SUPPL",163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf","2015-06-15 00:00:00",
25195,1,20563,"SUPPL",163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf","2015-06-15 00:00:00",
46765,2,20563,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf","2017-01-06 00:00:00",
46791,1,20563,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf","2017-01-11 00:00:00",
48665,2,20563,"SUPPL",176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf","2017-06-07 00:00:00",
48670,1,20563,"SUPPL",176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s176ltr.pdf","2017-06-08 00:00:00",
41435,3,20564,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020564_S007_Epivir.pdf","2007-09-26 00:00:00",
25196,1,20564,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF","2001-03-06 00:00:00",
41436,3,20564,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm","2005-01-06 00:00:00",
12745,2,20564,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf","2002-10-08 00:00:00",
25197,1,20564,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf","2002-10-08 00:00:00",
12746,2,20564,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf","2002-06-24 00:00:00",
25198,1,20564,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf","2002-06-24 00:00:00",
2748,1,20564,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf","2002-03-01 00:00:00",
20730,3,20564,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020564_S017_Epivir.pdf","2007-09-26 00:00:00",
12747,2,20564,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf","2003-12-02 00:00:00",
25199,1,20564,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf","2003-11-25 00:00:00",
2749,1,20564,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf","2004-12-02 00:00:00",
12748,2,20564,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf","2004-12-03 00:00:00",
41437,3,20564,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020564_S020_Epivir.pdf","2007-09-26 00:00:00",
25200,1,20564,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf","2004-10-04 00:00:00",
34853,2,20564,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf","2004-10-04 00:00:00",
25201,1,20564,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf","2006-06-20 00:00:00",
34854,2,20564,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf","2006-06-14 00:00:00",
41438,3,20564,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020564_S024_Epivir.pdf","2007-09-26 00:00:00",
2750,1,20564,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020564s026ltr.pdf","2006-10-31 00:00:00",
34855,2,20564,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020564s026lbl.pdf","2006-10-26 00:00:00",
2751,1,20564,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020564s028ltr.pdf","2008-02-07 00:00:00",
34856,2,20564,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020564s028lbl.pdf","2008-02-14 00:00:00",
25202,1,20564,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf","2011-11-22 00:00:00",
34857,2,20564,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf","2011-12-02 00:00:00",
2752,1,20564,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf","2015-03-26 00:00:00",
34858,2,20564,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf","2015-04-14 00:00:00",
51226,20,20564,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinical prea.pdf","1900-01-01 00:00:00",
51227,18,20564,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinpharm prea.pdf","1900-01-01 00:00:00",
51228,17,20564,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir statistical prea.pdf","1900-01-01 00:00:00",
2753,1,20564,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf","2015-02-24 00:00:00",
34859,2,20564,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf","2015-02-20 00:00:00",
25203,1,20564,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf","2015-10-02 00:00:00",
34860,2,20564,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf","2015-10-07 00:00:00",
2754,1,20564,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf","2016-07-22 00:00:00",
34861,2,20564,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf","2016-07-21 00:00:00",
50015,2,20564,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf","2017-10-12 00:00:00",
53921,1,20564,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020564Orig1s038,020596Orig1s037ltr.pdf","2018-05-01 00:00:00",
54028,2,20564,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf","2018-05-07 00:00:00",
25204,1,20570,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020570s004ltr.pdf","2009-05-19 00:00:00",
49828,2,20570,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020570s008lbl.pdf","2017-09-22 00:00:00",
49855,1,20570,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020570Orig1s008ltr.pdf","2017-09-25 00:00:00",
41439,3,20571,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571_S006_CAPTOSAR_AP.pdf","2007-07-06 00:00:00",
20731,3,20571,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571_S007_CAPTOSAR_AP.pdf","2007-07-06 00:00:00",
12749,2,20571,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf","1998-10-22 00:00:00",
25205,1,20571,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20571s8ltr.pdf","1998-10-22 00:00:00",
41440,3,20571,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571s008.cfm","1998-10-22 00:00:00",
25206,1,20571,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20571s9ltr.pdf","2000-04-20 00:00:00",
34862,2,20571,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20571s9lbl.pdf","2000-04-20 00:00:00",
41441,3,20571,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20571-S009_Camptosar.cfm","2000-04-20 00:00:00",
12750,2,20571,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf","2002-05-16 00:00:00",
25207,1,20571,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20571s016ltr.pdf","2002-05-16 00:00:00",
20732,3,20571,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-571s021_Camptosar.cfm","2005-04-05 00:00:00",
25208,1,20571,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20571se8-021ltr.pdf","2004-06-25 00:00:00",
34863,2,20571,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571se8-021_camptosar_lbl.pdf","2004-06-25 00:00:00",
53103,23,20571,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020571s021_irinotecan_WR.pdf","1900-01-01 00:00:00",
53104,20,20571,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020571s021_irinotecan_Campostar- MedRev-2_BPCA.pdf","1900-01-01 00:00:00",
53105,18,20571,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020571s021_irinotecan_Campostar- ClinPharmRev-2_BPCA.pdf","1900-01-01 00:00:00",
25209,1,20571,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20571s023ltr.pdf","2004-12-08 00:00:00",
34864,2,20571,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571s023lbl.pdf","2004-12-08 00:00:00",
2755,1,20571,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf","2005-07-26 00:00:00",
34865,2,20571,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf","2005-07-26 00:00:00",
2756,1,20571,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s026ltr.pdf","2005-06-08 00:00:00",
12751,2,20571,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf","2005-06-08 00:00:00",
2757,1,20571,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf","2005-07-26 00:00:00",
34866,2,20571,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf","2005-07-26 00:00:00",
12752,2,20571,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf","2005-07-26 00:00:00",
25210,1,20571,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf","2005-07-26 00:00:00",
2758,1,20571,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020571s030LTR.pdf","2006-08-04 00:00:00",
34867,2,20571,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020571s030lbl.pdf","2006-08-04 00:00:00",
2759,1,20571,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf","2010-05-21 00:00:00",
12753,2,20571,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf","2010-05-28 00:00:00",
12754,2,20571,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf","2010-05-28 00:00:00",
25211,1,20571,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf","2010-05-21 00:00:00",
2760,1,20571,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf","2010-05-21 00:00:00",
34868,2,20571,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf","2010-05-28 00:00:00",
2761,1,20571,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf","2010-05-21 00:00:00",
34869,2,20571,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf","2010-05-28 00:00:00",
12755,2,20571,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf","2010-05-28 00:00:00",
25212,1,20571,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf","2010-05-21 00:00:00",
25213,1,20571,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020571Orig1s042ltr.pdf","2012-07-17 00:00:00",
34870,2,20571,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020571s042lbl.pdf","2012-07-25 00:00:00",
2762,1,20571,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020571Orig1s048ltr.pdf","2014-12-23 00:00:00",
12756,2,20571,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf","2015-01-09 00:00:00",
12757,2,20572,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf","2009-04-03 00:00:00",
25214,1,20572,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015ltr.pdf","2009-04-03 00:00:00",
12758,2,20573,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf","2009-04-03 00:00:00",
25215,1,20573,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015ltr.pdf","2009-04-03 00:00:00",
20733,3,20574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-574_GyneLotrimin.cfm","1998-11-24 00:00:00",
25216,1,20574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20574ltr.pdf","1998-11-24 00:00:00",
34871,2,20574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf","1998-11-24 00:00:00",
2763,1,20574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020574s006ltr.pdf","2010-04-13 00:00:00",
34872,2,20574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf","2010-04-13 00:00:00",
2764,1,20576,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020576s008ltr.pdf","2006-03-01 00:00:00",
34873,2,20576,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf","2006-02-28 00:00:00",
2765,1,20576,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020576s010ltr.pdf","2010-04-08 00:00:00",
12759,2,20576,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf","2010-04-05 00:00:00",
23584,10,20578,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
12760,2,20578,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf","1998-07-27 00:00:00",
25217,1,20578,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf","1998-07-27 00:00:00",
41442,3,20578,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.cfm","1998-07-27 00:00:00",
2766,1,20578,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20578s13ltr.pdf","2002-02-05 00:00:00",
25218,1,20578,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf","2002-02-28 00:00:00",
2767,1,20578,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf","2004-06-25 00:00:00",
25219,1,20578,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf","2005-10-25 00:00:00",
2768,1,20578,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf","2010-01-20 00:00:00",
34874,2,20578,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf","2009-09-17 00:00:00",
2769,1,20578,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf","2010-01-20 00:00:00",
12761,2,20578,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf","2009-09-17 00:00:00",
25220,1,20578,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf","2010-01-20 00:00:00",
34875,2,20578,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf","2009-09-17 00:00:00",
2770,1,20578,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf","2011-01-20 00:00:00",
12762,2,20578,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf","2011-01-20 00:00:00",
2771,1,20578,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf","2013-06-20 00:00:00",
12763,2,20578,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf","2013-06-17 00:00:00",
2772,1,20578,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf","2013-06-20 00:00:00",
12764,2,20578,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf","2013-06-17 00:00:00",
2773,1,20578,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf","2014-10-09 00:00:00",
12765,2,20578,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf","2014-10-09 00:00:00",
25221,1,20578,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf","2015-02-17 00:00:00",
34876,2,20578,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf","2015-02-13 00:00:00",
41443,3,20579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020579_s000.pdf","2010-03-16 00:00:00",
2774,1,20579,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020579s016ltr.pdf","2005-10-25 00:00:00",
34877,2,20579,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf","2005-10-24 00:00:00",
2775,1,20579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s020ltr.pdf","2007-01-16 00:00:00",
12766,2,20579,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf","2007-01-16 00:00:00",
12767,2,20579,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf","2007-02-21 00:00:00",
25222,1,20579,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s021ltr.pdf","2007-02-23 00:00:00",
2776,1,20579,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s023ltr.pdf","2008-05-05 00:00:00",
25223,1,20579,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s024ltr.pdf","2008-12-04 00:00:00",
2777,1,20579,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s025ltr.pdf","2009-11-19 00:00:00",
12768,2,20579,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf","2009-10-30 00:00:00",
12769,2,20579,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf","2010-01-04 00:00:00",
25224,1,20579,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s026ltr.pdf","2009-12-29 00:00:00",
2778,1,20579,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020579s027ltr.pdf","2011-07-27 00:00:00",
12770,2,20579,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf","2011-07-27 00:00:00",
25225,1,20579,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s028ltr.pdf","2014-07-24 00:00:00",
34878,2,20579,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf","2014-07-24 00:00:00",
2779,1,20579,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf","2014-10-22 00:00:00",
34879,2,20579,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf","2014-10-21 00:00:00",
52352,23,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Original_WR.pdf","2009-09-17 00:00:00",
52353,25,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_1.pdf","2009-09-17 00:00:00",
52354,26,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_2.pdf","2009-09-17 00:00:00",
52355,27,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_3.pdf","2009-09-17 00:00:00",
52929,17,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Statistical_BPCA.pdf","2009-09-17 00:00:00",
52930,18,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Clinpharm_BPCA.pdf","2009-09-17 00:00:00",
52931,20,20579,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Clinical_BPCA.pdf","2009-09-17 00:00:00",
20734,3,20582,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020582s001_follistim_toc.cfm","2003-08-07 00:00:00",
25226,1,20582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU%20AND%20150IU%20VIALS_APPROV.PDF","1997-09-29 00:00:00",
25227,1,20582,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20582-S001_FOLLISTIM_APPROV.PDF","2004-06-04 00:00:00",
41444,3,20582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020582_follistim_toc.cfm","2003-08-07 00:00:00",
25228,1,20582,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20582-S002_FOLLISTIM_APPROV.PDF","2004-06-04 00:00:00",
41445,3,20582,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020582s002_follistim_toc.cfm","2003-08-07 00:00:00",
2780,1,20582,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20582s6ltr.pdf","2002-02-07 00:00:00",
12771,2,20582,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf","2002-02-07 00:00:00",
25229,1,20583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20583ltr.pdf","1998-03-09 00:00:00",
34880,2,20583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20583lbl.pdf","1998-03-09 00:00:00",
41446,3,20583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20583_Lotemax.cfm","2002-04-09 00:00:00",
20735,3,20583,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s027.pdf","2015-11-18 00:00:00",
20736,3,20583,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s028.pdf","2015-11-18 00:00:00",
41447,3,20584,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-584S001.pdf","2003-09-11 00:00:00",
20737,3,20584,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine.cfm","2001-07-18 00:00:00",
25230,1,20584,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_Approv.pdf","1999-05-27 00:00:00",
34881,2,20584,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_prntlbl.pdf","1999-05-27 00:00:00",
2781,1,20584,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf","2005-05-26 00:00:00",
34882,2,20584,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf","2005-05-26 00:00:00",
12772,2,20584,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_prntlbl.pdf","2000-08-11 00:00:00",
20738,3,20584,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_LodineXL.cfm","2001-11-09 00:00:00",
25231,1,20584,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_Approv.pdf","2000-08-11 00:00:00",
2782,1,20584,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf","2005-05-26 00:00:00",
34883,2,20584,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf","2005-05-26 00:00:00",
12773,2,20584,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf","2005-05-26 00:00:00",
25232,1,20584,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf","2005-05-26 00:00:00",
25233,1,20584,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009ltr.pdf","2006-01-20 00:00:00",
34884,2,20584,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf","2006-01-20 00:00:00",
2783,1,20586,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20586-S004%20AP%20ltr.pdf","2003-07-24 00:00:00",
34885,2,20586,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf","2003-04-25 00:00:00",
41448,3,20586,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-586s004_Pranactin.cfm","2004-07-15 00:00:00",
20739,3,20587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020587_sclerosol_toc.cfm","2003-08-07 00:00:00",
34886,2,20587,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020587s006lbl.pdf","2012-10-22 00:00:00",
23585,10,20588,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-20 00:00:00",
20740,3,20588,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf","1997-10-17 00:00:00",
44451,14,20588,"SUPPL",2,"Clinical Pharmacology & Biopharmaceutics Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.htm","2004-11-02 00:00:00",
20741,3,20588,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020588_s004_RISPERDAL TABLETS.pdf","2009-09-16 00:00:00",
25234,1,20588,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf","2002-03-03 00:00:00",
2784,1,20588,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf","1999-07-02 00:00:00",
34887,2,20588,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf","1999-07-02 00:00:00",
2785,1,20588,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf","2002-11-19 00:00:00",
2786,1,20588,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf","2003-11-28 00:00:00",
2787,1,20588,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
34888,2,20588,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
2788,1,20588,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
12774,2,20588,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
25235,1,20588,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf","2003-09-25 00:00:00",
41449,3,20588,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020588_S021_RISPERDAL_TABLETS.pdf","2008-02-19 00:00:00",
2789,1,20588,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf","2003-11-25 00:00:00",
25236,1,20588,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
34889,2,20588,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
41450,3,20588,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
2790,1,20588,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
12775,2,20588,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
41451,3,20588,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020588s028.pdf020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
25237,1,20588,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
34890,2,20588,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
25238,1,20588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf","2005-08-19 00:00:00",
34891,2,20588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf","2005-08-19 00:00:00",
12776,2,20588,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
25239,1,20588,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
41452,3,20588,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
2791,1,20588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
12777,2,20588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
20742,3,20588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
25240,1,20588,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf","2008-08-19 00:00:00",
2792,1,20588,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
34892,2,20588,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf","2010-08-30 00:00:00",
2793,1,20588,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf","2009-08-06 00:00:00",
12778,2,20588,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf","2009-08-06 00:00:00",
2794,1,20588,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
34893,2,20588,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf","2010-08-30 00:00:00",
2795,1,20588,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf","2011-08-26 00:00:00",
12779,2,20588,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf","2011-08-25 00:00:00",
25241,1,20588,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
34894,2,20588,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
2796,1,20588,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
34895,2,20588,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf","2010-08-30 00:00:00",
12780,2,20588,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf","2010-08-30 00:00:00",
25242,1,20588,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
12781,2,20588,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf","2010-12-04 00:00:00",
25243,1,20588,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf","2010-12-06 00:00:00",
25244,1,20588,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf","2011-06-17 00:00:00",
34896,2,20588,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf","2011-06-16 00:00:00",
2797,1,20588,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf","2012-08-03 00:00:00",
34897,2,20588,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf","2012-08-03 00:00:00",
2798,1,20588,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
12782,2,20588,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
25245,1,20588,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf","2012-03-13 00:00:00",
2799,1,20588,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf","2014-05-09 00:00:00",
12783,2,20588,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf","2014-04-29 00:00:00",
25246,1,20588,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
34898,2,20588,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf","2016-03-03 00:00:00",
47319,2,20588,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf","2017-02-24 00:00:00",
47421,1,20588,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf","2017-03-02 00:00:00",
55051,1,20588,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf","2018-07-30 00:00:00",
55145,2,20588,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf","2018-08-09 00:00:00",
12784,2,20589,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf","2003-04-25 00:00:00",
2800,1,20589,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20589s017ltr.pdf","2005-03-23 00:00:00",
34899,2,20589,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf","2005-03-23 00:00:00",
25247,1,20589,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020589s019ltr.pdf","2005-12-15 00:00:00",
2801,1,20589,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020589s023ltr.pdf","2008-06-16 00:00:00",
25248,1,20589,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020589s024ltr.pdf","2009-05-26 00:00:00",
25249,1,20589,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020589s026ltr.pdf","2010-09-07 00:00:00",
12785,2,20589,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf","2014-01-13 00:00:00",
25250,1,20589,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020589Orig1s029ltr.pdf","2013-12-24 00:00:00",
47666,1,20589,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20589Orig1s034ltr.pdf","2017-03-24 00:00:00",
47702,2,20589,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf","2017-03-24 00:00:00",
48798,1,20589,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020589Orig1s035ltr.pdf","2017-06-22 00:00:00",
48843,2,20589,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf","2017-06-27 00:00:00",
55368,2,20589,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf","2018-08-30 00:00:00",
2802,1,20591,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020591s011ltr.pdf","2008-03-04 00:00:00",
2803,1,20591,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s012ltr.pdf","2011-08-31 00:00:00",
12786,2,20591,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf","2011-08-29 00:00:00",
25251,1,20591,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020591s016ltr.pdf","2009-03-06 00:00:00",
25252,1,20591,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s018ltr.pdf","2011-09-16 00:00:00",
34900,2,20591,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf","2011-09-16 00:00:00",
2804,1,20591,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s019ltr.pdf","2011-11-16 00:00:00",
34901,2,20591,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf","2011-11-14 00:00:00",
12787,2,20591,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf","2012-01-23 00:00:00",
25253,1,20591,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf","2012-01-30 00:00:00",
25254,1,20591,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020591Orig1s021ltr.pdf","2012-09-14 00:00:00",
34902,2,20591,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf","2012-09-14 00:00:00",
2805,1,20591,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020591Orig1s025ltr.pdf","2014-12-30 00:00:00",
12788,2,20591,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf","2015-01-08 00:00:00",
2806,1,20591,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s026ltr.pdf","2016-02-01 00:00:00",
34903,2,20591,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf","2016-02-02 00:00:00",
12789,2,20591,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf","2016-07-13 00:00:00",
25255,1,20591,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s027ltr.pdf","2016-07-13 00:00:00",
49238,2,20591,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020591s029lbl.pdf","2017-08-04 00:00:00",
49246,1,20591,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020591Orig1s029ltr.pdf","2017-08-04 00:00:00",
20743,3,20592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020592_Original_Approval_Pkg .pdf","2007-11-19 00:00:00",
44059,10,20592,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
20744,3,20592,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_S006_ZUPREXA_ORAL_TABS_AP.pdf","2007-04-11 00:00:00",
44452,14,20592,"SUPPL",6,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_s006_zyprexa oral tablets.pdf","2011-01-07 00:00:00",
41453,3,20592,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-592S011_review.pdf","2004-04-15 00:00:00",
2807,1,20592,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20592se1-018ltr.pdf","2003-07-28 00:00:00",
34904,2,20592,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20592s18lbl_Zyprexa.pdf","2003-07-10 00:00:00",
41454,3,20592,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020592_S018_ZYPREXA_AP.pdf","2007-07-06 00:00:00",
2808,1,20592,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20592se1-019ltr.pdf","2004-01-22 00:00:00",
12790,2,20592,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf","2004-01-22 00:00:00",
20745,3,20592,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020592_s019_Zyprexa.pdf","2009-09-16 00:00:00",
25256,1,20592,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s020ltr.pdf","2005-06-29 00:00:00",
25257,1,20592,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s026ltr.pdf","2005-08-08 00:00:00",
12791,2,20592,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf","2006-02-22 00:00:00",
25258,1,20592,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf","2006-02-22 00:00:00",
2809,1,20592,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf","2006-09-18 00:00:00",
34905,2,20592,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf","2006-08-29 00:00:00",
2810,1,20592,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf","2006-02-22 00:00:00",
12792,2,20592,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf","2006-02-22 00:00:00",
2811,1,20592,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf","2005-09-15 00:00:00",
20746,3,20592,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020592_s034_Zyprexa Tabs.pdf","2009-09-16 00:00:00",
2812,1,20592,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf","2006-03-01 00:00:00",
34906,2,20592,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf","2006-02-28 00:00:00",
41455,3,20592,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020592Orig1s035.pdf","2012-03-16 00:00:00",
25259,1,20592,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf","2006-12-28 00:00:00",
34907,2,20592,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf","2006-12-04 00:00:00",
20747,3,20592,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/Zyprexa_20592s39_toc.cfm","2012-03-16 00:00:00",
34908,2,20592,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf","2009-03-20 00:00:00",
12793,2,20592,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf","2009-12-10 00:00:00",
25260,1,20592,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf","2010-01-26 00:00:00",
41456,3,20592,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm","2011-06-30 00:00:00",
52109,20,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592s040_olanzapine_Zyprexa_MedR_PREA.pdf","1900-01-01 00:00:00",
52110,20,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592s040_olanzapine_Zyprexa_MedR(2)_PREA.pdf","1900-01-01 00:00:00",
52111,18,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592s040_olanzapine_Zyprexa_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
52113,18,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592s040_olanzapine_Zyprexa_ClinPharm(2)_PREA.pdf","1900-01-01 00:00:00",
52114,17,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592s040_olanzapine_Zyprexa_StatR_PREA.pdf","1900-01-01 00:00:00",
52115,23,20592,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020592_olanzapine_Zyprexa_WR.pdf","1900-01-01 00:00:00",
2813,1,20592,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf","2010-01-26 00:00:00",
12794,2,20592,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf","2009-12-10 00:00:00",
20748,3,20592,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm","2011-06-30 00:00:00",
2814,1,20592,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf","2007-07-10 00:00:00",
12795,2,20592,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf","2007-07-10 00:00:00",
12796,2,20592,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf","2007-07-10 00:00:00",
25261,1,20592,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf","2007-07-10 00:00:00",
2815,1,20592,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf","2008-08-19 00:00:00",
20749,3,20592,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020592Orig1s049.pdf","2012-01-27 00:00:00",
25262,1,20592,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf","2009-11-19 00:00:00",
34909,2,20592,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf","2009-09-17 00:00:00",
25263,1,20592,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf","2010-02-01 00:00:00",
34910,2,20592,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf","2010-01-29 00:00:00",
25264,1,20592,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
34911,2,20592,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
41457,3,20592,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s053.pdf","2012-03-16 00:00:00",
2816,1,20592,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
34912,2,20592,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
41458,3,20592,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s055.pdf","2012-03-16 00:00:00",
12797,2,20592,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf","2010-12-04 00:00:00",
25265,1,20592,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf","2010-12-06 00:00:00",
12798,2,20592,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf","2011-06-29 00:00:00",
25266,1,20592,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf","2011-06-27 00:00:00",
25267,1,20592,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf","2011-06-27 00:00:00",
34913,2,20592,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf","2011-06-29 00:00:00",
2817,1,20592,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf","2014-12-23 00:00:00",
12799,2,20592,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf","2015-01-09 00:00:00",
2818,1,20592,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
12800,2,20592,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf","2013-07-30 00:00:00",
34914,2,20592,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf","2015-07-24 00:00:00",
45532,1,20592,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf","2016-10-14 00:00:00",
45600,2,20592,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf","2016-10-07 00:00:00",
47346,2,20592,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47376,1,20592,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
47347,2,20592,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47377,1,20592,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
53472,2,20592,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf","2018-03-28 00:00:00",
53477,8,20592,"SUPPL",71,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36","2018-03-28 00:00:00",
53520,1,20592,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf","2018-03-29 00:00:00",
44060,10,20593,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
2819,1,20593,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20593s006ltr.pdf","2002-01-24 00:00:00",
12801,2,20593,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20593s006lbl.pdf","2002-01-24 00:00:00",
41459,3,20593,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020593_S006_DEPACON.pdf","2008-02-19 00:00:00",
2820,1,20593,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
25268,1,20593,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020593s011ltr.pdf","2006-01-20 00:00:00",
34915,2,20593,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
2821,1,20593,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
12802,2,20593,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
25269,1,20593,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
34916,2,20593,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf","2011-10-07 00:00:00",
12803,2,20593,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s019lbl.pdf","2014-06-23 00:00:00",
25270,1,20593,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
2822,1,20593,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
12804,2,20593,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf","2011-10-12 00:00:00",
2823,1,20593,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf","2011-10-13 00:00:00",
12805,2,20593,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf","2011-10-07 00:00:00",
2824,1,20593,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
34917,2,20593,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s025lbl.pdf","2013-03-04 00:00:00",
2825,1,20593,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
34918,2,20593,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s026lbl.pdf","2013-09-17 00:00:00",
34919,2,20593,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s027lbl.pdf","2013-07-02 00:00:00",
25271,1,20593,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
34920,2,20593,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s028lbl.pdf","2014-12-03 00:00:00",
12806,2,20593,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s029lbl.pdf","2015-01-08 00:00:00",
25272,1,20593,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
12807,2,20593,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
25273,1,20593,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
25274,1,20593,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
34921,2,20593,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s031lbl.pdf","2014-08-22 00:00:00",
2826,1,20593,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
34922,2,20593,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s032lbl.pdf","2015-03-17 00:00:00",
2827,1,20593,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
12808,2,20593,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s033lbl.pdf","2015-10-06 00:00:00",
25275,1,20593,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
34923,2,20593,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020593s034lbl.pdf","2016-02-23 00:00:00",
45814,1,20593,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45843,2,20593,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020593s035lbl.pdf","2016-11-08 00:00:00",
47482,2,20593,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020593s036lbl.pdf","2017-03-07 00:00:00",
47505,1,20593,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49981,1,20593,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
50002,2,20593,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020593s037lbl.pdf","2017-10-10 00:00:00",
54069,1,20593,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54090,2,20593,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020593s038lbl.pdf","2018-05-10 00:00:00",
53538,20,20596,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinical prea.pdf","1900-01-01 00:00:00",
53539,18,20596,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinpharm prea.pdf","1900-01-01 00:00:00",
53540,17,20596,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir statistical prea.pdf","1900-01-01 00:00:00",
41460,3,20596,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S007_Epivir.pdf","2007-09-26 00:00:00",
20750,3,20596,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S010_Epivir.pdf","2007-09-26 00:00:00",
20751,3,20596,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm","2005-01-06 00:00:00",
25276,1,20596,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF","2001-03-06 00:00:00",
25277,1,20596,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf","2002-10-08 00:00:00",
34924,2,20596,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf","2002-10-08 00:00:00",
2828,1,20596,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf","2002-06-24 00:00:00",
34925,2,20596,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf","2002-06-24 00:00:00",
25278,1,20596,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf","2002-03-01 00:00:00",
41461,3,20596,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020596_S019_Epivir.pdf","2007-09-26 00:00:00",
2829,1,20596,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf","2003-11-25 00:00:00",
34926,2,20596,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf","2003-12-02 00:00:00",
12809,2,20596,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf","2004-12-03 00:00:00",
20752,3,20596,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020596_S021_Epivir.pdf","2007-09-26 00:00:00",
25279,1,20596,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf","2004-12-02 00:00:00",
25280,1,20596,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf","2004-10-04 00:00:00",
34927,2,20596,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf","2004-10-04 00:00:00",
25281,1,20596,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf","2006-06-20 00:00:00",
34928,2,20596,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf","2006-06-14 00:00:00",
41462,3,20596,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020596_S025_Epivir.pdf","2007-09-26 00:00:00",
2830,1,20596,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s027ltr.pdf","2006-11-06 00:00:00",
34929,2,20596,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s027.pdf","2006-10-26 00:00:00",
2831,1,20596,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf","2011-11-22 00:00:00",
12810,2,20596,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf","2011-12-02 00:00:00",
25282,1,20596,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf","2015-03-26 00:00:00",
34930,2,20596,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf","2015-04-14 00:00:00",
12811,2,20596,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf","2015-02-20 00:00:00",
25283,1,20596,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf","2015-02-24 00:00:00",
25284,1,20596,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf","2015-10-02 00:00:00",
34931,2,20596,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf","2015-10-07 00:00:00",
25285,1,20596,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf","2016-07-22 00:00:00",
34932,2,20596,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf","2016-07-21 00:00:00",
50016,2,20596,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf","2017-10-12 00:00:00",
53929,1,20596,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020564Orig1s038,020596Orig1s037ltr.pdf","2018-05-01 00:00:00",
54029,2,20596,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf","2018-05-07 00:00:00",
20753,3,20597,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020597Orig1s005Approv.pdf","2012-01-27 00:00:00",
12812,2,20597,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf","2003-04-04 00:00:00",
25286,1,20597,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597se1-010ltr.pdf","2003-04-04 00:00:00",
41463,3,20597,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s011Approv.pdf","2012-01-27 00:00:00",
41464,3,20597,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s013Approv.pdf","2012-01-27 00:00:00",
12813,2,20597,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf","2003-04-28 00:00:00",
12814,2,20597,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf","2003-04-28 00:00:00",
12815,2,20597,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf","2002-08-26 00:00:00",
25287,1,20597,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597scp025ltr.pdf","2002-08-26 00:00:00",
20754,3,20597,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020597Orig1s026Approv.pdf","2012-01-27 00:00:00",
2832,1,20597,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf","2003-07-28 00:00:00",
2833,1,20597,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf","2003-07-28 00:00:00",
2834,1,20597,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf","2010-09-07 00:00:00",
12816,2,20597,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf","2010-09-07 00:00:00",
2835,1,20597,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf","2010-09-07 00:00:00",
34933,2,20597,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf","2010-09-07 00:00:00",
25288,1,20597,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020597s044ltr.pdf","2012-03-15 00:00:00",
34934,2,20597,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf","2012-03-16 00:00:00",
2836,1,20597,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf","2014-11-28 00:00:00",
12817,2,20597,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf","2014-12-03 00:00:00",
12818,2,20597,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf","2013-03-15 00:00:00",
2837,1,20597,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf","2014-11-28 00:00:00",
34935,2,20597,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf","2014-12-03 00:00:00",
48008,2,20597,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020597s051lbl.pdf","2017-04-13 00:00:00",
48025,1,20597,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020597Orig1s051ltr.pdf","2017-04-14 00:00:00",
2838,1,20599,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf","2003-06-08 00:00:00",
41465,3,20599,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s002.pdf","2015-07-20 00:00:00",
25289,1,20599,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf","2003-06-08 00:00:00",
41466,3,20599,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s003.pdf","2015-07-20 00:00:00",
2839,1,20599,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf","2003-06-08 00:00:00",
20755,3,20599,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s005.pdf","2016-02-02 00:00:00",
2840,1,20599,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20599s008ltr.pdf","2004-09-24 00:00:00",
20756,3,20599,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020599Orig1s008.pdf","2016-02-02 00:00:00",
2841,1,20599,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf","2009-07-17 00:00:00",
20757,3,20599,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf","2015-03-10 00:00:00",
34936,2,20599,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf","2009-07-23 00:00:00",
12819,2,20599,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf","2009-07-23 00:00:00",
25290,1,20599,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf","2009-07-17 00:00:00",
41467,3,20599,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf","2015-03-10 00:00:00",
12820,2,20599,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf","2009-11-17 00:00:00",
25291,1,20599,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s013ltr.pdf","2010-01-20 00:00:00",
41468,3,20599,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s013.pdf","2015-03-10 00:00:00",
2842,1,20599,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020599Orig1s017ltr.pdf","2016-04-11 00:00:00",
34937,2,20599,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020599s017lbl.pdf","2016-04-12 00:00:00",
41469,3,20600,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020600_tazorac_toc.cfm","2003-08-07 00:00:00",
25292,1,20600,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf","2003-12-08 00:00:00",
34938,2,20600,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf","2003-12-08 00:00:00",
2843,1,20600,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf","2003-12-08 00:00:00",
34939,2,20600,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf","2003-12-08 00:00:00",
2844,1,20600,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020600s008ltr.pdf","2011-03-02 00:00:00",
12821,2,20600,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf","2011-03-04 00:00:00",
49053,2,20600,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020600s009lbl.pdf","2017-07-25 00:00:00",
49077,1,20600,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf","2017-07-25 00:00:00",
53704,2,20600,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020600s010lbl.pdf","2018-04-17 00:00:00",
53717,1,20600,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020600Orig1s010ltr.pdf","2018-04-17 00:00:00",
25293,1,20601,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf","1999-09-13 00:00:00",
34940,2,20601,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf","1999-09-13 00:00:00",
41470,3,20601,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm","1999-09-13 00:00:00",
2845,1,20601,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s013ltr.pdf","2006-03-01 00:00:00",
25294,1,20601,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s014ltr.pdf","2006-05-16 00:00:00",
2846,1,20601,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020601s017ltr.pdf","2009-05-04 00:00:00",
2847,1,20601,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020601s018ltr.pdf","2010-10-20 00:00:00",
48391,2,20601,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf","2017-05-17 00:00:00",
48397,1,20601,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020601Orig1s020ltr.pdf","2017-05-17 00:00:00",
55869,2,20601,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf","2018-10-11 00:00:00",
25295,1,20602,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf","1999-09-13 00:00:00",
34941,2,20602,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf","1999-09-13 00:00:00",
41471,3,20602,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm","1999-09-13 00:00:00",
25296,1,20602,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020602s008ltr.pdf","2006-03-01 00:00:00",
25297,1,20602,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020602s009ltr.pdf","2009-05-04 00:00:00",
2848,1,20602,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020602s010ltr.pdf","2010-10-20 00:00:00",
48392,2,20602,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020602Orig1s013lbl.pdf","2017-05-17 00:00:00",
48398,1,20602,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020602Orig1s013ltr.pdf","2017-05-17 00:00:00",
2849,1,20603,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_Approv.pdf","1998-06-12 00:00:00",
12822,2,20603,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf","1998-06-12 00:00:00",
41472,3,20603,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603s001_Ibuprofen.cfm","1998-06-12 00:00:00",
2850,1,20603,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf","1999-09-13 00:00:00",
20758,3,20603,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm","1999-09-13 00:00:00",
34942,2,20603,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf","1999-09-13 00:00:00",
20759,3,20603,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S3_InfantsMotrin.pdf","1999-04-15 00:00:00",
2851,1,20603,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf","2002-01-16 00:00:00",
12823,2,20603,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf","2002-01-16 00:00:00",
25298,1,20603,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020603s011ltr.pdf","2006-03-01 00:00:00",
25299,1,20603,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020603s013ltr.pdf","2009-05-06 00:00:00",
2852,1,20603,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020603s014ltr.pdf","2010-07-19 00:00:00",
45181,2,20603,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf","2016-08-29 00:00:00",
45217,1,20603,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020603Orig1s021ltr.pdf","2016-08-29 00:00:00",
47575,2,20603,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf","2017-03-17 00:00:00",
47593,1,20603,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020603Orig1s022ltr.pdf","2017-03-20 00:00:00",
41473,3,20604,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020604_s012_SAIZEN INJECTION.pdf","2009-09-16 00:00:00",
2853,1,20604,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf","2003-12-04 00:00:00",
20760,3,20604,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_S026_ZORBITIVE.pdf","2007-08-06 00:00:00",
34943,2,20604,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf","2003-12-08 00:00:00",
2854,1,20604,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20604se7-027ltr.pdf","2003-09-09 00:00:00",
34944,2,20604,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf","2003-09-09 00:00:00",
41474,3,20604,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_s027_SEROSTIM.pdf","2009-09-16 00:00:00",
2855,1,20604,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20604s029ltr.pdf","2005-02-17 00:00:00",
12824,2,20604,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf","2005-02-17 00:00:00",
2856,1,20604,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf","2004-07-14 00:00:00",
34945,2,20604,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf","2004-07-14 00:00:00",
2857,1,20604,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020604s031ltr.pdf","2005-08-31 00:00:00",
12825,2,20604,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf","2005-08-31 00:00:00",
25300,1,20604,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s034ltr.pdf","2006-09-25 00:00:00",
34946,2,20604,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf","2006-09-25 00:00:00",
12826,2,20604,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf","2006-12-04 00:00:00",
25301,1,20604,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s035ltr.pdf","2006-12-04 00:00:00",
12827,2,20604,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf","2007-07-16 00:00:00",
25302,1,20604,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s040ltr.pdf","2007-07-24 00:00:00",
41475,3,20604,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020604_s040_serostim.pdf","2011-02-15 00:00:00",
2858,1,20604,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf","2007-09-04 00:00:00",
12828,2,20604,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf","2007-08-30 00:00:00",
25303,1,20604,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf","2007-08-30 00:00:00",
34947,2,20604,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf","2007-09-04 00:00:00",
25304,1,20604,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020604s048ltr.pdf","2009-11-19 00:00:00",
12829,2,20604,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020604s049lbl.pdf","2012-04-06 00:00:00",
25305,1,20604,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf","2012-04-05 00:00:00",
48526,1,20604,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s074ltr.pdf","2017-05-25 00:00:00",
48547,2,20604,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf","2017-05-26 00:00:00",
2859,1,20604,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020604Orig1s078ltr.pdf","2014-06-19 00:00:00",
34948,2,20604,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf","2014-06-23 00:00:00",
46155,1,20604,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s089ltr.pdf","2016-12-14 00:00:00",
46187,2,20604,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s089lbl.pdf","2016-12-14 00:00:00",
46156,1,20604,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s090ltr.pdf","2016-12-14 00:00:00",
46200,2,20604,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s090lbl.pdf","2016-12-19 00:00:00",
48336,2,20604,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf","2017-05-10 00:00:00",
48361,1,20604,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s093ltr.pdf","2017-05-12 00:00:00",
41476,3,20605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020605ap.pdf","1997-01-24 00:00:00",
44061,10,20605,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm","2011-12-20 00:00:00",
20761,3,20605,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020605_S004_ZOFRAN.pdf","2007-09-26 00:00:00",
2860,1,20605,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF","2000-12-13 00:00:00",
12830,2,20605,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF","2000-12-13 00:00:00",
2861,1,20605,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf","2004-12-02 00:00:00",
12831,2,20605,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf","2004-12-03 00:00:00",
12832,2,20605,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf","2006-01-05 00:00:00",
25306,1,20605,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf","2006-01-06 00:00:00",
41477,3,20605,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020605_s008_Zofran Tabs.pdf","2009-09-16 00:00:00",
12833,2,20605,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf","2006-08-23 00:00:00",
25307,1,20605,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf","2006-09-18 00:00:00",
2862,1,20605,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf","2010-09-27 00:00:00",
12834,2,20605,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf","2010-09-29 00:00:00",
12835,2,20605,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf","2011-09-16 00:00:00",
25308,1,20605,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf","2011-09-16 00:00:00",
12836,2,20605,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf","2013-12-11 00:00:00",
25309,1,20605,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf","2013-12-13 00:00:00",
45485,1,20605,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf","2016-09-30 00:00:00",
2863,1,20605,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf","2014-09-23 00:00:00",
34949,2,20605,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf","2014-09-22 00:00:00",
45876,2,20605,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf","2016-11-10 00:00:00",
45879,1,20605,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s035,020605Orig1s019,020781Orig1s019ltr.pdf","2016-11-10 00:00:00",
49963,2,20605,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf","2017-10-06 00:00:00",
49977,1,20605,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020103Orig1s036,020605Orig1s020,020781Orig1s020ltr.pdf","2017-10-06 00:00:00",
20762,3,20606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020606ap.pdf","1997-06-25 00:00:00",
20763,3,20606,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020606_S009_IMODIUM_ADVANCED_CHEWABLE_TABLETS.pdf","2008-07-31 00:00:00",
25310,1,20606,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf","2004-06-16 00:00:00",
24176,21,20606,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-014, 021140se8-011_SUMR.pdf","2008-07-16 00:00:00",
25311,1,20606,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020606se8-014, 021140se8-011ltr.pdf","2008-05-05 00:00:00",
48010,2,20606,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020606Orig1s017lbl.pdf","2017-04-13 00:00:00",
48033,1,20606,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020606Orig1s017ltr.pdf","2017-04-14 00:00:00",
23167,8,20607,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085919.pdf","2009-10-30 00:00:00",
41478,3,20607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020607_arthrotec_toc.cfm","2003-08-08 00:00:00",
41479,3,20607,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20607s4.pdf","1999-02-22 00:00:00",
2864,1,20607,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020607s008ltr.pdf","2005-07-15 00:00:00",
2865,1,20607,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020607s009ltr.pdf","2006-01-30 00:00:00",
12837,2,20607,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020607s009lbl.pdf","2006-01-25 00:00:00",
12838,2,20607,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020607s010lbl.pdf","2007-08-27 00:00:00",
25312,1,20607,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020607s010ltr.pdf","2007-08-27 00:00:00",
2866,1,20607,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s013ltr.pdf","2009-11-10 00:00:00",
12839,2,20607,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s013lbl.pdf","2009-10-06 00:00:00",
25313,1,20607,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s014ltr.pdf","2009-02-27 00:00:00",
34950,2,20607,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s014lbl.pdf","2009-03-17 00:00:00",
25314,1,20607,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020607s016ltr.pdf","2010-12-22 00:00:00",
34951,2,20607,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020607s016lbl.pdf","2010-12-22 00:00:00",
25315,1,20607,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020607Orig1s021ltr.pdf","2015-04-03 00:00:00",
34952,2,20607,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020607s021lbl.pdf","2015-04-02 00:00:00",
2867,1,20607,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020607Orig1s025ltr.pdf","2013-03-08 00:00:00",
34953,2,20607,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020607s025lbl.pdf","2013-03-08 00:00:00",
2868,1,20607,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020607Orig1s028ltr.pdf","2014-09-05 00:00:00",
12840,2,20607,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020607s028lbl.pdf","2014-09-09 00:00:00",
12841,2,20607,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf","2016-05-11 00:00:00",
25316,1,20607,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020607Orig1s031ltr.pdf","2016-05-12 00:00:00",
25317,1,20608,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr009ltr.pdf","2004-03-10 00:00:00",
25318,1,20608,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr010ltr.pdf","2004-03-03 00:00:00",
2869,1,20608,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020608s018ltr.pdf","2007-10-04 00:00:00",
12842,2,20608,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf","2015-07-09 00:00:00",
25319,1,20608,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018956Orig1s095,020608Orig1s031ltr.pdf","2015-07-10 00:00:00",
46498,2,20608,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020608s034lbl.pdf","2016-12-21 00:00:00",
46523,1,20608,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020608Orig1s034ltr.pdf","2016-12-23 00:00:00",
47897,2,20608,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s036lbl.pdf","2017-04-07 00:00:00",
47898,2,20608,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s037lbl.pdf","2017-04-07 00:00:00",
47965,1,20608,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018956Orig1s099,020608s036s037ltr.pdf","2017-04-12 00:00:00",
50384,1,20608,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020608Orig1s038ltr.pdf","2017-11-13 00:00:00",
50403,2,20608,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf","2017-11-14 00:00:00",
2870,1,20610,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20610s001ltr.pdf","2002-06-18 00:00:00",
20764,3,20610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-610_Colazal.cfm","2000-07-18 00:00:00",
25320,1,20610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20610ltr.pdf","2000-07-18 00:00:00",
34954,2,20610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf","2000-07-18 00:00:00",
51775,23,20610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610_balsalazide_Colazal_12-17-01_HFD180_orig.pdf","1900-01-01 00:00:00",
51777,20,20610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610s016_balsalazide_Colazal-MedRev.pdf","1900-01-01 00:00:00",
51778,18,20610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610s016_balsalazide_Colazal-ClinPharRev.pdf","1900-01-01 00:00:00",
53079,17,20610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610s016_balsalazide_Colazal-StatRev.pdf","1900-01-01 00:00:00",
25321,1,20610,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s013ltr.pdf","2006-03-23 00:00:00",
12843,2,20610,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s014lbl.pdf","2006-09-25 00:00:00",
25322,1,20610,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s014ltr.pdf","2006-09-25 00:00:00",
25323,1,20610,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s016ltr.pdf","2006-12-28 00:00:00",
34955,2,20610,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s016lbl.pdf","2006-12-28 00:00:00",
53529,18,20610,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610s016_balsalazide_Colazal-ClinPharRev.pdf","1900-01-01 00:00:00",
53530,20,20610,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020610s016_balsalazide_Colazal-MedRev.pdf","1900-01-01 00:00:00",
2871,1,20610,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020610s017ltr.pdf","2007-11-08 00:00:00",
12844,2,20610,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020610s017lbl.pdf","2007-11-07 00:00:00",
2872,1,20610,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020610s018ltr.pdf","2008-07-14 00:00:00",
20765,3,20611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020611ap.pdf","1997-03-03 00:00:00",
2873,1,20611,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020611s006ltr.pdf","2005-05-02 00:00:00",
12845,2,20611,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020611s006lbl.pdf","2005-05-02 00:00:00",
2874,1,20611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf","2007-10-04 00:00:00",
12846,2,20611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf","2007-10-04 00:00:00",
2875,1,20612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20612ltr.pdf","1999-03-19 00:00:00",
20766,3,20612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm","1999-06-17 00:00:00",
34956,2,20612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20612lbl.pdf","1999-03-19 00:00:00",
41480,3,20612,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020612_S002_Lidoderm Patch_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
20767,3,20612,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020612_S003_Lidoderm Patch_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
2876,1,20612,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020612s007ltr.pdf","2005-05-17 00:00:00",
34957,2,20612,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020612s007lbl.pdf","2005-05-17 00:00:00",
2877,1,20612,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020612s008LTR.pdf","2006-05-01 00:00:00",
12847,2,20612,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf","2006-05-01 00:00:00",
2878,1,20612,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020612s011ltr.pdf","2010-04-19 00:00:00",
34958,2,20612,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf","2010-04-19 00:00:00",
2879,1,20612,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020612Orig1s012ltr.pdf","2015-01-08 00:00:00",
12848,2,20612,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf","2015-01-08 00:00:00",
2880,1,20613,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf","2001-12-20 00:00:00",
34959,2,20613,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf","2001-12-20 00:00:00",
41481,3,20613,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm","2004-05-27 00:00:00",
2881,1,20613,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020613Orig1s031ltr.pdf","2016-03-25 00:00:00",
12849,2,20613,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf","2016-03-29 00:00:00",
41482,3,20615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020615ap.pdf","1996-11-04 00:00:00",
12850,2,20615,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020615s002lbl.pdf","2009-05-13 00:00:00",
25324,1,20615,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020615s002ltr.pdf","2009-05-04 00:00:00",
12851,2,20615,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020615s003lbl.pdf","2010-08-09 00:00:00",
25325,1,20615,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020615s003ltr.pdf","2010-08-02 00:00:00",
20768,3,20616,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020616S1_Kadian.pdf","2011-02-04 00:00:00",
44453,14,20616,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
12852,2,20616,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf","2005-09-30 00:00:00",
25326,1,20616,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020616s010ltr.pdf","2005-10-20 00:00:00",
2882,1,20616,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf","2007-03-07 00:00:00",
34960,2,20616,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf","2007-03-07 00:00:00",
41483,3,20616,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S017_KADIAN.pdf","2007-11-19 00:00:00",
12853,2,20616,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf","2007-03-07 00:00:00",
25327,1,20616,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf","2007-03-07 00:00:00",
41484,3,20616,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S021_KADIAN.pdf","2007-11-19 00:00:00",
2883,1,20616,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020616s022ltr.pdf","2006-11-06 00:00:00",
34961,2,20616,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf","2006-11-06 00:00:00",
12854,2,20616,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf","2007-04-25 00:00:00",
25328,1,20616,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s025ltr.pdf","2007-05-01 00:00:00",
25329,1,20616,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020616Orig1s041ltr.pdf","2012-07-11 00:00:00",
34962,2,20616,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf","2012-07-12 00:00:00",
34963,2,20616,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf","2012-07-13 00:00:00",
25330,1,20616,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s047ltr.pdf","2013-04-17 00:00:00",
2884,1,20616,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s048ltr.pdf","2013-03-29 00:00:00",
2885,1,20616,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s051ltr.pdf","2014-04-17 00:00:00",
34964,2,20616,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf","2014-04-16 00:00:00",
2886,1,20616,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s053ltr.pdf","2014-08-20 00:00:00",
2887,1,20616,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020616Orig1s054ltr.pdf","2015-07-02 00:00:00",
2888,1,20616,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s055ltr.pdf","2016-04-22 00:00:00",
46253,1,20616,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s057ltr.pdf","2016-12-20 00:00:00",
46383,2,20616,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf","2016-12-21 00:00:00",
47921,8,20616,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf#page=33","2017-04-11 00:00:00",
45462,1,20616,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s058ltr.pdf","2016-10-04 00:00:00",
48568,1,20616,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020616Orig1s060ltr.pdf","2017-05-30 00:00:00",
55660,1,20616,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf","2018-09-28 00:00:00",
55661,1,20616,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf","2018-09-28 00:00:00",
34965,2,20622,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf","2003-04-28 00:00:00",
41485,3,20622,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf","2007-04-09 00:00:00",
2889,1,20622,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622s23ltr.pdf","2002-02-12 00:00:00",
2890,1,20622,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622slr026ltr.pdf","2002-08-29 00:00:00",
12855,2,20622,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf","2009-03-17 00:00:00",
25331,1,20622,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf","2009-03-03 00:00:00",
34966,2,20622,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020622s087lbl.pdf","2013-03-12 00:00:00",
2891,1,20622,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf","2014-01-29 00:00:00",
12856,2,20622,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf","2014-01-31 00:00:00",
45785,3,20622,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020622Orig1s089.pdf","2016-11-02 00:00:00",
51846,2,20622,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s102lbl.pdf","2018-01-26 00:00:00",
51899,1,20622,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020622Orig1s102ltr.pdf","2018-01-26 00:00:00",
55418,2,20622,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s104lbl.pdf","2018-09-10 00:00:00",
55439,1,20622,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020622Orig1s104ltr.pdf","2018-09-12 00:00:00",
41486,3,20623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020623_anzemet_toc.cfm","2010-03-03 00:00:00",
2892,1,20623,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020623s004ltr.pdf","2005-06-07 00:00:00",
34967,2,20623,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020623s004lbl.pdf","2005-06-07 00:00:00",
2893,1,20623,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s006,020624s016ltr.pdf","2007-06-04 00:00:00",
12857,2,20623,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf","2007-06-04 00:00:00",
25332,1,20623,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s007, 020624s017ltr.pdf","2007-09-26 00:00:00",
12858,2,20623,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020623s008lbl.pdf","2009-10-14 00:00:00",
25333,1,20623,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020623s008ltr.pdf","2009-11-10 00:00:00",
2894,1,20623,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020623s009ltr.pdf","2011-09-27 00:00:00",
34968,2,20623,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020623s009lbl.pdf","2011-09-28 00:00:00",
25334,1,20623,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020623Orig1s010,020624Orig1s023ltr.pdf","2013-09-17 00:00:00",
34969,2,20623,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf","2013-09-16 00:00:00",
2895,1,20623,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020623Orig1s012ltr.pdf","2014-09-23 00:00:00",
12859,2,20623,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020623s012lbl.pdf","2014-09-22 00:00:00",
41487,3,20624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020624_anzemet_toc.cfm","1998-10-20 00:00:00",
2896,1,20624,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scf003ltr.pdf","2004-05-27 00:00:00",
20769,3,20624,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020624_S008_AMZEMET_AP.pdf","2007-07-06 00:00:00",
25335,1,20624,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20624s8ltr.pdf","2002-03-22 00:00:00",
25336,1,20624,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scs009ltr.pdf","2003-07-28 00:00:00",
41488,3,20624,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020624_S009_ANZEMET.pdf","2008-02-19 00:00:00",
12860,2,20624,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf","2005-06-07 00:00:00",
25337,1,20624,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020624s013ltr.pdf","2005-06-07 00:00:00",
2897,1,20624,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s006,020624s016ltr.pdf","2007-06-04 00:00:00",
12861,2,20624,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf","2007-06-04 00:00:00",
25338,1,20624,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s007, 020624s017ltr.pdf","2007-09-26 00:00:00",
2898,1,20624,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020624s020ltr.pdf","2009-11-10 00:00:00",
34970,2,20624,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020624s020lbl.pdf","2009-10-14 00:00:00",
25339,1,20624,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020624s022ltr.pdf","2011-09-27 00:00:00",
34971,2,20624,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020624s022lbl.pdf","2011-09-29 00:00:00",
2899,1,20624,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020623Orig1s010,020624Orig1s023ltr.pdf","2013-09-17 00:00:00",
34972,2,20624,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf","2013-09-17 00:00:00",
2900,1,20624,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020624Orig1s025ltr.pdf","2014-09-23 00:00:00",
34973,2,20624,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020624s025lbl.pdf","2014-09-22 00:00:00",
12862,2,20625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf","2003-04-30 00:00:00",
41489,3,20625,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s006_ALLEGRA TABLETS.pdf","2008-08-08 00:00:00",
41490,3,20625,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s007_ALLEGRA TABLETS.pdf","2008-08-08 00:00:00",
41491,3,20625,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s008_ALLEGRA_TABLETS.pdf","2008-08-04 00:00:00",
20770,3,20625,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s009_ALLEGRA TABLETS.pdf","2008-08-04 00:00:00",
12863,2,20625,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf","2003-05-29 00:00:00",
25340,1,20625,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf","2003-06-08 00:00:00",
2901,1,20625,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf","2001-07-11 00:00:00",
25341,1,20625,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf","2003-06-08 00:00:00",
34974,2,20625,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf","2003-05-29 00:00:00",
51859,20,20625,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020625s012, 020872s011, 020786s014_fexofenadine_MedRev.pdf","1900-01-01 00:00:00",
51860,23,20625,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020625, 020786, 020872_fexofenadine_WR_amend.pdf","1900-01-01 00:00:00",
51861,25,20625,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813_fentanyl_Duragesic_WR(amended)_11-30-99.pdf","1900-01-01 00:00:00",
51862,26,20625,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019813_fentanyl_Duragesic_WR(amended)_2-22-01.pdf","1900-01-01 00:00:00",
51863,18,20625,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020625s012, 020872s011, 020786s014_fexofenadine_ClinPh.pdf","1900-01-01 00:00:00",
20771,3,20626,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s001_IMITREX_NASAL_SPRAY.pdf","2008-08-04 00:00:00",
23586,10,20626,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
41492,3,20626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020626_imitrex_toc.cfm","2010-03-03 00:00:00",
20772,3,20626,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s002_IMITREX_NASAL_SPRAY.pdf","2008-08-04 00:00:00",
12864,2,20626,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf","2004-10-15 00:00:00",
25342,1,20626,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20626s004ltr.pdf","2004-10-15 00:00:00",
52207,20,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex-MedRev-BPCA.pdf","1900-01-01 00:00:00",
52208,18,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex-ClinPharmRev_BPCA.pdf","1900-01-01 00:00:00",
52209,17,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex-StatsRev-BPCA.pdf","1900-01-01 00:00:00",
52210,23,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex_WR.pdf","1900-01-01 00:00:00",
52211,25,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex_amend.pdf","1900-01-01 00:00:00",
52212,26,20626,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020626Orig1s004_sumatriptan_Imitrex_amend-2.pdf","1900-01-01 00:00:00",
25343,1,20626,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20626s6ltr.pdf","2002-05-10 00:00:00",
20773,3,20626,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020626_S007_IMITREX TABLETS, NASAL SPRAY INJECTION.pdf","2007-07-24 00:00:00",
25344,1,20626,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf","2003-08-15 00:00:00",
2902,1,20626,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf","2010-07-28 00:00:00",
34975,2,20626,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf","2010-07-31 00:00:00",
2903,1,20626,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf","2010-07-28 00:00:00",
12865,2,20626,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf","2010-07-31 00:00:00",
25345,1,20626,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf","2010-07-28 00:00:00",
34976,2,20626,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf","2010-07-31 00:00:00",
25346,1,20626,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf","2012-03-05 00:00:00",
2904,1,20626,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf","2012-03-05 00:00:00",
12866,2,20626,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf","2012-03-06 00:00:00",
25347,1,20626,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf","2013-11-27 00:00:00",
34977,2,20626,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf","2013-11-26 00:00:00",
50698,2,20626,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf","2017-12-15 00:00:00",
50707,1,20626,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf","2017-12-15 00:00:00",
23169,8,20628,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf","2010-10-13 00:00:00",
41493,3,20628,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20628ap_s007.pdf","1997-02-27 00:00:00",
20774,3,20628,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020628_S015_Invirase.pdf","2007-09-26 00:00:00",
12867,2,20628,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20628s16lbl.pdf","2002-06-24 00:00:00",
20775,3,20628,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-628s016_Invirase.cfm","2005-04-27 00:00:00",
25348,1,20628,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20628s016ltr.pdf","2002-06-24 00:00:00",
23058,6,20628,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628s020ppi.pdf","2004-02-03 00:00:00",
25349,1,20628,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20628se2-020ltr.pdf","2004-01-14 00:00:00",
34978,2,20628,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628se2-020_Invirase_lbl.pdf","2004-01-15 00:00:00",
41494,3,20628,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020628_S020_INVIRASE.pdf","2007-11-19 00:00:00",
2905,1,20628,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
34979,2,20628,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
43562,6,20628,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf","2005-11-04 00:00:00",
2906,1,20628,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
12868,2,20628,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
20776,3,20628,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020628_S023_FORTOVASE.pdf","2007-08-06 00:00:00",
23059,6,20628,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf","2005-11-04 00:00:00",
2907,1,20628,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s024, 021785s003ltr.pdf","2007-04-09 00:00:00",
34980,2,20628,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf","2007-04-06 00:00:00",
25350,1,20628,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s025,021785s004ltr.pdf","2007-07-16 00:00:00",
34981,2,20628,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf","2007-07-16 00:00:00",
25351,1,20628,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s027,021785s006ltr.pdf","2010-01-26 00:00:00",
34982,2,20628,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf","2010-01-24 00:00:00",
2908,1,20628,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s032,021785s009ltr.pdf","2010-04-29 00:00:00",
34983,2,20628,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf","2010-05-07 00:00:00",
25352,1,20628,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s033,021785s010ltr.pdf","2010-10-12 00:00:00",
34984,2,20628,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf","2010-10-12 00:00:00",
2909,1,20628,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628Orig1s034,021785Orig1s011ltr.pdf","2012-12-04 00:00:00",
12869,2,20628,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf","2012-12-04 00:00:00",
51649,20,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020628 saquinavir clinical prea.pdf","1900-01-01 00:00:00",
51650,18,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020628 saquinavir clinpharm prea.pdf","1900-01-01 00:00:00",
51651,17,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020628 saquinavir statistical prea.pdf","1900-01-01 00:00:00",
52331,23,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Original_WRltr.pdf","2010-10-26 00:00:00",
52332,25,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Amendment_1ltr.pdf","2010-10-26 00:00:00",
52333,26,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Amendment_2ltr.pdf","2010-10-26 00:00:00",
52334,24,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Reissueltr.pdf","2010-10-26 00:00:00",
52335,40,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Reissue_Amendment_1ltr.pdf","2010-10-26 00:00:00",
52336,41,20628,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20628_21785_saquinavir_Reissue_Amendment_2ltr.pdf","2010-10-26 00:00:00",
25353,1,20628,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020628s037,021785s014ltr.pdf","2011-05-31 00:00:00",
25354,1,20628,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628s038,021785s015ltr.pdf","2012-02-27 00:00:00",
34985,2,20628,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf","2012-02-22 00:00:00",
25355,1,20628,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s039,021785Orig1s016ltr.pdf","2015-04-22 00:00:00",
34986,2,20628,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf","2015-04-28 00:00:00",
12870,2,20628,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf","2016-03-03 00:00:00",
25356,1,20628,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s041,021785Orig1s017ltr.pdf","2016-03-02 00:00:00",
2910,1,20628,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s042,21785Orig1s018ltr.pdf","2015-03-31 00:00:00",
34987,2,20628,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf","2015-04-02 00:00:00",
2911,1,20628,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s043,021785Orig1s019ltr.pdf","2015-12-17 00:00:00",
12871,2,20628,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf","2015-12-17 00:00:00",
45341,1,20628,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s045,021785Orig1s021ltr.pdf","2016-09-20 00:00:00",
45377,2,20628,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf","2016-09-23 00:00:00",
53054,2,20628,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf","2018-03-19 00:00:00",
53066,1,20628,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020628Orig1s046,021785Orig1s022ltr.pdf","2018-03-20 00:00:00",
2912,1,20629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629se5-008ltr.pdf","2003-10-16 00:00:00",
34988,2,20629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629se5-008_denavir_lbl.pdf","2003-10-16 00:00:00",
2913,1,20629,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629slr009ltr.pdf","2003-04-18 00:00:00",
34989,2,20629,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629slr009_denavir_lbl.pdf","2003-04-17 00:00:00",
2914,1,20629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020629Orig1s016ltr.pdf","2013-09-13 00:00:00",
12872,2,20629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020629s016lbl.pdf","2013-09-17 00:00:00",
12873,2,20630,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-005_ultiva_lbl.pdf","2004-04-05 00:00:00",
25357,1,20630,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20630se5-005ltr.pdf","2004-03-10 00:00:00",
46255,1,20630,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020630Orig1s016ltr.pdf","2016-12-20 00:00:00",
46376,2,20630,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf","2016-12-21 00:00:00",
54746,2,20630,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf","2018-07-04 00:00:00",
46254,1,20631,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020631Orig1s001ltr.pdf","2016-12-20 00:00:00",
46375,2,20631,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020631s001lbl.pdf","2016-12-21 00:00:00",
41495,3,20632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.cfm","2003-06-17 00:00:00",
20777,3,20632,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf","2008-02-19 00:00:00",
41496,3,20632,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf","2008-02-19 00:00:00",
20778,3,20632,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf","2008-02-19 00:00:00",
2915,1,20632,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf","2001-02-16 00:00:00",
34990,2,20632,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf","2001-02-16 00:00:00",
25358,1,20632,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf","2001-02-16 00:00:00",
34991,2,20632,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf","2001-02-16 00:00:00",
41497,3,20632,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf","2008-02-19 00:00:00",
20779,3,20632,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf","2008-02-19 00:00:00",
25359,1,20632,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf","2003-09-30 00:00:00",
41498,3,20632,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf","2007-07-09 00:00:00",
2916,1,20632,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf","2004-12-02 00:00:00",
12874,2,20632,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf","2004-12-03 00:00:00",
2917,1,20632,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf","2004-12-02 00:00:00",
2918,1,20632,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf","2005-12-15 00:00:00",
34992,2,20632,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf","2005-12-15 00:00:00",
44062,10,20632,"SUPPL",21,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm191652.htm","2007-07-09 00:00:00",
52193,20,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-MedRev.pdf","1900-01-01 00:00:00",
52194,18,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-ClinPharmRev.pdf","1900-01-01 00:00:00",
52195,18,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20632s021_SIBUTRAMINE HCL MONOHYDRATE_Clinical_Pharm_BPCA.pdf","1900-01-01 00:00:00",
52196,17,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-StatsRev.pdf","1900-01-01 00:00:00",
52197,17,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-StatsRev_amend.pdf","1900-01-01 00:00:00",
52198,23,20632,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632_sibutramine_Merdia_WR_orig.pdf","1900-01-01 00:00:00",
2919,1,20632,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf","2005-08-03 00:00:00",
34993,2,20632,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf","2005-08-03 00:00:00",
2920,1,20632,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf","2006-09-18 00:00:00",
34994,2,20632,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf","2006-08-29 00:00:00",
2921,1,20632,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf","2008-05-30 00:00:00",
25360,1,20632,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf","2008-12-30 00:00:00",
34995,2,20632,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf","2009-01-02 00:00:00",
12875,2,20632,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf","2009-05-11 00:00:00",
25361,1,20632,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf","2009-05-06 00:00:00",
25362,1,20632,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf","2010-08-10 00:00:00",
34996,2,20632,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf","2010-08-10 00:00:00",
43656,8,20632,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf","2010-08-10 00:00:00",
23170,8,20632,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf","2010-08-10 00:00:00",
25363,1,20632,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf","2010-08-10 00:00:00",
34997,2,20632,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf","2010-08-10 00:00:00",
41499,3,20634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020634_levaquin_toc.cfm","2007-04-24 00:00:00",
2922,1,20634,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf","1998-12-17 00:00:00",
20780,3,20634,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm","1999-07-02 00:00:00",
34998,2,20634,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf","2004-06-08 00:00:00",
44455,14,20634,"SUPPL",4,"Label Pt. 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P2.pdf","2004-06-08 00:00:00",
2923,1,20634,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF","2000-02-02 00:00:00",
20781,3,20634,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm","2004-09-09 00:00:00",
2924,1,20634,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF","2000-02-02 00:00:00",
41500,3,20634,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm","2004-09-09 00:00:00",
12876,2,20634,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf","2000-09-08 00:00:00",
25364,1,20634,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf","2000-09-08 00:00:00",
2925,1,20634,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf","2000-09-08 00:00:00",
34999,2,20634,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf","2000-09-08 00:00:00",
20782,3,20634,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25365,1,20634,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
35000,2,20634,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
20783,3,20634,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25366,1,20634,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
35001,2,20634,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
2926,1,20634,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
12877,2,20634,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
41501,3,20634,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25367,1,20634,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf","2002-10-30 00:00:00",
2927,1,20634,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf","2003-06-08 00:00:00",
35002,2,20634,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf","2003-06-08 00:00:00",
41502,3,20634,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S027_LEVAQUIN.pdf","2008-08-01 00:00:00",
2928,1,20634,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf","2003-12-04 00:00:00",
20784,3,20634,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S028_LEVAQUIN.pdf","2008-08-01 00:00:00",
25368,1,20634,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf","2004-03-10 00:00:00",
35003,2,20634,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf","2004-04-05 00:00:00",
35004,2,20634,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s030,20635s030lbl.pdf","2004-07-21 00:00:00",
25369,1,20634,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf","2004-09-15 00:00:00",
35005,2,20634,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf","2004-09-15 00:00:00",
41503,3,20634,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S033_Levaquin.pdf","2009-09-17 00:00:00",
2929,1,20634,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf","2004-09-15 00:00:00",
12878,2,20634,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf","2004-09-15 00:00:00",
41504,3,20634,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S034_Levaquin.pdf","2009-09-17 00:00:00",
2930,1,20634,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf","2004-12-02 00:00:00",
35006,2,20634,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf","2004-12-03 00:00:00",
2931,1,20634,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf","2004-11-08 00:00:00",
35007,2,20634,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf","2004-11-08 00:00:00",
25370,1,20634,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf","2005-08-08 00:00:00",
35008,2,20634,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf","2005-08-08 00:00:00",
35009,2,20634,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf","2006-01-27 00:00:00",
25371,1,20634,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf","2006-06-28 00:00:00",
35010,2,20634,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf","2006-06-28 00:00:00",
12879,2,20634,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf","2007-09-19 00:00:00",
25372,1,20634,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf","2007-09-25 00:00:00",
2932,1,20634,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf","2007-06-04 00:00:00",
12880,2,20634,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf","2007-06-04 00:00:00",
12881,2,20634,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf","2007-09-19 00:00:00",
25373,1,20634,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf","2007-09-25 00:00:00",
52008,23,20634,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_orig_5-16-06.pdf","1900-01-01 00:00:00",
52009,25,20634,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_amend_6-16-06.pdf","1900-01-01 00:00:00",
52014,18,20634,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin_ClinPharmRev2.pdf","1900-01-01 00:00:00",
52017,17,20634,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin-StatRev.pdf","1900-01-01 00:00:00",
52954,20,20634,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20634 levofloxacin clinical PREA.pdf","1900-01-01 00:00:00",
2933,1,20634,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf","2007-05-16 00:00:00",
35011,2,20634,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf","2007-05-16 00:00:00",
2934,1,20634,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf","2007-07-05 00:00:00",
12882,2,20634,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf","2007-06-27 00:00:00",
24177,21,20634,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf","2008-07-16 00:00:00",
25374,1,20634,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf","2008-05-08 00:00:00",
2935,1,20634,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf","2007-11-19 00:00:00",
35012,2,20634,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf","2007-11-19 00:00:00",
2936,1,20634,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf","2007-11-19 00:00:00",
12883,2,20634,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf","2007-11-19 00:00:00",
2937,1,20634,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf","2008-01-09 00:00:00",
12884,2,20634,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf","2007-12-14 00:00:00",
12885,2,20634,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf","2008-06-05 00:00:00",
25375,1,20634,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf","2008-04-18 00:00:00",
25376,1,20634,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf","2008-10-07 00:00:00",
35013,2,20634,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf","2008-10-08 00:00:00",
2938,1,20634,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf","2009-05-05 00:00:00",
35014,2,20634,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf","2009-05-11 00:00:00",
25377,1,20634,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf","2009-03-13 00:00:00",
2939,1,20634,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf","2011-03-03 00:00:00",
12886,2,20634,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf","2011-03-04 00:00:00",
25378,1,20634,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf","2011-06-14 00:00:00",
35015,2,20634,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf","2011-06-14 00:00:00",
25379,1,20634,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf","2012-05-01 00:00:00",
35016,2,20634,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf","2012-04-30 00:00:00",
41505,3,20634,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm","2015-03-11 00:00:00",
2940,1,20634,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
12887,2,20634,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
41506,3,20634,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf","2012-06-22 00:00:00",
12888,2,20634,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
25380,1,20634,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
41507,3,20634,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf","2012-06-22 00:00:00",
12889,2,20634,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf","2013-08-15 00:00:00",
25381,1,20634,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf","2013-08-16 00:00:00",
25382,1,20634,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf","2014-05-28 00:00:00",
35017,2,20634,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf","2014-05-28 00:00:00",
12890,2,20634,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf","2016-07-26 00:00:00",
25383,1,20634,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf","2016-07-26 00:00:00",
47149,1,20634,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020634Orig1s068,020635Orig1s074,021721Orig1s035ltr.pdf","2017-02-09 00:00:00",
47163,2,20634,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf","2017-02-10 00:00:00",
54740,2,20634,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf","2018-07-03 00:00:00",
54741,8,20634,"SUPPL",69,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51","2018-07-03 00:00:00",
54820,1,20634,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020634Orig1s069ltr.pdf","2018-07-06 00:00:00",
20785,3,20635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020635ap.pdf","1997-12-11 00:00:00",
23172,8,20635,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf","2009-11-19 00:00:00",
2941,1,20635,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf","1998-12-17 00:00:00",
20786,3,20635,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm","1999-07-02 00:00:00",
35018,2,20635,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf","2004-06-08 00:00:00",
20787,3,20635,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm","2004-09-09 00:00:00",
25384,1,20635,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF","2000-02-02 00:00:00",
41508,3,20635,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm","2004-09-09 00:00:00",
12891,2,20635,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf","2000-09-08 00:00:00",
25385,1,20635,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf","2000-09-08 00:00:00",
20788,3,20635,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25386,1,20635,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
35019,2,20635,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
20789,3,20635,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25387,1,20635,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
35020,2,20635,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
20790,3,20635,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm","2005-06-27 00:00:00",
25388,1,20635,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf","2001-12-18 00:00:00",
35021,2,20635,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf","2001-12-18 00:00:00",
2942,1,20635,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf","2002-10-30 00:00:00",
2943,1,20635,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf","2003-06-08 00:00:00",
35022,2,20635,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf","2003-06-08 00:00:00",
41509,3,20635,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020635_S026_LEVAQUIN.pdf","2008-08-01 00:00:00",
2944,1,20635,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf","2003-12-04 00:00:00",
41510,3,20635,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020635_S027_LEVAQUIN.pdf","2008-08-01 00:00:00",
12892,2,20635,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf","2004-04-05 00:00:00",
25389,1,20635,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf","2004-03-10 00:00:00",
2945,1,20635,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s030,20635s030ltr.pdf","2004-07-21 00:00:00",
2946,1,20635,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf","2004-09-15 00:00:00",
12893,2,20635,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf","2004-09-15 00:00:00",
2947,1,20635,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf","2004-09-15 00:00:00",
12894,2,20635,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf","2004-09-15 00:00:00",
25390,1,20635,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf","2004-12-02 00:00:00",
35023,2,20635,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf","2004-12-03 00:00:00",
2948,1,20635,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf","2004-11-08 00:00:00",
35024,2,20635,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf","2004-11-08 00:00:00",
25391,1,20635,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf","2005-08-08 00:00:00",
35025,2,20635,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf","2005-08-08 00:00:00",
12895,2,20635,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf","2006-01-27 00:00:00",
2949,1,20635,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf","2006-06-28 00:00:00",
12896,2,20635,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf","2006-06-28 00:00:00",
2950,1,20635,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf","2007-09-25 00:00:00",
35026,2,20635,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf","2007-09-19 00:00:00",
25392,1,20635,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf","2007-06-04 00:00:00",
35027,2,20635,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf","2007-06-04 00:00:00",
2951,1,20635,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf","2007-09-25 00:00:00",
35028,2,20635,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf","2007-09-19 00:00:00",
52004,20,20635,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin_ClinicalRev.pdf","1900-01-01 00:00:00",
52007,23,20635,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_orig_5-16-06.pdf","1900-01-01 00:00:00",
52010,25,20635,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_amend_6-16-06.pdf","1900-01-01 00:00:00",
52015,18,20635,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin_ClinPharmRev2.pdf","1900-01-01 00:00:00",
52016,17,20635,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin-StatRev.pdf","1900-01-01 00:00:00",
12897,2,20635,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf","2007-05-16 00:00:00",
25393,1,20635,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf","2007-05-16 00:00:00",
25394,1,20635,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf","2007-07-05 00:00:00",
35029,2,20635,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf","2007-06-27 00:00:00",
2952,1,20635,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf","2008-05-08 00:00:00",
24178,21,20635,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf","2008-07-16 00:00:00",
25395,1,20635,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf","2007-11-19 00:00:00",
35030,2,20635,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf","2007-11-19 00:00:00",
2953,1,20635,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf","2007-11-19 00:00:00",
35031,2,20635,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf","2007-11-19 00:00:00",
2954,1,20635,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf","2008-01-09 00:00:00",
12898,2,20635,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf","2007-12-14 00:00:00",
12899,2,20635,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf","2008-06-05 00:00:00",
25396,1,20635,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf","2008-04-18 00:00:00",
12900,2,20635,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf","2008-10-08 00:00:00",
25397,1,20635,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf","2008-10-07 00:00:00",
25398,1,20635,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf","2009-05-05 00:00:00",
35032,2,20635,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf","2009-05-11 00:00:00",
2955,1,20635,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf","2009-03-13 00:00:00",
2956,1,20635,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf","2011-03-03 00:00:00",
35033,2,20635,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf","2011-03-04 00:00:00",
2957,1,20635,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf","2011-06-14 00:00:00",
35034,2,20635,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf","2011-06-14 00:00:00",
25399,1,20635,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf","2012-05-01 00:00:00",
35035,2,20635,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf","2012-04-30 00:00:00",
41511,3,20635,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm","2015-03-11 00:00:00",
12901,2,20635,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
25400,1,20635,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
41512,3,20635,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020635Orig1s068s070.pdf","2012-06-22 00:00:00",
20791,3,20635,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020635Orig1s068s070.pdf","2012-06-22 00:00:00",
25401,1,20635,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
35036,2,20635,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
2958,1,20635,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf","2013-08-16 00:00:00",
35037,2,20635,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf","2013-08-15 00:00:00",
25402,1,20635,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf","2014-05-28 00:00:00",
35038,2,20635,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf","2014-05-28 00:00:00",
2959,1,20635,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf","2016-07-26 00:00:00",
35039,2,20635,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf","2016-07-26 00:00:00",
47150,1,20635,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020634Orig1s068,020635Orig1s074,021721Orig1s035ltr.pdf","2017-02-09 00:00:00",
47162,2,20635,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf","2017-02-10 00:00:00",
20792,3,20636,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020636_S002_VIRAMUNE.pdf","2007-08-06 00:00:00",
20793,3,20636,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020636_S005_VIRAMUNE.pdf","2007-08-06 00:00:00",
41513,3,20636,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020636_S007_VIRAMUNE.pdf","2007-08-06 00:00:00",
20794,3,20636,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_20-636S009_Viramune.cfm","2004-02-04 00:00:00",
25403,1,20636,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Approv.pdf","2004-06-30 00:00:00",
35040,2,20636,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf","2004-06-30 00:00:00",
20795,3,20636,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020636_S012_VIRAMUNE.pdf","2007-08-06 00:00:00",
25404,1,20636,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr006ltr.pdf","2004-06-30 00:00:00",
35041,2,20636,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf","2003-04-04 00:00:00",
20796,3,20636,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020636s017_020933s007_Viramune.cfm","2005-04-27 00:00:00",
25405,1,20636,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf","2002-03-27 00:00:00",
25406,1,20636,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr020,20933slr010ltr.pdf","2003-08-06 00:00:00",
35042,2,20636,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf","2003-08-06 00:00:00",
2960,1,20636,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr021,20933slr011ltr.pdf","2003-12-23 00:00:00",
35043,2,20636,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf","2003-12-29 00:00:00",
2961,1,20636,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20636slr022ltr.pdf","2004-05-26 00:00:00",
12902,2,20636,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20636slr022_viramune_lbl.pdf","2004-05-27 00:00:00",
2962,1,20636,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr.pdf","2005-03-02 00:00:00",
20797,3,20636,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020636_S025_VIRAMUNE.pdf","2007-08-06 00:00:00",
35044,2,20636,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf","2005-03-02 00:00:00",
12903,2,20636,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf","2007-04-20 00:00:00",
25407,1,20636,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015ltr.pdf","2007-04-20 00:00:00",
2963,1,20636,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027, 020933s017ltr.pdf","2008-06-30 00:00:00",
35045,2,20636,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf","2008-06-26 00:00:00",
25408,1,20636,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019ltr.pdf","2007-08-17 00:00:00",
35046,2,20636,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf","2007-08-17 00:00:00",
12904,2,20636,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf","2010-01-20 00:00:00",
25409,1,20636,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032ltr.pdf","2010-01-26 00:00:00",
2964,1,20636,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026ltr.pdf","2010-07-23 00:00:00",
35047,2,20636,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf","2010-07-22 00:00:00",
25410,1,20636,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027ltr.pdf","2011-01-14 00:00:00",
35048,2,20636,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf","2011-01-10 00:00:00",
2965,1,20636,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037ltr.pdf","2011-03-31 00:00:00",
12905,2,20636,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf","2011-03-28 00:00:00",
25411,1,20636,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf","2011-05-10 00:00:00",
2966,1,20636,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030ltr.pdf","2011-11-14 00:00:00",
35049,2,20636,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf","2011-11-10 00:00:00",
25412,1,20636,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933Orig1s033ltr.pdf","2012-11-13 00:00:00",
35050,2,20636,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf","2012-11-15 00:00:00",
12906,2,20636,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf","2014-01-28 00:00:00",
25413,1,20636,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933Orig1s035ltr.pdf","2014-01-28 00:00:00",
47735,2,20636,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf","2017-03-28 00:00:00",
47736,8,20636,"SUPPL",48,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19","2017-03-28 00:00:00",
47768,1,20636,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020636Orig1s048,020933Orig1s038ltr.pdf","2017-03-29 00:00:00",
55613,2,20636,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf","2018-09-25 00:00:00",
55615,8,20636,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf#page=19","2018-09-25 00:00:00",
55742,1,20636,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020636Orig1s050,020933Orig1s040ltr.pdf","2018-10-01 00:00:00",
20798,3,20637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020637Orig1s000.pdf","2013-02-25 00:00:00",
2967,1,20637,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20637se1-016ltr.pdf","2003-03-10 00:00:00",
20799,3,20637,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-637s016_Gliadel.cfm","2003-07-08 00:00:00",
35051,2,20637,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020637s016lbl.pdf","2003-03-05 00:00:00",
2968,1,20637,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020637s022ltr.pdf","2007-01-08 00:00:00",
25414,1,20637,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020637Orig1s026ltr.pdf","2013-08-20 00:00:00",
35052,2,20637,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020637s026lbl.pdf","2013-08-21 00:00:00",
2969,1,20637,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020637Orig1s027ltr.pdf","2014-11-24 00:00:00",
35053,2,20638,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/020638s003lbl.pdf","2005-01-28 00:00:00",
23174,8,20639,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf","2009-11-20 00:00:00",
23587,10,20639,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
41514,3,20639,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20639_seroquel_toc.cfm","2007-07-17 00:00:00",
44456,14,20639,"ORIG",1,"Other Important Information from FDA","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
2970,1,20639,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20639S11LTR.PDF","2001-03-27 00:00:00",
2971,1,20639,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf","2004-01-14 00:00:00",
12907,2,20639,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf","2004-01-15 00:00:00",
41515,3,20639,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf","2007-11-19 00:00:00",
20800,3,20639,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf","2007-11-19 00:00:00",
25415,1,20639,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf","2004-01-14 00:00:00",
35054,2,20639,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf","2004-01-15 00:00:00",
2972,1,20639,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639s020ltr.pdf","2004-07-21 00:00:00",
35055,2,20639,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639s020lbl.pdf","2004-07-21 00:00:00",
25416,1,20639,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s021ltr.pdf","2006-02-08 00:00:00",
2973,1,20639,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s023ltr.pdf","2006-09-25 00:00:00",
12908,2,20639,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf","2006-09-21 00:00:00",
25417,1,20639,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf","2008-05-14 00:00:00",
35056,2,20639,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf","2008-06-05 00:00:00",
2974,1,20639,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s026ltr.pdf","2006-10-23 00:00:00",
12909,2,20639,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf","2006-10-23 00:00:00",
25418,1,20639,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s030ltr.pdf","2008-10-28 00:00:00",
2975,1,20639,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s031ltr.pdf","2008-01-30 00:00:00",
25419,1,20639,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020639s035ltr.pdf","2007-08-02 00:00:00",
2976,1,20639,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf","2008-05-14 00:00:00",
12910,2,20639,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf","2008-06-05 00:00:00",
24179,21,20639,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020639se1-037_SUMR.pdf","2008-07-16 00:00:00",
41516,3,20639,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020639s037.pdf","2011-09-22 00:00:00",
2977,1,20639,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf","2008-05-14 00:00:00",
35057,2,20639,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf","2008-06-05 00:00:00",
25420,1,20639,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s039ltr.pdf","2008-01-30 00:00:00",
2978,1,20639,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf","2008-05-14 00:00:00",
35058,2,20639,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf","2008-06-05 00:00:00",
2979,1,20639,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s043ltr.pdf","2008-08-19 00:00:00",
12911,2,20639,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf","2009-12-11 00:00:00",
25421,1,20639,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf","2010-01-27 00:00:00",
53021,17,20639,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel statistical prea.pdf","1900-01-01 00:00:00",
53022,20,20639,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinical prea.pdf","1900-01-01 00:00:00",
53023,57,20639,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel CDTL review prea.pdf","1900-01-01 00:00:00",
53024,18,20639,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinpharm prea.pdf","1900-01-01 00:00:00",
53025,62,20639,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinpharm secondary review prea.pdf","1900-01-01 00:00:00",
2980,1,20639,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf","2010-01-27 00:00:00",
35059,2,20639,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf","2009-12-11 00:00:00",
20801,3,20639,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm","2012-03-07 00:00:00",
25422,1,20639,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf","2011-07-12 00:00:00",
35060,2,20639,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf","2011-07-12 00:00:00",
2981,1,20639,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s051ltr.pdf","2011-05-19 00:00:00",
35061,2,20639,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s051lbl.pdf","2011-05-23 00:00:00",
2982,1,20639,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020639s052ltr.pdf","2010-12-06 00:00:00",
12912,2,20639,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf","2010-12-04 00:00:00",
12913,2,20639,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf","2013-05-01 00:00:00",
25423,1,20639,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
20802,3,20639,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm","2012-03-07 00:00:00",
25424,1,20639,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf","2011-07-12 00:00:00",
35062,2,20639,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf","2011-07-12 00:00:00",
2983,1,20639,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s055ltr.pdf","2011-11-14 00:00:00",
2984,1,20639,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
35063,2,20639,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf","2013-05-01 00:00:00",
51625,57,20639,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel CDTL review prea.pdf","1900-01-01 00:00:00",
51626,20,20639,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinical prea.pdf","1900-01-01 00:00:00",
51627,18,20639,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinpharm prea.pdf","1900-01-01 00:00:00",
51628,18,20639,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel clinpharm secondary review prea.pdf","1900-01-01 00:00:00",
51629,17,20639,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020639_quetiapine fumarate_seroquel statistical prea.pdf","1900-01-01 00:00:00",
12914,2,20639,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf","2013-05-01 00:00:00",
25425,1,20639,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
25426,1,20639,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
35064,2,20639,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf","2013-05-01 00:00:00",
12915,2,20639,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf","2013-10-31 00:00:00",
25427,1,20639,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf","2013-10-30 00:00:00",
2985,1,20639,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf","2016-06-21 00:00:00",
12916,2,20639,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf","2016-06-21 00:00:00",
47305,2,20639,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020639s065lbl.pdf","2017-02-24 00:00:00",
47373,1,20639,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020639Orig1s065,022047Orig1s039ltr.pdf","2017-03-02 00:00:00",
20803,3,20641,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml","2007-03-02 00:00:00",
41517,3,20641,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml","2007-03-02 00:00:00",
2986,1,20641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641S007_Loratadine_Approv.pdf","2000-12-04 00:00:00",
12917,2,20641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf","2000-12-04 00:00:00",
20804,3,20641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641s007_LoratadineClaritin.cfm","2000-12-04 00:00:00",
25428,1,20641,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf","2002-11-27 00:00:00",
41518,3,20641,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm","2004-12-07 00:00:00",
25429,1,20641,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf","2003-11-25 00:00:00",
25430,1,20641,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s016ltr.pdf","2004-07-21 00:00:00",
2987,1,20641,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s017ltr.pdf","2004-10-29 00:00:00",
2988,1,20641,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020641s018ltr.pdf","2005-06-15 00:00:00",
25431,1,20641,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s024ltr.pdf","2008-07-30 00:00:00",
25432,1,20641,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s025ltr.pdf","2008-07-30 00:00:00",
2989,1,20641,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020641Orig1s032ltr.pdf","2013-03-01 00:00:00",
35065,2,20641,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf","2014-01-14 00:00:00",
2990,1,20641,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s036ltr.pdf","2015-04-22 00:00:00",
12918,2,20641,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf","2015-04-21 00:00:00",
25433,1,20641,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s037ltr.pdf","2015-10-23 00:00:00",
35066,2,20641,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf","2015-10-26 00:00:00",
2991,1,20641,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s038ltr.pdf","2015-11-09 00:00:00",
35067,2,20641,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf","2015-11-25 00:00:00",
2992,1,20641,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s040ltr.pdf","2015-12-31 00:00:00",
12919,2,20641,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf","2016-01-04 00:00:00",
45033,1,20641,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020641Orig1s042ltr.pdf","2016-08-09 00:00:00",
45089,2,20641,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf","2016-08-22 00:00:00",
54218,1,20641,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020641Orig1s045ltr.pdf","2018-05-16 00:00:00",
54314,2,20641,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641Orig1s045lbl.pdf","2018-05-23 00:00:00",
25434,1,20645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020645ltr.pdf","2005-02-23 00:00:00",
35068,2,20645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf","2005-02-23 00:00:00",
41519,3,20645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000TOC.cfm","2007-06-04 00:00:00",
44457,14,20645,"ORIG",1,"Label as it appears on Package","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645_box_lbl.pdf","2005-02-23 00:00:00",
2993,1,20645,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020645s008ltr.pdf","2011-07-05 00:00:00",
35069,2,20645,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf","2011-07-06 00:00:00",
41520,3,20646,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020646_gabitril_toc.cfm","2010-01-07 00:00:00",
43662,8,20646,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf","2010-10-13 00:00:00",
44063,10,20646,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107285.htm","2005-04-15 00:00:00",
2994,1,20646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s014ltr.pdf","2005-02-17 00:00:00",
35070,2,20646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf","2005-02-17 00:00:00",
2995,1,20646,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s015ltr.pdf","2005-12-06 00:00:00",
35071,2,20646,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf","2005-12-05 00:00:00",
2996,1,20646,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020646s016ltr.pdf","2009-05-04 00:00:00",
35072,2,20646,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf","2009-05-12 00:00:00",
25435,1,20646,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020646s017ltr.pdf","2010-10-13 00:00:00",
35073,2,20646,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf","2010-10-11 00:00:00",
12920,2,20646,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf","2015-11-12 00:00:00",
25436,1,20646,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020646Orig1s018ltr.pdf","2015-11-09 00:00:00",
25437,1,20646,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020646s020ltr.pdf","2012-01-30 00:00:00",
45020,2,20646,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf","2016-08-09 00:00:00",
45034,1,20646,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020646Orig1s021ltr.pdf","2016-08-09 00:00:00",
41521,3,20647,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020647a_s01_s02_s03.pdf","1997-08-06 00:00:00",
2997,1,20647,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf","2009-01-06 00:00:00",
35074,2,20647,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf","2016-04-14 00:00:00",
12921,2,20647,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf","2016-04-14 00:00:00",
25438,1,20647,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf","2009-01-06 00:00:00",
23588,10,20648,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm115425.htm","2006-03-31 00:00:00",
20805,3,20648,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020648_S002_DIASTAT_AP.pdf","2007-07-06 00:00:00",
25439,1,20648,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20648S2ltr.pdf","2001-04-11 00:00:00",
23060,6,20648,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008ppi.pdf","2006-03-27 00:00:00",
25440,1,20648,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020648s008ltr.pdf","2005-09-22 00:00:00",
35075,2,20648,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf","2006-03-27 00:00:00",
25441,1,20648,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020648Orig1s009ltr.pdf","2013-09-03 00:00:00",
25442,1,20648,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020648Orig1s012ltr.pdf","2014-12-17 00:00:00",
35076,2,20648,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf","2014-12-17 00:00:00",
45732,1,20648,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s013ltr.pdf","2016-10-31 00:00:00",
46378,2,20648,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s013lbl.pdf","2016-12-21 00:00:00",
46241,2,20648,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf","2016-12-20 00:00:00",
46469,1,20648,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s014ltr.pdf","2016-12-22 00:00:00",
41522,3,20649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020649_edex_toc.cfm","2003-08-08 00:00:00",
12922,2,20649,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf","2006-06-12 00:00:00",
25443,1,20649,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020649s015LTR.pdf","2006-06-12 00:00:00",
25444,1,20649,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020649Orig1s023ltr.pdf","2015-03-11 00:00:00",
35077,2,20649,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf","2015-03-26 00:00:00",
25445,1,20652,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20652s003ltr.pdf","2002-07-08 00:00:00",
12923,2,20655,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf","2003-12-01 00:00:00",
25446,1,20655,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20655slr006ltr.pdf","2003-11-26 00:00:00",
2998,1,20655,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20655s8ltr.pdf","2002-04-05 00:00:00",
12924,2,20655,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf","2002-04-05 00:00:00",
41523,3,20655,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-665s008_Alora.cfm","2004-05-27 00:00:00",
25447,1,20655,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020655s011ltr.pdf","2005-05-20 00:00:00",
35078,2,20655,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf","2005-05-20 00:00:00",
50261,2,20655,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf","2017-11-02 00:00:00",
12925,2,20657,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf","2001-04-17 00:00:00",
25448,1,20657,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf","2001-04-17 00:00:00",
41524,3,20657,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm","2001-10-26 00:00:00",
2999,1,20657,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf","2001-04-17 00:00:00",
35079,2,20657,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf","2001-04-17 00:00:00",
41525,3,20657,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm","2001-10-26 00:00:00",
3000,1,20657,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf","2002-09-11 00:00:00",
35080,2,20657,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s7lbl.pdf","2002-09-11 00:00:00",
3001,1,20657,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20657slr008ltr.pdf","2002-07-17 00:00:00",
35081,2,20657,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20657s8lbl.pdf","2002-07-17 00:00:00",
3002,1,20657,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20657slr010ltr.pdf","2003-09-30 00:00:00",
35082,2,20657,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20657slr010_sporanox_lbl.pdf","2003-09-30 00:00:00",
3003,1,20657,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf","2009-03-10 00:00:00",
12926,2,20657,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf","2009-03-17 00:00:00",
3004,1,20657,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf","2009-03-10 00:00:00",
35083,2,20657,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf","2009-03-17 00:00:00",
3005,1,20657,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf","2009-03-10 00:00:00",
12927,2,20657,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf","2009-03-17 00:00:00",
3006,1,20657,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020657s011,s018,s019,s021ltr.pdf","2009-03-10 00:00:00",
35084,2,20657,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020657s011s018s019s021lbl.pdf","2009-03-17 00:00:00",
3007,1,20657,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf","2010-08-03 00:00:00",
12928,2,20657,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020657s024lbl.pdf","2010-07-31 00:00:00",
3008,1,20657,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s025ltr.pdf","2011-01-07 00:00:00",
12929,2,20657,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s025lbl.pdf","2011-01-11 00:00:00",
12930,2,20657,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020657s026lbl.pdf","2011-04-18 00:00:00",
25449,1,20657,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020657s026ltr.pdf","2011-04-19 00:00:00",
3009,1,20657,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf","2012-03-27 00:00:00",
12931,2,20657,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s027lbl.pdf","2012-03-27 00:00:00",
12932,2,20657,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020657s028lbl.pdf","2012-03-27 00:00:00",
25450,1,20657,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020657s027,s028ltr.pdf","2012-03-27 00:00:00",
3010,1,20657,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf","2014-06-11 00:00:00",
35085,2,20657,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020657s032lbl.pdf","2014-06-10 00:00:00",
12933,2,20657,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf","2015-04-17 00:00:00",
25451,1,20657,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf","2015-04-17 00:00:00",
47660,2,20657,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020657s035lbl.pdf","2017-03-23 00:00:00",
47695,1,20657,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s060,020657Orig1s035ltr.pdf","2017-03-24 00:00:00",
49992,2,20657,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020083s061,020657s036lbl.pdf","2017-10-10 00:00:00",
50032,1,20657,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020083Orig1s061,020657Orig1s036ltr.pdf","2017-10-12 00:00:00",
41526,3,20658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020658_requip_toc.cfm","2007-07-17 00:00:00",
44064,10,20658,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm258819.htm","2011-12-20 00:00:00",
3011,1,20658,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20658slr012ltr.pdf","2003-06-22 00:00:00",
20806,3,20658,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020658_s012_RequipTOC.cfm","2006-05-16 00:00:00",
12934,2,20658,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf","2005-05-17 00:00:00",
25452,1,20658,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020658s013ltr.pdf","2005-05-17 00:00:00",
41527,3,20658,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020658Orig1s013.pdf","2016-02-03 00:00:00",
25453,1,20658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf","2009-01-06 00:00:00",
35086,2,20658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf","2009-01-06 00:00:00",
3012,1,20658,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf","2009-01-06 00:00:00",
12935,2,20658,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf","2009-01-06 00:00:00",
25454,1,20658,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf","2009-01-06 00:00:00",
35087,2,20658,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf","2009-01-06 00:00:00",
3013,1,20658,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf","2014-09-02 00:00:00",
35088,2,20658,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf","2014-09-02 00:00:00",
3014,1,20658,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf","2014-09-02 00:00:00",
35089,2,20658,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf","2014-09-02 00:00:00",
3015,1,20658,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf","2014-09-02 00:00:00",
35090,2,20658,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf","2014-09-02 00:00:00",
12936,2,20658,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf","2014-09-02 00:00:00",
25455,1,20658,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf","2014-09-02 00:00:00",
25456,1,20658,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020658s031ltr.pdf","2012-03-23 00:00:00",
3016,1,20658,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf","2014-09-02 00:00:00",
35091,2,20658,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf","2014-09-02 00:00:00",
45293,1,20658,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020658Orig1s033ltr.pdf","2016-09-15 00:00:00",
46965,2,20658,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020658s033lbl.pdf","2017-01-24 00:00:00",
48315,1,20658,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020658Orig1s034ltr.pdf","2017-05-09 00:00:00",
48332,2,20658,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020658s034lbl.pdf","2017-05-09 00:00:00",
41528,3,20659,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm","2005-04-27 00:00:00",
12937,2,20659,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf","2003-04-25 00:00:00",
3017,1,20659,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf","2001-03-06 00:00:00",
3018,1,20659,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf","2002-03-14 00:00:00",
35092,2,20659,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf","2002-03-14 00:00:00",
3019,1,20659,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf","2003-09-25 00:00:00",
12938,2,20659,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf","2003-09-25 00:00:00",
3020,1,20659,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf","2005-03-30 00:00:00",
35093,2,20659,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf","2005-03-30 00:00:00",
3021,1,20659,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf","2005-11-18 00:00:00",
35094,2,20659,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf","2005-11-17 00:00:00",
41529,3,20659,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S033_NORVIR.pdf","2007-11-19 00:00:00",
12939,2,20659,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf","2005-10-10 00:00:00",
25457,1,20659,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf","2005-10-11 00:00:00",
41530,3,20659,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S034_NORVIR.pdf","2007-11-19 00:00:00",
52166,20,20659,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20659s034_ritonavir_Norvir-MedRev.pdf","1900-01-01 00:00:00",
52167,18,20659,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20659s034_ritonavir_Norvir-ClinPharmRev.pdf","1900-01-01 00:00:00",
52168,23,20659,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020659, 020680_ritonavir_4-16-99_HFD530_orig.pdf","1900-01-01 00:00:00",
52169,25,20659,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020659, 020680_ritonavir_WR_amend1.pdf","1900-01-01 00:00:00",
3022,1,20659,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf","2007-05-16 00:00:00",
35095,2,20659,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf","2007-05-16 00:00:00",
3023,1,20659,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s039ltr.pdf","2008-05-20 00:00:00",
25458,1,20659,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf","2007-08-02 00:00:00",
35096,2,20659,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf","2007-08-02 00:00:00",
12940,2,20659,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf","2008-08-29 00:00:00",
25459,1,20659,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf","2008-09-03 00:00:00",
25460,1,20659,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf","2008-10-02 00:00:00",
35097,2,20659,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf","2009-08-04 00:00:00",
12941,2,20659,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf","2010-02-16 00:00:00",
25461,1,20659,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s045ltr.pdf","2010-02-17 00:00:00",
25462,1,20659,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf","2010-01-20 00:00:00",
35098,2,20659,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf","2009-12-02 00:00:00",
12942,2,20659,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf","2010-05-07 00:00:00",
25463,1,20659,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001ltr.pdf","2010-05-03 00:00:00",
3024,1,20659,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020659s055,022417s006ltr.pdf","2011-12-08 00:00:00",
12943,2,20659,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf","2011-12-14 00:00:00",
3025,1,20659,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007ltr.pdf","2012-02-27 00:00:00",
35099,2,20659,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf","2012-02-22 00:00:00",
3026,1,20659,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659Orig1s057ltr.pdf","2012-11-23 00:00:00",
35100,2,20659,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf","2012-11-28 00:00:00",
12944,2,20659,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf","2013-11-08 00:00:00",
25464,1,20659,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020659Orig1s058,022417Orig1s010ltr.pdf","2013-11-08 00:00:00",
3027,1,20659,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s012,020659Orig1s060ltr.pdf","2015-03-17 00:00:00",
12945,2,20659,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf","2015-03-19 00:00:00",
3028,1,20659,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659Orig1s061ltr.pdf","2015-04-03 00:00:00",
35101,2,20659,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf","2015-04-07 00:00:00",
25465,1,20659,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417Orig1s14ltr.pdf","2015-11-17 00:00:00",
35102,2,20659,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf","2015-11-12 00:00:00",
45948,1,20659,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s063,022417Orig1s015ltr.pdf","2016-11-23 00:00:00",
45989,2,20659,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf","2016-12-01 00:00:00",
46511,2,20659,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf","2016-12-22 00:00:00",
46530,1,20659,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s064022417Orig1s016ltr.pdf","2016-12-23 00:00:00",
45288,1,20659,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf","2016-09-19 00:00:00",
45311,2,20659,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf","2016-09-15 00:00:00",
48876,2,20659,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf","2017-06-30 00:00:00",
48884,1,20659,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf","2017-06-30 00:00:00",
48676,2,20659,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf","2017-06-08 00:00:00",
48677,1,20659,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s067,022417Orig1s019ltr.pdf","2017-06-08 00:00:00",
49917,2,20659,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf","2017-10-03 00:00:00",
49924,1,20659,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf","2017-10-03 00:00:00",
20807,3,20663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020663ap.pdf","2010-01-05 00:00:00",
20808,3,20664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020664_toc.cfm","2010-01-05 00:00:00",
3029,1,20664,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020664s007ltr.pdf","2007-02-23 00:00:00",
12946,2,20664,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s007lbl.pdf","2007-02-21 00:00:00",
25466,1,20664,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020664s008ltr.pdf","2006-12-28 00:00:00",
35103,2,20664,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020664s008lbl.pdf","2006-12-14 00:00:00",
25467,1,20664,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020664s010ltr.pdf","2008-01-09 00:00:00",
35104,2,20664,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020664s010lbl.pdf","2007-12-27 00:00:00",
12947,2,20664,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf","2011-07-18 00:00:00",
25468,1,20664,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020664s011ltr.pdf","2011-07-21 00:00:00",
12948,2,20664,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s012lbl.pdf","2011-08-12 00:00:00",
25469,1,20664,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020664s012ltr.pdf","2011-10-20 00:00:00",
3030,1,20664,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020664Orig1s013ltr.pdf","2014-09-10 00:00:00",
35105,2,20664,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020664s013lbl.pdf","2014-08-27 00:00:00",
23589,10,20665,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
41531,3,20665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020665_s000.pdf","2010-03-16 00:00:00",
41532,3,20665,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm","2003-08-08 00:00:00",
3031,1,20665,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20665se1-016,21283se1-001ltr.pdf","2002-08-14 00:00:00",
35106,2,20665,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf","2002-08-14 00:00:00",
41533,3,20665,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s001_Diovan.cfm","2002-08-14 00:00:00",
3032,1,20665,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020665Orig1s033ltr.pdf","2013-10-30 00:00:00",
35107,2,20665,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020665s033lbl.pdf","2013-10-31 00:00:00",
12949,2,20665,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf","2014-03-19 00:00:00",
25470,1,20665,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf","2014-03-19 00:00:00",
3033,1,20665,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf","2014-03-19 00:00:00",
12950,2,20665,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf","2014-03-19 00:00:00",
3034,1,20665,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s037ltr.pdf","2014-09-26 00:00:00",
35108,2,20665,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s037lbl.pdf","2014-09-26 00:00:00",
12951,2,20665,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf","2015-07-30 00:00:00",
25471,1,20665,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020665Orig1s038ltr.pdf","2015-07-28 00:00:00",
47110,2,20665,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020665s039lbl.pdf","2017-02-06 00:00:00",
47125,1,20665,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020665Orig1s039ltr.pdf","2017-02-07 00:00:00",
3035,1,20666,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf","2007-08-22 00:00:00",
35109,2,20666,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf","2007-08-21 00:00:00",
3036,1,20666,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf","2009-11-19 00:00:00",
35110,2,20666,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf","2009-10-21 00:00:00",
25472,1,20666,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf","2009-11-19 00:00:00",
35111,2,20666,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf","2009-10-21 00:00:00",
3037,1,20666,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf","2015-06-12 00:00:00",
12952,2,20666,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf","2015-06-12 00:00:00",
50846,2,20666,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf","2017-12-22 00:00:00",
50888,1,20666,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020666Orig1s010ltr.pdf","2017-12-27 00:00:00",
3038,1,20667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf","1997-07-01 00:00:00",
41534,3,20667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667.cfm","1997-07-01 00:00:00",
44065,10,20667,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm","2012-09-19 00:00:00",
54287,3,20667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/020667Orig1s000_LBL.pdf","2018-05-22 00:00:00",
20809,3,20667,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020667_S008_MirapexTOC.cfm","2007-06-12 00:00:00",
25473,1,20667,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20667slr008ltr.pdf","2003-05-30 00:00:00",
12953,2,20667,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf","2006-11-09 00:00:00",
25474,1,20667,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf","2006-11-14 00:00:00",
25475,1,20667,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf","2006-11-14 00:00:00",
35112,2,20667,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf","2006-11-09 00:00:00",
3039,1,20667,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf","2009-01-06 00:00:00",
12954,2,20667,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf","2009-01-06 00:00:00",
3040,1,20667,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf","2009-01-06 00:00:00",
13169,2,20667,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf","2009-01-06 00:00:00",
25476,1,20667,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf","2009-01-06 00:00:00",
35113,2,20667,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf","2009-01-06 00:00:00",
13170,2,20667,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf","2012-07-30 00:00:00",
25477,1,20667,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf","2012-07-18 00:00:00",
3041,1,20667,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf","2012-07-18 00:00:00",
35114,2,20667,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf","2012-07-19 00:00:00",
13171,2,20667,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf","2012-07-19 00:00:00",
25478,1,20667,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf","2012-07-18 00:00:00",
3042,1,20667,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf","2012-07-18 00:00:00",
35115,2,20667,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf","2012-07-19 00:00:00",
3043,1,20667,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf","2012-07-18 00:00:00",
13172,2,20667,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf","2012-07-19 00:00:00",
13173,2,20667,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf","2011-05-16 00:00:00",
25479,1,20667,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020667s025ltr.pdf","2011-05-16 00:00:00",
25480,1,20667,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s027ltr.pdf","2012-09-05 00:00:00",
35116,2,20667,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf","2012-09-06 00:00:00",
3044,1,20667,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020667Orig1s029ltr.pdf","2013-03-04 00:00:00",
35117,2,20667,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf","2013-03-05 00:00:00",
3045,1,20667,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf","2015-04-03 00:00:00",
13174,2,20667,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf","2015-04-02 00:00:00",
25481,1,20667,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf","2015-03-31 00:00:00",
35118,2,20667,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf","2015-04-02 00:00:00",
13175,2,20667,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf","2016-01-25 00:00:00",
25482,1,20667,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s033ltr.pdf","2016-01-15 00:00:00",
3046,1,20667,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s034ltr.pdf","2016-08-01 00:00:00",
13176,2,20667,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf","2016-08-02 00:00:00",
54142,2,20667,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020667s036lbl.pdf","2018-05-11 00:00:00",
54193,1,20667,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf","2018-05-15 00:00:00",
20810,3,20668,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020668_S001_Lexxel Tablets.pdf","2007-07-06 00:00:00",
41535,3,20668,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020668_S002_Lexxel Tablets.pdf","2007-07-06 00:00:00",
3047,1,20668,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_Approv.pdf","1998-10-28 00:00:00",
20811,3,20668,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668s003_Lexxel.cfm","2002-07-25 00:00:00",
35119,2,20668,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_prntlbl.pdf","1998-10-28 00:00:00",
20812,3,20668,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020668_S004_LEXXEL.pdf","2008-02-19 00:00:00",
3048,1,20668,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020668s005ltr.pdf","2005-08-04 00:00:00",
13177,2,20668,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf","2005-08-04 00:00:00",
3049,1,20668,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20668slr009ltr.pdf","2003-06-22 00:00:00",
13178,2,20668,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf","2004-06-10 00:00:00",
25483,1,20668,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668slr011ltr.pdf","2004-06-10 00:00:00",
3050,1,20668,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668s012ltr.pdf","2004-12-29 00:00:00",
3051,1,20668,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020668s013ltr.pdf","2007-10-10 00:00:00",
41536,3,20670,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020670s009Approv.pdf","2014-07-02 00:00:00",
25484,1,20670,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20670slr011ltr.pdf","2003-01-09 00:00:00",
3052,1,20670,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020670s014ltr.pdf","2007-03-23 00:00:00",
13179,2,20670,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf","2007-03-23 00:00:00",
41537,3,20670,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020670Orig1s014.pdf","2012-11-09 00:00:00",
13180,2,20671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf","1998-11-30 00:00:00",
20813,3,20671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20671s004.cfm","1998-11-30 00:00:00",
25485,1,20671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20671s4ltr.pdf","1998-11-30 00:00:00",
3053,1,20671,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20671s9ltr.pdf","2002-03-06 00:00:00",
23974,14,20671,"SUPPL",10,"PEDIATRIC STUDIES","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671SE8010PEDS.pdf","2003-03-26 00:00:00",
25486,1,20671,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr011ltr.pdf","2003-03-28 00:00:00",
3054,1,20671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr012ltr.pdf","2003-06-08 00:00:00",
35120,2,20671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20671slr012_hycamtin_lbl.pdf","2003-05-29 00:00:00",
3055,1,20671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020671s014LTR.pdf","2006-06-20 00:00:00",
13181,2,20671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf","2006-06-15 00:00:00",
25487,1,20671,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf","2010-04-05 00:00:00",
35121,2,20671,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf","2010-04-05 00:00:00",
3056,1,20671,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf","2010-04-05 00:00:00",
13182,2,20671,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf","2010-04-05 00:00:00",
3057,1,20671,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020671Orig1s020ltr.pdf","2014-03-05 00:00:00",
13183,2,20671,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf","2014-03-04 00:00:00",
25488,1,20671,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020671Orig1s021ltr.pdf","2015-06-04 00:00:00",
35122,2,20671,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf","2015-06-04 00:00:00",
55390,2,20671,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020671s023lbl.pdf","2018-09-06 00:00:00",
55454,1,20671,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020671Orig1s23Ltr.pdf","2018-09-12 00:00:00",
20814,3,20675,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20675a.cfm","1997-12-10 00:00:00",
3058,1,20675,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf","2001-03-08 00:00:00",
25489,1,20675,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf","2001-03-08 00:00:00",
25490,1,20675,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s009ltr.pdf","2004-07-28 00:00:00",
35123,2,20675,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20675s009lbl.pdf","2004-07-28 00:00:00",
25491,1,20675,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s011ltr.pdf","2004-09-29 00:00:00",
3059,1,20675,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020675s013ltr.pdf","2008-03-13 00:00:00",
13184,2,20675,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf","2008-03-13 00:00:00",
13185,2,20675,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf","2009-12-02 00:00:00",
25492,1,20675,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020675Orig1s022ltr.pdf","2013-06-18 00:00:00",
35124,2,20675,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020675s022lbl.pdf","2013-06-18 00:00:00",
41538,3,20676,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020676_vagistat-1_toc.cfm","2003-08-08 00:00:00",
35125,2,20676,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20676s4lbl.pdf","2003-04-30 00:00:00",
3060,1,20676,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020676s009ltr.pdf","2009-11-10 00:00:00",
13186,2,20676,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf","2014-08-13 00:00:00",
41539,3,20677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm","2005-01-06 00:00:00",
20815,3,20677,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm","2005-01-06 00:00:00",
41540,3,20677,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s003_Zagam.cfm","2005-01-06 00:00:00",
3061,1,20677,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20677slr004ltr.pdf","2002-10-02 00:00:00",
35126,2,20677,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20677s4lbl.pdf","2002-10-02 00:00:00",
13187,2,20677,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf","2003-04-07 00:00:00",
25493,1,20677,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20677slr006ltr.pdf","2003-04-18 00:00:00",
41541,3,20678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020678ap.pdf","2010-01-05 00:00:00",
25494,1,20678,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20678S03LTR.PDF","2000-04-12 00:00:00",
41542,3,20678,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-678s003_Clinimax%20E.cfm","2000-04-12 00:00:00",
3062,1,20678,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf","2002-07-25 00:00:00",
3063,1,20678,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf","2002-07-25 00:00:00",
25495,1,20678,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs012ltr.pdf","2003-06-08 00:00:00",
25496,1,20678,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr013ltr.pdf","2004-02-02 00:00:00",
25497,1,20678,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020678s021ltr.pdf","2010-01-20 00:00:00",
45427,2,20678,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020678s027lbl.pdf","2016-09-29 00:00:00",
45487,1,20678,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020678Orig1s027,020734Orig1s025ltr.pdf","2016-09-30 00:00:00",
20816,3,20680,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020680_S009_NORVIR.pdf","2007-11-19 00:00:00",
41543,3,20680,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm","2005-04-27 00:00:00",
3064,1,20682,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset_appltr.pdf","1999-08-16 00:00:00",
41544,3,20682,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset.cfm","1999-08-16 00:00:00",
25498,1,20682,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020682s008ltr.pdf","2009-05-04 00:00:00",
35127,2,20682,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf","2009-05-13 00:00:00",
13188,2,20682,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf","2012-09-17 00:00:00",
25499,1,20682,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020682Orig1s010ltr.pdf","2012-09-20 00:00:00",
20817,3,20683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020683_alesse_toc.cfm","2003-08-08 00:00:00",
3065,1,20683,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s004ltr.pdf","2008-02-05 00:00:00",
13189,2,20683,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf","2008-02-14 00:00:00",
3066,1,20683,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s006ltr.pdf","2008-02-05 00:00:00",
35128,2,20683,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf","2008-02-14 00:00:00",
3067,1,20683,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s007ltr.pdf","2008-02-05 00:00:00",
13190,2,20683,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf","2008-02-14 00:00:00",
49307,2,20683,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf","2017-08-10 00:00:00",
49427,1,20683,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020683Orig1s011ltr.pdf","2017-08-16 00:00:00",
53253,2,20683,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf","2018-03-23 00:00:00",
53491,1,20683,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020683Orig1s012ltr.pdf","2018-03-28 00:00:00",
41545,3,20685,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020685_s005ap.pdf","1997-02-19 00:00:00",
41546,3,20685,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020685s022.pdf","1998-12-17 00:00:00",
20818,3,20685,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20685s041.pdf","2003-04-25 00:00:00",
25500,1,20685,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20685s41ltr.pdf","2001-03-21 00:00:00",
41547,3,20685,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-685-S043.pdf","2004-05-06 00:00:00",
20819,3,20685,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020685_S044_Crixivan.pdf","2007-09-26 00:00:00",
3068,1,20685,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf","2004-05-07 00:00:00",
13191,2,20685,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf","2004-05-07 00:00:00",
41548,3,20685,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S046_Crixivan.pdf","2007-09-26 00:00:00",
13192,2,20685,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf","2004-05-07 00:00:00",
25501,1,20685,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf","2004-05-07 00:00:00",
41549,3,20685,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S047_Crixivan.pdf","2007-09-26 00:00:00",
3069,1,20685,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s50s53ltr.pdf","2002-01-25 00:00:00",
35129,2,20685,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf","2002-06-20 00:00:00",
41550,3,20685,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S052_Crixivan.pdf","2007-09-26 00:00:00",
25502,1,20685,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf","2002-06-20 00:00:00",
35130,2,20685,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf","2002-06-20 00:00:00",
41551,3,20685,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S054_Crixivan.pdf","2007-09-26 00:00:00",
3070,1,20685,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685slr055ltr.pdf","2002-09-19 00:00:00",
13193,2,20685,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf","2002-09-19 00:00:00",
25503,1,20685,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf","2002-06-20 00:00:00",
35131,2,20685,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf","2002-06-20 00:00:00",
3071,1,20685,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20685slr057ltr.pdf","2003-06-22 00:00:00",
35132,2,20685,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20685slr057_crixivan_lbl.pdf","2003-06-22 00:00:00",
25504,1,20685,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr058ltr.pdf","2004-01-14 00:00:00",
35133,2,20685,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr058_crixivan_lbl.pdf","2004-01-15 00:00:00",
3072,1,20685,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685s060ltr.pdf","2004-12-29 00:00:00",
13194,2,20685,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf","2004-12-29 00:00:00",
41552,3,20685,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S060_Crixivan.pdf","2007-09-26 00:00:00",
13195,2,20685,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf","2006-01-13 00:00:00",
25505,1,20685,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s061ltr.pdf","2006-01-20 00:00:00",
3073,1,20685,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s062LTR.pdf","2006-08-11 00:00:00",
13196,2,20685,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf","2006-08-09 00:00:00",
3074,1,20685,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s063ltr.pdf","2006-12-28 00:00:00",
13197,2,20685,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf","2006-12-14 00:00:00",
3075,1,20685,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020685s064ltr.pdf","2007-07-24 00:00:00",
13198,2,20685,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf","2007-07-24 00:00:00",
25506,1,20685,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s065ltr.pdf","2008-04-18 00:00:00",
35134,2,20685,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s065lbl.pdf","2008-04-23 00:00:00",
13199,2,20685,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf","2008-06-05 00:00:00",
25507,1,20685,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s066ltr.pdf","2008-04-22 00:00:00",
3076,1,20685,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s068ltr.pdf","2008-12-18 00:00:00",
35135,2,20685,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s068lbl.pdf","2009-01-02 00:00:00",
3077,1,20685,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020685s069ltr.pdf","2009-11-19 00:00:00",
13200,2,20685,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf","2009-10-21 00:00:00",
3078,1,20685,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020685s071ltr.pdf","2010-04-28 00:00:00",
13201,2,20685,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf","2010-05-03 00:00:00",
3079,1,20685,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
13202,2,20685,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf","2010-11-19 00:00:00",
13203,2,20685,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf","2012-02-22 00:00:00",
25508,1,20685,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020685s075ltr.pdf","2012-02-27 00:00:00",
3080,1,20685,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020685Orig1s076ltr.pdf","2014-07-28 00:00:00",
35136,2,20685,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf","2014-07-28 00:00:00",
3081,1,20685,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020685Orig1s077ltr.pdf","2015-04-03 00:00:00",
13204,2,20685,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf","2015-04-07 00:00:00",
45339,1,20685,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020685Orig1s078ltr.pdf","2016-09-20 00:00:00",
45379,2,20685,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020685s078lbl.pdf","2016-09-20 00:00:00",
13205,2,20687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf","2000-09-28 00:00:00",
23590,10,20687,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm","2006-10-12 00:00:00",
25509,1,20687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf","2000-09-28 00:00:00",
41553,3,20687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_mifepristone.cfm","2000-09-28 00:00:00",
3082,1,20687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s010ltr.pdf","2004-11-15 00:00:00",
35137,2,20687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf","2004-11-15 00:00:00",
25510,1,20687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s011ltr.pdf","2004-12-29 00:00:00",
3083,1,20687,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020687s013ltr.pdf","2005-07-21 00:00:00",
13206,2,20687,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf","2005-07-19 00:00:00",
13207,2,20687,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf","2011-06-10 00:00:00",
23975,14,20687,"SUPPL",14,"REMS approved 6/8/2011","http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_Full.pdf","2016-03-30 00:00:00",
25511,1,20687,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020687s014ltr.pdf","2011-06-09 00:00:00",
25512,1,20687,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020687s015ltr.pdf","2009-05-06 00:00:00",
35138,2,20687,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf","2009-04-28 00:00:00",
3084,1,20687,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf","2016-03-30 00:00:00",
23976,14,20687,"SUPPL",20,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=35","2016-03-30 00:00:00",
35139,2,20687,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf","2016-03-30 00:00:00",
43665,8,20687,"SUPPL",20,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf","2016-03-30 00:00:00",
46216,3,20687,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020TOC.cfm","2016-12-19 00:00:00",
20820,3,20688,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S001_PATANOL.pdf","2008-08-08 00:00:00",
41554,3,20688,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S002_PATANOL.pdf","2008-08-08 00:00:00",
41555,3,20688,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S003_PATANOL.pdf","2008-08-08 00:00:00",
20821,3,20688,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S004_PATANOL.pdf","2008-08-08 00:00:00",
41556,3,20688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S006_PATANOL.pdf","2008-08-08 00:00:00",
20822,3,20688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S008_PATANOL.pdf","2008-08-08 00:00:00",
20823,3,20688,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S009_PATANOL.pdf","2008-08-08 00:00:00",
20824,3,20688,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S010_PATANOL.pdf","2008-08-08 00:00:00",
20825,3,20688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020688_S011_PATANOL.pdf","2008-08-04 00:00:00",
25513,1,20688,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20688S12LTR.PDF","2000-03-20 00:00:00",
41557,3,20688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020688_S013_PATANOL.pdf","2008-08-04 00:00:00",
3085,1,20688,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20688slr016ltr.pdf","2003-05-29 00:00:00",
13208,2,20688,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pdf","2003-05-29 00:00:00",
20826,3,20690,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020690_s011_aricept.pdf","2011-02-15 00:00:00",
25514,1,20690,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20690slr011ltr.pdf","2004-05-07 00:00:00",
25515,1,20690,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003LTR.pdf","2006-10-18 00:00:00",
35140,2,20690,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf","2006-10-18 00:00:00",
25516,1,20690,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690Orig1s031ltr.pdf","2013-04-09 00:00:00",
3086,1,20690,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf","2010-11-30 00:00:00",
13209,2,20690,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf","2010-12-01 00:00:00",
3087,1,20690,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pdf","2012-03-05 00:00:00",
35141,2,20690,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf","2012-03-09 00:00:00",
13210,2,20690,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf","2012-09-26 00:00:00",
25517,1,20690,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf","2012-09-06 00:00:00",
25518,1,20690,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf","2013-09-10 00:00:00",
35142,2,20690,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf","2013-09-09 00:00:00",
25519,1,20690,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf","2015-07-22 00:00:00",
35143,2,20690,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf","2015-07-22 00:00:00",
13211,2,20692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf","1998-09-25 00:00:00",
20827,3,20692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm","1998-09-25 00:00:00",
23591,10,20692,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2005-11-30 00:00:00",
25520,1,20692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf","1998-09-25 00:00:00",
41558,3,20692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020692s000_SereventTOC.cfm","2005-12-06 00:00:00",
3088,1,20692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf","1998-09-25 00:00:00",
35144,2,20692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf","1998-09-25 00:00:00",
41559,3,20692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm","1998-09-25 00:00:00",
3089,1,20692,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf","2002-03-22 00:00:00",
13212,2,20692,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf","2002-03-22 00:00:00",
13213,2,20692,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf","2003-08-15 00:00:00",
20828,3,20692,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020692_s024_SEREVENT DISKUS.pdf","2008-08-01 00:00:00",
25521,1,20692,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf","2003-08-15 00:00:00",
25522,1,20692,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf","2004-10-04 00:00:00",
35145,2,20692,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf","2004-10-04 00:00:00",
3090,1,20692,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf","2007-03-01 00:00:00",
35146,2,20692,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf","2007-02-26 00:00:00",
3091,1,20692,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf","2006-03-23 00:00:00",
13214,2,20692,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf","2006-03-03 00:00:00",
13215,2,20692,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf","2008-03-24 00:00:00",
25523,1,20692,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf","2008-03-21 00:00:00",
3092,1,20692,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf","2011-01-04 00:00:00",
13216,2,20692,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf","2011-01-04 00:00:00",
25524,1,20692,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf","2010-11-22 00:00:00",
3093,1,20692,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf","2010-06-29 00:00:00",
35147,2,20692,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf","2010-06-28 00:00:00",
25525,1,20692,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf","2011-05-12 00:00:00",
35148,2,20692,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf","2011-05-16 00:00:00",
43666,8,20692,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf","2011-05-16 00:00:00",
3094,1,20692,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf","2011-07-05 00:00:00",
25526,1,20692,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf","2012-08-13 00:00:00",
25527,1,20692,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf","2014-04-16 00:00:00",
35149,2,20692,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf","2014-04-16 00:00:00",
45475,1,20692,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020692Orig1s045ltr.pdf","2016-10-05 00:00:00",
45585,2,20692,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf","2016-10-06 00:00:00",
20829,3,20694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020694ap.pdf","2010-01-05 00:00:00",
41560,3,20695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-695_Raxar_Pharma.pdf","2004-07-15 00:00:00",
41561,3,20695,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-695s003_Raxar.cfm","2004-06-28 00:00:00",
25528,1,20696,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20696s001ltr.pdf","2000-12-08 00:00:00",
3095,1,20697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20697ltr.pdf","1998-01-29 00:00:00",
20830,3,20697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20697_Tasmar.cfm","2002-04-09 00:00:00",
35150,2,20697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20697lbl-s4.pdf","1998-01-29 00:00:00",
3096,1,20697,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020697Orig1s004ltr.pdf","2013-05-14 00:00:00",
35151,2,20697,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020697s004lbl.pdf","2013-05-14 00:00:00",
3097,1,20697,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020697s010ltr.pdf","2006-03-01 00:00:00",
13217,2,20697,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020697s010lbl.pdf","2006-02-22 00:00:00",
13218,2,20697,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020697s012lbl.pdf","2007-01-25 00:00:00",
25529,1,20697,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020697s012ltr.pdf","2007-02-02 00:00:00",
13219,2,20697,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf","2009-02-10 00:00:00",
25530,1,20697,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015ltr.pdf","2009-02-13 00:00:00",
3098,1,20697,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s013,020697s015ltr.pdf","2009-02-13 00:00:00",
13220,2,20697,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020697s013s015lbl.pdf","2009-02-10 00:00:00",
3099,1,20697,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020697s016ltr.pdf","2009-07-07 00:00:00",
20831,3,20698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020698.cfm","1999-08-17 00:00:00",
25531,1,20698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20698ltr.pdf","1999-02-18 00:00:00",
35152,2,20698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20698pi.pdf","1999-02-18 00:00:00",
25532,1,20698,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698scp004ltr.pdf","2004-06-09 00:00:00",
25533,1,20698,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698s009ltr.pdf","2004-08-10 00:00:00",
3100,1,20699,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20699s1ltr.pdf","1999-03-11 00:00:00",
13221,2,20699,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf","1999-03-11 00:00:00",
20832,3,20699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020699_effexorxr_toc.cfm","2010-01-07 00:00:00",
23592,10,20699,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm","2005-04-15 00:00:00",
41562,3,20699,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s005_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf","2008-08-04 00:00:00",
41563,3,20699,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S010_EFFEXOR.pdf","2007-09-24 00:00:00",
41564,3,20699,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S012_EFFEXOR_XR.pdf","2008-08-04 00:00:00",
20833,3,20699,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_s013_EFFEXOR_XR.pdf","2008-08-04 00:00:00",
20834,3,20699,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
3101,1,20699,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf","2003-07-30 00:00:00",
13222,2,20699,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf","2003-04-28 00:00:00",
20835,3,20699,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm","2007-07-06 00:00:00",
13223,2,20699,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf","2004-06-02 00:00:00",
25534,1,20699,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf","2003-07-30 00:00:00",
41565,3,20699,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm","2007-07-06 00:00:00",
41566,3,20699,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
20836,3,20699,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
13224,2,20699,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf","2003-03-05 00:00:00",
25535,1,20699,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699se1-022ltr.pdf","2004-06-02 00:00:00",
41567,3,20699,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
41568,3,20699,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s024_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf","2008-08-04 00:00:00",
41569,3,20699,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S025_EFFEXOR_XR.pdf","2008-02-19 00:00:00",
41570,3,20699,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
20837,3,20699,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
41571,3,20699,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S028_EFFEXOR.pdf","2008-02-19 00:00:00",
20838,3,20699,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S029_EFFEXOR_AP.pdf","2007-07-06 00:00:00",
25536,1,20699,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20699slr029ltr.pdf","2002-10-22 00:00:00",
25537,1,20699,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf","2004-05-07 00:00:00",
3102,1,20699,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr032ltr.pdf","2003-03-10 00:00:00",
20839,3,20699,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S032_EFFEXOR_AP.pdf","2007-04-11 00:00:00",
41572,3,20699,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm","2007-07-06 00:00:00",
25538,1,20699,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf","2003-09-09 00:00:00",
41573,3,20699,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S038_EFFEXOR_AP.pdf","2007-07-06 00:00:00",
25539,1,20699,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf","2004-03-24 00:00:00",
41574,3,20699,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s039_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf","2008-07-31 00:00:00",
13225,2,20699,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
20840,3,20699,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S041_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
25540,1,20699,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
3103,1,20699,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf","2003-09-09 00:00:00",
41575,3,20699,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S043_EFFEXOR_AP.pdf","2007-07-06 00:00:00",
3104,1,20699,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20699slr045ltr.pdf","2004-03-19 00:00:00",
41576,3,20699,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s045_EFFEXOR_XR_EXTENDED_RELEASE_CAPS.pdf","2008-07-31 00:00:00",
25541,1,20699,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf","2004-04-20 00:00:00",
3105,1,20699,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020699s047ltr.pdf","2008-01-09 00:00:00",
13226,2,20699,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf","2007-12-27 00:00:00",
3106,1,20699,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
35153,2,20699,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
41577,3,20699,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S048_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
25542,1,20699,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf","2012-08-28 00:00:00",
35154,2,20699,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf","2012-09-11 00:00:00",
25543,1,20699,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf","2004-03-24 00:00:00",
13227,2,20699,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf","2004-05-27 00:00:00",
25544,1,20699,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf","2004-05-26 00:00:00",
41578,3,20699,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S052_EFFEXOR_TABLETS.pdf","2007-11-19 00:00:00",
3107,1,20699,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf","2005-11-22 00:00:00",
13228,2,20699,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf","2005-11-22 00:00:00",
35155,2,20699,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf","2007-08-02 00:00:00",
3108,1,20699,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf","2006-03-01 00:00:00",
3109,1,20699,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf","2005-11-22 00:00:00",
13229,2,20699,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf","2005-11-22 00:00:00",
25545,1,20699,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf","2005-02-23 00:00:00",
13230,2,20699,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf","2005-12-05 00:00:00",
25546,1,20699,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s059ltr.pdf","2005-12-05 00:00:00",
3110,1,20699,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf","2006-01-20 00:00:00",
25547,1,20699,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf","2006-01-20 00:00:00",
3111,1,20699,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020699s066ltr.pdf","2006-03-23 00:00:00",
3112,1,20699,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s067ltr.pdf","2008-02-05 00:00:00",
3113,1,20699,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf","2007-02-12 00:00:00",
35156,2,20699,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf","2007-02-21 00:00:00",
3114,1,20699,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf","2006-09-20 00:00:00",
35157,2,20699,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf","2006-09-15 00:00:00",
3115,1,20699,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf","2006-10-23 00:00:00",
13231,2,20699,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf","2006-10-23 00:00:00",
25548,1,20699,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf","2007-08-02 00:00:00",
35158,2,20699,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf","2007-08-02 00:00:00",
25549,1,20699,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf","2007-09-25 00:00:00",
35159,2,20699,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf","2007-09-26 00:00:00",
3116,1,20699,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf","2007-09-25 00:00:00",
35160,2,20699,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf","2007-09-26 00:00:00",
3117,1,20699,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf","2008-05-28 00:00:00",
35161,2,20699,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf","2008-11-20 00:00:00",
13232,2,20699,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf","2008-02-14 00:00:00",
25550,1,20699,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s083ltr.pdf","2008-02-14 00:00:00",
25551,1,20699,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf","2010-01-19 00:00:00",
35162,2,20699,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf","2009-11-13 00:00:00",
25552,1,20699,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf","2009-02-03 00:00:00",
35163,2,20699,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf","2009-02-04 00:00:00",
13233,2,20699,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf","2012-09-11 00:00:00",
25553,1,20699,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf","2012-08-28 00:00:00",
25554,1,20699,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf","2010-01-14 00:00:00",
35164,2,20699,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf","2010-01-08 00:00:00",
13234,2,20699,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf","2014-12-19 00:00:00",
25555,1,20699,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s091ltr.pdf","2014-12-19 00:00:00",
13235,2,20699,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf","2012-12-28 00:00:00",
25556,1,20699,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf","2012-12-21 00:00:00",
13236,2,20699,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf","2012-05-07 00:00:00",
25557,1,20699,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf","2012-05-09 00:00:00",
13237,2,20699,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf","2012-12-28 00:00:00",
25558,1,20699,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf","2012-12-21 00:00:00",
13238,2,20699,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf","2014-07-08 00:00:00",
25559,1,20699,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf","2014-07-09 00:00:00",
25560,1,20699,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s104ltr.pdf","2014-10-23 00:00:00",
25561,1,20699,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf","2014-07-09 00:00:00",
35166,2,20699,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf","2014-07-08 00:00:00",
3118,1,20699,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf","2016-03-02 00:00:00",
13239,2,20699,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf","2016-03-03 00:00:00",
46688,2,20699,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf","2017-01-06 00:00:00",
46741,1,20699,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021992Orig1s044,020699Orig1s107ltr.pdf","2017-01-10 00:00:00",
47778,2,20699,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf","2017-03-30 00:00:00",
47827,1,20699,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s108ltr.pdf","2017-04-03 00:00:00",
50811,2,20699,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf","2017-12-21 00:00:00",
50891,1,20699,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf","2017-12-20 00:00:00",
50812,2,20699,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf","2017-12-21 00:00:00",
50814,8,20699,"SUPPL",111,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf#page=36","2017-12-21 00:00:00",
50892,1,20699,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf","2017-12-27 00:00:00",
41579,3,20701,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020701_crinone_toc.cfm","2003-08-08 00:00:00",
25562,1,20701,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001//20701S7ltr.pdf","2001-04-11 00:00:00",
3119,1,20701,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20701S9ltr.pdf","2001-04-23 00:00:00",
41580,3,20701,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020701_S009_CRINONE.pdf","2007-11-19 00:00:00",
3120,1,20701,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr012ltr.pdf","2003-09-29 00:00:00",
25563,1,20701,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr012ltr.pdf","2003-11-26 00:00:00",
3121,1,20701,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20701s014ltr.pdf","2005-03-29 00:00:00",
13240,2,20701,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20701s014lbl.pdf","2005-03-29 00:00:00",
3122,1,20701,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf","2011-12-14 00:00:00",
13241,2,20701,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf","2011-12-14 00:00:00",
25564,1,20701,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf","2011-12-14 00:00:00",
35167,2,20701,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf","2011-12-14 00:00:00",
3123,1,20701,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf","2011-12-14 00:00:00",
35168,2,20701,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf","2011-12-14 00:00:00",
13242,2,20701,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020701s026lbl.pdf","2013-08-22 00:00:00",
20841,3,20702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020702_s000.pdf","2010-03-16 00:00:00",
20842,3,20702,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020702a_s002.pdf","1997-11-28 00:00:00",
3124,1,20702,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf","1998-07-10 00:00:00",
20843,3,20702,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20702s005.cfm","1998-11-12 00:00:00",
41581,3,20702,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702a_s004.pdf","1998-10-23 00:00:00",
20844,3,20702,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20702s005.cfm","1998-07-10 00:00:00",
25565,1,20702,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf","1998-07-10 00:00:00",
41582,3,20702,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020702_S008_LIPITOR_TABLETS_AP.pdf","2007-07-06 00:00:00",
41583,3,20702,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S009_LIPITOR.pdf","2007-11-19 00:00:00",
20845,3,20702,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S010_LIPITOR.pdf","2007-11-19 00:00:00",
20846,3,20702,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S011_LIPITOR.pdf","2007-11-19 00:00:00",
41584,3,20702,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S012_LIPITOR.pdf","2007-11-19 00:00:00",
20847,3,20702,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S013_LIPITOR.pdf","2007-11-19 00:00:00",
20848,3,20702,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702A_S014.PDF","1998-12-14 00:00:00",
25566,1,20702,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20702S18LTR.PDF","1999-12-02 00:00:00",
41585,3,20702,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020702-S018_Lipitor.cfm","2001-02-26 00:00:00",
41586,3,20702,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020702_S021_LIPITOR.pdf","2007-11-19 00:00:00",
20849,3,20702,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020702_S022_LIPITOR_AP.pdf","2007-07-06 00:00:00",
20850,3,20702,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020702_S024_LIPITOR_TABLETS.pdf","2008-02-19 00:00:00",
13243,2,20702,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf","2001-06-15 00:00:00",
20851,3,20702,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-702S025_Lipitor.cfm","2002-04-10 00:00:00",
25567,1,20702,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20702S25ltr.pdf","2001-06-15 00:00:00",
25568,1,20702,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702slr027ltr.pdf","2004-05-26 00:00:00",
41587,3,20702,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020702_s027_LIPITOR_TABLETS.pdf","2008-07-31 00:00:00",
43563,6,20702,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20702slr027_lipitor_lbl.pdf","2004-05-27 00:00:00",
20852,3,20702,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S028_LIPITOR.pdf","2007-12-06 00:00:00",
3125,1,20702,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf","2002-04-22 00:00:00",
35169,2,20702,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf","2002-04-22 00:00:00",
20853,3,20702,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S030_LIPITOR.pdf","2007-12-06 00:00:00",
20854,3,20702,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S031_LIPITOR.pdf","2007-12-06 00:00:00",
13244,2,20702,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s33lbl.pdf","2002-10-18 00:00:00",
25569,1,20702,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702se5-033ltr.pdf","2002-10-18 00:00:00",
3126,1,20702,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf","2004-06-08 00:00:00",
13245,2,20702,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf","2004-06-08 00:00:00",
41588,3,20702,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020702_S035_LIPITOR.pdf","2007-09-26 00:00:00",
3127,1,20702,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702slr036ltr.pdf","2003-06-08 00:00:00",
13246,2,20702,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702slr036_lipitor_lbl.pdf","2003-05-29 00:00:00",
41589,3,20702,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_S036_LIPITOR.pdf","2007-09-26 00:00:00",
13247,2,20702,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702scs037_lipitor_lbl.pdf","2003-10-10 00:00:00",
20855,3,20702,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_s037_LIPITOR_TABLETS.pdf","2008-08-01 00:00:00",
25570,1,20702,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702scs037ltr.pdf","2003-10-09 00:00:00",
25571,1,20702,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702s039ltr.pdf","2004-08-02 00:00:00",
41590,3,20702,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_s039_LIPITOR_TABLETS.pdf","2008-08-01 00:00:00",
3128,1,20702,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s042ltr.pdf","2005-10-20 00:00:00",
35170,2,20702,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020702s042lbl.pdf","2005-09-30 00:00:00",
3129,1,20702,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s043ltr.pdf","2005-10-14 00:00:00",
3130,1,20702,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s044LTR.pdf","2006-08-09 00:00:00",
35171,2,20702,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s044lbl.pdf","2006-08-09 00:00:00",
3131,1,20702,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s046LTR.pdf","2006-06-27 00:00:00",
23061,6,20702,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s046Pi.pdf","2006-06-28 00:00:00",
13248,2,20702,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s047lbl.pdf","2007-03-07 00:00:00",
25572,1,20702,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s047ltr.pdf","2007-03-07 00:00:00",
25573,1,20702,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s049ltr.pdf","2007-01-25 00:00:00",
35172,2,20702,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s049lbl.pdf","2007-01-18 00:00:00",
25574,1,20702,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s050ltr.pdf","2007-10-04 00:00:00",
35173,2,20702,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s050lbl.pdf","2007-09-26 00:00:00",
3132,1,20702,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s056ltr.pdf","2010-11-05 00:00:00",
20856,3,20702,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020702Orig1s056.pdf","2013-08-06 00:00:00",
35174,2,20702,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf","2009-06-22 00:00:00",
25575,1,20702,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s057ltr.pdf","2009-04-01 00:00:00",
35175,2,20702,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s057lbl.pdf","2009-04-03 00:00:00",
25576,1,20702,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702s060ltr.pdf","2012-02-28 00:00:00",
35176,2,20702,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702Orig1s060lbl.pdf","2012-02-28 00:00:00",
41591,3,20702,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020702s060.pdf","2012-03-30 00:00:00",
3133,1,20702,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063ltr.pdf","2012-11-05 00:00:00",
35177,2,20702,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf","2012-11-02 00:00:00",
3134,1,20702,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063ltr.pdf","2012-11-05 00:00:00",
13249,2,20702,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf","2012-11-02 00:00:00",
25577,1,20702,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020702Orig1s064ltr.pdf","2014-05-22 00:00:00",
35178,2,20702,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020702s064lbl.pdf","2014-05-28 00:00:00",
3135,1,20702,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020702Orig1s065ltr.pdf","2015-03-13 00:00:00",
35179,2,20702,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020702s065lbl.pdf","2015-03-17 00:00:00",
48839,1,20702,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020702Orig1s067s069ltr.pdf","2017-06-27 00:00:00",
48845,2,20702,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf","2017-06-27 00:00:00",
48840,1,20702,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020702Orig1s067s069ltr.pdf","2017-06-27 00:00:00",
48846,2,20702,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf","2017-06-27 00:00:00",
55168,2,20702,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020702s071lbl.pdf","2018-08-13 00:00:00",
55225,1,20702,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020702Oirg1s071ltr.pdf","2018-08-20 00:00:00",
20857,3,20704,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml","2007-03-02 00:00:00",
20858,3,20704,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml","2007-03-02 00:00:00",
3136,1,20704,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf","2002-11-27 00:00:00",
20859,3,20704,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm","2004-12-07 00:00:00",
25578,1,20704,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf","2003-11-25 00:00:00",
25579,1,20704,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020704s014ltr.pdf","2006-01-30 00:00:00",
3137,1,20704,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020704s020ltr.pdf","2008-10-23 00:00:00",
3138,1,20704,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020704s021ltr.pdf","2009-02-03 00:00:00",
3139,1,20704,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf","2014-07-24 00:00:00",
35180,2,20704,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf","2014-07-29 00:00:00",
13250,2,20704,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf","2015-12-01 00:00:00",
25580,1,20704,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf","2015-11-27 00:00:00",
45837,1,20704,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020704Orig1s029ltr.pdf","2016-11-08 00:00:00",
45900,2,20704,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020704Orig1s029lbl.pdf","2016-11-16 00:00:00",
48457,1,20704,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020704Orig1s032ltr.pdf","2017-05-19 00:00:00",
48465,2,20704,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020704Orig1s032lbl.pdf","2017-05-19 00:00:00",
54972,1,20704,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf","2018-07-25 00:00:00",
55108,2,20704,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf","2018-08-03 00:00:00",
20860,3,20705,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020705_S002_Rescriptor Tablets_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
13251,2,20705,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20705s03lbl.pdf","1999-07-14 00:00:00",
25581,1,20705,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20705s03ltr.pdf","1999-07-14 00:00:00",
41592,3,20705,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-705S003.pdf","2004-03-24 00:00:00",
20861,3,20705,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020705_S004_Rescriptor Tablets_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
13252,2,20705,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20705S8lbl.pdf","2003-04-22 00:00:00",
41593,3,20705,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020705_S008_RescriptorTOC.cfm","2007-07-09 00:00:00",
3140,1,20705,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20705s9ltr.pdf","2002-03-14 00:00:00",
20862,3,20705,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020705_S009_Rescriptor Tablets_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
3141,1,20705,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020705s010ltr.pdf","2006-04-13 00:00:00",
3142,1,20705,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020705Orig1s018ltr.pdf","2012-08-15 00:00:00",
13253,2,20705,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020705s018lbl.pdf","2012-08-15 00:00:00",
20863,3,20706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020706_emadine_toc.cfm","2010-05-25 00:00:00",
3143,1,20706,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20706slr011ltr.pdf","2003-06-08 00:00:00",
13254,2,20706,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf","2003-05-29 00:00:00",
23593,10,20707,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
41594,3,20707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020707_toc.cfm","2010-01-05 00:00:00",
25582,1,20707,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20707slr004ltr.pdf","2003-08-28 00:00:00",
3144,1,20707,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020707s005ltr.pdf","2006-11-22 00:00:00",
13255,2,20707,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020707s005lbl.pdf","2006-11-22 00:00:00",
25583,1,20707,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020707s006ltr.pdf","2010-03-24 00:00:00",
35181,2,20707,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020707s006lbl.pdf","2010-03-26 00:00:00",
20864,3,20708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020708_lupron_toc.cfm","2003-08-08 00:00:00",
44066,10,20708,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
20865,3,20708,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm","2001-08-06 00:00:00",
25584,1,20708,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF","1998-04-09 00:00:00",
3145,1,20708,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf","1999-02-11 00:00:00",
41595,3,20708,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5.cfm","1999-06-22 00:00:00",
41596,3,20708,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020708_S006_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
3146,1,20708,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf","2001-09-21 00:00:00",
13256,2,20708,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf","2001-09-21 00:00:00",
20866,3,20708,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron.cfm","2001-11-14 00:00:00",
3147,1,20708,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf","2004-01-22 00:00:00",
25585,1,20708,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf","2004-01-14 00:00:00",
25586,1,20708,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
41597,3,20708,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S020_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
3148,1,20708,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf","2005-10-20 00:00:00",
41598,3,20708,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S021_Lupron Depot_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
3149,1,20708,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf","2007-11-08 00:00:00",
25587,1,20708,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.pdf","2009-06-08 00:00:00",
35182,2,20708,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf","2009-06-04 00:00:00",
3150,1,20708,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf","2010-11-02 00:00:00",
35183,2,20708,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf","2010-10-29 00:00:00",
3151,1,20708,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf","2012-04-02 00:00:00",
35184,2,20708,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf","2012-03-28 00:00:00",
3152,1,20708,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf","2011-06-16 00:00:00",
35185,2,20708,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf","2011-06-16 00:00:00",
25588,1,20708,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf","2012-01-25 00:00:00",
35186,2,20708,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020708s033lbl.pdf","2012-01-23 00:00:00",
3153,1,20708,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf","2013-10-31 00:00:00",
13257,2,20708,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf","2013-11-05 00:00:00",
53743,2,20708,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf","2018-04-19 00:00:00",
53771,1,20708,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020708Orig1s035ltr.pdf","2018-04-23 00:00:00",
41599,3,20710,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020710_S001_PAXIL_TABLETS.pdf","2007-09-24 00:00:00",
44067,10,20710,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
41600,3,20710,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020710_S002_PAXIL_TABLETS.pdf","2007-09-24 00:00:00",
20867,3,20710,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020710_S004_PAXIL_TABLETS.pdf","2007-09-24 00:00:00",
41601,3,20710,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020710Orig1s007.pdf","2011-12-09 00:00:00",
41602,3,20710,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s010.pdf","2011-12-09 00:00:00",
41603,3,20710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s011.pdf","2011-12-09 00:00:00",
25589,1,20710,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf","2006-02-08 00:00:00",
3154,1,20710,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf","2006-02-08 00:00:00",
25590,1,20710,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf","2007-08-07 00:00:00",
35187,2,20710,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf","2007-08-03 00:00:00",
3155,1,20710,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-20 00:00:00",
25591,1,20710,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-20 00:00:00",
3156,1,20710,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
13258,2,20710,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf","2011-07-12 00:00:00",
25592,1,20710,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf","2009-11-19 00:00:00",
35188,2,20710,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf","2009-11-05 00:00:00",
3157,1,20710,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf","2008-11-03 00:00:00",
35189,2,20710,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf","2008-11-07 00:00:00",
25593,1,20710,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf","2009-02-03 00:00:00",
35190,2,20710,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf","2009-02-04 00:00:00",
3158,1,20710,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
35191,2,20710,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
25594,1,20710,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf","2010-11-02 00:00:00",
35192,2,20710,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf","2010-10-28 00:00:00",
3159,1,20710,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
35193,2,20710,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
3160,1,20710,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
13259,2,20710,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf","2011-07-12 00:00:00",
3161,1,20710,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf","2012-12-21 00:00:00",
13260,2,20710,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf","2012-12-31 00:00:00",
3162,1,20710,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf","2012-04-12 00:00:00",
35194,2,20710,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf","2012-04-17 00:00:00",
13261,2,20710,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
25595,1,20710,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
13262,2,20710,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf","2014-07-29 00:00:00",
25596,1,20710,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf","2014-07-23 00:00:00",
46695,2,20710,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020710s038lbl.pdf","2017-01-06 00:00:00",
46813,8,20710,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43","2017-01-13 00:00:00",
46814,1,20710,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf","2017-01-13 00:00:00",
20868,3,20711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020711_zyban_toc.cfm","2003-08-08 00:00:00",
23594,10,20711,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
20869,3,20711,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm","2006-05-16 00:00:00",
20870,3,20711,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm","2006-05-16 00:00:00",
25597,1,20711,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711SE8-012_Zyban_Approv.pdf","2001-02-07 00:00:00",
35195,2,20711,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20711s12lbl.pdf","2001-02-07 00:00:00",
41604,3,20711,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711s12_Zyban.cfm","2001-02-07 00:00:00",
25598,1,20711,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf","2004-07-01 00:00:00",
35196,2,20711,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf","2004-07-01 00:00:00",
3163,1,20711,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf","2004-07-01 00:00:00",
13263,2,20711,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf","2004-07-01 00:00:00",
25599,1,20711,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20711s15ltr.pdf","2002-02-21 00:00:00",
41605,3,20711,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020711_S015_ZYBAN.pdf","2007-07-09 00:00:00",
3164,1,20711,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf","2004-07-01 00:00:00",
35197,2,20711,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf","2004-07-01 00:00:00",
25600,1,20711,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf","2004-07-01 00:00:00",
35198,2,20711,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf","2004-07-01 00:00:00",
3165,1,20711,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf","2004-11-08 00:00:00",
35199,2,20711,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf","2004-11-08 00:00:00",
13264,2,20711,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf","2004-11-08 00:00:00",
25601,1,20711,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf","2004-11-08 00:00:00",
3166,1,20711,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf","2005-01-13 00:00:00",
13265,2,20711,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf","2005-01-13 00:00:00",
25602,1,20711,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s022ltr.pdf","2006-04-07 00:00:00",
25603,1,20711,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s024LTR.pdf","2006-05-02 00:00:00",
3167,1,20711,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf","2011-08-26 00:00:00",
35200,2,20711,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s026lbl.pdf","2011-08-22 00:00:00",
13266,2,20711,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020711s027lbl.pdf","2006-11-22 00:00:00",
25604,1,20711,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s027ltr.pdf","2006-11-22 00:00:00",
3168,1,20711,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020711s028ltr.pdf","2007-03-23 00:00:00",
13267,2,20711,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s028lbl.pdf","2007-03-23 00:00:00",
13268,2,20711,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf","2007-08-03 00:00:00",
25605,1,20711,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf","2007-08-07 00:00:00",
25606,1,20711,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s031ltr.pdf","2010-09-23 00:00:00",
35201,2,20711,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0020711s031lbl.pdf","2010-09-20 00:00:00",
3169,1,20711,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf","2009-07-08 00:00:00",
13269,2,20711,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf","2009-07-09 00:00:00",
13270,2,20711,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf","2009-07-09 00:00:00",
25607,1,20711,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf","2009-07-08 00:00:00",
3170,1,20711,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s034ltr.pdf","2010-03-03 00:00:00",
3171,1,20711,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf","2011-08-26 00:00:00",
13271,2,20711,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s035lbl.pdf","2011-08-22 00:00:00",
3172,1,20711,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020711s036ltr.pdf","2012-01-20 00:00:00",
35202,2,20711,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf","2012-02-01 00:00:00",
3173,1,20711,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s039ltr.pdf","2014-03-28 00:00:00",
13272,2,20711,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s039lbl.pdf","2014-04-01 00:00:00",
13273,2,20711,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s042lbl.pdf","2015-01-09 00:00:00",
25608,1,20711,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s042ltr.pdf","2014-12-30 00:00:00",
25609,1,20711,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s043ltr.pdf","2014-08-14 00:00:00",
35203,2,20711,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s043lbl.pdf","2014-08-15 00:00:00",
25610,1,20711,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020711Orig1s044ltr.pdf","2016-06-02 00:00:00",
35204,2,20711,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020711s044lbl.pdf","2016-06-02 00:00:00",
48249,2,20711,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf","2017-05-05 00:00:00",
48292,1,20711,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf","2017-05-09 00:00:00",
48250,2,20711,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf","2017-05-05 00:00:00",
48293,1,20711,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf","2017-05-09 00:00:00",
48251,2,20711,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf","2017-05-05 00:00:00",
48260,8,20711,"SUPPL",47,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf#page=37","2017-05-08 00:00:00",
48294,1,20711,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf","2017-05-09 00:00:00",
20871,3,20712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020712_carbatrol_toc.cfm","2007-04-17 00:00:00",
3174,1,20712,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s024ltr.pdf","2006-01-30 00:00:00",
3175,1,20712,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s025LTR.pdf","2006-07-13 00:00:00",
13274,2,20712,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf","2006-07-03 00:00:00",
3176,1,20712,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020712s029ltr.pdf","2008-01-09 00:00:00",
13275,2,20712,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf","2007-12-12 00:00:00",
23978,14,20712,"SUPPL",29,"Clinical Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710_ClinRev.pdf","2007-12-31 00:00:00",
13276,2,20712,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf","2009-04-28 00:00:00",
25611,1,20712,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020712s030ltr.pdf","2009-04-29 00:00:00",
3177,1,20712,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s031ltr.pdf","2011-02-03 00:00:00",
35205,2,20712,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf","2011-01-31 00:00:00",
3178,1,20712,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf","2013-03-25 00:00:00",
35206,2,20712,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf","2013-03-26 00:00:00",
25612,1,20712,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s034ltr.pdf","2011-09-06 00:00:00",
3179,1,20712,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf","2013-03-25 00:00:00",
35207,2,20712,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf","2013-03-26 00:00:00",
43672,8,20712,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf","2013-05-22 00:00:00",
55335,2,20712,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020712s036lbl.pdf","2018-08-28 00:00:00",
55350,1,20712,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020712Orig1s036ltr.pdf","2018-08-28 00:00:00",
20872,3,20713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20713.cfm","1998-04-22 00:00:00",
3180,1,20713,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020713Orig1s010ltr.pdf","2012-07-20 00:00:00",
13277,2,20713,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf","2012-07-19 00:00:00",
49329,2,20713,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020713s011lbl.pdf","2017-08-10 00:00:00",
49369,1,20713,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020713Orig1s011ltr.pdf","2017-08-15 00:00:00",
41606,3,20714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020714_nicotrol_toc.cfm","2003-08-08 00:00:00",
3181,1,20714,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20714slr010ltr.pdf","2002-09-08 00:00:00",
25613,1,20714,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr011ltr.pdf","2003-11-25 00:00:00",
25614,1,20714,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr.pdf","2004-07-21 00:00:00",
25615,1,20714,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020714s016ltr.pdf","2009-07-08 00:00:00",
20873,3,20715,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-715_Trelstar.cfm","2002-07-31 00:00:00",
23595,10,20715,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
25616,1,20715,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20715ltr.pdf","2000-06-15 00:00:00",
35208,2,20715,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20715lbl.pdf","2000-06-15 00:00:00",
25617,1,20715,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf","2002-01-15 00:00:00",
3182,1,20715,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf","2002-01-15 00:00:00",
25618,1,20715,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021288s002,020715s006ltr.pdf","2005-10-25 00:00:00",
3183,1,20715,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016, 021288s013ltr.pdf","2008-04-16 00:00:00",
3184,1,20715,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf","2011-01-20 00:00:00",
35209,2,20715,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf","2011-01-20 00:00:00",
25619,1,20715,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,022437s003ltr.pdf","2011-05-24 00:00:00",
35210,2,20715,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf","2011-05-23 00:00:00",
13278,2,20715,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf","2013-03-15 00:00:00",
25620,1,20715,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf","2013-03-15 00:00:00",
13279,2,20715,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf","2014-07-15 00:00:00",
25621,1,20715,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288Orig1s028,022437Orig1s008ltr.pdf","2014-07-15 00:00:00",
41607,3,20716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020716_vicoprofen_toc.cfm","2010-03-03 00:00:00",
3185,1,20716,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020716s008ltr.pdf","2006-11-06 00:00:00",
35211,2,20716,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020716s008lbl.pdf","2006-10-27 00:00:00",
3186,1,20716,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020716s010ltr.pdf","2008-07-31 00:00:00",
35212,2,20716,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020716s010lbl.pdf","2008-08-12 00:00:00",
3187,1,20716,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020716Orig1s011ltr.pdf","2012-08-29 00:00:00",
46256,1,20716,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf","2016-12-20 00:00:00",
46370,2,20716,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012lbl.pdf","2016-12-21 00:00:00",
46257,1,20716,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf","2016-12-20 00:00:00",
46371,2,20716,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf","2016-12-21 00:00:00",
46258,1,20716,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf","2016-12-20 00:00:00",
46372,2,20716,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf","2016-12-27 00:00:00",
46259,1,20716,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf","2016-12-20 00:00:00",
46373,2,20716,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf","2016-12-21 00:00:00",
46569,8,20716,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf#page=36","2016-12-28 00:00:00",
46261,1,20716,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf","2016-12-20 00:00:00",
46374,2,20716,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf","2016-12-21 00:00:00",
13280,2,20717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf","1998-12-24 00:00:00",
25622,1,20717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20717ltr.pdf","1998-12-24 00:00:00",
41608,3,20717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020717A_Provigil.cfm","1998-12-24 00:00:00",
41609,3,20717,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020717_S001_PROVIGIL_TABS_AP.pdf","2007-04-11 00:00:00",
52054,20,20717,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020717s21_modafinil_Provigil-MedRev.pdf","1900-01-01 00:00:00",
52055,23,20717,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020717_modafinil_Provigil_WR.pdf","1900-01-01 00:00:00",
52056,18,20717,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020717s21_modafinil_Provigil-ClinPharmRev.pdf","1900-01-01 00:00:00",
52057,17,20717,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020717s021_modafinil_Provigil-statistical review.pdf","1900-01-01 00:00:00",
41610,3,20717,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S002_PROVIGIL_TABS_AP.pdf","2007-04-11 00:00:00",
20874,3,20717,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S003_PROVIGIL_TABS_AP.pdf","2007-04-11 00:00:00",
41611,3,20717,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020717_S004_PROVIGIL_TABS_AP.pdf","2007-04-11 00:00:00",
3188,1,20717,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scp006ltr.pdf","2003-05-29 00:00:00",
41612,3,20717,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S006_PROVIGIL_TABS.pdf","2007-09-24 00:00:00",
3189,1,20717,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20717se1-008ltr.pdf","2004-02-02 00:00:00",
13281,2,20717,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-008_provigil_lbl.pdf","2004-02-03 00:00:00",
3190,1,20717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scf009ltr.pdf","2003-08-15 00:00:00",
20875,3,20717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S009_PROVIGIL_TABS.pdf","2007-09-24 00:00:00",
35213,2,20717,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf","2007-08-21 00:00:00",
35214,2,20717,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf","2007-08-21 00:00:00",
13282,2,20717,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf","2007-08-21 00:00:00",
25623,1,20717,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020717s020ltr.pdf","2007-08-22 00:00:00",
25624,1,20717,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf","2010-10-25 00:00:00",
35215,2,20717,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf","2010-10-25 00:00:00",
43674,8,20717,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf","2010-10-25 00:00:00",
3191,1,20717,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf","2010-10-25 00:00:00",
13283,2,20717,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf","2010-10-25 00:00:00",
23180,8,20717,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf","2010-10-25 00:00:00",
13284,2,20717,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf","2010-10-25 00:00:00",
25625,1,20717,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf","2010-10-25 00:00:00",
43675,8,20717,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf","2010-10-25 00:00:00",
25626,1,20717,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf","2015-01-20 00:00:00",
35216,2,20717,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf","2015-01-20 00:00:00",
3192,1,20717,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf","2015-01-20 00:00:00",
13285,2,20717,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf","2015-01-20 00:00:00",
3193,1,20717,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf","2012-01-19 00:00:00",
3194,1,20717,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf","2012-01-19 00:00:00",
3195,1,20718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20718ltr.pdf","1998-05-18 00:00:00",
20876,3,20718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20718_Integrilin.cfm","1998-05-18 00:00:00",
35217,2,20718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20718lbl.pdf","1998-05-18 00:00:00",
25627,1,20718,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20718s02ltr.pdf","1999-09-20 00:00:00",
35218,2,20718,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20718s02lbl.pdf","1999-09-20 00:00:00",
41613,3,20718,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20718S002_Integrilin.cfm","1999-09-20 00:00:00",
20877,3,20718,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm","2001-06-08 00:00:00",
25628,1,20718,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf","2001-06-08 00:00:00",
35219,2,20718,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf","2001-06-08 00:00:00",
3196,1,20718,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20718S10S13ltr.pdf","2001-06-08 00:00:00",
20878,3,20718,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-718_Integrilin.cfm","2001-06-08 00:00:00",
35220,2,20718,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf","2001-06-08 00:00:00",
3197,1,20718,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20718se8-017ltr.pdf","2003-06-22 00:00:00",
35221,2,20718,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20718se8-017_integrilin_lbl.pdf","2003-06-22 00:00:00",
3198,1,20718,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20718s022ltr.pdf","2004-07-21 00:00:00",
3199,1,20718,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020718s025ltr.pdf","2005-10-14 00:00:00",
35222,2,20718,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020718s025lbl.pdf","2005-10-14 00:00:00",
25629,1,20718,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020718s028ltr.pdf","2008-12-19 00:00:00",
35223,2,20718,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020718s028lbl.pdf","2009-01-02 00:00:00",
3200,1,20718,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020718s034ltr.pdf","2011-04-04 00:00:00",
35224,2,20718,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020718s034lbl.pdf","2011-04-01 00:00:00",
3201,1,20718,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020718Orig1s037ltr.pdf","2013-03-26 00:00:00",
35225,2,20718,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020718s037lbl.pdf","2013-03-25 00:00:00",
25630,1,20719,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_appltr.pdf","1999-10-01 00:00:00",
35226,2,20719,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_prntlbl.pdf","1999-10-01 00:00:00",
41614,3,20719,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay.cfm","1999-10-01 00:00:00",
41615,3,20720,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf","2003-06-17 00:00:00",
41616,3,20720,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf","1997-08-04 00:00:00",
41617,3,20720,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf","1997-08-14 00:00:00",
41618,3,20720,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf","2003-06-17 00:00:00",
41619,3,20720,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf","1997-08-14 00:00:00",
20879,3,20720,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf","2003-06-17 00:00:00",
41620,3,20720,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf","2003-06-17 00:00:00",
20880,3,20720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20720S12S14_Rezulin.cfm","1999-06-16 00:00:00",
25631,1,20720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf","1999-06-16 00:00:00",
35227,2,20720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf","1999-06-16 00:00:00",
13286,2,20720,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf","1999-06-16 00:00:00",
25632,1,20720,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf","1999-06-16 00:00:00",
41621,3,20720,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20720S12S14_Rezulin.cfm","1999-06-16 00:00:00",
20881,3,20723,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020723Orig1s001.pdf","2012-04-13 00:00:00",
35228,2,20723,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20723s1lbl.pdf","2003-04-22 00:00:00",
3202,1,20723,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr010ltr.pdf","2004-05-26 00:00:00",
35229,2,20723,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf","2004-05-26 00:00:00",
13287,2,20723,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf","2004-05-26 00:00:00",
25633,1,20723,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf","2004-05-26 00:00:00",
25634,1,20723,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf","2004-05-26 00:00:00",
35230,2,20723,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf","2004-05-26 00:00:00",
3203,1,20723,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723se1-015ltr.pdf","2004-03-03 00:00:00",
35231,2,20723,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723se1-015_aldara_lbl.pdf","2004-04-05 00:00:00",
3204,1,20723,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723s016ltr.pdf","2004-07-21 00:00:00",
13288,2,20723,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf","2004-07-21 00:00:00",
20882,3,20723,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020723_S016_ALDARA_CREAM.pdf","2007-11-19 00:00:00",
13289,2,20723,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf","2005-08-11 00:00:00",
25635,1,20723,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020723s018ltr.pdf","2005-08-11 00:00:00",
25636,1,20723,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020723s020LTR.pdf","2007-03-31 00:00:00",
35232,2,20723,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020723s020lbl.pdf","2007-03-31 00:00:00",
51979,20,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723s020_imiquimod_Aldara-MedRev.pdf","1900-01-01 00:00:00",
51980,23,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_orig.pdf","1900-01-01 00:00:00",
51981,25,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_amend.pdf","1900-01-01 00:00:00",
51982,26,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_amend2.pdf","1900-01-01 00:00:00",
51983,26,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_amend2.pdf","1900-01-01 00:00:00",
51984,27,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_amend3.pdf","1900-01-01 00:00:00",
51985,28,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723_imiquimod_WR_amend5(4).pdf","1900-01-01 00:00:00",
51986,17,20723,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020723s020_imiquimod_Aldara-StatsRev.pdf","1900-01-01 00:00:00",
3205,1,20723,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020723s022ltr.pdf","2010-10-19 00:00:00",
35233,2,20723,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf","2010-10-19 00:00:00",
3206,1,20725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020725s000ltr.pdf","2009-05-01 00:00:00",
24180,21,20725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725s000SumR.pdf","2010-08-10 00:00:00",
35234,2,20725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf","2009-05-13 00:00:00",
41622,3,20725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725_creon_toc.cfm","2010-08-10 00:00:00",
3207,1,20725,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s003ltr.pdf","2010-05-06 00:00:00",
35235,2,20725,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf","2010-05-07 00:00:00",
3208,1,20725,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s006ltr.pdf","2010-08-03 00:00:00",
13290,2,20725,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf","2010-07-31 00:00:00",
3209,1,20725,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s007ltr.pdf","2010-08-16 00:00:00",
35236,2,20725,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf","2010-08-19 00:00:00",
3210,1,20725,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s008ltr.pdf","2011-07-14 00:00:00",
13291,2,20725,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf","2011-07-14 00:00:00",
3211,1,20725,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s011ltr.pdf","2011-06-14 00:00:00",
13292,2,20725,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf","2011-06-14 00:00:00",
51453,20,20725,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20725 Creon clinical prea.pdf","1900-01-01 00:00:00",
13293,2,20725,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf","2011-06-16 00:00:00",
25637,1,20725,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s014ltr.pdf","2011-05-12 00:00:00",
35237,2,20725,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf","2013-03-15 00:00:00",
46120,8,20725,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf#page=16","2016-12-09 00:00:00",
41623,3,20726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020726_femara_toc.cfm","2003-08-07 00:00:00",
13294,2,20726,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf","2003-03-04 00:00:00",
25638,1,20726,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726se8-005ltr.pdf","2003-03-10 00:00:00",
13295,2,20726,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF","2001-01-10 00:00:00",
20883,3,20726,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-726S006_Femara.cfm","2001-01-10 00:00:00",
25639,1,20726,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20726S006LTR.PDF","2001-01-10 00:00:00",
3212,1,20726,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726s8ltr.pdf","2004-06-04 00:00:00",
13296,2,20726,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf","2003-01-17 00:00:00",
13297,2,20726,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf","2004-10-29 00:00:00",
25640,1,20726,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20726s011ltr.pdf","2005-01-26 00:00:00",
3213,1,20726,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020726s012rev2.pdf","2006-01-06 00:00:00",
35238,2,20726,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020726s012lbl.pdf","2006-01-05 00:00:00",
25641,1,20726,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020726s013LTR.pdf","2006-06-27 00:00:00",
3214,1,20726,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020726s014LTR.pdf","2007-04-20 00:00:00",
35239,2,20726,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf","2007-04-20 00:00:00",
13298,2,20726,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf","2010-03-03 00:00:00",
25642,1,20726,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf","2010-03-08 00:00:00",
3215,1,20726,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf","2010-03-08 00:00:00",
13299,2,20726,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf","2010-03-03 00:00:00",
25643,1,20726,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020726s017ltr.pdf","2008-08-13 00:00:00",
25644,1,20726,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020726s018ltr.pdf","2009-07-17 00:00:00",
35240,2,20726,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020726s018lbl.pdf","2009-07-09 00:00:00",
13300,2,20726,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf","2010-07-01 00:00:00",
25645,1,20726,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s019ltr.pdf","2010-06-29 00:00:00",
3216,1,20726,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s020ltr.pdf","2010-05-06 00:00:00",
13301,2,20726,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf","2010-05-06 00:00:00",
25646,1,20726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020726s024ltr.pdf","2012-01-03 00:00:00",
35241,2,20726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020726s024lbl.pdf","2011-12-23 00:00:00",
13302,2,20726,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf","2014-01-16 00:00:00",
25647,1,20726,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020726Orig1s027ltr.pdf","2014-01-17 00:00:00",
49006,1,20726,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020726Orig1s033ltr.pdf","2017-07-17 00:00:00",
49015,2,20726,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020726s033lbl.pdf","2017-07-19 00:00:00",
53631,1,20726,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020726Orig1s035ltr.pdf","2018-04-06 00:00:00",
53636,2,20726,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020726s035lbl.pdf","2018-04-09 00:00:00",
3217,1,20727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020727ltr.pdf","2005-06-24 00:00:00",
20884,3,20727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020727_s000_BidilTOC.cfm","2006-06-21 00:00:00",
35242,2,20727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020727lbl.pdf","2005-06-24 00:00:00",
13303,2,20727,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020727s004lbl.pdf","2013-04-01 00:00:00",
25648,1,20727,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020727Orig1s004ltr.pdf","2013-03-29 00:00:00",
3218,1,20727,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020727Orig1s005ltr.pdf","2015-04-03 00:00:00",
13304,2,20727,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020727s005lbl.pdf","2015-04-07 00:00:00",
3219,1,20729,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20729s10ltr.pdf","2002-02-14 00:00:00",
20885,3,20729,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020729_S010_UNIRETIC.pdf","2007-09-26 00:00:00",
25649,1,20729,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf","2003-11-25 00:00:00",
25650,1,20729,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020729s021ltr.pdf","2010-01-15 00:00:00",
35243,2,20729,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf","2010-01-20 00:00:00",
35244,2,20729,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf","2011-05-23 00:00:00",
13305,2,20729,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf","2011-09-02 00:00:00",
25651,1,20729,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020729s024ltr.pdf","2011-08-26 00:00:00",
3220,1,20729,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf","2012-01-23 00:00:00",
35245,2,20729,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf","2012-01-23 00:00:00",
25652,1,20729,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020729Orig1s026ltr.pdf","2012-09-17 00:00:00",
35246,2,20729,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf","2012-09-14 00:00:00",
3221,1,20732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf","2002-10-08 00:00:00",
13306,2,20732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf","2002-10-08 00:00:00",
23979,14,20732,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=352","2012-01-05 00:00:00",
41624,3,20732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm","2004-11-22 00:00:00",
3222,1,20732,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf","2006-10-13 00:00:00",
3223,1,20732,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf","2012-01-03 00:00:00",
35247,2,20732,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf","2011-12-23 00:00:00",
13307,2,20732,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf","2011-12-23 00:00:00",
25653,1,20732,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf","2012-01-03 00:00:00",
13308,2,20732,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf","2014-12-18 00:00:00",
25654,1,20732,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020732Orig1s010ltr.pdf","2014-12-12 00:00:00",
25655,1,20732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf","2015-09-24 00:00:00",
3224,1,20732,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf","2016-07-12 00:00:00",
46262,1,20732,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf","2016-12-20 00:00:00",
46368,2,20732,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf","2016-12-21 00:00:00",
46263,1,20732,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf","2016-12-20 00:00:00",
46369,2,20732,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf","2016-12-21 00:00:00",
49696,2,20732,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020732s016lbl.pdf","2017-09-08 00:00:00",
49807,1,20732,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s016ltr.pdf","2017-09-20 00:00:00",
49841,1,20732,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf","2017-09-22 00:00:00",
52249,2,20732,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf","2018-02-01 00:00:00",
52286,1,20732,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s018ltr.pdf","2018-02-02 00:00:00",
54595,1,20732,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s019,020733Orig1s023,022410Orig1s033ltr.pdf","2018-06-14 00:00:00",
54612,2,20732,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf","2018-06-19 00:00:00",
54618,8,20732,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32","2018-06-20 00:00:00",
50047,19,20733,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=352","2017-10-12 00:00:00",
3225,1,20733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf","2002-10-08 00:00:00",
13309,2,20733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf","2002-10-08 00:00:00",
23596,10,20733,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm","2006-10-11 00:00:00",
41625,3,20733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm","2004-11-22 00:00:00",
3226,1,20733,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf","2006-10-13 00:00:00",
25656,1,20733,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf","2012-01-03 00:00:00",
35248,2,20733,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf","2011-12-23 00:00:00",
13310,2,20733,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf","2011-12-23 00:00:00",
25657,1,20733,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf","2012-01-03 00:00:00",
3227,1,20733,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020733Orig1s014ltr.pdf","2014-12-12 00:00:00",
13311,2,20733,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020733Orig1s014lbl.pdf","2014-12-18 00:00:00",
3228,1,20733,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf","2015-09-24 00:00:00",
25658,1,20733,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf","2016-07-12 00:00:00",
46264,1,20733,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020733Orig1s018,s019ltr.pdf","2016-12-20 00:00:00",
46366,2,20733,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020733s018s019lbl.pdf","2016-12-21 00:00:00",
46265,1,20733,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020733Orig1s018,s019ltr.pdf","2016-12-20 00:00:00",
46367,2,20733,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020733s018s019lbl.pdf","2016-12-21 00:00:00",
49695,2,20733,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020733s020lbl.pdf","2017-09-08 00:00:00",
49808,1,20733,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020733Orig1s020ltr.pdf","2017-09-20 00:00:00",
49840,1,20733,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf","2017-09-22 00:00:00",
52247,2,20733,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020733s022lbl.pdf","2018-02-01 00:00:00",
52287,1,20733,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020733Orig1s022ltr.pdf","2018-02-02 00:00:00",
54594,1,20733,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s019,020733Orig1s023,022410Orig1s033ltr.pdf","2018-06-14 00:00:00",
54611,2,20733,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf","2018-06-19 00:00:00",
54619,8,20733,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32","2018-06-20 00:00:00",
3229,1,20734,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20734S03LTR.PDF","2000-04-12 00:00:00",
3230,1,20734,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf","2002-07-25 00:00:00",
25659,1,20734,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf","2002-07-25 00:00:00",
3231,1,20734,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs012ltr.pdf","2003-06-08 00:00:00",
3232,1,20734,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr013ltr.pdf","2004-02-02 00:00:00",
3233,1,20734,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020734s019ltr.pdf","2010-01-20 00:00:00",
45569,1,20734,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020678Orig1s027,020734Orig1s025ltr.pdf","2016-10-21 00:00:00",
45570,2,20734,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020734s025lbl.pdf","2016-10-21 00:00:00",
13312,2,20738,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_PRNTLBL.PDF","2004-06-18 00:00:00",
20886,3,20738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020738_tevetan_toc.cfm","2011-05-06 00:00:00",
25660,1,20738,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_APPROV.PDF","2004-06-18 00:00:00",
41626,3,20738,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020738s001_teveten_toc.cfm","2003-08-07 00:00:00",
44068,10,20738,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
41627,3,20738,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20738-s004_teveten.pdf","2001-07-05 00:00:00",
3234,1,20738,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf","2003-10-17 00:00:00",
13313,2,20738,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf","2011-05-05 00:00:00",
25661,1,20738,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020738s026ltr.pdf","2011-05-06 00:00:00",
13314,2,20738,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf","2012-01-23 00:00:00",
25662,1,20738,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf","2012-01-23 00:00:00",
13315,2,20738,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf","2012-09-14 00:00:00",
25663,1,20738,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738Orig1s028ltr.pdf","2012-09-14 00:00:00",
25664,1,20738,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020738Orig1s029ltr.pdf","2014-07-24 00:00:00",
35249,2,20738,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020738s029lbl.pdf","2014-07-24 00:00:00",
13316,2,20740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm","2010-03-02 00:00:00",
20887,3,20740,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm","2001-11-29 00:00:00",
25665,1,20740,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf","1999-05-24 00:00:00",
20888,3,20740,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf","2001-11-29 00:00:00",
25666,1,20740,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf","2001-03-30 00:00:00",
35250,2,20740,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf","2001-03-30 00:00:00",
41628,3,20740,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S006_Baycol.pdf","2001-12-03 00:00:00",
20889,3,20740,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf","2007-09-24 00:00:00",
3235,1,20740,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF","2000-07-23 00:00:00",
13317,2,20740,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf","2000-07-21 00:00:00",
41629,3,20740,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm","2001-11-29 00:00:00",
41630,3,20740,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740_S010_BAYCOL.pdf","2007-09-24 00:00:00",
41631,3,20740,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020740_S012_BAYCOL.pdf","2007-09-24 00:00:00",
3236,1,20740,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF","2000-07-23 00:00:00",
13318,2,20740,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf","2000-07-21 00:00:00",
41632,3,20740,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm","2001-11-29 00:00:00",
20890,3,20740,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf","2001-12-03 00:00:00",
20891,3,20740,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.pdf","2008-02-19 00:00:00",
35251,2,20740,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf","2003-04-22 00:00:00",
41633,3,20740,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S018_Baycol.pdf","2001-12-03 00:00:00",
35252,2,20740,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf","2002-04-23 00:00:00",
41634,3,20740,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S019_Baycol.pdf","2001-12-03 00:00:00",
20892,3,20741,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.pdf","2007-07-06 00:00:00",
3237,1,20741,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf","2002-01-18 00:00:00",
13319,2,20741,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf","2002-01-18 00:00:00",
13320,2,20741,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf","2002-10-21 00:00:00",
25667,1,20741,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-013ltr.pdf","2002-10-21 00:00:00",
20893,3,20741,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.pdf","2007-07-06 00:00:00",
41635,3,20741,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S016_PRANDIN_TABS_AP.pdf","2007-07-06 00:00:00",
13321,2,20741,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf","2003-08-29 00:00:00",
25668,1,20741,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf","2003-08-29 00:00:00",
3238,1,20741,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf","2003-10-17 00:00:00",
41636,3,20741,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020741_S019_PRANDIN_TABS_AP.pdf","2007-07-06 00:00:00",
3239,1,20741,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf","2005-02-11 00:00:00",
13322,2,20741,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf","2005-02-11 00:00:00",
3240,1,20741,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf","2006-06-28 00:00:00",
41637,3,20741,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020741_S030_PRANDIN_TABS_AP.pdf","2007-07-06 00:00:00",
3241,1,20741,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf","2008-07-15 00:00:00",
13323,2,20741,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf","2008-07-15 00:00:00",
3242,1,20741,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf","2009-06-16 00:00:00",
35253,2,20741,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf","2009-06-22 00:00:00",
3243,1,20741,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf","2010-08-03 00:00:00",
13324,2,20741,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf","2010-07-31 00:00:00",
3244,1,20741,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf","2012-03-05 00:00:00",
13325,2,20741,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf","2012-03-06 00:00:00",
47144,2,20741,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf","2017-02-09 00:00:00",
47152,1,20741,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf","2017-02-09 00:00:00",
47145,2,20741,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf","2017-02-09 00:00:00",
47153,1,20741,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf","2017-02-09 00:00:00",
13326,2,20742,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf","2003-07-10 00:00:00",
25669,1,20742,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742slr003ltr.pdf","2003-07-10 00:00:00",
3245,1,20742,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742scp004ltr.pdf","2003-05-29 00:00:00",
35254,2,20742,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf","2003-04-28 00:00:00",
13327,2,20742,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf","2004-05-27 00:00:00",
25670,1,20742,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf","2004-05-26 00:00:00",
3246,1,20742,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf","2004-05-26 00:00:00",
35255,2,20742,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf","2004-05-27 00:00:00",
13328,2,20742,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf","2004-10-04 00:00:00",
25671,1,20742,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742s008ltr.pdf","2004-10-04 00:00:00",
25672,1,20742,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020742s020ltr.pdf","2009-04-29 00:00:00",
25673,1,20742,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf","2015-12-22 00:00:00",
35256,2,20742,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf","2015-11-12 00:00:00",
25674,1,20742,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf","2015-12-22 00:00:00",
35257,2,20742,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf","2015-11-12 00:00:00",
41638,3,20743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020743_noritate_toc.cfm","2003-08-07 00:00:00",
3247,1,20743,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20743slr002ltr.pdf","2003-04-18 00:00:00",
13329,2,20743,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020743s002lbl.pdf","2003-04-04 00:00:00",
3248,1,20743,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20743scp006ltr.pdf","2004-07-06 00:00:00",
3249,1,20744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf","1999-11-18 00:00:00",
20894,3,20744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20744_Curosurf.cfm","2001-07-02 00:00:00",
35258,2,20744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf","1999-11-18 00:00:00",
25675,1,20744,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20744scs002ltr.pdf","2004-03-03 00:00:00",
25676,1,20744,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20744s4ltr.pdf","2002-03-01 00:00:00",
25677,1,20744,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020744s019ltr.pdf","2008-10-01 00:00:00",
35259,2,20744,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf","2008-10-03 00:00:00",
25678,1,20744,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020744Orig1s028ltr.pdf","2014-10-15 00:00:00",
35260,2,20744,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf","2014-10-15 00:00:00",
41639,3,20745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020745_s000_Zantac.cfm","2005-05-18 00:00:00",
25679,1,20746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20746ltr.pdf","1999-10-01 00:00:00",
35261,2,20746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20746lbl.pdf","1999-10-01 00:00:00",
41640,3,20746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20746_Rhinocort.cfm","2004-06-16 00:00:00",
25680,1,20746,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20746s4ltr.pdf","2001-10-26 00:00:00",
13330,2,20746,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf","2003-09-30 00:00:00",
25681,1,20746,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf","2003-09-26 00:00:00",
3250,1,20746,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746slr013ltr.pdf","2004-01-22 00:00:00",
35262,2,20746,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746slr013_rhinocort_lbl.pdf","2004-01-22 00:00:00",
25682,1,20746,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s015ltr.pdf","2004-08-31 00:00:00",
35263,2,20746,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746s015lbl.pdf","2004-08-31 00:00:00",
3251,1,20746,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s016ltr.pdf","2004-08-02 00:00:00",
3252,1,20746,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020746s021ltr.pdf","2007-10-22 00:00:00",
13331,2,20746,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf","2007-10-22 00:00:00",
3253,1,20746,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020746s024ltr.pdf","2009-05-29 00:00:00",
13332,2,20746,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf","2009-05-25 00:00:00",
13333,2,20746,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf","2010-12-28 00:00:00",
25683,1,20746,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020746s026ltr.pdf","2011-01-04 00:00:00",
13334,2,20746,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf","2015-03-25 00:00:00",
25684,1,20746,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020746Orig1s032ltr.pdf","2015-03-25 00:00:00",
3254,1,20746,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s033ltr.pdf","2016-03-14 00:00:00",
35264,2,20746,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s033lbl.pdf","2016-03-15 00:00:00",
25685,1,20746,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s034ltr.pdf","2016-04-25 00:00:00",
35265,2,20746,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s034lbl.pdf","2016-05-03 00:00:00",
45066,1,20746,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s036ltr.pdf","2016-08-29 00:00:00",
45177,2,20746,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s036lbl.pdf","2016-08-24 00:00:00",
48523,1,20746,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020746Orig1s037ltr.pdf","2017-05-25 00:00:00",
48535,2,20746,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020746Orig1s037lbl.pdf","2017-05-25 00:00:00",
3255,1,20747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20747ltr.pdf","1998-11-04 00:00:00",
13335,2,20747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf","1998-11-04 00:00:00",
41641,3,20747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20747_Actiq.cfm","2000-07-19 00:00:00",
44460,14,20747,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2011-12-30 00:00:00",
20895,3,20747,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020747Orig1s003.pdf","2012-02-28 00:00:00",
25686,1,20747,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20747S6ltr.pdf","2001-04-11 00:00:00",
3256,1,20747,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20747scm008ltr.pdf","2003-02-19 00:00:00",
25687,1,20747,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747slr009ltr.pdf","2003-01-29 00:00:00",
3257,1,20747,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s10ltr.pdf","2002-03-07 00:00:00",
3258,1,20747,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s011ltr.pdf","2002-06-10 00:00:00",
3259,1,20747,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20747s017ltr.pdf","2004-09-29 00:00:00",
13336,2,20747,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf","2004-09-29 00:00:00",
25688,1,20747,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s018ltr.pdf","2005-01-26 00:00:00",
20896,3,20747,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020747_S019_ACTIQ.pdf","2008-07-30 00:00:00",
25689,1,20747,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s019ltr.pdf","2005-09-15 00:00:00",
35266,2,20747,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf","2005-09-15 00:00:00",
25690,1,20747,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020747s023_ltr.pdf","2007-04-11 00:00:00",
35267,2,20747,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf","2006-09-12 00:00:00",
13337,2,20747,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf","2007-02-21 00:00:00",
25691,1,20747,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020747s027ltr.pdf","2007-02-12 00:00:00",
13338,2,20747,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf","2011-07-21 00:00:00",
25692,1,20747,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747Orig1s029ltr.pdf","2011-07-21 00:00:00",
3260,1,20747,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020747s030ltr.pdf","2010-01-20 00:00:00",
13339,2,20747,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf","2009-11-13 00:00:00",
25693,1,20747,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747s033ltr.pdf","2012-01-03 00:00:00",
35268,2,20747,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf","2011-12-28 00:00:00",
13340,2,20747,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf","2012-06-11 00:00:00",
25694,1,20747,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020747s034ltr.pdf","2012-06-07 00:00:00",
25695,1,20747,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020747Orig1s037ltr.pdf","2013-11-08 00:00:00",
25696,1,20747,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020747Orig1s041ltr.pdf","2014-12-30 00:00:00",
46267,1,20747,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf","2016-12-20 00:00:00",
46364,2,20747,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf","2016-12-21 00:00:00",
46268,1,20747,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf","2016-12-20 00:00:00",
46365,2,20747,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf","2016-12-21 00:00:00",
46572,8,20747,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf#page=21","2016-12-28 00:00:00",
49710,1,20747,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020747Orig1s047ltr.pdf","2017-09-11 00:00:00",
20897,3,20748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020748_differin.cfm","2003-05-08 00:00:00",
25697,1,20748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20748ltr.pdf","2000-05-26 00:00:00",
35269,2,20748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf","2000-05-26 00:00:00",
41642,3,20749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020749_lamisil_toc.cfm","2003-08-07 00:00:00",
25698,1,20749,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20749slr004ltr.pdf","2003-04-15 00:00:00",
35270,2,20749,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20749slr004_lamisil_lbl.pdf","2003-03-28 00:00:00",
41643,3,20750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020750_Tilade_toc.cfm","2010-03-03 00:00:00",
3261,1,20752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20752ltr.pdf","1998-05-28 00:00:00",
20898,3,20752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20752s000_PecidTOC.cfm","2005-06-23 00:00:00",
35271,2,20752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf","1998-05-28 00:00:00",
41644,3,20752,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf","1999-03-18 00:00:00",
20899,3,20752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf","2007-07-09 00:00:00",
25699,1,20752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf","2002-06-06 00:00:00",
35272,2,20752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf","2002-06-06 00:00:00",
3262,1,20753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20753LTR.PDF","1999-10-21 00:00:00",
13341,2,20753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF","1999-10-21 00:00:00",
20900,3,20753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-753_Aromasin.cfm","2004-05-27 00:00:00",
3263,1,20753,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20753slr003ltr.pdf","2003-11-25 00:00:00",
13342,2,20753,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.pdf","2003-12-02 00:00:00",
13343,2,20753,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf","2004-09-29 00:00:00",
25700,1,20753,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20753s005ltr.pdf","2004-09-29 00:00:00",
3264,1,20753,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020753s006ltr.pdf","2005-10-11 00:00:00",
13344,2,20753,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf","2005-10-07 00:00:00",
24138,15,20753,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020753s007PatientInfo.pdf","2009-01-02 00:00:00",
25701,1,20753,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020753s007ltr.pdf","2008-12-30 00:00:00",
13345,2,20753,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf","2011-03-28 00:00:00",
25702,1,20753,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf","2011-03-28 00:00:00",
13346,2,20753,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf","2011-03-28 00:00:00",
25703,1,20753,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf","2011-03-28 00:00:00",
3265,1,20753,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf","2011-03-28 00:00:00",
13347,2,20753,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf","2011-03-28 00:00:00",
3266,1,20753,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020753Orig1s014ltr.pdf","2013-02-20 00:00:00",
13348,2,20753,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf","2013-02-20 00:00:00",
25704,1,20753,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf","2014-05-06 00:00:00",
35273,2,20753,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf","2014-05-06 00:00:00",
3267,1,20753,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf","2014-05-06 00:00:00",
13349,2,20753,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf","2014-05-06 00:00:00",
13350,2,20753,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf","2016-07-27 00:00:00",
25705,1,20753,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020753Orig1s018ltr.pdf","2016-07-26 00:00:00",
54276,1,20753,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020753Orig1s020ltr.pdf","2018-05-21 00:00:00",
54284,2,20753,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020753s020lbl.pdf","2018-05-22 00:00:00",
20901,3,20755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020755_caverject_toc.cfm","2003-08-07 00:00:00",
3268,1,20755,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf","2003-09-09 00:00:00",
41645,3,20756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020756_crinone_toc.cfm","2003-08-07 00:00:00",
3269,1,20756,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S9ltr.pdf","2001-04-11 00:00:00",
25706,1,20756,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S10ltr.pdf","2001-04-23 00:00:00",
25707,1,20756,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr012ltr.pdf","2003-09-29 00:00:00",
41646,3,20757,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.cfm","2009-09-01 00:00:00",
41647,3,20757,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-757s001_Avapro.PDF","2005-04-27 00:00:00",
44069,10,20757,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
53099,17,20757,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020757s034_irbesartan_Avapro-StatsRev.pdf","1900-01-01 00:00:00",
53100,20,20757,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020757s034_irbesartan_Avapro-MedRev.pdf","1900-01-01 00:00:00",
53101,18,20757,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020757s034_irbesartan_Avapro-ClinPharmRev.pdf","1900-01-01 00:00:00",
53102,23,20757,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020757_irbesartan_Avapro_WR.pdf","1900-01-01 00:00:00",
41648,3,20757,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s002_Avapro.PDF","2005-04-27 00:00:00",
41649,3,20757,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s004_Avapro.PDF","2005-04-27 00:00:00",
41650,3,20757,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s005_Avapro.PDF","2005-04-27 00:00:00",
41651,3,20757,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s007_Avapro.PDF","2005-04-27 00:00:00",
41652,3,20757,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s008_Avapro.PDF","2005-04-27 00:00:00",
20902,3,20757,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s009_Avapro.PDF","2005-04-27 00:00:00",
20903,3,20757,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s011_Avapro.PDF","2005-04-27 00:00:00",
20904,3,20757,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s012_Avapro.PDF","2005-04-27 00:00:00",
41653,3,20757,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s013_Avapro.pdf","2005-04-27 00:00:00",
20905,3,20757,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757S014_Avapro.pdf","2004-05-27 00:00:00",
41654,3,20757,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s015_avapro.pdf","2004-05-27 00:00:00",
41655,3,20757,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s016_avapro.pdf","2004-05-27 00:00:00",
20906,3,20757,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s017_Avapro.PDF","2005-04-27 00:00:00",
23980,14,20757,"SUPPL",18,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P2.pdf","2005-04-27 00:00:00",
41656,3,20757,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P1.pdf","2005-04-27 00:00:00",
20907,3,20757,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s019_Avapro.PDF","2005-04-27 00:00:00",
20908,3,20757,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s020_Avapro.PDF","2005-04-27 00:00:00",
3270,1,20757,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757se1-021ltr.pdf","2002-09-20 00:00:00",
35274,2,20757,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20757s21lbl.pdf","2002-09-17 00:00:00",
41657,3,20757,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s021_Avapro.cfm","2004-05-27 00:00:00",
3271,1,20757,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757scm022ltr.pdf","2002-07-19 00:00:00",
41658,3,20757,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s022_Avapro.PDF","2005-04-27 00:00:00",
20909,3,20757,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s023_Avapro_P1.PDF","2005-05-05 00:00:00",
44461,14,20757,"SUPPL",23,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020757s023.pdf","2005-05-05 00:00:00",
41659,3,20757,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF","2005-05-05 00:00:00",
44462,14,20757,"SUPPL",24,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P2.PDF","2005-05-05 00:00:00",
23981,14,20757,"SUPPL",25,"Review Part 1","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s025_Avapro_P1.pdf","2005-07-29 00:00:00",
23982,14,20757,"SUPPL",25,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s025_Avapro_P2.pdf","2005-07-29 00:00:00",
20910,3,20757,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s026_Avapro.PDF","2005-07-29 00:00:00",
41660,3,20757,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s027_Avapro.PDF","2005-07-29 00:00:00",
23983,14,20757,"SUPPL",28,"Review Part 1","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P1.PDF","2005-07-29 00:00:00",
41661,3,20757,"SUPPL",28,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P2.PDF","2005-07-29 00:00:00",
20911,3,20757,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF","2005-05-03 00:00:00",
41662,3,20757,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s031_Avapro.PDF","2005-05-03 00:00:00",
41663,3,20757,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s032_Avapro.PDF","2005-05-03 00:00:00",
20912,3,20757,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s033_Avapro.PDF","2005-05-03 00:00:00",
25708,1,20757,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020757s037ltr.pdf","2005-11-30 00:00:00",
3272,1,20757,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s038LTR.pdf","2006-04-25 00:00:00",
13351,2,20757,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf","2006-04-25 00:00:00",
25709,1,20757,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s039ltr.pdf","2006-03-23 00:00:00",
35275,2,20757,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s039lbl.pdf","2006-03-22 00:00:00",
41664,3,20757,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020757_s039_avapro.pdf","2011-02-15 00:00:00",
25710,1,20757,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s055ltr.pdf","2011-08-02 00:00:00",
35276,2,20757,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s055lbl.pdf","2011-08-01 00:00:00",
3273,1,20757,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s056ltr.pdf","2011-12-14 00:00:00",
13352,2,20757,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf","2011-12-13 00:00:00",
3274,1,20757,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s058ltr.pdf","2012-01-23 00:00:00",
13353,2,20757,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf","2012-01-23 00:00:00",
25711,1,20757,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf","2016-02-09 00:00:00",
35277,2,20757,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf","2016-03-04 00:00:00",
25712,1,20757,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s060ltr.pdf","2012-09-14 00:00:00",
35278,2,20757,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s060lbl.pdf","2012-09-14 00:00:00",
25713,1,20757,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020757Orig1s064ltr.pdf","2014-06-02 00:00:00",
35279,2,20757,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020757s064lbl.pdf","2014-05-30 00:00:00",
25714,1,20757,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf","2016-02-09 00:00:00",
35280,2,20757,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf","2016-03-04 00:00:00",
54946,1,20757,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020757Orig1s069Ltr.pdf","2018-07-23 00:00:00",
55140,2,20757,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020757s069lbl.pdf","2018-08-09 00:00:00",
20913,3,20758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.cfm","2009-09-01 00:00:00",
20914,3,20758,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20758S003.cfm","1998-08-31 00:00:00",
20915,3,20758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20758-s016_avalide.pdf","2004-05-27 00:00:00",
41665,3,20758,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF","2005-05-05 00:00:00",
44463,14,20758,"SUPPL",23,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P2.PDF","2005-05-05 00:00:00",
41666,3,20758,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s029_Avapro_P1.PDF","2005-05-03 00:00:00",
44464,14,20758,"SUPPL",28,"Review Part 2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s029_Avapro_P2.pdf","2005-05-03 00:00:00",
20916,3,20758,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF","2005-05-03 00:00:00",
41667,3,20758,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s030_Avalide.pdf","2005-04-27 00:00:00",
20917,3,20758,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s031_Avalide.pdf","2005-04-27 00:00:00",
3275,1,20758,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20758s032ltr.pdf","2005-03-18 00:00:00",
25715,1,20758,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020758s035ltr.pdf","2005-11-30 00:00:00",
3276,1,20758,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020758s036LTR.pdf","2006-04-25 00:00:00",
35281,2,20758,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020758s036lbl.pdf","2006-04-25 00:00:00",
13354,2,20758,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf","2007-11-19 00:00:00",
25716,1,20758,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020758s037ltr.pdf","2007-11-19 00:00:00",
25717,1,20758,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020758s050ltr.pdf","2010-09-09 00:00:00",
35282,2,20758,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020758s050lbl.pdf","2010-09-10 00:00:00",
25718,1,20758,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf","2011-06-09 00:00:00",
35283,2,20758,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s058lbl.pdf","2011-06-06 00:00:00",
3277,1,20758,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf","2011-06-09 00:00:00",
35284,2,20758,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s059lbl.pdf","2011-06-06 00:00:00",
25719,1,20758,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s060ltr.pdf","2012-02-13 00:00:00",
35285,2,20758,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s060lbl.pdf","2012-02-17 00:00:00",
25720,1,20758,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s062ltr.pdf","2012-01-23 00:00:00",
35286,2,20758,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s062lbl.pdf","2012-01-23 00:00:00",
3278,1,20758,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758Orig1s064ltr.pdf","2012-10-29 00:00:00",
13355,2,20758,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf","2012-10-26 00:00:00",
3279,1,20758,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020758Orig1s067ltr.pdf","2014-06-02 00:00:00",
35287,2,20758,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020758s067lbl.pdf","2014-05-30 00:00:00",
25721,1,20758,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020758Orig1s070ltr.pdf","2016-02-09 00:00:00",
35288,2,20758,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020758s070lbl.pdf","2016-02-18 00:00:00",
48965,2,20758,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020758s072lbl.pdf","2017-07-13 00:00:00",
48972,1,20758,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020758Orig1s072ltr.pdf","2017-07-13 00:00:00",
54947,1,20758,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020758Orig1s073Ltr.pdf","2018-07-23 00:00:00",
55141,2,20758,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020758s073lbl.pdf","2018-08-09 00:00:00",
41668,3,20759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020760a.cfm","1997-12-18 00:00:00",
41669,3,20760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020760a.pdf","1997-12-18 00:00:00",
25722,1,20762,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20762s1ltr.pdf","1998-11-18 00:00:00",
41670,3,20762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020762_s000.pdf","2010-03-03 00:00:00",
41671,3,20762,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20762-S001_Nasonex.pdf","1998-11-18 00:00:00",
53339,20,20762,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020762_mometasone_Clinical_PREA.pdf","1900-01-01 00:00:00",
53340,17,20762,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020762_mometasone_Statistical_PREA.pdf","1900-01-01 00:00:00",
53341,20,20762,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20762 nasonex clinical prea.pdf","1900-01-01 00:00:00",
53342,18,20762,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20762 nasonex clinpharm prea.pdf","1900-01-01 00:00:00",
53343,17,20762,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20762 nasonex statistical prea.pdf","1900-01-01 00:00:00",
3280,1,20762,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s007ltr.pdf","2004-08-31 00:00:00",
13356,2,20762,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s007lbl.pdf","2004-08-31 00:00:00",
41672,3,20762,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020762_S007_NASONEX_AQUEOUS_NASAL_SPRAY.pdf","2008-04-02 00:00:00",
13357,2,20762,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20762s11lbl.pdf","2002-07-17 00:00:00",
25723,1,20762,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20762se5011ltr.pdf","2002-07-17 00:00:00",
3281,1,20762,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr014ltr.pdf","2003-03-10 00:00:00",
41673,3,20762,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020762_S014_NASONEX_AP.pdf","2007-07-09 00:00:00",
13358,2,20762,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20762slr021_nasonex_lbl.pdf","2003-12-29 00:00:00",
25724,1,20762,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr021ltr.pdf","2003-12-23 00:00:00",
13359,2,20762,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s023lbl.pdf","2004-12-30 00:00:00",
25725,1,20762,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s023ltr.pdf","2004-12-30 00:00:00",
41674,3,20762,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020762Orig1s023_FINAL_corrected.pdf","2013-02-27 00:00:00",
3282,1,20762,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020762s038ltr.pdf","2010-06-02 00:00:00",
35289,2,20762,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020762s038lbl.pdf","2010-05-28 00:00:00",
13360,2,20762,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020762s044lbl.pdf","2011-01-25 00:00:00",
25726,1,20762,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020762s044ltr.pdf","2011-01-25 00:00:00",
41675,3,20762,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020762Orig1s049.pdf","2016-07-27 00:00:00",
20918,3,20762,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020762Orig1s050.pdf","2016-07-27 00:00:00",
20919,3,20762,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020762Orig1s051.pdf","2016-07-27 00:00:00",
54707,1,20762,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020672Orig1s052s053Ltr.pdf","2018-06-27 00:00:00",
54714,2,20762,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s052lbl.pdf","2018-06-28 00:00:00",
54708,1,20762,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020672Orig1s052s053Ltr.pdf","2018-06-27 00:00:00",
54715,2,20762,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf","2018-06-28 00:00:00",
54790,8,20762,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf#page=12","2018-07-06 00:00:00",
3283,1,20763,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf","2013-10-18 00:00:00",
20920,3,20763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20763_Amerge.cfm","2004-05-27 00:00:00",
23597,10,20763,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2003-12-08 00:00:00",
25727,1,20763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20763ltr.pdf","1998-02-10 00:00:00",
35290,2,20763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20763lbl.pdf","1998-02-10 00:00:00",
35291,2,20763,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf","2013-10-18 00:00:00",
25728,1,20763,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf","2013-10-18 00:00:00",
35292,2,20763,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf","2013-10-18 00:00:00",
25729,1,20763,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20763slr005ltr.pdf","2003-11-05 00:00:00",
25730,1,20763,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020763s006ltr.pdf","2010-08-16 00:00:00",
35293,2,20763,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020763s006lbl.pdf","2010-08-19 00:00:00",
13361,2,20763,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf","2012-03-06 00:00:00",
25731,1,20763,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf","2012-03-05 00:00:00",
3284,1,20763,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf","2012-03-05 00:00:00",
35294,2,20763,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf","2012-03-06 00:00:00",
25732,1,20763,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf","2013-10-18 00:00:00",
35295,2,20763,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf","2013-10-18 00:00:00",
45972,1,20763,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020763Orig1s011ltr.pdf","2016-12-01 00:00:00",
45995,2,20763,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020763s011lbl.pdf","2016-12-01 00:00:00",
3285,1,20764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20764ltr.pdf","1998-08-24 00:00:00",
3286,1,20764,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf","1998-12-14 00:00:00",
13362,2,20764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf","1998-08-24 00:00:00",
13363,2,20764,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf","1998-12-14 00:00:00",
20921,3,20764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm","1999-05-20 00:00:00",
20922,3,20764,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm","1999-06-30 00:00:00",
13364,2,20764,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf","2003-01-17 00:00:00",
13365,2,20764,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
25733,1,20764,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
35296,2,20764,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf","2001-05-25 00:00:00",
41676,3,20764,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020764_S005.pdf","2005-12-08 00:00:00",
3287,1,20764,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-016,20764se8-009ltr.pdf","2004-01-22 00:00:00",
13366,2,20764,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf","2003-07-08 00:00:00",
25734,1,20764,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf","2003-07-06 00:00:00",
41677,3,20764,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020241_S017_020764_S011TOC.cfm","2007-05-29 00:00:00",
25735,1,20764,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
35297,2,20764,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
3288,1,20764,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
13367,2,20764,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
13368,2,20764,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
25736,1,20764,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
3289,1,20764,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf","2013-09-06 00:00:00",
35298,2,20764,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf","2013-09-06 00:00:00",
41678,3,20764,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020764_s020_Lamictal-optimized.pdf","2013-09-06 00:00:00",
3290,1,20764,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
13369,2,20764,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
3291,1,20764,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020764s029ltr.pdf","2009-05-13 00:00:00",
13370,2,20764,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf","2009-06-07 00:00:00",
13371,2,20764,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf","2009-05-12 00:00:00",
25737,1,20764,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf","2009-05-04 00:00:00",
3292,1,20764,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf","2009-05-04 00:00:00",
35299,2,20764,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf","2009-05-12 00:00:00",
3293,1,20764,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf","2013-12-26 00:00:00",
35300,2,20764,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf","2013-12-23 00:00:00",
3294,1,20764,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
13372,2,20764,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
25738,1,20764,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
35301,2,20764,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
25739,1,20764,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
35302,2,20764,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
3295,1,20764,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
13373,2,20764,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
13374,2,20764,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf","2011-08-05 00:00:00",
25740,1,20764,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf","2011-08-08 00:00:00",
25741,1,20764,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf","2011-06-02 00:00:00",
13375,2,20764,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf","2011-12-02 00:00:00",
25742,1,20764,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf","2011-12-02 00:00:00",
25743,1,20764,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf","2012-08-02 00:00:00",
35303,2,20764,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf","2012-08-02 00:00:00",
25744,1,20764,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
35304,2,20764,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
25745,1,20764,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf","2014-06-12 00:00:00",
35305,2,20764,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf","2014-06-30 00:00:00",
13376,2,20764,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf","2015-05-21 00:00:00",
25746,1,20764,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf","2015-05-20 00:00:00",
54960,1,20764,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf","2018-07-24 00:00:00",
54981,2,20764,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf","2018-07-26 00:00:00",
54982,8,20764,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64","2018-07-26 00:00:00",
54754,2,20764,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020764s050lbl.pdf","2018-07-05 00:00:00",
54845,1,20764,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf","2018-07-06 00:00:00",
13377,2,20766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf","1999-04-26 00:00:00",
25747,1,20766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf","1999-04-26 00:00:00",
41679,3,20766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm","1999-08-13 00:00:00",
13378,2,20766,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf","2001-04-23 00:00:00",
41680,3,20766,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf","2007-07-06 00:00:00",
20923,3,20766,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.pdf","2007-07-06 00:00:00",
3296,1,20766,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf","2003-12-19 00:00:00",
20924,3,20766,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES_AP.pdf","2007-07-06 00:00:00",
35306,2,20766,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf","2003-12-29 00:00:00",
52142,20,20766,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020766s018_orlistat_Xenical-MedRev.pdf","1900-01-01 00:00:00",
52143,18,20766,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020766s018_orlistat_Xenical-ClinPhamRev.pdf","1900-01-01 00:00:00",
52144,17,20766,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020766s018_orlistat_Xenical-StatsRev.pdf","1900-01-01 00:00:00",
52145,23,20766,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020766s018_orlistat_Xenical_8-9-00_HFD510_orig.pdf","1900-01-01 00:00:00",
13379,2,20766,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf","2004-11-01 00:00:00",
25748,1,20766,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf","2004-10-29 00:00:00",
41681,3,20766,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf","2007-07-06 00:00:00",
13380,2,20766,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf","2004-07-14 00:00:00",
25749,1,20766,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf","2004-07-14 00:00:00",
20925,3,20766,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.pdf","2007-07-06 00:00:00",
25750,1,20766,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf","2005-09-08 00:00:00",
35307,2,20766,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf","2005-09-08 00:00:00",
13381,2,20766,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf","2007-01-08 00:00:00",
25751,1,20766,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf","2007-01-12 00:00:00",
3297,1,20766,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf","2009-02-18 00:00:00",
13382,2,20766,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf","2009-02-12 00:00:00",
3298,1,20766,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf","2010-05-25 00:00:00",
13383,2,20766,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf","2010-05-25 00:00:00",
3299,1,20766,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf","2012-01-25 00:00:00",
13384,2,20766,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf","2012-01-24 00:00:00",
25752,1,20766,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf","2010-12-22 00:00:00",
35308,2,20766,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf","2010-12-22 00:00:00",
13385,2,20766,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf","2013-10-18 00:00:00",
25753,1,20766,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf","2013-10-18 00:00:00",
3300,1,20766,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf","2015-08-11 00:00:00",
35309,2,20766,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf","2015-08-10 00:00:00",
45070,1,20766,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020766Orig1s036ltr.pdf","2016-08-15 00:00:00",
41682,3,20767,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20210-S030_Propulsid.pdf","2000-03-06 00:00:00",
41683,3,20767,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20767-S011_Propulsid.pdf","2000-03-06 00:00:00",
20926,3,20768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020768_toc.cfm","2010-01-29 00:00:00",
23598,10,20768,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
25754,1,20768,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768s6ltr.pdf","2002-01-29 00:00:00",
20927,3,20768,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020768_S010_ZOMIG_TABLETS.pdf","2008-02-19 00:00:00",
25755,1,20768,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf","2002-10-09 00:00:00",
3301,1,20768,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf","2003-06-08 00:00:00",
3302,1,20768,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf","2004-11-19 00:00:00",
13386,2,20768,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf","2004-11-19 00:00:00",
52227,20,20768,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20768s012_zolmitriptan_Zomig-MedRev_BPCA.pdf","1900-01-01 00:00:00",
52228,20,20768,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20768s012_zolmitriptan_Zomig-MedRev2_BPCA.pdf","1900-01-01 00:00:00",
52229,18,20768,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20768s012_zolmitriptan_Zomig-ClinPharmRev_BPCA.pdf","1900-01-01 00:00:00",
52230,23,20768,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020768s012_zolmitriptan_WR.pdf","1900-01-01 00:00:00",
52231,25,20768,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020768s012_zolmitriptan_Amend.pdf","1900-01-01 00:00:00",
3303,1,20768,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf","2004-01-14 00:00:00",
3304,1,20768,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf","2010-08-16 00:00:00",
35310,2,20768,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf","2010-08-19 00:00:00",
25756,1,20768,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf","2012-09-18 00:00:00",
35311,2,20768,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf","2012-09-18 00:00:00",
3305,1,20768,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf","2012-09-18 00:00:00",
13387,2,20768,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf","2012-09-18 00:00:00",
41684,3,20769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020769_locoid_toc.cfm","2003-08-07 00:00:00",
3306,1,20769,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20769s003ltr.pdf","2004-08-25 00:00:00",
3307,1,20769,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020769s009LTR.pdf","2006-04-24 00:00:00",
25757,1,20769,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020769s011ltr.pdf","2009-10-26 00:00:00",
35312,2,20769,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020769s011lbl.pdf","2009-10-21 00:00:00",
13388,2,20769,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf","2014-12-19 00:00:00",
25758,1,20769,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020769Orig1s014ltr.pdf","2014-11-24 00:00:00",
13389,2,20771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20771lbl.pdf","1998-03-25 00:00:00",
25759,1,20771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20771ltr.pdf","1998-03-25 00:00:00",
41685,3,20771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20771_Detrol.cfm","1998-03-25 00:00:00",
3308,1,20771,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20771s4ltr.pdf","2001-04-06 00:00:00",
13390,2,20771,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20771s4lbl.pdf","2001-04-06 00:00:00",
20928,3,20771,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_S004_DetrolTOC2.cfm","2007-06-11 00:00:00",
41686,3,20771,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_s009_DETROL.pdf","2008-08-04 00:00:00",
25760,1,20771,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20771slr010ltr.pdf","2003-07-28 00:00:00",
20929,3,20771,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020771_s011_DELTROL 1 & 2 MG.pdf","2008-07-31 00:00:00",
25761,1,20771,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20771slr011ltr.pdf","2004-01-14 00:00:00",
13391,2,20771,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020771s013lbl.pdf","2005-10-24 00:00:00",
25762,1,20771,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020771s013ltr.pdf","2005-10-25 00:00:00",
3309,1,20771,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020771s014ltr.pdf","2006-04-05 00:00:00",
25763,1,20771,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020771s017, 21228s010ltr.pdf","2007-03-23 00:00:00",
13392,2,20771,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020771s019,021228s012lbl.pdf","2008-09-12 00:00:00",
25764,1,20771,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020771s019, 021228s012ltr.pdf","2008-09-15 00:00:00",
3310,1,20771,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020771s022ltr.pdf","2009-04-16 00:00:00",
35313,2,20771,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020771s022lbl.pdf","2009-04-16 00:00:00",
25765,1,20771,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020771s024ltr.pdf","2011-09-23 00:00:00",
35314,2,20771,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020771s024lbl.pdf","2011-09-23 00:00:00",
3311,1,20771,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020771Orig1s028ltr.pdf","2012-08-03 00:00:00",
13393,2,20771,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020771s028lbl.pdf","2012-08-02 00:00:00",
3312,1,20772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20772ap_ltr.pdf","1998-04-09 00:00:00",
20930,3,20772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20772.cfm","1998-12-11 00:00:00",
3313,1,20772,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020772s002ltr.pdf","2006-11-07 00:00:00",
3314,1,20772,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020772s005ltr.pdf","2014-03-10 00:00:00",
25766,1,20772,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020772s008ltr.pdf","2011-06-24 00:00:00",
25767,1,20772,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020772s011ltr.pdf","2011-01-05 00:00:00",
13394,2,20773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20773lbl.pdf","1998-10-29 00:00:00",
25768,1,20773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20773ltr.pdf","1998-10-29 00:00:00",
41687,3,20773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20773_SonoRx.cfm","2001-09-14 00:00:00",
3315,1,20774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20774ltr.pdf","1998-05-15 00:00:00",
13395,2,20774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf","1998-05-15 00:00:00",
20931,3,20774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20774.cfm","1998-05-15 00:00:00",
25769,1,20774,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20774slr003ltr.pdf","2002-12-15 00:00:00",
35315,2,20774,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20774slr003_perioChip_lbl.pdf","2002-12-15 00:00:00",
25770,1,20774,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20774slr007ltr.pdf","2004-03-03 00:00:00",
35316,2,20774,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20774slr007_periochiop_lbl.pdf","2004-04-05 00:00:00",
3316,1,20774,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020774s010ltr.pdf","2011-06-14 00:00:00",
13396,2,20774,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf","2011-07-07 00:00:00",
25771,1,20774,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774s011ltr.pdf","2012-01-17 00:00:00",
35317,2,20774,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s011lbl.pdf","2012-01-23 00:00:00",
3317,1,20774,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774Orig1s012ltr.pdf","2012-11-09 00:00:00",
13397,2,20774,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf","2012-11-08 00:00:00",
13398,2,20776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20776_Daypro_alta_lbl.pdf","2002-10-17 00:00:00",
20932,3,20776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-776_Daypro.cfm","2005-04-27 00:00:00",
23187,8,20776,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088580.pdf","2009-11-18 00:00:00",
25772,1,20776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20776ltr.pdf","2002-10-17 00:00:00",
25773,1,20776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020776s001ltr.pdf","2006-01-20 00:00:00",
35318,2,20776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020776s001lbl.pdf","2006-01-20 00:00:00",
25774,1,20776,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020776s002_ltr.pdf","2007-07-10 00:00:00",
3318,1,20776,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020776Orig1s006ltr.pdf","2016-05-12 00:00:00",
13399,2,20776,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf","2016-05-11 00:00:00",
20933,3,20778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020778ap.pdf","1997-03-14 00:00:00",
52061,20,20778,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/nelfinavir_Viracept-MedRev-20778.pdf","1900-01-01 00:00:00",
52062,23,20778,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/nelfinavir_Viracept_3-29-99_HFD530.pdf","1900-01-01 00:00:00",
52063,25,20778,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/nelfinavir_Viracept(amended)_6-18-01_HFD530.pdf","1900-01-01 00:00:00",
52064,18,20778,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/nelfinavir_Viracept-ClinPharmRev-20778.pdf","1900-01-01 00:00:00",
20934,3,20778,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020778_S010_VIRACEPT.pdf","2007-08-06 00:00:00",
41688,3,20778,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020778_S012_VIRACEPT.pdf","2007-08-06 00:00:00",
25775,1,20778,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20778S14ltr.pdf","2001-04-11 00:00:00",
41689,3,20778,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020778_S015_VIRACEPT.pdf","2007-08-06 00:00:00",
3319,1,20778,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf","2002-02-05 00:00:00",
3320,1,20778,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf","2002-02-05 00:00:00",
25776,1,20778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr039_Viracept_lbl.pdf","2003-07-30 00:00:00",
35319,2,20778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf","2003-04-04 00:00:00",
25777,1,20778,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf","2003-08-29 00:00:00",
35320,2,20778,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf","2003-08-28 00:00:00",
13400,2,20778,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf","2004-04-05 00:00:00",
20935,3,20778,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020778_S022_VIRACEPT.pdf","2007-08-06 00:00:00",
25778,1,20778,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf","2004-03-24 00:00:00",
13401,2,20778,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf","2004-06-07 00:00:00",
25779,1,20778,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf","2004-06-07 00:00:00",
25780,1,20778,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf","2005-10-20 00:00:00",
35321,2,20778,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf","2005-09-30 00:00:00",
3321,1,20778,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf","2007-01-08 00:00:00",
13402,2,20778,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf","2006-12-28 00:00:00",
35322,2,20778,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf","2007-12-03 00:00:00",
3322,1,20778,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s029ltr.pdf","2008-02-14 00:00:00",
35323,2,20778,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf","2008-02-14 00:00:00",
25781,1,20778,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf","2008-11-26 00:00:00",
3323,1,20778,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
35324,2,20778,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
3324,1,20778,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
13403,2,20778,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
3325,1,20778,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf","2011-02-28 00:00:00",
13404,2,20778,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf","2011-03-10 00:00:00",
13405,2,20778,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf","2012-04-09 00:00:00",
25782,1,20778,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf","2012-04-11 00:00:00",
25783,1,20778,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf","2012-02-27 00:00:00",
35325,2,20778,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf","2012-02-24 00:00:00",
25784,1,20778,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf","2013-05-31 00:00:00",
35326,2,20778,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf","2013-06-04 00:00:00",
25785,1,20778,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf","2015-03-31 00:00:00",
35327,2,20778,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf","2015-04-07 00:00:00",
45304,2,20778,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf","2016-09-15 00:00:00",
45360,1,20778,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf","2016-09-22 00:00:00",
20936,3,20779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020779ap.pdf","1997-03-14 00:00:00",
20937,3,20779,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept.cfm","2003-04-30 00:00:00",
25786,1,20779,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept_approv.pdf","2003-04-30 00:00:00",
41690,3,20779,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/020779_S020_VIRACEPT.pdf","2007-08-06 00:00:00",
25787,1,20779,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept_approv.pdf","2003-04-30 00:00:00",
41691,3,20779,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept.cfm","2003-04-30 00:00:00",
20938,3,20779,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020779_S026_VIRACEPT.pdf","2007-08-06 00:00:00",
25788,1,20779,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20779S32ltr.pdf","2001-04-11 00:00:00",
20939,3,20779,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S035_VIRACEPT.pdf","2007-08-06 00:00:00",
20940,3,20779,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S036_VIRACEPT.pdf","2007-08-06 00:00:00",
3326,1,20779,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf","2002-02-05 00:00:00",
25789,1,20779,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf","2002-02-05 00:00:00",
3327,1,20779,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr039_Viracept_lbl.pdf","2003-07-30 00:00:00",
35328,2,20779,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf","2003-04-04 00:00:00",
25790,1,20779,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf","2003-08-29 00:00:00",
35329,2,20779,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf","2003-08-28 00:00:00",
13406,2,20779,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf","2004-04-05 00:00:00",
25791,1,20779,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf","2004-03-24 00:00:00",
41692,3,20779,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020779_S042_VIRACEPT.pdf","2007-08-06 00:00:00",
3328,1,20779,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf","2004-06-07 00:00:00",
13407,2,20779,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf","2004-06-07 00:00:00",
20941,3,20779,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020779_S045_VIRACEPT.pdf","2007-08-06 00:00:00",
25792,1,20779,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf","2005-10-20 00:00:00",
35330,2,20779,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf","2005-09-30 00:00:00",
25793,1,20779,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf","2007-01-08 00:00:00",
35331,2,20779,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf","2006-12-28 00:00:00",
35332,2,20779,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf","2007-12-03 00:00:00",
3329,1,20779,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020779s050ltr.pdf","2008-02-14 00:00:00",
35333,2,20779,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf","2008-02-14 00:00:00",
25794,1,20779,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf","2008-11-26 00:00:00",
3330,1,20779,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
13408,2,20779,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
25795,1,20779,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
35334,2,20779,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
13409,2,20779,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf","2011-03-10 00:00:00",
25796,1,20779,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf","2011-02-28 00:00:00",
25797,1,20779,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf","2012-04-11 00:00:00",
35335,2,20779,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf","2012-04-09 00:00:00",
25798,1,20779,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf","2012-02-27 00:00:00",
35336,2,20779,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf","2012-02-24 00:00:00",
3331,1,20779,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf","2013-05-31 00:00:00",
13410,2,20779,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf","2013-06-04 00:00:00",
3332,1,20779,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf","2015-03-31 00:00:00",
35337,2,20779,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf","2015-04-07 00:00:00",
45303,2,20779,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf","2016-09-15 00:00:00",
45361,1,20779,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf","2016-09-22 00:00:00",
41693,3,20780,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S001_Cipro.pdf","2008-08-08 00:00:00",
41694,3,20780,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S002_CIPRO.pdf","2008-08-08 00:00:00",
20942,3,20780,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S003_Cipro.pdf","2008-08-08 00:00:00",
25799,1,20780,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf","2000-08-30 00:00:00",
35338,2,20780,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf","2000-08-30 00:00:00",
41695,3,20780,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm","2000-08-30 00:00:00",
13411,2,20780,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf","2002-04-17 00:00:00",
20943,3,20780,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020780_S011_CIPRO.pdf","2008-08-01 00:00:00",
25800,1,20780,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf","2002-04-17 00:00:00",
13412,2,20780,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
20944,3,20780,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S012_CIPRO.pdf","2007-11-19 00:00:00",
25801,1,20780,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
25802,1,20780,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf","2004-03-28 00:00:00",
35339,2,20780,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf","2004-04-05 00:00:00",
41696,3,20780,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm","2008-07-31 00:00:00",
13413,2,20780,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
25803,1,20780,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
41697,3,20780,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S014_CIPRO.pdf","2007-11-19 00:00:00",
13414,2,20780,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf","2004-04-05 00:00:00",
20945,3,20780,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S015_CIPRO.pdf","2007-11-19 00:00:00",
25804,1,20780,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf","2004-03-28 00:00:00",
13415,2,20780,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf","2005-01-11 00:00:00",
25805,1,20780,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf","2005-01-11 00:00:00",
3333,1,20780,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf","2004-07-21 00:00:00",
20946,3,20780,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S017_CIPRO.pdf","2008-07-31 00:00:00",
35340,2,20780,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf","2004-07-21 00:00:00",
13416,2,20780,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf","2004-07-21 00:00:00",
20947,3,20780,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S018_CIPRO.pdf","2008-07-31 00:00:00",
25806,1,20780,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf","2004-07-21 00:00:00",
25807,1,20780,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019ltr.pdf","2005-05-20 00:00:00",
35341,2,20780,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf","2005-05-20 00:00:00",
3334,1,20780,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf","2005-11-18 00:00:00",
20948,3,20780,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020780_S020_CIPRO.pdf","2007-07-09 00:00:00",
35342,2,20780,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf","2005-11-17 00:00:00",
3335,1,20780,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf","2006-06-28 00:00:00",
13417,2,20780,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020780s24lbl.pdf","2007-06-27 00:00:00",
25808,1,20780,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf","2007-07-05 00:00:00",
3336,1,20780,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025ltr.pdf","2008-01-22 00:00:00",
35343,2,20780,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf","2008-01-23 00:00:00",
13418,2,20780,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf","2008-10-09 00:00:00",
25809,1,20780,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s049,020780s026,021473s024ltr.pdf","2008-10-07 00:00:00",
25810,1,20780,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf","2009-02-18 00:00:00",
35344,2,20780,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf","2009-02-20 00:00:00",
3337,1,20780,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020780s028,021473s025ltr.pdf","2009-05-07 00:00:00",
13419,2,20780,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf","2009-05-11 00:00:00",
25811,1,20780,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf","2009-06-30 00:00:00",
25812,1,20780,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030ltr.pdf","2009-04-10 00:00:00",
35345,2,20780,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf","2009-04-16 00:00:00",
13420,2,20780,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf","2011-11-16 00:00:00",
25813,1,20780,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s074,020780s032ltr.pdf","2011-11-21 00:00:00",
3338,1,20780,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf","2011-03-02 00:00:00",
35346,2,20780,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf","2011-03-04 00:00:00",
3339,1,20780,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036ltr.pdf","2011-06-14 00:00:00",
13421,2,20780,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf","2011-06-14 00:00:00",
25814,1,20780,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf","2011-08-08 00:00:00",
3340,1,20780,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf","2011-10-20 00:00:00",
13422,2,20780,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf","2011-11-04 00:00:00",
3341,1,20780,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780Orig1s039ltr.pdf","2013-01-31 00:00:00",
13423,2,20780,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf","2013-02-01 00:00:00",
3342,1,20780,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s082,020780Orig1s040ltr.pdf","2013-08-16 00:00:00",
13424,2,20780,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf","2013-08-15 00:00:00",
13425,2,20780,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf","2015-03-02 00:00:00",
25815,1,20780,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf","2015-02-12 00:00:00",
45290,1,20780,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537Orig1s085,020780Orig1s042ltr.pdf","2016-09-19 00:00:00",
45384,2,20780,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf","2016-09-20 00:00:00",
25816,1,20780,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf","2016-07-26 00:00:00",
35347,2,20780,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf","2016-07-26 00:00:00",
49099,2,20780,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf","2017-07-27 00:00:00",
49100,8,20780,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf#page=41","2017-07-27 00:00:00",
49104,1,20780,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019537Orig1s087,020780Orig1s044ltr.pdf","2017-07-28 00:00:00",
13426,2,20781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20781lbl.pdf","1999-01-27 00:00:00",
20949,3,20781,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020781_S001_ZOFRAN.pdf","2007-09-26 00:00:00",
25817,1,20781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20781ltr.pdf","1999-01-27 00:00:00",
41698,3,20781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20781_Zofran.pdf","1999-01-27 00:00:00",
44070,10,20781,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm","2011-12-20 00:00:00",
25818,1,20781,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20103slr021,20781slr003ltr.pdf","2004-07-01 00:00:00",
3343,1,20781,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf","2004-12-02 00:00:00",
13427,2,20781,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf","2004-12-03 00:00:00",
25819,1,20781,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf","2006-01-06 00:00:00",
25820,1,20781,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf","2006-09-18 00:00:00",
35348,2,20781,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf","2006-08-23 00:00:00",
3344,1,20781,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf","2010-09-27 00:00:00",
13428,2,20781,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf","2010-09-29 00:00:00",
25821,1,20781,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf","2011-09-16 00:00:00",
35349,2,20781,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf","2011-09-16 00:00:00",
3345,1,20781,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf","2013-12-13 00:00:00",
35350,2,20781,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf","2013-12-11 00:00:00",
45486,1,20781,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf","2016-09-30 00:00:00",
54223,3,20781,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020781Orig1s017Rev.pdf","2018-05-17 00:00:00",
13429,2,20781,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf","2014-09-22 00:00:00",
25822,1,20781,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf","2014-09-23 00:00:00",
45877,2,20781,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf","2016-11-10 00:00:00",
45881,1,20781,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s035,020605Orig1s019,020781Orig1s019ltr.pdf","2016-11-10 00:00:00",
49964,2,20781,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf","2017-10-06 00:00:00",
49978,1,20781,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020103Orig1s036,020605Orig1s020,020781Orig1s020ltr.pdf","2017-10-06 00:00:00",
13430,2,20782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf","2003-04-04 00:00:00",
20950,3,20782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020782_s000_DepakoteTOC.cfm","2006-01-03 00:00:00",
25823,1,20782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.pdf","2004-06-02 00:00:00",
44071,10,20782,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
25824,1,20784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20784ltr.pdf","2004-04-20 00:00:00",
41699,3,20784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020784s000TOC.cfm","2007-07-03 00:00:00",
3346,1,20785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20785ltr.pdf","1998-07-16 00:00:00",
13431,2,20785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf","1998-07-16 00:00:00",
20951,3,20785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020785s000_ThalidomideTOC.cfm","2006-09-06 00:00:00",
23984,14,20785,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=58","2010-08-16 00:00:00",
44072,10,20785,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107296.htm","2003-12-12 00:00:00",
13432,2,20785,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf","2001-09-05 00:00:00",
25825,1,20785,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf","2001-09-05 00:00:00",
3347,1,20785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf","2001-09-05 00:00:00",
35351,2,20785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf","2003-04-23 00:00:00",
41700,3,20785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf","2001-09-05 00:00:00",
13433,2,20785,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf","2003-01-17 00:00:00",
20952,3,20785,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S020_THALOMID.pdf","2007-07-27 00:00:00",
25826,1,20785,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf","2003-01-17 00:00:00",
20953,3,20785,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S021_THALOMID.pdf","2007-07-27 00:00:00",
25827,1,20785,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf","2004-06-18 00:00:00",
35352,2,20785,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf","2003-03-06 00:00:00",
13434,2,20785,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf","2003-10-31 00:00:00",
25828,1,20785,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf","2003-10-31 00:00:00",
3348,1,20785,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf","2003-10-31 00:00:00",
13435,2,20785,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf","2003-10-31 00:00:00",
25829,1,20785,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf","2003-10-31 00:00:00",
35353,2,20785,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf","2003-10-31 00:00:00",
25830,1,20785,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf","2004-03-10 00:00:00",
25831,1,20785,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf","2004-03-10 00:00:00",
3349,1,20785,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf","2006-05-26 00:00:00",
13436,2,20785,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf","2006-05-26 00:00:00",
25832,1,20785,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020785s032_ltr.pdf","2007-01-16 00:00:00",
25833,1,20785,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf","2012-02-08 00:00:00",
35354,2,20785,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf","2012-02-06 00:00:00",
3350,1,20785,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020785s039ltr.pdf","2010-08-06 00:00:00",
13437,2,20785,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf","2012-02-06 00:00:00",
25834,1,20785,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf","2012-02-08 00:00:00",
25835,1,20785,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf","2012-02-08 00:00:00",
35355,2,20785,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf","2012-02-06 00:00:00",
3351,1,20785,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s048ltr.pdf","2013-02-12 00:00:00",
35356,2,20785,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf","2013-02-12 00:00:00",
3352,1,20785,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s050ltr.pdf","2013-11-18 00:00:00",
25836,1,20785,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s051ltr.pdf","2015-08-10 00:00:00",
35357,2,20785,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf","2015-08-07 00:00:00",
25837,1,20785,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s054ltr.pdf","2014-09-16 00:00:00",
3353,1,20785,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s055ltr.pdf","2014-06-23 00:00:00",
35358,2,20785,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf","2014-06-23 00:00:00",
3354,1,20785,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s057ltr.pdf","2015-09-15 00:00:00",
3355,1,20785,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s058ltr.pdf","2015-10-29 00:00:00",
25838,1,20785,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s059ltr.pdf","2015-12-02 00:00:00",
25839,1,20785,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020785Orig1s060ltr.pdf","2016-04-25 00:00:00",
47031,2,20785,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s061lbl.pdf","2017-01-27 00:00:00",
47049,1,20785,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s061ltr.pdf","2017-01-31 00:00:00",
48700,1,20785,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s063ltr.pdf","2017-06-12 00:00:00",
50539,2,20785,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s064lbl.pdf","2017-12-01 00:00:00",
50575,1,20785,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s064ltr.pdf","2017-12-01 00:00:00",
50946,1,20785,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s065ltr.pdf","2017-12-29 00:00:00",
50951,2,20785,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf","2018-01-02 00:00:00",
50952,8,20785,"SUPPL",65,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf#page=25","2018-01-02 00:00:00",
41701,3,20786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020786_allegra-d_toc.cfm","2010-05-25 00:00:00",
41702,3,20786,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s001_ALLEGRA TABS.pdf","2008-08-08 00:00:00",
20954,3,20786,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s002_ALLEGRA D.pdf","2008-08-08 00:00:00",
41703,3,20786,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s003_ALLEGRA TABS.pdf","2008-08-08 00:00:00",
41704,3,20786,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s004_ALLEGRA CAPSULES.pdf","2008-08-04 00:00:00",
41705,3,20786,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s005_ALLEGRA D.pdf","2008-08-08 00:00:00",
41706,3,20786,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s006_ALLEGRA CAPSULES.pdf","2008-08-04 00:00:00",
41707,3,20786,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020786_s009_ALLEGRA D.pdf","2008-08-04 00:00:00",
3356,1,20786,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20786slr012ltr.pdf","2002-11-01 00:00:00",
20955,3,20786,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020786_S012_ALLEGRA D.pdf","2007-08-06 00:00:00",
3357,1,20786,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf","2003-06-08 00:00:00",
13438,2,20786,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf","2003-05-29 00:00:00",
3358,1,20786,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020786s026ltr.pdf","2010-04-19 00:00:00",
13439,2,20786,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf","2010-04-19 00:00:00",
25840,1,20786,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020786s027ltr.pdf","2011-01-27 00:00:00",
35359,2,20786,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf","2012-03-27 00:00:00",
3359,1,20786,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf","2012-02-13 00:00:00",
3360,1,20786,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s029ltr(r).pdf","2012-08-27 00:00:00",
35360,2,20786,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf","2012-10-12 00:00:00",
3361,1,20786,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s031ltr.pdf","2012-12-11 00:00:00",
13440,2,20786,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf","2013-01-08 00:00:00",
13441,2,20786,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf","2015-06-19 00:00:00",
25841,1,20786,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf","2015-06-10 00:00:00",
3362,1,20786,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf","2016-06-07 00:00:00",
35361,2,20786,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf","2016-06-10 00:00:00",
20956,3,20788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020788_propecia_toc.cfm","2003-08-07 00:00:00",
23599,10,20788,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm","2011-12-20 00:00:00",
25842,1,20788,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf","2004-10-29 00:00:00",
35362,2,20788,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf","2004-11-01 00:00:00",
13442,2,20788,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf","2003-04-24 00:00:00",
3363,1,20788,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf","2002-04-10 00:00:00",
35363,2,20788,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf","2002-04-10 00:00:00",
3364,1,20788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf","2002-04-10 00:00:00",
35364,2,20788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf","2002-04-10 00:00:00",
3365,1,20788,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf","2002-04-10 00:00:00",
35365,2,20788,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf","2002-04-10 00:00:00",
25843,1,20788,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf","2004-10-29 00:00:00",
35366,2,20788,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf","2004-11-01 00:00:00",
3366,1,20788,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf","2004-10-29 00:00:00",
35367,2,20788,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf","2004-11-01 00:00:00",
25844,1,20788,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020788s015ltr.pdf","2010-03-29 00:00:00",
35368,2,20788,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020788s015lbl.pdf","2010-03-26 00:00:00",
25845,1,20788,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
3367,1,20788,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s017ltr.pdf","2011-03-16 00:00:00",
13443,2,20788,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf","2011-03-14 00:00:00",
20957,3,20788,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s017.pdf","2014-07-02 00:00:00",
3368,1,20788,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s018ltr.pdf","2011-04-19 00:00:00",
20958,3,20788,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s018.pdf","2014-01-16 00:00:00",
35369,2,20788,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s018lbl.pdf","2011-04-15 00:00:00",
20959,3,20788,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s020.pdf","2014-07-02 00:00:00",
25846,1,20788,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf","2012-04-12 00:00:00",
35370,2,20788,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf","2012-04-11 00:00:00",
3369,1,20788,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf","2012-04-12 00:00:00",
20960,3,20788,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s021.pdf","2014-07-02 00:00:00",
35371,2,20788,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf","2012-04-11 00:00:00",
3370,1,20788,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s022ltr.pdf","2011-06-13 00:00:00",
13444,2,20788,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf","2011-06-10 00:00:00",
20961,3,20788,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s023.pdf","2014-07-02 00:00:00",
25847,1,20788,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf","2012-04-12 00:00:00",
35372,2,20788,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf","2012-04-11 00:00:00",
13445,2,20788,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf","2014-02-03 00:00:00",
25848,1,20788,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020788Orig1s024ltr.pdf","2014-02-04 00:00:00",
13446,2,20789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf","2000-03-27 00:00:00",
23192,8,20789,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152828.pdf","2009-09-30 00:00:00",
25849,1,20789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20789ltr.pdf","2000-03-27 00:00:00",
25850,1,20789,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20789scm001ltr.pdf","2003-08-28 00:00:00",
35373,2,20789,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf","2003-08-28 00:00:00",
41708,3,20789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020789_Zonegran.cfm","2000-03-27 00:00:00",
44073,10,20789,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm","2012-02-03 00:00:00",
3371,1,20789,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20789slr005ltr.pdf","2002-10-07 00:00:00",
13447,2,20789,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf","2002-10-07 00:00:00",
13448,2,20789,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf","2012-01-31 00:00:00",
25851,1,20789,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020789s012ltr.pdf","2012-01-30 00:00:00",
3372,1,20789,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020789s019ltr.pdf","2006-12-04 00:00:00",
35374,2,20789,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf","2006-11-22 00:00:00",
3373,1,20789,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020789Orig1s021ltr.pdf","2015-06-22 00:00:00",
35375,2,20789,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf","2015-07-14 00:00:00",
3374,1,20789,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf","2009-05-04 00:00:00",
35376,2,20789,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf","2009-05-13 00:00:00",
25852,1,20789,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf","2010-04-21 00:00:00",
35377,2,20789,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf","2010-04-20 00:00:00",
3375,1,20789,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf","2009-05-04 00:00:00",
35378,2,20789,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf","2009-05-13 00:00:00",
3376,1,20789,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf","2010-04-21 00:00:00",
13449,2,20789,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf","2010-04-20 00:00:00",
3377,1,20789,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s029ltr.pdf","2011-05-31 00:00:00",
25853,1,20789,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s030ltr.pdf","2011-09-27 00:00:00",
35379,2,20789,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf","2011-09-29 00:00:00",
3378,1,20789,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020789Orig1s034ltr.pdf","2016-04-08 00:00:00",
35380,2,20789,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf","2016-04-07 00:00:00",
20962,3,20791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020791_testoderm_toc.cfm","2003-08-07 00:00:00",
20963,3,20792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020792ap.pdf","1997-10-07 00:00:00",
3379,1,20793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20793ltr.pdf","1999-09-21 00:00:00",
20964,3,20793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020793_000_CafcitTOC.cfm","2005-07-15 00:00:00",
25854,1,20793,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20793s1ltr.pdf","2000-04-12 00:00:00",
35381,2,20793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf","1999-09-21 00:00:00",
35382,2,20793,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf","2000-04-12 00:00:00",
3380,1,20793,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s3ltr.pdf","2002-01-18 00:00:00",
3381,1,20793,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s4ltr.pdf","2002-02-08 00:00:00",
25855,1,20793,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020793s009ltr.pdf","2010-06-16 00:00:00",
35383,2,20793,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf","2015-12-22 00:00:00",
13450,2,20796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF","1999-12-30 00:00:00",
20965,3,20796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm","1999-12-30 00:00:00",
25856,1,20796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20796LTR.PDF","1999-12-30 00:00:00",
13451,2,20796,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf","2009-02-04 00:00:00",
25857,1,20796,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf","2009-02-03 00:00:00",
3382,1,20796,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf","2009-02-03 00:00:00",
13452,2,20796,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf","2009-02-04 00:00:00",
3383,1,20796,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf","2010-10-13 00:00:00",
35384,2,20796,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf","2010-10-11 00:00:00",
3384,1,20796,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf","2014-06-17 00:00:00",
13453,2,20796,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf","2014-06-17 00:00:00",
13454,2,20796,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf","2015-01-20 00:00:00",
25858,1,20796,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020796Orig1s024ltr.pdf","2015-01-20 00:00:00",
3385,1,20796,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf","2016-02-24 00:00:00",
13455,2,20796,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf","2016-02-26 00:00:00",
20966,3,20799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-799_Floxin.cfm","2005-01-07 00:00:00",
3386,1,20799,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799se2-006ltr.pdf","2003-10-09 00:00:00",
13456,2,20799,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-006_floxin_lbl.pdf","2003-10-10 00:00:00",
3387,1,20799,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799slr012ltr.pdf","2003-10-09 00:00:00",
13457,2,20799,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799slr012_floxin_lbl.pdf","2003-10-10 00:00:00",
25859,1,20799,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20799slr015ltr.pdf","2004-02-25 00:00:00",
25860,1,20799,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020799s016ltr.pdf","2005-05-17 00:00:00",
50399,2,20799,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020799s016lbl.pdf","2017-11-14 00:00:00",
3388,1,20800,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf","2003-06-08 00:00:00",
3389,1,20800,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-001ltr.pdf","2004-06-01 00:00:00",
41709,3,20800,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-800_Twinject.cfm","2005-04-08 00:00:00",
3390,1,20800,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf","2005-02-23 00:00:00",
25861,1,20800,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s006ltr.pdf","2005-07-15 00:00:00",
25862,1,20800,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s007ltr.pdf","2005-07-08 00:00:00",
25863,1,20800,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020800s011ltr.pdf","2007-01-08 00:00:00",
35385,2,20800,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf","2009-12-02 00:00:00",
13458,2,20800,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf","2011-01-31 00:00:00",
25864,1,20800,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020800s020ltr.pdf","2011-02-03 00:00:00",
20967,3,20800,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf","2013-10-21 00:00:00",
13459,2,20800,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf","2014-04-25 00:00:00",
25865,1,20800,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s024ltr.pdf","2014-04-24 00:00:00",
25866,1,20800,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s027ltr.pdf","2014-07-28 00:00:00",
35386,2,20800,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf","2014-07-29 00:00:00",
3391,1,20800,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf","2014-10-22 00:00:00",
35387,2,20800,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf","2014-10-21 00:00:00",
13460,2,20800,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf","2016-05-20 00:00:00",
25867,1,20800,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020800Orig1s034ltr.pdf","2016-05-19 00:00:00",
47090,3,20800,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020800Orig1s034pkg.pdf","2017-02-02 00:00:00",
55369,2,20800,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020800s035lbl.pdf","2018-08-30 00:00:00",
55473,1,20800,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020800Orig1s035ltr.pdf","2018-09-13 00:00:00",
13461,2,20801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf","1998-09-24 00:00:00",
25868,1,20801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20801ltr.pdf","1998-09-24 00:00:00",
41710,3,20801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20801.cfm","1998-09-24 00:00:00",
13462,2,20801,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf","2001-04-10 00:00:00",
25869,1,20801,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20801S4ltr.pdf","2003-04-09 00:00:00",
25870,1,20801,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20801s7ltr.pdf","2002-01-31 00:00:00",
3392,1,20801,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf","2004-10-29 00:00:00",
3393,1,20801,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020801s012ltr.pdf","2008-01-09 00:00:00",
20968,3,20801,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.pdf","2012-03-27 00:00:00",
41711,3,20802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.cfm","2005-07-13 00:00:00",
3394,1,20802,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf","1999-10-07 00:00:00",
35388,2,20802,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf","1999-10-07 00:00:00",
41712,3,20802,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.cfm","1999-10-07 00:00:00",
3395,1,20802,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf","2003-06-08 00:00:00",
13463,2,20802,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf","2003-06-08 00:00:00",
25871,1,20802,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20802s010ltr.pdf","2004-08-31 00:00:00",
25872,1,20802,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020802s015ltr.pdf","2007-02-12 00:00:00",
25873,1,20802,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020802s019ltr.pdf","2010-02-17 00:00:00",
13464,2,20802,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf","2014-04-22 00:00:00",
25874,1,20802,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s022ltr.pdf","2014-04-17 00:00:00",
3396,1,20802,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf","2014-07-17 00:00:00",
13465,2,20802,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf","2014-07-30 00:00:00",
50080,1,20802,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020802Orig1s031ltr.pdf","2017-10-18 00:00:00",
50205,2,20802,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf","2017-10-27 00:00:00",
50959,2,20802,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020802s032lbl.pdf","2018-01-03 00:00:00",
50960,1,20802,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020802s032ltr.pdf","2018-01-09 00:00:00",
13466,2,20803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf","1998-03-09 00:00:00",
25875,1,20803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20803ltr.pdf","1998-03-09 00:00:00",
41713,3,20803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020803_alrex_toc.cfm","2003-08-07 00:00:00",
3397,1,20805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf","1998-02-10 00:00:00",
13467,2,20805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf","1998-02-10 00:00:00",
41714,3,20805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805.cfm","1998-02-10 00:00:00",
47625,2,20805,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020805s011lbl.pdf","2017-03-21 00:00:00",
47686,1,20805,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020805Orig1s011ltr.pdf","2017-03-24 00:00:00",
20969,3,20807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan.cfm","2003-04-04 00:00:00",
25876,1,20807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan_Approv.pdf","1998-03-06 00:00:00",
44465,14,20807,"ORIG",1,"Approvable Letter","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan_Approvableltr.pdf","1997-09-08 00:00:00",
3398,1,20807,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20807slr005ltr.pdf","2003-04-18 00:00:00",
13468,2,20807,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020807s011lbl.pdf","2006-11-09 00:00:00",
25877,1,20807,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020807s011ltr.pdf","2006-11-13 00:00:00",
25878,1,20807,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020807s015ltr.pdf","2007-03-15 00:00:00",
41715,3,20808,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf","2004-06-30 00:00:00",
25879,1,20808,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808scp002ltr.pdf","2003-09-25 00:00:00",
25880,1,20808,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808slr004ltr.pdf","2003-12-23 00:00:00",
35389,2,20808,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf","2003-12-29 00:00:00",
3399,1,20808,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf","2015-07-10 00:00:00",
35390,2,20808,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf","2015-07-09 00:00:00",
47895,2,20808,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf","2017-04-07 00:00:00",
47957,1,20808,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf","2017-04-12 00:00:00",
47900,2,20808,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf","2017-04-07 00:00:00",
47943,1,20808,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf","2017-04-12 00:00:00",
25881,1,20809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20809ltr.pdf","1998-05-04 00:00:00",
35391,2,20809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20809lbl.pdf","1998-05-04 00:00:00",
41716,3,20809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20809A_Diclofenac.cfm","1998-05-04 00:00:00",
20970,3,20811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020811ap.pdf","1997-11-03 00:00:00",
3400,1,20811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19700s019ltr.pdf","2002-02-08 00:00:00",
35392,2,20811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf","2002-02-08 00:00:00",
20971,3,20812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020812_PediatricTOC.cfm","2005-06-23 00:00:00",
35393,2,20812,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf","2006-07-18 00:00:00",
41717,3,20812,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020812Orig1s007.pdf","2013-05-10 00:00:00",
3401,1,20812,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20812s011ltr.pdf","2004-09-15 00:00:00",
20972,3,20812,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf","2013-04-18 00:00:00",
3402,1,20812,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020812s012ltr.pdf","2006-04-07 00:00:00",
25882,1,20812,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020812s014ltr.pdf","2008-06-16 00:00:00",
25883,1,20812,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020812s015ltr.pdf","2009-05-27 00:00:00",
3403,1,20812,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020812s017ltr.pdf","2011-04-28 00:00:00",
25884,1,20812,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020812Orig1s019ltr.pdf","2013-07-26 00:00:00",
35394,2,20812,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf","2013-08-05 00:00:00",
47744,2,20812,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf","2017-03-29 00:00:00",
47748,1,20812,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s023ltr.pdf","2017-03-29 00:00:00",
48941,1,20812,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s024ltr.pdf","2017-07-11 00:00:00",
48950,2,20812,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf","2017-07-11 00:00:00",
13469,2,20813,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf","2009-05-12 00:00:00",
25885,1,20813,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017533s045,020813s005ltr.pdf","2009-05-01 00:00:00",
3404,1,20813,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf","2010-09-21 00:00:00",
13470,2,20813,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf","2010-09-07 00:00:00",
3405,1,20813,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf","2010-09-21 00:00:00",
35395,2,20813,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf","2010-09-07 00:00:00",
25886,1,20813,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s046,020813s008ltr.pdf","2011-12-05 00:00:00",
3406,1,20813,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813Orig1s009ltr.pdf","2013-11-06 00:00:00",
35396,2,20813,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf","2013-11-01 00:00:00",
46283,2,20813,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020813s010lbl.pdf","2016-12-20 00:00:00",
46461,1,20813,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s058,020813Orig1s010ltr.pdf","2016-12-22 00:00:00",
46628,8,20813,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf#page=20","2016-12-30 00:00:00",
41718,3,20815,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020815_evista_toc.cfm","2009-12-03 00:00:00",
43680,8,20815,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf","2009-11-18 00:00:00",
20973,3,20815,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20815s2_Evista.pdf","1998-11-24 00:00:00",
13471,2,20815,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf","1999-09-30 00:00:00",
25887,1,20815,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20815s03ltr.pdf","1999-09-30 00:00:00",
41719,3,20815,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista.cfm","1999-09-30 00:00:00",
25888,1,20815,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020815s018ltr.pdf","2007-07-24 00:00:00",
35397,2,20815,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf","2007-07-24 00:00:00",
3407,1,20815,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025ltr.pdf","2007-09-25 00:00:00",
54755,2,20815,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020815s034lbl.pdf","2018-07-05 00:00:00",
54842,1,20815,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020815Orig1s034ltr.pdf","2018-07-06 00:00:00",
20974,3,20816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020816_azopt.cfm","2003-06-19 00:00:00",
25889,1,20816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20816ltr.pdf","1998-04-01 00:00:00",
35398,2,20816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20816lbl.pdf","1998-04-01 00:00:00",
51787,20,20816,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021114s002_levobetaxolol_Betaxon MedRev.pdf","1900-01-01 00:00:00",
51788,23,20816,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021114_levobetaxolol_Betaxon_10-15-99_HFD550_orig.pdf","1900-01-01 00:00:00",
3408,1,20816,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20816slr006ltr.pdf","2003-07-28 00:00:00",
35399,2,20816,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20816slr006_azopt_lbl.pdf","2003-07-28 00:00:00",
25890,1,20816,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020816s009LTR.pdf","2006-10-02 00:00:00",
25891,1,20816,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020816s012ltr.pdf","2011-03-10 00:00:00",
35400,2,20816,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020816s012lbl.pdf","2011-03-11 00:00:00",
13472,2,20816,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf","2015-11-12 00:00:00",
25892,1,20816,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020816Orig1s019ltr.pdf","2015-11-13 00:00:00",
3409,1,20818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_APPROV.PDF","2004-06-02 00:00:00",
13473,2,20818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF","2004-06-02 00:00:00",
23600,10,20818,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
41720,3,20818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020818_diovan_toc.cfm","2003-08-08 00:00:00",
25893,1,20818,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20818s12ltr.pdf","2002-01-17 00:00:00",
25894,1,20818,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818S016_Diovan_Approv.pdf","2004-06-02 00:00:00",
41721,3,20818,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818s016_Diovan.cfm","2003-07-08 00:00:00",
25895,1,20818,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020818s024ltr.pdf","2005-07-15 00:00:00",
35401,2,20818,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020818s024lbl.pdf","2005-07-15 00:00:00",
43564,6,20818,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20818s024PiJul7.pdf","2005-07-08 00:00:00",
13474,2,20818,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf","2006-05-02 00:00:00",
25896,1,20818,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s027LTR.pdf","2006-05-02 00:00:00",
13475,2,20818,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf","2006-11-22 00:00:00",
25897,1,20818,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s032ltr.pdf","2006-12-04 00:00:00",
25898,1,20818,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020818s035_ltr.pdf","2007-09-11 00:00:00",
25899,1,20818,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020818s036ltr.pdf","2008-08-05 00:00:00",
3410,1,20818,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020818s043ltr.pdf","2010-04-23 00:00:00",
13476,2,20818,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf","2010-05-03 00:00:00",
25900,1,20818,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf","2011-12-14 00:00:00",
35402,2,20818,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s046lbl.pdf","2011-12-12 00:00:00",
25901,1,20818,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s047ltr.pdf","2011-06-09 00:00:00",
35403,2,20818,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s047lbl.pdf","2011-06-27 00:00:00",
25902,1,20818,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf","2011-12-14 00:00:00",
35404,2,20818,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s049lbl.pdf","2011-12-12 00:00:00",
13477,2,20818,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf","2012-02-17 00:00:00",
25903,1,20818,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818s051ltr.pdf","2012-02-17 00:00:00",
13478,2,20818,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf","2012-01-23 00:00:00",
25904,1,20818,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf","2012-01-23 00:00:00",
25905,1,20818,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf","2012-07-30 00:00:00",
35405,2,20818,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s054lbl.pdf","2012-07-30 00:00:00",
25906,1,20818,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818Orig1s056ltr.pdf","2012-10-09 00:00:00",
35406,2,20818,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s056lbl.pdf","2012-10-05 00:00:00",
25907,1,20818,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf","2014-03-19 00:00:00",
35407,2,20818,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf","2014-03-19 00:00:00",
3411,1,20818,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s060ltr.pdf","2014-06-03 00:00:00",
13479,2,20818,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf","2014-06-03 00:00:00",
3412,1,20818,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf","2014-03-19 00:00:00",
13480,2,20818,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf","2014-03-19 00:00:00",
25908,1,20818,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s064ltr.pdf","2014-09-26 00:00:00",
35408,2,20818,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s064lbl.pdf","2014-09-26 00:00:00",
35409,2,20818,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020818s066lbl.pdf","2015-07-30 00:00:00",
20975,3,20819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20819_Zemplar.cfm","1998-04-17 00:00:00",
25909,1,20819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20819ltr.pdf","1998-04-17 00:00:00",
35410,2,20819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20819lbl.pdf","1998-04-17 00:00:00",
52157,23,20819,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020819_paricalcitol_WR.pdf","1900-01-01 00:00:00",
52158,40,20819,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020819_paricalcitol_WR Amend1.pdf","1900-01-01 00:00:00",
52159,20,20819,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020819s014_paricalcitol_MedRev_BPCA.pdf","1900-01-01 00:00:00",
52160,17,20819,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020819s014_paricalcitol_StatsRev_BPCA.pdf","1900-01-01 00:00:00",
3413,1,20819,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20819S3LTR.PDF","2000-02-02 00:00:00",
13481,2,20819,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20819S3LBL.PDF","2000-02-02 00:00:00",
25910,1,20819,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf","2003-03-10 00:00:00",
3414,1,20819,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf","2003-03-10 00:00:00",
13482,2,20819,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-014_zemplar_lbl.pdf","2004-04-05 00:00:00",
25911,1,20819,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20819se5-014ltr.pdf","2004-04-07 00:00:00",
3415,1,20819,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020819s015ltr.pdf","2005-09-08 00:00:00",
13483,2,20819,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf","2005-09-08 00:00:00",
25912,1,20819,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020819s021ltr.pdf","2009-11-19 00:00:00",
35411,2,20819,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020819s021lbl.pdf","2009-09-17 00:00:00",
25913,1,20819,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s024ltr.pdf","2011-02-04 00:00:00",
3416,1,20819,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s025ltr.pdf","2011-04-11 00:00:00",
35412,2,20819,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020819s025lbl.pdf","2011-04-07 00:00:00",
3417,1,20822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20822ltr.pdf","1998-07-17 00:00:00",
20976,3,20822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020822a.cfm","1998-07-17 00:00:00",
35413,2,20822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20822lbl.pdf","1998-07-17 00:00:00",
51822,20,20822,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020822s016, 021046s002_citalopram_Celexa-MedRev.pdf","1900-01-01 00:00:00",
51823,23,20822,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020822_citalopram_Celexa_WR.pdf","1900-01-01 00:00:00",
51824,18,20822,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020822s016, 021046s002_citalopram_Celexa-ClinPharmRev.pdf","1900-01-01 00:00:00",
20977,3,20822,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020822_s019_CelexaTOC.cfm","2006-05-18 00:00:00",
25914,1,20822,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf","2002-11-19 00:00:00",
25915,1,20822,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf","2004-04-20 00:00:00",
3418,1,20822,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf","2004-05-26 00:00:00",
3419,1,20822,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf","2005-02-23 00:00:00",
13484,2,20822,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf","2005-02-28 00:00:00",
3420,1,20822,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf","2007-08-07 00:00:00",
13485,2,20822,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf","2007-08-03 00:00:00",
3421,1,20822,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf","2008-09-19 00:00:00",
13486,2,20822,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf","2008-09-19 00:00:00",
3422,1,20822,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf","2009-02-03 00:00:00",
13487,2,20822,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf","2009-02-04 00:00:00",
20978,3,20822,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf","2011-10-11 00:00:00",
25916,1,20822,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf","2011-08-17 00:00:00",
35414,2,20822,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf","2011-08-16 00:00:00",
3423,1,20822,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf","2011-08-17 00:00:00",
13488,2,20822,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf","2011-08-16 00:00:00",
41722,3,20822,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf","2011-10-11 00:00:00",
20979,3,20822,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020822Orig1s042.pdf","2013-09-11 00:00:00",
25917,1,20822,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf","2012-03-29 00:00:00",
35415,2,20822,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf","2012-03-28 00:00:00",
3424,1,20822,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf","2012-12-05 00:00:00",
13489,2,20822,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf","2012-12-03 00:00:00",
25918,1,20822,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s045ltr.pdf","2014-04-17 00:00:00",
35416,2,20822,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822s045lbl.pdf","2014-05-12 00:00:00",
13490,2,20822,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf","2014-07-21 00:00:00",
25919,1,20822,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf","2014-07-10 00:00:00",
46683,2,20822,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf","2017-01-06 00:00:00",
46779,8,20822,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf#page=33","2017-01-11 00:00:00",
46780,1,20822,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf","2017-01-11 00:00:00",
3425,1,20823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf","2000-04-21 00:00:00",
13491,2,20823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf","2000-04-21 00:00:00",
20980,3,20823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20823_Exelon.cfm","2000-04-21 00:00:00",
13492,2,20823,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20823S3LBL.PDF","2001-01-05 00:00:00",
20981,3,20823,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020823_S003_EXELON_AP.pdf","2007-06-18 00:00:00",
3426,1,20823,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35417,2,20823,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
3427,1,20823,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf","2004-05-07 00:00:00",
3428,1,20823,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr.pdf","2004-09-24 00:00:00",
3429,1,20823,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016, 021025s008ltr.pdf","2006-07-03 00:00:00",
13493,2,20823,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf","2006-06-28 00:00:00",
20982,3,20823,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020823_016_exelon.pdf","2006-06-27 00:00:00",
25920,1,20823,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35418,2,20823,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
3430,1,20823,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35419,2,20823,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
13494,2,20823,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
25921,1,20823,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35420,2,20823,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf","2015-02-05 00:00:00",
45799,1,20823,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020823s035,021025s023,022083s023ltr.pdf","2016-11-03 00:00:00",
45808,2,20823,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020823s035,021025s023lbl.pdf","2016-11-04 00:00:00",
13495,2,20825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20825lbl.pdf","2001-02-05 00:00:00",
25922,1,20825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20825ltr.pdf","2001-02-05 00:00:00",
41723,3,20825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-825_Geodan.cfm","2001-02-05 00:00:00",
44074,10,20825,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
53440,20,20825,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020825_Ziprasidone_Clinical_PREA.pdf","1900-01-01 00:00:00",
53441,58,20825,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020825_Ziprasidone_Clin Addendum_PREA.pdf","1900-01-01 00:00:00",
53445,18,20825,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020825_Ziprasidone_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53446,17,20825,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020825_Ziprasidone_Statistical_PREA.pdf","1900-01-01 00:00:00",
25923,1,20825,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20825s6ltr.pdf","2002-02-15 00:00:00",
25924,1,20825,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr001ltr.pdf","2003-12-24 00:00:00",
13496,2,20825,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020825s009lbl.pdf","2004-10-01 00:00:00",
25925,1,20825,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009rev2.pdf","2004-10-01 00:00:00",
44466,14,20825,"SUPPL",9,"Corrected Approval Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009ltr.pdf","2004-10-01 00:00:00",
3431,1,20825,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr.pdf","2004-08-25 00:00:00",
3432,1,20825,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf","2005-08-19 00:00:00",
35421,2,20825,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf","2005-08-19 00:00:00",
25926,1,20825,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf","2005-08-19 00:00:00",
35422,2,20825,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf","2005-08-19 00:00:00",
3433,1,20825,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021, 020919s012ltr.pdf","2007-03-07 00:00:00",
13497,2,20825,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf","2007-03-07 00:00:00",
20983,3,20825,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020825_s021_GEODON.pdf","2008-07-30 00:00:00",
3434,1,20825,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014ltr.pdf","2007-05-29 00:00:00",
35423,2,20825,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf","2007-05-29 00:00:00",
13498,2,20825,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf","2007-10-04 00:00:00",
25927,1,20825,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026, 020919s016ltr.pdf","2007-10-04 00:00:00",
3435,1,20825,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019ltr.pdf","2008-05-21 00:00:00",
3436,1,20825,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030, 020919s021ltr.pdf","2008-08-19 00:00:00",
13499,2,20825,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s034lbl.pdf","2009-11-23 00:00:00",
20984,3,20825,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf","2012-10-12 00:00:00",
25928,1,20825,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s034ltr.pdf","2009-11-24 00:00:00",
25929,1,20825,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023ltr.pdf","2009-08-04 00:00:00",
35424,2,20825,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf","2009-08-14 00:00:00",
13500,2,20825,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf","2010-12-04 00:00:00",
25930,1,20825,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf","2010-12-07 00:00:00",
3437,1,20825,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf","2013-07-05 00:00:00",
35425,2,20825,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf","2013-07-05 00:00:00",
25931,1,20825,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf","2013-03-05 00:00:00",
35426,2,20825,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf","2013-03-04 00:00:00",
3438,1,20825,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf","2013-08-16 00:00:00",
13501,2,20825,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf","2013-08-15 00:00:00",
25932,1,20825,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919Orig1s035ltr.pdf","2013-12-19 00:00:00",
35427,2,20825,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf","2013-12-19 00:00:00",
3439,1,20825,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf","2014-12-11 00:00:00",
35428,2,20825,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf","2014-12-11 00:00:00",
25933,1,20825,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf","2015-08-24 00:00:00",
35429,2,20825,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf","2015-09-14 00:00:00",
47314,2,20825,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf","2017-02-24 00:00:00",
47417,1,20825,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020825Orig1s056,021483Orig1s015,020919Orig1s044ltr.pdf","2017-03-02 00:00:00",
13502,2,20827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf","1998-03-30 00:00:00",
25934,1,20827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_Approv.pdf","1998-03-30 00:00:00",
41724,3,20827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3.cfm","1998-03-30 00:00:00",
3440,1,20827,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20827slr006ltr.pdf","2002-08-07 00:00:00",
25935,1,20827,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020827s013ltr.pdf","2008-09-09 00:00:00",
25936,1,20827,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020827s014ltr.pdf","2009-11-10 00:00:00",
49514,2,20827,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf","2017-08-22 00:00:00",
41725,3,20828,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020828_fortovase_toc.cfm","2010-03-04 00:00:00",
20985,3,20828,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020828_S006_FORTOVASE.pdf","2007-07-27 00:00:00",
3441,1,20828,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20828s010ltr.pdf","2002-07-02 00:00:00",
35430,2,20828,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20828s10lbl.pdf","2002-07-02 00:00:00",
13503,2,20828,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828se2-015_fortovase_lbl.pdf","2004-01-15 00:00:00",
20986,3,20828,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020828_S015_FORTOVASE.pdf","2007-07-27 00:00:00",
23062,6,20828,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828s015ppi.pdf","2004-02-03 00:00:00",
25937,1,20828,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20828se2-015ltr.pdf","2004-01-14 00:00:00",
3442,1,20828,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
13504,2,20828,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
23063,6,20828,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf","2005-11-04 00:00:00",
41726,3,20828,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S019_FORTOVASE.pdf","2007-07-27 00:00:00",
25938,1,20828,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
35431,2,20828,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
41727,3,20828,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S020_FORTOVASE.pdf","2007-07-27 00:00:00",
43565,6,20828,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf","2005-11-04 00:00:00",
23601,10,20829,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm","2008-08-12 00:00:00",
25939,1,20829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20829ltr.pdf","1998-02-20 00:00:00",
35432,2,20829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20829lbl.pdf","1998-02-20 00:00:00",
41728,3,20829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020829s000_SingulairTOC.cfm","1998-02-20 00:00:00",
41729,3,20829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20830-s001_singulair.pdf","2001-07-05 00:00:00",
53344,20,20829,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast clinical prea.pdf","1900-01-01 00:00:00",
53345,18,20829,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast clinpharm prea.pdf","1900-01-01 00:00:00",
53346,17,20829,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast statistical prea.pdf","1900-01-01 00:00:00",
13505,2,20829,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20829s12lbl.pdf","2003-04-24 00:00:00",
13506,2,20829,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf","2003-04-07 00:00:00",
25940,1,20829,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-017,20830se1-020ltr.pdf","2002-12-31 00:00:00",
25941,1,20829,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf","2003-10-09 00:00:00",
35433,2,20829,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf","2003-10-10 00:00:00",
41730,3,20829,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf","2007-07-09 00:00:00",
20987,3,20829,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S025_SINGULAIR_TABLETS_AP.pdf","2007-07-06 00:00:00",
25942,1,20829,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr025,20830slr028ltr.pdf","2003-11-13 00:00:00",
35434,2,20829,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf","2003-11-13 00:00:00",
25943,1,20829,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf","2003-12-23 00:00:00",
35435,2,20829,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf","2003-12-29 00:00:00",
41731,3,20829,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S026_SINGULAIR_TABLETS_AP.pdf","2007-07-06 00:00:00",
25944,1,20829,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf","2004-11-17 00:00:00",
35436,2,20829,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf","2004-11-17 00:00:00",
3443,1,20829,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21409s011ltr.pdf","2005-01-11 00:00:00",
35437,2,20829,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf","2005-01-11 00:00:00",
3444,1,20829,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf","2005-07-29 00:00:00",
13507,2,20829,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf","2005-07-29 00:00:00",
41732,3,20829,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020829s033_020830s035_021409s012Approv.pdf","2012-02-14 00:00:00",
13508,2,20829,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf","2005-12-05 00:00:00",
25945,1,20829,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf","2005-12-06 00:00:00",
13509,2,20829,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf","2005-05-27 00:00:00",
25946,1,20829,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf","2005-05-27 00:00:00",
3445,1,20829,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf","2007-04-20 00:00:00",
35438,2,20829,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf","2007-04-20 00:00:00",
3446,1,20829,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf","2005-06-29 00:00:00",
35439,2,20829,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf","2005-06-29 00:00:00",
3447,1,20829,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf","2006-05-22 00:00:00",
35440,2,20829,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf","2006-05-22 00:00:00",
3448,1,20829,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf","2006-12-28 00:00:00",
13510,2,20829,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf","2006-12-14 00:00:00",
25947,1,20829,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf","2007-04-20 00:00:00",
25948,1,20829,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf","2007-04-20 00:00:00",
3449,1,20829,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf","2007-04-20 00:00:00",
3450,1,20829,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf","2008-03-11 00:00:00",
13511,2,20829,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046lbl.pdf","2008-03-11 00:00:00",
3451,1,20829,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf","2008-04-22 00:00:00",
13512,2,20829,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf","2008-06-05 00:00:00",
13513,2,20829,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s048lbl.pdf","2008-04-29 00:00:00",
25949,1,20829,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf","2008-04-28 00:00:00",
13514,2,20829,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf","2009-02-04 00:00:00",
25950,1,20829,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf","2009-01-30 00:00:00",
3452,1,20829,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf","2009-11-10 00:00:00",
13515,2,20829,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf","2009-09-15 00:00:00",
13516,2,20829,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s052lbl.pdf","2010-04-28 00:00:00",
25951,1,20829,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf","2010-04-29 00:00:00",
25952,1,20829,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
3453,1,20829,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf","2010-08-16 00:00:00",
35441,2,20829,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf","2010-08-19 00:00:00",
3454,1,20829,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf","2011-05-03 00:00:00",
13517,2,20829,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf","2011-04-29 00:00:00",
25953,1,20829,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf","2012-03-28 00:00:00",
35442,2,20829,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s059lbl.pdf","2012-03-26 00:00:00",
3455,1,20829,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf","2011-12-21 00:00:00",
13518,2,20829,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf","2011-12-20 00:00:00",
3456,1,20829,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf","2012-10-22 00:00:00",
13519,2,20829,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf","2012-10-22 00:00:00",
13520,2,20829,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s062lbl.pdf","2012-07-18 00:00:00",
25954,1,20829,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s062ltr.pdf","2012-07-17 00:00:00",
13521,2,20829,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf","2012-09-28 00:00:00",
25955,1,20829,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf","2012-10-02 00:00:00",
13522,2,20829,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf","2013-03-26 00:00:00",
25956,1,20829,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf","2013-03-22 00:00:00",
13523,2,20829,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf","2013-12-31 00:00:00",
25957,1,20829,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf","2013-12-31 00:00:00",
25958,1,20829,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf","2014-11-28 00:00:00",
35443,2,20829,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf","2014-12-19 00:00:00",
46161,1,20829,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020829Orig1s069,020830Orig1s071,021409Orig1s047ltr.pdf","2016-12-15 00:00:00",
46176,2,20829,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf","2016-12-14 00:00:00",
3457,1,20830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20830ltr.pdf","2005-04-26 00:00:00",
20988,3,20830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20830_Singulair.cfm","2001-05-24 00:00:00",
23602,10,20830,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm","2008-08-12 00:00:00",
41733,3,20830,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20830-s001_singulair.pdf","2001-07-05 00:00:00",
13524,2,20830,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_prntlbl.pdf","2000-03-03 00:00:00",
20989,3,20830,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830s008_Singulair.cfm","2001-09-07 00:00:00",
25959,1,20830,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_Approv.pdf","2000-03-03 00:00:00",
3458,1,20830,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20830s11ltr.pdf","2001-11-23 00:00:00",
13525,2,20830,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf","2003-04-24 00:00:00",
3459,1,20830,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-017,20830se1-020ltr.pdf","2002-12-31 00:00:00",
13526,2,20830,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf","2004-06-17 00:00:00",
20990,3,20830,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf","2007-07-09 00:00:00",
25960,1,20830,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf","2003-10-09 00:00:00",
35444,2,20830,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf","2004-06-17 00:00:00",
13527,2,20830,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf","2003-11-13 00:00:00",
25961,1,20830,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr025,20830slr028ltr.pdf","2003-11-13 00:00:00",
41734,3,20830,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020830_S028_SINGULAIR_AP.pdf","2007-07-06 00:00:00",
3460,1,20830,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf","2003-12-23 00:00:00",
35445,2,20830,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf","2003-12-29 00:00:00",
41735,3,20830,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020830_S029_SINGULAIR_TABLETS_AP.pdf","2007-07-06 00:00:00",
3461,1,20830,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf","2004-11-17 00:00:00",
13528,2,20830,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf","2004-11-17 00:00:00",
25962,1,20830,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21409s011ltr.pdf","2005-01-11 00:00:00",
35446,2,20830,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf","2005-01-11 00:00:00",
3462,1,20830,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf","2005-07-29 00:00:00",
13529,2,20830,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf","2005-07-29 00:00:00",
3463,1,20830,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf","2005-12-06 00:00:00",
13530,2,20830,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf","2005-12-05 00:00:00",
3464,1,20830,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf","2005-05-27 00:00:00",
35447,2,20830,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf","2005-05-27 00:00:00",
3465,1,20830,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf","2007-04-20 00:00:00",
13531,2,20830,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf","2007-04-20 00:00:00",
13532,2,20830,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf","2005-06-29 00:00:00",
25963,1,20830,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf","2005-06-29 00:00:00",
13533,2,20830,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf","2006-05-22 00:00:00",
25964,1,20830,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf","2006-05-22 00:00:00",
25965,1,20830,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf","2006-12-28 00:00:00",
35448,2,20830,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf","2006-12-14 00:00:00",
3466,1,20830,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf","2007-04-20 00:00:00",
25966,1,20830,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020830s047ltr.pdf","2008-01-09 00:00:00",
3467,1,20830,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf","2008-03-11 00:00:00",
35449,2,20830,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf","2008-03-13 00:00:00",
3468,1,20830,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf","2008-04-22 00:00:00",
13534,2,20830,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf","2008-06-05 00:00:00",
3469,1,20830,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf","2008-04-28 00:00:00",
35450,2,20830,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020830s050lbl.pdf","2008-04-29 00:00:00",
25967,1,20830,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf","2009-01-30 00:00:00",
35451,2,20830,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf","2009-02-04 00:00:00",
25968,1,20830,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf","2009-11-10 00:00:00",
35452,2,20830,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2009/020829s051_020830s052_021409s028lbl.pdf","2009-08-28 00:00:00",
25969,1,20830,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf","2010-04-29 00:00:00",
35453,2,20830,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020830s053lbl.pdf","2010-04-28 00:00:00",
25970,1,20830,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
3470,1,20830,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf","2010-08-16 00:00:00",
13535,2,20830,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf","2010-08-19 00:00:00",
3471,1,20830,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf","2011-05-03 00:00:00",
35454,2,20830,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf","2011-04-29 00:00:00",
13536,2,20830,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020830s061lbl.pdf","2012-03-27 00:00:00",
25971,1,20830,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf","2012-03-28 00:00:00",
13537,2,20830,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf","2011-12-20 00:00:00",
25972,1,20830,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf","2011-12-21 00:00:00",
3472,1,20830,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf","2012-10-22 00:00:00",
13538,2,20830,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf","2012-10-22 00:00:00",
3473,1,20830,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf","2012-10-02 00:00:00",
13539,2,20830,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf","2012-09-28 00:00:00",
13540,2,20830,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf","2013-03-26 00:00:00",
25973,1,20830,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf","2013-03-22 00:00:00",
3474,1,20830,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf","2013-12-31 00:00:00",
35455,2,20830,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf","2013-12-31 00:00:00",
3475,1,20830,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf","2014-11-28 00:00:00",
13541,2,20830,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf","2014-12-19 00:00:00",
46162,1,20830,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020829Orig1s069,020830Orig1s071,021409Orig1s047ltr.pdf","2016-12-15 00:00:00",
46177,2,20830,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf","2016-12-14 00:00:00",
13542,2,20831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_prntlbl.pdf","2001-02-16 00:00:00",
23603,10,20831,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2003-12-09 00:00:00",
25974,1,20831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_approv.pdf","2001-02-16 00:00:00",
41736,3,20831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil.cfm","2001-02-16 00:00:00",
43681,8,20831,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf","2009-11-19 00:00:00",
3476,1,20831,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21279ltr.pdf","2004-06-04 00:00:00",
35456,2,20831,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf","2003-04-24 00:00:00",
41737,3,20831,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020831_S002_FORADIL_AP.pdf","2007-07-09 00:00:00",
3477,1,20831,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20831se5-005ltr.pdf","2003-07-06 00:00:00",
13543,2,20831,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20831se5-005_foradil_lbl.pdf","2003-07-08 00:00:00",
3478,1,20831,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020831s009LTR.pdf","2006-06-20 00:00:00",
35457,2,20831,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020831s009lbl.pdf","2006-06-20 00:00:00",
25975,1,20831,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003ltr.pdf","2010-06-03 00:00:00",
35458,2,20831,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020831s021lbl.pdf","2010-06-02 00:00:00",
3479,1,20831,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s022ltr.pdf","2011-05-25 00:00:00",
25976,1,20831,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s024ltr.pdf","2011-02-14 00:00:00",
3480,1,20831,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s025ltr.pdf","2011-05-06 00:00:00",
35459,2,20831,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020831s025lbl.pdf","2011-05-05 00:00:00",
3481,1,20831,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831s027ltr.pdf","2012-03-26 00:00:00",
13544,2,20831,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027lbl.pdf","2012-03-23 00:00:00",
3482,1,20831,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831Orig1s028ltr.pdf","2012-10-02 00:00:00",
13545,2,20831,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf","2012-09-28 00:00:00",
25977,1,20831,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf","2013-04-01 00:00:00",
25978,1,20831,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf","2013-04-01 00:00:00",
3483,1,20832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20832ltr.pdf","2000-07-14 00:00:00",
20991,3,20832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-832_CHLORAPREP.cfm","2000-07-14 00:00:00",
3484,1,20832,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20832s002.pdf","2002-04-26 00:00:00",
35460,2,20832,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20832s2lbl.pdf","2002-04-26 00:00:00",
25979,1,20832,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20832scp004ltr.pdf","2003-08-28 00:00:00",
35461,2,20832,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20832scp004_chloraprep_lbl.pdf","2003-08-28 00:00:00",
25980,1,20832,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr006ltr.pdf","2004-06-15 00:00:00",
44467,14,20832,"SUPPL",6,"General Correspondence","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832S006GenCorresltr.pdf","2004-06-16 00:00:00",
3485,1,20832,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr007ltr.pdf","2004-07-07 00:00:00",
3486,1,20832,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s008ltr.pdf","2005-05-04 00:00:00",
13546,2,20832,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf","2005-05-04 00:00:00",
20992,3,20832,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020832_S008_CHLORAPREP_WITH_TINT.pdf","2007-12-06 00:00:00",
25981,1,20832,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s010ltr.pdf","2006-04-07 00:00:00",
25982,1,20832,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s011,021555s005rev2.pdf","2006-01-06 00:00:00",
25983,1,20832,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s012ltr.pdf","2006-12-28 00:00:00",
3487,1,20832,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s013LTR.pdf","2006-10-18 00:00:00",
3488,1,20832,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s014ltr.pdf","2008-06-06 00:00:00",
3489,1,20832,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s015ltr.pdf","2006-12-04 00:00:00",
35462,2,20832,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s015lbl.pdf","2006-11-22 00:00:00",
3490,1,20832,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s016LTR.pdf","2006-10-18 00:00:00",
13547,2,20832,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf","2006-10-11 00:00:00",
3491,1,20832,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020832s018ltr.pdf","2007-05-16 00:00:00",
13548,2,20832,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf","2007-05-16 00:00:00",
25984,1,20832,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s022ltr.pdf","2008-10-24 00:00:00",
25985,1,20832,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s025ltr.pdf","2010-03-08 00:00:00",
3492,1,20832,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s026ltr.pdf","2010-07-23 00:00:00",
25986,1,20832,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf","2012-08-17 00:00:00",
35463,2,20832,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf","2014-01-15 00:00:00",
3493,1,20832,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf","2012-08-17 00:00:00",
35464,2,20832,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf","2014-01-15 00:00:00",
3494,1,20832,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s029ltr.pdf","2013-01-10 00:00:00",
13549,2,20832,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf","2014-01-15 00:00:00",
25987,1,20832,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Origs030,021555Orig1s017ltr.pdf","2012-08-17 00:00:00",
13550,2,20832,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf","2013-11-20 00:00:00",
25988,1,20832,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020832Orig1s031,021555Orig1s018ltr.pdf","2013-10-11 00:00:00",
13551,2,20832,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf","2014-07-31 00:00:00",
25989,1,20832,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020832Orig1s034,021555Orig1s019ltr.pdf","2014-07-01 00:00:00",
49806,1,20832,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020832Orig1s042ltr.pdf","2017-09-19 00:00:00",
49822,2,20832,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020832Orig1s042lbl.pdf","2017-09-21 00:00:00",
3495,1,20833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20833ltr.pdf","2000-09-29 00:00:00",
41738,3,20833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-833_Flovent.cfm","2004-12-07 00:00:00",
25990,1,20833,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20833slr002ltr.pdf","2002-11-01 00:00:00",
3496,1,20833,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20833slr008ltr.pdf","2002-11-01 00:00:00",
3497,1,20833,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20833s012ltr.pdf","2004-12-30 00:00:00",
13552,2,20833,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20833s012lbl.pdf","2004-12-30 00:00:00",
25991,1,20833,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020833s014ltr.pdf","2005-08-03 00:00:00",
35465,2,20833,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s014lbl.pdf","2005-08-03 00:00:00",
3498,1,20833,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020833s015ltr.pdf","2005-09-15 00:00:00",
13553,2,20833,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s015lbl.pdf","2005-09-15 00:00:00",
25992,1,20833,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020833s021ltr.pdf","2010-05-05 00:00:00",
35466,2,20833,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020833s021lbl.pdf","2010-05-04 00:00:00",
3499,1,20833,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020833Orig1s028ltr.pdf","2014-04-16 00:00:00",
35467,2,20833,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020833s028lbl.pdf","2014-04-16 00:00:00",
25993,1,20833,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020833Orig1s030ltr.pdf","2014-11-14 00:00:00",
3500,1,20833,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020833Orig1s031ltr.pdf","2016-08-01 00:00:00",
13554,2,20833,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf","2016-08-02 00:00:00",
45509,1,20833,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020833Orig1s032ltr.pdf","2016-10-06 00:00:00",
45594,2,20833,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s032lbl.pdf","2016-10-07 00:00:00",
49026,2,20833,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020833s033lbl.pdf","2017-07-20 00:00:00",
49038,1,20833,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020833Orig1s033,021433Orig1s033ltr.pdf","2017-07-21 00:00:00",
20993,3,20834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020834_rogaine_toc.cfm","2003-08-08 00:00:00",
3501,1,20834,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20834slr003ltr.pdf","2003-02-14 00:00:00",
35468,2,20834,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020834s003lbl.pdf","2003-05-29 00:00:00",
25994,1,20834,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20834scs007ltr.pdf","2004-06-30 00:00:00",
3502,1,20834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020834s009ltr.pdf","2005-06-07 00:00:00",
25995,1,20834,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020834s011ltr.pdf","2006-09-20 00:00:00",
3503,1,20834,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020834Orig1s014ltr.pdf","2015-04-29 00:00:00",
13555,2,20834,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf","2015-04-29 00:00:00",
3504,1,20835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.htm","1998-03-27 00:00:00",
3505,1,20835,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf","2000-04-14 00:00:00",
13556,2,20835,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf","2000-04-14 00:00:00",
20994,3,20835,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm","2001-08-17 00:00:00",
23604,10,20835,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2009-04-24 00:00:00",
41739,3,20835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.cfm","2004-05-25 00:00:00",
53397,20,20835,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22055_retapumulin_clinical_PREA.pdf","2009-04-24 00:00:00",
53398,18,20835,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22055_retapumulin_clinpharm_PREA.pdf","2009-04-24 00:00:00",
13557,2,20835,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf","2000-04-14 00:00:00",
25996,1,20835,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf","2000-04-14 00:00:00",
41740,3,20835,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm","2001-08-17 00:00:00",
25997,1,20835,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf","2000-04-14 00:00:00",
35469,2,20835,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf","2000-04-14 00:00:00",
41741,3,20835,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm","2001-08-17 00:00:00",
3506,1,20835,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf","2000-04-14 00:00:00",
13558,2,20835,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf","2000-04-14 00:00:00",
20995,3,20835,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm","2001-08-17 00:00:00",
3507,1,20835,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf","2002-05-17 00:00:00",
35470,2,20835,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf","2003-05-20 00:00:00",
25998,1,20835,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf","2002-05-17 00:00:00",
20996,3,20835,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf","2008-02-19 00:00:00",
20997,3,20835,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf","2008-02-19 00:00:00",
20998,3,20835,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf","2008-02-19 00:00:00",
3508,1,20835,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20835slr014ltr.pdf","2004-02-25 00:00:00",
13559,2,20835,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf","2004-04-05 00:00:00",
41742,3,20835,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020835_S014_ACTONEL TABLETS.pdf","2007-07-27 00:00:00",
25999,1,20835,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s018ltr.pdf","2005-05-17 00:00:00",
35471,2,20835,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf","2005-05-17 00:00:00",
3509,1,20835,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf","2006-01-30 00:00:00",
35472,2,20835,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf","2006-01-25 00:00:00",
3510,1,20835,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s020ltr.pdf","2005-09-15 00:00:00",
35473,2,20835,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf","2005-09-15 00:00:00",
13560,2,20835,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf","2006-08-14 00:00:00",
26000,1,20835,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf","2006-08-21 00:00:00",
3511,1,20835,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf","2006-08-21 00:00:00",
35474,2,20835,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf","2006-08-14 00:00:00",
3512,1,20835,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s025ltr.pdf","2007-04-20 00:00:00",
13561,2,20835,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf","2007-04-20 00:00:00",
3513,1,20835,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s028ltr.pdf","2007-07-27 00:00:00",
13562,2,20835,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf","2007-07-27 00:00:00",
3514,1,20835,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf","2008-04-25 00:00:00",
26001,1,20835,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf","2008-04-25 00:00:00",
13563,2,20835,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf","2009-07-30 00:00:00",
26002,1,20835,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s035ltr.pdf","2009-07-31 00:00:00",
51086,23,20835,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020835s035_Risedronate_Clinpharm_BPCA.pdf","2009-04-24 00:00:00",
54081,17,20835,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020835s035_Risedronate_Statistical_BPCA.pdf","1900-01-01 00:00:00",
54082,20,20835,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020835s035_Risedronate_Clinical_BPCA.pdf","1900-01-01 00:00:00",
13564,2,20835,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf","2010-01-04 00:00:00",
26003,1,20835,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s036ltr.pdf","2010-01-06 00:00:00",
3515,1,20835,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf","2011-02-02 00:00:00",
35475,2,20835,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf","2011-01-31 00:00:00",
13565,2,20835,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf","2011-01-31 00:00:00",
26004,1,20835,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf","2011-02-02 00:00:00",
3516,1,20835,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s044ltr.pdf","2011-08-24 00:00:00",
3517,1,20835,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020835Orig1s045ltr.pdf","2013-04-23 00:00:00",
13566,2,20835,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf","2013-04-23 00:00:00",
3518,1,20835,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s047ltr.pdf","2015-03-27 00:00:00",
13567,2,20835,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf","2015-03-27 00:00:00",
26005,1,20835,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s048ltr.pdf","2015-04-13 00:00:00",
35476,2,20835,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf","2015-04-10 00:00:00",
46085,8,20835,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf#page=38","2016-12-07 00:00:00",
13568,2,20837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf","1999-03-25 00:00:00",
20999,3,20837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20837_Xenopex.cfm","1999-03-25 00:00:00",
26006,1,20837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20837ltr.pdf","1999-03-25 00:00:00",
13569,2,20837,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf","2002-01-30 00:00:00",
26007,1,20837,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20837scs010ltr.pdf","2003-07-28 00:00:00",
41743,3,20837,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020837_S010_Xopenex_APPROVAL PACKAGE.pdf","2006-10-26 00:00:00",
26008,1,20837,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020837s020_ltr.pdf","2006-09-18 00:00:00",
3519,1,20837,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020837Orig1s036ltr.pdf","2012-09-10 00:00:00",
13570,2,20837,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf","2012-09-11 00:00:00",
26009,1,20837,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020837Orig1s038ltr.pdf","2013-09-23 00:00:00",
35477,2,20837,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020837s038lbl.pdf","2013-09-24 00:00:00",
26010,1,20837,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s039ltr.pdf","2014-04-02 00:00:00",
35478,2,20837,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020837s039lbl.pdf","2014-04-01 00:00:00",
3520,1,20837,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s040ltr.pdf","2014-01-22 00:00:00",
3521,1,20837,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s041ltr.pdf","2015-01-23 00:00:00",
13571,2,20837,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf","2015-01-29 00:00:00",
51288,20,20837,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20837 levalbuterol clinical prea.pdf","1900-01-01 00:00:00",
51289,18,20837,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20837 levalbuterol clinpharm prea.pdf","1900-01-01 00:00:00",
51290,17,20837,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20837 levalbuterol statistical prea.pdf","1900-01-01 00:00:00",
3522,1,20837,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s043ltr.pdf","2015-04-02 00:00:00",
13572,2,20837,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbledt.pdf","2015-04-14 00:00:00",
21000,3,20838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm","2003-05-22 00:00:00",
26011,1,20838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20838ltr.pdf","1998-06-04 00:00:00",
35479,2,20838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf","1998-06-04 00:00:00",
44075,10,20838,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
54097,20,20838,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_Candesartan_Clinical_BPCA.pdf","1900-01-01 00:00:00",
54098,18,20838,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_Candesartan_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
54099,17,20838,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_Candesartan_Statisitical_BPCA.pdf","1900-01-01 00:00:00",
21001,3,20838,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf","2004-05-27 00:00:00",
26012,1,20838,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20838se4-015ltr.pdf","2002-09-13 00:00:00",
35480,2,20838,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf","2002-09-13 00:00:00",
41744,3,20838,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20838s015_Atacand.cfm","2004-05-27 00:00:00",
26013,1,20838,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr017ltr.pdf","2004-05-27 00:00:00",
3523,1,20838,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr019ltr.pdf","2003-05-29 00:00:00",
3524,1,20838,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020838s022ltr.pdf","2005-05-20 00:00:00",
13573,2,20838,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf","2005-05-20 00:00:00",
3525,1,20838,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20838s023ltr.pdf","2004-12-30 00:00:00",
13574,2,20838,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf","2005-02-23 00:00:00",
26014,1,20838,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20838s024ltr.pdf","2005-02-23 00:00:00",
3526,1,20838,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020838s026LTR.pdf","2006-08-21 00:00:00",
35481,2,20838,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf","2006-08-21 00:00:00",
26015,1,20838,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020838s031ltr.pdf","2009-11-05 00:00:00",
35482,2,20838,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf","2009-10-23 00:00:00",
51274,23,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_candesartan_Original_WR.pdf","1999-03-15 00:00:00",
51275,25,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20838_candesartan_Amendment_1.pdf","2003-11-02 00:00:00",
51276,26,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_candesartan_Amendment_2_WR.pdf","2003-01-08 00:00:00",
51277,27,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_candesartan_Amendment_3_WR.pdf","2004-08-27 00:00:00",
51278,28,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020838_candesartan_Amendment_4_WR.pdf","2005-03-15 00:00:00",
51279,29,20838,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM176534.pdf","2007-01-30 00:00:00",
3527,1,20838,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s032ltr.pdf","2012-04-16 00:00:00",
13575,2,20838,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf","2012-04-17 00:00:00",
26016,1,20838,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020838s033ltr.pdf","2011-07-05 00:00:00",
35483,2,20838,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf","2011-06-28 00:00:00",
3528,1,20838,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s035ltr.pdf","2012-05-02 00:00:00",
35484,2,20838,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf","2012-05-01 00:00:00",
13576,2,20838,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf","2015-02-09 00:00:00",
26017,1,20838,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020838Orig1s036ltr.pdf","2015-02-10 00:00:00",
26018,1,20838,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020838Orig1s038ltr.pdf","2013-04-30 00:00:00",
35485,2,20838,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf","2013-04-29 00:00:00",
3529,1,20838,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020838Orig1s039ltr.pdf","2016-02-11 00:00:00",
13577,2,20838,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf","2016-02-11 00:00:00",
21002,3,20839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf","2010-03-04 00:00:00",
23605,10,20839,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm190836.htm","2010-08-09 00:00:00",
41745,3,20839,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-001.PDF","2005-08-04 00:00:00",
21003,3,20839,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF","2005-08-04 00:00:00",
41746,3,20839,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020-839_S-003.PDF","2005-08-04 00:00:00",
21004,3,20839,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF","2005-08-04 00:00:00",
21005,3,20839,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF","2005-08-04 00:00:00",
41747,3,20839,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-006.PDF","2005-08-04 00:00:00",
41748,3,20839,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-007.PDF","2005-08-04 00:00:00",
41749,3,20839,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-009.PDF","2005-08-04 00:00:00",
41750,3,20839,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-010.PDF","2005-08-04 00:00:00",
41751,3,20839,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-011.PDF","2005-08-04 00:00:00",
21006,3,20839,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF","2005-08-04 00:00:00",
21007,3,20839,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF","2005-08-04 00:00:00",
21008,3,20839,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF","2005-08-04 00:00:00",
21009,3,20839,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF","2005-08-04 00:00:00",
21010,3,20839,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF","2005-08-04 00:00:00",
3530,1,20839,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s18ltr.pdf","2002-01-28 00:00:00",
41752,3,20839,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-018.PDF","2005-08-04 00:00:00",
13578,2,20839,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.htm","2002-02-27 00:00:00",
26019,1,20839,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s19ltr.pdf","2002-02-27 00:00:00",
41753,3,20839,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.cfm","2002-02-27 00:00:00",
41754,3,20839,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-020.PDF","2005-08-04 00:00:00",
3531,1,20839,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf","2003-10-09 00:00:00",
3532,1,20839,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20839s023ltr.pdf","2004-10-15 00:00:00",
3533,1,20839,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf","2003-10-09 00:00:00",
3534,1,20839,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s028ltr.pdf","2005-04-28 00:00:00",
3535,1,20839,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf","2005-04-28 00:00:00",
13579,2,20839,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf","2005-04-28 00:00:00",
13580,2,20839,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf","2005-04-28 00:00:00",
26020,1,20839,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf","2005-04-28 00:00:00",
3536,1,20839,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s033ltr.pdf","2005-10-19 00:00:00",
13581,2,20839,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf","2005-10-19 00:00:00",
21011,3,20839,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf","2006-08-17 00:00:00",
26021,1,20839,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s034LTR.pdf","2006-08-21 00:00:00",
35486,2,20839,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s034lbl.pdf","2006-08-18 00:00:00",
13582,2,20839,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf","2006-08-07 00:00:00",
26022,1,20839,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s035LTR.pdf","2006-08-07 00:00:00",
3537,1,20839,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s037ltr.pdf","2007-05-09 00:00:00",
35487,2,20839,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s037lbl.pdf","2007-05-07 00:00:00",
3538,1,20839,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s038ltr.pdf","2007-09-25 00:00:00",
35488,2,20839,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf","2007-09-26 00:00:00",
41755,3,20839,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020839Orig1s038.pdf","2012-03-02 00:00:00",
26023,1,20839,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s040ltr.pdf","2009-08-26 00:00:00",
35489,2,20839,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf","2009-05-11 00:00:00",
13583,2,20839,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf","2010-03-12 00:00:00",
26024,1,20839,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s042ltr.pdf","2010-03-18 00:00:00",
45786,3,20839,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020839Orig1s042.pdf","2016-11-02 00:00:00",
3539,1,20839,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s044ltr.pdf","2010-01-20 00:00:00",
35490,2,20839,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf","2009-11-16 00:00:00",
3540,1,20839,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s048ltr.pdf","2010-08-16 00:00:00",
35491,2,20839,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf","2010-08-19 00:00:00",
3541,1,20839,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s051ltr.pdf","2011-05-10 00:00:00",
24181,21,20839,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051SumR.pdf","2011-07-08 00:00:00",
35492,2,20839,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s051lbl.pdf","2011-05-06 00:00:00",
41756,3,20839,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051TOC.cfm","2011-07-08 00:00:00",
51479,23,20839,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20839_clopidogrel_Original_WRltr.pdf","2001-10-15 00:00:00",
51480,25,20839,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20839_clopidogrel_Amendment_1ltr.pdf","2007-08-24 00:00:00",
53220,17,20839,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20839s051 clopidogrel statistical BPCA.pdf","1900-01-01 00:00:00",
53221,20,20839,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20839s051 clopidogrel Clinical BPCA.pdf","1900-01-01 00:00:00",
54034,18,20839,"SUPPL",51,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20839s051 clopidogrel clinpharm BPCA_CORRECTED.pdf","1900-01-01 00:00:00",
3542,1,20839,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s052ltr.pdf","2011-02-07 00:00:00",
35493,2,20839,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s052lbl.pdf","2011-02-04 00:00:00",
3543,1,20839,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s053ltr.pdf","2011-05-06 00:00:00",
3544,1,20839,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s055ltr.pdf","2011-12-22 00:00:00",
35494,2,20839,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s055lbl.pdf","2011-12-23 00:00:00",
3545,1,20839,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s057ltr.pdf","2013-09-13 00:00:00",
13584,2,20839,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf","2013-09-17 00:00:00",
13585,2,20839,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf","2013-12-17 00:00:00",
26025,1,20839,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s058ltr.pdf","2013-12-16 00:00:00",
3546,1,20839,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020839Orig1s061ltr.pdf","2015-07-20 00:00:00",
13586,2,20839,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061lbl.pdf","2015-07-17 00:00:00",
45316,2,20839,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf","2016-09-16 00:00:00",
45348,1,20839,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf","2016-09-21 00:00:00",
45317,2,20839,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf","2016-09-16 00:00:00",
45349,1,20839,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf","2016-09-21 00:00:00",
48966,2,20839,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s067lbl.pdf","2017-07-13 00:00:00",
48971,1,20839,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020839Orig1s067ltr.pdf","2017-07-13 00:00:00",
50249,2,20839,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s068lbl.pdf","2017-10-31 00:00:00",
54356,1,20839,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020839Orig1s070ltr.pdf","2018-05-29 00:00:00",
54365,2,20839,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf","2018-05-29 00:00:00",
54366,8,20839,"SUPPL",70,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf#page=23","2018-05-29 00:00:00",
13587,2,20841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20841lbl.pdf","1998-03-09 00:00:00",
21012,3,20841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020841_Lotemax.cfm","2002-04-11 00:00:00",
26026,1,20841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20841ltr.pdf","1998-03-09 00:00:00",
26027,1,20843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20843ltr.pdf","1998-12-16 00:00:00",
35495,2,20843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20843lbl.pdf","1998-12-16 00:00:00",
41757,3,20843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020843_s000_PrometriumTOC.cfm","2005-06-16 00:00:00",
13588,2,20843,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf","2004-12-10 00:00:00",
26028,1,20843,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf","2004-12-10 00:00:00",
13589,2,20843,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf","2004-12-10 00:00:00",
26029,1,20843,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf","2004-12-10 00:00:00",
26030,1,20843,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf","2004-03-10 00:00:00",
3547,1,20843,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf","2009-07-07 00:00:00",
35496,2,20843,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020843s010lbl.pdf","2009-07-06 00:00:00",
26031,1,20843,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf","2011-11-03 00:00:00",
35497,2,20843,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf","2011-11-04 00:00:00",
3548,1,20844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20844ltr.pdf","1998-10-26 00:00:00",
3549,1,20844,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax_appltr_prntlbl.pdf","1999-07-23 00:00:00",
13590,2,20844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20844lbl.pdf","1998-10-26 00:00:00",
13591,2,20844,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax_appltr_prntlbl.pdf","1999-07-23 00:00:00",
21013,3,20844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020844s000_Topamax.cfm","2004-09-15 00:00:00",
21014,3,20844,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax.cfm","2000-07-03 00:00:00",
53031,17,20844,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505 topiramate statistical prea.pdf","1900-01-01 00:00:00",
53032,20,20844,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020505 topiramate clinical prea.pdf","1900-01-01 00:00:00",
41758,3,20844,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S4_Topamax.cfm","2000-07-03 00:00:00",
13592,2,20844,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
26032,1,20844,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2004-06-28 00:00:00",
21015,3,20844,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-844s010_Topamax.cfm","2004-09-08 00:00:00",
26033,1,20844,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf","2001-08-28 00:00:00",
35498,2,20844,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf","2001-08-28 00:00:00",
3550,1,20844,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
35499,2,20844,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
3551,1,20844,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr012ltr.pdf","2003-06-08 00:00:00",
3552,1,20844,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr016ltr.pdf","2002-11-26 00:00:00",
3553,1,20844,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2003-12-19 00:00:00",
13593,2,20844,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
13594,2,20844,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf","2005-07-05 00:00:00",
26034,1,20844,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf","2005-07-08 00:00:00",
3554,1,20844,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf","2003-12-19 00:00:00",
35500,2,20844,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf","2003-12-29 00:00:00",
3555,1,20844,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr017ltr.pdf","2003-06-22 00:00:00",
3556,1,20844,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf","2003-07-30 00:00:00",
13595,2,20844,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf","2004-08-12 00:00:00",
26035,1,20844,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf","2004-08-12 00:00:00",
26036,1,20844,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf","2003-07-30 00:00:00",
3557,1,20844,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf","2004-08-12 00:00:00",
13596,2,20844,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf","2005-07-05 00:00:00",
26037,1,20844,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf","2005-07-08 00:00:00",
26038,1,20844,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029, 020844s024ltr.pdf","2006-10-23 00:00:00",
26039,1,20844,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
35501,2,20844,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
3558,1,20844,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
35502,2,20844,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
3559,1,20844,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s036,020844s030ltr.pdf","2009-04-27 00:00:00",
13597,2,20844,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf","2009-04-28 00:00:00",
13598,2,20844,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf","2010-01-04 00:00:00",
26040,1,20844,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf","2009-12-30 00:00:00",
3560,1,20844,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf","2009-05-04 00:00:00",
13599,2,20844,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf","2009-05-12 00:00:00",
26041,1,20844,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf","2009-05-04 00:00:00",
35503,2,20844,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf","2009-05-12 00:00:00",
3561,1,20844,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf","2011-03-08 00:00:00",
13600,2,20844,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf","2011-03-04 00:00:00",
3562,1,20844,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr.pdf","2011-07-19 00:00:00",
13601,2,20844,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf","2011-07-18 00:00:00",
3563,1,20844,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844Orig1s041ltr.pdf","2012-11-01 00:00:00",
35504,2,20844,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020844s041lbl.pdf","2012-10-29 00:00:00",
13602,2,20844,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf","2014-04-01 00:00:00",
26042,1,20844,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844Orig1s043ltr.pdf","2014-04-02 00:00:00",
3564,1,20844,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844Orig1s044ltr.pdf","2014-01-30 00:00:00",
13603,2,20844,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf","2014-01-31 00:00:00",
3565,1,20844,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844Orig1s045ltr.pdf","2014-10-23 00:00:00",
13604,2,20844,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf","2014-10-23 00:00:00",
13605,2,20844,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf","2014-12-19 00:00:00",
26043,1,20844,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844Orig1s046ltr.pdf","2014-12-19 00:00:00",
48379,2,20844,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf","2017-05-16 00:00:00",
48382,8,20844,"SUPPL",48,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf#page=50","2017-05-16 00:00:00",
48410,1,20844,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020505Orig1s057,020844Orig1s048ltr.pdf","2017-05-17 00:00:00",
54646,1,20844,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020505Orig1s058,020844Orig1s049ltr.pdf","2018-06-21 00:00:00",
54730,2,20844,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058,020844s049lbl.pdf","2018-06-29 00:00:00",
13606,2,20845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm","1999-12-23 00:00:00",
21016,3,20845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845_INOmax.cfm","1999-12-23 00:00:00",
26044,1,20845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20845ltr.pdf","1999-12-23 00:00:00",
53350,20,20845,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020845 nitric oxide clinical both_PREA.pdf","1900-01-01 00:00:00",
53351,18,20845,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020845 nitric oxide clinpharm both_PREA.pdf","1900-01-01 00:00:00",
53352,17,20845,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020845 nitric oxide statistical both_PREA.pdf","1900-01-01 00:00:00",
3566,1,20845,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20845slr002ltr.pdf","2004-06-16 00:00:00",
26045,1,20845,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020845s004ltr.pdf","2008-01-09 00:00:00",
3567,1,20845,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020845s009ltr.pdf","2009-11-19 00:00:00",
13607,2,20845,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf","2009-09-17 00:00:00",
3568,1,20845,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020845s011ltr.pdf","2010-12-22 00:00:00",
13608,2,20845,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf","2010-12-22 00:00:00",
3569,1,20845,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020845Orig1s014ltr.pdf","2013-03-05 00:00:00",
13609,2,20845,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf","2013-03-08 00:00:00",
21017,3,20845,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020845Orig1s014.pdf","2016-07-27 00:00:00",
26046,1,20845,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf","2015-10-14 00:00:00",
35505,2,20845,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf","2015-10-15 00:00:00",
13610,2,20845,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf","2015-10-15 00:00:00",
21018,3,20845,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020845Orig1s017.pdf","2016-07-27 00:00:00",
26047,1,20845,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf","2015-10-14 00:00:00",
3570,1,20845,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020845Orig1s018ltr.pdf","2016-04-07 00:00:00",
3571,1,20846,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20846s1ltr.pdf","1999-07-26 00:00:00",
13611,2,20846,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf","1999-07-26 00:00:00",
21019,3,20846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020846.pdf","1999-02-04 00:00:00",
26048,1,20846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20846ltr.pdf","1998-04-29 00:00:00",
35506,2,20846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20846lbl.pdf","1998-04-29 00:00:00",
23064,6,20847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20847lblpt.pdf","1998-08-04 00:00:00",
26049,1,20847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20847ltr.pdf","1998-08-04 00:00:00",
35507,2,20847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20847lblmd.pdf","1998-08-04 00:00:00",
41759,3,20847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20847.cfm","1998-08-04 00:00:00",
13612,2,20849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20849lbl.pdf","1998-08-26 00:00:00",
21020,3,20849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020849_s000_Prosol.cfm","2005-07-11 00:00:00",
26050,1,20849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20849ltr.pdf","1998-08-26 00:00:00",
3572,1,20849,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20849slr007ltr.pdf","2003-05-29 00:00:00",
26051,1,20849,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20849scs008ltr.pdf","2003-05-30 00:00:00",
3573,1,20850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20850ltr.pdf","1998-11-10 00:00:00",
35508,2,20850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20850lbl.pdf","1998-11-10 00:00:00",
41760,3,20850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.cfm","2001-08-06 00:00:00",
44076,10,20850,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
26052,1,20850,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20850slr005ltr.pdf","2003-10-31 00:00:00",
26053,1,20850,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20850slr011ltr.pdf","2004-04-07 00:00:00",
35509,2,20850,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020850s011lbl.pdf","2004-05-06 00:00:00",
13613,2,20850,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020850s013lbl.pdf","2005-09-08 00:00:00",
26054,1,20850,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020850s013ltr.pdf","2005-09-08 00:00:00",
3574,1,20850,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020850s019ltr.pdf","2007-03-06 00:00:00",
13614,2,20850,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf","2009-09-17 00:00:00",
26055,1,20850,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf","2009-11-19 00:00:00",
3575,1,20850,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf","2009-11-19 00:00:00",
13615,2,20850,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf","2009-09-17 00:00:00",
13616,2,20850,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s025lbl.pdf","2009-10-21 00:00:00",
26056,1,20850,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s025ltr.pdf","2009-11-20 00:00:00",
3576,1,20850,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s031ltr.pdf","2012-01-23 00:00:00",
35510,2,20850,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s031lbl.pdf","2012-01-23 00:00:00",
3577,1,20850,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020850s032ltr.pdf","2011-07-07 00:00:00",
35511,2,20850,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020850s032lbl.pdf","2011-07-12 00:00:00",
26057,1,20850,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s033ltr.pdf","2012-09-24 00:00:00",
35512,2,20850,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf","2012-09-24 00:00:00",
13617,2,20850,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s035lbl.pdf","2012-01-23 00:00:00",
26058,1,20850,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s035ltr.pdf","2012-01-23 00:00:00",
3578,1,20850,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s036ltr.pdf","2012-10-26 00:00:00",
13618,2,20850,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s036lbl.pdf","2012-10-26 00:00:00",
26059,1,20850,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020850Orig1s038ltr.pdf","2014-12-15 00:00:00",
35513,2,20850,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020850s038lbl.pdf","2014-12-15 00:00:00",
52262,2,20850,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020850s040lbl.pdf","2018-02-02 00:00:00",
52298,1,20850,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020850Orig1s040ltr.pdf","2018-02-02 00:00:00",
13619,2,20855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Prntlbl.pdf","2004-06-09 00:00:00",
21021,3,20855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020855_mesnex.cfm","2003-05-08 00:00:00",
26060,1,20855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-855_Mesnex_Approv.pdf","2003-05-08 00:00:00",
26061,1,20855,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020855Orig1s001ltr.pdf","2013-01-10 00:00:00",
3579,1,20855,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf","2014-03-19 00:00:00",
13620,2,20855,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020855s002lbl.pdf","2014-03-19 00:00:00",
21022,3,20857,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-857s008_Combivir.cfm","2005-01-11 00:00:00",
3580,1,20857,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf","2002-08-09 00:00:00",
13621,2,20857,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf","2002-08-09 00:00:00",
21023,3,20857,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S009_Combivar.pdf","2007-09-24 00:00:00",
21024,3,20857,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S010_Combivar.pdf","2007-09-24 00:00:00",
26062,1,20857,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf","2002-08-09 00:00:00",
35514,2,20857,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf","2002-08-09 00:00:00",
41761,3,20857,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S011_Epivir.pdf","2007-09-24 00:00:00",
26063,1,20857,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr012ltr.pdf","2002-10-08 00:00:00",
35515,2,20857,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857s12lbl.pdf","2002-10-08 00:00:00",
3581,1,20857,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857slr014ltr.pdf","2004-05-26 00:00:00",
35516,2,20857,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857slr014_combivir_lbl.pdf","2004-05-27 00:00:00",
3582,1,20857,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857s015ltr.pdf","2004-10-04 00:00:00",
35517,2,20857,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857s015lbl.pdf","2004-10-04 00:00:00",
3583,1,20857,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s018ltr.pdf","2006-07-03 00:00:00",
13622,2,20857,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf","2006-06-28 00:00:00",
13623,2,20857,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf","2006-10-26 00:00:00",
26064,1,20857,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s020ltr.pdf","2006-11-06 00:00:00",
13624,2,20857,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf","2007-04-25 00:00:00",
26065,1,20857,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020857s021ltr.pdf","2007-05-01 00:00:00",
3584,1,20857,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020857s023ltr.pdf","2009-02-04 00:00:00",
13625,2,20857,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf","2009-02-04 00:00:00",
3585,1,20857,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020857s026ltr.pdf","2010-10-04 00:00:00",
35518,2,20857,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020857s026lbl.pdf","2010-10-12 00:00:00",
3586,1,20857,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020857s028ltr.pdf","2011-11-22 00:00:00",
13626,2,20857,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf","2011-12-02 00:00:00",
13627,2,20857,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf","2015-09-29 00:00:00",
26066,1,20857,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020857Orig1s030ltr.pdf","2015-09-28 00:00:00",
47366,2,20857,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s031lbl.pdf","2017-02-28 00:00:00",
47453,1,20857,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020857Orig1s031ltr.pdf","2017-03-03 00:00:00",
47922,2,20857,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s032lbl.pdf","2017-04-11 00:00:00",
48024,1,20857,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020857Orig1s032ltr.pdf","2017-04-14 00:00:00",
53913,1,20857,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020857Orig1s033ltr.pdf","2018-05-01 00:00:00",
54179,2,20857,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020857s033lbl.pdf","2018-05-14 00:00:00",
3587,1,20859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20859ltr.pdf","1999-08-13 00:00:00",
3588,1,20859,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20859S1LTR.PDF","2001-02-22 00:00:00",
21025,3,20859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20859_Sonata.cfm","2000-07-03 00:00:00",
23200,8,20859,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM349707.pdf","2013-04-26 00:00:00",
23606,10,20859,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2003-12-12 00:00:00",
35519,2,20859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf","1999-08-13 00:00:00",
35520,2,20859,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20859S1LBL.PDF","2001-02-22 00:00:00",
3589,1,20859,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf","2002-06-03 00:00:00",
3590,1,20859,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf","2002-05-31 00:00:00",
26067,1,20859,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf","2003-06-08 00:00:00",
26068,1,20859,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf","2003-06-08 00:00:00",
3591,1,20859,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf","2008-01-09 00:00:00",
35521,2,20859,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s009lbl.pdf","2007-12-14 00:00:00",
3592,1,20859,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf","2008-01-09 00:00:00",
13628,2,20859,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf","2007-12-14 00:00:00",
3593,1,20859,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020859Orig1s013ltr.pdf","2013-04-24 00:00:00",
35522,2,20859,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020859s013lbl.pdf","2013-04-23 00:00:00",
26069,1,20860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20860LTR.PDF","1998-07-14 00:00:00",
41762,3,20860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20860.cfm","1999-01-21 00:00:00",
21026,3,20862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020862_Hectorol.cfm","1999-06-09 00:00:00",
26070,1,20862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20862ltr.pdf","1999-06-09 00:00:00",
35523,2,20862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20862lbl.pdf","1999-06-09 00:00:00",
3594,1,20862,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862se1-006ltr.pdf","2004-04-29 00:00:00",
35524,2,20862,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20862se1-006_hectorol_lbl.pdf","2004-05-04 00:00:00",
3595,1,20862,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862s016ltr.pdf","2004-12-30 00:00:00",
3596,1,20862,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020862s018ltr.pdf","2005-06-29 00:00:00",
35525,2,20862,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020862s018lbl.pdf","2005-06-29 00:00:00",
13629,2,20862,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf","2006-07-21 00:00:00",
26071,1,20862,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020862s019ltr.pdf","2006-07-21 00:00:00",
3597,1,20862,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020862s023ltr.pdf","2008-07-14 00:00:00",
13630,2,20862,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf","2008-07-14 00:00:00",
3598,1,20862,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020862s024ltr.pdf","2009-07-17 00:00:00",
13631,2,20862,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf","2009-07-23 00:00:00",
13632,2,20862,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf","2011-03-04 00:00:00",
26072,1,20862,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020862s030ltr.pdf","2011-02-15 00:00:00",
3599,1,20863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf","1999-01-15 00:00:00",
13633,2,20863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/cilo_label.htm","2004-06-14 00:00:00",
21027,3,20863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20863.cfm","1999-01-15 00:00:00",
3600,1,20863,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20863slr007ltr.pdf","2004-03-03 00:00:00",
26073,1,20863,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020863s011ltr.pdf","2005-11-30 00:00:00",
35526,2,20863,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020863s011lbl.pdf","2005-11-30 00:00:00",
13634,2,20863,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf","2007-01-24 00:00:00",
26074,1,20863,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s019ltr.pdf","2007-01-25 00:00:00",
3601,1,20863,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s021ltr.pdf","2007-11-19 00:00:00",
13635,2,20863,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf","2007-11-19 00:00:00",
13636,2,20863,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf","2015-01-29 00:00:00",
26075,1,20863,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s022ltr.pdf","2015-01-26 00:00:00",
13637,2,20863,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf","2015-08-04 00:00:00",
26076,1,20863,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s023ltr.pdf","2015-07-31 00:00:00",
48449,2,20863,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf","2017-05-18 00:00:00",
48454,1,20863,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020863Orig1s024ltr.pdf","2017-05-19 00:00:00",
3602,1,20864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf","1998-06-29 00:00:00",
13638,2,20864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf","1998-06-29 00:00:00",
41763,3,20864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.cfm","1999-04-08 00:00:00",
44077,10,20864,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2003-12-12 00:00:00",
41764,3,20864,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf","2004-04-15 00:00:00",
26077,1,20864,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF","1999-12-30 00:00:00",
21028,3,20864,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf","2004-04-15 00:00:00",
41765,3,20864,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-005.pdf","2004-04-21 00:00:00",
41766,3,20864,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-007.pdf","2004-04-21 00:00:00",
21029,3,20864,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020864_s008_MAXALT_TABLETS.pdf","2008-08-01 00:00:00",
26078,1,20864,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf","2002-04-22 00:00:00",
3603,1,20864,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35527,2,20864,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
3604,1,20864,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020864s013ltr.pdf","2010-08-16 00:00:00",
35528,2,20864,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020864s013lbl.pdf","2010-08-19 00:00:00",
3605,1,20864,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35529,2,20864,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
13639,2,20864,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
26079,1,20864,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
13640,2,20864,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
26080,1,20864,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
3606,1,20864,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35530,2,20864,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
3607,1,20865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf","1998-06-29 00:00:00",
3608,1,20865,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF","1999-11-23 00:00:00",
13641,2,20865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf","1998-06-29 00:00:00",
41767,3,20865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.cfm","1999-04-08 00:00:00",
44078,10,20865,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2003-12-12 00:00:00",
53399,20,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864 rizatriptan clinical bpca.pdf","1900-01-01 00:00:00",
53400,20,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan clinical1 bpca.pdf","1900-01-01 00:00:00",
53401,57,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan CDTL clinical bpca.pdf","1900-01-01 00:00:00",
53402,57,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan CDTL addendum bpca.pdf","1900-01-01 00:00:00",
53403,60,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan DD memo bpca.pdf","1900-01-01 00:00:00",
53404,18,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan clinpharm bpca.pdf","1900-01-01 00:00:00",
53405,17,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan statistical bpca.pdf","1900-01-01 00:00:00",
53406,17,20865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20865 rizatriptan statistical 2 bpca.pdf","1900-01-01 00:00:00",
41768,3,20865,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-865S002_review.pdf","2004-04-21 00:00:00",
41769,3,20865,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf","2004-06-09 00:00:00",
41770,3,20865,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-005.pdf","2004-04-21 00:00:00",
21030,3,20865,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-006.pdf","2004-04-21 00:00:00",
21031,3,20865,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-007.pdf","2004-04-21 00:00:00",
3609,1,20865,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf","2002-04-22 00:00:00",
41771,3,20865,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020865_s009_MAXALT_TABLETS.pdf","2008-08-01 00:00:00",
26081,1,20865,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35531,2,20865,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
13642,2,20865,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf","2010-08-19 00:00:00",
26082,1,20865,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020865s014ltr.pdf","2010-08-16 00:00:00",
3610,1,20865,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
13643,2,20865,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
3611,1,20865,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35532,2,20865,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
3612,1,20865,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35533,2,20865,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
3613,1,20865,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf","2011-12-21 00:00:00",
35534,2,20865,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf","2011-12-20 00:00:00",
21032,3,20866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm","2011-10-03 00:00:00",
24182,21,20866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866Orig1s000SumR.pdf","2011-10-03 00:00:00",
3614,1,20866,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020866s002ltr.pdf","2011-03-28 00:00:00",
35535,2,20866,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf","2011-03-28 00:00:00",
47120,2,20866,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf","2017-02-07 00:00:00",
47122,1,20866,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf","2017-02-07 00:00:00",
47121,2,20866,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf","2017-02-07 00:00:00",
47123,1,20866,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf","2017-02-07 00:00:00",
3615,1,20866,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020866Orig1s008ltr.pdf","2015-10-21 00:00:00",
13644,2,20866,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf","2015-10-22 00:00:00",
3616,1,20866,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020866Orig1s009ltr.pdf","2016-02-04 00:00:00",
13645,2,20866,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf","2016-02-11 00:00:00",
21033,3,20868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020868a.pdf","1997-11-26 00:00:00",
3617,1,20868,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20868slr005ltr.pdf","2003-05-29 00:00:00",
13646,2,20868,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf","2003-04-28 00:00:00",
26083,1,20868,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20868slr006ltr.pdf","2004-03-24 00:00:00",
35536,2,20868,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20868slr006_flagyl_lbl.pdf","2004-04-05 00:00:00",
3618,1,20868,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf","2010-08-24 00:00:00",
13647,2,20868,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf","2010-08-20 00:00:00",
26084,1,20868,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020868Orig1s009ltr.pdf","2013-08-20 00:00:00",
35537,2,20868,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020868s009lbl.pdf","2013-08-21 00:00:00",
26085,1,20868,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020868Orig1s011ltr.pdf","2015-07-14 00:00:00",
35538,2,20868,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020868s011lbl.pdf","2015-07-16 00:00:00",
53603,2,20868,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf","2018-04-04 00:00:00",
53625,1,20868,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012623Orig1s067, 020334Orig1s010, 020868Orig1s012ltr.pdf","2018-04-05 00:00:00",
3619,1,20869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20869ltr.pdf","1998-04-07 00:00:00",
35539,2,20869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20869lbl.pdf","1998-04-07 00:00:00",
41772,3,20869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020869_cosopt_toc.cfm","2003-08-08 00:00:00",
41773,3,20869,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-869-s-001_cosopt.pdf","1999-01-04 00:00:00",
26086,1,20869,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20869s012.pdf","2002-04-23 00:00:00",
35540,2,20869,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20869s12lbl.pdf","2002-04-23 00:00:00",
13648,2,20869,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf","2005-03-30 00:00:00",
26087,1,20869,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s020ltr.pdf","2005-03-30 00:00:00",
3620,1,20869,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s022ltr.pdf","2005-12-15 00:00:00",
35541,2,20869,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s022lbl.pdf","2005-12-15 00:00:00",
26088,1,20869,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf","2006-05-01 00:00:00",
35542,2,20869,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf","2006-05-01 00:00:00",
3621,1,20869,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf","2006-05-01 00:00:00",
35543,2,20869,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf","2006-05-01 00:00:00",
3622,1,20869,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s030LTR.pdf","2006-08-14 00:00:00",
35544,2,20869,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s030lbl.pdf","2006-08-11 00:00:00",
13649,2,20869,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf","2008-11-07 00:00:00",
26089,1,20869,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020869s034ltr.pdf","2008-10-23 00:00:00",
13650,2,20869,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf","2010-06-24 00:00:00",
26090,1,20869,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020869s036ltr.pdf","2010-06-22 00:00:00",
3623,1,20869,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020869Orig1s040ltr.pdf","2015-08-03 00:00:00",
13651,2,20869,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf","2015-08-04 00:00:00",
13652,2,20870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20870lbl.pdf","1998-08-07 00:00:00",
26091,1,20870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20870ltr.pdf","1998-08-07 00:00:00",
41774,3,20870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20870_CombiPatch.cfm","1998-08-07 00:00:00",
3624,1,20870,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20870slr010ltr.pdf","2004-06-23 00:00:00",
35545,2,20870,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20870slr010_CombiPatch_lbl.pdf","2004-06-23 00:00:00",
13653,2,20870,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20870s013lbl.pdf","2005-01-18 00:00:00",
26092,1,20870,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20870s013ltr.pdf","2005-01-18 00:00:00",
26093,1,20870,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020870s015ltr.pdf","2005-11-18 00:00:00",
35546,2,20870,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020870s015lbl.pdf","2005-11-18 00:00:00",
26094,1,20870,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020870Orig1s017ltr.pdf","2013-09-20 00:00:00",
35547,2,20870,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020870s017lbl.pdf","2013-09-24 00:00:00",
26095,1,20870,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020870Orig1s019ltr.pdf","2015-05-11 00:00:00",
35548,2,20870,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020870s019lbl.pdf","2015-05-08 00:00:00",
50266,2,20870,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020870s023lbl.pdf","2017-11-02 00:00:00",
21034,3,20872,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf","2004-05-26 00:00:00",
26096,1,20872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf","2000-02-25 00:00:00",
26097,1,20872,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf","2001-10-29 00:00:00",
35549,2,20872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf","2000-02-25 00:00:00",
41775,3,20872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-872_Allegra.cfm","2004-05-26 00:00:00",
26098,1,20872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf","2001-10-29 00:00:00",
41776,3,20872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf","2004-05-26 00:00:00",
3625,1,20872,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf","2003-06-08 00:00:00",
35550,2,20872,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf","2003-05-29 00:00:00",
21035,3,20872,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf","2004-05-26 00:00:00",
26099,1,20872,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf","2001-10-29 00:00:00",
41777,3,20872,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf","2008-08-04 00:00:00",
26100,1,20872,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf","2001-07-11 00:00:00",
21036,3,20872,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf","2008-08-01 00:00:00",
21037,3,20872,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf","2008-08-01 00:00:00",
41778,3,20872,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf","2008-08-01 00:00:00",
3626,1,20872,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf","2003-06-08 00:00:00",
35551,2,20872,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf","2003-05-29 00:00:00",
3627,1,20872,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf","2005-10-19 00:00:00",
13654,2,20872,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf","2005-10-19 00:00:00",
3628,1,20872,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf","2008-06-30 00:00:00",
13655,2,20872,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf","2008-06-30 00:00:00",
26101,1,20872,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf","2011-01-27 00:00:00",
35552,2,20872,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf","2013-11-26 00:00:00",
3629,1,20872,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf","2012-02-27 00:00:00",
13656,2,20872,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf","2012-03-27 00:00:00",
3630,1,20872,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf","2012-08-27 00:00:00",
35553,2,20872,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf","2012-11-13 00:00:00",
13657,2,20872,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf","2014-08-06 00:00:00",
26102,1,20872,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf","2014-04-17 00:00:00",
26103,1,20872,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf","2014-09-16 00:00:00",
35554,2,20872,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf","2014-09-23 00:00:00",
3631,1,20872,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf","2016-05-12 00:00:00",
35555,2,20872,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf","2016-05-12 00:00:00",
13658,2,20873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf","2000-12-15 00:00:00",
21038,3,20873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20873_Angiomax.cfm","2004-04-08 00:00:00",
26104,1,20873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20873ltr.pdf","2000-12-15 00:00:00",
53199,20,20873,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020873_Bivalirudin_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53200,18,20873,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020873_Bivalirudin_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
54031,23,20873,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020873_Bivalirudin_Original_WR.pdf","1900-01-01 00:00:00",
3632,1,20873,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20873s004LTR.pdf","2002-06-20 00:00:00",
26105,1,20873,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s006ltr.pdf","2005-06-15 00:00:00",
26106,1,20873,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20873slr009ltr.pdf","2004-05-07 00:00:00",
26107,1,20873,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s011ltr.pdf","2005-12-05 00:00:00",
35556,2,20873,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf","2005-12-05 00:00:00",
3633,1,20873,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s014ltr.pdf","2005-09-08 00:00:00",
3634,1,20873,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020873s023ltr.pdf","2010-06-29 00:00:00",
35557,2,20873,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf","2010-07-01 00:00:00",
26108,1,20873,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020873Orig1s029ltr.pdf","2013-05-22 00:00:00",
35558,2,20873,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf","2013-05-21 00:00:00",
26109,1,20873,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020873Orig1s036ltr.pdf","2016-03-22 00:00:00",
35559,2,20873,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf","2016-03-22 00:00:00",
3635,1,20874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20874ltr.pdf","2000-10-05 00:00:00",
13659,2,20874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf","2000-10-05 00:00:00",
41779,3,20874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-874_Lunelle.cfm","2005-04-11 00:00:00",
21039,3,20882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20882.cfm","1998-10-09 00:00:00",
24143,16,20882,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
26110,1,20882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20882ltr.pdf","1998-10-09 00:00:00",
3636,1,20882,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf","2000-10-12 00:00:00",
13660,2,20882,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf","2000-10-12 00:00:00",
41780,3,20882,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm","2004-05-06 00:00:00",
3637,1,20882,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf","2002-01-30 00:00:00",
3638,1,20882,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf","2004-06-10 00:00:00",
3639,1,20882,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf","2005-02-23 00:00:00",
13661,2,20882,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf","2005-02-23 00:00:00",
26111,1,20882,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20882scs017ltr.pdf","2004-05-04 00:00:00",
3640,1,20882,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf","2006-05-05 00:00:00",
3641,1,20882,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf","2011-03-07 00:00:00",
35560,2,20882,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf","2011-03-04 00:00:00",
26112,1,20882,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028ltr.pdf","2009-05-01 00:00:00",
35561,2,20882,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf","2009-04-28 00:00:00",
3642,1,20882,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf","2010-10-13 00:00:00",
35562,2,20882,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020882s030lbl.pdf","2010-10-11 00:00:00",
13662,2,20882,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf","2011-08-11 00:00:00",
26113,1,20882,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf","2011-08-12 00:00:00",
3643,1,20882,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
35563,2,20882,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
13663,2,20882,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
26114,1,20882,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
26115,1,20882,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
35564,2,20882,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
26116,1,20882,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf","2014-08-20 00:00:00",
35565,2,20882,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf","2014-08-20 00:00:00",
26117,1,20882,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf","2015-09-17 00:00:00",
35566,2,20882,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf","2015-09-23 00:00:00",
26118,1,20882,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf","2015-04-22 00:00:00",
35567,2,20882,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf","2015-04-27 00:00:00",
47712,2,20882,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf","2017-03-27 00:00:00",
47713,8,20882,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32","2017-03-27 00:00:00",
47753,1,20882,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020235Orig1s062,020882Orig1s045,021129Orig1s044ltr.pdf","2017-03-29 00:00:00",
50104,1,20882,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf","2017-10-19 00:00:00",
3644,1,20883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20883ltr.pdf","2000-06-30 00:00:00",
13664,2,20883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf","2000-06-30 00:00:00",
21040,3,20883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-883_Acova.cfm","2002-04-05 00:00:00",
53179,20,20883,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020883se8-014_Argatroban_Clinical_PREA.pdf","1900-01-01 00:00:00",
53180,18,20883,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020883se8-014_Argatroban_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
26119,1,20883,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20883s4ltr.pdf","2002-04-03 00:00:00",
35568,2,20883,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20883s4lbl.pdf","2002-04-03 00:00:00",
3645,1,20883,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20883slr007ltr.pdf","2003-11-13 00:00:00",
26120,1,20883,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s009ltr.pdf","2005-09-08 00:00:00",
3646,1,20883,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s010ltr.pdf","2005-04-12 00:00:00",
13665,2,20883,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf","2008-05-19 00:00:00",
24183,21,20883,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020883se8-014_sumr.pdf","2008-07-16 00:00:00",
26121,1,20883,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020883se8-014ltr.pdf","2008-05-08 00:00:00",
3647,1,20883,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020883Orig1s016ltr.pdf","2014-03-11 00:00:00",
13666,2,20883,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf","2014-03-11 00:00:00",
26122,1,20883,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020883Orig1s018ltr.pdf","2016-05-27 00:00:00",
35569,2,20883,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020883s018lbl.pdf","2016-06-01 00:00:00",
49290,2,20883,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020883s019lbl.pdf","2017-08-09 00:00:00",
49363,1,20883,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020883Orig1s019ltr.pdf","2017-08-15 00:00:00",
13667,2,20884,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf","2003-04-24 00:00:00",
26123,1,20884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_APPROV.PDF","2003-04-30 00:00:00",
35570,2,20884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf","2003-04-30 00:00:00",
41781,3,20884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_Aggrenox.cfm","2003-04-30 00:00:00",
3648,1,20884,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20884S3ltr.pdf","2001-04-23 00:00:00",
3649,1,20884,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20884slr007ltr.pdf","2004-02-02 00:00:00",
3650,1,20884,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020884s012ltr.pdf","2007-03-31 00:00:00",
13668,2,20884,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf","2007-03-31 00:00:00",
3651,1,20884,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020884s014ltr.pdf","2006-12-04 00:00:00",
13669,2,20884,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf","2006-12-04 00:00:00",
3652,1,20884,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020884s018ltr.pdf","2009-10-05 00:00:00",
35571,2,20884,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf","2009-10-14 00:00:00",
3653,1,20884,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020884Orig1s030ltr.pdf","2012-09-11 00:00:00",
35572,2,20884,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf","2012-09-11 00:00:00",
26124,1,20884,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020884Orig1s035ltr.pdf","2015-11-13 00:00:00",
35573,2,20884,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf","2015-11-12 00:00:00",
3654,1,20885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20885ltr.pdf","1998-10-09 00:00:00",
21041,3,20885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020885a.pdf","1998-10-09 00:00:00",
23607,10,20885,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
41782,3,20885,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020885Orig1s002.pdf","2011-12-09 00:00:00",
41783,3,20885,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020885Orig1s003.pdf","2011-12-09 00:00:00",
21042,3,20885,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020885Orig1s004.pdf","2011-12-09 00:00:00",
3655,1,20886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20886ltr.pdf","1999-02-02 00:00:00",
13670,2,20886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf","1999-02-02 00:00:00",
21043,3,20886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20886.cfm","1999-02-02 00:00:00",
3656,1,20887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20887ltr.pdf","1998-09-14 00:00:00",
13671,2,20887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf","1998-09-14 00:00:00",
21044,3,20887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20887.cfm","1998-09-14 00:00:00",
35574,2,20888,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20888s2lbl.pdf","2003-04-24 00:00:00",
13672,2,20889,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf","2004-06-08 00:00:00",
35575,2,20890,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20890s2lbl.pdf","2003-04-25 00:00:00",
3657,1,20892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20892ltr.pdf","1998-09-25 00:00:00",
13673,2,20892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf","1998-09-25 00:00:00",
21045,3,20892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.cfm","1998-09-25 00:00:00",
3658,1,20892,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020892s013ltr.pdf","2011-11-07 00:00:00",
13674,2,20892,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf","2011-11-04 00:00:00",
3659,1,20892,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020892Orig1s016ltr.pdf","2013-08-05 00:00:00",
26125,1,20892,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020892Orig1s019ltr.pdf","2016-04-11 00:00:00",
35576,2,20892,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf","2016-04-08 00:00:00",
3660,1,20895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20895ltr.pdf","1998-03-27 00:00:00",
13675,2,20895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf","1998-03-27 00:00:00",
21046,3,20895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_toc.cfm","2009-04-13 00:00:00",
23608,10,20895,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm162833.htm","2007-10-30 00:00:00",
41784,3,20895,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S001_VIAGRA.pdf","2008-02-19 00:00:00",
21047,3,20895,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S002_VIAGRA.pdf","2008-02-19 00:00:00",
41785,3,20895,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S003_VIAGRA.pdf","2008-02-19 00:00:00",
3661,1,20895,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf","2002-09-19 00:00:00",
35577,2,20895,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf","2002-09-19 00:00:00",
13676,2,20895,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf","2002-09-19 00:00:00",
26126,1,20895,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf","2002-09-19 00:00:00",
13677,2,20895,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf","2002-09-19 00:00:00",
26127,1,20895,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf","2002-09-19 00:00:00",
3662,1,20895,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s020ltr.pdf","2006-07-03 00:00:00",
13678,2,20895,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf","2006-06-28 00:00:00",
13679,2,20895,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf","2005-07-08 00:00:00",
26128,1,20895,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020895s021ltr.pdf","2005-07-15 00:00:00",
13680,2,20895,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf","2006-10-11 00:00:00",
26129,1,20895,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s023ltr.pdf","2006-10-13 00:00:00",
3663,1,20895,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s026ltr.pdf","2008-02-27 00:00:00",
13681,2,20895,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf","2008-02-26 00:00:00",
3664,1,20895,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020895s027ltr.pdf","2007-10-22 00:00:00",
35578,2,20895,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020895s027lbl.pdf","2007-10-18 00:00:00",
3665,1,20895,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028, s029ltr.pdf","2008-08-13 00:00:00",
3666,1,20895,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028, s029ltr.pdf","2008-08-13 00:00:00",
3667,1,20895,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020895s033ltr.pdf","2010-01-15 00:00:00",
13682,2,20895,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf","2010-01-20 00:00:00",
3668,1,20895,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020895s036ltr.pdf","2011-02-04 00:00:00",
35579,2,20895,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020895s036lbl.pdf","2011-01-31 00:00:00",
26130,1,20895,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042ltr.pdf","2014-03-11 00:00:00",
35580,2,20895,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf","2014-03-11 00:00:00",
3669,1,20895,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042ltr.pdf","2014-03-11 00:00:00",
35581,2,20895,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf","2014-03-11 00:00:00",
26131,1,20895,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s044ltr.pdf","2015-03-27 00:00:00",
35582,2,20895,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s044lbl.pdf","2015-03-27 00:00:00",
3670,1,20895,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s045ltr.pdf","2015-09-17 00:00:00",
13683,2,20895,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf","2015-09-23 00:00:00",
50687,2,20895,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s048lbl.pdf","2017-12-14 00:00:00",
50711,1,20895,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020895Orig1s048ltr.pdf","2017-12-15 00:00:00",
49445,2,20895,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s049lbl.pdf","2017-08-17 00:00:00",
49505,1,20895,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020895Orig1s049ltr.pdf","2017-08-22 00:00:00",
3671,1,20896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20896ltr.pdf","1998-04-30 00:00:00",
35583,2,20896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20896lbl.pdf","1998-04-30 00:00:00",
41786,3,20896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20896.cfm","1998-04-30 00:00:00",
3672,1,20896,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda_approv.pdf","2001-04-30 00:00:00",
41787,3,20896,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm","2001-04-30 00:00:00",
3673,1,20896,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.htm","2001-04-30 00:00:00",
13684,2,20896,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf","2003-04-25 00:00:00",
41788,3,20896,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm","2001-04-30 00:00:00",
13685,2,20896,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf","2001-09-07 00:00:00",
21048,3,20896,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm","2001-09-07 00:00:00",
26132,1,20896,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf","2001-09-07 00:00:00",
3674,1,20896,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf","2001-09-07 00:00:00",
35584,2,20896,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf","2001-09-07 00:00:00",
41789,3,20896,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm","2001-09-07 00:00:00",
3675,1,20896,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20896slr012ltr.pdf","2003-03-26 00:00:00",
13686,2,20896,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf","2003-03-26 00:00:00",
3676,1,20896,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020896s016ltr.pdf","2005-06-16 00:00:00",
35585,2,20896,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020896s016lbl.pdf","2005-06-15 00:00:00",
3677,1,20896,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020896s026ltr.pdf","2011-02-09 00:00:00",
35586,2,20896,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020896s026lbl.pdf","2011-02-09 00:00:00",
3678,1,20896,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020896Orig1s032ltr.pdf","2013-12-16 00:00:00",
35587,2,20896,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020896s032lbl.pdf","2013-12-11 00:00:00",
51280,23,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896_capecitabine_Original_WR.pdf","2005-03-16 00:00:00",
51281,25,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896_capecitabine_Amendment_1.pdf","2007-01-19 00:00:00",
51282,26,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896_capecitabine_Amendment_2.pdf","2008-05-07 00:00:00",
51283,27,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM366917.pdf","2011-07-01 00:00:00",
52404,20,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896s032_Xeloda capecitabine clinical bpca.pdf","1900-01-01 00:00:00",
52405,18,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896s032_Xeloda capecitabine clinpharm bpca.pdf","1900-01-01 00:00:00",
52406,17,20896,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020896s032_Xeloda capecitabine statistical bpca.pdf","1900-01-01 00:00:00",
26133,1,20896,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020896Orig1s034ltr.pdf","2014-10-21 00:00:00",
35588,2,20896,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020896s034lbl.pdf","2014-10-21 00:00:00",
13687,2,20896,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf","2015-03-05 00:00:00",
26134,1,20896,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s036ltr.pdf","2015-03-03 00:00:00",
3679,1,20896,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s037ltr.pdf","2015-03-24 00:00:00",
13688,2,20896,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf","2015-03-24 00:00:00",
46173,1,20896,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020896Orig1s039ltr.pdf","2016-12-15 00:00:00",
46204,2,20896,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020896s039lbl.pdf","2016-12-19 00:00:00",
21049,3,20897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897.cfm","1998-12-16 00:00:00",
26135,1,20897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20897ltr.pdf","1998-12-16 00:00:00",
35589,2,20897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20897lbl.pdf","1998-12-16 00:00:00",
53118,20,20897,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020897s009, 017577s033, 018211s016_oxybutynin-Ditropan-MedRev.pdf","1900-01-01 00:00:00",
53119,18,20897,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020897s009, 017577s033, 018211s016_oxybutynin-Ditropan-ClinPharmRev.pdf","1900-01-01 00:00:00",
53120,23,20897,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/017577, 018211, 020897_oxybutynin_Ditropan_11-30-00_HFD580_orig.pdf","1900-01-01 00:00:00",
41790,3,20897,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020897_S002_DITROPAN_AP.pdf","2007-04-11 00:00:00",
13689,2,20897,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
3680,1,20897,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf","2003-05-29 00:00:00",
35590,2,20897,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf","2003-04-16 00:00:00",
26136,1,20897,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20897se8-013ltr.pdf","2004-06-30 00:00:00",
35591,2,20897,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20897se8-013_Ditropan_lbl.pdf","2004-07-01 00:00:00",
3681,1,20897,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020897s018ltr.pdf","2008-03-17 00:00:00",
13690,2,20897,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf","2008-02-14 00:00:00",
13691,2,20897,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf","2009-07-23 00:00:00",
26137,1,20897,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020897s024ltr.pdf","2009-07-17 00:00:00",
3682,1,20897,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s028ltr.pdf","2011-07-05 00:00:00",
13692,2,20897,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf","2011-06-30 00:00:00",
26138,1,20897,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s029ltr.pdf","2011-12-20 00:00:00",
35592,2,20897,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s029lbl.pdf","2011-12-20 00:00:00",
3683,1,20897,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897s030ltr.pdf","2012-03-27 00:00:00",
35593,2,20897,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s030lbl.pdf","2012-03-27 00:00:00",
13693,2,20897,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf","2012-11-15 00:00:00",
26139,1,20897,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897Orig1s031ltr.pdf","2012-11-14 00:00:00",
26140,1,20897,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020897Orig1s032ltr.pdf","2013-08-05 00:00:00",
35594,2,20897,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020897s032lbl.pdf","2013-08-09 00:00:00",
3684,1,20897,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020897Orig1s033ltr.pdf","2015-03-02 00:00:00",
35595,2,20897,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf","2015-03-04 00:00:00",
45294,1,20897,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020897Orig1s035ltr.pdf","2016-09-15 00:00:00",
45407,2,20897,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020897s035lbl.pdf","2016-09-28 00:00:00",
3685,1,20898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20898ltr.pdf","1998-11-30 00:00:00",
35596,2,20898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen_prntlbl.pdf","1998-11-30 00:00:00",
41791,3,20898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen.cfm","2001-06-19 00:00:00",
3686,1,20898,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20898slr021ltr.pdf","2004-03-16 00:00:00",
13694,2,20898,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20898slr021_Thyrogen_lbl.pdf","2004-04-05 00:00:00",
13695,2,20898,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020898s029lbl.pdf","2007-12-27 00:00:00",
26141,1,20898,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020898s029ltr.pdf","2008-01-09 00:00:00",
26142,1,20898,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020898s031ltr.pdf","2006-01-30 00:00:00",
35597,2,20898,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020898s031lbl.pdf","2006-01-25 00:00:00",
3687,1,20898,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020898s038ltr.pdf","2008-08-19 00:00:00",
13696,2,20898,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020898s038lbl.pdf","2008-08-29 00:00:00",
13697,2,20898,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf","2012-07-31 00:00:00",
26143,1,20898,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020898Orig1s051ltr.pdf","2012-07-31 00:00:00",
3688,1,20898,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020898Orig1s054ltr.pdf","2014-03-24 00:00:00",
35598,2,20898,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020898s054lbl.pdf","2014-03-25 00:00:00",
48096,2,20898,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020898s060lbl.pdf","2017-04-25 00:00:00",
48147,1,20898,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020898s060ltr.pdf","2017-04-27 00:00:00",
23609,10,20899,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110260.htm","2008-07-11 00:00:00",
3689,1,20899,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20899scm007ltr.pdf","2002-05-10 00:00:00",
13698,2,20899,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf","2007-10-04 00:00:00",
3690,1,20899,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020899s010ltr.pdf","2007-11-19 00:00:00",
3691,1,20899,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020899s011ltr.pdf","2008-06-09 00:00:00",
35599,2,20899,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020899s011lbl.pdf","2008-06-12 00:00:00",
26144,1,20899,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020899Orig1s015ltr.pdf","2012-08-20 00:00:00",
35600,2,20899,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020899s015lbl.pdf","2012-08-20 00:00:00",
45313,2,20899,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf","2016-09-16 00:00:00",
45346,1,20899,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf","2016-09-20 00:00:00",
45314,2,20899,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf","2016-09-16 00:00:00",
45347,1,20899,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf","2016-09-20 00:00:00",
3692,1,20900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20900ltr.pdf","1999-02-04 00:00:00",
21050,3,20900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20900_Pylori-Chek.cfm","1999-02-04 00:00:00",
35601,2,20900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20900lbl.pdf","1999-02-04 00:00:00",
21051,3,20901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20901.cfm","1999-07-08 00:00:00",
26145,1,20901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20901ltr.pdf","1998-11-24 00:00:00",
35602,2,20901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf","1998-11-24 00:00:00",
3693,1,20901,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20901slr002ltr.pdf","2004-05-26 00:00:00",
13699,2,20901,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf","2004-05-27 00:00:00",
13700,2,20902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_prntlbl.pdf","1999-08-05 00:00:00",
26146,1,20902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_appltr.pdf","1999-08-05 00:00:00",
41792,3,20902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902_Pepcid.cfm","1999-08-05 00:00:00",
3694,1,20902,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf","2004-10-29 00:00:00",
3695,1,20902,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020902s009LTR.pdf","2006-06-12 00:00:00",
3696,1,20903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903ltr.pdf","1998-06-03 00:00:00",
26147,1,20903,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf","1998-12-09 00:00:00",
35603,2,20903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903lbl.pdf","1998-06-03 00:00:00",
35604,2,20903,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf","1998-12-09 00:00:00",
41793,3,20903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020903_rebetol_toc.cfm","2003-08-08 00:00:00",
3697,1,20903,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf","1998-12-09 00:00:00",
13701,2,20903,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf","1998-12-09 00:00:00",
13702,2,20903,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf","2003-04-25 00:00:00",
3698,1,20903,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf","2001-03-13 00:00:00",
21052,3,20903,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf","2004-06-04 00:00:00",
3699,1,20903,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf","2001-03-13 00:00:00",
41794,3,20903,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf","2004-06-04 00:00:00",
3700,1,20903,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf","2001-07-26 00:00:00",
21053,3,20903,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm","2005-04-15 00:00:00",
35605,2,20903,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf","2001-07-26 00:00:00",
13703,2,20903,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf","2003-04-25 00:00:00",
3701,1,20903,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf","2001-07-26 00:00:00",
35606,2,20903,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf","2001-07-26 00:00:00",
41795,3,20903,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm","2005-04-15 00:00:00",
13704,2,20903,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf","2001-07-26 00:00:00",
26148,1,20903,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf","2001-07-26 00:00:00",
41796,3,20903,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm","2005-04-15 00:00:00",
3702,1,20903,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s13ltr.pdf","2001-12-28 00:00:00",
13705,2,20903,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf","2003-04-25 00:00:00",
13706,2,20903,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf","2003-04-25 00:00:00",
26149,1,20903,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s15ltr.pdf","2002-02-21 00:00:00",
3703,1,20903,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf","2001-07-26 00:00:00",
21265,3,20903,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm","2005-04-15 00:00:00",
35607,2,20903,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf","2001-07-26 00:00:00",
26150,1,20903,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s20ltr.pdf","2002-03-06 00:00:00",
41797,3,20903,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-903s020_Rebetol.cfm","2005-04-15 00:00:00",
3704,1,20903,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr023ltr.pdf","2002-09-03 00:00:00",
13707,2,20903,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf","2002-09-03 00:00:00",
26151,1,20903,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr025ltr.pdf","2003-07-31 00:00:00",
35608,2,20903,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903slr025_Rebetron_lbl.pdf","2002-11-13 00:00:00",
3705,1,20903,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr028ltr.pdf","2003-06-22 00:00:00",
35609,2,20903,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr028_rebetol_lbl.pdf","2003-06-22 00:00:00",
13708,2,20903,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pdf","2003-06-08 00:00:00",
26152,1,20903,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr029ltr.pdf","2003-06-08 00:00:00",
3706,1,20903,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr030ltr.pdf","2004-06-14 00:00:00",
21266,3,20903,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S30_REBETOL REBETRON.pdf","2008-08-01 00:00:00",
35610,2,20903,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903s30lbl_Rebetol.pdf","2003-07-09 00:00:00",
13709,2,20903,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pdf","2003-10-16 00:00:00",
21267,3,20903,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S32_REBETOL RETETRON.pdf","2008-08-01 00:00:00",
26153,1,20903,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr032ltr.pdf","2003-10-16 00:00:00",
13710,2,20903,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.pdf","2004-06-10 00:00:00",
26154,1,20903,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr033ltr.pdf","2004-06-10 00:00:00",
3707,1,20903,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr034ltr.pdf","2004-06-24 00:00:00",
13711,2,20903,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pdf","2004-06-24 00:00:00",
26155,1,20903,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020903s038ltr.pdf","2006-09-18 00:00:00",
35611,2,20903,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020903s038lbl.pdf","2006-08-29 00:00:00",
3708,1,20903,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s039ltr.pdf","2007-04-20 00:00:00",
13712,2,20903,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf","2007-04-20 00:00:00",
13713,2,20903,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf","2007-12-14 00:00:00",
26156,1,20903,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s040ltr.pdf","2008-01-09 00:00:00",
3709,1,20903,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf","2010-01-20 00:00:00",
13714,2,20903,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf","2009-11-16 00:00:00",
3710,1,20903,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf","2010-01-20 00:00:00",
35612,2,20903,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf","2009-11-16 00:00:00",
26157,1,20903,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf","2010-01-20 00:00:00",
35613,2,20903,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf","2009-11-16 00:00:00",
3711,1,20903,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf","2010-01-20 00:00:00",
13715,2,20903,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf","2009-11-16 00:00:00",
13716,2,20903,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf","2010-10-29 00:00:00",
26158,1,20903,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002ltr.pdf","2010-11-03 00:00:00",
26159,1,20903,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004ltr.pdf","2011-05-10 00:00:00",
3712,1,20903,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546Orig1s006ltr.pdf","2013-02-08 00:00:00",
35614,2,20903,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf","2013-02-08 00:00:00",
26160,1,20903,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546Orig1s007ltr.pdf","2013-06-04 00:00:00",
35615,2,20903,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf","2013-06-04 00:00:00",
3713,1,20903,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546Orig1s008ltr.pdf","2013-11-18 00:00:00",
13717,2,20903,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf","2013-11-22 00:00:00",
26161,1,20903,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546Orig1s009ltr.pdf","2015-05-22 00:00:00",
35616,2,20903,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf","2015-05-27 00:00:00",
13718,2,20905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf","1998-09-10 00:00:00",
26162,1,20905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20905ltr.pdf","1998-09-10 00:00:00",
51995,17,20905,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020757s034_irbesartan_Avapro-StatsRev.pdf","1900-01-01 00:00:00",
52886,23,20905,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020905_leflunomide_Arava_WR.pdf","1900-01-01 00:00:00",
13719,2,20905,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf","2003-06-22 00:00:00",
21268,3,20905,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S006_ARAVA.pdf","2007-11-19 00:00:00",
26163,1,20905,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf","2003-06-22 00:00:00",
3714,1,20905,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf","2003-06-22 00:00:00",
21269,3,20905,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S007_ARAVA.pdf","2007-11-19 00:00:00",
35617,2,20905,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf","2003-06-22 00:00:00",
26164,1,20905,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905se5-012ltr.pdf","2004-03-10 00:00:00",
35618,2,20905,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905se5-012_Arava_lbl.pdf","2004-04-05 00:00:00",
41799,3,20905,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020905_S012_ARAVA.pdf","2008-07-31 00:00:00",
26165,1,20905,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905s014ltr.pdf","2004-12-02 00:00:00",
35619,2,20905,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905s014lbl.pdf","2004-12-03 00:00:00",
3715,1,20905,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020905s015ltr.pdf","2005-10-25 00:00:00",
35620,2,20905,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020905s015lbl.pdf","2005-10-25 00:00:00",
3716,1,20905,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020905s016ltr.pdf","2007-11-19 00:00:00",
13720,2,20905,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf","2007-11-13 00:00:00",
3717,1,20905,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020905s018ltr.pdf","2009-04-07 00:00:00",
3718,1,20905,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020905s020ltr.pdf","2010-09-13 00:00:00",
13721,2,20905,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf","2010-09-10 00:00:00",
26166,1,20905,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020905s022ltr.pdf","2011-07-12 00:00:00",
35621,2,20905,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020905s022lbl.pdf","2011-07-12 00:00:00",
13722,2,20905,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf","2012-11-06 00:00:00",
26167,1,20905,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020905Orig1s025ltr.pdf","2012-11-06 00:00:00",
13723,2,20905,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf","2015-09-03 00:00:00",
26168,1,20905,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020905Orig1s027ltr.pdf","2015-09-01 00:00:00",
3719,1,20905,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020905Orig1s028ltr.pdf","2014-11-18 00:00:00",
45562,1,20905,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020905Orig1s031ltr.pdf","2016-10-20 00:00:00",
47274,2,20905,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020905s031lbl.pdf","2017-02-22 00:00:00",
26169,1,20906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20906_Etopophos_appltr_chemr.pdf","1998-02-27 00:00:00",
41800,3,20906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20906.cfm","1998-02-27 00:00:00",
3720,1,20906,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457slr006,20906slr002ltr.pdf","2002-11-05 00:00:00",
26170,1,20907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20907ltr.pdf","1998-11-18 00:00:00",
35622,2,20907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf","1998-11-18 00:00:00",
41801,3,20907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20907.cfm","1998-11-18 00:00:00",
41802,3,20907,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020907_S001.pdf","2005-12-08 00:00:00",
21270,3,20907,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S002.pdf","2005-12-08 00:00:00",
41803,3,20907,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S003.pdf","2005-12-08 00:00:00",
41804,3,20907,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S004.pdf","2005-12-08 00:00:00",
26171,1,20907,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf","2005-07-08 00:00:00",
35623,2,20907,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf","2005-07-07 00:00:00",
41805,3,20907,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020907_S006.pdf","2005-12-08 00:00:00",
21271,3,20907,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020907_S007.pdf","2005-12-08 00:00:00",
26172,1,20907,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf","2007-01-08 00:00:00",
35624,2,20907,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf","2007-01-08 00:00:00",
26173,1,20907,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf","2007-01-08 00:00:00",
35625,2,20907,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf","2007-01-08 00:00:00",
13724,2,20907,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf","2013-10-17 00:00:00",
26174,1,20907,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf","2013-10-10 00:00:00",
50291,2,20907,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf","2017-11-03 00:00:00",
50631,1,20907,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020907s019ltr.pdf","2017-12-07 00:00:00",
13725,2,20908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf","1999-03-26 00:00:00",
21272,3,20908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020908_000_VagifemTOC.cfm","2005-07-15 00:00:00",
26175,1,20908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20908ltr.pdf","1999-03-26 00:00:00",
35626,2,20908,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf","2009-12-02 00:00:00",
3721,1,20908,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020908s016ltr.pdf","2011-05-19 00:00:00",
26176,1,20908,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020908s017ltr.pdf","2012-04-13 00:00:00",
35627,2,20908,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020908s017lbl.pdf","2012-04-17 00:00:00",
47391,2,20908,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s024lbl.pdf","2017-03-02 00:00:00",
47465,1,20908,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020908Orig1s024ltr.pdf","2017-03-03 00:00:00",
50285,2,20908,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf","2017-11-03 00:00:00",
3722,1,20911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Approv.pdf","2004-06-14 00:00:00",
13726,2,20911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf","2004-06-14 00:00:00",
41806,3,20911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_Qvar.cfm","2004-02-11 00:00:00",
3723,1,20911,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20911s005ltr.pdf","2002-05-09 00:00:00",
26177,1,20911,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20911slr008ltr.pdf","2003-08-15 00:00:00",
3724,1,20911,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020911s015_ltr.pdf","2006-11-22 00:00:00",
35628,2,20911,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf","2007-01-16 00:00:00",
3725,1,20911,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020911s017ltr.pdf","2008-08-20 00:00:00",
35629,2,20911,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf","2008-08-26 00:00:00",
3726,1,20911,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020911Orig1s022ltr.pdf","2012-08-01 00:00:00",
35630,2,20911,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf","2012-07-30 00:00:00",
3727,1,20911,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Orig1s025ltr.pdf","2014-07-24 00:00:00",
35631,2,20911,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf","2014-07-30 00:00:00",
3728,1,20911,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Origs026ltr.pdf","2014-05-23 00:00:00",
13727,2,20911,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf","2014-05-28 00:00:00",
49912,2,20911,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf","2017-10-03 00:00:00",
49931,1,20911,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf","2017-10-03 00:00:00",
49913,2,20911,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf","2017-10-03 00:00:00",
49932,1,20911,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf","2017-10-03 00:00:00",
3729,1,20912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20912ltr.pdf","1998-05-14 00:00:00",
3730,1,20912,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF","1999-07-09 00:00:00",
13728,2,20912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20912lbl.pdf","1998-05-14 00:00:00",
21273,3,20912,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm","2004-05-26 00:00:00",
35632,2,20912,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf","1999-07-09 00:00:00",
21274,3,20912,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf","2004-05-26 00:00:00",
26178,1,20912,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf","2001-03-23 00:00:00",
3731,1,20912,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf","2001-09-25 00:00:00",
26179,1,20912,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf","2002-07-24 00:00:00",
26180,1,20912,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf","2004-05-26 00:00:00",
3732,1,20912,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20912slr013ltr.pdf","2003-03-10 00:00:00",
13729,2,20912,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf","2012-06-11 00:00:00",
26181,1,20912,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf","2012-06-08 00:00:00",
3733,1,20912,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf","2013-10-11 00:00:00",
13730,2,20912,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf","2013-10-17 00:00:00",
26182,1,20912,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf","2013-10-11 00:00:00",
35633,2,20912,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf","2013-10-17 00:00:00",
3734,1,20912,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf","2015-04-22 00:00:00",
35634,2,20912,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf","2015-04-28 00:00:00",
45214,2,20912,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf","2016-08-31 00:00:00",
3735,1,20913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20913ltr.pdf","1998-05-14 00:00:00",
21275,3,20913,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm","2004-05-26 00:00:00",
26183,1,20913,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF","1999-07-09 00:00:00",
35635,2,20913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf","1998-05-14 00:00:00",
35636,2,20913,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf","1999-07-09 00:00:00",
41807,3,20913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20913.pdf","2010-06-04 00:00:00",
41808,3,20913,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf","2004-05-26 00:00:00",
3736,1,20913,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf","2001-03-23 00:00:00",
3737,1,20913,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf","2001-09-25 00:00:00",
26184,1,20913,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf","2002-07-24 00:00:00",
3738,1,20913,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf","2003-07-24 00:00:00",
26185,1,20913,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf","2002-05-17 00:00:00",
13731,2,20913,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf","2012-06-11 00:00:00",
26186,1,20913,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf","2012-06-08 00:00:00",
3739,1,20913,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf","2015-04-22 00:00:00",
35637,2,20913,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf","2015-04-28 00:00:00",
45213,2,20913,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf","2016-09-07 00:00:00",
3740,1,20916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20916ltr.pdf","1998-06-29 00:00:00",
13732,2,20918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf","1998-06-22 00:00:00",
26187,1,20918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20918_ltr.pdf","1998-06-22 00:00:00",
41809,3,20918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020918s000_GlucagenTOC.cfm","2005-06-23 00:00:00",
3741,1,20918,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20918slr003ltr.pdf","2002-07-11 00:00:00",
41810,3,20918,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020918_S003_GLUCAGEN.pdf","2007-07-20 00:00:00",
26188,1,20918,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918slr008ltr.pdf","2004-03-02 00:00:00",
35638,2,20918,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918slr008_glucagen_lbl.pdf","2004-04-05 00:00:00",
41811,3,20918,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020918_S008_GLUCAGEN.pdf","2007-07-20 00:00:00",
3742,1,20918,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918s012ltr.pdf","2004-12-29 00:00:00",
13733,2,20918,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf","2004-12-29 00:00:00",
26189,1,20918,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020918s017ltr.pdf","2005-11-18 00:00:00",
35639,2,20918,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020918s017lbl.pdf","2005-11-18 00:00:00",
3743,1,20918,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020918s030ltr.pdf","2010-12-21 00:00:00",
35640,2,20918,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020918s030lbl.pdf","2010-12-22 00:00:00",
13734,2,20918,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf","2012-01-06 00:00:00",
26190,1,20918,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020918s034ltr.pdf","2012-01-17 00:00:00",
3744,1,20918,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020918Orig1s040ltr.pdf","2013-04-30 00:00:00",
3745,1,20918,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020918Orig1s042ltr.pdf","2014-03-19 00:00:00",
3746,1,20918,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020918Orig1s043ltr.pdf","2015-12-15 00:00:00",
13735,2,20918,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf","2015-12-15 00:00:00",
53737,2,20918,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf","2018-04-19 00:00:00",
53763,1,20918,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020918Orig1s049ltr.pdf","2018-04-20 00:00:00",
54866,2,20918,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s052lbl.pdf","2018-07-09 00:00:00",
3747,1,20919,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr001ltr.pdf","2003-12-24 00:00:00",
13736,2,20919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20919lbl.pdf","2002-06-21 00:00:00",
23610,10,20919,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
26191,1,20919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20919ltr.pdf","2002-06-21 00:00:00",
41812,3,20919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-919_Geodon.cfm","2005-04-08 00:00:00",
3748,1,20919,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr.pdf","2004-08-25 00:00:00",
3749,1,20919,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf","2005-08-19 00:00:00",
13737,2,20919,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf","2005-08-19 00:00:00",
26192,1,20919,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf","2005-08-19 00:00:00",
35641,2,20919,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf","2005-08-19 00:00:00",
21276,3,20919,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020919_s012_GEODON.pdf","2008-07-30 00:00:00",
26193,1,20919,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021, 020919s012ltr.pdf","2007-03-07 00:00:00",
35642,2,20919,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf","2007-03-07 00:00:00",
13738,2,20919,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf","2007-05-29 00:00:00",
26194,1,20919,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014ltr.pdf","2007-05-29 00:00:00",
3750,1,20919,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026, 020919s016ltr.pdf","2007-10-04 00:00:00",
35643,2,20919,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf","2007-10-04 00:00:00",
26195,1,20919,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019ltr.pdf","2008-05-21 00:00:00",
3751,1,20919,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030, 020919s021ltr.pdf","2008-08-19 00:00:00",
26196,1,20919,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020919s022ltr.pdf","2008-12-24 00:00:00",
26197,1,20919,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023ltr.pdf","2009-08-04 00:00:00",
35644,2,20919,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf","2009-07-21 00:00:00",
26198,1,20919,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf","2010-12-07 00:00:00",
35645,2,20919,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf","2010-12-04 00:00:00",
13739,2,20919,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf","2013-07-05 00:00:00",
26199,1,20919,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf","2013-07-05 00:00:00",
26200,1,20919,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf","2013-03-05 00:00:00",
35646,2,20919,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf","2013-03-04 00:00:00",
13740,2,20919,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf","2013-08-15 00:00:00",
26201,1,20919,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf","2013-08-16 00:00:00",
13741,2,20919,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf","2013-12-19 00:00:00",
26202,1,20919,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919Orig1s035ltr.pdf","2013-12-19 00:00:00",
3752,1,20919,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf","2014-12-11 00:00:00",
35647,2,20919,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf","2014-12-11 00:00:00",
26203,1,20919,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf","2015-08-24 00:00:00",
35648,2,20919,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf","2015-09-14 00:00:00",
47313,2,20919,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf","2017-02-24 00:00:00",
47419,1,20919,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020825Orig1s056,021483Orig1s015,020919Orig1s044ltr.pdf","2017-03-02 00:00:00",
3753,1,20920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20920ltr.pdf","2001-08-10 00:00:00",
35649,2,20920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20920lbl.pdf","2001-08-10 00:00:00",
41813,3,20920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-920_Natrecor.cfm","2001-08-10 00:00:00",
26204,1,20920,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20920slr003ltr.pdf","2004-07-06 00:00:00",
26205,1,20920,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s006ltr.pdf","2005-05-02 00:00:00",
3754,1,20920,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s008ltr.pdf","2005-04-28 00:00:00",
35650,2,20920,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020920s008lbl.pdf","2005-04-28 00:00:00",
3755,1,20920,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020920s012ltr.pdf","2006-12-28 00:00:00",
13742,2,20920,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020920s012lbl.pdf","2007-04-16 00:00:00",
3756,1,20920,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020920s023ltr.pdf","2009-06-17 00:00:00",
13743,2,20920,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020920s023lbl.pdf","2009-06-22 00:00:00",
3757,1,20920,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020920s031ltr.pdf","2012-07-09 00:00:00",
13744,2,20920,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020920s031lbl.pdf","2012-07-10 00:00:00",
3758,1,20920,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020920Orig1s033ltr.pdf","2013-04-30 00:00:00",
13745,2,20920,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/20920s033lbl.pdf","2013-04-30 00:00:00",
3759,1,20922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20922ltr.pdf","1999-12-10 00:00:00",
13746,2,20922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf","1999-12-10 00:00:00",
21277,3,20922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-922_Solage.cfm","2002-04-10 00:00:00",
13747,2,20922,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf","2007-05-01 00:00:00",
26206,1,20922,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020922s003ltr.pdf","2007-05-01 00:00:00",
3760,1,20922,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020922s006ltr.pdf","2010-01-05 00:00:00",
13748,2,20922,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf","2010-01-04 00:00:00",
3761,1,20923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20923ltr.pdf","1998-05-28 00:00:00",
35651,2,20923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20923lbl.pdf","1998-05-29 00:00:00",
41814,3,20923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20923_Optiray.cfm","2004-03-09 00:00:00",
45075,2,20923,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf","2016-08-17 00:00:00",
45132,1,20923,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf","2016-08-12 00:00:00",
3762,1,20923,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf","2015-07-10 00:00:00",
35652,2,20923,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf","2015-07-09 00:00:00",
48136,2,20923,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf","2017-04-27 00:00:00",
48210,1,20923,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s054,020923Orig1s019ltr.pdf","2017-05-02 00:00:00",
47876,2,20923,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s020lbl.pdf","2017-04-06 00:00:00",
47962,1,20923,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf","2017-04-12 00:00:00",
50678,2,20923,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s021lbl.pdf","2017-12-13 00:00:00",
50743,1,20923,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020923Orig1s021ltr.pdf","2017-12-18 00:00:00",
13749,2,20926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20926lbl.pdf","1998-10-30 00:00:00",
21278,3,20926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020926.cfm","1999-07-04 00:00:00",
26207,1,20926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20926ltr.pdf","1998-10-30 00:00:00",
26208,1,20926,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20926S2LTR.PDF","2000-05-05 00:00:00",
26209,1,20926,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-006,21179se1-002ltr.pdf","2004-03-03 00:00:00",
3763,1,20927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20927ltr.pdf","1998-09-22 00:00:00",
35653,2,20927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20927lbl.pdf","1998-09-22 00:00:00",
41815,3,20927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020927.cfm","1998-09-22 00:00:00",
44079,10,20927,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
13750,2,20928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20928lbl.pdf","1998-09-11 00:00:00",
26210,1,20928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20928ltr.pdf","1998-09-11 00:00:00",
41816,3,20928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20928.pdf","1998-09-11 00:00:00",
26211,1,20928,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20928slr010ltr.pdf","2004-02-25 00:00:00",
35654,2,20928,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20928slr010_glucagon_lbl.pdf","2004-04-05 00:00:00",
53738,2,20928,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf","2018-04-19 00:00:00",
53764,1,20928,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s055ltr.pdf","2018-04-20 00:00:00",
54865,2,20928,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s056lbl.pdf","2018-07-06 00:00:00",
21279,3,20929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-929_Pulmicort.cfm","2004-02-11 00:00:00",
26212,1,20929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20929ltr.pdf","2000-08-08 00:00:00",
35655,2,20929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf","2000-08-08 00:00:00",
51789,23,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Orig.pdf","1900-01-01 00:00:00",
51790,25,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Amend.pdf","1900-01-01 00:00:00",
51791,26,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Amend2.pdf","1900-01-01 00:00:00",
51792,27,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Amend3.pdf","1900-01-01 00:00:00",
51793,28,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Amend4.pdf","1900-01-01 00:00:00",
51794,29,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020929_budesonide_WR_Amend5.pdf","1900-01-01 00:00:00",
51795,20,20929,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/budesonide_Pulmicort-MedRev-20929s013.pdf","1900-01-01 00:00:00",
3764,1,20929,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020929s002ltr.pdf","2006-07-21 00:00:00",
3765,1,20929,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929slr012ltr.pdf","2003-01-10 00:00:00",
21280,3,20929,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S013_PULMICORT_RESPULES_AP.pdf","2007-04-11 00:00:00",
26213,1,20929,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929se8-013ltr.pdf","2003-03-10 00:00:00",
35656,2,20929,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020929s013lbl.pdf","2003-02-26 00:00:00",
13751,2,20929,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf","2003-09-30 00:00:00",
26214,1,20929,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf","2003-09-26 00:00:00",
41817,3,20929,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S015_PULMICORT_TURBOHALER_AP.pdf","2007-04-11 00:00:00",
3766,1,20929,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020929s022ltr.pdf","2005-07-08 00:00:00",
26215,1,20929,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020929s032ltr.pdf","2007-07-05 00:00:00",
3767,1,20929,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020929s043ltr.pdf","2009-11-10 00:00:00",
13752,2,20929,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020929s043lbl.pdf","2009-10-14 00:00:00",
13753,2,20929,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020929s044lbl.pdf","2010-07-06 00:00:00",
26216,1,20929,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020929s044ltr.pdf","2010-07-23 00:00:00",
3768,1,20931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20931ltr.pdf","1999-10-04 00:00:00",
23204,8,20931,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266314.pdf","2011-08-02 00:00:00",
35657,2,20931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf","1999-10-04 00:00:00",
41818,3,20931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-931_Tikosyn.cfm","2002-04-04 00:00:00",
54288,3,20931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/020931Orig1s013REMS.pdf","2018-05-22 00:00:00",
3769,1,20931,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020931s003ltr.pdf","2011-07-13 00:00:00",
3770,1,20931,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020931Orig1s007ltr.pdf","2013-12-09 00:00:00",
13754,2,20931,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf","2013-12-12 00:00:00",
3771,1,20931,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s009ltr.pdf","2015-07-15 00:00:00",
26217,1,20931,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s010ltr.pdf","2015-11-27 00:00:00",
26218,1,20931,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf","2016-03-10 00:00:00",
35658,2,20931,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf","2016-03-14 00:00:00",
3772,1,20931,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf","2016-03-10 00:00:00",
13755,2,20931,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf","2016-03-14 00:00:00",
50606,3,20931,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020931s013.pdf","2017-12-06 00:00:00",
3773,1,20932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20932ltr.pdf","1998-10-26 00:00:00",
21281,3,20932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20932.cfm","1998-10-26 00:00:00",
3774,1,20933,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Approv.pdf","2004-06-30 00:00:00",
13756,2,20933,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf","2004-06-30 00:00:00",
41819,3,20933,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_20-636S009_Viramune.cfm","2004-02-09 00:00:00",
3775,1,20933,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr006ltr.pdf","2004-06-30 00:00:00",
13757,2,20933,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf","2003-04-04 00:00:00",
3776,1,20933,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf","2002-03-27 00:00:00",
41820,3,20933,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020636s017_020933s007_Viramune.cfm","2005-04-27 00:00:00",
13758,2,20933,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf","2003-08-06 00:00:00",
26219,1,20933,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr020,20933slr010ltr.pdf","2004-06-30 00:00:00",
13759,2,20933,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf","2003-12-29 00:00:00",
26220,1,20933,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr021,20933slr011ltr.pdf","2003-12-23 00:00:00",
3777,1,20933,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr.pdf","2005-03-02 00:00:00",
21282,3,20933,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020933_S014_VIRAMUNE.pdf","2007-07-27 00:00:00",
35659,2,20933,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf","2005-03-02 00:00:00",
3778,1,20933,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015ltr.pdf","2007-04-20 00:00:00",
13760,2,20933,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf","2007-04-20 00:00:00",
3779,1,20933,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027, 020933s017ltr.pdf","2008-06-30 00:00:00",
13761,2,20933,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf","2008-06-26 00:00:00",
3780,1,20933,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019ltr.pdf","2007-08-17 00:00:00",
13762,2,20933,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf","2007-08-17 00:00:00",
3781,1,20933,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032ltr.pdf","2010-01-26 00:00:00",
13763,2,20933,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf","2010-01-20 00:00:00",
3782,1,20933,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026ltr.pdf","2010-07-23 00:00:00",
35660,2,20933,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf","2010-07-22 00:00:00",
26221,1,20933,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027ltr.pdf","2011-01-14 00:00:00",
35661,2,20933,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf","2011-01-10 00:00:00",
3783,1,20933,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037ltr.pdf","2011-03-31 00:00:00",
13764,2,20933,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf","2011-03-28 00:00:00",
26222,1,20933,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf","2011-05-10 00:00:00",
13765,2,20933,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf","2011-11-10 00:00:00",
26223,1,20933,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030ltr.pdf","2011-11-14 00:00:00",
13766,2,20933,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf","2012-11-15 00:00:00",
26224,1,20933,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933Orig1s033ltr.pdf","2012-11-13 00:00:00",
26225,1,20933,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933Orig1s035ltr.pdf","2014-01-28 00:00:00",
35662,2,20933,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf","2014-01-28 00:00:00",
47737,2,20933,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf","2017-03-28 00:00:00",
47738,8,20933,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19","2017-03-28 00:00:00",
47767,1,20933,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020636Orig1s048,020933Orig1s038ltr.pdf","2017-03-29 00:00:00",
55612,2,20933,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf","2018-09-25 00:00:00",
55614,8,20933,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf#page=19","2018-09-25 00:00:00",
55743,1,20933,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020636Orig1s050,020933Orig1s040ltr.pdf","2018-10-01 00:00:00",
21283,3,20934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20934.cfm","1999-06-16 00:00:00",
26226,1,20934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20934ltr.pdf","1999-02-28 00:00:00",
35663,2,20934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20934lbl.pdf","1999-02-28 00:00:00",
3784,1,20934,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934s4ltr.pdf","2002-02-28 00:00:00",
3785,1,20934,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scm006ltr.pdf","2002-10-09 00:00:00",
3786,1,20934,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scp007ltr.pdf","2002-10-08 00:00:00",
26227,1,20934,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934slr011ltr.pdf","2003-12-04 00:00:00",
26228,1,20934,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934scs012ltr.pdf","2004-01-02 00:00:00",
35664,2,20934,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20934scs012_luxiq_lbl.pdf","2004-01-02 00:00:00",
3787,1,20934,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020934s016LTR.pdf","2006-07-13 00:00:00",
49010,2,20934,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020934s016lbl.pdf","2017-07-18 00:00:00",
13767,2,20936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20936lbl.pdf","1999-02-16 00:00:00",
21284,3,20936,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020936Orig1s001.pdf","2011-12-09 00:00:00",
23611,10,20936,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
26229,1,20936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20936ltr.pdf","1999-02-16 00:00:00",
41821,3,20936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-936_Paxil.cfm","1999-02-16 00:00:00",
41822,3,20936,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s002.pdf","2011-12-09 00:00:00",
41823,3,20936,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s003.pdf","2011-12-09 00:00:00",
21285,3,20936,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s004.pdf","2011-12-09 00:00:00",
21286,3,20936,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s006.pdf","2011-12-09 00:00:00",
21287,3,20936,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s007.pdf","2011-12-09 00:00:00",
21288,3,20936,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-936s008_Paroxetine_PaxilCR.cfm","2002-02-12 00:00:00",
26230,1,20936,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20982ltr.pdf","2002-02-12 00:00:00",
35665,2,20936,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20982lbl.pdf","2002-02-12 00:00:00",
13768,2,20936,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-011_paxil_lbl.pdf","2003-09-09 00:00:00",
26231,1,20936,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-011ltr.pdf","2003-09-09 00:00:00",
41824,3,20936,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S011_PAXIL CR.pdf","2007-08-06 00:00:00",
3788,1,20936,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-012ltr.pdf","2003-10-17 00:00:00",
13769,2,20936,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-012_paxil_lbl.pdf","2003-10-17 00:00:00",
21289,3,20936,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S012_PAXIL_AP.pdf","2007-07-06 00:00:00",
26232,1,20936,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20936se2-013ltr.pdf","2004-02-02 00:00:00",
35666,2,20936,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20936se2-013_paxil_lbl.pdf","2004-02-03 00:00:00",
3789,1,20936,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf","2005-07-15 00:00:00",
3790,1,20936,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr019ltr.pdf","2004-05-27 00:00:00",
3791,1,20936,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr.pdf","2005-01-13 00:00:00",
13770,2,20936,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf","2005-01-13 00:00:00",
26233,1,20936,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046ltr.pdf","2006-03-23 00:00:00",
26234,1,20936,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf","2006-02-08 00:00:00",
3792,1,20936,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-20 00:00:00",
3793,1,20936,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf","2006-02-08 00:00:00",
26235,1,20936,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf","2006-02-08 00:00:00",
3794,1,20936,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf","2007-08-07 00:00:00",
35667,2,20936,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020936s029lbl.pdf","2007-08-03 00:00:00",
26236,1,20936,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-20 00:00:00",
3795,1,20936,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf","2006-09-20 00:00:00",
3796,1,20936,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
13771,2,20936,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf","2011-07-12 00:00:00",
3797,1,20936,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf","2009-11-19 00:00:00",
35668,2,20936,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s035lbl.pdf","2009-11-05 00:00:00",
3798,1,20936,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf","2008-11-03 00:00:00",
13772,2,20936,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf","2008-11-07 00:00:00",
3799,1,20936,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf","2009-02-03 00:00:00",
35669,2,20936,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s038lbl.pdf","2009-02-04 00:00:00",
26237,1,20936,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020936s039ltr.pdf","2009-11-19 00:00:00",
3800,1,20936,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
13773,2,20936,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
26238,1,20936,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf","2010-11-02 00:00:00",
35670,2,20936,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020936s041lbl.pdf","2010-10-28 00:00:00",
3801,1,20936,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf","2011-03-24 00:00:00",
13774,2,20936,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf","2011-03-28 00:00:00",
3802,1,20936,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf","2011-07-12 00:00:00",
13775,2,20936,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf","2011-07-12 00:00:00",
26239,1,20936,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf","2012-12-21 00:00:00",
35671,2,20936,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s045lbl.pdf","2012-12-31 00:00:00",
3803,1,20936,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf","2012-04-12 00:00:00",
13776,2,20936,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s046lbl.pdf","2012-04-17 00:00:00",
3804,1,20936,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf","2014-07-23 00:00:00",
35672,2,20936,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020936s049lbl.pdf","2014-07-30 00:00:00",
46696,2,20936,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf","2017-01-06 00:00:00",
46815,1,20936,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf","2017-01-13 00:00:00",
46816,8,20936,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf#page=44","2017-01-13 00:00:00",
21290,3,20937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm","1999-12-08 00:00:00",
26240,1,20937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf","1999-12-08 00:00:00",
35673,2,20937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf","1999-12-08 00:00:00",
44080,10,20937,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
13777,2,20937,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf","2004-06-10 00:00:00",
26241,1,20937,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf","2004-06-10 00:00:00",
41825,3,20937,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm","2004-01-29 00:00:00",
3805,1,20937,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020937s007ltr.pdf","2005-11-30 00:00:00",
3806,1,20937,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf","2006-08-07 00:00:00",
35674,2,20937,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf","2006-08-07 00:00:00",
26242,1,20937,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf","2007-09-06 00:00:00",
35675,2,20937,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf","2007-09-06 00:00:00",
13778,2,20937,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020937s016lbl.pdf","2010-12-20 00:00:00",
26243,1,20937,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf","2010-12-22 00:00:00",
26244,1,20937,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf","2013-05-23 00:00:00",
35676,2,20937,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf","2013-05-23 00:00:00",
13779,2,20937,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s022lbl.pdf","2013-08-27 00:00:00",
26245,1,20937,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022, 020975Orig1s023, 020976Orig1s024ltr.pdf","2013-08-27 00:00:00",
3807,1,20937,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf","2014-08-11 00:00:00",
35677,2,20937,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf","2014-08-08 00:00:00",
13780,2,20937,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2014/020937s02420975s2520976s26lbl.pdf","2014-11-26 00:00:00",
26246,1,20937,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf","2014-11-26 00:00:00",
45222,2,20937,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf","2016-08-29 00:00:00",
53837,2,20937,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf","2018-04-27 00:00:00",
53840,8,20937,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf#page=13","2018-04-27 00:00:00",
53896,1,20937,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020937Orig1s027,020975Orig1s028,020976Orig1s029Ltr.pdf","2018-05-01 00:00:00",
21291,3,20938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-938_Mobic.cfm","2001-07-18 00:00:00",
23208,8,20938,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf","2009-11-19 00:00:00",
26247,1,20938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20938ltr.pdf","2000-04-13 00:00:00",
35678,2,20938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20938lbl.pdf","2000-04-13 00:00:00",
3808,1,20938,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20938s004ltr.pdf","2004-07-21 00:00:00",
35679,2,20938,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20938s004lbl.pdf","2004-07-21 00:00:00",
13781,2,20938,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020938s007lbl.pdf","2003-05-06 00:00:00",
26248,1,20938,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20938slr007ltr.pdf","2003-05-29 00:00:00",
3809,1,20938,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf","2005-08-15 00:00:00",
35680,2,20938,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf","2005-08-15 00:00:00",
52026,20,20938,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020938s013_meloxicam_Mobic-Med.pdf","1900-01-01 00:00:00",
52029,23,20938,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020938, 021530_meloxicam_Mobic_11-22-04_HFD550.pdf","1900-01-01 00:00:00",
52030,17,20938,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020938s013_meloxicam_Mobic-Stat.pdf","1900-01-01 00:00:00",
13782,2,20938,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf","2005-08-15 00:00:00",
26249,1,20938,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf","2005-08-15 00:00:00",
26250,1,20938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf","2007-02-02 00:00:00",
35681,2,20938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf","2007-02-02 00:00:00",
3810,1,20938,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf","2008-07-01 00:00:00",
13783,2,20938,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf","2008-06-30 00:00:00",
13784,2,20938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s019lbl.pdf","2010-04-28 00:00:00",
26251,1,20938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf","2010-04-29 00:00:00",
13785,2,20938,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf","2010-08-01 00:00:00",
26252,1,20938,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf","2010-08-03 00:00:00",
26253,1,20938,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf","2011-08-05 00:00:00",
35682,2,20938,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf","2011-08-05 00:00:00",
3811,1,20938,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf","2012-03-12 00:00:00",
35683,2,20938,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020938s022lbl.pdf","2012-03-05 00:00:00",
13786,2,20938,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf","2016-05-11 00:00:00",
26254,1,20938,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf","2016-05-12 00:00:00",
26255,1,20938,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf","2016-05-12 00:00:00",
35684,2,20938,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf","2016-05-11 00:00:00",
26256,1,20938,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s026ltr.pdf","2016-07-01 00:00:00",
35685,2,20938,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s026lbl.pdf","2016-07-05 00:00:00",
3812,1,20939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20939ltr.pdf","2000-01-28 00:00:00",
13787,2,20939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20939lbl.pdf","2000-01-28 00:00:00",
21292,3,20939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-939_Diltiazem.cfm","2000-01-28 00:00:00",
13788,2,20941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf","2000-07-25 00:00:00",
21293,3,20941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-941_Abreva.cfm","2001-08-21 00:00:00",
26257,1,20941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20941ltr.pdf","2000-07-25 00:00:00",
3813,1,20941,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf","2007-05-29 00:00:00",
35686,2,20941,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf","2007-05-29 00:00:00",
3814,1,20941,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf","2008-02-14 00:00:00",
13789,2,20941,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf","2015-02-17 00:00:00",
26258,1,20941,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020941Orig1s011ltr.pdf","2015-02-02 00:00:00",
46874,1,20941,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020941Orig1s012ltr.pdf","2017-01-18 00:00:00",
46952,2,20941,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020941Orig1s012lbl.pdf","2017-01-24 00:00:00",
26259,1,20942,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20942_Versed_approv.pdf","2004-06-30 00:00:00",
41826,3,20942,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020942_versed_toc.cfm","2003-08-08 00:00:00",
21294,3,20943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-943_VerelanPM.cfm","1998-11-25 00:00:00",
26260,1,20943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20943ltr.pdf","1998-11-25 00:00:00",
35687,2,20943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20943lbl.pdf","1998-11-25 00:00:00",
3815,1,20943,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf","2010-04-09 00:00:00",
35688,2,20943,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf","2010-04-30 00:00:00",
13790,2,20943,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20943slr013_verapamil_lbl.pdf","2004-05-07 00:00:00",
26261,1,20943,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20943slr013ltr.pdf","2004-05-07 00:00:00",
3816,1,20943,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020943s020ltr.pdf","2007-05-07 00:00:00",
13791,2,20943,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020943s021lbl.pdf","2009-12-17 00:00:00",
26262,1,20943,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020943s021ltr.pdf","2009-12-24 00:00:00",
26263,1,20943,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf","2010-04-05 00:00:00",
35689,2,20943,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf","2010-04-04 00:00:00",
13792,2,20943,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020943s028lbl.pdf","2011-11-14 00:00:00",
26264,1,20943,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020943s028ltr.pdf","2011-11-16 00:00:00",
3817,1,20943,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020943Orig1s029ltr.pdf","2014-10-14 00:00:00",
35690,2,20943,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020943s029lbl.pdf","2014-10-15 00:00:00",
45916,1,20943,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020943Orig1s032ltr.pdf","2016-11-22 00:00:00",
45938,2,20943,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020943s032lbl.pdf","2016-11-21 00:00:00",
3818,1,20944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_Approv.pdf","1998-12-18 00:00:00",
21295,3,20944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil.cfm","2004-05-26 00:00:00",
35691,2,20944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf","1998-12-18 00:00:00",
26265,1,20944,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf","2004-12-30 00:00:00",
41827,3,20944,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf","2013-04-18 00:00:00",
3819,1,20944,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf","2004-12-30 00:00:00",
21296,3,20944,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf","2013-04-18 00:00:00",
26266,1,20944,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020944s005ltr.pdf","2006-04-07 00:00:00",
3820,1,20944,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020944s006ltr.pdf","2008-06-13 00:00:00",
3821,1,20944,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020944s008ltr.pdf","2009-05-27 00:00:00",
47743,2,20944,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf","2017-03-28 00:00:00",
47766,1,20944,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020944Orig1s011ltr.pdf","2017-03-29 00:00:00",
13793,2,20945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Prntlbl.pdf","2004-06-10 00:00:00",
26267,1,20945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Approv.pdf","2004-06-10 00:00:00",
41828,3,20945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945_Ritonovir.cfm","2004-03-28 00:00:00",
13794,2,20945,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf","2003-04-25 00:00:00",
26268,1,20945,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf","2001-03-06 00:00:00",
3822,1,20945,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf","2002-03-14 00:00:00",
35692,2,20945,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf","2002-03-14 00:00:00",
3823,1,20945,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf","2003-09-25 00:00:00",
13795,2,20945,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf","2003-09-25 00:00:00",
13796,2,20945,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf","2005-03-30 00:00:00",
26269,1,20945,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf","2005-03-30 00:00:00",
3824,1,20945,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf","2005-11-18 00:00:00",
35693,2,20945,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf","2005-11-17 00:00:00",
41829,3,20945,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S016_NORVIR.pdf","2007-11-19 00:00:00",
26270,1,20945,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf","2005-10-11 00:00:00",
35694,2,20945,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf","2005-10-10 00:00:00",
41830,3,20945,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S017_NORVIR.pdf","2007-11-19 00:00:00",
13797,2,20945,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf","2007-05-16 00:00:00",
26271,1,20945,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf","2007-05-16 00:00:00",
3825,1,20945,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s019ltr.pdf","2008-05-20 00:00:00",
26272,1,20945,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf","2007-08-02 00:00:00",
35695,2,20945,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf","2007-08-02 00:00:00",
13798,2,20945,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf","2008-08-29 00:00:00",
26273,1,20945,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf","2008-09-03 00:00:00",
3826,1,20945,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf","2008-10-02 00:00:00",
13799,2,20945,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf","2009-08-04 00:00:00",
3827,1,20945,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf","2010-01-20 00:00:00",
35696,2,20945,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf","2009-12-02 00:00:00",
26274,1,20945,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020945s028ltr.pdf","2010-04-29 00:00:00",
35697,2,20945,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020945s028lbl.pdf","2010-05-07 00:00:00",
3828,1,20945,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020945s032ltr.pdf","2011-12-08 00:00:00",
35698,2,20945,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020945s032lbl.pdf","2011-12-14 00:00:00",
3829,1,20945,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s033ltr.pdf","2012-04-02 00:00:00",
35699,2,20945,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s033lbl.pdf","2012-03-29 00:00:00",
3830,1,20945,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s034ltr.pdf","2012-02-23 00:00:00",
13800,2,20945,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s034lbl.pdf","2012-02-22 00:00:00",
3831,1,20945,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945Orig1s035ltr.pdf","2012-11-21 00:00:00",
35700,2,20945,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf","2012-11-28 00:00:00",
13801,2,20945,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf","2013-11-08 00:00:00",
26275,1,20945,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020945Orig1s036ltr.pdf","2013-11-08 00:00:00",
26276,1,20945,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s038ltr.pdf","2015-03-18 00:00:00",
35701,2,20945,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s038lbl.pdf","2015-03-17 00:00:00",
13802,2,20945,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s039lbl.pdf","2015-04-02 00:00:00",
26277,1,20945,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s039ltr.pdf","2015-04-01 00:00:00",
3832,1,20945,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s040ltr.pdf","2015-11-13 00:00:00",
13803,2,20945,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s040lbl.pdf","2015-11-12 00:00:00",
45947,1,20945,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s041ltr.pdf","2016-11-23 00:00:00",
45999,2,20945,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s041lbl.pdf","2016-12-02 00:00:00",
46513,2,20945,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s042lbl.pdf","2016-12-22 00:00:00",
46851,1,20945,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s042ltr.pdf","2017-01-17 00:00:00",
45319,2,20945,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s043lbl.pdf","2016-09-16 00:00:00",
45330,1,20945,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s043ltr.pdf","2016-09-20 00:00:00",
48879,2,20945,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020945s044lbl.pdf","2017-06-30 00:00:00",
48883,1,20945,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020945Orig1s044ltr.pdf","2017-06-30 00:00:00",
3833,1,20946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20946ltr.pdf","1998-09-01 00:00:00",
35702,2,20946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20946lbl.pdf","1998-09-01 00:00:00",
41831,3,20946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20946.pdf","1998-09-01 00:00:00",
41832,3,20946,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20946S001_Preven.pdf","1999-06-07 00:00:00",
13804,2,20947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020947lbl.pdf","2009-11-12 00:00:00",
21297,3,20947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947_pennsaid_toc.cfm","2010-05-06 00:00:00",
24184,21,20947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947s000sumr.pdf","2010-05-06 00:00:00",
26278,1,20947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020947s000ltr.pdf","2009-11-13 00:00:00",
26279,1,20947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf","2010-03-31 00:00:00",
35703,2,20947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf","2010-04-04 00:00:00",
43687,8,20947,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf","2009-11-18 00:00:00",
3834,1,20947,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf","2010-03-31 00:00:00",
13805,2,20947,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf","2010-04-04 00:00:00",
26280,1,20947,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020947s007ltr.pdf","2011-07-18 00:00:00",
26281,1,20947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020947Orig1s008ltr.pdf","2013-10-24 00:00:00",
35704,2,20947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020947s008lbl.pdf","2013-10-21 00:00:00",
13806,2,20947,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf","2016-05-11 00:00:00",
26282,1,20947,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf","2016-05-11 00:00:00",
3835,1,20947,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf","2016-05-11 00:00:00",
13807,2,20947,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf","2016-05-11 00:00:00",
41833,3,20949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-949_AccuNeb.cfm","2005-01-28 00:00:00",
3836,1,20949,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf","2006-06-06 00:00:00",
24139,15,20949,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020949S011PI.pdf","2006-06-06 00:00:00",
13808,2,20949,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf","2011-03-07 00:00:00",
26283,1,20949,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf","2011-03-07 00:00:00",
21298,3,20950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb.cfm","2001-03-21 00:00:00",
26284,1,20950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_Approv.pdf","2001-03-21 00:00:00",
35705,2,20950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf","2001-03-21 00:00:00",
26285,1,20950,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020950s012LTR.pdf","2006-06-06 00:00:00",
44606,15,20950,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020950s012PI.pdf","2006-06-06 00:00:00",
3837,1,20950,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf","2005-10-20 00:00:00",
26286,1,20950,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020950s032ltr.pdf","2011-03-07 00:00:00",
35706,2,20950,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf","2011-03-07 00:00:00",
3838,1,20950,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf","2012-05-31 00:00:00",
35707,2,20950,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf","2012-06-06 00:00:00",
13809,2,20951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20951lbl.pdf","1999-07-09 00:00:00",
21299,3,20951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020951A_Tagament.cfm","2000-05-18 00:00:00",
26287,1,20951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20951ltr.pdf","1999-07-09 00:00:00",
3839,1,20954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20954ltr.pdf","1999-02-04 00:00:00",
3840,1,20954,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954slr001ltr.pdf","2002-12-23 00:00:00",
21300,3,20954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20954.cfm","1999-06-14 00:00:00",
35708,2,20954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20954lbl.pdf","1999-02-04 00:00:00",
41834,3,20954,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S001_BUSULFEX.pdf","2004-03-09 00:00:00",
3841,1,20954,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954s003.pdf","2002-04-24 00:00:00",
41835,3,20954,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S003_BUSULFEX.pdf","2004-03-09 00:00:00",
26288,1,20954,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20954se2-004ltr.pdf","2003-01-13 00:00:00",
35709,2,20954,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020954s004lbl.pdf","2003-03-06 00:00:00",
41836,3,20954,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954S004_Busulfex.cfm","2004-06-04 00:00:00",
21301,3,20954,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954s005_Busulfex.cfm","2003-07-08 00:00:00",
26289,1,20954,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954scp005ltr.pdf","2002-11-13 00:00:00",
35710,2,20954,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20954scp005_busulfex_lbl.pdf","2002-11-13 00:00:00",
26290,1,20954,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020954s008_LTR.pdf","2007-04-25 00:00:00",
35711,2,20954,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf","2007-04-20 00:00:00",
13810,2,20954,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf","2011-06-29 00:00:00",
26291,1,20954,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf","2011-06-29 00:00:00",
3842,1,20954,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf","2011-06-29 00:00:00",
35712,2,20954,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf","2011-06-29 00:00:00",
3843,1,20954,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020954Orig1s014ltr.pdf","2015-01-20 00:00:00",
35713,2,20954,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020954s014lbl.pdf","2015-01-20 00:00:00",
13811,2,20954,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020954s016lbl.pdf","2016-05-23 00:00:00",
26292,1,20954,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020954Orig1s016ltr.pdf","2016-05-20 00:00:00",
51912,2,20954,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s017lbl.pdf","2018-01-26 00:00:00",
52107,1,20954,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s017ltr.pdf","2018-01-30 00:00:00",
55766,1,20954,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s018,020954Orig1s019ltr.pdf","2018-10-01 00:00:00",
55796,2,20954,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf","2018-10-03 00:00:00",
55767,1,20954,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020954Orig1s018,020954Orig1s019ltr.pdf","2018-10-01 00:00:00",
55797,2,20954,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020954s018s019lbl.pdf","2018-10-03 00:00:00",
21302,3,20955,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020955_S001_FERRLECIT_AP.pdf","2007-04-30 00:00:00",
26293,1,20955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20955ltr.pdf","1999-02-18 00:00:00",
35714,2,20955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf","1999-02-18 00:00:00",
41837,3,20955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20955_Ferrlecit.cfm","1999-02-18 00:00:00",
3844,1,20955,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20955s3ltr.pdf","2003-07-23 00:00:00",
35715,2,20955,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20955s3lbl.pdf","2003-04-25 00:00:00",
41838,3,20955,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020955_S003_FERRLECIT_AP.pdf","2007-04-30 00:00:00",
26294,1,20955,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20955s005ltr.pdf","2002-06-07 00:00:00",
3845,1,20955,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20955s006ltr.pdf","2004-08-25 00:00:00",
35716,2,20955,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20955s006lbl.pdf","2004-08-25 00:00:00",
52203,20,20955,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20955s006_sodium ferric gluconate_Ferrlecit-MedRev.pdf","1900-01-01 00:00:00",
52204,18,20955,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20955s006_sodium ferric gluconate_Ferrlecit-ClinPharmRev.pdf","1900-01-01 00:00:00",
52205,17,20955,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20955s006_sodium ferric gluconate_Ferrlecit-StatsRev.pdf","1900-01-01 00:00:00",
52206,23,20955,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020955_sodium ferric_Ferrlecit_WR_orig.pdf","1900-01-01 00:00:00",
13812,2,20955,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020955s010lbl.pdf","2006-10-05 00:00:00",
26295,1,20955,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020955s010LTR.pdf","2006-10-05 00:00:00",
26296,1,20955,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf","2011-08-26 00:00:00",
35717,2,20955,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf","2011-08-26 00:00:00",
26297,1,20955,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf","2011-08-26 00:00:00",
35718,2,20955,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf","2011-08-26 00:00:00",
3846,1,20958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf","2000-10-16 00:00:00",
13813,2,20958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf","2000-10-16 00:00:00",
41839,3,20958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-958_Pepcid.cfm","2003-09-25 00:00:00",
13814,2,20958,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf","2003-04-25 00:00:00",
41840,3,20958,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020958_S002_PEPCIDTOC.cfm","2007-06-18 00:00:00",
3847,1,20958,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf","2003-11-13 00:00:00",
26298,1,20958,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf","2004-10-29 00:00:00",
3848,1,20958,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf","2005-07-21 00:00:00",
13815,2,20958,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf","2005-07-21 00:00:00",
3849,1,20958,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf","2006-06-12 00:00:00",
3850,1,20958,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf","2008-11-18 00:00:00",
41841,3,20958,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020958Orig1s015.pdf","2012-03-27 00:00:00",
26299,1,20958,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf","2013-08-01 00:00:00",
35719,2,20958,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf","2013-09-19 00:00:00",
26300,1,20958,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf","2016-06-14 00:00:00",
35720,2,20958,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf","2016-06-14 00:00:00",
13816,2,20961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20961lbl.pdf","1998-08-26 00:00:00",
21303,3,20961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20961_Vitravene.cfm","1998-08-26 00:00:00",
26301,1,20961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20961ltr.pdf","1998-08-26 00:00:00",
41842,3,20962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20962.pdf","1998-02-04 00:00:00",
3851,1,20963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20963ltr.pdf","1998-10-21 00:00:00",
35721,2,20963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20963lbl.pdf","1998-10-21 00:00:00",
41843,3,20963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020963_timolol.cfm","2003-05-22 00:00:00",
53131,20,20963,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/40_19845 timolol clinical bpca.pdf","1900-01-01 00:00:00",
53132,23,20963,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/41_020963_timolol_WR.pdf","1900-01-01 00:00:00",
13817,2,20963,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20963s5lbl.pdf","2003-04-25 00:00:00",
13818,2,20963,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20963slr007_droptainer_lbl.pdf","2003-07-08 00:00:00",
26302,1,20963,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20963slr007ltr.pdf","2003-07-08 00:00:00",
3852,1,20963,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020963s010ltr.pdf","2007-06-14 00:00:00",
13819,2,20963,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020963s010lbl.pdf","2007-06-12 00:00:00",
3853,1,20965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20965ltr.pdf","1999-12-07 00:00:00",
21304,3,20965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-965_Levulan.cfm","1999-12-07 00:00:00",
35722,2,20965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20965lbl.pdf","1999-12-07 00:00:00",
26303,1,20965,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr002ltr.pdf","2003-03-28 00:00:00",
35723,2,20965,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr002_levulan_lbl.pdf","2003-03-28 00:00:00",
26304,1,20965,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr003ltr.pdf","2003-07-06 00:00:00",
35724,2,20965,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr003_levulan_lbl.pdf","2003-07-08 00:00:00",
3854,1,20965,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965scm004ltr.pdf","2003-07-28 00:00:00",
3855,1,20965,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020965s006ltr.pdf","2009-11-20 00:00:00",
13820,2,20965,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020965s006lbl.pdf","2009-07-23 00:00:00",
3856,1,20965,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020965s007ltr.pdf","2010-03-18 00:00:00",
13821,2,20965,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020965s007lbl.pdf","2010-03-17 00:00:00",
52872,2,20965,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s015lbl.pdf","2018-03-08 00:00:00",
52913,1,20965,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020965Orig1s015ltr.pdf","2018-03-12 00:00:00",
53749,2,20965,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s016lbl.pdf","2018-04-20 00:00:00",
53784,1,20965,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020965Orig1s016ltr","2018-04-23 00:00:00",
3857,1,20966,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20966ltr.pdf","1999-03-30 00:00:00",
3858,1,20966,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf","2001-04-17 00:00:00",
13822,2,20966,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20966lbl.pdf","1999-03-30 00:00:00",
21305,3,20966,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm","2001-10-26 00:00:00",
35725,2,20966,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf","2001-04-17 00:00:00",
41844,3,20966,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020996_sporanox_toc.cfm","2003-08-13 00:00:00",
3859,1,20966,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf","2001-04-17 00:00:00",
13823,2,20966,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf","2001-04-17 00:00:00",
41845,3,20966,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm","2001-10-26 00:00:00",
21306,3,20966,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox.cfm","2001-10-26 00:00:00",
26305,1,20966,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf","2001-04-17 00:00:00",
35726,2,20966,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_prntlbl.pdf","2001-04-17 00:00:00",
26306,1,20966,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966s5ltr.pdf","2002-02-28 00:00:00",
3860,1,20966,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966slr006ltr.pdf","2002-07-17 00:00:00",
35727,2,20966,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20966s6lbl.pdf","2002-07-17 00:00:00",
3861,1,20966,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20966s011ltr.pdf","2004-07-21 00:00:00",
35728,2,20966,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20966s011lbl.pdf","2004-07-21 00:00:00",
26307,1,20966,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf","2009-03-10 00:00:00",
35729,2,20966,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf","2009-04-03 00:00:00",
3862,1,20966,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf","2009-03-10 00:00:00",
13824,2,20966,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf","2009-04-03 00:00:00",
26308,1,20966,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf","2009-03-10 00:00:00",
35730,2,20966,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s017s018s020lbl.pdf","2009-04-03 00:00:00",
3863,1,20966,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s022ltr.pdf","2009-04-27 00:00:00",
13825,2,20966,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020966s022lbl.pdf","2009-04-28 00:00:00",
13826,2,20968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20968lbl.pdf","1999-06-30 00:00:00",
26309,1,20968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20968ltr.pdf","1999-06-30 00:00:00",
41846,3,20968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20968_Monistat.cfm","2000-07-03 00:00:00",
3864,1,20969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20969ltr.pdf","1999-02-25 00:00:00",
21307,3,20969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20969.cfm","1999-02-25 00:00:00",
35731,2,20969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20969lbl.pdf","1999-02-25 00:00:00",
13827,2,20969,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020969s006lbl.pdf","2013-11-01 00:00:00",
26310,1,20969,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020969Orig1s006ltr.pdf","2013-11-06 00:00:00",
51000,2,20969,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020969s010lbl.pdf","2018-01-09 00:00:00",
51033,1,20969,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020969Orig1s10ltr.pdf","2018-01-11 00:00:00",
3865,1,20971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_Approv.pdf","2000-04-03 00:00:00",
13828,2,20971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_prntlbl.pdf","2000-04-03 00:00:00",
21308,3,20971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020971_SeptocaineTOC.cfm","2002-08-14 00:00:00",
3866,1,20971,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20971s007ltr.pdf","2004-10-18 00:00:00",
3867,1,20971,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20971s009ltr.pdf","2005-02-08 00:00:00",
41847,3,20971,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020971Orig1s009.pdf","2013-06-03 00:00:00",
21309,3,20971,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020971Orig1s013.pdf","2013-06-03 00:00:00",
13829,2,20971,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020971s017lbl.pdf","2006-11-13 00:00:00",
26311,1,20971,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020971s017LTR.pdf","2006-11-14 00:00:00",
3868,1,20971,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s021ltr.pdf","2010-02-26 00:00:00",
21310,3,20971,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020971Orig1s021.pdf","2015-01-28 00:00:00",
35732,2,20971,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020971s021lbl.pdf","2010-03-03 00:00:00",
3869,1,20971,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s023ltr.pdf","2010-11-18 00:00:00",
21311,3,20971,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2010/020971Orig1s023.pdf","2015-01-28 00:00:00",
21312,3,20972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20972.cfm","1998-09-17 00:00:00",
21313,3,20972,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_S001_Sustiva.cfm","2004-03-10 00:00:00",
26312,1,20972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20972ltr.pdf","1998-09-17 00:00:00",
26313,1,20972,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_s001_Sustiva_Approv.pdf","2004-06-18 00:00:00",
35733,2,20972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20972lbl.pdf","1998-09-17 00:00:00",
35734,2,20972,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20972S7LBL.PDF","2000-02-09 00:00:00",
3870,1,20972,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972s7ltr.pdf","2002-03-01 00:00:00",
14033,2,20972,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf","2003-04-25 00:00:00",
41848,3,20972,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020972_S014_SUSTIVA.pdf","2007-07-18 00:00:00",
3871,1,20972,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr016ltr.pdf","2003-01-29 00:00:00",
35735,2,20972,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr016_Sustiva_lbl.pdf","2003-01-29 00:00:00",
3872,1,20972,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf","2002-09-20 00:00:00",
14034,2,20972,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf","2003-06-22 00:00:00",
26314,1,20972,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf","2003-06-22 00:00:00",
3873,1,20972,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf","2003-06-22 00:00:00",
14035,2,20972,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_sustiva_lbl.pdf","2003-06-22 00:00:00",
14036,2,20972,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf","2003-12-01 00:00:00",
26315,1,20972,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf","2003-11-26 00:00:00",
14037,2,20972,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf","2004-08-25 00:00:00",
26316,1,20972,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf","2004-08-25 00:00:00",
41849,3,20972,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020972_S022_SUSTIVA.pdf","2007-07-18 00:00:00",
3874,1,20972,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf","2004-10-29 00:00:00",
14038,2,20972,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf","2004-11-01 00:00:00",
14039,2,20972,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf","2005-04-28 00:00:00",
26317,1,20972,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf","2005-04-28 00:00:00",
3875,1,20972,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf","2006-04-05 00:00:00",
14040,2,20972,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf","2007-02-05 00:00:00",
21314,3,20972,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020972_S027_SUSTIVA.pdf","2007-07-20 00:00:00",
3876,1,20972,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf","2007-02-02 00:00:00",
35736,2,20972,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf","2007-02-02 00:00:00",
26318,1,20972,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf","2008-08-20 00:00:00",
35737,2,20972,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf","2008-08-26 00:00:00",
14041,2,20972,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf","2009-04-23 00:00:00",
26319,1,20972,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf","2009-03-12 00:00:00",
26320,1,20972,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf","2009-11-10 00:00:00",
35738,2,20972,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf","2009-10-01 00:00:00",
14042,2,20972,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf","2010-04-04 00:00:00",
26321,1,20972,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf","2010-04-05 00:00:00",
3877,1,20972,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf","2010-12-03 00:00:00",
35739,2,20972,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s036lbl.pdf","2010-11-29 00:00:00",
14043,2,20972,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf","2011-09-26 00:00:00",
26322,1,20972,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf","2011-09-29 00:00:00",
51648,23,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_Original_WR.pdf","1996-09-17 00:00:00",
51657,25,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_1.pdf","1999-09-17 00:00:00",
51662,26,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_2.pdf","2001-08-08 00:00:00",
51667,27,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_3.pdf","2003-07-02 00:00:00",
51670,28,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_4.pdf","2005-02-28 00:00:00",
51692,29,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_5.pdf","2008-01-31 00:00:00",
51694,30,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_6.pdf","2009-12-23 00:00:00",
51697,31,20972,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020972_efavirenz_WR_Amendment_7.pdf","2011-07-18 00:00:00",
3878,1,20972,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf","2011-12-21 00:00:00",
35740,2,20972,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s040lbl.pdf","2011-12-19 00:00:00",
3879,1,20972,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf","2012-06-26 00:00:00",
14044,2,20972,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf","2012-06-26 00:00:00",
26323,1,20972,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf","2012-08-15 00:00:00",
35741,2,20972,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf","2012-08-15 00:00:00",
3880,1,20972,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf","2013-05-07 00:00:00",
35742,2,20972,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf","2013-05-21 00:00:00",
52446,20,20972,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20972 efavirenz clinical bpca.pdf","1900-01-01 00:00:00",
52447,18,20972,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20972 efavirenz clinpharm bpca.pdf","1900-01-01 00:00:00",
26324,1,20972,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf","2014-05-27 00:00:00",
35743,2,20972,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf","2014-05-28 00:00:00",
26325,1,20972,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf","2015-04-01 00:00:00",
35744,2,20972,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf","2015-04-02 00:00:00",
26326,1,20972,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf","2016-04-01 00:00:00",
35745,2,20972,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf","2016-04-01 00:00:00",
45194,1,20972,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf","2016-08-31 00:00:00",
45211,2,20972,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf","2016-08-31 00:00:00",
45623,2,20972,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf","2016-10-17 00:00:00",
47054,1,20972,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s042,020972Orig1s054ltr.pdf","2017-01-31 00:00:00",
47061,2,20972,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf","2017-01-30 00:00:00",
50005,2,20972,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf","2017-10-11 00:00:00",
50029,1,20972,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s044,020972Orig1s056ltr.pdf","2017-10-12 00:00:00",
21315,3,20973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20973_Aciphex.cfm","1999-08-19 00:00:00",
26327,1,20973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20973ltr.pdf","1999-08-19 00:00:00",
35746,2,20973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf","1999-08-19 00:00:00",
44081,10,20973,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
54126,20,20973,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020973s022_Rabeprazole_Clinical_PREA.pdf","1900-01-01 00:00:00",
54127,18,20973,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020973s022_Rabeprazole_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
14045,2,20973,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf","2003-04-25 00:00:00",
41850,3,20973,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020973_S008_ACIPHEX_DELAYED_RELEASE_TABS.pdf","2007-07-06 00:00:00",
14046,2,20973,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf","2002-02-12 00:00:00",
21316,3,20973,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020973Orig1s009.pdf","2012-03-02 00:00:00",
26328,1,20973,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s009ltr.pdf","2002-02-12 00:00:00",
3881,1,20973,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s012ltr.pdf","2002-05-29 00:00:00",
21317,3,20973,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm","2003-04-25 00:00:00",
26329,1,20973,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf","2002-11-08 00:00:00",
35747,2,20973,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf","2002-11-08 00:00:00",
26330,1,20973,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973slr014ltr.pdf","2002-09-23 00:00:00",
3882,1,20973,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf","2002-09-30 00:00:00",
3883,1,20973,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20973slr016ltr.pdf","2003-08-15 00:00:00",
26331,1,20973,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020973s020ltr.pdf","2005-06-07 00:00:00",
35748,2,20973,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020973s020lbl.pdf","2005-06-07 00:00:00",
3884,1,20973,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020973se5-022ltr.pdf","2008-07-02 00:00:00",
14047,2,20973,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf","2008-06-30 00:00:00",
24185,21,20973,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020973se022_SUMR.pdf","2008-08-12 00:00:00",
3885,1,20973,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020973s025ltr.pdf","2010-09-08 00:00:00",
14048,2,20973,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf","2010-09-10 00:00:00",
14049,2,20973,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf","2011-05-26 00:00:00",
26332,1,20973,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020973s028ltr.pdf","2011-05-25 00:00:00",
26333,1,20973,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973Orig1s029ltr.pdf","2012-10-10 00:00:00",
35749,2,20973,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029lbl.pdf","2012-10-09 00:00:00",
3886,1,20973,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973s030ltr.pdf","2012-05-10 00:00:00",
35750,2,20973,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s030lbl.pdf","2012-05-10 00:00:00",
3887,1,20973,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020973Orig1s032ltr.pdf","2013-04-23 00:00:00",
14050,2,20973,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf","2013-04-23 00:00:00",
3888,1,20973,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf","2016-04-06 00:00:00",
35751,2,20973,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s033lbledt.pdf","2016-04-05 00:00:00",
26334,1,20973,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf","2014-10-21 00:00:00",
35752,2,20973,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf","2014-10-16 00:00:00",
3889,1,20973,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf","2014-12-24 00:00:00",
14051,2,20973,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf","2014-12-29 00:00:00",
45655,1,20973,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s037ltr.pdf","2016-10-26 00:00:00",
47878,2,20973,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s037lbl.pdf","2017-04-06 00:00:00",
51021,2,20973,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s038lbl.pdf","2018-01-10 00:00:00",
51034,1,20973,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020973Orig1s038ltr.pdf","2018-01-11 00:00:00",
54521,2,20973,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf","2018-06-11 00:00:00",
54522,8,20973,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf#page=34","2018-06-11 00:00:00",
54581,1,20973,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020973Orig1s039ltr.pdf","2018-06-14 00:00:00",
21318,3,20974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20974_Prozac.cfm","1999-03-09 00:00:00",
26335,1,20974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20974ltr.pdf","1999-03-09 00:00:00",
41851,3,20974,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020974Orig1s001.pdf","2014-07-07 00:00:00",
44082,10,20974,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
26336,1,20974,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf","2004-08-25 00:00:00",
3890,1,20974,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf","2005-12-05 00:00:00",
3891,1,20974,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf","2005-02-23 00:00:00",
3892,1,20974,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf","2006-04-13 00:00:00",
35753,2,20974,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf","2006-09-21 00:00:00",
21319,3,20975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm","1999-12-08 00:00:00",
26337,1,20975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf","1999-12-08 00:00:00",
35754,2,20975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf","1999-12-08 00:00:00",
44083,10,20975,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
3893,1,20975,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf","2004-06-10 00:00:00",
14052,2,20975,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf","2004-06-10 00:00:00",
41852,3,20975,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm","2004-01-29 00:00:00",
26338,1,20975,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020975s007ltr.pdf","2005-11-30 00:00:00",
3894,1,20975,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf","2006-08-07 00:00:00",
35755,2,20975,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf","2006-08-07 00:00:00",
3895,1,20975,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020975s010ltr.pdf","2008-08-20 00:00:00",
14053,2,20975,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020975s010lbl.pdf","2008-08-26 00:00:00",
3896,1,20975,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf","2007-09-06 00:00:00",
14054,2,20975,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf","2007-09-06 00:00:00",
3897,1,20975,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf","2010-12-22 00:00:00",
14055,2,20975,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020975s017lbl.pdf","2010-12-20 00:00:00",
3898,1,20975,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020975s022ltr.pdf020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf","2013-05-23 00:00:00",
35756,2,20975,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf","2013-05-23 00:00:00",
14056,2,20975,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf","2013-08-27 00:00:00",
26339,1,20975,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020975Orig1s023,%20020976Orig1s024ltr.pdf","2013-08-27 00:00:00",
26340,1,20975,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf","2014-08-11 00:00:00",
35757,2,20975,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf","2014-08-08 00:00:00",
3899,1,20975,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf","2014-11-26 00:00:00",
14057,2,20975,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf","2014-11-26 00:00:00",
45221,2,20975,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf","2016-08-29 00:00:00",
53841,2,20975,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf","2018-04-27 00:00:00",
53842,8,20975,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf#page=13","2018-04-27 00:00:00",
53897,1,20975,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020937Orig1s027,020975Orig1s028,020976Orig1s029Ltr.pdf","2018-05-01 00:00:00",
14058,2,20976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf","1999-12-08 00:00:00",
23612,10,20976,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
26341,1,20976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf","1999-12-08 00:00:00",
41853,3,20976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm","1999-12-08 00:00:00",
21320,3,20976,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm","2004-01-29 00:00:00",
26342,1,20976,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf","2004-06-10 00:00:00",
35758,2,20976,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf","2004-06-10 00:00:00",
26343,1,20976,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020976s007ltr.pdf","2005-11-30 00:00:00",
14059,2,20976,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf","2006-08-07 00:00:00",
26344,1,20976,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf","2006-08-07 00:00:00",
3900,1,20976,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf","2007-09-06 00:00:00",
14060,2,20976,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf","2007-09-06 00:00:00",
3901,1,20976,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf","2010-12-22 00:00:00",
14061,2,20976,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020976s016lbl.pdf","2010-12-20 00:00:00",
3902,1,20976,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf","2013-05-23 00:00:00",
35759,2,20976,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf","2013-05-23 00:00:00",
26345,1,20976,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020975Orig1s023,%20020976Orig1s024ltr.pdf","2013-08-27 00:00:00",
35760,2,20976,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf","2013-08-27 00:00:00",
26346,1,20976,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf","2014-08-11 00:00:00",
35761,2,20976,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf","2014-08-08 00:00:00",
14062,2,20976,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf","2014-11-26 00:00:00",
26347,1,20976,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf","2014-11-26 00:00:00",
45220,2,20976,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf","2016-08-29 00:00:00",
53843,2,20976,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf","2018-04-27 00:00:00",
53844,8,20976,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13","2018-04-27 00:00:00",
53898,1,20976,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020937Orig1s027,020975Orig1s028,020976Orig1s029Ltr.pdf","2018-05-01 00:00:00",
3903,1,20977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf","1998-12-17 00:00:00",
35762,2,20977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf","1998-12-17 00:00:00",
41854,3,20977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm","1998-12-17 00:00:00",
44084,10,20977,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094302.htm","2003-12-12 00:00:00",
41855,3,20977,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-977S-002_review.pdf","2004-04-14 00:00:00",
26348,1,20977,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf","2002-01-28 00:00:00",
14063,2,20977,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf","2002-10-02 00:00:00",
26349,1,20977,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf","2002-10-02 00:00:00",
14064,2,20977,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf","2002-08-14 00:00:00",
26350,1,20977,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf","2002-08-14 00:00:00",
3904,1,20977,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf","2003-07-28 00:00:00",
14065,2,20977,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf","2003-09-25 00:00:00",
3905,1,20977,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf","2004-04-20 00:00:00",
3906,1,20977,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf","2009-08-25 00:00:00",
35763,2,20977,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf","2004-05-03 00:00:00",
3907,1,20977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf","2004-08-05 00:00:00",
14066,2,20977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf","2004-08-05 00:00:00",
21321,3,20977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020977_S012_Ziagen.pdf","2007-09-26 00:00:00",
26351,1,20977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf","2009-08-25 00:00:00",
26352,1,20977,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf","2004-07-28 00:00:00",
35764,2,20977,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf","2004-07-28 00:00:00",
14067,2,20977,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf","2006-08-14 00:00:00",
26353,1,20977,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf","2006-08-21 00:00:00",
41856,3,20977,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020977_S014_ZIAGEN.pdf","2007-09-26 00:00:00",
26354,1,20977,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf","2007-05-09 00:00:00",
35765,2,20977,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf","2007-05-09 00:00:00",
14068,2,20977,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf","2008-07-22 00:00:00",
26355,1,20977,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf","2008-07-23 00:00:00",
14069,2,20977,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf","2009-01-02 00:00:00",
26356,1,20977,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf","2008-12-29 00:00:00",
51934,20,20977,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020977s019_Abacavir_Clinical_PREA.pdf","1900-01-01 00:00:00",
51935,18,20977,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020977s019_Abacavir_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
26357,1,20977,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf","2010-08-10 00:00:00",
26358,1,20977,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf","2011-05-17 00:00:00",
14070,2,20977,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf","2011-11-22 00:00:00",
26359,1,20977,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf","2011-11-22 00:00:00",
3908,1,20977,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf","2012-03-19 00:00:00",
35766,2,20977,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf","2012-03-16 00:00:00",
3909,1,20977,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf","2012-05-22 00:00:00",
35767,2,20977,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf","2012-05-22 00:00:00",
26360,1,20977,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf","2013-09-13 00:00:00",
35768,2,20977,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf","2013-09-17 00:00:00",
3910,1,20977,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf","2015-03-25 00:00:00",
35769,2,20977,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf","2015-04-01 00:00:00",
3911,1,20977,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf","2015-02-24 00:00:00",
35770,2,20977,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf","2015-02-20 00:00:00",
3912,1,20977,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf","2015-10-02 00:00:00",
35771,2,20977,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf","2015-10-07 00:00:00",
47619,2,20977,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf","2017-03-21 00:00:00",
47688,1,20977,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020977Orig1s032,020978Orig1s035ltr.pdf","2017-03-24 00:00:00",
54073,1,20977,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf","2018-05-10 00:00:00",
54249,2,20977,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf","2018-05-18 00:00:00",
54074,1,20977,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf","2018-05-10 00:00:00",
54250,2,20977,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf","2018-05-18 00:00:00",
54251,8,20977,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf#page=27","2018-05-18 00:00:00",
21322,3,20978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm","1998-12-17 00:00:00",
23613,10,20978,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094302.htm","2003-12-12 00:00:00",
26361,1,20978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf","1998-12-17 00:00:00",
35772,2,20978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf","1998-12-17 00:00:00",
41857,3,20978,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-978S-002_review.pdf","2004-04-14 00:00:00",
26362,1,20978,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf","2002-01-28 00:00:00",
14071,2,20978,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf","2002-10-02 00:00:00",
26363,1,20978,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf","2002-10-02 00:00:00",
21323,3,20978,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020978_S009_ZIAGEN.pdf","2007-09-26 00:00:00",
3913,1,20978,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf","2002-08-14 00:00:00",
14072,2,20978,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf","2002-08-14 00:00:00",
14073,2,20978,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf","2003-09-25 00:00:00",
26364,1,20978,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf","2003-07-28 00:00:00",
3914,1,20978,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf","2004-04-20 00:00:00",
3915,1,20978,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf","2009-08-25 00:00:00",
35773,2,20978,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf","2004-05-03 00:00:00",
3916,1,20978,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf","2004-08-05 00:00:00",
14074,2,20978,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf","2004-08-05 00:00:00",
26365,1,20978,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf","2009-08-25 00:00:00",
41858,3,20978,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf","2007-09-26 00:00:00",
14075,2,20978,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf","2004-07-28 00:00:00",
26366,1,20978,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf","2004-07-28 00:00:00",
3917,1,20978,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf","2006-08-21 00:00:00",
21324,3,20978,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020978_S016_ZIAGEN.pdf","2007-09-26 00:00:00",
35774,2,20978,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf","2006-08-14 00:00:00",
3918,1,20978,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf","2007-05-09 00:00:00",
14076,2,20978,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf","2007-05-09 00:00:00",
3919,1,20978,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf","2008-07-23 00:00:00",
35775,2,20978,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf","2008-07-22 00:00:00",
3920,1,20978,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf","2008-12-29 00:00:00",
35776,2,20978,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf","2009-01-02 00:00:00",
3921,1,20978,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf","2010-08-10 00:00:00",
3922,1,20978,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf","2011-05-17 00:00:00",
26367,1,20978,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf","2011-11-22 00:00:00",
35777,2,20978,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf","2011-11-22 00:00:00",
3923,1,20978,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf","2012-03-19 00:00:00",
14077,2,20978,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf","2012-03-16 00:00:00",
3924,1,20978,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf","2012-05-22 00:00:00",
35778,2,20978,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf","2012-05-22 00:00:00",
26368,1,20978,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf","2013-09-13 00:00:00",
35779,2,20978,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf","2013-09-17 00:00:00",
3925,1,20978,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf","2015-03-25 00:00:00",
35780,2,20978,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf","2015-04-01 00:00:00",
51223,20,20978,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinical prea.pdf","1900-01-01 00:00:00",
51224,18,20978,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir clinpharm prea.pdf","1900-01-01 00:00:00",
51225,17,20978,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20977 abacavir statistical prea.pdf","1900-01-01 00:00:00",
3926,1,20978,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf","2015-02-24 00:00:00",
35781,2,20978,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf","2015-02-20 00:00:00",
3927,1,20978,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf","2015-10-02 00:00:00",
35782,2,20978,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf","2015-10-07 00:00:00",
47621,2,20978,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020977s032,020978s035lbl.pdf","2017-03-21 00:00:00",
47687,1,20978,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020977Orig1s032,020978Orig1s035ltr.pdf","2017-03-24 00:00:00",
54075,1,20978,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf","2018-05-10 00:00:00",
54256,2,20978,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf","2018-05-18 00:00:00",
54076,1,20978,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020977Orig1s033s034,020978Orig1s036s037ltr.pdf","2018-05-10 00:00:00",
54253,8,20978,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf#page=27","2018-05-18 00:00:00",
54255,2,20978,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf","2018-05-18 00:00:00",
26369,1,20980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980_appltr.pdf","2004-06-08 00:00:00",
41859,3,20980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980.cfm","1999-03-10 00:00:00",
14078,2,20980,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf","2007-07-27 00:00:00",
26370,1,20980,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020980s005ltr.pdf","2007-07-27 00:00:00",
3928,1,20980,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020980s009ltr.pdf","2012-03-26 00:00:00",
14079,2,20981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf","2007-10-12 00:00:00",
21325,3,20981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981_hycamtin_toc.cfm","2009-01-15 00:00:00",
26371,1,20981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020981s000ltr.pdf","2007-10-22 00:00:00",
44634,21,20981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981s000_SumR.pdf","2009-01-15 00:00:00",
3929,1,20981,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020981s002ltr.pdf","2010-07-02 00:00:00",
14080,2,20981,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf","2010-07-06 00:00:00",
3930,1,20981,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020981s005ltr.pdf","2011-10-12 00:00:00",
14081,2,20981,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf","2011-10-12 00:00:00",
26372,1,20981,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020981Orig1s006ltr.pdf","2014-06-19 00:00:00",
35783,2,20981,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf","2014-06-23 00:00:00",
55391,2,20981,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020981s008lbl.pdf","2018-09-06 00:00:00",
55453,1,20981,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020981Orig1s008Ltr.pdf","2018-09-12 00:00:00",
3931,1,20983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20983ltr.pdf","2001-04-19 00:00:00",
21326,3,20983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-983_Ventolin-HFA.cfm","2001-04-19 00:00:00",
35784,2,20983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf","2001-04-19 00:00:00",
3932,1,20983,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020983s009ltr.pdf","2005-04-28 00:00:00",
35785,2,20983,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf","2005-04-28 00:00:00",
41860,3,20983,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020983Orig1s009Approv.pdf","2012-02-14 00:00:00",
51155,23,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983_Tab_2_albuterol_WR_12_31_01.pdf","2008-08-27 00:00:00",
51157,25,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983_Tab_3_albuterol_WR_12_31_01.pdf","2008-08-27 00:00:00",
51185,26,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983_Tab_4_albuterol_amendment_11_18_04.pdf","2008-08-27 00:00:00",
51189,27,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983_Tab_5_albuterol_amendment_8_18_05.pdf","2008-08-27 00:00:00",
51192,28,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983_Tab_6_albuterol_amendment_12_7_05.pdf","2008-08-27 00:00:00",
53160,20,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983s013_Albuterol_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53161,18,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983s013_Albuterol_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53162,17,20983,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020983s013_Albuterol_Statistical_BPCA.pdf","1900-01-01 00:00:00",
14082,2,20983,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf","2008-03-27 00:00:00",
26373,1,20983,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020983s016ltr.pdf","2008-04-02 00:00:00",
3933,1,20983,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020983Orig1s027ltr.pdf","2012-09-07 00:00:00",
35786,2,20983,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf","2012-09-11 00:00:00",
3934,1,20983,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020983Orig1s032ltr.pdf","2014-12-23 00:00:00",
14083,2,20983,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf","2015-01-09 00:00:00",
3935,1,20984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20984ltr.pdf","1999-08-18 00:00:00",
14084,2,20984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf","1999-08-18 00:00:00",
21327,3,20984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20984_Raplon.cfm","2001-07-02 00:00:00",
14085,2,20984,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf","2010-11-22 00:00:00",
26374,1,20984,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020984s003ltr.pdf","2010-11-30 00:00:00",
26375,1,20985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20985ltr.pdf","2000-10-27 00:00:00",
35787,2,20985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20985lbl.pdf","2000-10-27 00:00:00",
41861,3,20985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/carac_20985.cfm","2003-04-25 00:00:00",
14086,2,20985,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20985slr004_carac_lbl.pdf","2003-12-29 00:00:00",
26376,1,20985,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20985slr004ltr.pdf","2003-12-19 00:00:00",
3936,1,20986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20986ltr.pdf","2000-06-07 00:00:00",
14087,2,20986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf","2000-06-07 00:00:00",
21328,3,20986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm","2000-06-07 00:00:00",
3937,1,20986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s2ltr.pdf","2002-04-11 00:00:00",
35788,2,20986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf","2002-04-11 00:00:00",
3938,1,20986,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_Approv.pdf","2001-12-21 00:00:00",
21329,3,20986,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986se3003_Novolog.cfm","2001-12-21 00:00:00",
35789,2,20986,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf","2001-12-21 00:00:00",
26377,1,20986,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s4ltr.pdf","2002-04-11 00:00:00",
35790,2,20986,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf","2002-04-11 00:00:00",
3939,1,20986,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986se8-011ltr.pdf","2002-12-04 00:00:00",
35791,2,20986,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf","2002-12-04 00:00:00",
3940,1,20986,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf","2004-10-15 00:00:00",
35792,2,20986,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf","2004-10-15 00:00:00",
26378,1,20986,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986slr020ltr.pdf","2004-03-24 00:00:00",
35793,2,20986,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf","2004-04-05 00:00:00",
3941,1,20986,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986scp023ltr.pdf","2004-04-29 00:00:00",
35794,2,20986,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf","2004-05-04 00:00:00",
3942,1,20986,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s024ltr.pdf","2004-08-02 00:00:00",
35795,2,20986,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf","2004-08-02 00:00:00",
35796,2,20986,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf","2005-11-01 00:00:00",
26379,1,20986,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020986s033ltr.pdf","2005-09-15 00:00:00",
35797,2,20986,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf","2005-09-15 00:00:00",
51987,20,20986,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020986s033_insulin aspart_Novolog-MedRev.pdf","1900-01-01 00:00:00",
51989,25,20986,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020986_insulin aspart_NovoLog_HFD510_amend1.pdf","1900-01-01 00:00:00",
51990,26,20986,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020986_insulin aspart_NovoLog_4.15.03_HFD510_amend2.pdf","1900-01-01 00:00:00",
51991,27,20986,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020986_insulin aspart_NovoLog_12.17.03_HFD510_amend3.pdf","1900-01-01 00:00:00",
51992,30,20986,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020986_insulin aspart_NovoLog_10.5.04_HFD510_amend6.pdf","1900-01-01 00:00:00",
3943,1,20986,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020986s037ltr.pdf","2007-02-12 00:00:00",
14088,2,20986,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf","2007-02-02 00:00:00",
14089,2,20986,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf","2006-11-06 00:00:00",
26380,1,20986,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020986s040ltr.pdf","2006-11-06 00:00:00",
3944,1,20986,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s045ltr.pdf","2009-07-17 00:00:00",
14090,2,20986,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf","2009-07-16 00:00:00",
3945,1,20986,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s047ltr.pdf","2008-03-18 00:00:00",
35798,2,20986,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf","2008-03-17 00:00:00",
26381,1,20986,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
3946,1,20986,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
26382,1,20986,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf","2008-11-28 00:00:00",
3947,1,20986,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s054ltr.pdf","2009-05-13 00:00:00",
3948,1,20986,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf","2009-07-24 00:00:00",
14091,2,20986,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf","2009-07-23 00:00:00",
3949,1,20986,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s057ltr.pdf","2012-11-07 00:00:00",
35799,2,20986,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf","2012-11-05 00:00:00",
3950,1,20986,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
14092,2,20986,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf","2015-03-03 00:00:00",
26383,1,20986,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf","2015-02-27 00:00:00",
26384,1,20986,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf","2010-06-29 00:00:00",
21330,3,20986,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020986Orig1s061.pdf","2014-07-07 00:00:00",
26385,1,20986,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s061ltr.pdf","2013-11-06 00:00:00",
35800,2,20986,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf","2013-11-01 00:00:00",
26386,1,20986,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s062ltr.pdf","2012-11-29 00:00:00",
3951,1,20986,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s064ltr.pdf","2012-12-19 00:00:00",
14093,2,20986,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf","2012-12-18 00:00:00",
14094,2,20986,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf","2013-03-12 00:00:00",
26387,1,20986,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s067ltr.pdf","2013-03-12 00:00:00",
26388,1,20986,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020986Orig1s075ltr.pdf","2014-02-27 00:00:00",
3952,1,20986,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s078ltr.pdf","2015-01-16 00:00:00",
35801,2,20986,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf","2015-01-15 00:00:00",
47581,2,20986,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020986Orig1s079Lbledt.pdf","2017-03-17 00:00:00",
47590,1,20986,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020986Orig1s079Ltredt.pdf","2017-03-20 00:00:00",
3953,1,20986,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s080ltr.pdf","2015-01-26 00:00:00",
35802,2,20986,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf","2015-01-29 00:00:00",
3954,1,20986,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf","2015-02-27 00:00:00",
35803,2,20986,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf","2015-03-03 00:00:00",
3955,1,20986,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s082ltr.pdf","2015-04-20 00:00:00",
14095,2,20986,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf","2015-04-23 00:00:00",
45539,1,20986,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020986Orig1s084ltr.pdf","2016-10-14 00:00:00",
45607,2,20986,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf","2016-10-12 00:00:00",
3956,1,20987,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20987ltr.pdf","2000-02-02 00:00:00",
14096,2,20987,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf","2000-02-02 00:00:00",
23614,10,20987,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
26389,1,20987,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf","2001-06-12 00:00:00",
35804,2,20987,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/020987S1S2lbl.pdf","2003-04-09 00:00:00",
41862,3,20987,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20987_Protonix.cfm","2000-02-02 00:00:00",
3957,1,20987,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf","2001-06-12 00:00:00",
35805,2,20987,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20987s5lbl.pdf","2003-04-25 00:00:00",
3958,1,20987,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987s007.pdf","2002-04-19 00:00:00",
21331,3,20987,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-987s007_Protonix.cfm","2002-04-19 00:00:00",
35806,2,20987,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20987s7lbl.pdf","2002-04-19 00:00:00",
3959,1,20987,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf","2002-10-28 00:00:00",
14097,2,20987,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf","2004-04-05 00:00:00",
26390,1,20987,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr017ltr.pdf","2004-03-10 00:00:00",
3960,1,20987,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr020ltr.pdf","2004-05-07 00:00:00",
35807,2,20987,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr020_protonix_lbl.pdf","2004-05-07 00:00:00",
3961,1,20987,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20987slr021ltr.pdf","2004-01-14 00:00:00",
3962,1,20987,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr022ltr.pdf","2004-01-14 00:00:00",
14098,2,20987,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf","2004-01-15 00:00:00",
26391,1,20987,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr023ltr.pdf","2004-03-16 00:00:00",
35808,2,20987,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf","2004-04-05 00:00:00",
26392,1,20987,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987s026ltr.pdf","2004-12-02 00:00:00",
26393,1,20987,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020987s032LTR.pdf","2006-07-27 00:00:00",
3963,1,20987,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf","2008-01-09 00:00:00",
26394,1,20987,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf","2009-11-25 00:00:00",
35809,2,20987,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf","2009-11-16 00:00:00",
3964,1,20987,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf","2009-11-25 00:00:00",
14099,2,20987,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf","2009-11-16 00:00:00",
3965,1,20987,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf","2010-09-08 00:00:00",
14100,2,20987,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf","2010-09-10 00:00:00",
3966,1,20987,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf","2011-10-31 00:00:00",
14101,2,20987,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf","2011-11-01 00:00:00",
3967,1,20987,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf","2011-05-25 00:00:00",
35810,2,20987,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf","2011-05-25 00:00:00",
14102,2,20987,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf","2012-10-15 00:00:00",
26395,1,20987,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf","2012-10-11 00:00:00",
35811,2,20987,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf","2012-05-15 00:00:00",
26396,1,20987,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf","2013-12-13 00:00:00",
35812,2,20987,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf","2013-12-11 00:00:00",
3968,1,20987,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf","2014-12-24 00:00:00",
14103,2,20987,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf","2014-12-29 00:00:00",
45658,1,20987,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf","2016-10-26 00:00:00",
45718,2,20987,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf","2016-10-31 00:00:00",
50838,2,20987,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf","2017-12-22 00:00:00",
50876,1,20987,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf","2017-12-27 00:00:00",
48940,1,20987,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Origs053,022020Orig1s015ltr.pdf","2017-07-10 00:00:00",
48949,2,20987,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf","2017-07-11 00:00:00",
48957,8,20987,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf#page=30","2017-07-12 00:00:00",
54504,2,20987,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054,022020s016,020988s060lbl.pdf","2018-06-11 00:00:00",
54571,1,20987,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf","2018-06-14 00:00:00",
23615,10,20988,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
26397,1,20988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_Approv.pdf","2001-03-22 00:00:00",
35813,2,20988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf","2001-03-22 00:00:00",
41863,3,20988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix.cfm","2001-03-22 00:00:00",
3969,1,20988,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20988s3ltr.pdf","2001-10-19 00:00:00",
35814,2,20988,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf","2001-10-19 00:00:00",
26398,1,20988,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr007ltr.pdf","2003-03-10 00:00:00",
3970,1,20988,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf","2002-10-28 00:00:00",
26399,1,20988,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr015ltr.pdf","2004-03-10 00:00:00",
35815,2,20988,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf","2004-04-05 00:00:00",
26400,1,20988,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr016ltr.pdf","2003-11-05 00:00:00",
3971,1,20988,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr017ltr.pdf","2003-11-26 00:00:00",
35816,2,20988,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf","2003-12-01 00:00:00",
14104,2,20988,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf","2004-05-07 00:00:00",
26401,1,20988,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr019ltr.pdf","2004-05-07 00:00:00",
3972,1,20988,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr020ltr.pdf","2004-01-14 00:00:00",
35817,2,20988,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf","2004-01-15 00:00:00",
3973,1,20988,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr021ltr.pdf","2004-01-14 00:00:00",
26402,1,20988,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988scf024ltr.pdf","2004-04-07 00:00:00",
35818,2,20988,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf","2004-04-05 00:00:00",
14105,2,20988,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf","2004-04-05 00:00:00",
26403,1,20988,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr025ltr.pdf","2004-04-07 00:00:00",
3974,1,20988,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s027ltr.pdf","2004-12-08 00:00:00",
14106,2,20988,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf","2004-12-08 00:00:00",
3975,1,20988,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s028ltr.pdf","2004-12-02 00:00:00",
26404,1,20988,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s029ltr.pdf","2004-10-29 00:00:00",
3976,1,20988,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s031ltr.pdf","2005-08-08 00:00:00",
35819,2,20988,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf","2005-08-08 00:00:00",
3977,1,20988,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s032ltr.pdf","2005-08-08 00:00:00",
14107,2,20988,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf","2005-08-08 00:00:00",
3978,1,20988,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf","2008-01-09 00:00:00",
3979,1,20988,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020988s040ltr.pdf","2010-09-08 00:00:00",
35820,2,20988,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf","2010-09-10 00:00:00",
14108,2,20988,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf","2011-06-27 00:00:00",
26405,1,20988,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s041ltr.pdf","2011-06-09 00:00:00",
26406,1,20988,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s042ltr.pdf","2011-12-13 00:00:00",
35821,2,20988,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf","2011-12-14 00:00:00",
26407,1,20988,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s043ltr.pdf","2011-05-25 00:00:00",
35822,2,20988,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf","2011-05-25 00:00:00",
26408,1,20988,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988Orig1s044ltr.pdf","2012-10-02 00:00:00",
35823,2,20988,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf","2012-10-01 00:00:00",
14109,2,20988,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf","2012-05-16 00:00:00",
26409,1,20988,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988s045ltr.pdf","2012-05-14 00:00:00",
3980,1,20988,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020988Orig1s048ltr.pdf","2013-12-16 00:00:00",
35824,2,20988,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf","2013-12-17 00:00:00",
26410,1,20988,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020988Orig1s052ltr.pdf","2014-12-23 00:00:00",
35825,2,20988,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf","2014-12-29 00:00:00",
45654,1,20988,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/20988Orig1s054ltr.pdf","2016-10-26 00:00:00",
45719,2,20988,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf","2016-10-31 00:00:00",
50840,2,20988,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s055lbl.pdf","2017-12-22 00:00:00",
50877,1,20988,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf","2017-12-27 00:00:00",
48930,2,20988,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s059lbl.pdf","2017-07-07 00:00:00",
48938,1,20988,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020988Orig1s059ltr.pdf","2017-07-10 00:00:00",
54506,2,20988,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054,022020s016,020988s060lbl.pdf","2018-06-11 00:00:00",
54569,1,20988,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf","2018-06-14 00:00:00",
3981,1,20989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20989ltr.pdf","2000-01-11 00:00:00",
35826,2,20989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf","2000-01-11 00:00:00",
41864,3,20989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-989_Evoxac.cfm","2000-01-11 00:00:00",
3982,1,20989,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020989s006ltr.pdf","2005-12-16 00:00:00",
14110,2,20989,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf","2005-12-15 00:00:00",
26411,1,20989,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020989s008ltr.pdf","2006-12-28 00:00:00",
35827,2,20989,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020989s008lbl.pdf","2006-12-14 00:00:00",
3983,1,20990,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf","2003-07-31 00:00:00",
14111,2,20990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf","1999-12-07 00:00:00",
21332,3,20990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20990_Zoloft.cfm","1999-12-07 00:00:00",
23616,10,20990,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053351.htm","2005-07-29 00:00:00",
26412,1,20990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20990ltr.pdf","1999-12-07 00:00:00",
35828,2,20990,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf","2003-04-25 00:00:00",
26413,1,20990,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf","2003-07-23 00:00:00",
21333,3,20990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm","2001-08-17 00:00:00",
26414,1,20990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf","2001-08-17 00:00:00",
35829,2,20990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf","2001-08-17 00:00:00",
3984,1,20990,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf","2002-09-20 00:00:00",
26415,1,20990,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf","2002-05-16 00:00:00",
35830,2,20990,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf","2002-05-16 00:00:00",
26416,1,20990,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf","2002-09-18 00:00:00",
21334,3,20990,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm","2007-03-02 00:00:00",
26417,1,20990,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf","2003-09-25 00:00:00",
35831,2,20990,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf","2003-09-25 00:00:00",
14112,2,20990,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf","2003-03-05 00:00:00",
26418,1,20990,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf","2004-07-01 00:00:00",
3985,1,20990,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf","2004-08-25 00:00:00",
14113,2,20990,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf","2004-08-25 00:00:00",
26419,1,20990,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf","2004-08-25 00:00:00",
35832,2,20990,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf","2004-08-25 00:00:00",
3986,1,20990,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf","2005-02-23 00:00:00",
14114,2,20990,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf","2005-07-14 00:00:00",
14115,2,20990,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf","2005-07-14 00:00:00",
26420,1,20990,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf","2005-02-23 00:00:00",
26421,1,20990,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf","2005-07-29 00:00:00",
3987,1,20990,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf","2006-05-16 00:00:00",
3988,1,20990,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf","2006-09-15 00:00:00",
35833,2,20990,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf","2006-09-15 00:00:00",
26422,1,20990,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
14116,2,20990,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf","2006-09-15 00:00:00",
26423,1,20990,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf","2006-09-15 00:00:00",
3989,1,20990,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf","2007-08-07 00:00:00",
14117,2,20990,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf","2007-08-03 00:00:00",
26424,1,20990,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf","2007-10-10 00:00:00",
35834,2,20990,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf","2007-10-10 00:00:00",
26425,1,20990,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf","2008-03-07 00:00:00",
35835,2,20990,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf","2008-03-07 00:00:00",
3990,1,20990,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf","2009-02-03 00:00:00",
14118,2,20990,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf","2009-02-04 00:00:00",
3991,1,20990,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
35836,2,20990,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
3992,1,20990,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf","2012-12-21 00:00:00",
14119,2,20990,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf","2012-12-28 00:00:00",
46535,2,20990,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46550,1,20990,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
26426,1,20990,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
35837,2,20990,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
14120,2,20990,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf","2011-08-24 00:00:00",
26427,1,20990,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf","2011-08-22 00:00:00",
3993,1,20990,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf","2013-02-04 00:00:00",
14121,2,20990,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf","2013-02-06 00:00:00",
3994,1,20990,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf","2014-07-08 00:00:00",
35838,2,20990,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf","2014-07-08 00:00:00",
14122,2,20990,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf","2012-12-28 00:00:00",
26428,1,20990,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf","2012-12-21 00:00:00",
3995,1,20990,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf","2014-07-08 00:00:00",
35839,2,20990,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf","2014-07-08 00:00:00",
3996,1,20990,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf","2014-09-16 00:00:00",
35840,2,20990,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf","2014-09-19 00:00:00",
46536,2,20990,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46551,1,20990,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
46537,2,20990,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf","2016-12-27 00:00:00",
46552,1,20990,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf","2016-12-27 00:00:00",
48726,2,20990,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s088,020990s046lbl.pdf","2017-06-16 00:00:00",
48747,1,20990,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s088,020990Orig1s046ltr.pdf","2017-06-16 00:00:00",
50668,2,20990,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf","2017-12-12 00:00:00",
50722,1,20990,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf","2017-12-18 00:00:00",
50667,2,20990,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf","2017-12-12 00:00:00",
50669,8,20990,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf#page=27","2017-12-12 00:00:00",
50723,1,20990,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf","2017-12-18 00:00:00",
14123,2,20992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf","1999-03-24 00:00:00",
21335,3,20992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20992.cfm","1999-03-24 00:00:00",
26429,1,20992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20992ltr.htm","1999-03-24 00:00:00",
3997,1,20992,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s11ltr.pdf","2002-02-22 00:00:00",
14124,2,20992,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf","2002-06-21 00:00:00",
21336,3,20992,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020992_S016_CENESTINTOC.cfm","2007-06-18 00:00:00",
26430,1,20992,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s016LTR.pdf","2002-06-21 00:00:00",
26431,1,20992,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992se2-021ltr.pdf","2004-03-03 00:00:00",
35841,2,20992,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf","2004-04-05 00:00:00",
26432,1,20992,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992slr024ltr.pdf","2004-02-02 00:00:00",
3998,1,20992,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992s026ltr.pdf","2004-10-29 00:00:00",
35842,2,20992,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf","2004-11-01 00:00:00",
14125,2,20992,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf","2015-03-24 00:00:00",
26433,1,20992,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020992Orig1s034ltr.pdf","2015-03-24 00:00:00",
50263,2,20992,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020992s037lbl.pdf","2017-11-02 00:00:00",
3999,1,20997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20997ltr.pdf","1999-08-05 00:00:00",
14126,2,20997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20997lbl.pdf","1999-08-05 00:00:00",
21337,3,20997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20997_Chirocaine.cfm","1999-08-05 00:00:00",
14127,2,20998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf","1998-12-31 00:00:00",
21338,3,20998,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020998_S001_CELEBREX.pdf","2007-07-18 00:00:00",
26435,1,20998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20998ltr.pdf","1998-12-31 00:00:00",
41866,3,20998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20998.cfm","1998-12-31 00:00:00",
44085,10,20998,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2003-12-09 00:00:00",
21339,3,20998,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S004_CELEBREX.pdf","2007-07-18 00:00:00",
41867,3,20998,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S006_CELEBREX.pdf","2007-07-18 00:00:00",
14128,2,20998,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf","2004-05-28 00:00:00",
21340,3,20998,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm","2004-05-28 00:00:00",
26436,1,20998,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf","2004-05-28 00:00:00",
21341,3,20998,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S008_CELEBREX.pdf","2007-07-18 00:00:00",
14129,2,20998,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf","2002-06-07 00:00:00",
26437,1,20998,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998s009ltr.pdf","2002-06-07 00:00:00",
41868,3,20998,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s009_Celebrex.cfm","2002-06-07 00:00:00",
14130,2,20998,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf","2001-10-18 00:00:00",
21342,3,20998,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-998s010_Celebrex.cfm","2005-02-02 00:00:00",
26438,1,20998,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20998s10ltr.pdf","2001-10-18 00:00:00",
21343,3,20998,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s013_Celebrex.cfm","2005-02-08 00:00:00",
26439,1,20998,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998scs013ltr.pdf","2002-08-29 00:00:00",
21344,3,20998,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020998_S014_CELEBREXTOC.cfm","2009-06-29 00:00:00",
4000,1,20998,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20998slr016ltr.pdf","2004-01-14 00:00:00",
14131,2,20998,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.pdf","2004-01-15 00:00:00",
21345,3,20998,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020998_s016_CelebrexTOC.cfm","2006-05-30 00:00:00",
4001,1,20998,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20998s017ltr.pdf","2005-02-17 00:00:00",
35844,2,20998,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s017lbl.pdf","2005-02-17 00:00:00",
26440,1,20998,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf","2005-08-03 00:00:00",
35845,2,20998,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf","2005-08-03 00:00:00",
14132,2,20998,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf","2005-08-03 00:00:00",
26441,1,20998,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf","2005-08-03 00:00:00",
14133,2,20998,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf","2006-12-26 00:00:00",
26442,1,20998,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020998s021ltr.pdf","2006-12-28 00:00:00",
51807,20,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998s021_celecoxib_Celebrex-MedRev.pdf","1900-01-01 00:00:00",
51808,23,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_4.24.00_orig.pdf","1900-01-01 00:00:00",
51809,25,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_1.15.01_amend.pdf","1900-01-01 00:00:00",
51810,26,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_amend2.pdf","1900-01-01 00:00:00",
51811,27,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_1.14.02_amend3.pdf","1900-01-01 00:00:00",
51812,28,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_1.25.02_amend4.pdf","1900-01-01 00:00:00",
51813,29,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998_celecoxib_WR_12.19.05_amend5.pdf","1900-01-01 00:00:00",
51814,18,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998s021_celecoxib_Celebrex-ClinPharmRev.pdf","1900-01-01 00:00:00",
51815,17,20998,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020998s021_celecoxib_Celebrex-StatsRev.pdf","1900-01-01 00:00:00",
26443,1,20998,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s022ltr.pdf","2007-06-07 00:00:00",
35846,2,20998,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020998s022lbl.pdf","2007-06-04 00:00:00",
26444,1,20998,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s023ltr.pdf","2007-11-08 00:00:00",
14134,2,20998,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf","2008-01-18 00:00:00",
26445,1,20998,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s026ltr.pdf","2008-01-18 00:00:00",
14135,2,20998,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf","2009-01-06 00:00:00",
26446,1,20998,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s027ltr.pdf","2009-01-06 00:00:00",
14136,2,20998,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf","2011-02-09 00:00:00",
26447,1,20998,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003ltr.pdf","2011-02-09 00:00:00",
4002,1,20998,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf","2016-05-11 00:00:00",
26448,1,20998,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf","2016-05-11 00:00:00",
35847,2,20998,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020998s048lbl.pdf","2016-05-11 00:00:00",
54721,2,20998,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf","2018-06-28 00:00:00",
54722,8,20998,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf#page=21","2018-06-28 00:00:00",
54831,1,20998,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020998Orig1s050ltr.pdf","2018-07-06 00:00:00",
14137,2,21001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf","2001-05-07 00:00:00",
23617,10,21001,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2003-12-08 00:00:00",
26449,1,21001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_Approv.pdf","2001-05-07 00:00:00",
41869,3,21001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert.cfm","2004-04-15 00:00:00",
53169,20,21001,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021001se5-011_Almotriptan_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53170,18,21001,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021001se5-011_Almotriptan_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
26450,1,21001,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21001slr002ltr.pdf","2004-06-07 00:00:00",
4003,1,21001,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf","2009-04-01 00:00:00",
14138,2,21001,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf","2009-04-03 00:00:00",
26451,1,21001,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf","2009-04-01 00:00:00",
35848,2,21001,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf","2009-04-03 00:00:00",
4004,1,21001,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s010,s011ltr.pdf","2009-05-06 00:00:00",
35849,2,21001,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf","2009-05-11 00:00:00",
14139,2,21001,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf","2009-05-11 00:00:00",
4005,1,21001,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021001Orig1s014ltr.pdf","2014-08-11 00:00:00",
35850,2,21001,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf","2014-08-08 00:00:00",
48385,2,21001,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021001s015lbl.pdf","2017-05-17 00:00:00",
48399,1,21001,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021001Orig1s015ltr.pdf","2017-05-17 00:00:00",
51213,23,21001,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021001_almotriptan_WR_10-5-01.pdf","2001-10-05 00:00:00",
51214,24,21001,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021001_almotriptan_Tab_3_Amendment_2-1-05.pdf","2005-02-01 00:00:00",
4006,1,21003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_Approv.pdf","1998-12-08 00:00:00",
14140,2,21003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf","1998-12-08 00:00:00",
21346,3,21003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm","1998-12-08 00:00:00",
21347,3,21003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-003SE1002_EpivirHBV.cfm","2001-08-16 00:00:00",
26452,1,21003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf","2001-08-16 00:00:00",
35851,2,21003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf","2001-08-16 00:00:00",
26453,1,21003,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr005ltr.pdf","2003-11-25 00:00:00",
35852,2,21003,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf","2003-12-01 00:00:00",
4007,1,21003,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr.pdf","2004-12-02 00:00:00",
14141,2,21003,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf","2004-12-03 00:00:00",
4008,1,21003,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr.pdf","2004-09-29 00:00:00",
35853,2,21003,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf","2004-09-29 00:00:00",
26454,1,21003,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010, 021004s010ltr.pdf","2007-10-04 00:00:00",
35854,2,21003,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf","2007-10-04 00:00:00",
4009,1,21003,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013ltr.pdf","2011-01-27 00:00:00",
35855,2,21003,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf","2011-01-24 00:00:00",
4010,1,21003,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004Orig1s015ltr.pdf","2013-12-24 00:00:00",
14142,2,21003,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf","2013-12-23 00:00:00",
48330,2,21003,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s016,021004s016lbl.pdf","2017-05-09 00:00:00",
48340,1,21003,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s016,021004Orig1s016ltr.pdf","2017-05-10 00:00:00",
49870,2,21003,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s017,021004s017lbl.pdf","2017-09-28 00:00:00",
49888,1,21003,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s017,021004Orig1s017ltr.pdf","2017-09-29 00:00:00",
4011,1,21004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_Approv.pdf","1998-12-08 00:00:00",
35856,2,21004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf","1998-12-08 00:00:00",
41870,3,21004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm","1998-12-08 00:00:00",
4012,1,21004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf","2001-08-16 00:00:00",
21348,3,21004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-003SE1002_EpivirHBV.cfm","2001-08-16 00:00:00",
35857,2,21004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf","2001-08-16 00:00:00",
26455,1,21004,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr005ltr.pdf","2003-11-25 00:00:00",
35858,2,21004,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf","2003-12-01 00:00:00",
4013,1,21004,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr.pdf","2004-12-02 00:00:00",
14143,2,21004,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf","2004-12-03 00:00:00",
4014,1,21004,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr.pdf","2004-09-29 00:00:00",
35859,2,21004,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf","2004-09-29 00:00:00",
4015,1,21004,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010, 021004s010ltr.pdf","2007-10-04 00:00:00",
35860,2,21004,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf","2007-10-04 00:00:00",
14144,2,21004,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf","2011-01-24 00:00:00",
26456,1,21004,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013ltr.pdf","2011-01-27 00:00:00",
26457,1,21004,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004Orig1s015ltr.pdf","2013-12-24 00:00:00",
35861,2,21004,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf","2013-12-23 00:00:00",
48329,2,21004,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s016,021004s016lbl.pdf","2017-05-09 00:00:00",
48342,1,21004,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s016,021004Orig1s016ltr.pdf","2017-05-10 00:00:00",
49871,2,21004,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s017,021004s017lbl.pdf","2017-09-28 00:00:00",
49887,1,21004,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s017,021004Orig1s017ltr.pdf","2017-09-29 00:00:00",
4016,1,21005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21005ltr.pdf","2000-10-16 00:00:00",
14145,2,21005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21005lbl.pdf","2000-10-16 00:00:00",
21349,3,21005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21005_Solaraze.cfm","2003-07-08 00:00:00",
26458,1,21005,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21005slr006ltr.pdf","2003-05-29 00:00:00",
35862,2,21005,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21005slr006_solaraze_lbl.pdf","2003-05-29 00:00:00",
26459,1,21005,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005scs007ltr.pdf","2004-03-24 00:00:00",
4017,1,21005,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005s009ltr.pdf","2004-07-28 00:00:00",
26460,1,21005,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021005s010ltr.pdf","2007-06-07 00:00:00",
14146,2,21005,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021005s013lbl.pdf","2011-12-14 00:00:00",
26461,1,21005,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021005s013ltr.pdf","2011-12-14 00:00:00",
4018,1,21005,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021005Orig1s016ltr.pdf","2016-05-11 00:00:00",
14147,2,21005,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf","2016-05-11 00:00:00",
23215,8,21005,"SUPPL",16,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf","2016-05-18 00:00:00",
4019,1,21006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_Approv.pdf","2001-11-08 00:00:00",
21350,3,21006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova.cfm","2001-11-08 00:00:00",
35863,2,21006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_prntlbl.pdf","2001-11-08 00:00:00",
44086,10,21006,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2003-12-09 00:00:00",
4020,1,21006,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf","2009-03-05 00:00:00",
35864,2,21006,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf","2009-04-03 00:00:00",
26462,1,21006,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf","2009-03-05 00:00:00",
35865,2,21006,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf","2009-04-23 00:00:00",
14148,2,21006,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf","2009-04-03 00:00:00",
26463,1,21006,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf","2009-03-05 00:00:00",
4021,1,21006,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021006Orig1s019ltr.pdf","2013-10-15 00:00:00",
35866,2,21006,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021006s019lbl.pdf","2013-10-17 00:00:00",
55254,2,21006,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021006s022lbl.pdf","2018-08-21 00:00:00",
55326,1,21006,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021006Orig1s022ltr.pdf","2018-08-27 00:00:00",
4022,1,21007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_Approv.pdf","1999-04-15 00:00:00",
35867,2,21007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf","1999-04-15 00:00:00",
41871,3,21007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21007&21039_Agenerase.cfm","2004-05-26 00:00:00",
4023,1,21007,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Approv.pdf","2001-05-11 00:00:00",
14149,2,21007,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf","2001-05-11 00:00:00",
21351,3,21007,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007S006_Agenerase.cfm","2004-05-26 00:00:00",
26464,1,21007,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf","2002-02-05 00:00:00",
14150,2,21007,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf","2002-08-02 00:00:00",
26465,1,21007,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr010ltr.pdf","2002-08-02 00:00:00",
26466,1,21007,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf","2002-02-05 00:00:00",
4024,1,21007,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf","2002-10-02 00:00:00",
14151,2,21007,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf","2002-10-02 00:00:00",
26467,1,21007,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf","2002-10-02 00:00:00",
35868,2,21007,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf","2002-10-02 00:00:00",
4025,1,21007,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21007slr016,21039slr016ltr.pdf","2004-03-02 00:00:00",
14152,2,21007,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf","2004-04-05 00:00:00",
4026,1,21007,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021007s017ltr.pdf","2005-11-18 00:00:00",
35869,2,21007,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021007s017lbl.pdf","2005-11-16 00:00:00",
14153,2,21008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf","1998-11-25 00:00:00",
21352,3,21008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021008.cfm","1998-11-25 00:00:00",
26468,1,21008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf","1998-11-25 00:00:00",
26469,1,21008,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21008scs007ltr.pdf","2003-12-23 00:00:00",
26470,1,21008,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008scs010ltr.pdf","2004-04-29 00:00:00",
35870,2,21008,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21008scs010_sandostatin_lbl.pdf","2004-05-03 00:00:00",
4027,1,21008,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008s015ltr.pdf","2004-10-18 00:00:00",
26471,1,21008,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf","2006-05-16 00:00:00",
35871,2,21008,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf","2006-05-16 00:00:00",
14154,2,21008,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf","2006-05-16 00:00:00",
26472,1,21008,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf","2006-05-16 00:00:00",
26473,1,21008,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021008s021ltr.pdf","2008-03-05 00:00:00",
35872,2,21008,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf","2008-03-05 00:00:00",
26474,1,21008,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf","2010-02-05 00:00:00",
35873,2,21008,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf","2010-02-04 00:00:00",
4028,1,21008,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021008s025ltr.pdf","2011-10-03 00:00:00",
35874,2,21008,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf","2011-09-30 00:00:00",
26475,1,21008,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021008Orig1s028ltr.pdf","2014-05-20 00:00:00",
35875,2,21008,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s028lbl.pdf","2014-06-02 00:00:00",
41872,3,21008,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021008Orig1s028.pdf","2015-09-23 00:00:00",
14155,2,21008,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf","2014-07-22 00:00:00",
35876,2,21008,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf","2016-07-25 00:00:00",
14156,2,21009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf","1999-12-08 00:00:00",
26476,1,21009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21009ltr.pdf","1999-12-08 00:00:00",
41873,3,21009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021009_Alocril.cfm","2004-05-26 00:00:00",
4029,1,21009,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21009s2ltr.pdf","2002-03-08 00:00:00",
4030,1,21009,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf","2007-08-22 00:00:00",
35877,2,21009,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf","2007-08-22 00:00:00",
14157,2,21009,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf","2007-08-22 00:00:00",
26477,1,21009,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf","2007-08-22 00:00:00",
4031,1,21009,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf","2004-10-22 00:00:00",
26478,1,21009,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf","2004-10-22 00:00:00",
26479,1,21009,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021009s010ltr.pdf","2008-07-08 00:00:00",
35878,2,21009,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf","2008-07-09 00:00:00",
4032,1,21011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21011ltr.pdf","2000-08-31 00:00:00",
14158,2,21011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf","2000-08-31 00:00:00",
41874,3,21011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-011_Roxicodone.cfm","2004-03-10 00:00:00",
26480,1,21011,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s002ltr.pdf","2009-02-24 00:00:00",
35879,2,21011,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf","2009-02-24 00:00:00",
14159,2,21011,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf","2009-06-07 00:00:00",
26481,1,21011,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s003ltr.pdf","2009-05-20 00:00:00",
46269,1,21011,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021011Orig1s006ltr.pdf","2016-12-20 00:00:00",
46363,2,21011,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf","2016-12-21 00:00:00",
46573,8,21011,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf#page=26","2016-12-28 00:00:00",
55662,1,21011,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.pdf","2018-09-28 00:00:00",
55663,1,21011,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.pdf","2018-09-28 00:00:00",
14160,2,21012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf","1999-08-03 00:00:00",
26482,1,21012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect_appltrs.pdf","1999-08-03 00:00:00",
41875,3,21012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect.cfm","1999-08-03 00:00:00",
4033,1,21012,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21012s007ltr.pdf","2004-10-08 00:00:00",
35880,2,21012,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21012s007lbl.pdf","2004-10-08 00:00:00",
24144,16,21014,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-03-16 00:00:00",
26483,1,21014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21014ltr.pdf","1999-01-10 00:00:00",
35881,2,21014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21014lbl.pdf","1999-01-10 00:00:00",
41876,3,21014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-014_Trileptal.cfm","2002-02-28 00:00:00",
4034,1,21014,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014se5-003ltr.pdf","2003-08-15 00:00:00",
35882,2,21014,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21014se5-003_trileptal_lbl.pdf","2003-08-15 00:00:00",
41877,3,21014,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021014_s003_TrileptalTOC.cfm","2006-05-31 00:00:00",
4035,1,21014,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf","2002-04-01 00:00:00",
4036,1,21014,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014scs007ltr.pdf","2003-04-15 00:00:00",
4037,1,21014,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr.pdf","2005-03-30 00:00:00",
14161,2,21014,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf","2005-03-30 00:00:00",
14162,2,21014,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf","2005-10-28 00:00:00",
26484,1,21014,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008rel2_ltr.pdf","2005-11-01 00:00:00",
52094,20,21014,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021014s013_oxcarbazepine_Trileptal-MedRev.pdf","1900-01-01 00:00:00",
52096,18,21014,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021014s013_oxcarbazepine_Trileptal-ClinPharmRev.pdf","1900-01-01 00:00:00",
52099,17,21014,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021014s013_oxcarbazepine_Trileptal-StatsRev.pdf","1900-01-01 00:00:00",
52101,23,21014,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021014_oxcarbazepine_Trileptal_WR_orig.pdf","1900-01-01 00:00:00",
26485,1,21014,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s014ltr.pdf","2005-11-18 00:00:00",
4038,1,21014,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
14163,2,21014,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
26486,1,21014,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
35883,2,21014,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4039,1,21014,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf","2007-09-06 00:00:00",
4040,1,21014,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
35884,2,21014,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
14164,2,21014,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
26487,1,21014,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
4041,1,21014,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
35885,2,21014,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
26488,1,21014,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021ltr.pdf","2009-05-04 00:00:00",
35886,2,21014,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf","2009-05-12 00:00:00",
26489,1,21014,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
35887,2,21014,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4042,1,21014,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
35888,2,21014,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4043,1,21014,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285Orig1s023ltr.pdf","2013-02-12 00:00:00",
35889,2,21014,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf","2013-02-12 00:00:00",
26490,1,21014,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025ltr.pdf","2011-11-14 00:00:00",
4044,1,21014,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285Orig1s027ltr.pdf","2014-07-08 00:00:00",
35890,2,21014,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf","2014-07-08 00:00:00",
4045,1,21014,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285Orig1s030ltr.pdf","2014-06-10 00:00:00",
14165,2,21014,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf","2014-06-10 00:00:00",
47668,1,21014,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1s036,021285Orig1s031ltr.pdf","2017-03-24 00:00:00",
47726,2,21014,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s036lbl.pdf","2017-03-28 00:00:00",
50460,2,21014,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s041,021285s034lbl.pdf","2017-11-20 00:00:00",
50489,1,21014,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1ss041,021285Orig1s034ltr.pdf","2017-11-27 00:00:00",
53236,2,21014,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf","2018-03-23 00:00:00",
53242,8,21014,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26","2018-03-23 00:00:00",
53501,1,21014,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021014Orig1s042,021285Orig1s035ltr.pdf","2018-03-28 00:00:00",
4046,1,21015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21015ltr.pdf","2000-02-28 00:00:00",
14166,2,21015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21015lbl.pdf","2000-02-28 00:00:00",
21353,3,21015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-015_AndroGel.cfm","2004-01-15 00:00:00",
23987,14,21015,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=4","2011-04-04 00:00:00",
43691,8,21015,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188474.pdf","2009-10-30 00:00:00",
53125,23,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021015_Testosterone gel_WR_Amend.pdf","1900-01-01 00:00:00",
53126,23,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021015_Testosterone gel_WR_Amend2.pdf","1900-01-01 00:00:00",
53127,20,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22227, 22228 testosterone clinical bpca.pdf","1900-01-01 00:00:00",
53128,18,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22227, 22228 testosterone clinpharm bpca.pdf","1900-01-01 00:00:00",
53129,18,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022227, 022228_Testoterone_ClinPharm.pdf","1900-01-01 00:00:00",
53130,17,21015,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22227, 22228 testosterone statistical bpca.pdf","1900-01-01 00:00:00",
4047,1,21015,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21015slr004ltr.pdf","2002-10-22 00:00:00",
35891,2,21015,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21015s4lbl.pdf","2002-10-22 00:00:00",
21354,3,21015,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s008_AndrogelTOC.cfm","2006-06-01 00:00:00",
26491,1,21015,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015slr008ltr.pdf","2003-09-29 00:00:00",
21355,3,21015,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s010_AndrogelTOC.cfm","2006-06-01 00:00:00",
26492,1,21015,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015scp010ltr.pdf","2003-09-30 00:00:00",
4048,1,21015,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s011ltr.pdf","2005-08-16 00:00:00",
4049,1,21015,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21015s012ltr.pdf","2004-12-02 00:00:00",
14167,2,21015,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21015s012lbl.pdf","2004-12-03 00:00:00",
4050,1,21015,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s013ltr.pdf","2005-08-19 00:00:00",
35892,2,21015,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021015s013lbl.pdf","2005-08-19 00:00:00",
4051,1,21015,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s016ltr.pdf","2008-01-09 00:00:00",
35893,2,21015,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s016lbl.pdf","2007-12-14 00:00:00",
26493,1,21015,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf","2008-01-09 00:00:00",
35894,2,21015,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf","2008-01-08 00:00:00",
4052,1,21015,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf","2008-01-09 00:00:00",
14168,2,21015,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf","2008-01-08 00:00:00",
4053,1,21015,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021015s022ltr.pdf","2009-10-26 00:00:00",
14169,2,21015,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf","2009-10-01 00:00:00",
4054,1,21015,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s028ltr.pdf","2011-03-14 00:00:00",
14170,2,21015,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s028lbl.pdf","2011-03-11 00:00:00",
26494,1,21015,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s032ltr.pdf","2011-12-05 00:00:00",
35895,2,21015,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s032lbl.pdf","2011-12-02 00:00:00",
14171,2,21015,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf","2012-09-24 00:00:00",
26495,1,21015,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021015Orig1s034ltr.pdf","2012-09-24 00:00:00",
14172,2,21015,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf","2013-05-20 00:00:00",
26496,1,21015,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021015Orig1s036ltr.pdf","2013-05-22 00:00:00",
26497,1,21015,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s038ltr.pdf","2014-11-14 00:00:00",
35896,2,21015,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015Orig1s038lbl.pdf","2014-12-18 00:00:00",
4055,1,21015,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s039ltr.pdf","2014-06-23 00:00:00",
14173,2,21015,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015s039lbl.pdf","2014-06-23 00:00:00",
14174,2,21015,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf","2015-05-13 00:00:00",
26498,1,21015,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021015Orig1s040ltr.pdf","2015-05-13 00:00:00",
45672,1,21015,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021015Orig1s043ltr.pdf","2016-10-27 00:00:00",
45740,2,21015,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021015s043lbl.pdf","2016-11-01 00:00:00",
26499,1,21016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21016ltr.pdf","2003-01-29 00:00:00",
35897,2,21016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21016_relpax_lbl.pdf","2003-04-07 00:00:00",
41878,3,21016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21016_Relpax.cfm","2003-12-02 00:00:00",
44087,10,21016,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
26500,1,21016,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21016slr003ltr.pdf","2004-05-07 00:00:00",
4056,1,21016,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf","2010-07-23 00:00:00",
35898,2,21016,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf","2010-07-31 00:00:00",
14175,2,21016,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf","2010-07-31 00:00:00",
26501,1,21016,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf","2010-07-23 00:00:00",
4057,1,21016,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021016s018ltr.pdf","2011-04-15 00:00:00",
14176,2,21016,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf","2011-04-15 00:00:00",
14177,2,21016,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf","2013-10-08 00:00:00",
26502,1,21016,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf","2013-10-08 00:00:00",
26503,1,21016,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf","2013-10-08 00:00:00",
35899,2,21016,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf","2013-10-08 00:00:00",
4058,1,21016,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf","2013-10-08 00:00:00",
14178,2,21016,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf","2013-10-08 00:00:00",
4059,1,21016,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf","2013-10-08 00:00:00",
14179,2,21016,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf","2013-10-08 00:00:00",
4060,1,21017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf","1999-12-22 00:00:00",
35900,2,21017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21017lbl.pdf","1999-12-22 00:00:00",
41879,3,21017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21017_Humalog.cfm","1999-12-22 00:00:00",
41880,3,21017,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021017_S002_Humalog Mix_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
4061,1,21017,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf","2004-04-29 00:00:00",
35901,2,21017,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf","2004-05-04 00:00:00",
4062,1,21017,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017slr010ltr.pdf","2003-07-28 00:00:00",
4063,1,21017,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017scm013ltr.pdf","2003-11-25 00:00:00",
14180,2,21017,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21017scm013_humalog_lbl.pdf","2003-12-02 00:00:00",
4064,1,21017,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf","2004-04-29 00:00:00",
14181,2,21017,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf","2004-05-04 00:00:00",
4065,1,21017,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017scm018ltr.pdf","2004-04-29 00:00:00",
14182,2,21017,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017scm018_humalog_lbl.pdf","2004-05-04 00:00:00",
4066,1,21017,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
26504,1,21017,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf","2007-08-27 00:00:00",
35902,2,21017,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf","2007-08-23 00:00:00",
4067,1,21017,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf","2007-09-11 00:00:00",
14183,2,21017,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf","2007-09-11 00:00:00",
4068,1,21017,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf","2009-03-23 00:00:00",
14184,2,21017,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf","2009-03-17 00:00:00",
4069,1,21017,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s072ltr.pdf","2013-03-12 00:00:00",
35903,2,21017,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s072lbl.pdf","2013-03-11 00:00:00",
35904,2,21017,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021017s074lbl.pdf","2011-11-16 00:00:00",
55628,2,21017,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf","2018-09-27 00:00:00",
55754,1,21017,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021017Orig1s075,021017Orig1s079ltr.pdf","2018-10-01 00:00:00",
55629,2,21017,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf","2018-09-27 00:00:00",
55755,1,21017,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021017Orig1s075,021017Orig1s079ltr.pdf","2018-10-01 00:00:00",
4070,1,21017,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s082ltr.pdf","2013-01-31 00:00:00",
14185,2,21017,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s082lbl.pdf","2013-02-01 00:00:00",
14186,2,21017,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf","2015-03-02 00:00:00",
26505,1,21017,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021017Orig1s108ltr.pdf","2015-02-27 00:00:00",
46764,2,21017,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021017s122lbl.pdf","2017-01-06 00:00:00",
46790,1,21017,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021017Orig1s122ltr.pdf","2017-01-11 00:00:00",
14187,2,21018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21018lbl.pdf","1999-12-22 00:00:00",
26506,1,21018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf","1999-12-22 00:00:00",
41881,3,21018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21017_Humalog.cfm","1999-12-22 00:00:00",
26507,1,21018,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21018scm011ltr.pdf","2003-11-25 00:00:00",
35905,2,21018,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21018scm011_humalog_lbl.pdf","2003-12-02 00:00:00",
26508,1,21018,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf","2007-09-11 00:00:00",
26509,1,21018,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf","2007-09-11 00:00:00",
35906,2,21018,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf","2007-09-11 00:00:00",
26510,1,21018,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021018s035ltr.pdf","2008-05-07 00:00:00",
26511,1,21018,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf","2007-08-27 00:00:00",
35907,2,21018,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf","2007-08-23 00:00:00",
14188,2,21018,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf","2009-03-17 00:00:00",
26512,1,21018,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf","2009-03-23 00:00:00",
26513,1,21018,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s067ltr.pdf","2013-03-12 00:00:00",
35908,2,21018,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf","2013-03-11 00:00:00",
14189,2,21018,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021018s069lbl.pdf","2011-11-16 00:00:00",
55626,2,21018,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf","2018-09-27 00:00:00",
55757,1,21018,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021018Orig1s070s074ltr.pdf","2018-10-01 00:00:00",
55627,2,21018,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf","2018-09-27 00:00:00",
55756,1,21018,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021018Orig1s070s074ltr.pdf","2018-10-01 00:00:00",
4071,1,21018,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s077ltr.pdf","2013-01-31 00:00:00",
35909,2,21018,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s077lbl.pdf","2013-02-01 00:00:00",
4072,1,21018,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021018orig1s100ltr.pdf","2015-02-27 00:00:00",
35910,2,21018,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021018s100lbl.pdf","2015-03-02 00:00:00",
46763,2,21018,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021018s111lbl.pdf","2017-01-06 00:00:00",
46789,1,21018,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021018Orig1s111ltr.pdf","2017-01-11 00:00:00",
4073,1,21019,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf","2001-04-03 00:00:00",
21356,3,21019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019a.cfm","1999-10-06 00:00:00",
26514,1,21019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf","1999-10-06 00:00:00",
35911,2,21019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf","1999-10-06 00:00:00",
4074,1,21022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf","1999-12-17 00:00:00",
14190,2,21022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf","1999-12-17 00:00:00",
41882,3,21022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm","1999-12-17 00:00:00",
43566,6,21022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022LBLB.PDF","1999-12-17 00:00:00",
14191,2,21022,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf","2003-06-22 00:00:00",
26515,1,21022,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf","2003-06-22 00:00:00",
26516,1,21022,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf","2003-12-24 00:00:00",
35912,2,21022,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf","2003-12-29 00:00:00",
14192,2,21022,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf","2004-12-08 00:00:00",
26517,1,21022,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf","2004-12-08 00:00:00",
41883,3,21023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-023_Restasis.cfm","2005-04-08 00:00:00",
26518,1,21024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21024ltr.pdf","1998-06-22 00:00:00",
35913,2,21024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21024lbl.pdf","1998-06-22 00:00:00",
41884,3,21024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21024.cfm","1998-06-22 00:00:00",
26519,1,21024,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_Approv.pdf","2000-10-20 00:00:00",
35914,2,21024,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_prntlbl.pdf","2000-10-20 00:00:00",
41885,3,21024,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024S5_Priftin.cfm","2000-10-20 00:00:00",
4075,1,21024,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021024s008ltr.pdf","2009-06-02 00:00:00",
14193,2,21024,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf","2009-06-03 00:00:00",
21357,3,21024,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021024Orig1s008.pdf","2013-06-03 00:00:00",
4076,1,21024,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021024s009ltr.pdf","2010-08-09 00:00:00",
35915,2,21024,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021024s009lbl.pdf","2010-07-30 00:00:00",
26520,1,21024,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s010ltr.pdf","2014-11-24 00:00:00",
4077,1,21024,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s011ltr.pdf","2014-11-26 00:00:00",
35916,2,21024,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021024s011lbl.pdf","2014-12-03 00:00:00",
43692,8,21024,"SUPPL",11,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426514.pdf","2014-12-11 00:00:00",
51640,20,21024,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21024s011 rifapentine clinical prea.pdf","1900-01-01 00:00:00",
51641,18,21024,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21024s011 rifapentine clinpharm prea.pdf","1900-01-01 00:00:00",
51642,17,21024,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21024s011 rifapentine statistical prea.pdf","1900-01-01 00:00:00",
4078,1,21024,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021024Orig1s013ltr.pdf","2015-07-08 00:00:00",
35917,2,21024,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021024s013lbl.pdf","2015-07-23 00:00:00",
4079,1,21025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20823ltr.pdf","2000-04-21 00:00:00",
35918,2,21025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21025lbl.pdf","2000-04-21 00:00:00",
41886,3,21025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-025_Exelon.cfm","2000-04-21 00:00:00",
21358,3,21025,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021025_S003_EXELON_AP.pdf","2007-06-18 00:00:00",
26521,1,21025,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823slr012,21025slr006ltr.pdf","2004-05-07 00:00:00",
4080,1,21025,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20823s014,21025s007ltr.pdf","2004-09-24 00:00:00",
21359,3,21025,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021025_s008_exelon_capsules.pdf","2006-06-27 00:00:00",
26522,1,21025,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020823s016, 021025s008ltr.pdf","2006-07-03 00:00:00",
35919,2,21025,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf","2006-06-28 00:00:00",
4081,1,21025,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35920,2,21025,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
14194,2,21025,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
26523,1,21025,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
4082,1,21025,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020823Orig1s009,s027,s028,s029,021025Orig1s018,s019,s0020ltr.pdf","2013-10-04 00:00:00",
35921,2,21025,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf","2013-10-08 00:00:00",
4083,1,21025,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020823Orig1s032,021025Orig1s022ltr.pdf","2015-02-05 00:00:00",
35922,2,21025,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020823s032,021025s022lbl.pdf","2015-02-05 00:00:00",
45800,1,21025,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020823s035,021025s023,022083s023ltr.pdf","2016-11-03 00:00:00",
45807,2,21025,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020823s035,021025s023lbl.pdf","2016-11-04 00:00:00",
4084,1,21026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021026ltr.pdf","2006-03-01 00:00:00",
35923,2,21026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021026s000lbl.pdf","2006-02-22 00:00:00",
41887,3,21026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021026_vusion_toc.cfm","2009-11-05 00:00:00",
4085,1,21026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021026s004ltr.pdf","2007-10-04 00:00:00",
35924,2,21026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021026s004lbl.pdf","2007-10-10 00:00:00",
4086,1,21026,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021026s006ltr.pdf","2010-04-02 00:00:00",
35925,2,21026,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021026s006lbl.pdf","2010-04-04 00:00:00",
55370,2,21026,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf","2018-08-30 00:00:00",
21360,3,21027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21027_Hectorol.cfm","2000-04-06 00:00:00",
26524,1,21027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21027ltr.pdf","2000-04-06 00:00:00",
35926,2,21027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf","2000-04-06 00:00:00",
4087,1,21027,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21027scm007ltr.pdf","2003-12-04 00:00:00",
26525,1,21027,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021027s012ltr.pdf","2005-06-23 00:00:00",
35927,2,21027,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf","2005-06-23 00:00:00",
4088,1,21027,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021027s013,020862s019ltr.pdf","2006-07-21 00:00:00",
14195,2,21027,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf","2006-07-21 00:00:00",
4089,1,21027,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021027s015ltr.pdf","2008-12-11 00:00:00",
21361,3,21027,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021027Orig1s015.pdf","2012-05-09 00:00:00",
35928,2,21027,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf","2009-01-02 00:00:00",
14196,2,21027,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf","2016-06-02 00:00:00",
26526,1,21027,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021027Orig1s026ltr.pdf","2016-06-06 00:00:00",
4090,1,21028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21028ltr.pdf","1999-07-19 00:00:00",
35929,2,21028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21028lbl.pdf","1999-07-19 00:00:00",
41888,3,21028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021028A_Velosulin.cfm","1999-07-19 00:00:00",
4091,1,21028,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21028slr005ltr.pdf","2004-05-26 00:00:00",
14197,2,21028,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21028slr005_velosulin_lbl.pdf","2004-05-27 00:00:00",
26527,1,21029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21029ltr.pdf","1999-08-11 00:00:00",
35930,2,21029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf","1999-08-11 00:00:00",
41889,3,21029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21029_Temodar.cfm","1999-08-11 00:00:00",
14198,2,21029,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf","2002-01-18 00:00:00",
26528,1,21029,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21029s4ltr.pdf","2002-01-18 00:00:00",
41890,3,21029,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21029-S004_TEMODAR_review.pdf","2004-04-14 00:00:00",
26529,1,21029,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21029se8-005ltr.pdf","2003-03-26 00:00:00",
35931,2,21029,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf","2003-03-26 00:00:00",
52213,20,21029,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021029s005_temozaolomide_Temodar-ClinicalRev.pdf","1900-01-01 00:00:00",
52214,18,21029,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21029 temodar clinpharm bpca.pdf","1900-01-01 00:00:00",
52215,17,21029,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21029 temodar clinical statistical bpca.pdf","1900-01-01 00:00:00",
52216,23,21029,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021029_temozolomide_Temodar_WR ltr.pdf","1900-01-01 00:00:00",
52217,25,21029,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021029_temozolomide_Temodar_WR amend.pdf","1900-01-01 00:00:00",
26530,1,21029,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029s006ltr.pdf","2004-07-21 00:00:00",
4092,1,21029,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029slr007ltr.pdf","2004-06-30 00:00:00",
4093,1,21029,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s008ltr.pdf","2005-03-18 00:00:00",
14199,2,21029,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf","2005-03-15 00:00:00",
26531,1,21029,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s009ltr.pdf","2005-03-31 00:00:00",
4094,1,21029,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021029s010ltr.pdf","2005-04-28 00:00:00",
4095,1,21029,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s008, s011ltr.pdf","2006-04-07 00:00:00",
4096,1,21029,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s012ltr.pdf","2006-10-23 00:00:00",
35932,2,21029,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf","2006-10-23 00:00:00",
26532,1,21029,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf","2010-04-29 00:00:00",
35933,2,21029,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf","2010-04-28 00:00:00",
14200,2,21029,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf","2011-02-09 00:00:00",
4097,1,21029,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.pdf","2011-06-09 00:00:00",
14201,2,21029,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf","2011-06-07 00:00:00",
35934,2,21029,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf","2013-01-09 00:00:00",
26533,1,21029,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021029Orig1s026ltr.pdf","2014-05-06 00:00:00",
35935,2,21029,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf","2014-05-06 00:00:00",
26534,1,21029,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s028ltr.pdf","2015-04-03 00:00:00",
35936,2,21029,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf","2015-04-07 00:00:00",
4098,1,21029,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s029ltr.pdf","2015-09-22 00:00:00",
14202,2,21029,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf","2015-09-23 00:00:00",
47337,2,21029,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s030lbl.pdf","2017-02-27 00:00:00",
47430,1,21029,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s030ltr.pdf","2017-03-02 00:00:00",
14203,2,21029,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf","2016-02-18 00:00:00",
26535,1,21029,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021029Orig1s031ltr.pdf","2016-02-16 00:00:00",
49995,2,21029,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s032lbl.pdf","2017-10-10 00:00:00",
50027,1,21029,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s032ltr.pdf","2017-10-12 00:00:00",
4099,1,21035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21035ltr.pdf","1999-11-30 00:00:00",
14204,2,21035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf","1999-11-30 00:00:00",
23618,10,21035,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2007-03-28 00:00:00",
41891,3,21035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21035_Keppra.cfm","1999-11-30 00:00:00",
4100,1,21035,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf","2002-05-22 00:00:00",
4101,1,21035,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf","2002-05-22 00:00:00",
4102,1,21035,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21035slr030lr.pdf","2003-09-09 00:00:00",
4103,1,21035,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf","2004-10-29 00:00:00",
4104,1,21035,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr.pdf","2004-10-29 00:00:00",
4105,1,21035,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021505s006_021035s038ltr.pdf","2006-01-30 00:00:00",
4106,1,21035,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021035s040,021505s007ltr.pdf","2005-06-23 00:00:00",
35937,2,21035,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf","2005-06-23 00:00:00",
51996,20,21035,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s040, 021505s007_levetiracetam_Keppra-MedRev.pdf","1900-01-01 00:00:00",
51997,23,21035,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Keppra_WR_orig.pdf","1900-01-01 00:00:00",
51998,25,21035,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Keppra_WR_amend.pdf","1900-01-01 00:00:00",
51999,18,21035,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s040, 021505s007_levetiracetam_Keppra-ClinPharmRev.pdf","1900-01-01 00:00:00",
52000,17,21035,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s040, 021505s007_levetiracetam_Keppra-StatRev.pdf","1900-01-01 00:00:00",
26536,1,21035,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s048ltr.pdf","2006-01-20 00:00:00",
4107,1,21035,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf","2006-08-18 00:00:00",
14205,2,21035,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf","2006-08-18 00:00:00",
26537,1,21035,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
35938,2,21035,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
26538,1,21035,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf","2006-08-18 00:00:00",
35939,2,21035,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf","2006-08-18 00:00:00",
14206,2,21035,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf","2007-03-23 00:00:00",
26539,1,21035,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057, 021505s013ltr.pdf","2007-03-23 00:00:00",
4108,1,21035,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf","2007-09-25 00:00:00",
26540,1,21035,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
35940,2,21035,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
52306,23,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Tab 2_WR_21Aug01_WR.pdf","2008-06-03 00:00:00",
52307,25,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Tab 3_amendment_22mar02_WR.pdf","2008-06-03 00:00:00",
52308,40,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_BPCA Reissue_1_WR.pdf","2008-06-03 00:00:00",
52309,41,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_BPCA Reissue_2_WR.pdf","2008-06-03 00:00:00",
52310,26,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Tab 4_amendment_23jul04_WR.pdf","2008-06-03 00:00:00",
52311,42,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035_levetiracetam_Tab 5_amendment_31jan06_WR.pdf","2008-06-03 00:00:00",
52943,20,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s073_Levetiracetam_Medical_BPCA.pdf","2008-06-03 00:00:00",
52944,18,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s073_Levetiracetam_Clinpharm_BPCA.pdf","2008-06-03 00:00:00",
52946,62,21035,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021035s073_Levetiracetam_Cllinical_Safety_BPCA.pdf","2008-06-03 00:00:00",
4109,1,21035,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
14207,2,21035,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
4110,1,21035,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf","2009-05-04 00:00:00",
14208,2,21035,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf","2009-05-13 00:00:00",
4111,1,21035,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf","2009-05-04 00:00:00",
14209,2,21035,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf","2009-05-13 00:00:00",
26541,1,21035,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
35941,2,21035,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
4112,1,21035,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
14210,2,21035,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
4113,1,21035,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
14211,2,21035,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf","2013-07-30 00:00:00",
26542,1,21035,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf","2011-08-12 00:00:00",
4114,1,21035,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf","2014-03-11 00:00:00",
14212,2,21035,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s091lbl.pdf","2014-03-10 00:00:00",
14213,2,21035,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf","2015-03-12 00:00:00",
26543,1,21035,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf","2015-03-12 00:00:00",
26544,1,21035,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf","2014-08-11 00:00:00",
35942,2,21035,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf","2014-08-08 00:00:00",
45706,1,21035,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf","2016-10-28 00:00:00",
45766,2,21035,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021035s096,021505s036lbl.pdf","2016-11-01 00:00:00",
48108,2,21035,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s099,021505s038lbl.pdf","2017-04-25 00:00:00",
48146,1,21035,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf","2017-04-27 00:00:00",
50209,8,21035,"SUPPL",100,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf#page=28","2017-10-27 00:00:00",
50210,2,21035,"SUPPL",100,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf","2017-10-27 00:00:00",
50216,1,21035,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf","2017-10-30 00:00:00",
4115,1,21036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21036ltr.pdf","1999-07-26 00:00:00",
14214,2,21036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf","1999-07-26 00:00:00",
21362,3,21036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21036.cfm","1999-07-26 00:00:00",
21363,3,21036,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-036-s001_Relenza.cfm","2004-04-12 00:00:00",
26545,1,21036,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21036S1LTR.PDF","2000-04-26 00:00:00",
35943,2,21036,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21036S1LBL.PDF","2000-04-26 00:00:00",
14215,2,21036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21036S4lbl.pdf","2001-04-27 00:00:00",
26546,1,21036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr005ltr.pdf","2004-06-15 00:00:00",
35944,2,21036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021036s005lbl.pdf","2003-10-07 00:00:00",
26547,1,21036,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr006ltr.pdf","2003-08-15 00:00:00",
35945,2,21036,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21036slr006_relenza_lbl.pdf","2003-08-15 00:00:00",
26548,1,21036,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021036s007ltr.pdf","2009-10-16 00:00:00",
14216,2,21036,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021036s008lbl.pdf","2006-04-03 00:00:00",
21364,3,21036,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021036Orig1s008.pdf","2014-01-16 00:00:00",
26549,1,21036,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s008ltr.pdf","2006-04-05 00:00:00",
4116,1,21036,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s010ltr.pdf","2009-10-16 00:00:00",
14217,2,21036,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021036s012lbl.pdf","2007-09-11 00:00:00",
26550,1,21036,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s012ltr.pdf","2007-09-11 00:00:00",
4117,1,21036,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s013ltr.pdf","2007-03-15 00:00:00",
26551,1,21036,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s014ltr.pdf","2009-10-16 00:00:00",
4118,1,21036,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s015ltr.pdf","2009-10-16 00:00:00",
4119,1,21036,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s016ltr.pdf","2008-02-25 00:00:00",
35946,2,21036,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s016lbl.pdf","2008-02-25 00:00:00",
4120,1,21036,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s017ltr.pdf","2008-10-07 00:00:00",
35947,2,21036,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s017lbl.pdf","2008-10-09 00:00:00",
26552,1,21036,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021036s018ltr.pdf","2009-10-16 00:00:00",
26553,1,21036,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s019ltr.pdf","2010-03-29 00:00:00",
35948,2,21036,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf","2010-03-26 00:00:00",
4121,1,21036,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s024ltr.pdf","2010-05-07 00:00:00",
4122,1,21036,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s025ltr.pdf","2010-12-15 00:00:00",
35949,2,21036,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s025lbl.pdf","2010-12-10 00:00:00",
14218,2,21036,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021036s027lbl.pdf","2011-12-23 00:00:00",
26554,1,21036,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021036s027ltr.pdf","2011-12-22 00:00:00",
54691,2,21036,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021036s030lbl.pdf","2018-06-27 00:00:00",
54698,1,21036,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021036Orig1s030ltr.pdf","2018-06-27 00:00:00",
21365,3,21037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21037_Magnevist.pdf","2004-06-09 00:00:00",
44088,10,21037,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2011-12-21 00:00:00",
4123,1,21037,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21037s010ltr.pdf","2004-09-17 00:00:00",
4124,1,21037,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf","2010-08-31 00:00:00",
14219,2,21037,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf","2010-09-07 00:00:00",
26555,1,21037,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021037s014ltr.pdf","2006-09-15 00:00:00",
4125,1,21037,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019596s043, 021037s018ltr.pdf","2007-09-06 00:00:00",
35950,2,21037,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf","2007-09-06 00:00:00",
26556,1,21037,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf","2009-05-29 00:00:00",
35951,2,21037,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf","2009-05-25 00:00:00",
4126,1,21037,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf","2010-12-22 00:00:00",
14220,2,21037,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021037s023lbl.pdf","2010-12-20 00:00:00",
26557,1,21037,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf","2012-04-02 00:00:00",
35952,2,21037,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021037s025lbl.pdf","2012-03-29 00:00:00",
14221,2,21037,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf","2013-10-22 00:00:00",
26558,1,21037,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037Orig1s029ltr.pdf","2013-10-18 00:00:00",
4127,1,21037,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf","2014-06-12 00:00:00",
35953,2,21037,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057,021037s030lbl.pdf","2014-06-17 00:00:00",
14222,2,21037,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021037s031lbl.pdf","2015-09-21 00:00:00",
26559,1,21037,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021037Orig1s031ltr.pdf","2015-08-03 00:00:00",
53849,2,21037,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s036lbl.pdf","2018-04-27 00:00:00",
53891,1,21037,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s063,021037Orig1s036_replacement ltr.pdf","2018-05-01 00:00:00",
54987,2,21037,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf","2018-07-26 00:00:00",
55014,1,21037,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021037Orig1s037,s038Ltr.pdf","2018-07-26 00:00:00",
54988,2,21037,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf","2018-07-26 00:00:00",
54990,8,21037,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13","2018-07-26 00:00:00",
55015,1,21037,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021037Orig1s037,s038Ltr.pdf","2018-07-26 00:00:00",
4128,1,21038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21038ltr.pdf","1999-12-17 00:00:00",
14223,2,21038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf","1999-12-17 00:00:00",
21366,3,21038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-038_Precedex.cfm","1999-12-17 00:00:00",
26560,1,21038,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021038s010ltr.pdf","2008-10-21 00:00:00",
4129,1,21038,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021038s017ltr.pdf","2010-10-19 00:00:00",
14224,2,21038,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021038s017lbl.pdf","2010-10-19 00:00:00",
21367,3,21038,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021038Orig1s017.pdf","2013-10-21 00:00:00",
4130,1,21038,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf","2014-12-01 00:00:00",
35954,2,21038,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf","2014-11-20 00:00:00",
21368,3,21038,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021038Orig1s020.pdf","2015-07-21 00:00:00",
35955,2,21038,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s020lbl.pdf","2013-03-19 00:00:00",
4131,1,21038,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf","2013-06-18 00:00:00",
14225,2,21038,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s021lbl.pdf","2013-06-17 00:00:00",
51508,23,21038,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Original_WR.pdf","2007-03-14 00:00:00",
51510,25,21038,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Amendment_1.pdf","2010-12-14 00:00:00",
51512,26,21038,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Amendment_2.pdf","2011-08-30 00:00:00",
26561,1,21038,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf","2013-06-18 00:00:00",
35956,2,21038,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s022lbl.pdf","2013-06-17 00:00:00",
51509,23,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Original_WR.pdf","2007-03-14 00:00:00",
51511,25,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Amendment_1.pdf","2010-12-14 00:00:00",
51513,26,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21038_dexmedetomidine_Amendment_2.pdf","2011-08-30 00:00:00",
52608,20,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021038s022, s021 dexmedetomidine Precedex clinical bpca.pdf","1900-01-01 00:00:00",
52609,18,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021038s022, s021 dexmedetomidine Precedex clinpharm bpca.pdf","1900-01-01 00:00:00",
52610,17,21038,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021038s022, s021 dexmedetomidine Precedex statistical bpca.pdf","1900-01-01 00:00:00",
4132,1,21038,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf","2014-12-01 00:00:00",
35957,2,21038,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf","2014-11-20 00:00:00",
14226,2,21038,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf","2014-11-20 00:00:00",
26562,1,21038,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf","2014-12-01 00:00:00",
4133,1,21038,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021038Orig1s027ltr.pdf","2016-04-12 00:00:00",
35958,2,21038,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021038s027lbl.pdf","2016-04-12 00:00:00",
4134,1,21039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_Approv.pdf","1999-04-15 00:00:00",
14227,2,21039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_prntlbl.pdf","1999-04-15 00:00:00",
21369,3,21039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21007&21039_Agenerase.cfm","2004-05-26 00:00:00",
14228,2,21039,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf","2001-05-11 00:00:00",
21370,3,21039,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007S006_Agenerase.cfm","2004-05-26 00:00:00",
26563,1,21039,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Approv.pdf","2001-05-11 00:00:00",
26564,1,21039,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf","2002-02-05 00:00:00",
14229,2,21039,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf","2002-08-02 00:00:00",
26565,1,21039,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr010ltr.pdf","2002-08-02 00:00:00",
4135,1,21039,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf","2002-02-05 00:00:00",
14230,2,21039,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf","2002-10-02 00:00:00",
26566,1,21039,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf","2002-10-02 00:00:00",
4136,1,21039,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf","2002-10-02 00:00:00",
35959,2,21039,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf","2002-10-02 00:00:00",
4137,1,21039,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21007slr016,21039slr016ltr.pdf","2004-03-02 00:00:00",
14231,2,21039,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf","2004-04-05 00:00:00",
26567,1,21039,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021039s017ltr.pdf","2005-11-18 00:00:00",
35960,2,21039,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021039s017lbl.pdf","2005-11-08 00:00:00",
4138,1,21040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21040LTR.PDF","1999-10-22 00:00:00",
4139,1,21040,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf","2003-12-23 00:00:00",
14232,2,21040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF","1999-10-22 00:00:00",
14233,2,21040,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf","2004-02-10 00:00:00",
21371,3,21040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021040_s000_OrthoPrefestTOC.cfm","2005-08-02 00:00:00",
26568,1,21040,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf","2003-12-23 00:00:00",
35961,2,21040,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf","2004-02-10 00:00:00",
26569,1,21040,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf","2003-12-23 00:00:00",
35962,2,21040,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf","2004-02-10 00:00:00",
4140,1,21040,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf","2003-12-23 00:00:00",
35963,2,21040,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf","2004-02-10 00:00:00",
4141,1,21040,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf","2003-12-23 00:00:00",
14234,2,21040,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf","2004-02-10 00:00:00",
4142,1,21040,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr010ltr.pdf","2004-06-10 00:00:00",
26570,1,21040,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21040s012ltr.pdf","2004-07-21 00:00:00",
35964,2,21040,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21040s012lbl.pdf","2004-07-21 00:00:00",
50281,2,21040,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021040s013lbl.pdf","2017-11-03 00:00:00",
21372,3,21041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-041_DepoCyt.cfm","2002-07-05 00:00:00",
26571,1,21041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21041ltr.pdf","1999-04-01 00:00:00",
35965,2,21041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21041lbl.pdf","1999-04-01 00:00:00",
26572,1,21041,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21041scp008,010ltr.pdf","2003-10-09 00:00:00",
4143,1,21041,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21041scp008,010ltr.pdf","2003-10-09 00:00:00",
26573,1,21041,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021041s018_LTR.pdf","2007-04-25 00:00:00",
35966,2,21041,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021041s018lbl.pdf","2007-04-20 00:00:00",
26574,1,21041,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021041s023ltr.pdf","2011-08-16 00:00:00",
35967,2,21041,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021041s023lbl.pdf","2011-08-11 00:00:00",
4144,1,21041,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021041Orig1s031ltr.pdf","2014-12-30 00:00:00",
35968,2,21041,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021041s031lbl.pdf","2015-01-09 00:00:00",
4145,1,21042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21042ltr.pdf","1999-05-20 00:00:00",
14235,2,21042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf","1999-05-20 00:00:00",
41892,3,21042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm","1999-05-20 00:00:00",
41893,3,21042,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S001_VIOXX.pdf","2008-08-04 00:00:00",
44089,10,21042,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2004-09-30 00:00:00",
44468,14,21042,"ORIG",1,"FDA Public Health Advisory","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm","2004-09-30 00:00:00",
52171,60,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib DD.pdf","1900-01-01 00:00:00",
52172,60,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib dd 2.pdf","1900-01-01 00:00:00",
52173,57,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib CDTL.pdf","1900-01-01 00:00:00",
52174,18,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib_Vioxx-ClinPharmRev-21042s026_21052s019.pdf","1900-01-01 00:00:00",
52175,18,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib clinpharm (2).pdf","1900-01-01 00:00:00",
52176,17,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib_Vioxx-StatsRev-21042s026_21052s019.pdf","1900-01-01 00:00:00",
52177,23,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021042, 021052_rofecoxib_Vioxx_5-7-01.pdf","1900-01-01 00:00:00",
52178,25,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021042, 021052_rofecoxib_Vioxx_12-6-01_HFD550_amend.pdf","1900-01-01 00:00:00",
52179,26,21042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021042, 021052_rofecoxib_Vioxx_5-14-03_HFD550_amend2.pdf","1900-01-01 00:00:00",
41894,3,21042,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_S002_VIOXX.pdf","2008-08-04 00:00:00",
21373,3,21042,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S004_VIOXX.pdf","2008-08-04 00:00:00",
4146,1,21042,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14236,2,21042,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
21374,3,21042,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21375,3,21042,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
26575,1,21042,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
35969,2,21042,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
4147,1,21042,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14237,2,21042,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
41895,3,21042,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21376,3,21042,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
26576,1,21042,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
35970,2,21042,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
21377,3,21042,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021042_S011_VIOXX.pdf","2008-08-04 00:00:00",
4148,1,21042,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14238,2,21042,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
41896,3,21042,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21378,3,21042,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
26577,1,21042,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
35971,2,21042,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.htm","2002-04-11 00:00:00",
4149,1,21042,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14239,2,21042,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
41897,3,21042,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21379,3,21042,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S015_VIOXX.pdf","2008-08-01 00:00:00",
21380,3,21042,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S016_VIOXX.pdf","2008-08-01 00:00:00",
21381,3,21042,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_VioxxTOC.cfm","2006-06-01 00:00:00",
4150,1,21042,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-018,21052se8-012ltr.pdf","2003-08-15 00:00:00",
14240,2,21042,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf","2003-08-15 00:00:00",
26578,1,21042,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
41898,3,21042,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
4151,1,21042,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
21382,3,21042,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
26579,1,21042,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
41899,3,21042,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
21383,3,21042,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s023_VioxxtmTOC.cfm","2006-06-01 00:00:00",
26580,1,21042,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042slr023ltr.pdf","2003-12-19 00:00:00",
21384,3,21042,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_VioxxtmTOC.cfm","2006-06-01 00:00:00",
26581,1,21042,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr024ltr.pdf","2003-12-19 00:00:00",
4152,1,21042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf","2004-08-25 00:00:00",
14241,2,21042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf","2004-08-19 00:00:00",
21385,3,21042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S026_VIOXX.pdf","2008-07-31 00:00:00",
52170,20,21042,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/rofecoxib_Vioxx-MedRev-21042s026_21052s019.pdf","1900-01-01 00:00:00",
21386,3,21042,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S028_VIOXX.pdf","2008-07-31 00:00:00",
26582,1,21042,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr.pdf","2004-09-16 00:00:00",
4153,1,21042,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052Orig1s024ltr.pdf","2016-05-11 00:00:00",
14242,2,21042,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf","2016-05-11 00:00:00",
26583,1,21043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21043ltr.pdf","2000-03-07 00:00:00",
35972,2,21043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21043lbl.pdf","2000-03-07 00:00:00",
41900,3,21043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-043_RID.cfm","2004-06-16 00:00:00",
26584,1,21043,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21043s005ltr.pdf","2004-12-30 00:00:00",
4154,1,21043,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021043s006LTR.pdf","2006-05-30 00:00:00",
23619,10,21044,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129288.htm","2005-04-15 00:00:00",
26585,1,21044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21044ltr.pdf","2004-09-27 00:00:00",
35973,2,21044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021044lbl.pdf","2004-09-24 00:00:00",
41901,3,21044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021044s000_PalladoneTOC.cfm","2005-11-30 00:00:00",
43697,8,21044,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf","2009-11-20 00:00:00",
14243,2,21044,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf","2014-04-16 00:00:00",
26586,1,21044,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021044Orig1s013ltr.pdf","2014-04-17 00:00:00",
14244,2,21045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21045lbl.pdf","1999-07-28 00:00:00",
26587,1,21045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_Plan%20B_Approv.pdf","1999-07-28 00:00:00",
41902,3,21045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_PlanB.cfm","1999-07-28 00:00:00",
44090,10,21045,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109775.htm","2006-08-23 00:00:00",
4155,1,21045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021045s011ltr.pdf","2006-08-24 00:00:00",
21387,3,21045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s11_planb.cfm","2006-08-29 00:00:00",
35974,2,21045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021045s011lbl.pdf","2006-08-24 00:00:00",
4156,1,21045,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021045s015ltr.pdf","2009-11-20 00:00:00",
35975,2,21045,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021045s015lbl.pdf","2009-08-14 00:00:00",
49883,2,21045,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021045s016lbl.pdf","2017-09-29 00:00:00",
49897,1,21045,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021045Orig1s016ltr.pdf","2017-09-29 00:00:00",
53863,1,21045,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021045Orig1s017ltr.pdf","2018-04-27 00:00:00",
54006,2,21045,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021045Orig1s017lbl.pdf","2018-05-03 00:00:00",
21388,3,21046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-046_Celexa.pdf","1999-12-22 00:00:00",
26588,1,21046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21046ltr.pdf","1999-12-22 00:00:00",
43698,8,21046,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf","2009-11-16 00:00:00",
44091,10,21046,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm053339.htm","2016-04-11 00:00:00",
4157,1,21046,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf","2002-11-19 00:00:00",
4158,1,21046,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf","2004-04-20 00:00:00",
4159,1,21046,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf","2004-05-26 00:00:00",
4160,1,21046,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf","2005-02-23 00:00:00",
26589,1,21046,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf","2007-08-07 00:00:00",
35976,2,21046,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021046s013lbl.pdf","2007-08-03 00:00:00",
26590,1,21046,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf","2008-09-19 00:00:00",
35977,2,21046,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf","2008-09-19 00:00:00",
14245,2,21046,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf","2009-02-04 00:00:00",
26591,1,21046,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf","2009-02-03 00:00:00",
4161,1,21046,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf","2011-08-17 00:00:00",
21389,3,21046,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf","2011-10-11 00:00:00",
35978,2,21046,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf","2011-08-16 00:00:00",
4162,1,21046,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf","2011-08-17 00:00:00",
35979,2,21046,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf","2011-08-16 00:00:00",
41903,3,21046,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf","2011-10-11 00:00:00",
4163,1,21046,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf","2012-03-29 00:00:00",
35980,2,21046,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf","2012-03-29 00:00:00",
41904,3,21046,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021046Orig1s019.pdf","2013-09-11 00:00:00",
4164,1,21046,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf","2012-12-05 00:00:00",
14246,2,21046,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf","2012-12-03 00:00:00",
21390,3,21047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-047_Repronex.cfm","2004-08-09 00:00:00",
26592,1,21047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21047ltr.pdf","1999-08-27 00:00:00",
35981,2,21047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21047lbl.pdf","1999-08-27 00:00:00",
41905,3,21047,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-047S001.pdf","2004-08-10 00:00:00",
14247,2,21048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21048lbl.pdf","1999-09-20 00:00:00",
26593,1,21048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21048ltr.pdf","1999-09-20 00:00:00",
41906,3,21048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021048s000_EstradiolTOC.cfm","2006-01-03 00:00:00",
23620,10,21052,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2004-09-30 00:00:00",
26594,1,21052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_appltr.pdf","1999-05-20 00:00:00",
35982,2,21052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_prntlbl.pdf","1999-05-20 00:00:00",
41907,3,21052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm","1999-05-20 00:00:00",
44469,14,21052,"ORIG",1,"FDA Public Health Advisory","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm","2004-09-30 00:00:00",
4165,1,21052,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14248,2,21052,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
21391,3,21052,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21392,3,21052,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
26595,1,21052,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
35983,2,21052,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
4166,1,21052,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
14249,2,21052,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
41908,3,21052,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
21393,3,21052,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2002-04-11 00:00:00",
26596,1,21052,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2002-04-11 00:00:00",
35984,2,21052,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2002-04-11 00:00:00",
4167,1,21052,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2004-06-30 00:00:00",
14250,2,21052,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2004-06-30 00:00:00",
41909,3,21052,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2004-06-30 00:00:00",
14251,2,21052,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf","2004-06-30 00:00:00",
21394,3,21052,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm","2004-06-30 00:00:00",
26597,1,21052,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf","2004-06-30 00:00:00",
21395,3,21052,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021052_S010_VIOXX.pdf","2008-08-01 00:00:00",
41910,3,21052,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_VioxxTOC.cfm","2006-06-01 00:00:00",
4168,1,21052,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-018,21052se8-012ltr.pdf","2003-08-15 00:00:00",
35985,2,21052,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf","2003-08-15 00:00:00",
21396,3,21052,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
26598,1,21052,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
4169,1,21052,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
41911,3,21052,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
4170,1,21052,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf","2003-07-06 00:00:00",
41912,3,21052,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm","2006-06-01 00:00:00",
26599,1,21052,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr024ltr.pdf","2003-12-19 00:00:00",
41913,3,21052,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_VioxxtmTOC.cfm","2006-06-01 00:00:00",
26600,1,21052,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf","2004-08-25 00:00:00",
35986,2,21052,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf","2004-08-19 00:00:00",
41914,3,21052,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021052_S019_VIOXX.pdf","2008-07-31 00:00:00",
4171,1,21052,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr.pdf","2004-09-16 00:00:00",
21397,3,21052,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021052_S021_VIOXX.pdf","2008-07-31 00:00:00",
4172,1,21052,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052Orig1s024ltr.pdf","2016-05-11 00:00:00",
14252,2,21052,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf","2016-05-11 00:00:00",
4173,1,21055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21055ltr.pdf","1999-12-29 00:00:00",
35987,2,21055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21055lbl.pdf","1999-12-29 00:00:00",
41915,3,21055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21055_Targretin.cfm","2002-04-11 00:00:00",
26601,1,21055,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21055slr002,003ltr.pdf","2003-05-29 00:00:00",
35988,2,21055,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf","2003-04-28 00:00:00",
4174,1,21055,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21055slr002,003ltr.pdf","2003-05-29 00:00:00",
14253,2,21055,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf","2003-04-28 00:00:00",
4175,1,21055,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021055s006ltr.pdf","2011-05-19 00:00:00",
35989,2,21055,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021055s006lbl.pdf","2011-05-18 00:00:00",
14254,2,21055,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021055s008lbl.pdf","2014-03-26 00:00:00",
26602,1,21055,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021055s008ltr.pdf","2012-01-09 00:00:00",
14255,2,21055,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021055s010lbl.pdf","2015-08-04 00:00:00",
26603,1,21055,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021055Orig1s010ltr.pdf","2015-07-30 00:00:00",
4176,1,21056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21056ltr.pdf","2000-06-28 00:00:00",
21398,3,21056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-056_Targretin.cfm","2001-07-12 00:00:00",
35990,2,21056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21056lbl.pdf","2000-06-28 00:00:00",
4177,1,21056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021056s003ltr.pdf","2011-04-13 00:00:00",
14256,2,21056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf","2011-04-11 00:00:00",
4178,1,21057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21057ltr.pdf","1999-07-29 00:00:00",
14257,2,21057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf","1999-07-29 00:00:00",
21399,3,21057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21057_Antagon.cfm","2004-05-27 00:00:00",
4179,1,21057,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021057s007ltr.pdf","2008-07-02 00:00:00",
14258,2,21057,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf","2008-06-30 00:00:00",
4180,1,21057,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021057Orig1s010ltr.pdf","2014-12-23 00:00:00",
14259,2,21057,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf","2015-01-09 00:00:00",
4181,1,21060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021060ltr.pdf","2004-12-29 00:00:00",
21400,3,21060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-060_Prialt.cfm","2005-04-27 00:00:00",
26604,1,21060,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021060s001ltr.pdf","2005-05-27 00:00:00",
35991,2,21060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021060lbl.pdf","2004-12-29 00:00:00",
41916,3,21060,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021060_S001_PRIALT.pdf","2007-07-20 00:00:00",
14260,2,21060,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf","2007-04-20 00:00:00",
26605,1,21060,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021060s003_LTR.pdf","2007-04-25 00:00:00",
14261,2,21060,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf","2011-09-02 00:00:00",
26606,1,21060,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021060s006ltr.pdf","2011-09-06 00:00:00",
14262,2,21064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf","2001-07-31 00:00:00",
23621,10,21064,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110260.htm","2003-11-20 00:00:00",
26607,1,21064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_Approv.pdf","2001-07-31 00:00:00",
26608,1,21064,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064s1ltr.pdf","2002-02-21 00:00:00",
41917,3,21064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity.cfm","2001-07-31 00:00:00",
4182,1,21064,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064slr002ltr.pdf","2002-07-08 00:00:00",
4183,1,21064,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21064scm004ltr.pdf","2004-06-02 00:00:00",
14263,2,21064,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf","2007-10-04 00:00:00",
4184,1,21064,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021064s007ltr.pdf","2007-10-15 00:00:00",
14264,2,21064,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf","2007-10-10 00:00:00",
4185,1,21064,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021064s009ltr.pdf","2008-05-14 00:00:00",
14265,2,21064,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf","2008-06-05 00:00:00",
14266,2,21064,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf","2011-10-25 00:00:00",
21401,3,21064,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011TOC.cfm","2012-08-14 00:00:00",
26609,1,21064,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021064s011ltr.pdf","2011-10-26 00:00:00",
44635,21,21064,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011SumR.pdf","2012-08-14 00:00:00",
14267,2,21064,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf","2015-08-19 00:00:00",
26610,1,21064,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021064Orig1s017ltr.pdf","2015-08-20 00:00:00",
46938,1,21064,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021064Orig1s020ltr.pdf","2017-01-24 00:00:00",
46939,2,21064,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021064s020lbl.pdf","2017-01-24 00:00:00",
4186,1,21065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21065LTR.PDF","1999-10-15 00:00:00",
14268,2,21065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF","1999-10-15 00:00:00",
23065,6,21065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLPATIENT.PDF","1999-10-15 00:00:00",
41918,3,21065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21065_Femhrt.cfm","1999-10-15 00:00:00",
26611,1,21065,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21065slr009ltr.pdf","2004-01-22 00:00:00",
35992,2,21065,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf","2004-01-22 00:00:00",
14269,2,21065,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf","2005-01-21 00:00:00",
26612,1,21065,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21065s012ltr.pdf","2005-01-21 00:00:00",
4187,1,21065,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021065Orig1s020ltr.pdf","2014-01-10 00:00:00",
35993,2,21065,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf","2014-01-10 00:00:00",
50277,2,21065,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021065s024lbl.pdf","2017-11-02 00:00:00",
14270,2,21066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf","1999-07-02 00:00:00",
21402,3,21066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-066_Zaditor.cfm","1999-07-02 00:00:00",
21403,3,21066,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021066Orig1s001.pdf","2011-12-16 00:00:00",
26613,1,21066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21066ltr.pdf","1999-07-02 00:00:00",
35994,2,21066,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21066s4lbl.pdf","2001-07-20 00:00:00",
26614,1,21066,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021066s011ltr.pdf","2006-10-23 00:00:00",
35995,2,21066,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021066s011lbl.pdf","2006-10-23 00:00:00",
26615,1,21066,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021066s013ltr.pdf","2008-07-14 00:00:00",
26616,1,21066,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021066s018ltr.pdf","2012-05-08 00:00:00",
35996,2,21066,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021066Orig1s018lbl.pdf","2015-04-21 00:00:00",
26617,1,21067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21067ltr.pdf","2005-03-31 00:00:00",
35997,2,21067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf","2005-03-31 00:00:00",
41919,3,21067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021067s000_AsmanexTOC.cfm","2006-07-05 00:00:00",
53335,20,21067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021067s003_Mometasone_Clinical_PREA.pdf","1900-01-01 00:00:00",
53336,18,21067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021067s003_Mometasone_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53337,17,21067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021067s003_Mometasone_Statistical_PREA.pdf","1900-01-01 00:00:00",
53338,17,21067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021067s003_Mometasone_Statistical2_PREA.pdf","1900-01-01 00:00:00",
14271,2,21067,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf","2010-09-02 00:00:00",
26618,1,21067,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf","2010-09-02 00:00:00",
4188,1,21067,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s007ltr.pdf","2008-02-29 00:00:00",
14272,2,21067,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf","2010-09-20 00:00:00",
26619,1,21067,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021067s013ltr.pdf","2010-09-21 00:00:00",
53458,2,21067,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf","2018-03-27 00:00:00",
53511,1,21067,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021067Orig1s026s028ltr.pdf","2018-03-29 00:00:00",
53459,2,21067,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf","2018-03-27 00:00:00",
53512,1,21067,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021067Orig1s026s028ltr.pdf","2018-03-29 00:00:00",
14273,2,21068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf","1998-11-20 00:00:00",
26620,1,21068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21068ltr.pdf","1998-11-20 00:00:00",
26621,1,21068,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf","2002-04-17 00:00:00",
41920,3,21068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021068.cfm","1998-11-20 00:00:00",
26622,1,21068,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf","2004-07-08 00:00:00",
21404,3,21071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia.cfm","2004-05-27 00:00:00",
21405,3,21071,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia.cfm","2004-05-27 00:00:00",
26623,1,21071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21071ltr.pdf","1999-05-25 00:00:00",
26624,1,21071,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21071S1LTR.PDF","2000-04-04 00:00:00",
35998,2,21071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf","1999-05-25 00:00:00",
35999,2,21071,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf","2000-04-04 00:00:00",
44092,10,21071,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2008-02-21 00:00:00",
21406,3,21071,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021071_S004_AVANDIA.pdf","2007-07-27 00:00:00",
26625,1,21071,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21071se1-004ltr.pdf","2003-03-10 00:00:00",
36000,2,21071,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf","2003-02-27 00:00:00",
4189,1,21071,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21071slr008ltr.pdf","2002-12-03 00:00:00",
4190,1,21071,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf","2004-05-26 00:00:00",
4191,1,21071,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s010ltr.pdf","2005-05-17 00:00:00",
14274,2,21071,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf","2005-05-17 00:00:00",
14275,2,21071,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf","2005-03-03 00:00:00",
26626,1,21071,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s012ltr.pdf","2005-03-03 00:00:00",
4192,1,21071,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf","2005-01-11 00:00:00",
14276,2,21071,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf","2005-01-11 00:00:00",
41921,3,21071,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia Tabs.pdf","2009-09-14 00:00:00",
14277,2,21071,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf","2005-08-03 00:00:00",
26627,1,21071,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s015ltr.pdf","2005-08-03 00:00:00",
52180,20,21071,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021071s015_rosiglitazone_Avandia-MedRev.pdf","1900-01-01 00:00:00",
52182,23,21071,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021071s015_rosiglitazone_Avandia_WR.pdf","1900-01-01 00:00:00",
52183,25,21071,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021071s015_rosiglitazone_Avandia_WR_amend.pdf","1900-01-01 00:00:00",
52184,25,21071,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021071s015_rosiglitazone_Avandia_WR_amend.pdf","1900-01-01 00:00:00",
52185,26,21071,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021071s015_rosiglitazone_Avandia_WR_amend2.pdf","1900-01-01 00:00:00",
4193,1,21071,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s016LTR.pdf","2006-04-25 00:00:00",
36001,2,21071,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf","2006-04-25 00:00:00",
14278,2,21071,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf","2006-06-20 00:00:00",
26628,1,21071,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf","2006-06-20 00:00:00",
4194,1,21071,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf","2006-06-20 00:00:00",
36002,2,21071,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf","2006-06-20 00:00:00",
26629,1,21071,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s023ltr.pdf","2007-05-01 00:00:00",
36003,2,21071,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf","2007-04-25 00:00:00",
14279,2,21071,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf","2008-07-14 00:00:00",
26630,1,21071,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s026ltr.pdf","2008-07-14 00:00:00",
4195,1,21071,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s027ltr.pdf","2007-09-25 00:00:00",
14280,2,21071,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf","2007-09-26 00:00:00",
26631,1,21071,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s028LTR.pdf","2007-08-17 00:00:00",
36004,2,21071,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf","2007-08-15 00:00:00",
4196,1,21071,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s029ltr.pdf","2008-01-18 00:00:00",
36005,2,21071,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf","2008-01-18 00:00:00",
4197,1,21071,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s031ltr.pdf","2007-11-19 00:00:00",
36006,2,21071,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf","2007-11-19 00:00:00",
26632,1,21071,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s032ltr.pdf","2008-02-25 00:00:00",
36007,2,21071,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf","2008-02-25 00:00:00",
14281,2,21071,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf","2008-10-31 00:00:00",
26633,1,21071,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s034ltr.pdf","2008-10-21 00:00:00",
4198,1,21071,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf","2011-02-03 00:00:00",
36008,2,21071,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf","2011-02-04 00:00:00",
26634,1,21071,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf","2011-05-24 00:00:00",
36009,2,21071,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf","2011-05-17 00:00:00",
4199,1,21071,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf","2011-11-21 00:00:00",
23221,8,21071,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040MedG.pdf","2011-11-16 00:00:00",
36010,2,21071,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf","2011-11-16 00:00:00",
4200,1,21071,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf","2012-06-04 00:00:00",
14282,2,21071,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf","2012-06-06 00:00:00",
4201,1,21071,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf","2013-01-30 00:00:00",
4202,1,21071,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf","2013-09-19 00:00:00",
26635,1,21071,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf","2014-05-08 00:00:00",
36011,2,21071,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf","2014-05-12 00:00:00",
14283,2,21071,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf","2014-05-12 00:00:00",
26636,1,21071,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf","2014-05-08 00:00:00",
44993,3,21071,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021071Orig1s048.pdf","2014-05-07 00:00:00",
4203,1,21071,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf","2014-05-08 00:00:00",
36012,2,21071,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf","2014-05-12 00:00:00",
26637,1,21071,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf","2015-12-17 00:00:00",
45354,1,21071,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021071Orig1s051ltr.pdf","2016-09-21 00:00:00",
45381,2,21071,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf","2016-09-21 00:00:00",
14284,2,21073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf","1999-07-15 00:00:00",
26638,1,21073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21073ltr.pdf","1999-07-15 00:00:00",
41922,3,21073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021073A_Actos.cfm","2000-06-30 00:00:00",
41923,3,21073,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S001_ACTOS.pdf","2007-09-13 00:00:00",
21407,3,21073,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S002_ACTOS.pdf","2007-09-13 00:00:00",
41924,3,21073,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S003_ACTOS.pdf","2007-09-13 00:00:00",
21408,3,21073,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S004_ACTOS.pdf","2008-02-19 00:00:00",
21409,3,21073,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S005_ACTOS.pdf","2007-09-13 00:00:00",
21410,3,21073,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S006_ACTOS.pdf","2008-02-19 00:00:00",
21411,3,21073,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S007_ACTOS.pdf","2008-02-19 00:00:00",
21412,3,21073,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S008_ACTOS TABLETS.pdf","2007-07-27 00:00:00",
4204,1,21073,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073se8010ltr.pdf","2002-07-12 00:00:00",
21413,3,21073,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S010_Actos Tablets_APPROVAL PACKAGE.pdf","2007-07-09 00:00:00",
36013,2,21073,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf","2002-07-12 00:00:00",
41925,3,21073,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S012_ACTOS TABLETS.pdf","2007-07-27 00:00:00",
21414,3,21073,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S013_ACTOS_TABLETS.pdf","2008-02-19 00:00:00",
21415,3,21073,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S014_ACTOS.pdf","2007-11-19 00:00:00",
41926,3,21073,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S015_ACTOS_TABLETS.pdf","2008-02-19 00:00:00",
4205,1,21073,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073s16ltr.pdf","2002-01-07 00:00:00",
21416,3,21073,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S016_ACTOS.pdf","2007-11-19 00:00:00",
26639,1,21073,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-017ltr.pdf","2003-01-17 00:00:00",
4206,1,21073,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073scp018ltr.pdf","2002-12-03 00:00:00",
4207,1,21073,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-020ltr.pdf","2003-12-04 00:00:00",
36014,2,21073,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf","2003-12-08 00:00:00",
41927,3,21073,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021073_S020_ACTOS TABLETS_AP.pdf","2007-07-06 00:00:00",
14285,2,21073,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf","2003-06-22 00:00:00",
26640,1,21073,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073slr071ltr.pdf","2003-06-22 00:00:00",
4208,1,21073,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s023ltr.pdf","2004-08-05 00:00:00",
14286,2,21073,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf","2004-08-05 00:00:00",
41928,3,21073,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s023_ACTOS TABS.pdf","2008-07-31 00:00:00",
4209,1,21073,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s024ltr.pdf","2004-07-21 00:00:00",
14287,2,21073,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf","2004-07-21 00:00:00",
41929,3,21073,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s024_ACTOS TABS.pdf","2008-07-31 00:00:00",
26641,1,21073,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s026ltr.pdf","2007-03-06 00:00:00",
36015,2,21073,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf","2007-03-07 00:00:00",
4210,1,21073,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s027ltr.pdf","2006-09-18 00:00:00",
36016,2,21073,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf","2006-09-01 00:00:00",
4211,1,21073,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf","2006-11-07 00:00:00",
36017,2,21073,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf","2006-11-06 00:00:00",
26642,1,21073,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf","2006-10-02 00:00:00",
14288,2,21073,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf","2007-09-11 00:00:00",
26643,1,21073,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s030_ltr.pdf","2007-09-11 00:00:00",
4212,1,21073,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s031LTR.pdf","2007-08-17 00:00:00",
36018,2,21073,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf","2007-08-15 00:00:00",
4213,1,21073,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s033ltr.pdf","2008-05-09 00:00:00",
43567,6,21073,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s033PI.pdf","2008-06-12 00:00:00",
26644,1,21073,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s034ltr.pdf","2008-12-18 00:00:00",
36019,2,21073,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf","2009-01-02 00:00:00",
14289,2,21073,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf","2011-02-09 00:00:00",
4214,1,21073,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021073s037ltr.pdf","2009-10-26 00:00:00",
14290,2,21073,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf","2009-09-18 00:00:00",
4215,1,21073,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021073s040ltr.pdf","2010-07-30 00:00:00",
14291,2,21073,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf","2011-08-04 00:00:00",
26645,1,21073,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-05 00:00:00",
4216,1,21073,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-05 00:00:00",
14292,2,21073,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf","2011-08-04 00:00:00",
26646,1,21073,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf","2012-05-22 00:00:00",
4217,1,21073,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021073Orig1s046ltr.pdf","2013-11-14 00:00:00",
36020,2,21073,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf","2013-11-14 00:00:00",
46137,1,21073,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021073Orig1s048ltr.pdf","2016-12-13 00:00:00",
46170,2,21073,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf","2016-12-15 00:00:00",
50863,2,21073,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf","2017-12-26 00:00:00",
50864,8,21073,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35","2017-12-26 00:00:00",
50915,1,21073,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021073Orig1s049ltr.pdf","2017-12-27 00:00:00",
4218,1,21074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21074ltr.pdf","2001-10-02 00:00:00",
14293,2,21074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf","2001-10-02 00:00:00",
21417,3,21074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard.cfm","2004-05-27 00:00:00",
4219,1,21074,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s007ltr.pdf","2012-05-21 00:00:00",
4220,1,21074,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s008ltr.pdf","2012-06-11 00:00:00",
4221,1,21074,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021074Orig1s009ltr.pdf","2013-02-20 00:00:00",
36021,2,21074,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/21074Orig1s009lbl.pdf","2014-01-14 00:00:00",
26647,1,21074,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021074Orig1s010ltr.pdf","2015-11-16 00:00:00",
36022,2,21074,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021074Orig1s010lbl.pdf","2015-11-13 00:00:00",
45838,1,21074,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021074Orig1s011ltr.pdf","2016-11-08 00:00:00",
45899,2,21074,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021074Orig1s011lbl.pdf","2016-11-16 00:00:00",
49697,1,21074,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021074Orig1s012ltr.pdf","2017-09-08 00:00:00",
49704,2,21074,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021074Orig1s012lbl.pdf","2017-09-08 00:00:00",
4222,1,21075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21075ltr.pdf","1999-12-22 00:00:00",
14294,2,21075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21075lbl.pdf","1999-12-22 00:00:00",
21418,3,21075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21075_Nutropin.cfm","1999-12-22 00:00:00",
4223,1,21075,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21075s008ltr.pdf","2004-10-26 00:00:00",
14295,2,21075,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21075s008lbl.pdf","2004-10-26 00:00:00",
4224,1,21076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21076ltr.pdf","1999-11-29 00:00:00",
14296,2,21076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf","1999-11-29 00:00:00",
23622,10,21076,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2005-07-28 00:00:00",
41930,3,21076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve.cfm","2004-05-26 00:00:00",
4225,1,21076,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21076slr007LTR.pdf","2002-07-31 00:00:00",
26648,1,21076,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021076s011ltr.pdf","2006-01-20 00:00:00",
26649,1,21076,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021076s013ltr.pdf","2008-08-06 00:00:00",
26650,1,21076,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021076s014ltr.pdf","2009-04-21 00:00:00",
49756,1,21076,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021076Orig1s015ltr.pdf","2017-09-15 00:00:00",
49821,2,21076,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021076Orig1s015lbl.pdf","2017-09-21 00:00:00",
21419,3,21077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_AdvairDiskus.cfm","2003-08-28 00:00:00",
23623,10,21077,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2005-11-30 00:00:00",
26651,1,21077,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077se1-003ltr.pdf","2003-11-25 00:00:00",
36023,2,21077,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf","2003-12-02 00:00:00",
41931,3,21077,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077Orig1S003.pdf","2007-09-24 00:00:00",
4226,1,21077,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21077slr008ltr.pdf","2002-08-21 00:00:00",
26652,1,21077,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077se5-017ltr.pdf","2004-04-29 00:00:00",
36024,2,21077,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf","2004-05-04 00:00:00",
41932,3,21077,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021077Orig1s017.pdf","2012-10-12 00:00:00",
14297,2,21077,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf","2003-08-15 00:00:00",
21420,3,21077,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_s019_ADVAIR DISKUS.pdf","2008-08-01 00:00:00",
26653,1,21077,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077slr019ltr.pdf","2003-08-15 00:00:00",
26654,1,21077,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf","2004-10-04 00:00:00",
36025,2,21077,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf","2004-10-04 00:00:00",
4227,1,21077,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s026LTR.pdf","2006-10-02 00:00:00",
36026,2,21077,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf","2006-09-28 00:00:00",
14298,2,21077,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf","2007-02-26 00:00:00",
26655,1,21077,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf","2007-03-01 00:00:00",
14299,2,21077,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf","2006-03-03 00:00:00",
26656,1,21077,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf","2006-03-23 00:00:00",
14300,2,21077,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf","2008-05-02 00:00:00",
26657,1,21077,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf","2008-05-01 00:00:00",
44636,21,21077,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021077se2-029_SUMR.pdf","2008-07-16 00:00:00",
4228,1,21077,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021077s036ltr.pdf","2009-04-03 00:00:00",
4229,1,21077,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s041ltr.pdf","2011-01-07 00:00:00",
4230,1,21077,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf","2010-06-29 00:00:00",
14301,2,21077,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf","2010-06-28 00:00:00",
26658,1,21077,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf","2011-05-12 00:00:00",
4231,1,21077,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf","2011-07-05 00:00:00",
26659,1,21077,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf","2012-08-13 00:00:00",
21421,3,21077,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021077Orig1s050.pdf","2013-08-06 00:00:00",
14302,2,21077,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf","2014-04-16 00:00:00",
26660,1,21077,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s051ltr.pdf","2014-04-16 00:00:00",
41933,3,21077,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s051.pdf","2015-11-18 00:00:00",
44994,3,21077,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s052.pdf","2014-06-17 00:00:00",
4232,1,21077,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s053ltr.pdf","2014-11-14 00:00:00",
14303,2,21077,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf","2014-12-20 00:00:00",
4233,1,21077,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021077Orig1s054ltr.pdf","2016-05-02 00:00:00",
14304,2,21077,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf","2016-05-05 00:00:00",
44470,14,21077,"SUPPL",54,"Package Labeling","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077Orig1s054pkglbl.pdf","2016-06-23 00:00:00",
50827,2,21077,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf","2017-12-21 00:00:00",
50881,1,21077,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s056s057ltr.pdf","2017-12-27 00:00:00",
50828,2,21077,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s056s057lbl.pdf","2017-12-21 00:00:00",
50882,1,21077,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s056s057ltr.pdf","2017-12-27 00:00:00",
47458,1,21077,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s058ltr.pdf","2017-03-03 00:00:00",
47493,2,21077,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf","2017-03-08 00:00:00",
4234,1,21078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Approv.pdf","2003-06-16 00:00:00",
21422,3,21078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021078_malarone.cfm","2003-06-16 00:00:00",
21423,3,21078,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s001_MalaroneTOC.cfm","2006-07-10 00:00:00",
26661,1,21078,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078s001ltr.pdf","2002-02-28 00:00:00",
36027,2,21078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Prntlbl.pdf","2003-06-16 00:00:00",
14305,2,21078,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf","2004-09-07 00:00:00",
26662,1,21078,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s002ltr.pdf","2004-09-07 00:00:00",
14306,2,21078,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf","2002-08-02 00:00:00",
26663,1,21078,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078se8-003ltr.pdf","2002-08-02 00:00:00",
41934,3,21078,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s003_MalaroneTOC.cfm","2006-07-10 00:00:00",
21424,3,21078,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s004_MalaroneTOC.cfm","2006-07-10 00:00:00",
41935,3,21078,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021078_s005_MalaroneTOC.cfm","2006-07-10 00:00:00",
26664,1,21078,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21078se5-006ltr.pdf","2003-12-08 00:00:00",
36028,2,21078,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21078se5-006_malarone_lbl.pdf","2003-12-08 00:00:00",
14307,2,21078,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf","2004-12-03 00:00:00",
26665,1,21078,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s007ltr.pdf","2004-12-02 00:00:00",
26666,1,21078,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf","2005-03-03 00:00:00",
36029,2,21078,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf","2005-03-03 00:00:00",
4235,1,21078,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf","2005-03-03 00:00:00",
14308,2,21078,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf","2005-03-03 00:00:00",
4236,1,21078,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021078s012ltr.pdf","2008-01-09 00:00:00",
14309,2,21078,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf","2008-06-12 00:00:00",
26667,1,21078,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s014ltr.pdf","2008-05-09 00:00:00",
4237,1,21078,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s016ltr.pdf","2008-12-29 00:00:00",
36030,2,21078,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s016lbl.pdf","2009-01-02 00:00:00",
26668,1,21078,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021078s017ltr.pdf","2009-11-09 00:00:00",
4238,1,21078,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021078Orig1s022ltr.pdf","2013-03-01 00:00:00",
14310,2,21078,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf","2013-03-01 00:00:00",
4239,1,21079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21079ltr.pdf","1999-09-24 00:00:00",
21425,3,21079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21079_Alamast.pdf","2004-05-26 00:00:00",
36031,2,21079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf","1999-09-24 00:00:00",
26669,1,21079,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf","2005-05-17 00:00:00",
36032,2,21079,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf","2005-05-17 00:00:00",
26670,1,21079,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf","2005-05-17 00:00:00",
36033,2,21079,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf","2005-05-17 00:00:00",
23624,10,21081,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm239389.htm","2011-11-09 00:00:00",
26671,1,21081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21081ltr.pdf","2000-04-20 00:00:00",
36034,2,21081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf","2000-04-20 00:00:00",
41936,3,21081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus.cfm","2002-03-18 00:00:00",
26672,1,21081,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21081se2-005ltr.pdf","2003-05-30 00:00:00",
36035,2,21081,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021081s025lbl.pdf","2003-05-06 00:00:00",
26673,1,21081,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21081s011ltr.pdf","2004-08-11 00:00:00",
36036,2,21081,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21081s011lbl.pdf","2004-08-11 00:00:00",
14311,2,21081,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s014lbl.pdf","2005-02-17 00:00:00",
26674,1,21081,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s014ltr.pdf","2005-02-17 00:00:00",
4240,1,21081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s017ltr.pdf","2005-03-18 00:00:00",
14312,2,21081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s017lbl.pdf","2005-03-18 00:00:00",
21426,3,21081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021081_s017_Lantus.pdf","2009-09-17 00:00:00",
4241,1,21081,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021081s024ltr.pdf","2007-05-01 00:00:00",
14313,2,21081,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf","2007-05-01 00:00:00",
41937,3,21081,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021081Orig1s024.pdf","2013-01-24 00:00:00",
26675,1,21081,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021081s034ltr.pdf","2009-11-09 00:00:00",
36037,2,21081,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021081s034lbl.pdf","2009-09-18 00:00:00",
41938,3,21081,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021081Orig1s034.pdf","2012-11-09 00:00:00",
26676,1,21081,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s055ltr.pdf","2013-05-17 00:00:00",
36038,2,21081,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s055lbl.pdf","2013-05-21 00:00:00",
26677,1,21081,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s057ltr.pdf","2013-10-22 00:00:00",
36039,2,21081,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s057lbl.pdf","2013-10-22 00:00:00",
26678,1,21081,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s062ltr.pdf","2015-02-27 00:00:00",
36040,2,21081,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s062lbl.pdf","2015-03-03 00:00:00",
14314,2,21081,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s063lbl.pdf","2015-07-22 00:00:00",
26679,1,21081,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s063ltr.pdf","2015-07-20 00:00:00",
4242,1,21082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21082ltr.pdf","2001-03-01 00:00:00",
21427,3,21082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-082_Tavist.cfm","2002-08-08 00:00:00",
36041,2,21082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21082lbl.pdf","2001-03-01 00:00:00",
21428,3,21083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A.cfm","1999-09-15 00:00:00",
26680,1,21083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A_Rapamune_appltr.pdf","1999-09-15 00:00:00",
14315,2,21083,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
26681,1,21083,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
4243,1,21083,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-006,21110se1-004ltr.pdf","2003-04-18 00:00:00",
21429,3,21083,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf","2009-09-14 00:00:00",
36042,2,21083,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf","2003-04-11 00:00:00",
26682,1,21083,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
36043,2,21083,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
14316,2,21083,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
26683,1,21083,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
4244,1,21083,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
36044,2,21083,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
14317,2,21083,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
26684,1,21083,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
4245,1,21083,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf","2004-06-14 00:00:00",
36045,2,21083,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf","2003-03-26 00:00:00",
14318,2,21083,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf","2003-10-10 00:00:00",
26685,1,21083,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf","2003-10-09 00:00:00",
26686,1,21083,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf","2004-07-21 00:00:00",
36046,2,21083,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf","2004-07-21 00:00:00",
26687,1,21083,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf","2005-03-14 00:00:00",
36047,2,21083,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf","2005-03-14 00:00:00",
52199,20,21083,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/sirolimus_Rapamune-MedRev-21083s019.pdf","1900-01-01 00:00:00",
52200,18,21083,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/sirolimus_Rapamune clinical pharmacology review 21083s019.pdf","1900-01-01 00:00:00",
52201,17,21083,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/sirolimus_Rapamune-StatsRev-21083s019.pdf","1900-01-01 00:00:00",
52202,23,21083,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21083_sirolimus_Rapamune_09-15-99_HFD590.pdf","1900-01-01 00:00:00",
14319,2,21083,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf","2005-07-07 00:00:00",
26688,1,21083,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf","2005-07-08 00:00:00",
4246,1,21083,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf","2005-07-08 00:00:00",
14320,2,21083,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf","2005-07-07 00:00:00",
26689,1,21083,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf","2005-10-14 00:00:00",
36048,2,21083,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf","2005-10-14 00:00:00",
4247,1,21083,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf","2005-10-14 00:00:00",
14321,2,21083,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf","2005-10-14 00:00:00",
26690,1,21083,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf","2006-06-06 00:00:00",
36049,2,21083,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf","2006-06-06 00:00:00",
4248,1,21083,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf","2006-06-06 00:00:00",
14322,2,21083,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf","2006-06-06 00:00:00",
4249,1,21083,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026, 021110s035_ltr.pdf","2007-01-16 00:00:00",
14323,2,21083,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf","2007-01-16 00:00:00",
36050,2,21083,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf","2006-10-23 00:00:00",
4250,1,21083,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029, 021110s037ltr.pdf","2007-02-12 00:00:00",
4251,1,21083,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021101s038ltr.pdf","2007-01-25 00:00:00",
36051,2,21083,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf","2007-01-16 00:00:00",
4252,1,21083,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf","2007-05-09 00:00:00",
36052,2,21083,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf","2007-05-07 00:00:00",
14324,2,21083,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf","2008-01-18 00:00:00",
26691,1,21083,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_CKD.pdf","2008-01-18 00:00:00",
4253,1,21083,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045ltr.pdf","2007-10-22 00:00:00",
14325,2,21083,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf","2007-10-22 00:00:00",
4254,1,21083,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf","2008-03-07 00:00:00",
36053,2,21083,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s048lbl.pdf","2008-03-07 00:00:00",
14326,2,21083,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s048lbl.pdf","2008-03-07 00:00:00",
26692,1,21083,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf","2008-03-10 00:00:00",
14327,2,21083,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf","2009-02-04 00:00:00",
14328,2,21083,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf","2009-10-01 00:00:00",
26693,1,21083,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050ltr.pdf","2009-11-10 00:00:00",
4255,1,21083,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041ltr.pdf","2009-11-10 00:00:00",
36054,2,21083,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf","2009-10-14 00:00:00",
14329,2,21083,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf","2010-05-03 00:00:00",
26694,1,21083,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf","2010-04-28 00:00:00",
14330,2,21083,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf","2010-05-03 00:00:00",
26695,1,21083,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf","2010-04-28 00:00:00",
4256,1,21083,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf","2010-12-07 00:00:00",
36055,2,21083,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s044s047,021083s044s047lbl.pdf","2010-12-01 00:00:00",
26696,1,21083,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052ltr.pdf","2010-02-01 00:00:00",
36056,2,21083,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf","2010-02-04 00:00:00",
4257,1,21083,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056ltr.pdf","2010-07-08 00:00:00",
14331,2,21083,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf","2010-08-27 00:00:00",
4258,1,21083,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf","2010-12-07 00:00:00",
36057,2,21083,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s044s047,021083s044s047lbl.pdf","2010-12-01 00:00:00",
26697,1,21083,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058ltr.pdf","2010-11-08 00:00:00",
36058,2,21083,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s048lbl.pdf","2010-11-04 00:00:00",
4259,1,21083,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s049,021110s059ltr.pdf","2011-07-13 00:00:00",
4260,1,21083,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060ltr.pdf","2011-06-09 00:00:00",
14332,2,21083,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf","2012-12-14 00:00:00",
26698,1,21083,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110Orig1s065ltr.pdf","2012-12-11 00:00:00",
4261,1,21083,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110Orig1s067ltr.pdf","2013-03-08 00:00:00",
36059,2,21083,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf","2013-03-08 00:00:00",
4262,1,21083,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083Orig1s054ltr.pdf","2013-09-17 00:00:00",
4263,1,21083,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s055,021110Orig1s073ltr.pdf","2015-05-29 00:00:00",
36060,2,21083,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf","2015-06-01 00:00:00",
4264,1,21083,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110Orig1s074ltr.pdf","2015-03-10 00:00:00",
14333,2,21083,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf","2015-03-09 00:00:00",
4265,1,21083,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s058,021110Orig1075ltr.pdf","2015-11-09 00:00:00",
14334,2,21083,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf","2015-11-12 00:00:00",
47992,2,21083,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021083s059,021110s076lbl.pdf","2017-04-12 00:00:00",
54336,1,21083,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s061,021110Orig1s080ltr.pdf","2018-05-24 00:00:00",
54343,2,21083,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf","2018-05-25 00:00:00",
51052,2,21083,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf","2018-01-16 00:00:00",
51055,8,21083,"SUPPL",62,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf#page=41","2018-01-16 00:00:00",
51061,1,21083,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s062, 021110Orig1s081ltr.pdf","2018-01-17 00:00:00",
21430,3,21084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21084_SERPACWA.cfm","2001-10-11 00:00:00",
26699,1,21084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21084ltr.pdf","2000-02-17 00:00:00",
36061,2,21084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21084lbl.pdf","2000-02-17 00:00:00",
26700,1,21085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21085ltr.pdf","1999-12-10 00:00:00",
36062,2,21085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21085lbl.pdf","1999-12-10 00:00:00",
41939,3,21085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-085_Avelox.cfm","2004-05-27 00:00:00",
51385,20,21085,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/13_21085 moxifloxacin clinical prea.pdf","1900-01-01 00:00:00",
51386,18,21085,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/14_21085 moxifloxacin clinpharm prea.pdf","1900-01-01 00:00:00",
51387,17,21085,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/12_21085 moxifloxacin statistical prea.pdf","1900-01-01 00:00:00",
4266,1,21085,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf","2002-06-12 00:00:00",
36063,2,21085,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf","2002-06-12 00:00:00",
26701,1,21085,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf","2002-06-12 00:00:00",
36064,2,21085,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf","2002-06-12 00:00:00",
21431,3,21085,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm","2004-05-27 00:00:00",
26702,1,21085,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_Approv.pdf","2001-04-27 00:00:00",
36065,2,21085,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_prntlbl.pdf","2001-04-27 00:00:00",
26703,1,21085,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-085s012ltr.pdf","2002-05-16 00:00:00",
36066,2,21085,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf","2002-05-16 00:00:00",
26704,1,21085,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
36067,2,21085,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
4267,1,21085,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
14335,2,21085,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
26705,1,21085,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
36068,2,21085,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
26706,1,21085,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf","2003-10-06 00:00:00",
36069,2,21085,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf","2003-10-10 00:00:00",
4268,1,21085,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf","2004-05-26 00:00:00",
14336,2,21085,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf","2004-05-27 00:00:00",
21432,3,21085,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021085_S022_Avelox_Tablets.pdf","2008-02-19 00:00:00",
4269,1,21085,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr023ltr.pdf","2004-03-10 00:00:00",
14337,2,21085,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf","2004-04-05 00:00:00",
4270,1,21085,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr.pdf","2004-07-30 00:00:00",
14338,2,21085,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf","2004-07-30 00:00:00",
4271,1,21085,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf","2005-06-14 00:00:00",
36070,2,21085,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf","2005-06-14 00:00:00",
4272,1,21085,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf","2005-11-30 00:00:00",
14339,2,21085,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf","2005-11-30 00:00:00",
4273,1,21085,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf","2005-11-30 00:00:00",
14340,2,21085,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf","2005-11-30 00:00:00",
4274,1,21085,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021085s036,021277s030ltr.pdf","2007-06-04 00:00:00",
36071,2,21085,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf","2007-06-04 00:00:00",
4275,1,21085,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s038ltr.pdf","2008-02-20 00:00:00",
14341,2,21085,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf","2008-02-25 00:00:00",
26707,1,21085,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf","2008-12-31 00:00:00",
36072,2,21085,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf","2009-01-02 00:00:00",
4276,1,21085,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s040, 021277s034ltr.pdf","2008-10-07 00:00:00",
36073,2,21085,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf","2008-10-09 00:00:00",
4277,1,21085,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035ltr.pdf","2009-06-29 00:00:00",
14342,2,21085,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf","2009-05-15 00:00:00",
26708,1,21085,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf","2009-05-05 00:00:00",
4278,1,21085,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038ltr.pdf","2010-11-02 00:00:00",
14343,2,21085,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s044lbl.pdf","2010-10-25 00:00:00",
14344,2,21085,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf","2009-12-02 00:00:00",
26709,1,21085,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf","2010-01-25 00:00:00",
4279,1,21085,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040ltr.pdf","2010-04-09 00:00:00",
36074,2,21085,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf","2010-03-05 00:00:00",
4280,1,21085,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041ltr.pdf","2011-03-02 00:00:00",
36075,2,21085,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf","2011-03-04 00:00:00",
4281,1,21085,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf","2011-10-20 00:00:00",
14345,2,21085,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf","2011-10-20 00:00:00",
26710,1,21085,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049ltr.pdf","2011-08-08 00:00:00",
14346,2,21085,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf","2011-10-20 00:00:00",
26711,1,21085,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf","2011-10-20 00:00:00",
4282,1,21085,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s055,021277Orig1s052ltr.pdf","2012-08-28 00:00:00",
36076,2,21085,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf","2012-09-11 00:00:00",
26712,1,21085,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277Orig1s053ltr.pdf","2012-12-26 00:00:00",
36077,2,21085,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf","2012-12-21 00:00:00",
14347,2,21085,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf","2013-08-15 00:00:00",
26713,1,21085,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085Orig1s057ltr.pdf","2013-08-16 00:00:00",
26714,1,21085,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277Orig1s055ltr.pdf","2014-11-24 00:00:00",
36078,2,21085,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf","2014-12-03 00:00:00",
26715,1,21085,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277Orig1s056ltr.pdf","2015-05-13 00:00:00",
36079,2,21085,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf","2015-06-05 00:00:00",
45430,2,21085,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf","2016-09-30 00:00:00",
45433,1,21085,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf","2016-09-30 00:00:00",
45431,2,21085,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf","2016-09-30 00:00:00",
45432,1,21085,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf","2016-09-30 00:00:00",
47525,8,21085,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021085s061s062,021277s057s058lbl.pdf#page=33","2017-03-13 00:00:00",
14348,2,21085,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf","2016-07-26 00:00:00",
26716,1,21085,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085Orig1s063ltr.pdf","2016-07-26 00:00:00",
4283,1,21086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21086ltr.pdf","2000-04-06 00:00:00",
21433,3,21086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-086_ZyprexaZydis.cfm","2000-04-06 00:00:00",
36080,2,21086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21086lbl.pdf","2000-04-06 00:00:00",
44093,10,21086,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
4284,1,21086,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf","2006-09-18 00:00:00",
36081,2,21086,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf","2006-08-29 00:00:00",
26717,1,21086,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf","2005-09-15 00:00:00",
4285,1,21086,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf","2006-03-01 00:00:00",
14349,2,21086,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf","2006-02-28 00:00:00",
14350,2,21086,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf","2006-12-04 00:00:00",
26718,1,21086,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf","2006-12-28 00:00:00",
14351,2,21086,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf","2009-03-20 00:00:00",
26719,1,21086,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf","2007-07-10 00:00:00",
36082,2,21086,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf","2007-07-10 00:00:00",
4286,1,21086,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf","2007-07-10 00:00:00",
14352,2,21086,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf","2007-07-10 00:00:00",
26720,1,21086,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf","2008-08-19 00:00:00",
4287,1,21086,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf","2009-11-19 00:00:00",
14353,2,21086,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf","2009-09-17 00:00:00",
4288,1,21086,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf","2010-02-01 00:00:00",
14354,2,21086,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf","2010-01-29 00:00:00",
4289,1,21086,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
36083,2,21086,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
4290,1,21086,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
14355,2,21086,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
4291,1,21086,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf","2010-12-06 00:00:00",
14356,2,21086,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf","2010-12-04 00:00:00",
26721,1,21086,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf","2011-06-27 00:00:00",
36084,2,21086,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf","2011-06-29 00:00:00",
4292,1,21086,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf","2011-06-27 00:00:00",
14357,2,21086,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf","2011-06-29 00:00:00",
26722,1,21086,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf","2014-12-23 00:00:00",
36085,2,21086,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf","2015-01-09 00:00:00",
4293,1,21086,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
14358,2,21086,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf","2013-07-30 00:00:00",
14359,2,21086,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf","2015-07-24 00:00:00",
45533,1,21086,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf","2016-10-14 00:00:00",
45601,2,21086,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf","2016-10-07 00:00:00",
47344,2,21086,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47378,1,21086,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
47345,2,21086,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47379,1,21086,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
53473,2,21086,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf","2018-03-28 00:00:00",
53476,8,21086,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36","2018-03-28 00:00:00",
53523,1,21086,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf","2018-03-29 00:00:00",
21434,3,21087,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S001_TamifluTOC.cfm","2007-06-18 00:00:00",
26723,1,21087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21087LTR.PDF","1999-10-27 00:00:00",
36086,2,21087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf","1999-10-27 00:00:00",
41940,3,21087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu.cfm","2001-05-29 00:00:00",
44094,10,21087,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm","2006-12-13 00:00:00",
52146,20,21087,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021087SLR016_oseltamivir_Tamiflu-MedRev.pdf","1900-01-01 00:00:00",
52148,23,21087,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021087s000_oseltamivir_WR_Amend.pdf","1900-01-01 00:00:00",
4294,1,21087,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21087s2.ltr.pdf","2000-11-17 00:00:00",
21435,3,21087,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-087SE1-002_review.pdf","2004-04-14 00:00:00",
36087,2,21087,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf","2000-11-17 00:00:00",
21436,3,21087,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S003_TamifluTOC.cfm","2007-06-18 00:00:00",
21437,3,21087,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S004_TamifluTOC.cfm","2007-06-18 00:00:00",
14360,2,21087,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf","2001-07-24 00:00:00",
41941,3,21087,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm","2007-06-22 00:00:00",
14361,2,21087,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf","2001-07-24 00:00:00",
21438,3,21087,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm","2007-06-22 00:00:00",
41942,3,21087,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S007_TamifluTOC.cfm","2007-06-22 00:00:00",
36088,2,21087,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s8lbl.pdf","2001-07-24 00:00:00",
41943,3,21087,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm","2007-06-22 00:00:00",
21439,3,21087,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm","2007-06-22 00:00:00",
36089,2,21087,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf","2003-04-22 00:00:00",
21440,3,21087,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm","2007-06-22 00:00:00",
26724,1,21087,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf","2002-04-26 00:00:00",
36090,2,21087,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf","2002-04-26 00:00:00",
21441,3,21087,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S011_TamilfluTOC.cfm","2007-06-22 00:00:00",
41944,3,21087,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S012_TamifluTOC.cfm","2007-06-22 00:00:00",
4295,1,21087,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s013ltr.pdf","2009-11-05 00:00:00",
4296,1,21087,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf","2009-10-16 00:00:00",
26725,1,21087,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s015ltr.pdf","2009-11-05 00:00:00",
14362,2,21087,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf","2004-07-01 00:00:00",
26726,1,21087,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf","2004-07-01 00:00:00",
41945,3,21087,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm","2007-06-22 00:00:00",
26727,1,21087,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s017ltr.pdf","2009-11-05 00:00:00",
26728,1,21087,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf","2009-10-19 00:00:00",
4297,1,21087,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf","2009-10-19 00:00:00",
26729,1,21087,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf","2009-10-19 00:00:00",
4298,1,21087,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s023ltr.pdf","2005-04-28 00:00:00",
36091,2,21087,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s023lbl.pdf","2005-04-28 00:00:00",
26730,1,21087,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf","2009-10-19 00:00:00",
4299,1,21087,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s025ltr.pdf","2005-11-01 00:00:00",
14363,2,21087,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf","2005-11-01 00:00:00",
4300,1,21087,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s026ltr.pdf","2005-08-19 00:00:00",
14364,2,21087,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf","2005-08-19 00:00:00",
4301,1,21087,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s027ltr.pdf","2009-10-19 00:00:00",
26731,1,21087,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf","2009-10-19 00:00:00",
4302,1,21087,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf","2009-10-19 00:00:00",
4303,1,21087,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf","2006-01-18 00:00:00",
14365,2,21087,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf","2006-01-10 00:00:00",
23066,6,21087,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf","2006-01-10 00:00:00",
41946,3,21087,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021087Orig1s030.pdf","2014-07-07 00:00:00",
4304,1,21087,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf","2009-10-19 00:00:00",
14366,2,21087,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf","2006-11-14 00:00:00",
26732,1,21087,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf","2006-11-16 00:00:00",
43568,6,21087,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033ppi.pdf","2006-11-14 00:00:00",
26733,1,21087,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s034ltr.pdf","2009-10-19 00:00:00",
26734,1,21087,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf","2009-10-21 00:00:00",
26735,1,21087,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s036ltr.pdf","2009-10-19 00:00:00",
26736,1,21087,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf","2009-10-21 00:00:00",
26737,1,21087,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf","2009-10-21 00:00:00",
26738,1,21087,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf","2009-10-21 00:00:00",
4305,1,21087,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf","2007-07-05 00:00:00",
21442,3,21087,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021087Orig1s040.pdf","2013-06-03 00:00:00",
36092,2,21087,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf","2007-07-05 00:00:00",
26739,1,21087,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf","2007-10-10 00:00:00",
36093,2,21087,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf","2007-10-10 00:00:00",
26740,1,21087,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf","2008-01-18 00:00:00",
36094,2,21087,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf","2008-01-18 00:00:00",
26741,1,21087,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s043ltr.pdf","2009-10-19 00:00:00",
4306,1,21087,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s044ltr.pdf","2007-12-18 00:00:00",
14367,2,21087,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf","2010-12-16 00:00:00",
26742,1,21087,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf","2010-12-21 00:00:00",
4307,1,21087,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s046ltr.pdf","2009-10-19 00:00:00",
26743,1,21087,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf","2009-04-29 00:00:00",
36095,2,21087,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf","2009-04-29 00:00:00",
4308,1,21087,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf","2010-02-26 00:00:00",
36096,2,21087,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf","2010-03-03 00:00:00",
41947,3,21087,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s048.pdf","2015-07-21 00:00:00",
14368,2,21087,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf","2010-03-03 00:00:00",
26744,1,21087,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf","2010-02-26 00:00:00",
41948,3,21087,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s049.pdf","2015-07-20 00:00:00",
14369,2,21087,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf","2010-11-05 00:00:00",
26745,1,21087,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf","2010-11-10 00:00:00",
4309,1,21087,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf","2011-03-24 00:00:00",
14370,2,21087,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf","2011-03-23 00:00:00",
21443,3,21087,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021087Orig1s056.pdf","2013-06-03 00:00:00",
26746,1,21087,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf","2011-02-09 00:00:00",
36097,2,21087,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s057lbl.pdf","2011-02-07 00:00:00",
14371,2,21087,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf","2012-08-17 00:00:00",
26747,1,21087,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf","2012-08-20 00:00:00",
4310,1,21087,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf","2014-11-28 00:00:00",
36098,2,21087,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf","2014-12-03 00:00:00",
4311,1,21087,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf","2013-01-29 00:00:00",
14372,2,21087,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf","2013-08-12 00:00:00",
44471,14,21087,"SUPPL",61,"Package Labeling","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf","2013-08-12 00:00:00",
4312,1,21087,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf","2012-12-21 00:00:00",
21444,3,21087,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm","2013-04-08 00:00:00",
36099,2,21087,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.pdf","2012-12-21 00:00:00",
44637,21,21087,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf","2012-12-21 00:00:00",
4313,1,21087,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf","2014-06-03 00:00:00",
36100,2,21087,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf","2014-06-03 00:00:00",
14373,2,21087,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf","2014-10-15 00:00:00",
26748,1,21087,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf","2014-10-16 00:00:00",
26749,1,21087,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf","2016-06-22 00:00:00",
36101,2,21087,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf","2016-06-21 00:00:00",
53629,1,21087,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021087Orig1s069,021246Orig1s052ltr.pdf","2018-04-06 00:00:00",
53667,2,21087,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s069,021246s052lbl.pdf","2018-04-13 00:00:00",
21445,3,21088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/02-1088_Vidaur.cfm","2000-03-03 00:00:00",
26750,1,21088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21088ltr.pdf","2000-03-03 00:00:00",
36102,2,21088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21088lbl.pdf","2000-03-03 00:00:00",
44095,10,21088,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
14374,2,21088,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf","2005-09-14 00:00:00",
26751,1,21088,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s007ltr.pdf","2005-09-14 00:00:00",
26752,1,21088,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21088slr015ltr.pdf","2003-08-15 00:00:00",
26753,1,21088,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s022ltr.pdf","2005-09-22 00:00:00",
36103,2,21088,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s022lbl.pdf","2005-09-22 00:00:00",
14375,2,21088,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf","2011-01-20 00:00:00",
26754,1,21088,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021088s025ltr.pdf","2011-01-20 00:00:00",
41949,3,21090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-090_Cyclessa.cfm","2004-05-06 00:00:00",
26755,1,21090,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21090slr003ltr.pdf","2004-02-25 00:00:00",
4314,1,21090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021090s004LTR.pdf","2007-03-31 00:00:00",
14376,2,21090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf","2007-03-31 00:00:00",
49316,2,21090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf","2017-08-10 00:00:00",
49370,1,21090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021090Orig1s008ltr.pdf","2017-08-15 00:00:00",
4315,1,21092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21092ltr.pdf","1999-12-17 00:00:00",
36104,2,21092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21092lbl.pdf","1999-12-17 00:00:00",
41950,3,21092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21092_Helicosol.cfm","1999-12-17 00:00:00",
14377,2,21093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf","2000-09-05 00:00:00",
21446,3,21093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-093_AtacandHCT.cfm","2004-05-27 00:00:00",
26756,1,21093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21093ltr.pdf","2000-09-05 00:00:00",
44096,10,21093,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
4316,1,21093,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21093s004ltr.pdf","2004-12-30 00:00:00",
14378,2,21093,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf","2006-08-18 00:00:00",
26757,1,21093,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021093s006LTR.pdf","2006-08-18 00:00:00",
26758,1,21093,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021093s008ltr.pdf","2008-05-20 00:00:00",
4317,1,21093,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf","2011-03-16 00:00:00",
14379,2,21093,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf","2011-03-11 00:00:00",
4318,1,21093,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021093s013ltr.pdf","2011-06-17 00:00:00",
36105,2,21093,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf","2011-06-16 00:00:00",
4319,1,21093,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021093s015ltr.pdf","2012-04-02 00:00:00",
36106,2,21093,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf","2012-03-29 00:00:00",
4320,1,21093,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021093Orig1s016ltr.pdf","2015-02-10 00:00:00",
14380,2,21093,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf","2015-02-10 00:00:00",
4321,1,21093,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021093Orig1s018ltr.pdf","2013-04-30 00:00:00",
36107,2,21093,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf","2013-04-29 00:00:00",
4322,1,21093,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021093Orig1s019ltr.pdf","2016-02-11 00:00:00",
14381,2,21093,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf","2016-03-04 00:00:00",
4323,1,21097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21097ltr.pdf","2000-09-21 00:00:00",
14382,2,21097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf","2000-09-21 00:00:00",
41951,3,21097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21097_Visicol.cfm","2000-09-21 00:00:00",
43707,8,21097,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134684.pdf","2013-03-19 00:00:00",
44097,10,21097,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103354.htm","2006-10-11 00:00:00",
26759,1,21097,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21097s005ltr.pdf","2002-03-12 00:00:00",
4324,1,21097,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf","2005-02-11 00:00:00",
26760,1,21097,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf","2005-02-11 00:00:00",
26761,1,21097,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021097s010ltr.pdf","2006-04-07 00:00:00",
36108,2,21097,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021097s10lblM.pdf","2006-05-02 00:00:00",
4325,1,21097,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf","2009-03-27 00:00:00",
36109,2,21097,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s013lbl.pdf","2009-03-26 00:00:00",
21447,3,21097,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021097Orig1s014.pdf","2011-10-10 00:00:00",
26762,1,21097,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf","2009-11-25 00:00:00",
36110,2,21097,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf","2009-10-14 00:00:00",
26763,1,21097,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf","2011-12-14 00:00:00",
4326,1,21097,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021097Orig1s016ltr.pdf","2013-03-08 00:00:00",
36111,2,21097,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf","2013-03-08 00:00:00",
4327,1,21098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin_Approv.pdf","2001-05-11 00:00:00",
21448,3,21098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm","2001-05-11 00:00:00",
23625,10,21098,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm","2011-11-16 00:00:00",
36112,2,21098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf","2001-05-11 00:00:00",
4328,1,21098,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-005ltr.pdf","2003-05-30 00:00:00",
14383,2,21098,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf","2003-05-13 00:00:00",
4329,1,21098,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf","2010-04-09 00:00:00",
36113,2,21098,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf","2010-04-19 00:00:00",
4330,1,21098,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf","2012-02-17 00:00:00",
14384,2,21098,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf","2012-02-13 00:00:00",
21449,3,21098,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf","2016-02-03 00:00:00",
26764,1,21098,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf","2012-04-12 00:00:00",
36114,2,21098,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf","2012-04-10 00:00:00",
4331,1,21098,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf","2015-06-03 00:00:00",
14385,2,21098,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf","2015-06-04 00:00:00",
49296,2,21098,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf","2017-08-09 00:00:00",
49372,1,21098,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021098Orig1s028ltr.pdf","2017-08-15 00:00:00",
21450,3,21102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021102_s000_21065_FemhrtTOC.cfm","2006-01-03 00:00:00",
4332,1,21103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21103ltr.pdf","2000-04-11 00:00:00",
14386,2,21103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf","2000-04-11 00:00:00",
21451,3,21103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-103_Activella.cfm","2007-11-06 00:00:00",
14387,2,21105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21105lbl.pdf","2001-06-26 00:00:00",
26765,1,21105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21105ltr.pdf","2001-06-26 00:00:00",
41952,3,21105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-105_Zotrim.cfm","2001-11-07 00:00:00",
21452,3,21106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021106_somavert.cfm","2003-06-25 00:00:00",
26766,1,21106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21106ltr.pdf","2003-03-28 00:00:00",
36115,2,21106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21106_somavert_lbl.pdf","2003-03-25 00:00:00",
26767,1,21106,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021106s015ltr.pdf","2008-08-20 00:00:00",
36116,2,21106,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021106s015lbl.pdf","2008-08-26 00:00:00",
26768,1,21106,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021106s028ltr.pdf","2010-07-23 00:00:00",
36117,2,21106,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021106s028lbl.pdf","2010-07-22 00:00:00",
36118,2,21106,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021106s031lbl.pdf","2012-07-13 00:00:00",
4333,1,21106,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021106Orig1s036ltr.pdf","2013-12-13 00:00:00",
14388,2,21106,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf","2013-12-12 00:00:00",
21453,3,21107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21107a_Lotronex.cfm","2000-08-29 00:00:00",
23988,14,21107,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=29","2010-10-01 00:00:00",
26769,1,21107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21107ltr.pdf","2000-02-09 00:00:00",
36119,2,21107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf","2000-02-09 00:00:00",
41953,3,21107,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S001_LOTRONEX_TABLET.pdf","2007-11-19 00:00:00",
43708,8,21107,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf","2010-09-15 00:00:00",
44098,10,21107,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110450.htm","2003-12-17 00:00:00",
21454,3,21107,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S002_LOTRONEX_TABLET.pdf","2007-11-19 00:00:00",
4334,1,21107,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21107s5ltr.pdf","2002-06-07 00:00:00",
14389,2,21107,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf","2002-06-07 00:00:00",
21455,3,21107,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S005_LOTRONEX_TABLETS.pdf","2007-11-19 00:00:00",
21456,3,21107,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S006_LOTRONEX_TABLETS.pdf","2007-11-19 00:00:00",
26770,1,21107,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107slr007ltr.pdf","2003-03-26 00:00:00",
4335,1,21107,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107scf008ltr.pdf","2003-12-24 00:00:00",
36120,2,21107,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf","2003-12-29 00:00:00",
4336,1,21107,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s010ltr.pdf","2005-02-08 00:00:00",
14390,2,21107,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf","2005-02-04 00:00:00",
4337,1,21107,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s011ltr.pdf","2005-02-23 00:00:00",
14391,2,21107,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf","2005-02-23 00:00:00",
4338,1,21107,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021107s012ltr.pdf","2006-03-23 00:00:00",
14392,2,21107,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf","2006-03-14 00:00:00",
4339,1,21107,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021107s013ltr.pdf","2008-04-09 00:00:00",
36121,2,21107,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf","2008-05-06 00:00:00",
26771,1,21107,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s014ltr.pdf","2010-09-07 00:00:00",
36122,2,21107,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf","2010-10-01 00:00:00",
4340,1,21107,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s016ltr.pdf","2010-09-07 00:00:00",
14393,2,21107,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf","2010-09-07 00:00:00",
26772,1,21107,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021107Orig1s024ltr.pdf","2014-05-12 00:00:00",
4341,1,21107,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021107Orig1s025ltr.pdf","2015-07-27 00:00:00",
26773,1,21107,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s026ltr.pdf","2016-01-11 00:00:00",
48424,3,21107,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021107Orig1s026.pdf","2017-05-17 00:00:00",
14394,2,21107,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf","2016-01-26 00:00:00",
26774,1,21107,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s027ltr.pdf","2016-01-11 00:00:00",
4342,1,21108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21108LTr.PDF","2000-08-31 00:00:00",
4343,1,21108,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21108slr001ltr.pdf","2002-07-14 00:00:00",
14395,2,21108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21108lbl.pdf","2000-08-31 00:00:00",
14396,2,21108,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21108s1lbl.pdf","2004-06-15 00:00:00",
41954,3,21108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-108_Renova.cfm","2004-03-28 00:00:00",
4344,1,21108,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021108Orig1s015ltr.pdf","2014-06-17 00:00:00",
36123,2,21108,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf","2014-06-17 00:00:00",
4345,1,21110,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
21457,3,21110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune.cfm","2001-10-11 00:00:00",
26775,1,21110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21110ltr.pdf","2000-08-25 00:00:00",
36124,2,21110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune_prntlbl.pdf","2000-08-25 00:00:00",
36125,2,21110,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
4346,1,21110,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21110scf003ltr.pdf","2002-08-22 00:00:00",
4347,1,21110,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-006,21110se1-004ltr.pdf","2003-04-18 00:00:00",
14397,2,21110,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf","2003-04-11 00:00:00",
41955,3,21110,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf","2009-09-14 00:00:00",
14398,2,21110,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
26776,1,21110,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
26777,1,21110,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
36126,2,21110,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
4348,1,21110,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
36127,2,21110,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
14399,2,21110,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf","2003-01-23 00:00:00",
26778,1,21110,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf","2003-01-23 00:00:00",
26779,1,21110,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr012,%2021110slr011ltr.pdf","2004-06-14 00:00:00",
36128,2,21110,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021110s011lbl.pdf","2003-01-31 00:00:00",
14400,2,21110,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf","2003-03-21 00:00:00",
26780,1,21110,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf","2003-03-28 00:00:00",
14401,2,21110,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf","2003-03-28 00:00:00",
26781,1,21110,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf","2003-10-02 00:00:00",
36129,2,21110,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf","2003-10-10 00:00:00",
26782,1,21110,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21110scf018ltr.pdf","2004-03-02 00:00:00",
36130,2,21110,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21110scf018_rapamune_lbl.pdf","2004-04-05 00:00:00",
26783,1,21110,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf","2004-07-21 00:00:00",
36131,2,21110,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf","2004-07-21 00:00:00",
26784,1,21110,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf","2005-03-14 00:00:00",
36132,2,21110,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf","2005-03-14 00:00:00",
4349,1,21110,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf","2005-07-08 00:00:00",
36133,2,21110,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf","2005-07-07 00:00:00",
14402,2,21110,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf","2005-07-07 00:00:00",
26785,1,21110,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf","2005-07-08 00:00:00",
26786,1,21110,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf","2005-10-14 00:00:00",
36134,2,21110,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf","2005-10-14 00:00:00",
4350,1,21110,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf","2005-10-14 00:00:00",
14403,2,21110,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf","2005-10-14 00:00:00",
4351,1,21110,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf","2006-06-06 00:00:00",
36135,2,21110,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf","2006-06-06 00:00:00",
14404,2,21110,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf","2006-06-06 00:00:00",
26787,1,21110,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf","2006-06-06 00:00:00",
4352,1,21110,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026, 021110s035_ltr.pdf","2007-01-16 00:00:00",
14405,2,21110,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf","2007-01-16 00:00:00",
14406,2,21110,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf","2006-10-23 00:00:00",
4353,1,21110,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029, 021110s037ltr.pdf","2007-02-12 00:00:00",
14407,2,21110,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf","2007-01-16 00:00:00",
26788,1,21110,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021110s038ltr.pdf","2007-01-25 00:00:00",
26789,1,21110,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf","2007-05-09 00:00:00",
36136,2,21110,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf","2007-05-07 00:00:00",
26790,1,21110,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_CKD.pdf","2008-01-18 00:00:00",
36137,2,21110,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf","2008-01-18 00:00:00",
4354,1,21110,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045ltr.pdf","2007-10-22 00:00:00",
14408,2,21110,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf","2007-10-22 00:00:00",
26791,1,21110,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf","2008-03-07 00:00:00",
4355,1,21110,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf","2008-03-10 00:00:00",
4356,1,21110,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s038,021110s049ltr.pdf","2009-02-03 00:00:00",
36138,2,21110,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf","2009-02-04 00:00:00",
26792,1,21110,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050ltr.pdf","2009-11-10 00:00:00",
36139,2,21110,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf","2009-10-01 00:00:00",
4357,1,21110,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041ltr.pdf","2009-11-10 00:00:00",
14409,2,21110,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf","2009-10-14 00:00:00",
14410,2,21110,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf","2010-02-04 00:00:00",
26793,1,21110,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052ltr.pdf","2010-02-01 00:00:00",
14411,2,21110,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf","2010-05-03 00:00:00",
26794,1,21110,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf","2010-04-28 00:00:00",
4358,1,21110,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf","2010-04-28 00:00:00",
36140,2,21110,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf","2010-05-03 00:00:00",
4359,1,21110,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf","2010-12-07 00:00:00",
36141,2,21110,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s055lbl.pdf","2010-11-23 00:00:00",
4360,1,21110,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056ltr.pdf","2010-07-08 00:00:00",
14412,2,21110,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf","2010-08-27 00:00:00",
4361,1,21110,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf","2010-12-07 00:00:00",
36142,2,21110,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.pdf","2010-11-23 00:00:00",
26795,1,21110,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058ltr.pdf","2010-11-24 00:00:00",
36143,2,21110,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s058lbl.pdf","2010-11-04 00:00:00",
26796,1,21110,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s049,021110s059ltr.pdf","2011-07-13 00:00:00",
4362,1,21110,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060ltr.pdf","2011-06-09 00:00:00",
4363,1,21110,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110Orig1s065ltr.pdf","2012-12-11 00:00:00",
36144,2,21110,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf","2012-12-14 00:00:00",
4364,1,21110,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110Orig1s067ltr.pdf","2013-03-08 00:00:00",
14413,2,21110,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf","2013-03-08 00:00:00",
26797,1,21110,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083Orig1s054ltr.pdf","2013-09-17 00:00:00",
36145,2,21110,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021110s068lbl.pdf","2013-09-17 00:00:00",
14414,2,21110,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf","2015-06-01 00:00:00",
26798,1,21110,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s055,021110Orig1s073ltr.pdf","2015-05-29 00:00:00",
14415,2,21110,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf","2015-03-09 00:00:00",
26799,1,21110,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110Orig1s074ltr.pdf","2015-03-10 00:00:00",
26800,1,21110,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s058,021110Orig1075ltr.pdf","2015-11-09 00:00:00",
36146,2,21110,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf","2015-11-12 00:00:00",
47994,2,21110,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021083s059,021110s076lbl.pdf","2017-04-12 00:00:00",
54335,1,21110,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s061,021110Orig1s080ltr.pdf","2018-05-24 00:00:00",
54344,2,21110,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf","2018-05-25 00:00:00",
54345,8,21110,"SUPPL",80,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf#page=41","2018-05-25 00:00:00",
51053,2,21110,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf","2018-01-16 00:00:00",
51062,1,21110,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021083Orig1s062, 021110Orig1s081ltr.pdf","2018-01-17 00:00:00",
14416,2,21112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.pdf","2002-01-18 00:00:00",
41956,3,21112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-112_Tri-Luma.cfm","2002-03-26 00:00:00",
4365,1,21112,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021112Orig1s006ltr.pdf","2012-12-26 00:00:00",
4366,1,21112,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021112Orig1s006ltr.pdf","2013-01-28 00:00:00",
36147,2,21112,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf","2013-01-22 00:00:00",
14417,2,21112,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf","2014-04-01 00:00:00",
26802,1,21112,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021112Orig1s009ltr.pdf","2014-04-02 00:00:00",
23626,10,21113,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
26803,1,21113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21113ltr.pdf","2002-03-04 00:00:00",
36148,2,21113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm","2002-03-04 00:00:00",
41957,3,21113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.cfm","2002-03-04 00:00:00",
26804,1,21113,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21113s002ltr.pdf","2004-10-04 00:00:00",
4367,1,21113,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021113s004ltr.pdf","2005-11-18 00:00:00",
36149,2,21113,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf","2005-11-18 00:00:00",
4368,1,21113,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021113s006ltr.pdf","2008-10-21 00:00:00",
26805,1,21113,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021113s008ltr.pdf","2009-11-25 00:00:00",
36150,2,21113,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf","2009-08-13 00:00:00",
4369,1,21113,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021113Orig1s012ltr.pdf","2012-10-22 00:00:00",
14418,2,21113,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf","2012-10-22 00:00:00",
4370,1,21113,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021113Orig1s017ltr.pdf","2014-12-05 00:00:00",
14419,2,21113,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf","2014-12-10 00:00:00",
4371,1,21114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/021114_Betaxon_approv.pdf","2004-10-26 00:00:00",
14420,2,21114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21114lbl.pdf","2000-02-29 00:00:00",
41958,3,21114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021114_s000_Betaxon.cfm","2005-06-10 00:00:00",
26806,1,21114,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021114s002LTR.pdf","2006-10-02 00:00:00",
52001,23,21114,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021114_levobetaxolol_Betaxon_10-15-99_HFD550_orig.pdf","1900-01-01 00:00:00",
52002,20,21114,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021114s002_levobetaxolol_Betaxon MedRev.pdf","1900-01-01 00:00:00",
14421,2,21114,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021114s003lbl.pdf","2010-03-09 00:00:00",
26807,1,21114,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021114s003ltr.pdf","2010-03-18 00:00:00",
21458,3,21116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-116_Thyro-Tabs.cfm","2004-08-10 00:00:00",
26808,1,21116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21116ltr.pdf","2002-10-24 00:00:00",
36151,2,21116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21116lbl.pdf","2002-10-24 00:00:00",
4372,1,21116,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021116s006ltr.pdf","2006-03-23 00:00:00",
36152,2,21116,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021116s006lbl.pdf","2006-03-14 00:00:00",
49658,1,21116,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021116Orig1s013ltr.pdf","2017-09-01 00:00:00",
49659,2,21116,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021116s013lbl.pdf","2017-09-01 00:00:00",
26809,1,21116,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021116Orig1s016ltr.pdf","2016-05-24 00:00:00",
26810,1,21117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21117ltr.pdf","2000-01-28 00:00:00",
41959,3,21117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021117_CalciumChloride.cfm","2004-03-08 00:00:00",
26811,1,21117,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21117scs002ltr.pdf","2003-03-26 00:00:00",
55008,1,21117,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021117Orig1s015Ltr.pdf","2018-07-26 00:00:00",
4373,1,21119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21119ltr.pdf","2000-04-12 00:00:00",
14422,2,21119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf","2000-04-12 00:00:00",
14423,2,21119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf","2001-08-22 00:00:00",
21459,3,21119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-119S001_Visudyne.cfm","2001-08-22 00:00:00",
26812,1,21119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21119s1ltr.pdf","2001-08-22 00:00:00",
41960,3,21119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-119_Visudyne.cfm","2000-04-12 00:00:00",
14424,2,21119,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf","2002-04-30 00:00:00",
26813,1,21119,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s003ltr.pdf","2002-04-30 00:00:00",
41961,3,21119,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s003_Visudyne.cfm","2005-03-08 00:00:00",
26814,1,21119,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s004ltr.pdf","2002-05-29 00:00:00",
36153,2,21119,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf","2002-05-29 00:00:00",
41962,3,21119,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s004_Visudyne.cfm","2005-03-08 00:00:00",
4374,1,21119,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119slr005ltr.pdf","2002-12-09 00:00:00",
14425,2,21119,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf","2002-11-25 00:00:00",
26815,1,21119,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf","2004-03-02 00:00:00",
4375,1,21119,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf","2004-03-02 00:00:00",
26816,1,21119,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21119s012ltr.pdf","2005-03-30 00:00:00",
36154,2,21119,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf","2005-03-30 00:00:00",
4376,1,21119,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021119se8-013ltr.pdf","2008-07-01 00:00:00",
14426,2,21119,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf","2008-06-30 00:00:00",
4377,1,21119,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021119s021ltr.pdf","2007-04-09 00:00:00",
14427,2,21119,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf","2007-03-31 00:00:00",
14428,2,21119,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf","2012-06-29 00:00:00",
26817,1,21119,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021119s022ltr.pdf","2012-06-29 00:00:00",
26818,1,21119,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021119Orig1s027ltr.pdf","2016-05-12 00:00:00",
36155,2,21119,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf","2016-05-17 00:00:00",
4378,1,21120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120.pdf_Novantrone_Approv.pdf","2004-06-10 00:00:00",
14429,2,21120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120.pdf_Novantrone_Prntlbl.pdf","2004-06-10 00:00:00",
21460,3,21120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120_Novantrone.cfm","2004-04-12 00:00:00",
23627,10,21120,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm","2008-07-29 00:00:00",
4379,1,21121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21121ltr.pdf","2000-08-01 00:00:00",
14430,2,21121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21121lbl.pdf","2000-08-01 00:00:00",
21461,3,21121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-121_Concerta.cfm","2000-08-01 00:00:00",
44099,10,21121,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
26819,1,21121,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21121s4ltr.pdf","2002-04-01 00:00:00",
41963,3,21121,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021121_S004_CONCERTA_AP.pdf","2007-06-22 00:00:00",
14431,2,21121,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf","2004-11-01 00:00:00",
26820,1,21121,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21121s008ltr.pdf","2004-10-29 00:00:00",
52032,20,21121,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021121s008_methylphenidate_Concerta-MedRev.pdf","1900-01-01 00:00:00",
52033,23,21121,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021121_methylphenidate_Concerta_6-25-03_HFD120_orig.pdf","1900-01-01 00:00:00",
52034,25,21121,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021121_methylphenidate_Concerta_9-2-03_HFD120_amend.pdf","1900-01-01 00:00:00",
52035,18,21121,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021121s008_methylphenidate_Concerta-ClinPharmRev.pdf","1900-01-01 00:00:00",
52036,17,21121,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021121s008_methylphenidate_Concerta-StatsRev.pdf","1900-01-01 00:00:00",
26821,1,21121,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf","2006-09-18 00:00:00",
36156,2,21121,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf","2006-09-12 00:00:00",
26822,1,21121,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf","2006-09-18 00:00:00",
36157,2,21121,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf","2006-09-12 00:00:00",
14432,2,21121,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf","2007-05-07 00:00:00",
26823,1,21121,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021121s014ltr.pdf","2007-05-09 00:00:00",
4380,1,21121,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf","2008-07-01 00:00:00",
14433,2,21121,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf","2008-06-30 00:00:00",
14434,2,21121,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf","2008-06-30 00:00:00",
21462,3,21121,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021121s017.pdf","2011-09-22 00:00:00",
26824,1,21121,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf","2008-07-01 00:00:00",
4381,1,21121,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021121s022ltr.pdf","2010-01-25 00:00:00",
14435,2,21121,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf","2009-11-23 00:00:00",
26825,1,21121,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf","2010-11-30 00:00:00",
36158,2,21121,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf","2010-12-01 00:00:00",
4382,1,21121,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf","2010-11-30 00:00:00",
14436,2,21121,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf","2010-12-01 00:00:00",
14437,2,21121,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf","2013-05-09 00:00:00",
26826,1,21121,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s029ltr.pdf","2013-05-07 00:00:00",
4383,1,21121,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s031ltr.pdf","2013-06-14 00:00:00",
36159,2,21121,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s031lbl.pdf","2013-06-18 00:00:00",
14438,2,21121,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf","2013-12-17 00:00:00",
26827,1,21121,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s032ltr.pdf","2013-12-16 00:00:00",
26828,1,21121,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021121Orig1s035ltr.pdf","2015-04-21 00:00:00",
36160,2,21121,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021121s035lbl.pdf","2015-04-22 00:00:00",
48421,3,21121,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021121Orig1s037.pdf","2017-05-17 00:00:00",
46718,2,21121,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf","2017-01-06 00:00:00",
46793,8,21121,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf#page=30","2017-01-11 00:00:00",
46794,1,21121,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021121Orig1s038ltr.pdf","2017-01-11 00:00:00",
14439,2,21123,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf","2004-05-03 00:00:00",
26829,1,21123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet_Approv.pdf","2001-08-15 00:00:00",
26830,1,21123,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr001ltr.pdf","2004-04-20 00:00:00",
36161,2,21123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21123lbl.pdf","2001-08-15 00:00:00",
41964,3,21123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet.cfm","2001-08-15 00:00:00",
26831,1,21123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021123s003ltr.pdf","2009-11-10 00:00:00",
36162,2,21123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021123s003lbl.pdf","2009-09-17 00:00:00",
4384,1,21123,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021123s005ltr.pdf","2011-06-28 00:00:00",
14440,2,21123,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021123s005lbl.pdf","2011-06-29 00:00:00",
14441,2,21123,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf","2013-10-22 00:00:00",
26832,1,21123,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021123Orig1s008ltr.pdf","2013-10-21 00:00:00",
46271,1,21123,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf","2016-12-20 00:00:00",
46360,2,21123,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf","2016-12-21 00:00:00",
46272,1,21123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf","2016-12-20 00:00:00",
46361,2,21123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf","2016-12-21 00:00:00",
46273,1,21123,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf","2016-12-20 00:00:00",
46362,2,21123,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf","2016-12-21 00:00:00",
49597,2,21123,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf","2017-08-30 00:00:00",
49598,8,21123,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf#page=45","2017-08-30 00:00:00",
49626,1,21123,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021123Orig1s014ltr.pdf","2017-08-30 00:00:00",
55668,1,21123,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021123IOrig1s016s017ltr.pdf","2018-09-28 00:00:00",
55669,1,21123,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021123IOrig1s016s017ltr.pdf","2018-09-28 00:00:00",
4385,1,21124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21124ltr.pdf","2000-03-17 00:00:00",
14442,2,21124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf","2000-03-17 00:00:00",
41965,3,21124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-124_TerbinafineLamisil.cfm","2002-05-15 00:00:00",
26833,1,21124,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021124s007ltr.pdf","2008-07-31 00:00:00",
4386,1,21124,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021124s008ltr.pdf","2009-06-17 00:00:00",
4387,1,21124,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021124s009ltr.pdf","2010-02-22 00:00:00",
4388,1,21124,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021124s011ltr.pdf","2012-03-26 00:00:00",
4389,1,21124,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021124Orig1s013ltr.pdf","2013-11-15 00:00:00",
36163,2,21124,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf","2013-11-19 00:00:00",
4390,1,21127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21127ltr.pdf","2000-05-22 00:00:00",
14443,2,21127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21127lbl.pdf","2000-05-22 00:00:00",
41966,3,21127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21127_Optivar.cfm","2002-05-22 00:00:00",
4391,1,21127,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127s003ltr.pdf","2004-09-03 00:00:00",
4392,1,21127,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf","2004-05-04 00:00:00",
36164,2,21127,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf","2004-05-04 00:00:00",
14444,2,21127,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf","2004-05-04 00:00:00",
26834,1,21127,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf","2004-05-04 00:00:00",
4393,1,21127,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021127s013ltr.pdf","2008-07-08 00:00:00",
14445,2,21127,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021127s013lbl.pdf","2008-07-09 00:00:00",
21463,3,21128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-128_ChildrensMotrin.cfm","2004-03-10 00:00:00",
26835,1,21128,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf","2003-12-23 00:00:00",
4394,1,21128,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s006ltr.pdf","2005-04-28 00:00:00",
26836,1,21128,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s007ltr.pdf","2006-01-19 00:00:00",
26837,1,21128,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021128s009ltr.pdf","2009-05-06 00:00:00",
49901,2,21128,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021228Orig1s010lbl.pdf","2017-10-02 00:00:00",
21464,3,21129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-129_Neurontin.cfm","2004-05-06 00:00:00",
44100,10,21129,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
41967,3,21129,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm","2004-05-06 00:00:00",
26838,1,21129,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf","2002-01-30 00:00:00",
4395,1,21129,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf","2004-06-10 00:00:00",
14446,2,21129,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf","2005-02-23 00:00:00",
26839,1,21129,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf","2005-02-23 00:00:00",
4396,1,21129,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf","2006-05-05 00:00:00",
4397,1,21129,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf","2011-03-07 00:00:00",
36165,2,21129,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf","2011-03-04 00:00:00",
14447,2,21129,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf","2009-04-28 00:00:00",
26840,1,21129,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021129s027ltr.pdf","2009-05-01 00:00:00",
14448,2,21129,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021129s029lbl.pdf","2010-10-11 00:00:00",
26841,1,21129,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf","2010-10-13 00:00:00",
4398,1,21129,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf","2011-08-12 00:00:00",
36166,2,21129,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf","2011-08-11 00:00:00",
4399,1,21129,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
36167,2,21129,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
4400,1,21129,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
14449,2,21129,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
26842,1,21129,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf","2013-05-07 00:00:00",
36168,2,21129,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf","2013-05-09 00:00:00",
4401,1,21129,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf","2014-08-20 00:00:00",
14450,2,21129,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf","2014-08-20 00:00:00",
4402,1,21129,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf","2015-09-17 00:00:00",
14451,2,21129,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf","2015-09-23 00:00:00",
4403,1,21129,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf","2015-04-22 00:00:00",
36169,2,21129,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf","2015-04-27 00:00:00",
47714,2,21129,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf","2017-03-27 00:00:00",
47715,8,21129,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32","2017-03-27 00:00:00",
47752,1,21129,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020235Orig1s062,020882Orig1s045,021129Orig1s044ltr.pdf","2017-03-29 00:00:00",
50103,1,21129,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf","2017-10-19 00:00:00",
50124,2,21129,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf","2017-10-20 00:00:00",
4404,1,21130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf","2000-04-18 00:00:00",
14452,2,21130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf","2000-04-18 00:00:00",
41968,3,21130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm","2000-04-18 00:00:00",
52019,20,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21130 linezolid clinical bpca.pdf","1900-01-01 00:00:00",
52020,23,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/IND 49195, 55618_WR orig.pdf","1900-01-01 00:00:00",
52021,25,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/IND 49195, 55618_WR amend.pdf","1900-01-01 00:00:00",
52022,26,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021130, 021131, 021132_WR amend2.pdf","1900-01-01 00:00:00",
52023,27,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021130, 021131, 021132_WR amend3.pdf","1900-01-01 00:00:00",
52024,28,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021130, 021131, 021132_WR amend4.pdf","1900-01-01 00:00:00",
52025,18,21130,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21130 linezolid clinpharm bpca.pdf","1900-01-01 00:00:00",
14453,2,21130,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf","2003-04-07 00:00:00",
26843,1,21130,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf","2004-07-01 00:00:00",
14454,2,21130,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf","2003-04-07 00:00:00",
26844,1,21130,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf","2004-07-01 00:00:00",
41969,3,21130,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm","2005-06-27 00:00:00",
26845,1,21130,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf","2003-07-28 00:00:00",
26846,1,21130,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf","2004-01-14 00:00:00",
4405,1,21130,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf","2004-06-25 00:00:00",
14455,2,21130,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf","2004-06-25 00:00:00",
26847,1,21130,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf","2005-02-11 00:00:00",
14456,2,21130,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
26848,1,21130,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
26849,1,21130,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
36170,2,21130,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
4406,1,21130,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf","2005-11-08 00:00:00",
4407,1,21130,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf","2007-05-01 00:00:00",
14457,2,21130,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf","2007-05-01 00:00:00",
41970,3,21130,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021130Orig1s012.pdf","2014-07-07 00:00:00",
14458,2,21130,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf","2008-06-26 00:00:00",
26850,1,21130,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
26851,1,21130,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
4408,1,21130,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf","2010-01-26 00:00:00",
14459,2,21130,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf","2009-12-11 00:00:00",
4409,1,21130,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf","2010-07-23 00:00:00",
36171,2,21130,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021130s022lbl.pdf","2010-07-19 00:00:00",
4410,1,21130,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
14460,2,21130,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
4411,1,21130,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
36172,2,21130,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
26852,1,21130,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf","2012-02-15 00:00:00",
36173,2,21130,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021130s028lbl.pdf","2012-02-14 00:00:00",
4412,1,21130,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf","2014-01-28 00:00:00",
36174,2,21130,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf","2014-01-27 00:00:00",
48993,1,21130,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021130Origs034,021131Orig1s028,021132Orig1s033ltr.pdf","2017-07-14 00:00:00",
48994,2,21130,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf","2017-07-14 00:00:00",
14461,2,21130,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf","2015-06-10 00:00:00",
26853,1,21130,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf","2015-06-10 00:00:00",
52264,2,21130,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf","2018-02-02 00:00:00",
52295,1,21130,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021130Orig1s037,021131Orig1s030,021132Orig1s035ltr.pdf","2018-02-02 00:00:00",
4413,1,21131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf","2000-04-18 00:00:00",
14462,2,21131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf","2000-04-18 00:00:00",
21465,3,21131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm","2000-04-18 00:00:00",
26854,1,21131,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf","2004-07-01 00:00:00",
36175,2,21131,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf","2003-04-07 00:00:00",
4414,1,21131,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf","2004-07-01 00:00:00",
36176,2,21131,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf","2003-04-07 00:00:00",
41971,3,21131,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm","2005-07-11 00:00:00",
4415,1,21131,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf","2003-07-28 00:00:00",
26855,1,21131,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf","2004-01-14 00:00:00",
4416,1,21131,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf","2004-06-25 00:00:00",
14463,2,21131,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf","2004-06-25 00:00:00",
26856,1,21131,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf","2005-02-11 00:00:00",
14464,2,21131,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
26857,1,21131,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
26858,1,21131,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
36177,2,21131,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
4417,1,21131,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf","2005-11-08 00:00:00",
4418,1,21131,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf","2007-05-01 00:00:00",
21466,3,21131,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021131Orig1s012.pdf","2014-07-07 00:00:00",
36178,2,21131,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf","2007-05-01 00:00:00",
4419,1,21131,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
36179,2,21131,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf","2008-06-26 00:00:00",
4420,1,21131,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
26859,1,21131,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf","2010-01-26 00:00:00",
36180,2,21131,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf","2009-12-11 00:00:00",
4421,1,21131,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf","2010-07-23 00:00:00",
36181,2,21131,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021131s020lbl.pdf","2010-07-16 00:00:00",
14465,2,21131,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
26860,1,21131,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
4422,1,21131,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
14466,2,21131,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
26861,1,21131,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf","2012-02-15 00:00:00",
36182,2,21131,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021131s024lbl.pdf","2012-02-14 00:00:00",
4423,1,21131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf","2014-01-28 00:00:00",
14467,2,21131,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf","2014-01-27 00:00:00",
48992,1,21131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021130Origs034,021131Orig1s028,021132Orig1s033ltr.pdf","2017-07-14 00:00:00",
48995,2,21131,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf","2017-07-14 00:00:00",
4424,1,21131,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf","2015-06-10 00:00:00",
36183,2,21131,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf","2015-06-10 00:00:00",
52265,2,21131,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf","2018-02-02 00:00:00",
52296,1,21131,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021130Orig1s037,021131Orig1s030,021132Orig1s035ltr.pdf","2018-02-02 00:00:00",
26862,1,21132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf","2000-04-18 00:00:00",
36184,2,21132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf","2000-04-18 00:00:00",
41972,3,21132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm","2000-04-18 00:00:00",
4425,1,21132,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf","2004-07-01 00:00:00",
14468,2,21132,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf","2003-04-07 00:00:00",
14469,2,21132,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf","2003-04-07 00:00:00",
21467,3,21132,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm","2005-07-11 00:00:00",
26863,1,21132,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf","2004-07-01 00:00:00",
26864,1,21132,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf","2003-07-28 00:00:00",
26865,1,21132,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf","2004-01-14 00:00:00",
4426,1,21132,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf","2004-06-25 00:00:00",
14470,2,21132,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf","2004-06-25 00:00:00",
26866,1,21132,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf","2005-02-11 00:00:00",
26867,1,21132,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
36185,2,21132,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
4427,1,21132,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf","2005-05-17 00:00:00",
36186,2,21132,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf","2005-05-17 00:00:00",
4428,1,21132,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf","2005-11-08 00:00:00",
26868,1,21132,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf","2007-05-01 00:00:00",
36187,2,21132,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf","2007-05-01 00:00:00",
41973,3,21132,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021132Orig1s012.pdf","2014-07-07 00:00:00",
26869,1,21132,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
36188,2,21132,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf","2008-06-26 00:00:00",
4429,1,21132,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013, s014,021132s014,s015ltr.pdf","2008-06-24 00:00:00",
26870,1,21132,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf","2010-01-26 00:00:00",
36189,2,21132,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf","2009-12-11 00:00:00",
4430,1,21132,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf","2010-07-23 00:00:00",
36190,2,21132,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021132s021lbl.pdf","2010-07-19 00:00:00",
26871,1,21132,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
36191,2,21132,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
4431,1,21132,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf","2013-05-07 00:00:00",
14471,2,21132,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf","2013-05-09 00:00:00",
4432,1,21132,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf","2012-02-15 00:00:00",
36192,2,21132,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021132s027lbl.pdf","2012-02-14 00:00:00",
26872,1,21132,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf","2014-01-28 00:00:00",
36193,2,21132,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf","2014-01-27 00:00:00",
48991,1,21132,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021130Origs034,021131Orig1s028,021132Orig1s033ltr.pdf","2017-07-14 00:00:00",
48996,2,21132,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf","2017-07-14 00:00:00",
4433,1,21132,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf","2015-06-10 00:00:00",
14472,2,21132,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf","2015-06-10 00:00:00",
52266,2,21132,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf","2018-02-02 00:00:00",
52297,1,21132,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021130Orig1s037,021131Orig1s030,021132Orig1s035ltr.pdf","2018-02-02 00:00:00",
4434,1,21134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21134ltr.pdf","2000-05-01 00:00:00",
21468,3,21134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat.cfm","2000-05-01 00:00:00",
36194,2,21134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21134lbl.pdf","2000-05-01 00:00:00",
4435,1,21134,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021134s004ltr.pdf","2010-07-21 00:00:00",
36195,2,21134,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdf","2010-07-22 00:00:00",
14473,2,21134,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf","2011-07-25 00:00:00",
26873,1,21134,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021134s005ltr.pdf","2011-07-25 00:00:00",
26874,1,21134,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021134Orig1s007ltr_corrected.pdf","2014-03-10 00:00:00",
36196,2,21134,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021134s007lbl.pdf","2014-03-10 00:00:00",
45162,2,21134,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021134s008lbl.pdf","2016-08-29 00:00:00",
45163,1,21134,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021134Orig1s008ltr.pdf","2016-08-29 00:00:00",
47071,1,21134,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021134Orig1s009ltr.pdf","2017-01-31 00:00:00",
48386,2,21134,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021134s009lbl.pdf","2017-05-17 00:00:00",
51907,1,21134,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021134Orig1s010ltr.pdf","2018-01-26 00:00:00",
51910,2,21134,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021134s010lbl.pdf","2018-01-26 00:00:00",
4436,1,21135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21135ltr.pdf","2000-11-13 00:00:00",
21469,3,21135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.cfm","2004-06-29 00:00:00",
36197,2,21135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf","2004-06-29 00:00:00",
4437,1,21135,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-005ltr.pdf","2003-06-08 00:00:00",
14474,2,21135,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf","2003-06-08 00:00:00",
26875,1,21135,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-006ltr.pdf","2003-07-24 00:00:00",
14475,2,21135,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf","2005-06-21 00:00:00",
26876,1,21135,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf","2005-06-21 00:00:00",
41974,3,21135,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf","2008-07-30 00:00:00",
26877,1,21135,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s010ltr.pdf","2005-03-31 00:00:00",
4438,1,21135,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s013ltr.pdf","2005-10-19 00:00:00",
36198,2,21135,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf","2005-10-19 00:00:00",
14476,2,21135,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf","2007-02-21 00:00:00",
26878,1,21135,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021135s017ltr.pdf","2008-01-09 00:00:00",
36199,2,21135,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf","2007-12-14 00:00:00",
14477,2,21135,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf","2011-06-29 00:00:00",
26879,1,21135,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021135s020ltr.pdf","2011-06-28 00:00:00",
14478,2,21135,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf","2013-04-01 00:00:00",
14479,2,21135,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf","2012-09-25 00:00:00",
26880,1,21135,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021135Orig1s024ltr.pdf","2012-09-24 00:00:00",
51210,20,21135,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21135 iron sucrose clinical prea.pdf","1900-01-01 00:00:00",
51211,18,21135,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21135 iron sucrose clinpharm prea.pdf","1900-01-01 00:00:00",
51212,17,21135,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21135 iron sucrose statistical prea.pdf","1900-01-01 00:00:00",
50525,2,21135,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf","2017-11-29 00:00:00",
50554,1,21135,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021135Orig1s032ltr.pdf","2017-12-01 00:00:00",
4439,1,21136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21136ltr.pdf","2004-06-17 00:00:00",
4440,1,21136,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21136se1-001ltr.pdf","2004-06-17 00:00:00",
14480,2,21136,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf","2004-06-17 00:00:00",
36200,2,21136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136lbl.pdf","2004-06-17 00:00:00",
41975,3,21136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-136_21-209_SecreFlo.cfm","2004-08-26 00:00:00",
41976,3,21136,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021136_S001_SECRETFLO_INJ.pdf","2007-09-26 00:00:00",
26881,1,21136,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136scm005ltr.pdf","2004-03-02 00:00:00",
26882,1,21136,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136scf006ltr.pdf","2004-03-02 00:00:00",
41977,3,21136,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021136_S006_SECRETFLO_INJ.pdf","2007-09-26 00:00:00",
26883,1,21136,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136s009ltr.pdf","2004-07-28 00:00:00",
4441,1,21136,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021136s011ltr.pdf","2005-09-15 00:00:00",
45642,2,21136,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf","2016-10-27 00:00:00",
45704,1,21136,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021136Orig1s012,021209Orig1s001ltr.pdf","2016-10-28 00:00:00",
45641,2,21136,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf","2016-10-27 00:00:00",
14481,2,21137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet_Prntlbl.pdf","2004-06-08 00:00:00",
26884,1,21137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21137ltr.pdf","2003-06-08 00:00:00",
41978,3,21137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet.cfm","2004-06-04 00:00:00",
14482,2,21140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_prntlbl.pdf","2000-11-29 00:00:00",
21470,3,21140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium.cfm","2000-01-29 00:00:00",
26885,1,21140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_Approv.pdf","2000-11-29 00:00:00",
4442,1,21140,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21140slr002ltr.pdf","2004-06-07 00:00:00",
36201,2,21140,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21140slr002_imodium_lbl.pdf","2004-06-07 00:00:00",
4443,1,21140,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf","2004-06-16 00:00:00",
21471,3,21140,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021140_S003_IMODIUM_ADVANCED_CAPLETS.pdf","2008-07-31 00:00:00",
26886,1,21140,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020606se8-014, 021140se8-011ltr.pdf","2008-05-05 00:00:00",
44638,21,21140,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-014, 021140se8-011_SUMR.pdf","2008-07-16 00:00:00",
4444,1,21140,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021140s012ltr.pdf","2007-09-25 00:00:00",
36202,2,21140,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021140s012lbl.pdf","2007-09-19 00:00:00",
26887,1,21140,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021140s013ltr.pdf","2008-02-07 00:00:00",
26888,1,21140,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021140s016ltr.pdf","2012-05-08 00:00:00",
4445,1,21140,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021140Orig1s020ltr.pdf","2015-03-19 00:00:00",
36203,2,21140,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021140Orig1s020lbl.pdf","2015-03-24 00:00:00",
48009,2,21140,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021140Orig1s025lbl.pdf","2017-04-13 00:00:00",
48032,1,21140,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021140Orig1s025ltr.pdf","2017-04-14 00:00:00",
4446,1,21141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21176ltr.pdf","2000-05-26 00:00:00",
36204,2,21141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21176lbl.pdf","2000-05-26 00:00:00",
41979,3,21141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol.cfm","2000-05-26 00:00:00",
4447,1,21142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21142ltr.pdf","2000-05-26 00:00:00",
21472,3,21142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-142_Olux.cfm","2004-03-28 00:00:00",
36205,2,21142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21142lbl.pdf","2000-05-26 00:00:00",
26889,1,21142,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142s3ltr.pdf","2002-03-29 00:00:00",
4448,1,21142,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142se1-004ltr.pdf","2002-12-20 00:00:00",
14483,2,21142,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-004_Olux_lbl.pdf","2003-04-07 00:00:00",
4449,1,21142,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scm007ltr.pdf","2003-07-28 00:00:00",
14484,2,21142,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf","2003-12-02 00:00:00",
26890,1,21142,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142slr009ltr.pdf","2003-11-25 00:00:00",
14485,2,21142,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf","2004-01-02 00:00:00",
26891,1,21142,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scs010ltr.pdf","2004-01-02 00:00:00",
26892,1,21142,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021142s012ltr.pdf","2006-07-21 00:00:00",
4450,1,21142,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021142Orig1s019ltr.pdf","2014-04-24 00:00:00",
14486,2,21142,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf","2014-04-25 00:00:00",
53818,2,21142,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021142s022lbl.pdf","2018-04-26 00:00:00",
53871,1,21142,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021142Orig1s022ltr.pdf","2018-04-27 00:00:00",
4451,1,21143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21143ltr.pdf","2000-04-12 00:00:00",
14487,2,21143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf","2000-04-12 00:00:00",
41980,3,21143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21143_Trivagizole3.cfm","2001-07-30 00:00:00",
45065,1,21143,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021143Orig1s012ltr.pdf","2016-08-25 00:00:00",
45178,2,21143,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021143Orig1s012lbl.pdf","2016-08-25 00:00:00",
4452,1,21144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21144ltr.pdf","2004-04-07 00:00:00",
4453,1,21144,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf","2005-02-11 00:00:00",
14488,2,21144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf","2004-04-05 00:00:00",
23628,10,21144,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107824.htm","2004-07-13 00:00:00",
36206,2,21144,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf","2005-02-11 00:00:00",
41981,3,21144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-144_Ketek.cfm","2004-07-08 00:00:00",
43713,8,21144,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf","2009-11-19 00:00:00",
26893,1,21144,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf","2005-02-11 00:00:00",
36207,2,21144,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf","2005-02-11 00:00:00",
26894,1,21144,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021144s004ltr.pdf","2005-11-08 00:00:00",
36208,2,21144,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021144s004lbl.pdf","2005-11-03 00:00:00",
26895,1,21144,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s005ltr.pdf","2005-04-12 00:00:00",
4454,1,21144,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021144s011ltr.pdf","2006-07-03 00:00:00",
14489,2,21144,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf","2006-07-03 00:00:00",
4455,1,21144,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021144s012ltr.pdf","2007-02-23 00:00:00",
14490,2,21144,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf","2007-02-12 00:00:00",
21473,3,21144,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021144Orig1s012Approv.pdf","2012-02-14 00:00:00",
26896,1,21144,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf","2010-12-10 00:00:00",
36209,2,21144,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s013lbl.pdf","2010-12-08 00:00:00",
4456,1,21144,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf","2010-12-10 00:00:00",
14491,2,21144,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf","2010-12-09 00:00:00",
4457,1,21144,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021144s015ltr.pdf","2011-06-29 00:00:00",
26897,1,21144,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s018ltr.pdf","2015-03-27 00:00:00",
36210,2,21144,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s018lbl.pdf","2015-03-27 00:00:00",
4458,1,21144,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s019ltr.pdf","2015-11-09 00:00:00",
14492,2,21144,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf","2015-11-12 00:00:00",
14493,2,21145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf","2000-07-27 00:00:00",
21474,3,21145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21145_Vaniga.cfm","2003-07-08 00:00:00",
26898,1,21145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21145ltr.pdf","2000-07-27 00:00:00",
41982,3,21145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021145_S001_VANIQA CREAM.pdf","2007-09-13 00:00:00",
41983,3,21145,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S002_VANIQA CREAM.pdf","2007-09-13 00:00:00",
21475,3,21145,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S003_VANIQA CREAM.pdf","2007-09-13 00:00:00",
41984,3,21145,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S005_VANIQA CREAM.pdf","2007-09-13 00:00:00",
14494,2,21146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf","2001-07-09 00:00:00",
21476,3,21146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine.cfm","2004-05-27 00:00:00",
26899,1,21146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_Approv.pdf","2001-07-09 00:00:00",
4459,1,21146,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021146Orig1s015ltr.pdf","2015-11-04 00:00:00",
14495,2,21146,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf","2015-11-04 00:00:00",
47069,1,21146,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021146Orig1s016ltr.pdf","2017-01-31 00:00:00",
50259,2,21146,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.pdf","2017-11-02 00:00:00",
4460,1,21148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21148ltr.pdf","2000-06-20 00:00:00",
4461,1,21148,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21148S1ltr.pdf","2001-04-10 00:00:00",
21477,3,21148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-148_Norditropin.cfm","2004-06-14 00:00:00",
36211,2,21148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21148lbl.pdf","2000-06-20 00:00:00",
4462,1,21148,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021148s004ltr.pdf","2005-04-28 00:00:00",
4463,1,21148,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s006ltr.pdf","2004-10-05 00:00:00",
4464,1,21148,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s007ltr.pdf","2004-11-08 00:00:00",
14496,2,21148,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021148s013lbl.pdf","2006-09-01 00:00:00",
26900,1,21148,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021148s013ltr.pdf","2006-09-18 00:00:00",
4465,1,21148,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s015ltr.pdf","2007-02-23 00:00:00",
36212,2,21148,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s015lbl.pdf","2007-02-21 00:00:00",
4466,1,21148,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s016ltr.pdf","2007-06-04 00:00:00",
36213,2,21148,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s016lbl.pdf","2007-06-04 00:00:00",
4467,1,21148,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s017ltr.pdf","2007-09-25 00:00:00",
36214,2,21148,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s017lbl.pdf","2007-09-26 00:00:00",
26901,1,21148,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s018ltr.pdf","2007-09-25 00:00:00",
36215,2,21148,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf","2007-09-19 00:00:00",
26902,1,21148,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021148s023ltr.pdf","2008-11-03 00:00:00",
36216,2,21148,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021148s023lbl.pdf","2008-11-07 00:00:00",
14497,2,21148,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021148s025lbl.pdf","2009-03-26 00:00:00",
26903,1,21148,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021148s025ltr.pdf","2009-03-16 00:00:00",
36217,2,21148,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf","2010-03-02 00:00:00",
4468,1,21148,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021148s035ltr.pdf","2011-05-26 00:00:00",
14498,2,21148,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021148s035lbl.pdf","2011-05-25 00:00:00",
52712,2,21148,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf","2018-02-26 00:00:00",
52720,1,21148,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021148Orig1s037s038ltr.pdf","2018-02-26 00:00:00",
52713,2,21148,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf","2018-02-26 00:00:00",
52721,1,21148,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021148Orig1s037s038ltr.pdf","2018-02-26 00:00:00",
26904,1,21148,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021148Orig1s039ltr.pdf","2013-10-15 00:00:00",
36218,2,21148,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf","2013-10-14 00:00:00",
14499,2,21148,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021148s041lbl.pdf","2014-09-30 00:00:00",
26905,1,21148,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021148Orig1s041ltr.pdf","2014-09-29 00:00:00",
4469,1,21148,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s042ltr.pdf","2015-01-26 00:00:00",
36219,2,21148,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s042lbl.pdf","2015-01-29 00:00:00",
4470,1,21148,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s043ltr.pdf","2015-06-15 00:00:00",
14500,2,21148,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf","2015-06-15 00:00:00",
14501,2,21148,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s044lbl.pdf","2015-07-23 00:00:00",
26906,1,21148,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s044ltr.pdf","2015-07-10 00:00:00",
46157,1,21148,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021148Orig1s048ltr.pdf","2016-12-14 00:00:00",
46184,2,21148,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021148s048lbl.pdf","2016-12-14 00:00:00",
49619,2,21148,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021148s049lbl.pdf","2017-08-30 00:00:00",
49635,1,21148,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021148Orig1s049ltr.pdf","2017-08-31 00:00:00",
4471,1,21149,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf","2000-09-20 00:00:00",
14502,2,21149,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf","2000-09-20 00:00:00",
41985,3,21149,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.cfm","2004-12-07 00:00:00",
26907,1,21149,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf","2003-07-28 00:00:00",
14503,2,21149,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf","2007-07-31 00:00:00",
26908,1,21149,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf","2007-07-31 00:00:00",
4472,1,21149,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf","2010-06-08 00:00:00",
14504,2,21149,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf","2010-06-07 00:00:00",
14505,2,21150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf","2001-08-10 00:00:00",
26909,1,21150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21150ltr.pdf","2001-08-10 00:00:00",
41986,3,21150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-150_Zyrtec-D.cfm","2001-08-10 00:00:00",
4473,1,21150,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21150se8-002ltr.pdf","2003-05-29 00:00:00",
14506,2,21150,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf","2003-04-17 00:00:00",
4474,1,21150,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf","2004-03-24 00:00:00",
14507,2,21150,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf","2004-04-05 00:00:00",
21478,3,21150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021150s007TOC.cfm","2008-05-21 00:00:00",
26910,1,21150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/21150s007ltr.pdf","2007-11-13 00:00:00",
4475,1,21151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21151ltr.pdf","2000-02-22 00:00:00",
14508,2,21151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf","2000-02-22 00:00:00",
41987,3,21151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021151_s000_BetapaceAFTOC.cfm","2006-01-11 00:00:00",
26911,1,21151,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs004ltr.pdf","2003-03-26 00:00:00",
4476,1,21151,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs005ltr.pdf","2003-04-18 00:00:00",
4477,1,21151,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s009ltr.pdf","2011-02-09 00:00:00",
14509,2,21151,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf","2011-02-09 00:00:00",
26912,1,21151,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s010ltr.pdf","2011-08-18 00:00:00",
36220,2,21151,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf","2011-08-24 00:00:00",
21479,3,21152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021152s000TOC.cfm","2007-09-10 00:00:00",
26913,1,21152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf","2005-04-06 00:00:00",
4478,1,21152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf","2010-09-08 00:00:00",
14510,2,21152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf","2010-09-07 00:00:00",
4479,1,21152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf","2015-01-20 00:00:00",
14511,2,21152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf","2015-01-20 00:00:00",
51113,20,21152,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152 fluticasone clinical prea.pdf","1900-01-01 00:00:00",
51115,18,21152,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152_cutivate_clinpharm_prea.pdf","1900-01-01 00:00:00",
51116,17,21152,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152_cutivate_statistical_prea.pdf","1900-01-01 00:00:00",
4480,1,21152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf","2011-05-16 00:00:00",
36221,2,21152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf","2011-05-16 00:00:00",
26914,1,21153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium_Approv.pdf","2001-02-20 00:00:00",
36222,2,21153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf","2001-02-20 00:00:00",
41988,3,21153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium.cfm","2001-02-20 00:00:00",
44101,10,21153,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
51721,23,21153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021153_esomeprazole_(Nexium)_Original_WR.pdf","2001-12-31 00:00:00",
51722,25,21153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021153_esomeprazole_(Nexium)_Amendment_3_WR.pdf","2005-12-20 00:00:00",
51723,26,21153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021153_esomeprazole_(Nexium)_Amendment_3_WR.pdf","2005-12-20 00:00:00",
51724,27,21153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021153_esomeprazole_(Nexium)_Amendment_4_WR.pdf","2007-03-29 00:00:00",
51725,28,21153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021153_esomeprazole_(Nexium)_Amendment_5_WR.pdf","2008-10-02 00:00:00",
26915,1,21153,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21153slr004ltr.pdf","2003-03-10 00:00:00",
4481,1,21153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21153slr005ltr.pdf","2002-09-20 00:00:00",
41989,3,21153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-153S005_review.pdf","2004-04-14 00:00:00",
4482,1,21153,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr008ltr.pdf","2004-01-14 00:00:00",
36223,2,21153,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf","2004-01-15 00:00:00",
41990,3,21153,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153Orig1s008.pdf","2012-10-12 00:00:00",
14512,2,21153,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf","2004-05-04 00:00:00",
26916,1,21153,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr015ltr.pdf","2004-04-29 00:00:00",
41991,3,21153,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153_S015_NEXIUM_DELAYED_RELEASE.pdf","2008-02-19 00:00:00",
26917,1,21153,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153s019ltr.pdf","2004-12-02 00:00:00",
36224,2,21153,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf","2004-12-03 00:00:00",
4483,1,21153,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021153s020ltr.pdf","2005-06-08 00:00:00",
14513,2,21153,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf","2005-06-08 00:00:00",
14514,2,21153,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf","2006-02-22 00:00:00",
26918,1,21153,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s021ltr.pdf","2006-03-01 00:00:00",
14515,2,21153,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf","2006-05-02 00:00:00",
26919,1,21153,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s022LTR.pdf","2006-05-02 00:00:00",
4484,1,21153,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s023LTR.pdf","2006-10-18 00:00:00",
36225,2,21153,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf","2006-10-13 00:00:00",
4485,1,21153,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s024ltr.pdf","2006-09-20 00:00:00",
14516,2,21153,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf","2006-09-18 00:00:00",
14517,2,21153,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf","2006-09-27 00:00:00",
26920,1,21153,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s025ltr.pdf","2006-10-02 00:00:00",
4486,1,21153,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf","2007-05-01 00:00:00",
36226,2,21153,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf","2007-05-01 00:00:00",
14518,2,21153,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf","2007-05-01 00:00:00",
26921,1,21153,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf","2008-01-18 00:00:00",
14519,2,21153,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf","2009-01-16 00:00:00",
26922,1,21153,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf","2009-01-21 00:00:00",
4487,1,21153,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf","2009-11-25 00:00:00",
36227,2,21153,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf","2009-10-14 00:00:00",
4488,1,21153,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf","2010-03-08 00:00:00",
14520,2,21153,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf","2010-03-05 00:00:00",
4489,1,21153,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf","2011-06-27 00:00:00",
14521,2,21153,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf","2011-06-29 00:00:00",
4490,1,21153,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf","2010-09-09 00:00:00",
36228,2,21153,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf","2010-09-10 00:00:00",
14522,2,21153,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf","2011-07-06 00:00:00",
26923,1,21153,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf","2011-07-06 00:00:00",
14523,2,21153,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf","2012-01-24 00:00:00",
26924,1,21153,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf","2012-01-24 00:00:00",
4491,1,21153,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf","2012-10-11 00:00:00",
14524,2,21153,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf","2012-10-12 00:00:00",
4492,1,21153,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf","2012-10-02 00:00:00",
14525,2,21153,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf","2012-10-01 00:00:00",
14526,2,21153,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf","2012-12-10 00:00:00",
26925,1,21153,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf","2012-11-29 00:00:00",
21480,3,21153,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s045.pdf","2014-08-05 00:00:00",
4493,1,21153,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf","2014-03-28 00:00:00",
36229,2,21153,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf","2014-04-01 00:00:00",
21481,3,21153,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s047.pdf","2014-08-05 00:00:00",
41992,3,21153,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021153Orig1s048.pdf","2014-08-05 00:00:00",
14527,2,21153,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf","2014-03-05 00:00:00",
26926,1,21153,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf","2014-02-27 00:00:00",
26927,1,21153,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf","2014-12-24 00:00:00",
36230,2,21153,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf","2014-12-29 00:00:00",
46480,1,21153,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021957Orig1s018,021153Orig1s051,022101Orig1s015ltr.pdf","2016-12-22 00:00:00",
46488,2,21153,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf","2016-12-21 00:00:00",
45660,1,21153,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf","2016-10-26 00:00:00",
45693,2,21153,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf","2016-10-28 00:00:00",
54498,2,21153,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf","2018-06-11 00:00:00",
54503,8,21153,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33","2018-06-11 00:00:00",
54568,1,21153,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021153Orig1s053,022101Orig1s017,021957Orig1s020ltr.pdf","2018-06-14 00:00:00",
4494,1,21156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf","1999-12-23 00:00:00",
21482,3,21156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm","2004-05-28 00:00:00",
23629,10,21156,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2003-12-09 00:00:00",
26928,1,21156,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.pdf","2002-08-29 00:00:00",
36231,2,21156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf","1999-12-23 00:00:00",
4495,1,21156,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.pdf","2002-08-29 00:00:00",
4496,1,21156,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003ltr.pdf","2011-02-09 00:00:00",
23229,8,21156,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf","2011-02-09 00:00:00",
36232,2,21156,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf","2011-02-09 00:00:00",
14528,2,21158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021158lbl.pdf","2003-04-04 00:00:00",
23230,8,21158,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152723.pdf","2009-11-19 00:00:00",
26929,1,21158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158ltr.pdf","2003-04-18 00:00:00",
26930,1,21158,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158se1-001ltr.pdf","2003-08-15 00:00:00",
36233,2,21158,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21158se1-001_factive_lbl.pdf","2003-08-15 00:00:00",
41993,3,21158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21158_Factive.cfm","2003-09-24 00:00:00",
4497,1,21158,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s002ltr.pdf","2004-07-30 00:00:00",
36234,2,21158,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s002lbl.pdf","2004-07-30 00:00:00",
26931,1,21158,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s003ltr.pdf","2004-09-10 00:00:00",
36235,2,21158,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s003lbl.pdf","2004-09-10 00:00:00",
26932,1,21158,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021158s005ltr.pdf","2006-11-06 00:00:00",
36236,2,21158,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021158s005lbl.pdf","2006-10-27 00:00:00",
14529,2,21158,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf","2007-05-07 00:00:00",
26933,1,21158,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s007ltr.pdf","2007-05-07 00:00:00",
26934,1,21158,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s011ltr.pdf","2008-01-09 00:00:00",
4498,1,21158,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021158s012ltr.pdf","2008-10-08 00:00:00",
14530,2,21158,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf","2008-10-09 00:00:00",
36237,2,21158,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf","2009-04-03 00:00:00",
4499,1,21158,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021158s014ltr.pdf","2009-05-04 00:00:00",
36238,2,21158,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf","2009-05-11 00:00:00",
26935,1,21158,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s018ltr.pdf","2011-03-03 00:00:00",
36239,2,21158,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s018lbl.pdf","2011-03-04 00:00:00",
14531,2,21158,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s021lbl.pdf","2011-10-20 00:00:00",
26936,1,21158,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s021ltr.pdf","2011-10-20 00:00:00",
4500,1,21158,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021158Orig1s022ltr.pdf","2013-08-16 00:00:00",
14532,2,21158,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf","2013-08-15 00:00:00",
4501,1,21158,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021158Orig1s023ltr.pdf","2016-07-26 00:00:00",
14533,2,21158,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf","2016-07-26 00:00:00",
4502,1,21159,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21159scp001ltr.pdf","2004-02-27 00:00:00",
26937,1,21159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21159ltr.pdf","2003-03-10 00:00:00",
36240,2,21159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf","2003-02-28 00:00:00",
41994,3,21159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21159_Loprox.cfm","2003-07-08 00:00:00",
26938,1,21159,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021159s009LTR.pdf","2006-06-14 00:00:00",
36241,2,21159,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf","2006-06-14 00:00:00",
4503,1,21159,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021159Orig1s019ltr.pdf","2012-12-11 00:00:00",
36242,2,21159,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf","2012-12-07 00:00:00",
4504,1,21159,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021159Orig1s020ltr.pdf","2013-05-10 00:00:00",
36243,2,21159,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf","2013-05-14 00:00:00",
4505,1,21160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf","2001-04-02 00:00:00",
26939,1,21160,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf","2004-03-02 00:00:00",
36244,2,21160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf","2001-04-02 00:00:00",
41995,3,21160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021160_Phoslo.cfm","2001-04-02 00:00:00",
4506,1,21160,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf","2011-03-31 00:00:00",
47810,2,21160,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf","2017-03-30 00:00:00",
23630,10,21162,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
26940,1,21162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21162ltr.pdf","2000-11-17 00:00:00",
36245,2,21162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf","2000-11-17 00:00:00",
41996,3,21162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-162_Micards.cfm","2004-03-11 00:00:00",
26941,1,21162,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21162scm005ltr.pdf","2004-04-29 00:00:00",
26942,1,21162,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021162s008ltr.pdf","2005-09-08 00:00:00",
36246,2,21162,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf","2005-09-08 00:00:00",
4507,1,21162,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021162s016ltr.pdf","2007-03-06 00:00:00",
4508,1,21162,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf","2009-11-25 00:00:00",
36247,2,21162,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf","2009-09-17 00:00:00",
14534,2,21162,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf","2009-09-17 00:00:00",
26943,1,21162,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf","2009-11-25 00:00:00",
26944,1,21162,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf","2011-05-06 00:00:00",
36248,2,21162,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf","2011-05-27 00:00:00",
4509,1,21162,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s030ltr.pdf","2012-01-23 00:00:00",
14535,2,21162,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf","2012-01-23 00:00:00",
14536,2,21162,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf","2011-05-27 00:00:00",
26945,1,21162,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf","2011-05-06 00:00:00",
26946,1,21162,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021162Orig1s032ltr.pdf","2016-01-14 00:00:00",
36249,2,21162,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf","2016-01-25 00:00:00",
4510,1,21162,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s034ltr.pdf","2012-01-23 00:00:00",
14537,2,21162,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf","2012-01-23 00:00:00",
4511,1,21162,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162Orig1s035ltr.pdf","2012-10-26 00:00:00",
14538,2,21162,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf","2012-11-07 00:00:00",
26947,1,21162,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021162Orig1s037ltr.pdf","2014-12-15 00:00:00",
36250,2,21162,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf","2014-12-16 00:00:00",
52261,2,21162,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021162s040lbl.pdf","2018-02-02 00:00:00",
52299,1,21162,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021162Orig1s040ltr.pdf","2018-02-02 00:00:00",
14539,2,21163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21163lbl.pdf","2000-05-18 00:00:00",
21483,3,21163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-163_Multi-12.cfm","2004-03-28 00:00:00",
26948,1,21163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21163ltr.pdf","2000-05-18 00:00:00",
26949,1,21163,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21163slr005ltr.pdf","2004-06-07 00:00:00",
4512,1,21163,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21163s011ltr.pdf","2004-09-17 00:00:00",
14540,2,21163,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21163s011lbl.pdf","2004-09-17 00:00:00",
26950,1,21163,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021163s016ltr.pdf","2008-12-11 00:00:00",
36251,2,21163,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf","2016-03-22 00:00:00",
14541,2,21165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21165lbl.pdf","2001-12-21 00:00:00",
26951,1,21165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex_Approv.pdf","2001-12-21 00:00:00",
26952,1,21165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21165s1ltr.pdf","2002-02-08 00:00:00",
36252,2,21165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex_Prntlbl.pdf","2004-06-01 00:00:00",
41997,3,21165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-165_Clarinex.cfm","2001-12-21 00:00:00",
41998,3,21165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21165s001_Clarinex.cfm","2003-07-08 00:00:00",
4513,1,21165,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf","2004-02-03 00:00:00",
4514,1,21165,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
4515,1,21165,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
26953,1,21165,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
4516,1,21165,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf","2010-12-28 00:00:00",
14542,2,21165,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf","2012-05-03 00:00:00",
4517,1,21165,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf","2014-04-24 00:00:00",
36253,2,21165,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf","2014-04-25 00:00:00",
4518,1,21166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166ltr.pdf","2004-03-02 00:00:00",
14543,2,21166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf","2004-04-05 00:00:00",
26954,1,21166,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166s001ltr.pdf","2004-09-15 00:00:00",
41999,3,21166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21166_EstrogelTOC.cfm","2005-06-23 00:00:00",
4519,1,21166,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021166s005_ltr.pdf","2007-07-30 00:00:00",
36254,2,21166,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021166s005lbl.pdf","2007-07-27 00:00:00",
14544,2,21166,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf","2008-01-30 00:00:00",
26955,1,21166,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021166s007ltr.pdf","2008-01-29 00:00:00",
14545,2,21166,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf","2014-03-27 00:00:00",
26956,1,21166,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021166Orig1s010ltr.pdf","2014-03-27 00:00:00",
50275,2,21166,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf","2017-11-02 00:00:00",
14546,2,21167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf","2000-08-16 00:00:00",
21484,3,21167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm","2004-04-13 00:00:00",
26957,1,21167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf","2000-08-16 00:00:00",
4520,1,21168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21168ltr.pdf","2000-08-04 00:00:00",
14547,2,21168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf","2000-08-04 00:00:00",
14548,2,21168,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf","2002-05-31 00:00:00",
21485,3,21168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-168_Depakote.cfm","2003-12-15 00:00:00",
23631,10,21168,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2008-02-01 00:00:00",
26958,1,21168,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21168s001ltr.pdf","2002-05-31 00:00:00",
53232,20,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53233,20,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinical(DPP)_BPCA.pdf","1900-01-01 00:00:00",
53234,20,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinical(DNP2)_BPCA.pdf","1900-01-01 00:00:00",
53235,20,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinical(DNP)_BPCA.pdf","1900-01-01 00:00:00",
54051,18,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
54052,18,21168,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021168_Divalproex_Clinpharm_1_BPCA.pdf","1900-01-01 00:00:00",
26959,1,21168,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116","2004-06-02 00:00:00",
4521,1,21168,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.pdf","2004-06-02 00:00:00",
21486,3,21168,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021168_S004_DepakoteTOC.cfm","2006-07-10 00:00:00",
36255,2,21168,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf","2003-04-04 00:00:00",
4522,1,21168,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21168se5-007ltr.pdf","2004-06-15 00:00:00",
14549,2,21168,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-007_depakote_lbl.pdf","2004-06-15 00:00:00",
21487,3,21168,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021168_S007_DepakoteTOC.cfm","2006-07-10 00:00:00",
26960,1,21168,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021168s009ltr.pdf","2006-01-20 00:00:00",
36256,2,21168,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf","2006-01-13 00:00:00",
4523,1,21168,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021168s012ltr.pdf","2005-12-13 00:00:00",
36257,2,21168,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021168s012lbl.pdf","2005-12-13 00:00:00",
4524,1,21168,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf","2006-10-23 00:00:00",
14550,2,21168,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf","2006-10-18 00:00:00",
14551,2,21168,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf","2008-03-27 00:00:00",
26961,1,21168,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021168s015ltr.pdf","2008-03-26 00:00:00",
26962,1,21168,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf","2011-10-19 00:00:00",
36258,2,21168,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf","2011-10-12 00:00:00",
4525,1,21168,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf","2011-10-19 00:00:00",
14552,2,21168,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf","2011-10-12 00:00:00",
4526,1,21168,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021168s018ltr.pdf","2009-05-04 00:00:00",
36259,2,21168,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021168s018lbl.pdf","2009-05-07 00:00:00",
4527,1,21168,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf","2014-06-23 00:00:00",
36260,2,21168,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s019lbl.pdf","2014-06-23 00:00:00",
4528,1,21168,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf","2011-10-19 00:00:00",
14553,2,21168,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf","2011-10-12 00:00:00",
4529,1,21168,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf","2011-10-19 00:00:00",
36261,2,21168,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf","2011-10-12 00:00:00",
4530,1,21168,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf","2013-03-01 00:00:00",
36262,2,21168,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s023lbl.pdf","2013-03-01 00:00:00",
4531,1,21168,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf","2013-09-17 00:00:00",
36263,2,21168,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s024lbl.pdf","2013-09-17 00:00:00",
14554,2,21168,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf","2013-07-02 00:00:00",
14555,2,21168,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf","2014-12-03 00:00:00",
26963,1,21168,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf","2014-11-24 00:00:00",
26964,1,21168,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf","2015-01-08 00:00:00",
36264,2,21168,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s027lbl.pdf","2015-01-08 00:00:00",
26965,1,21168,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf","2014-06-11 00:00:00",
36265,2,21168,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf","2014-06-10 00:00:00",
14556,2,21168,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf","2014-08-22 00:00:00",
26966,1,21168,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf","2014-08-21 00:00:00",
4532,1,21168,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021168Orig1s030ltr.pdf","2015-04-16 00:00:00",
14557,2,21168,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf","2015-04-21 00:00:00",
4533,1,21168,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf","2015-03-17 00:00:00",
36266,2,21168,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s031lbl.pdf","2015-03-17 00:00:00",
4534,1,21168,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf","2015-09-25 00:00:00",
36267,2,21168,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s032lbl.pdf","2015-10-06 00:00:00",
14558,2,21168,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf","2016-02-24 00:00:00",
26967,1,21168,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf","2016-02-23 00:00:00",
45815,1,21168,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf","2016-11-04 00:00:00",
45844,2,21168,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s035lbl.pdf","2016-11-08 00:00:00",
47483,2,21168,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s036lbl.pdf","2017-03-07 00:00:00",
47504,1,21168,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf","2017-03-08 00:00:00",
49980,1,21168,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf","2017-10-06 00:00:00",
50003,2,21168,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s037lbl.pdf","2017-10-10 00:00:00",
54070,1,21168,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf","2018-05-10 00:00:00",
54091,2,21168,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf","2018-05-10 00:00:00",
54092,8,21168,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf#page=44","2018-05-10 00:00:00",
4535,1,21169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21169ltr.pdf","2001-02-28 00:00:00",
14559,2,21169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21169lbl.pdf","2001-02-28 00:00:00",
23632,10,21169,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2005-07-29 00:00:00",
42000,3,21169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-169_Reminyl.cfm","2001-12-18 00:00:00",
26968,1,21169,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf","2002-05-02 00:00:00",
4536,1,21169,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr007ltr.pdf","2003-09-09 00:00:00",
4537,1,21169,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
26969,1,21169,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf","2005-05-03 00:00:00",
4538,1,21169,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
26970,1,21169,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
26971,1,21169,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
26972,1,21169,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf","2012-03-05 00:00:00",
36268,2,21169,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf","2012-03-06 00:00:00",
4539,1,21169,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf","2012-03-05 00:00:00",
36269,2,21169,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf","2012-03-06 00:00:00",
4540,1,21169,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf","2013-07-02 00:00:00",
14560,2,21169,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf","2013-07-11 00:00:00",
14561,2,21169,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf","2012-05-01 00:00:00",
26973,1,21169,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf","2012-03-05 00:00:00",
26974,1,21169,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf","2015-02-12 00:00:00",
36270,2,21169,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf","2015-02-10 00:00:00",
4541,1,21169,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf","2015-12-17 00:00:00",
36271,2,21169,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf","2015-12-17 00:00:00",
47237,1,21169,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023ltr.pdf","2017-02-16 00:00:00",
47242,2,21169,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf","2017-02-16 00:00:00",
46276,1,21171,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021171Orig1s024,s025ltr.pdf","2016-12-20 00:00:00",
46358,2,21171,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf","2016-12-21 00:00:00",
46277,1,21171,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021171Orig1s024,s025ltr.pdf","2016-12-20 00:00:00",
46359,2,21171,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf","2016-12-21 00:00:00",
4542,1,21172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_Approv.pdf","2001-11-01 00:00:00",
14562,2,21172,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf","2002-05-03 00:00:00",
21488,3,21172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog.cfm","2001-11-01 00:00:00",
26975,1,21172,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172S001ltr.pdf","2002-05-03 00:00:00",
36272,2,21172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf","2001-11-01 00:00:00",
4543,1,21172,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172s003ltr.pdf","2002-06-26 00:00:00",
36273,2,21172,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf","2002-06-26 00:00:00",
26976,1,21172,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172scp009ltr.pdf","2002-11-18 00:00:00",
36274,2,21172,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf","2002-11-18 00:00:00",
14563,2,21172,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf","2004-10-15 00:00:00",
26977,1,21172,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf","2004-10-15 00:00:00",
4544,1,21172,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s021ltr.pdf","2005-11-30 00:00:00",
36275,2,21172,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf","2005-11-30 00:00:00",
26978,1,21172,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s023ltr.pdf","2005-11-18 00:00:00",
36276,2,21172,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf","2005-11-18 00:00:00",
26979,1,21172,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021172s034ltr.pdf","2007-07-24 00:00:00",
36277,2,21172,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf","2007-07-24 00:00:00",
26980,1,21172,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
26981,1,21172,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
26982,1,21172,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf","2008-11-28 00:00:00",
26983,1,21172,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf","2009-05-13 00:00:00",
14564,2,21172,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf","2010-05-17 00:00:00",
26984,1,21172,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf","2010-05-12 00:00:00",
26985,1,21172,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf","2015-02-27 00:00:00",
36278,2,21172,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf","2015-03-03 00:00:00",
4545,1,21172,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf","2010-05-12 00:00:00",
36279,2,21172,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf","2010-05-17 00:00:00",
4546,1,21172,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021172Orig1s051ltr.pdf","2012-12-19 00:00:00",
14565,2,21172,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf","2012-12-18 00:00:00",
4547,1,21172,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021172Orig1s053ltr.pdf","2013-03-12 00:00:00",
36280,2,21172,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf","2013-03-12 00:00:00",
48331,2,21172,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021172s062lbl.pdf","2017-05-09 00:00:00",
48343,1,21172,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021172Orig1s062ltr.pdf","2017-05-10 00:00:00",
14566,2,21172,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf","2015-03-03 00:00:00",
26986,1,21172,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf","2015-02-27 00:00:00",
14567,2,21172,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf","2015-04-22 00:00:00",
26987,1,21172,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s064ltr.pdf","2015-04-20 00:00:00",
14568,2,21174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21174lbl.pdf","2000-05-17 00:00:00",
21489,3,21174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21174_Mylotorg.cfm","2001-06-04 00:00:00",
26988,1,21174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21174ltr.pdf","2000-05-17 00:00:00",
14569,2,21174,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21174s2lbl.pdf","2003-04-23 00:00:00",
4548,1,21174,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174se8-012ltr.pdf","2004-04-20 00:00:00",
4549,1,21174,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174slr014ltr.pdf","2004-06-24 00:00:00",
4550,1,21174,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174s015ltr.pdf","2004-07-28 00:00:00",
14570,2,21174,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021174s020lbl.pdf","2006-01-25 00:00:00",
26989,1,21174,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021174s020ltr.pdf","2006-01-30 00:00:00",
26990,1,21174,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s021ltr.pdf","2005-06-15 00:00:00",
4551,1,21174,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s024ltr.pdf","2005-10-20 00:00:00",
14571,2,21175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf","2002-01-17 00:00:00",
26991,1,21175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_approv.pdf","2002-01-17 00:00:00",
42001,3,21175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa.cfm","2004-05-27 00:00:00",
4552,1,21176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_Approv.pdf","2004-06-30 00:00:00",
36281,2,21176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf","2004-06-30 00:00:00",
42002,3,21176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol.cfm","2002-04-11 00:00:00",
14572,2,21176,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf","2003-03-05 00:00:00",
26992,1,21176,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr004ltr.pdf","2004-06-30 00:00:00",
4553,1,21176,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21176scp005ltr.pdf","2002-10-17 00:00:00",
36282,2,21176,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf","2002-10-17 00:00:00",
26993,1,21176,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs008ltr.pdf","2003-08-28 00:00:00",
36283,2,21176,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf","2003-08-28 00:00:00",
4554,1,21176,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr009ltr.pdf","2003-10-16 00:00:00",
14573,2,21176,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf","2003-10-16 00:00:00",
4555,1,21176,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs010ltr.pdf","2003-11-25 00:00:00",
36284,2,21176,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf","2003-12-02 00:00:00",
4556,1,21176,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s014_ltr.pdf","2006-09-18 00:00:00",
36285,2,21176,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf","2006-09-12 00:00:00",
26994,1,21176,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s015LTR.pdf","2006-07-13 00:00:00",
36286,2,21176,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf","2006-07-13 00:00:00",
4557,1,21176,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s017ltr.pdf","2008-01-23 00:00:00",
36287,2,21176,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf","2008-01-23 00:00:00",
14574,2,21176,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf","2007-08-30 00:00:00",
26995,1,21176,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021176s019ltr.pdf","2007-08-30 00:00:00",
4558,1,21176,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s021ltr.pdf","2008-06-06 00:00:00",
4559,1,21176,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf","2009-10-26 00:00:00",
14575,2,21176,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf","2009-10-07 00:00:00",
51484,23,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Original_WR1.pdf","2004-08-31 00:00:00",
51486,25,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_1_WR.pdf","2006-01-19 00:00:00",
51489,26,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_2_WR.pdf","2006-03-28 00:00:00",
51501,27,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_3_WR.pdf","2007-04-02 00:00:00",
53223,20,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_Colesevelam_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53224,17,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_Colesevelam_Statistical_BPCA.pdf","1900-01-01 00:00:00",
54046,23,21176,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Original_WR1.pdf","1900-01-01 00:00:00",
4560,1,21176,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf","2010-09-16 00:00:00",
14576,2,21176,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf","2010-09-20 00:00:00",
26996,1,21176,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf","2011-07-19 00:00:00",
36288,2,21176,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf","2011-07-18 00:00:00",
4561,1,21176,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf","2012-01-17 00:00:00",
36289,2,21176,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf","2012-01-06 00:00:00",
4562,1,21176,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf","2012-07-13 00:00:00",
14577,2,21176,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf","2012-07-13 00:00:00",
14578,2,21176,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf","2013-07-02 00:00:00",
26997,1,21176,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf","2013-07-02 00:00:00",
4563,1,21176,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf","2014-01-23 00:00:00",
36290,2,21176,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf","2014-01-23 00:00:00",
4564,1,21176,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf","2013-07-02 00:00:00",
36291,2,21176,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf","2013-07-02 00:00:00",
4565,1,21178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21178ltr.pdf","2000-07-31 00:00:00",
21490,3,21178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-178_Glucovance.cfm","2003-12-31 00:00:00",
36292,2,21178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21178lbl.pdf","2000-07-31 00:00:00",
14579,2,21178,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf","2002-09-30 00:00:00",
21491,3,21178,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-178S004_Glucovance.cfm","2003-10-29 00:00:00",
26998,1,21178,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21178se1-004ltr.pdf","2002-09-30 00:00:00",
14580,2,21178,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-007_glucovance_lbl.pdf","2004-04-05 00:00:00",
26999,1,21178,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21178se5-007ltr.pdf","2004-03-19 00:00:00",
51968,20,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021178s007_glyburide-metformin_Glucovance-MedRev.pdf","1900-01-01 00:00:00",
51969,17,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021178s007_glyburide-metformin_Glucovance-StatsRev.pdf","1900-01-01 00:00:00",
51970,23,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/glyburide-metformin_Glucovance_1-31-01_HFD510.pdf","1900-01-01 00:00:00",
51971,25,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/glyburide-metformin_Glucovance(amended)_10-8-01_HFD510.pdf","1900-01-01 00:00:00",
51972,26,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/glyburide-metformin_Glucovance(amended)_10-8-01_HFD510.pdf","1900-01-01 00:00:00",
51973,27,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/glyburide-metformin_Glucovance(amended)_6-14-02_HFD510.pdf","1900-01-01 00:00:00",
51974,28,21178,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/glyburide-metformin_(amended)_5-29-03_HFD510.pdf","1900-01-01 00:00:00",
14581,2,21178,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf","2006-12-26 00:00:00",
27000,1,21178,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021178s009ltr.pdf","2006-12-28 00:00:00",
4566,1,21178,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021178s010ltr.pdf","2008-09-17 00:00:00",
36293,2,21178,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021178s010lbl.pdf","2008-09-19 00:00:00",
36294,2,21178,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021178s011lbl.pdf","2009-12-02 00:00:00",
4567,1,21178,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021178s012ltr.pdf","2010-11-30 00:00:00",
14582,2,21178,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf","2010-12-01 00:00:00",
4568,1,21178,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021178Orig1s015ltr.pdf","2013-10-16 00:00:00",
36295,2,21178,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021178s015lbl.pdf","2013-10-22 00:00:00",
47924,2,21178,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf","2017-04-11 00:00:00",
47953,1,21178,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021178Orig1s016s017ltr.pdf","2017-04-12 00:00:00",
47925,2,21178,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf","2017-04-11 00:00:00",
47954,1,21178,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021178Orig1s016s017ltr.pdf","2017-04-12 00:00:00",
14583,2,21179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf","2000-07-12 00:00:00",
27001,1,21179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21179ltr.pdf","2000-07-12 00:00:00",
42003,3,21179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-179_Renagel.cfm","2004-03-11 00:00:00",
27002,1,21179,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-006,21179se1-002ltr.pdf","2004-03-03 00:00:00",
27003,1,21179,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021179s015ltr.pdf","2005-07-26 00:00:00",
14584,2,21179,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf","2007-10-22 00:00:00",
27004,1,21179,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s020ltr.pdf","2007-10-22 00:00:00",
4569,1,21179,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s021LTR.pdf","2007-08-17 00:00:00",
14585,2,21179,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf","2007-08-17 00:00:00",
4570,1,21179,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf","2011-06-24 00:00:00",
36296,2,21179,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021179s029lbl.pdf","2011-06-16 00:00:00",
4571,1,21179,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021179Orig1s030ltr.pdf","2014-11-28 00:00:00",
36297,2,21179,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021179Orig1s030lbl.pdf","2014-12-19 00:00:00",
4572,1,21179,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021179Orig1s032ltr.pdf","2016-03-11 00:00:00",
14586,2,21179,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf","2016-03-14 00:00:00",
21492,3,21180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm","2001-11-20 00:00:00",
21493,3,21180,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s001_ORTHO EVRA.pdf","2008-08-01 00:00:00",
27005,1,21180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_Ortho%20EVRA_Approv.pdf","2001-11-20 00:00:00",
36298,2,21180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf","2001-11-20 00:00:00",
44102,10,21180,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110402.htm","2006-09-22 00:00:00",
42004,3,21180,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s002_ORTHO EVRA.pdf","2008-08-01 00:00:00",
21494,3,21180,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s003_OrthoTOC.cfm","2006-07-11 00:00:00",
42005,3,21180,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s004_OrthoTOC.cfm","2006-07-11 00:00:00",
42006,3,21180,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21180_S005_OrthoEvraTOC.cfm","2007-06-29 00:00:00",
4573,1,21180,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180slr008ltr.pdf","2004-03-02 00:00:00",
42007,3,21180,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021180_s008_ORTHO EVRA.pdf","2008-07-31 00:00:00",
4574,1,21180,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180s014ltr.pdf","2004-12-02 00:00:00",
4575,1,21180,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s015ltr.pdf","2005-05-17 00:00:00",
14587,2,21180,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf","2005-05-17 00:00:00",
4576,1,21180,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s019ltr.pdf","2005-11-18 00:00:00",
36299,2,21180,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf","2005-11-10 00:00:00",
27006,1,21180,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s020LTR.pdf","2006-05-21 00:00:00",
14588,2,21180,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf","2006-09-20 00:00:00",
27007,1,21180,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s022ltr.pdf","2006-09-20 00:00:00",
36300,2,21180,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf","2008-01-18 00:00:00",
27008,1,21180,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf","2008-11-03 00:00:00",
36301,2,21180,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf","2008-11-07 00:00:00",
4577,1,21180,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s029ltr.pdf","2009-11-10 00:00:00",
14589,2,21180,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf","2009-08-13 00:00:00",
4578,1,21180,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf","2008-11-03 00:00:00",
14590,2,21180,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf","2008-11-07 00:00:00",
27009,1,21180,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,%20s030,%20s031ltr.pdf","2008-11-03 00:00:00",
36302,2,21180,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf","2008-11-07 00:00:00",
4579,1,21180,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s033ltr.pdf","2009-11-10 00:00:00",
14591,2,21180,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf","2009-09-17 00:00:00",
4580,1,21180,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s034ltr.pdf","2010-01-25 00:00:00",
14592,2,21180,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf","2009-12-02 00:00:00",
4581,1,21180,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021180s035ltr.pdf","2010-04-19 00:00:00",
14593,2,21180,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf","2010-04-19 00:00:00",
27010,1,21180,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s038ltr.pdf","2011-07-28 00:00:00",
36303,2,21180,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf","2011-08-12 00:00:00",
27011,1,21180,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s039ltr.pdf","2011-03-25 00:00:00",
36304,2,21180,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf","2011-03-28 00:00:00",
14594,2,21180,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf","2011-12-28 00:00:00",
27012,1,21180,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s040ltr.pdf","2012-01-03 00:00:00",
14595,2,21180,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf","2012-08-22 00:00:00",
27013,1,21180,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021180Orig1s043ltr.pdf","2012-08-24 00:00:00",
4582,1,21180,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021180Orig1s044ltr.pdf","2013-07-03 00:00:00",
36305,2,21180,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf","2013-07-03 00:00:00",
14596,2,21180,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf","2014-04-14 00:00:00",
27014,1,21180,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021180Orig1s046ltr.pdf","2014-04-14 00:00:00",
4583,1,21180,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021180Orig1s047ltr.pdf","2015-10-23 00:00:00",
36306,2,21180,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf","2015-10-26 00:00:00",
49299,2,21180,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf","2017-08-09 00:00:00",
49371,1,21180,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021180Orig1s048ltr.pdf","2017-08-15 00:00:00",
4584,1,21183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx_Approv.pdf","2004-06-30 00:00:00",
4585,1,21183,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s1ltr.pdf","2002-01-28 00:00:00",
21495,3,21183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx.cfm","2004-03-11 00:00:00",
21496,3,21183,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021183_S001_VIDEX_AP.pdf","2007-07-09 00:00:00",
36307,2,21183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21183lbl1.pdf","2000-10-31 00:00:00",
44103,10,21183,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm","2010-08-09 00:00:00",
4586,1,21183,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s2ltr.pdf","2002-01-29 00:00:00",
42008,3,21183,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-183s002_Videx.cfm","2005-04-08 00:00:00",
27015,1,21183,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf","2002-04-01 00:00:00",
36308,2,21183,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf","2002-04-01 00:00:00",
4587,1,21183,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr004ltr.pdf","2002-08-05 00:00:00",
14597,2,21183,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf","2002-08-05 00:00:00",
14598,2,21183,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf","2002-09-26 00:00:00",
27016,1,21183,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf","2002-09-26 00:00:00",
4588,1,21183,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf","2002-09-26 00:00:00",
36309,2,21183,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf","2002-09-26 00:00:00",
14599,2,21183,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf","2003-03-07 00:00:00",
27017,1,21183,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf","2003-03-10 00:00:00",
4589,1,21183,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf","2004-01-22 00:00:00",
36310,2,21183,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf","2004-01-22 00:00:00",
27018,1,21183,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf","2006-09-18 00:00:00",
36311,2,21183,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf","2006-08-21 00:00:00",
4590,1,21183,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf","2006-12-28 00:00:00",
14600,2,21183,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf","2006-12-04 00:00:00",
4591,1,21183,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021183s020ltr.pdf","2008-10-02 00:00:00",
36312,2,21183,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021183s020lbl.pdf","2008-10-03 00:00:00",
53230,20,21183,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021183s020_Didansine (Videx EC)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53231,18,21183,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021183s020_Didansine (Videx EC)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
14601,2,21183,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf","2009-06-22 00:00:00",
27019,1,21183,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021183s022ltr.pdf","2009-06-16 00:00:00",
4592,1,21183,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf","2010-02-01 00:00:00",
14602,2,21183,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023lbl.pdf","2010-01-29 00:00:00",
4593,1,21183,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024ltr.pdf","2011-05-12 00:00:00",
4594,1,21183,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021183s025ltr.pdf","2011-11-22 00:00:00",
14603,2,21183,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025lbl.pdf","2011-11-22 00:00:00",
43716,8,21183,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025MG.pdf","2011-11-22 00:00:00",
52079,2,21183,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s028lbl.pdf","2018-01-25 00:00:00",
52103,1,21183,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021183Orig1s028ltr.pdf","2018-01-30 00:00:00",
4595,1,21184,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21184s1ltr.pdf","2001-10-24 00:00:00",
14604,2,21184,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf","2001-10-24 00:00:00",
27020,1,21184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21184ltr.pdf","2000-09-29 00:00:00",
36313,2,21184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf","2000-09-29 00:00:00",
42009,3,21184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-184_Tazorac.cfm","2004-03-28 00:00:00",
42010,3,21184,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-184S001_Tazorac.cfm","2001-12-12 00:00:00",
14605,2,21184,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf","2004-05-27 00:00:00",
21497,3,21184,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-184s002_Avage.cfm","2004-01-15 00:00:00",
27021,1,21184,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21184se1-002ltr.pdf","2004-05-27 00:00:00",
14606,2,21184,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf","2013-12-17 00:00:00",
27022,1,21184,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021184Orig1s007ltr.pdf","2013-12-17 00:00:00",
45315,2,21184,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf","2016-09-16 00:00:00",
45350,1,21184,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021184Orig1s008ltr.pdf","2016-11-09 00:00:00",
49052,2,21184,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf","2017-07-25 00:00:00",
49076,1,21184,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf","2017-07-25 00:00:00",
4596,1,21187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21187ltr.pdf","2001-10-03 00:00:00",
36314,2,21187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf","2001-10-03 00:00:00",
42011,3,21187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm","2001-10-03 00:00:00",
4597,1,21187,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr007ltr.pdf","2004-03-02 00:00:00",
4598,1,21187,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr008ltr.pdf","2004-03-10 00:00:00",
27023,1,21187,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021187s012ltr.pdf","2005-08-03 00:00:00",
36315,2,21187,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf","2005-08-03 00:00:00",
14607,2,21187,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf","2007-10-04 00:00:00",
27024,1,21187,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021187s017ltr.pdf","2007-10-04 00:00:00",
4599,1,21187,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021187s018ltr.pdf","2008-05-05 00:00:00",
4600,1,21187,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s021ltr.pdf","2013-10-21 00:00:00",
36316,2,21187,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf","2013-10-08 00:00:00",
42012,3,21187,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm","2015-03-10 00:00:00",
44639,21,21187,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf","2015-01-09 00:00:00",
4601,1,21187,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s022ltr.pdf","2013-10-21 00:00:00",
14608,2,21187,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf","2013-10-08 00:00:00",
21498,3,21187,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm","2015-04-06 00:00:00",
24186,21,21187,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf","2015-01-09 00:00:00",
4602,1,21187,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s024ltr.pdf","2014-06-19 00:00:00",
14609,2,21187,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf","2014-06-23 00:00:00",
14610,2,21187,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf","2014-11-07 00:00:00",
27025,1,21187,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s025ltr.pdf","2014-11-03 00:00:00",
45470,1,21187,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021187Orig1s027ltr.pdf","2016-10-04 00:00:00",
45583,2,21187,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf","2016-10-06 00:00:00",
48613,2,21187,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s028lbl.pdf","2017-06-01 00:00:00",
48626,1,21187,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s028ltr.pdf","2017-06-02 00:00:00",
52626,2,21187,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf","2018-02-14 00:00:00",
52639,1,21187,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187Orig1s031ltr.pdf","2018-02-14 00:00:00",
49308,2,21187,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf","2017-08-10 00:00:00",
49374,1,21187,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s032ltr.pdf","2017-08-15 00:00:00",
52768,3,21187,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021187Orig1s034.pdf","2018-02-28 00:00:00",
21499,3,21190,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-190_Buspar.cfm","2004-03-11 00:00:00",
4603,1,21191,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21191sce001ltr.pdf","2004-04-29 00:00:00",
14611,2,21191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21191lbl.pdf","2002-05-31 00:00:00",
21500,3,21191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-191_Imagent.cfm","2002-05-31 00:00:00",
27026,1,21191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21191ltr.pdf","2002-05-31 00:00:00",
14612,2,21192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf","2004-06-08 00:00:00",
27027,1,21192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21192ltr.pdf","2000-10-06 00:00:00",
42013,3,21192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm","2004-03-24 00:00:00",
14613,2,21192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21192s2lbl.pdf","2003-05-01 00:00:00",
42014,3,21192,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s003_LESCOL_CAPSULES.pdf","2008-08-01 00:00:00",
4604,1,21192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf","2002-09-06 00:00:00",
21501,3,21192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s004_LESCOL_CAPSULES.pdf","2008-08-01 00:00:00",
36317,2,21192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf","2002-09-06 00:00:00",
14614,2,21192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf","2003-06-08 00:00:00",
27028,1,21192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf","2003-06-08 00:00:00",
14615,2,21192,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf","2005-01-11 00:00:00",
27029,1,21192,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf","2005-01-11 00:00:00",
14616,2,21192,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf","2006-04-12 00:00:00",
27030,1,21192,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf","2006-04-13 00:00:00",
4605,1,21192,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf","2006-04-13 00:00:00",
14617,2,21192,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf","2006-04-12 00:00:00",
4606,1,21192,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf","2006-04-05 00:00:00",
36318,2,21192,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf","2006-04-05 00:00:00",
27031,1,21192,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf","2007-06-14 00:00:00",
36319,2,21192,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf","2007-06-14 00:00:00",
27032,1,21192,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf","2011-06-28 00:00:00",
36320,2,21192,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf","2011-06-28 00:00:00",
4607,1,21192,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf","2012-02-28 00:00:00",
21502,3,21192,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021192s019.pdf","2012-03-30 00:00:00",
36321,2,21192,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019lbl.pdf","2012-02-28 00:00:00",
44472,14,21192,"SUPPL",19,"Tracked Changes Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019-trackedchangeslbl.pdf","2012-02-28 00:00:00",
4608,1,21192,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf","2012-11-05 00:00:00",
36322,2,21192,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf","2012-11-06 00:00:00",
49273,2,21192,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020261s052,021192s026lbl.pdf","2017-08-08 00:00:00",
49282,1,21192,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020261Orig1s052,021192Orig1s026ltr.pdf","2017-08-08 00:00:00",
4609,1,21196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21196ltr.pdf","2002-07-17 00:00:00",
14618,2,21196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21196lbl.pdf","2002-07-17 00:00:00",
21503,3,21196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-196_Xyrem.cfm","2002-07-17 00:00:00",
27033,1,21196,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21196slr001ltr.pdf","2003-11-25 00:00:00",
44104,10,21196,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm332408.htm","2012-12-17 00:00:00",
44473,14,21196,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345","2015-07-07 00:00:00",
14619,2,21196,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021196s005lbl.pdf","2005-11-22 00:00:00",
27034,1,21196,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s005ltr.pdf","2005-11-22 00:00:00",
27035,1,21196,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s007ltr.pdf","2005-09-22 00:00:00",
27036,1,21196,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s009ltr.pdf","2006-07-03 00:00:00",
27037,1,21196,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s012LTR.pdf","2006-11-16 00:00:00",
14620,2,21196,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf","2012-12-17 00:00:00",
27038,1,21196,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021196Orig1s013ltr.pdf","2012-12-20 00:00:00",
4610,1,21196,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s015ltr.pdf","2015-03-02 00:00:00",
27039,1,21196,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021196Orig1s019ltr.pdf","2014-04-14 00:00:00",
36323,2,21196,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021196Orig1s019lbl.pdf","2014-04-14 00:00:00",
54059,3,21196,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021196Orig1s019.pdf","2018-05-08 00:00:00",
4611,1,21196,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s023ltr.pdf","2015-07-16 00:00:00",
14621,2,21196,"SUPPL",23,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345","2016-02-24 00:00:00",
48960,2,21196,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s026lbl.pdf","2017-07-13 00:00:00",
46991,2,21196,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s027lbl.pdf","2017-01-26 00:00:00",
47011,8,21196,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s027lbl.pdf#page=22","2017-01-30 00:00:00",
47012,1,21196,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021196Orig1s027ltr.pdf","2017-01-30 00:00:00",
50436,2,21196,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s028lbl.pdf","2017-11-17 00:00:00",
50450,1,21196,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021196Orig1s028ltr.pdf","2017-11-17 00:00:00",
14622,2,21197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf","2000-08-11 00:00:00",
21504,3,21197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm","2000-08-11 00:00:00",
27040,1,21197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf","2000-08-11 00:00:00",
27041,1,21197,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf","2004-05-07 00:00:00",
4612,1,21197,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf","2004-05-07 00:00:00",
4613,1,21197,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf","2004-05-07 00:00:00",
27042,1,21197,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf","2008-04-10 00:00:00",
36324,2,21197,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf","2008-04-16 00:00:00",
4614,1,21199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21199ltr.pdf","2000-08-18 00:00:00",
36325,2,21199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21199lbl.pdf","2000-08-18 00:00:00",
42015,3,21199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-199_Quixin.cfm","2004-03-24 00:00:00",
4615,1,21199,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s2ltr.pdf","2002-04-18 00:00:00",
36326,2,21199,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s2lbl.pdf","2002-04-18 00:00:00",
27043,1,21199,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s003ltr.pdf","2002-06-04 00:00:00",
36327,2,21199,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s003lbl.pdf","2002-06-04 00:00:00",
4616,1,21199,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf","2005-04-12 00:00:00",
36328,2,21199,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf","2005-04-12 00:00:00",
14623,2,21199,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf","2005-04-12 00:00:00",
27044,1,21199,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf","2005-04-12 00:00:00",
4617,1,21199,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021199Orig1s014ltr.pdf","2014-12-04 00:00:00",
14624,2,21199,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021199s014lbl.pdf","2014-12-10 00:00:00",
27045,1,21200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21200ltr.pdf","2002-07-24 00:00:00",
36329,2,21200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf","2002-07-24 00:00:00",
42016,3,21200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-200_Zelnorm.cfm","2002-07-22 00:00:00",
44105,10,21200,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103223.htm","2003-12-12 00:00:00",
4618,1,21200,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200s005ltr.pdf","2004-08-25 00:00:00",
36330,2,21200,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf","2004-08-25 00:00:00",
27046,1,21200,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scm006ltr.pdf","2004-06-16 00:00:00",
36331,2,21200,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf","2004-06-16 00:00:00",
4619,1,21200,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf","2004-04-29 00:00:00",
36332,2,21200,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf","2004-05-04 00:00:00",
27047,1,21200,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf","2004-04-29 00:00:00",
36333,2,21200,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf","2004-05-04 00:00:00",
4620,1,21200,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021200s009ltr.pdf","2004-04-27 00:00:00",
36334,2,21200,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf","2004-04-27 00:00:00",
4621,1,21200,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021200s010ltr.pdf","2005-05-26 00:00:00",
27048,1,21200,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021200s012LTR.pdf","2006-06-06 00:00:00",
14625,2,21200,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf","2007-03-07 00:00:00",
27049,1,21200,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021200s014ltr.pdf","2007-03-06 00:00:00",
24187,21,21201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000_Sumr.pdf","2010-04-22 00:00:00",
27050,1,21201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021201s000ltr.pdf","2010-04-09 00:00:00",
36335,2,21201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf","2010-04-04 00:00:00",
42017,3,21201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000TOC.cfm","2010-04-22 00:00:00",
52773,2,21201,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021201s002lbl.pdf","2018-03-01 00:00:00",
52789,1,21201,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021201s002ltr.pdf","2018-03-02 00:00:00",
4622,1,21202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21202ltr.pdf","2000-10-13 00:00:00",
4623,1,21202,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21202S1ltr.pdf","2001-04-19 00:00:00",
14626,2,21202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf","2000-10-13 00:00:00",
42018,3,21202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-202_Glucophage.cfm","2004-06-04 00:00:00",
4624,1,21202,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf","2002-01-08 00:00:00",
4625,1,21202,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21202scs008ltr.pdf","2003-04-18 00:00:00",
14627,2,21202,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf","2003-04-17 00:00:00",
4626,1,21202,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf","2004-03-24 00:00:00",
4627,1,21202,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf","2004-03-24 00:00:00",
4628,1,21202,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf","2006-11-06 00:00:00",
36336,2,21202,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf","2006-11-06 00:00:00",
14628,2,21202,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf","2008-08-29 00:00:00",
27051,1,21202,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf","2008-08-28 00:00:00",
54382,1,21202,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020357Orig1s034, 021202Orig1s018ltr.pdf","2018-05-31 00:00:00",
54396,2,21202,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf","2018-05-31 00:00:00",
47935,2,21202,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf","2017-04-11 00:00:00",
47945,1,21202,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf","2017-04-12 00:00:00",
47936,2,21202,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf","2017-04-11 00:00:00",
47946,1,21202,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf","2017-04-12 00:00:00",
27052,1,21203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21203ltr.pdf","2001-09-05 00:00:00",
36337,2,21203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21203lbl.pdf","2001-09-05 00:00:00",
42019,3,21203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-203_Tricor.cfm","2005-04-15 00:00:00",
14629,2,21203,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021203s005lbl.pdf","2014-12-10 00:00:00",
27053,1,21203,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021203Orig1s005ltr.pdf","2014-12-09 00:00:00",
46975,2,21203,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021203s006lbl.pdf","2017-01-25 00:00:00",
47008,1,21203,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021203Orig1s006ltr.pdf","2017-01-30 00:00:00",
54274,1,21203,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s007,021656Orig1s026ltr.pdf","2018-05-21 00:00:00",
54294,2,21203,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf","2018-05-22 00:00:00",
4629,1,21204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21204ltr.pdf","2000-12-22 00:00:00",
21505,3,21204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-204_Stsrlix.cfm","2002-03-18 00:00:00",
36338,2,21204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21204lbl.pdf","2000-12-22 00:00:00",
4630,1,21204,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21204slr005ltr.pdf","2002-11-26 00:00:00",
36339,2,21204,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21204slr005_Starlix_lbl.pdf","2002-11-26 00:00:00",
14630,2,21204,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21204se1-006_starlix_lbl.pdf","2003-10-27 00:00:00",
27054,1,21204,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21204se1-006ltr.pdf","2003-10-27 00:00:00",
42020,3,21204,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021204_S006_STARLIX_TABS_AP.pdf","2007-07-06 00:00:00",
14631,2,21204,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21204slr009_starlix_lbl.pdf","2004-07-07 00:00:00",
27055,1,21204,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21204slr009ltr.pdf","2004-07-06 00:00:00",
27056,1,21204,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021204s010LTR.pdf","2006-11-14 00:00:00",
36340,2,21204,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021204s010lbl.pdf","2006-11-13 00:00:00",
4631,1,21204,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021204s011ltr.pdf","2008-07-17 00:00:00",
36341,2,21204,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021204s011lbl.pdf","2008-07-16 00:00:00",
27057,1,21204,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021204s014ltr.pdf","2011-08-26 00:00:00",
36342,2,21204,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021204s014lbl.pdf","2011-08-26 00:00:00",
47608,1,21204,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021204Orig1s015ltr.pdf","2017-03-20 00:00:00",
48133,2,21204,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021204s015lbl.pdf","2017-04-27 00:00:00",
54191,1,21204,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021204Orig1s023ltr.pdf","2018-05-15 00:00:00",
54246,2,21204,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021204s023lbl.pdf","2018-05-18 00:00:00",
27058,1,21205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Approv.pdf","2004-06-28 00:00:00",
36343,2,21205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Prntlbl.pdf","2004-06-28 00:00:00",
42021,3,21205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205_Trizinir.cfm","2004-03-28 00:00:00",
4632,1,21205,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s2ltr.pdf","2002-02-05 00:00:00",
42022,3,21205,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s002_Trizivir.cfm","2005-04-08 00:00:00",
4633,1,21205,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf","2004-03-01 00:00:00",
36344,2,21205,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s003lbl.pdf","2002-06-04 00:00:00",
42023,3,21205,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s003_Trizivir.cfm","2005-03-08 00:00:00",
27059,1,21205,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf","2004-03-01 00:00:00",
42024,3,21205,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021205_S005_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
4634,1,21205,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf","2002-08-13 00:00:00",
21506,3,21205,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s006_Trizivir.cfm","2005-03-08 00:00:00",
36345,2,21205,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s6lbl.pdf","2002-08-13 00:00:00",
27060,1,21205,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr007ltr.pdf","2002-10-08 00:00:00",
36346,2,21205,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s7lbl.pdf","2002-10-08 00:00:00",
42025,3,21205,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S009_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
42026,3,21205,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S010_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
27061,1,21205,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021205s011ltr.pdf","2005-05-17 00:00:00",
36347,2,21205,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021205s011lbl.pdf","2005-05-17 00:00:00",
42027,3,21205,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021205_S011_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
42028,3,21205,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S012_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
4635,1,21205,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021205s014LTR.pdf","2006-08-18 00:00:00",
36348,2,21205,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021205s014lbl.pdf","2006-08-14 00:00:00",
42029,3,21205,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S014_TRIZIVIR_AP.pdf","2007-07-09 00:00:00",
27062,1,21205,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021205s018ltr.pdf","2007-05-09 00:00:00",
36349,2,21205,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021205s018lbl.pdf","2007-05-09 00:00:00",
4636,1,21205,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021205s021ltr.pdf","2009-03-11 00:00:00",
14632,2,21205,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf","2009-04-03 00:00:00",
4637,1,21205,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s023ltr.pdf","2011-04-04 00:00:00",
36350,2,21205,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s023lbl.pdf","2011-04-01 00:00:00",
27063,1,21205,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf","2010-08-10 00:00:00",
27064,1,21205,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf","2011-05-17 00:00:00",
27065,1,21205,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s029ltr.pdf","2011-11-22 00:00:00",
36351,2,21205,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s029lbl.pdf","2011-11-25 00:00:00",
27066,1,21205,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s030ltr.pdf","2012-03-13 00:00:00",
36352,2,21205,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s030lbl.pdf","2012-03-12 00:00:00",
4638,1,21205,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s031ltr.pdf","2012-05-22 00:00:00",
36353,2,21205,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s031lbl.pdf","2012-05-22 00:00:00",
4639,1,21205,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021205Orig1s034ltr.pdf","2015-10-02 00:00:00",
36354,2,21205,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf","2015-10-07 00:00:00",
47367,2,21205,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s035lbl.pdf","2017-02-28 00:00:00",
47437,1,21205,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021205Orig1s035ltr.pdf","2017-03-03 00:00:00",
47600,1,21205,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021205Orig1s036ltr.pdf","2017-03-20 00:00:00",
48059,2,21205,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s036lbl.pdf","2017-04-18 00:00:00",
53985,1,21205,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021205Orig1s037ltr.pdf","2018-05-03 00:00:00",
54871,2,21205,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf","2018-07-12 00:00:00",
54872,8,21205,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf#page=34","2018-07-12 00:00:00",
14633,2,21208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_prntlbl.pdf","2001-01-12 00:00:00",
21507,3,21208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021208_remeron.cfm","2002-04-29 00:00:00",
23633,10,21208,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
27067,1,21208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_Approv.pdf","2001-01-12 00:00:00",
27068,1,21208,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf","2003-07-24 00:00:00",
27069,1,21208,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf","2004-06-07 00:00:00",
14634,2,21208,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf","2005-01-13 00:00:00",
27070,1,21208,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf","2005-01-13 00:00:00",
4640,1,21208,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf","2007-08-02 00:00:00",
36355,2,21208,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf","2007-07-31 00:00:00",
27071,1,21208,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021208s012ltr.pdf","2012-01-03 00:00:00",
36356,2,21208,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021208s012.pdf","2012-01-26 00:00:00",
14635,2,21208,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf","2010-05-28 00:00:00",
27072,1,21208,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf","2010-05-21 00:00:00",
4641,1,21208,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf","2010-05-21 00:00:00",
36357,2,21208,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf","2010-05-28 00:00:00",
4642,1,21208,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf","2012-11-01 00:00:00",
23234,8,21208,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016mg.pdf","2012-11-06 00:00:00",
36358,2,21208,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016lbl.pdf","2012-11-06 00:00:00",
14636,2,21208,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf","2016-08-01 00:00:00",
27073,1,21208,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf","2014-07-23 00:00:00",
36359,2,21208,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf","2014-07-30 00:00:00",
4643,1,21208,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf","2015-12-31 00:00:00",
14637,2,21208,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021208s022lbl.pdf","2015-12-31 00:00:00",
45762,2,21209,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013,021209s002lbl.pdf","2016-11-01 00:00:00",
14639,2,21210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21210lbl.pdf","2000-08-21 00:00:00",
27075,1,21210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21210ltr.pdf","2000-08-21 00:00:00",
42031,3,21210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21210_Unithroid.cfm","2000-08-21 00:00:00",
44106,10,21210,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm161257.htm","2009-05-30 00:00:00",
21508,3,21210,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021210_s002_Unithroid.pdf","2005-05-13 00:00:00",
27076,1,21210,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21210se4-002ltr.pdf","2004-06-24 00:00:00",
4644,1,21210,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21210s003ltr.pdf","2004-12-22 00:00:00",
21509,3,21210,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021210_S003_Unithroid.pdf","2005-05-13 00:00:00",
27077,1,21210,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021210s004ltr.pdf","2008-02-14 00:00:00",
36360,2,21210,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021210s004lbl.pdf","2008-02-14 00:00:00",
21510,3,21210,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021210_s006_unithroid tabs.pdf","2011-02-15 00:00:00",
27078,1,21211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21211ltr.pdf","2004-03-28 00:00:00",
36361,2,21211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf","2004-04-05 00:00:00",
42032,3,21211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021211s000_FollistimTOC.cfm","2006-07-25 00:00:00",
4645,1,21211,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21211s002ltr.pdf","2005-02-17 00:00:00",
36362,2,21211,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf","2005-02-17 00:00:00",
27079,1,21211,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021211s007ltr.pdf","2010-07-01 00:00:00",
36363,2,21211,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf","2010-06-28 00:00:00",
4646,1,21211,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021211s011ltr.pdf","2011-08-24 00:00:00",
14640,2,21211,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf","2011-08-22 00:00:00",
4647,1,21212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21212ltr.pdf","2002-06-11 00:00:00",
21511,3,21212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-212_Caverject.cfm","2002-06-11 00:00:00",
36364,2,21212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21212lbl.pdf","2002-06-11 00:00:00",
4648,1,21212,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf","2003-09-09 00:00:00",
14641,2,21212,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf","2013-12-23 00:00:00",
27080,1,21212,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021212Orig1s007ltr.pdf","2013-12-20 00:00:00",
27081,1,21212,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021212Orig1s010ltr.pdf","2014-06-12 00:00:00",
27082,1,21212,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021212Orig1s011ltr.pdf","2015-10-28 00:00:00",
36365,2,21212,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021212s011lbl.pdf","2015-11-04 00:00:00",
4649,1,21212,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s014ltr.pdf","2016-05-06 00:00:00",
14642,2,21212,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf","2016-05-06 00:00:00",
45701,1,21212,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf","2016-10-28 00:00:00",
45756,2,21212,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf","2016-11-01 00:00:00",
45702,1,21212,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf","2016-10-28 00:00:00",
45755,2,21212,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf","2016-11-01 00:00:00",
21512,3,21214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm","2004-06-16 00:00:00",
27083,1,21214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21214ltr.pdf","2000-08-03 00:00:00",
36366,2,21214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf","2000-08-03 00:00:00",
21513,3,21214,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf","2015-11-18 00:00:00",
36367,2,21214,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf","2012-12-10 00:00:00",
14643,2,21214,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf","2012-12-10 00:00:00",
21514,3,21214,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf","2015-11-17 00:00:00",
4650,1,21216,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf","2004-06-10 00:00:00",
14644,2,21216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf","2000-10-12 00:00:00",
21515,3,21216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm","2004-05-06 00:00:00",
27084,1,21216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf","2000-10-12 00:00:00",
44608,16,21216,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
4651,1,21217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s000ltr.pdf","2010-03-03 00:00:00",
24188,21,21217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000SumR.pdf","2010-05-23 00:00:00",
27085,1,21217,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s001ltr.pdf","2010-03-31 00:00:00",
36368,2,21217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021217lbl.pdf","2010-03-02 00:00:00",
42033,3,21217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000TOC.cfm","2010-05-23 00:00:00",
44474,14,21217,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
4652,1,21217,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s002ltr.pdf","2012-07-11 00:00:00",
36369,2,21217,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf","2012-07-12 00:00:00",
14645,2,21217,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf","2012-08-28 00:00:00",
27086,1,21217,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s004ltr.pdf","2012-08-28 00:00:00",
43720,8,21217,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004mg.pdf","2012-08-28 00:00:00",
4653,1,21217,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s005ltr.pdf","2013-03-19 00:00:00",
36370,2,21217,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021217s005lbl.pdf","2013-03-18 00:00:00",
4654,1,21217,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s006ltr.pdf","2013-04-17 00:00:00",
4655,1,21217,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s009ltr.pdf","2015-06-04 00:00:00",
14646,2,21217,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021217s009lbl.pdf","2015-06-04 00:00:00",
14647,2,21217,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf","2014-06-26 00:00:00",
27087,1,21217,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s012ltr.pdf","2014-06-19 00:00:00",
27088,1,21217,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s013ltr.pdf","2014-04-17 00:00:00",
36371,2,21217,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217s013lbl.pdf","2014-04-16 00:00:00",
4656,1,21217,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s014ltr.pdf","2014-08-20 00:00:00",
4657,1,21217,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s015ltr.pdf","2015-07-02 00:00:00",
27089,1,21217,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s017ltr.pdf","2016-04-22 00:00:00",
46278,1,21217,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s019ltr.pdf","2016-12-20 00:00:00",
46357,2,21217,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021217s019lbl.pdf","2016-12-21 00:00:00",
45463,1,21217,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s020ltr.pdf","2016-10-04 00:00:00",
48566,1,21217,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021217Orig1s021ltr.pdf","2017-05-30 00:00:00",
55674,1,21217,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021217Orig1s023s024ltr.pdf","2018-10-01 00:00:00",
55675,1,21217,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021217Orig1s023s024ltr.pdf","2018-10-01 00:00:00",
4658,1,21222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21222ltr.pdf","2001-08-29 00:00:00",
14648,2,21222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf","2001-08-29 00:00:00",
14649,2,21222,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf","2002-08-21 00:00:00",
21516,3,21222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-222_Spectracef.cfm","2001-12-07 00:00:00",
27090,1,21222,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21222se1-001ltr.pdf","2002-08-26 00:00:00",
27091,1,21222,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21222s003ltr.pdf","2004-03-28 00:00:00",
27092,1,21222,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021222s006ltr.pdf","2009-11-12 00:00:00",
27093,1,21222,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021222s009ltr.pdf","2006-01-19 00:00:00",
36372,2,21222,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021222s009lbl.pdf","2006-01-06 00:00:00",
4659,1,21222,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021222s012ltr.pdf","2008-08-05 00:00:00",
14650,2,21222,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf","2008-07-23 00:00:00",
14651,2,21222,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf","2012-08-07 00:00:00",
27094,1,21222,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf","2012-08-07 00:00:00",
4660,1,21222,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf","2012-08-07 00:00:00",
36373,2,21222,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf","2012-08-07 00:00:00",
21517,3,21223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-223_Zometa.cfm","2001-08-20 00:00:00",
23634,10,21223,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2003-12-12 00:00:00",
27095,1,21223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21223ltr.pdf","2001-08-20 00:00:00",
36374,2,21223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21223lbl.pdf","2001-08-20 00:00:00",
52394,23,21223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021223_Tab 4 zoledronic_Zometa(amended)_8-30-06_HFD510_WR.pdf","1900-01-01 00:00:00",
53442,18,21223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021223_Zoledronic_Acid_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53443,17,21223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021223_Zoledronic_Acid_Statistical_BPCA.pdf","1900-01-01 00:00:00",
53444,20,21223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021223_Zoledronic_Acid_Clinical_BPCA.pdf","1900-01-01 00:00:00",
4661,1,21223,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf","2002-02-22 00:00:00",
14652,2,21223,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf","2002-02-22 00:00:00",
42034,3,21223,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm","2002-02-22 00:00:00",
4662,1,21223,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21223scf004ltr.pdf","2003-03-26 00:00:00",
14653,2,21223,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21223scf004_zometa_lbl.pdf","2003-03-26 00:00:00",
42035,3,21223,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021223_s004_ZOMETA.pdf","2008-08-01 00:00:00",
4663,1,21223,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf","2004-03-02 00:00:00",
36375,2,21223,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf","2004-03-25 00:00:00",
14654,2,21223,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21223slr008_zometa_lbl.pdf","2004-04-05 00:00:00",
27096,1,21223,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr008ltr.pdf","2004-03-28 00:00:00",
27097,1,21223,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf","2005-02-03 00:00:00",
36376,2,21223,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf","2005-02-03 00:00:00",
14655,2,21223,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf","2005-02-03 00:00:00",
27098,1,21223,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf","2005-02-03 00:00:00",
14656,2,21223,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s011lbl.pdf","2005-10-14 00:00:00",
27099,1,21223,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s011ltr.pdf","2005-10-14 00:00:00",
4664,1,21223,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021223s012LTRpdf.pdf","2006-05-26 00:00:00",
36377,2,21223,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021223s012lbl.pdf","2006-05-26 00:00:00",
14657,2,21223,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021223s014lbl.pdf","2007-11-07 00:00:00",
27100,1,21223,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf","2007-11-08 00:00:00",
27101,1,21223,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf","2007-11-08 00:00:00",
14658,2,21223,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021223s016lbl.pdf","2008-03-24 00:00:00",
27102,1,21223,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021223s016ltr.pdf","2008-03-21 00:00:00",
14659,2,21223,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021223s018lbl.pdf","2009-11-17 00:00:00",
27103,1,21223,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021223s018ltr.pdf","2010-01-25 00:00:00",
27104,1,21223,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s022ltr.pdf","2012-03-16 00:00:00",
36378,2,21223,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s022lbl.pdf","2012-03-16 00:00:00",
4665,1,21223,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s023ltr_replacement.pdf","2012-11-14 00:00:00",
36379,2,21223,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s023lbl.pdf","2012-11-15 00:00:00",
27105,1,21223,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021223Orig1s027ltr.pdf","2013-10-01 00:00:00",
36380,2,21223,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021223s027lbl.pdf","2013-10-01 00:00:00",
14660,2,21223,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf","2014-04-08 00:00:00",
27106,1,21223,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021223Orig1s028ltr_replacement.pdf","2014-04-08 00:00:00",
14661,2,21223,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s031lbl.pdf","2015-01-08 00:00:00",
27107,1,21223,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s031ltr.pdf","2015-01-07 00:00:00",
4666,1,21223,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s032ltr.pdf","2015-06-10 00:00:00",
36381,2,21223,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s032lbl.pdf","2015-06-11 00:00:00",
27108,1,21223,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021223Orig1s034ltr.pdf","2016-04-04 00:00:00",
36382,2,21223,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s034lbl.pdf","2016-03-31 00:00:00",
46586,1,21223,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021223Orig1s035ltr.pdf","2016-12-29 00:00:00",
46596,2,21223,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s035lbl.pdf","2016-12-30 00:00:00",
4667,1,21224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21224ltr.pdf","2001-06-22 00:00:00",
14662,2,21224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21224lbl.pdf","2001-06-22 00:00:00",
21518,3,21224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-224_Reminyl.cfm","2002-03-05 00:00:00",
23635,10,21224,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2005-07-29 00:00:00",
4668,1,21224,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf","2002-05-02 00:00:00",
4669,1,21224,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr007ltr.pdf","2003-09-09 00:00:00",
27109,1,21224,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
4670,1,21224,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf","2005-05-03 00:00:00",
27110,1,21224,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
4671,1,21224,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
4672,1,21224,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
14663,2,21224,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf","2012-03-06 00:00:00",
27111,1,21224,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf","2012-03-05 00:00:00",
4673,1,21224,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf","2012-03-05 00:00:00",
36383,2,21224,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf","2012-03-06 00:00:00",
4674,1,21224,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf","2013-07-02 00:00:00",
14664,2,21224,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf","2013-07-11 00:00:00",
4675,1,21224,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf","2012-03-05 00:00:00",
36384,2,21224,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf","2012-05-01 00:00:00",
4676,1,21224,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf","2015-02-12 00:00:00",
36385,2,21224,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf","2015-02-10 00:00:00",
14665,2,21224,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf","2015-12-17 00:00:00",
27112,1,21224,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf","2015-12-17 00:00:00",
47238,1,21224,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023ltr.pdf","2017-02-16 00:00:00",
47241,2,21224,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf","2017-02-16 00:00:00",
21519,3,21225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm","2004-05-06 00:00:00",
53314,20,21225,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21225_mirena_clinical_PREA.pdf","1900-01-01 00:00:00",
53315,18,21225,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21225_mirena_clinpharm_PREA.pdf","1900-01-01 00:00:00",
53316,17,21225,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21225_mirena_statistical_PREA.pdf","1900-01-01 00:00:00",
27113,1,21225,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21225slr009ltr.pdf","2004-01-14 00:00:00",
27114,1,21225,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21225sce010ltr.pdf","2003-08-29 00:00:00",
4677,1,21225,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s017ltr.pdf","2008-05-30 00:00:00",
4678,1,21225,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s018ltr.pdf","2008-06-06 00:00:00",
4679,1,21225,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s019ltr.pdf","2008-07-24 00:00:00",
36386,2,21225,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf","2008-07-22 00:00:00",
4680,1,21225,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021225s027ltr.pdf","2009-11-10 00:00:00",
36387,2,21225,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf","2009-10-14 00:00:00",
4681,1,21225,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021225Orig1s031ltr.pdf","2015-10-26 00:00:00",
21520,3,21225,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021225Orig1s031.pdf","2016-02-03 00:00:00",
36388,2,21225,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf","2015-10-26 00:00:00",
4682,1,21225,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021225Orig1s032_correctionltr.pdf","2013-08-08 00:00:00",
36389,2,21225,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf","2013-08-09 00:00:00",
36390,2,21225,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf","2014-05-30 00:00:00",
42036,3,21225,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021225Orig1s033.pdf","2015-03-09 00:00:00",
46506,2,21225,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021225s037lbl.pdf","2016-12-21 00:00:00",
46524,1,21225,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/21225Orig1s037ltr.pdf","2016-12-23 00:00:00",
48684,2,21225,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s038lbl.pdf","2017-06-08 00:00:00",
48688,1,21225,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1s038ltr.pdf","2017-06-09 00:00:00",
48556,2,21225,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s039lbl.pdf","2017-05-30 00:00:00",
48560,1,21225,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1S039ltr.pdf","2017-05-30 00:00:00",
4683,1,21226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21226ltr.pdf","2000-09-15 00:00:00",
21521,3,21226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm","2000-09-15 00:00:00",
23067,6,21226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226ppi.pdf","2000-09-15 00:00:00",
36391,2,21226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226lbl.pdf","2000-09-15 00:00:00",
51316,20,21226,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21226 lopinavir-ritonavir clinical prea.pdf","1900-01-01 00:00:00",
51340,18,21226,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21226 lopinavir ritonavir clinpharm prea.pdf","1900-01-01 00:00:00",
51341,17,21226,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21226 lopinavir-ritonavir statistical prea.pdf","1900-01-01 00:00:00",
14666,2,21226,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf","2001-03-13 00:00:00",
21522,3,21226,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm","2001-03-13 00:00:00",
27115,1,21226,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21251s2ltr.pdf","2001-03-13 00:00:00",
27116,1,21226,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21226s3ltr.pdf","2002-01-18 00:00:00",
36392,2,21226,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf","2002-01-18 00:00:00",
42037,3,21226,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-251S003_Kaletra.cfm","2002-01-18 00:00:00",
21523,3,21226,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021226_S006_KALETRA.pdf","2007-09-26 00:00:00",
36393,2,21226,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf","2002-11-27 00:00:00",
14667,2,21226,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf","2003-12-08 00:00:00",
27117,1,21226,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21226slr012,21251slr009ltr.pdf","2003-12-08 00:00:00",
4684,1,21226,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21226s014,21251s010ltr.pdf","2004-10-26 00:00:00",
36394,2,21226,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf","2004-10-26 00:00:00",
42038,3,21226,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021226_S014_KALETRA.pdf","2007-09-26 00:00:00",
14668,2,21226,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s016lbl.pdf","2005-05-03 00:00:00",
27118,1,21226,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s016ltr.pdf","2005-05-03 00:00:00",
14669,2,21226,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf","2005-03-30 00:00:00",
21524,3,21226,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021226_S017_KALETRA.pdf","2007-09-26 00:00:00",
27119,1,21226,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s017,021251s011ltr.pdf","2005-03-30 00:00:00",
27120,1,21226,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s018_LTR.pdf","2007-04-25 00:00:00",
36395,2,21226,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s018lbl.pdf","2007-04-25 00:00:00",
14670,2,21226,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021226s019lbl.pdf","2006-12-28 00:00:00",
27121,1,21226,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021226s019ltr.pdf","2007-01-08 00:00:00",
4685,1,21226,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s020ltr.pdf","2007-07-16 00:00:00",
36396,2,21226,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s020lbl.pdf","2007-07-10 00:00:00",
27122,1,21226,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s022ltr.pdf","2007-10-04 00:00:00",
36397,2,21226,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s022lbl.pdf","2007-09-26 00:00:00",
27123,1,21226,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021226s030ltr.pdf","2010-06-09 00:00:00",
36398,2,21226,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021226s030lbl.pdf","2010-05-07 00:00:00",
27124,1,21226,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s035ltr.pdf","2012-02-27 00:00:00",
36399,2,21226,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf","2012-02-22 00:00:00",
4686,1,21226,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s036ltr.pdf","2012-06-28 00:00:00",
36400,2,21226,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s036lbl.pdf","2012-06-28 00:00:00",
4687,1,21226,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s037ltr.pdf","2013-01-22 00:00:00",
36401,2,21226,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s037lbl.pdf","2013-01-22 00:00:00",
27125,1,21226,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s038ltr.pdf","2013-11-08 00:00:00",
36402,2,21226,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf","2013-11-08 00:00:00",
27126,1,21226,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s040ltr.pdf","2015-07-06 00:00:00",
36403,2,21226,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf","2015-07-01 00:00:00",
14671,2,21226,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s041lbl.pdf","2015-04-02 00:00:00",
27127,1,21226,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s041ltr.pdf","2015-04-01 00:00:00",
4688,1,21226,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s042ltr.pdf","2015-11-13 00:00:00",
14672,2,21226,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf","2015-11-12 00:00:00",
45944,1,21226,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021226Orig1s043ltr.pdf","2016-11-23 00:00:00",
46000,2,21226,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s043lbl.pdf","2016-12-02 00:00:00",
45340,1,21226,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021226Orig1s044ltr.pdf","2016-09-20 00:00:00",
45378,2,21226,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf","2016-09-20 00:00:00",
48736,2,21226,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf","2017-06-16 00:00:00",
48737,8,21226,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf#page=50","2017-06-16 00:00:00",
48743,1,21226,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021226Orig1s045ltr.pdf","2017-06-16 00:00:00",
4689,1,21227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_Approv.pdf","2001-01-26 00:00:00",
4690,1,21227,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf","2002-09-20 00:00:00",
14673,2,21227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_prntlbl.pdf","2001-01-26 00:00:00",
14674,2,21227,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf","2002-09-20 00:00:00",
42039,3,21227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas.cfm","2001-01-26 00:00:00",
54100,20,21227,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021227_Caspofungin_Clinical_BPCA.pdf","1900-01-01 00:00:00",
54101,18,21227,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021227_Caspofungin_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
54102,17,21227,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021227_Caspofungin_Statistical_BPCA.pdf","1900-01-01 00:00:00",
27128,1,21227,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf","2002-09-20 00:00:00",
36404,2,21227,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf","2002-09-20 00:00:00",
27129,1,21227,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227slr005ltr.pdf","2002-11-21 00:00:00",
36405,2,21227,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227_cancidas_lbl.pdf","2002-11-21 00:00:00",
4691,1,21227,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21227se1-007ltr.pdf","2004-05-28 00:00:00",
36406,2,21227,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021227s007lbl.pdf","2003-03-07 00:00:00",
4692,1,21227,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf","2004-03-24 00:00:00",
14675,2,21227,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf","2004-04-05 00:00:00",
27130,1,21227,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227s012ltr.pdf","2004-10-04 00:00:00",
36407,2,21227,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227s012lbl.pdf","2004-10-04 00:00:00",
4693,1,21227,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf","2004-03-24 00:00:00",
21525,3,21227,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021227_S014_CANCIDAS.pdf","2008-07-31 00:00:00",
36408,2,21227,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf","2004-04-05 00:00:00",
27131,1,21227,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21227s015ltr.pdf","2005-02-17 00:00:00",
36409,2,21227,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21227s015lbl.pdf","2005-02-17 00:00:00",
4694,1,21227,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s021ltr.pdf","2008-07-31 00:00:00",
36410,2,21227,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021227s021lbl.pdf","2008-08-13 00:00:00",
51284,23,21227,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021227_Caspofungin_WR_Amend_4.pdf","2007-08-15 00:00:00",
4695,1,21227,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s022ltr.pdf","2008-07-24 00:00:00",
14676,2,21227,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021227s023lbl.pdf","2009-06-29 00:00:00",
27132,1,21227,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s023ltr.pdf","2009-06-30 00:00:00",
27133,1,21227,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s024ltr.pdf","2009-05-07 00:00:00",
4696,1,21227,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s027ltr.pdf","2010-02-05 00:00:00",
14677,2,21227,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s027lbl.pdf","2010-02-04 00:00:00",
4697,1,21227,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s028ltr.pdf","2010-11-02 00:00:00",
36411,2,21227,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s028lbl.pdf","2010-10-25 00:00:00",
27134,1,21227,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021227s029ltr.pdf","2012-05-02 00:00:00",
4698,1,21227,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s030ltr.pdf","2013-08-05 00:00:00",
36412,2,21227,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s030lbl.pdf","2013-08-06 00:00:00",
4699,1,21227,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s031ltr.pdf","2013-01-10 00:00:00",
14678,2,21227,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s031lbl.pdf","2013-01-11 00:00:00",
27135,1,21227,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021227Orig1s033ltr.pdf","2014-10-27 00:00:00",
36413,2,21227,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021227s033lbl.pdf","2014-11-18 00:00:00",
4700,1,21227,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf","2016-04-14 00:00:00",
14679,2,21227,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf","2016-04-13 00:00:00",
27136,1,21227,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf","2016-04-14 00:00:00",
36414,2,21227,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf","2016-04-13 00:00:00",
49340,2,21227,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s036lbl.pdf","2017-08-11 00:00:00",
49403,1,21227,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021227Orig1s036ltr.pdf","2017-08-15 00:00:00",
49560,2,21227,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s037lbl.pdf","2017-08-25 00:00:00",
49624,1,21227,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021227Orig1s037ltr.pdf","2017-08-30 00:00:00",
52978,2,21227,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021227s038lbl.pdf","2018-03-15 00:00:00",
52988,1,21227,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021227Orig1s038ltr.pdf","2018-03-15 00:00:00",
4701,1,21228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21228ltr.pdf","2000-12-22 00:00:00",
14680,2,21228,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21228s1lbl.pdf","2003-05-01 00:00:00",
21526,3,21228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-228_Detrol.cfm","2004-02-11 00:00:00",
36415,2,21228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf","2000-12-22 00:00:00",
42040,3,21228,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S001_DetrolTOC.cfm","2007-06-11 00:00:00",
53133,17,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_Detrol_StatsRev-21228s006.pdf","1900-01-01 00:00:00",
53134,18,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_DetrolLA_ClinPharmRev-21228s006.pdf","1900-01-01 00:00:00",
53135,20,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/Tolterodine_Detrol_MedRev-21228s006 (R).pdf","1900-01-01 00:00:00",
53136,20,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_Detrol_MedRev(BPCA)-21228s006.pdf","1900-01-01 00:00:00",
53137,23,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_detrol_021228_Orig1_WR.pdf","1900-01-01 00:00:00",
53138,25,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_detrol_021228_Amend1_WR.pdf","1900-01-01 00:00:00",
53139,26,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_detrol_021228_Amend2_WR.pdf","1900-01-01 00:00:00",
53140,27,21228,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/tolterodine_detrol_021228_Amend3_WR.pdf","1900-01-01 00:00:00",
21527,3,21228,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S002_DetrolTOC.cfm","2007-06-11 00:00:00",
42041,3,21228,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S003_DetrolTOC.cfm","2007-06-11 00:00:00",
27137,1,21228,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21228slr004ltr.pdf","2003-07-28 00:00:00",
4702,1,21228,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21228slr005ltr.pdf","2004-01-22 00:00:00",
27138,1,21228,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21228se8-006ltr.pdf","2004-04-20 00:00:00",
36416,2,21228,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21228se8-006_detrol_lbl.pdf","2004-05-03 00:00:00",
42042,3,21228,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021228_S006_DetrolTOC.cfm","2007-06-11 00:00:00",
4703,1,21228,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021228s007ltr.pdf","2005-10-25 00:00:00",
14681,2,21228,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s007lbl.pdf","2005-10-25 00:00:00",
27139,1,21228,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021228s008ltr.pdf","2005-07-21 00:00:00",
36417,2,21228,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s008lbl.pdf","2005-07-21 00:00:00",
4704,1,21228,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020771s017, 21228s010ltr.pdf","2007-03-23 00:00:00",
47866,2,21228,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021228Orig1s010lbl.pdf","2017-04-05 00:00:00",
4705,1,21228,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020771s019, 021228s012ltr.pdf","2008-09-15 00:00:00",
27140,1,21228,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021228s015ltr.pdf","2010-01-06 00:00:00",
36418,2,21228,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021228s015lbl.pdf","2010-01-08 00:00:00",
4706,1,21228,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021228s016ltr.pdf","2011-09-23 00:00:00",
36419,2,21228,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021228s016lbl.pdf","2011-09-23 00:00:00",
4707,1,21228,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021228Orig1s021ltr.pdf","2012-08-03 00:00:00",
14682,2,21228,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021228s021lbl.pdf","2012-08-02 00:00:00",
54920,2,21228,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf","2018-07-19 00:00:00",
54929,1,21228,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021228Orig1s023ltr.pdf","2018-07-20 00:00:00",
14683,2,21229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf","2003-06-20 00:00:00",
23636,10,21229,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2003-06-20 00:00:00",
27141,1,21229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21229ltr_Prilosec.pdf","2003-06-24 00:00:00",
42043,3,21229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-229_Prilosec.cfm","2005-04-08 00:00:00",
4708,1,21229,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21229s002ltr.pdf","2004-12-30 00:00:00",
36420,2,21229,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf","2004-12-30 00:00:00",
14684,2,21229,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf","2006-10-05 00:00:00",
27142,1,21229,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021229s005LTR.pdf","2006-10-05 00:00:00",
14685,2,21229,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf","2007-03-23 00:00:00",
27143,1,21229,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021229s006ltr.pdf","2007-03-23 00:00:00",
4709,1,21229,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s008ltr.pdf","2008-01-24 00:00:00",
4710,1,21229,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s009ltr.pdf","2008-03-04 00:00:00",
27144,1,21229,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s010ltr.pdf","2008-06-20 00:00:00",
27145,1,21229,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021229s013ltr.pdf","2009-11-10 00:00:00",
27146,1,21229,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s014ltr.pdf","2010-07-08 00:00:00",
27147,1,21229,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s017ltr.pdf","2010-12-22 00:00:00",
27148,1,21229,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s019ltr.pdf","2011-03-02 00:00:00",
27149,1,21229,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s020ltr.pdf","2011-06-29 00:00:00",
4711,1,21229,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s021ltr.pdf","2011-07-25 00:00:00",
4712,1,21229,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s023ltr.pdf","2011-08-31 00:00:00",
14686,2,21229,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf","2012-03-27 00:00:00",
4713,1,21229,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021229Orig1s024ltr.pdf","2012-09-14 00:00:00",
14687,2,21229,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf","2013-09-19 00:00:00",
27150,1,21229,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021229Orig1s025ltr.pdf","2013-09-10 00:00:00",
27151,1,21229,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021229Orig1s026ltr.pdf","2015-06-24 00:00:00",
36421,2,21229,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf","2015-07-02 00:00:00",
45545,1,21229,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021229Orig1s029ltr.pdf","2016-10-14 00:00:00",
45691,2,21229,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf","2016-10-27 00:00:00",
53619,1,21229,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s031ltr.pdf","2018-04-05 00:00:00",
53626,2,21229,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s031lbl.pdf","2018-04-05 00:00:00",
54599,1,21229,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s032ltr.pdf","2018-06-14 00:00:00",
54617,2,21229,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s032lbl.pdf","2018-06-20 00:00:00",
4714,1,21231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21231ltr.pdf","2001-02-13 00:00:00",
14688,2,21231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf","2001-02-13 00:00:00",
21528,3,21231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm","2004-06-14 00:00:00",
23637,10,21231,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
4715,1,21231,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf","2002-10-09 00:00:00",
21529,3,21231,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021231_S003_ZOMIG_TABLETS.pdf","2008-02-19 00:00:00",
4716,1,21231,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf","2003-06-08 00:00:00",
27152,1,21231,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf","2004-01-14 00:00:00",
4717,1,21231,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021231s009ltr.pdf","2010-08-16 00:00:00",
14689,2,21231,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf","2010-08-19 00:00:00",
4718,1,21231,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf","2012-09-18 00:00:00",
14690,2,21231,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf","2012-09-18 00:00:00",
27153,1,21231,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf","2012-09-18 00:00:00",
36422,2,21231,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf","2012-09-18 00:00:00",
14691,2,21232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21232lbl.pdf","2002-01-18 00:00:00",
21530,3,21232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-232_Orfadin.cfm","2002-01-18 00:00:00",
27154,1,21232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21232ltr.pdf","2002-01-18 00:00:00",
4719,1,21232,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021232s008ltr.pdf","2010-02-05 00:00:00",
36423,2,21232,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021232s008lbl.pdf","2010-02-04 00:00:00",
4720,1,21232,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021232Orig1s010ltr.pdf","2013-02-15 00:00:00",
14692,2,21232,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf","2013-02-14 00:00:00",
14693,2,21232,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021232s013lbl.pdf","2014-05-28 00:00:00",
27155,1,21232,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021232Orig1s013ltr.pdf","2014-05-22 00:00:00",
36424,2,21232,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021232s017lbl.pdf","2016-06-17 00:00:00",
48924,2,21232,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s019lbl.pdf","2017-07-07 00:00:00",
49661,2,21232,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s020lbl.pdf","2017-09-05 00:00:00",
49670,1,21232,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021232Orig1s020ltr.pdf","2017-09-06 00:00:00",
14694,2,21234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021234lbl.pdf","2007-02-02 00:00:00",
27156,1,21234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021234s000ltr.pdf","2007-02-12 00:00:00",
42044,3,21234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021234s000TOC.cfm","2008-01-23 00:00:00",
4721,1,21234,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s003ltr.pdf","2008-06-06 00:00:00",
14695,2,21234,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021234s003lbl.pdf","2008-06-19 00:00:00",
27157,1,21234,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s004ltr.pdf","2008-10-28 00:00:00",
4722,1,21234,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf","2011-02-04 00:00:00",
14696,2,21234,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s005lbl.pdf","2011-01-31 00:00:00",
14697,2,21234,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf","2009-10-06 00:00:00",
27158,1,21234,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021234s006ltr.pdf","2009-11-10 00:00:00",
36425,2,21234,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf","2009-10-06 00:00:00",
4723,1,21234,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf","2011-02-04 00:00:00",
23236,8,21234,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009MedG.pdf","2011-03-04 00:00:00",
27159,1,21234,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s009ltr.pdf","2011-02-28 00:00:00",
36426,2,21234,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009lbl.pdf","2011-03-04 00:00:00",
27160,1,21234,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf","2016-05-11 00:00:00",
36427,2,21234,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf","2016-05-11 00:00:00",
4724,1,21234,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf","2016-05-11 00:00:00",
36428,2,21234,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf","2016-05-11 00:00:00",
55382,2,21234,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf","2018-09-05 00:00:00",
55472,1,21234,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021234Orig1s015ltr.pdf","2018-09-13 00:00:00",
21531,3,21235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-235_Prozac.cfm","2004-10-18 00:00:00",
27161,1,21235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21235ltr.pdf","2001-02-26 00:00:00",
36429,2,21235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21235LBL.PDF","2001-02-26 00:00:00",
44107,10,21235,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
4725,1,21235,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf","2004-08-25 00:00:00",
27162,1,21235,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf","2005-12-06 00:00:00",
27163,1,21235,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf","2005-02-23 00:00:00",
4726,1,21235,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf","2006-04-13 00:00:00",
14698,2,21235,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf","2006-09-21 00:00:00",
27164,1,21235,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf","2007-03-23 00:00:00",
14699,2,21235,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf","2007-08-03 00:00:00",
27165,1,21235,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
14700,2,21235,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf","2008-03-13 00:00:00",
27166,1,21235,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf","2008-03-12 00:00:00",
14701,2,21235,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf","2008-03-24 00:00:00",
27167,1,21235,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf","2008-03-24 00:00:00",
4727,1,21235,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf","2009-02-03 00:00:00",
14702,2,21235,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf","2009-02-04 00:00:00",
14703,2,21235,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s015lbl.pdf","2011-04-04 00:00:00",
27168,1,21235,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
4728,1,21235,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
14704,2,21235,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s016lbl.pdf","2011-04-04 00:00:00",
21532,3,21235,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021235Orig1s016.pdf","2013-10-23 00:00:00",
14705,2,21235,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s017lbl.pdf","2011-04-04 00:00:00",
27169,1,21235,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf","2011-04-13 00:00:00",
4729,1,21235,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf","2011-06-23 00:00:00",
14706,2,21235,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf","2011-06-16 00:00:00",
14707,2,21235,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf","2013-01-07 00:00:00",
27170,1,21235,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf","2013-01-07 00:00:00",
4730,1,21235,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf","2013-01-07 00:00:00",
14708,2,21235,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf","2013-01-07 00:00:00",
14709,2,21235,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf","2013-07-30 00:00:00",
27171,1,21235,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
47717,2,21235,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf","2017-03-27 00:00:00",
47718,8,21235,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28","2017-03-27 00:00:00",
47756,1,21235,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf","2017-03-29 00:00:00",
4731,1,21235,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf","2014-07-24 00:00:00",
14710,2,21235,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf","2014-07-23 00:00:00",
14711,2,21235,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021235s025lbl.pdf","2015-08-06 00:00:00",
27172,1,21235,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021235Orig1s025ltr.pdf","2015-08-06 00:00:00",
46699,2,21235,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021235s026lbl.pdf","2017-01-06 00:00:00",
46820,1,21235,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf","2017-01-13 00:00:00",
4732,1,21238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21238ltr.pdf","2001-06-27 00:00:00",
21533,3,21238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-238_Kytril.cfm","2001-06-27 00:00:00",
36430,2,21238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21238lbl.pdf","2001-06-27 00:00:00",
4733,1,21238,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005ltr.pdf","2005-11-30 00:00:00",
36431,2,21238,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf","2005-11-30 00:00:00",
27173,1,21238,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf","2009-11-12 00:00:00",
36432,2,21238,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf","2009-10-14 00:00:00",
14712,2,21241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21241lbl.pdf","2002-08-22 00:00:00",
27174,1,21241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21241ltr.pdf","2002-08-22 00:00:00",
42045,3,21241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021241_sooo_Orthotricyclene.cfm","2004-08-26 00:00:00",
42046,3,21241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021241_s003_OrthoTOC.cfm","2006-07-11 00:00:00",
27175,1,21241,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf","2012-06-20 00:00:00",
36433,2,21241,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021241s017lbl.pdf","2012-07-13 00:00:00",
14713,2,21241,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021241s025lbl.pdf","2015-08-04 00:00:00",
27176,1,21241,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021241Orig1s025ltr.pdf","2015-08-03 00:00:00",
49293,2,21241,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021241s027lbl.pdf","2017-08-09 00:00:00",
49373,1,21241,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021241Orig1s027ltr.pdf","2017-08-15 00:00:00",
21534,3,21243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21243_Azulfidine.cfm","2010-10-15 00:00:00",
4734,1,21246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21246ltr.pdf","2000-12-14 00:00:00",
14714,2,21246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf","2000-12-14 00:00:00",
14715,2,21246,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf","2003-05-01 00:00:00",
21535,3,21246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-246_Tamiflu.cfm","2004-08-09 00:00:00",
21536,3,21246,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm","2007-06-22 00:00:00",
44108,10,21246,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm","2003-12-12 00:00:00",
21537,3,21246,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021246_S002_TamifluTOC.cfm","2007-06-22 00:00:00",
14716,2,21246,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf","2003-05-01 00:00:00",
42047,3,21246,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm","2007-06-22 00:00:00",
14717,2,21246,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf","2003-04-22 00:00:00",
42048,3,21246,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm","2007-06-22 00:00:00",
21538,3,21246,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021246_S006_TamifluTOC.cfm","2007-06-22 00:00:00",
4735,1,21246,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf","2002-04-26 00:00:00",
36434,2,21246,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf","2002-04-26 00:00:00",
42049,3,21246,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm","2007-06-22 00:00:00",
4736,1,21246,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf","2009-10-16 00:00:00",
21539,3,21246,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm","2007-06-22 00:00:00",
27177,1,21246,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf","2004-07-01 00:00:00",
36435,2,21246,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf","2004-07-01 00:00:00",
4737,1,21246,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf","2009-10-19 00:00:00",
4738,1,21246,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s019_021246s012ltr.pdf","2009-10-19 00:00:00",
27178,1,21246,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf","2009-10-19 00:00:00",
27179,1,21246,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf","2009-10-19 00:00:00",
4739,1,21246,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf","2009-10-19 00:00:00",
21540,3,21246,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021246Orig1s017.pdf","2014-07-07 00:00:00",
23068,6,21246,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf","2006-01-10 00:00:00",
27180,1,21246,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf","2006-01-18 00:00:00",
36436,2,21246,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf","2006-01-05 00:00:00",
4740,1,21246,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf","2009-10-19 00:00:00",
27181,1,21246,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf","2009-10-19 00:00:00",
4741,1,21246,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf","2009-10-19 00:00:00",
23069,6,21246,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021ppi.pdf","2006-11-14 00:00:00",
27182,1,21246,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf","2006-11-16 00:00:00",
36437,2,21246,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021lbl.pdf","2006-11-14 00:00:00",
4742,1,21246,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf","2009-10-21 00:00:00",
4743,1,21246,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021246s023ltr.pdf","2009-10-19 00:00:00",
27183,1,21246,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf","2009-10-21 00:00:00",
4744,1,21246,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf","2009-10-21 00:00:00",
4745,1,21246,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf","2009-10-21 00:00:00",
14718,2,21246,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf","2007-07-05 00:00:00",
21541,3,21246,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021246Orig1s027.pdf","2013-06-03 00:00:00",
27184,1,21246,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf","2007-07-05 00:00:00",
14719,2,21246,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf","2007-10-10 00:00:00",
27185,1,21246,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf","2007-10-10 00:00:00",
27186,1,21246,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf","2008-01-18 00:00:00",
36438,2,21246,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf","2008-01-18 00:00:00",
4746,1,21246,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf","2010-12-21 00:00:00",
14720,2,21246,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf","2010-12-16 00:00:00",
4747,1,21246,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021246s032ltr.pdf","2009-10-19 00:00:00",
4748,1,21246,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf","2009-04-30 00:00:00",
14721,2,21246,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf","2009-04-30 00:00:00",
27187,1,21246,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf","2010-02-26 00:00:00",
36439,2,21246,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf","2010-03-03 00:00:00",
42050,3,21246,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s034.pdf","2015-07-22 00:00:00",
14722,2,21246,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf","2010-03-03 00:00:00",
21542,3,21246,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s035.pdf","2015-07-20 00:00:00",
27188,1,21246,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf","2010-02-26 00:00:00",
4749,1,21246,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf","2010-11-10 00:00:00",
36440,2,21246,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021246s038lbl.pdf","2010-11-05 00:00:00",
4750,1,21246,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf","2011-03-24 00:00:00",
21543,3,21246,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021246Orig1s039.pdf","2013-06-03 00:00:00",
36441,2,21246,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf","2011-03-23 00:00:00",
27189,1,21246,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf","2011-02-09 00:00:00",
36442,2,21246,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021246s040lbl.pdf","2011-02-07 00:00:00",
4751,1,21246,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf","2012-08-20 00:00:00",
14723,2,21246,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf","2012-08-17 00:00:00",
27190,1,21246,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf","2014-11-28 00:00:00",
36443,2,21246,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf","2014-12-03 00:00:00",
4752,1,21246,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf","2013-01-29 00:00:00",
36444,2,21246,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf","2013-08-12 00:00:00",
44475,14,21246,"SUPPL",44,"Package Labeling","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf","2013-08-12 00:00:00",
21544,3,21246,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm","2013-04-08 00:00:00",
24189,21,21246,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf","2012-12-21 00:00:00",
27191,1,21246,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf","2012-12-21 00:00:00",
36445,2,21246,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021246s045lbl.pdf","2012-12-21 00:00:00",
4753,1,21246,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf","2014-06-03 00:00:00",
36446,2,21246,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf","2014-06-03 00:00:00",
14724,2,21246,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf","2014-10-15 00:00:00",
27192,1,21246,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf","2014-10-16 00:00:00",
4754,1,21246,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf","2016-06-22 00:00:00",
36447,2,21246,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf","2016-06-21 00:00:00",
53630,1,21246,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021087Orig1s069,021246Orig1s052ltr.pdf","2018-04-06 00:00:00",
53668,2,21246,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s069,021246s052lbl.pdf","2018-04-13 00:00:00",
14725,2,21247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf","2006-02-02 00:00:00",
27193,1,21247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021247s000ltr.pdf","2006-02-02 00:00:00",
42051,3,21247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021247_aerospan_toc.cfm","2008-12-22 00:00:00",
14726,2,21247,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf","2012-11-19 00:00:00",
27194,1,21247,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021247Orig1s007ltr.pdf","2012-11-19 00:00:00",
27195,1,21247,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021247Orig1s008ltr.pdf","2013-08-29 00:00:00",
36448,2,21247,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021247s008lbl.pdf","2013-08-29 00:00:00",
48834,2,21247,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s015lbl.pdf","2017-06-26 00:00:00",
48836,1,21247,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s015ltr.pdf","2017-06-27 00:00:00",
50459,2,21247,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s016lbl.pdf","2017-11-20 00:00:00",
50492,1,21247,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s016ltr.pdf","2017-11-27 00:00:00",
53820,2,21247,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021247s017lbl.pdf","2018-04-26 00:00:00",
53868,1,21247,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021247Orig1s017ltr.pdf","2018-04-27 00:00:00",
14727,2,21248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf","2000-09-25 00:00:00",
27196,1,21248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21248ltr.pdf","2000-09-25 00:00:00",
42052,3,21248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-248_Trisenox.cfm","2001-07-12 00:00:00",
14728,2,21248,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf","2010-07-30 00:00:00",
27197,1,21248,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf","2010-07-28 00:00:00",
4755,1,21248,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf","2010-07-28 00:00:00",
36449,2,21248,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf","2010-07-30 00:00:00",
4756,1,21248,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021248Orig1s013ltr.pdf","2015-02-24 00:00:00",
14729,2,21248,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021248s013lbl.pdf","2015-02-23 00:00:00",
51058,1,21248,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021248Orig1s015ltr.pdf","2018-01-17 00:00:00",
51070,2,21248,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021248s015lbledt.pdf","2018-01-17 00:00:00",
4761,1,21251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21251ltr.pdf","2000-09-15 00:00:00",
14733,2,21251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251lbl.pdf","2000-09-15 00:00:00",
21548,3,21251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm","2000-09-15 00:00:00",
23070,6,21251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251ppi.pdf","2000-09-15 00:00:00",
27204,1,21251,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21251s2ltr.pdf","2001-03-13 00:00:00",
36455,2,21251,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf","2001-03-13 00:00:00",
42053,3,21251,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm","2001-03-13 00:00:00",
27205,1,21251,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21226s3ltr.pdf","2002-01-18 00:00:00",
36456,2,21251,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf","2002-01-18 00:00:00",
42054,3,21251,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-251S003_Kaletra.cfm","2002-01-18 00:00:00",
14734,2,21251,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf","2002-11-27 00:00:00",
42055,3,21251,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021251_S005_KALETRA.pdf","2007-09-26 00:00:00",
4762,1,21251,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21226slr012,21251slr009ltr.pdf","2003-12-08 00:00:00",
14735,2,21251,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf","2003-12-08 00:00:00",
21549,3,21251,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021251_S010_KALETRA.pdf","2007-09-26 00:00:00",
27206,1,21251,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21226s014,21251s010ltr.pdf","2004-10-26 00:00:00",
36457,2,21251,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf","2004-10-26 00:00:00",
14736,2,21251,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf","2005-03-30 00:00:00",
27207,1,21251,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s017,021251s011ltr.pdf","2005-03-30 00:00:00",
14737,2,21251,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf","2007-04-25 00:00:00",
27208,1,21251,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf","2007-04-25 00:00:00",
27209,1,21251,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf","2007-01-08 00:00:00",
36458,2,21251,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf","2006-12-28 00:00:00",
14738,2,21251,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf","2007-03-07 00:00:00",
27210,1,21251,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf","2007-03-07 00:00:00",
14739,2,21251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf","2007-07-05 00:00:00",
27211,1,21251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf","2007-07-05 00:00:00",
4763,1,21251,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s017ltr.pdf","2008-08-05 00:00:00",
4764,1,21251,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf","2007-11-19 00:00:00",
36459,2,21251,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf","2007-11-19 00:00:00",
4765,1,21251,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf","2007-10-04 00:00:00",
14740,2,21251,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf","2007-09-26 00:00:00",
14741,2,21251,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf","2008-06-26 00:00:00",
27212,1,21251,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf","2008-06-24 00:00:00",
52316,23,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251, 55984ind_ABT-378_WR.pdf","2008-03-07 00:00:00",
52317,25,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251, 55984ind_ABT-378_WR.pdf","2008-03-07 00:00:00",
52318,26,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251_Lopinavir_WR.pdf","2008-03-07 00:00:00",
52319,27,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55984ind, 021226, 021251_Amendment 3_WR.pdf","2008-03-07 00:00:00",
52320,28,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251, 020680, 020659, 020945, 55984ind, 43718ind_WR.pdf","2008-03-07 00:00:00",
52321,29,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251, 55984ind_Lopinavir_Ritonavir_Amendment 5_WR.pdf","2008-03-07 00:00:00",
52322,30,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226, 021251_Lopinavir_Ritonavir_Amendment 6_WR.pdf","2008-03-07 00:00:00",
52941,18,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021226-21251_Lopinavir-Ritonavir_Clinpharm_BPCAini.pdf","2008-03-07 00:00:00",
52942,20,21251,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021251_Lopinavir-Ritonavir_Clinical_BPCA.pdf","2008-03-07 00:00:00",
4766,1,21251,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf","2009-04-10 00:00:00",
14742,2,21251,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf","2009-04-16 00:00:00",
14743,2,21251,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf","2008-10-09 00:00:00",
27213,1,21251,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf","2008-10-08 00:00:00",
14744,2,21251,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf","2009-04-23 00:00:00",
27214,1,21251,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf","2009-04-24 00:00:00",
4767,1,21251,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf","2010-02-05 00:00:00",
14745,2,21251,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf","2010-02-04 00:00:00",
4768,1,21251,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf","2010-05-03 00:00:00",
36460,2,21251,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf","2010-05-07 00:00:00",
27215,1,21251,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf","2010-06-16 00:00:00",
36461,2,21251,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s033lbl.pdf","2010-06-15 00:00:00",
4769,1,21251,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf","2011-03-01 00:00:00",
36462,2,21251,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf","2011-03-04 00:00:00",
4770,1,21251,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf","2011-05-10 00:00:00",
4771,1,21251,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf","2012-04-24 00:00:00",
14746,2,21251,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf","2012-04-24 00:00:00",
14747,2,21251,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf","2012-02-22 00:00:00",
27216,1,21251,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf","2012-02-27 00:00:00",
4772,1,21251,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf","2012-05-18 00:00:00",
14748,2,21251,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf","2012-05-17 00:00:00",
27217,1,21251,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf","2013-01-22 00:00:00",
36463,2,21251,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf","2013-01-22 00:00:00",
27218,1,21251,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf","2013-11-08 00:00:00",
36464,2,21251,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf","2013-11-08 00:00:00",
4773,1,21251,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf","2015-01-29 00:00:00",
36465,2,21251,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf","2015-01-30 00:00:00",
27219,1,21251,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf","2015-07-06 00:00:00",
36466,2,21251,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf","2015-07-01 00:00:00",
14749,2,21251,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf","2015-04-02 00:00:00",
27220,1,21251,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf","2015-04-01 00:00:00",
4774,1,21251,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf","2015-11-17 00:00:00",
14750,2,21251,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf","2015-11-12 00:00:00",
45945,1,21251,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s052,021906Orig1s046ltr.pdf","2016-11-23 00:00:00",
45967,2,21251,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s052_021906s046lbl.pdf","2016-11-29 00:00:00",
45322,2,21251,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf","2016-09-15 00:00:00",
45331,1,21251,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf","2016-09-20 00:00:00",
48734,2,21251,"SUPPL",54,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s054,021906s049lbl.pdf","2017-06-16 00:00:00",
48745,1,21251,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021251Orig1s054,021906s049ltr.pdf","2017-06-16 00:00:00",
50075,2,21251,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf","2017-10-18 00:00:00",
50079,8,21251,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51","2017-10-18 00:00:00",
50082,1,21251,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/212906Orig1s050,021251Orig1s055ltr.pdf","2017-10-18 00:00:00",
4775,1,21252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21252ltr.pdf","2001-01-05 00:00:00",
21550,3,21252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-252_Canasa.cfm","2001-01-05 00:00:00",
36467,2,21252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf","2003-04-08 00:00:00",
51337,20,21252,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/11_21252 mesalamine clinical prea.pdf","1900-01-01 00:00:00",
51338,18,21252,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/10_21252 mesalamine clinpharm prea.pdf","1900-01-01 00:00:00",
51339,17,21252,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/9_21252 mesalamine statistical prea.pdf","1900-01-01 00:00:00",
4776,1,21252,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21252slr002ltr.pdf","2003-10-17 00:00:00",
4777,1,21252,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s005ltr.pdf","2004-11-08 00:00:00",
36468,2,21252,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf","2004-11-08 00:00:00",
4778,1,21252,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s006ltr.pdf","2004-09-29 00:00:00",
4779,1,21252,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021252s007LTR.pdf","2006-06-12 00:00:00",
27221,1,21252,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021252s009ltr.pdf","2008-05-28 00:00:00",
14751,2,21252,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf","2013-02-08 00:00:00",
27222,1,21252,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s013ltr.pdf","2013-02-07 00:00:00",
45203,2,21252,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf","2016-09-02 00:00:00",
45228,1,21252,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021252Orig1s014ltr.pdf","2016-09-02 00:00:00",
14752,2,21252,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf","2013-12-19 00:00:00",
27223,1,21252,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s020ltr.pdf","2013-12-20 00:00:00",
49141,2,21252,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021252s023lbl.pdf","2017-07-31 00:00:00",
49183,1,21252,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021252Orig1s023ltr.pdf","2017-08-02 00:00:00",
23638,10,21253,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
27224,1,21253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21253ltr.pdf","2004-04-07 00:00:00",
36469,2,21253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21253_zyprexa_lbl.pdf","2004-04-05 00:00:00",
42056,3,21253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21253_Zyprexa.TOC.cfm","2005-07-13 00:00:00",
4780,1,21253,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf","2006-02-22 00:00:00",
14753,2,21253,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf","2006-02-22 00:00:00",
4781,1,21253,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf","2006-09-18 00:00:00",
14754,2,21253,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf","2006-08-29 00:00:00",
4782,1,21253,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf","2006-02-22 00:00:00",
14755,2,21253,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf","2006-02-22 00:00:00",
4783,1,21253,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf","2005-09-15 00:00:00",
4784,1,21253,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf","2006-03-01 00:00:00",
14756,2,21253,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf","2006-02-28 00:00:00",
4785,1,21253,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf","2006-12-28 00:00:00",
14757,2,21253,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf","2006-12-04 00:00:00",
27225,1,21253,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf","2007-07-10 00:00:00",
36470,2,21253,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf","2007-07-10 00:00:00",
4786,1,21253,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf","2008-08-19 00:00:00",
4787,1,21253,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf","2009-11-19 00:00:00",
14758,2,21253,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf","2009-09-17 00:00:00",
4788,1,21253,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf","2010-02-01 00:00:00",
14759,2,21253,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf","2010-01-29 00:00:00",
27226,1,21253,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
36471,2,21253,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
4789,1,21253,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf","2010-06-03 00:00:00",
14760,2,21253,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf","2010-06-03 00:00:00",
4790,1,21253,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf","2010-12-06 00:00:00",
36472,2,21253,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf","2010-12-04 00:00:00",
4791,1,21253,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf","2014-12-23 00:00:00",
36473,2,21253,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf","2015-01-09 00:00:00",
36474,2,21253,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf","2015-07-24 00:00:00",
45534,1,21253,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf","2016-10-14 00:00:00",
45982,2,21253,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf","2016-12-01 00:00:00",
47342,2,21253,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47381,1,21253,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
47343,2,21253,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020592s068s069,021086s044s045,021253s057s058lbl.pdf","2017-02-27 00:00:00",
47380,1,21253,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
53474,2,21253,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf","2018-03-28 00:00:00",
53475,8,21253,"SUPPL",59,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36","2018-03-28 00:00:00",
53522,1,21253,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf","2018-03-29 00:00:00",
4792,1,21254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021254s000LTR.pdf","2006-06-14 00:00:00",
21551,3,21254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021254s000TOC.cfm","2008-05-06 00:00:00",
23639,10,21254,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2006-06-19 00:00:00",
36475,2,21254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf","2006-06-14 00:00:00",
4793,1,21254,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf","2008-03-21 00:00:00",
36476,2,21254,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf","2008-03-24 00:00:00",
4794,1,21254,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s004ltr.pdf","2008-08-05 00:00:00",
4795,1,21254,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021254s007ltr.pdf","2009-10-26 00:00:00",
36477,2,21254,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf","2009-09-21 00:00:00",
14761,2,21254,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf","2012-12-21 00:00:00",
27227,1,21254,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021254Orig1s009ltr.pdf","2012-12-21 00:00:00",
51119,20,21254,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinical_prea.pdf","1900-01-01 00:00:00",
51120,18,21254,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinpharm_prea.pdf","1900-01-01 00:00:00",
51121,17,21254,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_statistical_prea.pdf","1900-01-01 00:00:00",
27228,1,21254,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021254s012ltr.pdf","2011-01-07 00:00:00",
14762,2,21254,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf","2010-06-28 00:00:00",
27229,1,21254,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf","2010-06-29 00:00:00",
27230,1,21254,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf","2011-05-12 00:00:00",
36478,2,21254,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf","2011-05-16 00:00:00",
27231,1,21254,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf","2011-07-05 00:00:00",
4796,1,21254,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf","2012-08-13 00:00:00",
4797,1,21254,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s023ltr.pdf","2014-11-14 00:00:00",
36479,2,21254,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf","2014-12-20 00:00:00",
4798,1,21254,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s024ltr.pdf","2014-12-12 00:00:00",
36480,2,21254,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf","2014-12-11 00:00:00",
47457,1,21254,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s026ltr.pdf","2017-03-03 00:00:00",
47492,2,21254,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf","2017-03-08 00:00:00",
50841,2,21254,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf","2017-12-22 00:00:00",
50875,1,21254,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s027ltr.pdf","2017-12-27 00:00:00",
4799,1,21256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256ltr.pdf","2004-04-20 00:00:00",
14763,2,21256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf","2004-05-03 00:00:00",
21552,3,21256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-256_SyntheticHS.cfm","2004-08-09 00:00:00",
27232,1,21256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256s001ltr.pdf","2004-09-10 00:00:00",
4800,1,21256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s002ltr.pdf","2007-07-05 00:00:00",
36481,2,21256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021256s002lbl.pdf","2007-06-27 00:00:00",
4801,1,21256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s004ltr.pdf","2007-07-05 00:00:00",
49017,2,21256,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf","2017-07-19 00:00:00",
49032,1,21256,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021256Orig1s013ltr.pdf","2017-07-21 00:00:00",
14764,2,21257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21257lbl.pdf","2001-03-16 00:00:00",
27233,1,21257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan_approv.pdf","2004-06-28 00:00:00",
42057,3,21257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan.cfm","2001-08-20 00:00:00",
14765,2,21257,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf","2003-02-13 00:00:00",
27234,1,21257,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf","2003-02-13 00:00:00",
27235,1,21257,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf","2003-02-13 00:00:00",
36482,2,21257,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf","2003-03-05 00:00:00",
14766,2,21257,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf","2003-02-13 00:00:00",
27236,1,21257,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf","2003-02-13 00:00:00",
14767,2,21257,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf","2003-05-29 00:00:00",
27237,1,21257,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257scp010ltr.pdf","2003-06-08 00:00:00",
4802,1,21257,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf","2004-02-27 00:00:00",
14768,2,21257,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf","2004-03-03 00:00:00",
27238,1,21257,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf","2004-02-27 00:00:00",
36483,2,21257,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf","2004-03-03 00:00:00",
27239,1,21257,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf","2006-01-30 00:00:00",
36484,2,21257,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf","2006-01-27 00:00:00",
4803,1,21257,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf","2006-01-30 00:00:00",
14769,2,21257,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf","2006-01-27 00:00:00",
4804,1,21257,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021257s018ltr.pdf","2010-09-02 00:00:00",
36485,2,21257,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021257s018lbl.pdf","2010-09-07 00:00:00",
4805,1,21257,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021257s025ltr.pdf","2011-09-12 00:00:00",
36486,2,21257,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021257s025lbl.pdf","2011-09-12 00:00:00",
4806,1,21258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21258ltr.pdf","2003-11-28 00:00:00",
21553,3,21258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021258s000_ClimaraTOC.cfm","2006-06-07 00:00:00",
36487,2,21258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf","2004-04-01 00:00:00",
4807,1,21258,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021258s003ltr.pdf","2005-06-24 00:00:00",
36488,2,21258,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf","2005-06-24 00:00:00",
4808,1,21258,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021258Orig1s006ltr.pdf","2013-10-11 00:00:00",
36489,2,21258,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf","2013-10-17 00:00:00",
50264,2,21258,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf","2017-11-02 00:00:00",
4809,1,21259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate_Approv.pdf","2004-06-09 00:00:00",
4810,1,21259,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21259s1ltr.pdf","2002-04-09 00:00:00",
14770,2,21259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf","2001-04-03 00:00:00",
14771,2,21259,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf","2002-04-09 00:00:00",
42058,3,21259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate.cfm","2003-12-31 00:00:00",
44109,10,21259,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
27240,1,21259,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm005ltr.pdf","2003-06-08 00:00:00",
4811,1,21259,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm006ltr.pdf","2003-06-22 00:00:00",
27241,1,21259,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm008ltr.pdf","2003-09-29 00:00:00",
27242,1,21259,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s017ltr.pdf","2006-03-01 00:00:00",
4812,1,21259,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s018LTR.pdf","2006-08-14 00:00:00",
36490,2,21259,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021259s018lbl.pdf","2006-08-11 00:00:00",
4813,1,21259,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021259s019ltr.pdf","2008-08-28 00:00:00",
36491,2,21259,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021259s019lbl.pdf","2008-08-29 00:00:00",
14772,2,21259,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf","2007-05-07 00:00:00",
27243,1,21259,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021259s020ltr.pdf","2007-05-09 00:00:00",
27244,1,21259,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021259s021ltr.pdf","2009-05-14 00:00:00",
36492,2,21259,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021259s021lbl.pdf","2009-04-23 00:00:00",
14773,2,21259,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf","2010-10-18 00:00:00",
27245,1,21259,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021259s022ltr.pdf","2010-10-20 00:00:00",
4814,1,21259,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf","2013-05-07 00:00:00",
36493,2,21259,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s023lbl.pdf","2013-05-06 00:00:00",
27246,1,21259,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf","2013-05-07 00:00:00",
36494,2,21259,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s024lbl.pdf","2013-05-06 00:00:00",
4815,1,21259,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s026ltr.pdf","2013-06-06 00:00:00",
14774,2,21259,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf","2013-06-11 00:00:00",
14775,2,21259,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf","2013-12-17 00:00:00",
27247,1,21259,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s027ltr.pdf","2013-12-17 00:00:00",
27248,1,21259,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021259Orig1s029ltr.pdf","2015-04-20 00:00:00",
36495,2,21259,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf","2015-04-21 00:00:00",
46707,2,21259,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf","2017-01-06 00:00:00",
46756,8,21259,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf#page=20","2017-01-10 00:00:00",
46757,1,21259,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021259Orig1s030ltr.pdf","2017-01-10 00:00:00",
4816,1,21260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21260ltr.pdf","2002-03-20 00:00:00",
14776,2,21260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf","2002-03-20 00:00:00",
23989,14,21260,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
42059,3,21260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-260_Avinza.cfm","2004-01-15 00:00:00",
43731,8,21260,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf","2012-07-11 00:00:00",
4817,1,21260,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021260s006ltr.pdf","2005-10-25 00:00:00",
36496,2,21260,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021260s006lbl.pdf","2005-10-24 00:00:00",
4818,1,21260,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021260s013ltr.pdf","2008-12-23 00:00:00",
14777,2,21260,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf","2012-07-12 00:00:00",
27249,1,21260,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260s015ltr.pdf","2012-07-11 00:00:00",
27250,1,21260,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260Orig1s016ltr.pdf","2012-07-11 00:00:00",
36497,2,21260,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s016lbl.pdf","2012-07-12 00:00:00",
27251,1,21260,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s017ltr.pdf","2013-05-08 00:00:00",
36498,2,21260,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021260s017lbl.pdf","2013-05-06 00:00:00",
4819,1,21260,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s018ltr.pdf","2013-04-16 00:00:00",
4820,1,21260,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s022ltr.pdf","2014-04-17 00:00:00",
36499,2,21260,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021260s022lbl.pdf","2014-04-16 00:00:00",
27252,1,21260,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s023ltr.pdf","2014-08-20 00:00:00",
4821,1,21260,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021260Orig1s024ltr.pdf","2015-07-06 00:00:00",
27253,1,21261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-261_Monistat%203_Approv.pdf","2001-02-02 00:00:00",
36500,2,21261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21261lbl.pdf","2001-02-02 00:00:00",
42060,3,21261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-261_Monistat3.cfm","2001-08-21 00:00:00",
4822,1,21261,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21261slr004ltr.pdf","2003-06-22 00:00:00",
27254,1,21261,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021261s007ltr.pdf","2008-10-30 00:00:00",
49513,2,21261,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf","2017-08-22 00:00:00",
27255,1,21262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_Approv.pdf","2001-03-16 00:00:00",
36501,2,21262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf","2001-03-16 00:00:00",
42061,3,21262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_AlphaganP.cfm","2004-05-27 00:00:00",
14778,2,21262,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf","2001-12-20 00:00:00",
27256,1,21262,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf","2001-12-20 00:00:00",
42062,3,21262,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm","2004-05-27 00:00:00",
27257,1,21262,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf","2004-02-27 00:00:00",
4823,1,21262,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf","2004-02-27 00:00:00",
14779,2,21262,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf","2006-05-24 00:00:00",
27258,1,21262,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021262s018LTR.pdf","2006-05-25 00:00:00",
14780,2,21262,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf","2010-08-28 00:00:00",
27259,1,21262,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf","2010-08-16 00:00:00",
21554,3,21264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-264_Apokyn.cfm","2004-08-27 00:00:00",
27260,1,21264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21264ltr.pdf","2004-04-29 00:00:00",
36502,2,21264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21264_apokyn_lbl.pdf","2004-05-04 00:00:00",
27261,1,21264,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf","2009-01-06 00:00:00",
27262,1,21264,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf","2009-01-06 00:00:00",
27263,1,21264,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021264s009ltr.pdf","2010-09-07 00:00:00",
36503,2,21264,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021264s009lbl.pdf","2010-09-07 00:00:00",
4824,1,21264,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021264Orig1s010ltr.pdf","2014-07-28 00:00:00",
14781,2,21264,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf","2014-07-28 00:00:00",
47582,2,21264,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021264s014lbl.pdf","2017-03-17 00:00:00",
47589,1,21264,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021264Orig1s014ltr.pdf","2017-03-20 00:00:00",
4825,1,21265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_Approv.pdf","2001-02-21 00:00:00",
14782,2,21265,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf","2003-05-02 00:00:00",
21555,3,21265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite.cfm","2001-02-21 00:00:00",
36504,2,21265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-265_Infuvite%20Pediatric_prntlbl.pdf","2001-02-21 00:00:00",
4826,1,21265,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21265slr005ltr.pdf","2004-06-07 00:00:00",
14783,2,21265,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf","2009-01-02 00:00:00",
27264,1,21265,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021265s015ltr.pdf","2008-12-23 00:00:00",
4827,1,21265,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021265Orig1s030,021646Orig1s022ltr.pdf","2016-03-21 00:00:00",
36505,2,21265,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021265s030,021646s022lbl.pdf","2016-03-22 00:00:00",
14784,2,21266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf","2010-04-28 00:00:00",
21556,3,21266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.cfm","2010-04-28 00:00:00",
27265,1,21266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21266ltr.pdf","2010-04-28 00:00:00",
27266,1,21266,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf","2003-04-14 00:00:00",
36506,2,21266,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf","2003-03-28 00:00:00",
4828,1,21266,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf","2004-04-29 00:00:00",
14785,2,21266,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf","2004-05-04 00:00:00",
21557,3,21266,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm","2007-01-10 00:00:00",
14786,2,21266,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf","2004-05-04 00:00:00",
27267,1,21266,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf","2004-04-29 00:00:00",
42063,3,21266,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm","2007-01-10 00:00:00",
14787,2,21266,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf","2004-03-03 00:00:00",
27268,1,21266,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf","2004-02-27 00:00:00",
21558,3,21266,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266Orig1s009.pdf","2012-11-09 00:00:00",
27269,1,21266,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf","2004-12-29 00:00:00",
36507,2,21266,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf","2004-12-29 00:00:00",
4829,1,21266,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf","2005-03-29 00:00:00",
14788,2,21266,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf","2005-03-29 00:00:00",
4830,1,21266,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf","2005-07-15 00:00:00",
14789,2,21266,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf","2005-07-08 00:00:00",
4831,1,21266,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf","2006-01-19 00:00:00",
14790,2,21266,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf","2006-01-05 00:00:00",
14791,2,21266,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf","2006-03-22 00:00:00",
27270,1,21266,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf","2006-03-22 00:00:00",
14792,2,21266,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf","2008-02-14 00:00:00",
27271,1,21266,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s016ltr.pdf","2008-02-07 00:00:00",
4832,1,21266,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf","2006-05-22 00:00:00",
36508,2,21266,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf","2006-05-22 00:00:00",
4833,1,21266,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf","2006-12-28 00:00:00",
14793,2,21266,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf","2006-12-04 00:00:00",
4834,1,21266,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf","2008-03-13 00:00:00",
36509,2,21266,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf","2008-03-13 00:00:00",
4835,1,21266,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
14794,2,21266,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27272,1,21266,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf","2008-06-03 00:00:00",
27273,1,21266,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
36510,2,21266,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27274,1,21266,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
36511,2,21266,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
14795,2,21266,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27275,1,21266,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
4836,1,21266,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf","2010-12-21 00:00:00",
14796,2,21266,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf","2010-12-26 00:00:00",
4837,1,21266,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf","2010-11-30 00:00:00",
36512,2,21266,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s032lbl.pdf","2010-11-21 00:00:00",
4838,1,21266,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf","2011-06-02 00:00:00",
36513,2,21266,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf","2011-06-16 00:00:00",
27276,1,21266,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf","2011-11-21 00:00:00",
36514,2,21266,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf","2011-11-21 00:00:00",
14797,2,21266,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf","2014-04-08 00:00:00",
27277,1,21266,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf","2014-04-08 00:00:00",
4839,1,21266,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf","2015-02-05 00:00:00",
14798,2,21266,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf","2015-02-05 00:00:00",
48742,1,21266,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s041,021267Orig1s053,021630Orig1s031ltr.pdf","2017-06-16 00:00:00",
48762,2,21266,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf","2017-06-19 00:00:00",
49157,2,21266,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf","2017-07-31 00:00:00",
49187,1,21266,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s043,021267Orig1s054,021630Orig1s032ltr.pdf","2017-08-02 00:00:00",
4840,1,21267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_Approv.pdf","2004-06-30 00:00:00",
14799,2,21267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_prntlbl.pdf","2004-06-30 00:00:00",
21559,3,21267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.cfm","2003-12-02 00:00:00",
4841,1,21267,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf","2003-04-14 00:00:00",
14800,2,21267,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf","2003-03-28 00:00:00",
4842,1,21267,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf","2004-04-29 00:00:00",
14801,2,21267,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf","2004-05-04 00:00:00",
21560,3,21267,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm","2007-01-10 00:00:00",
27278,1,21267,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf","2004-04-29 00:00:00",
36515,2,21267,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf","2004-05-04 00:00:00",
42064,3,21267,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm","2007-01-10 00:00:00",
4843,1,21267,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf","2004-02-27 00:00:00",
14802,2,21267,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf","2004-03-03 00:00:00",
27279,1,21267,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf","2004-12-29 00:00:00",
36516,2,21267,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf","2004-12-29 00:00:00",
42065,3,21267,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021267Orig1s009.pdf","2012-11-09 00:00:00",
14803,2,21267,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf","2005-03-29 00:00:00",
27280,1,21267,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf","2005-03-29 00:00:00",
14804,2,21267,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf","2005-07-08 00:00:00",
27281,1,21267,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf","2005-07-15 00:00:00",
4844,1,21267,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf","2006-01-19 00:00:00",
14805,2,21267,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf","2006-01-05 00:00:00",
14806,2,21267,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf","2006-03-22 00:00:00",
27282,1,21267,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf","2006-03-22 00:00:00",
14807,2,21267,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf","2008-02-14 00:00:00",
27283,1,21267,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021267s016ltr.pdf","2008-02-07 00:00:00",
14808,2,21267,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf","2006-05-22 00:00:00",
27284,1,21267,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf","2006-05-22 00:00:00",
27285,1,21267,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf","2006-12-28 00:00:00",
36517,2,21267,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf","2006-12-04 00:00:00",
14809,2,21267,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf","2008-03-13 00:00:00",
27286,1,21267,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf","2008-03-13 00:00:00",
4845,1,21267,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
14810,2,21267,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27287,1,21267,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf","2008-06-03 00:00:00",
27288,1,21267,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
36518,2,21267,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27289,1,21267,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
36519,2,21267,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
4846,1,21267,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
14811,2,21267,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
27290,1,21267,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf","2010-12-21 00:00:00",
36520,2,21267,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf","2010-12-26 00:00:00",
27291,1,21267,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf","2010-11-30 00:00:00",
36521,2,21267,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021267s036lbl.pdf","2010-11-21 00:00:00",
14812,2,21267,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf","2011-06-16 00:00:00",
27292,1,21267,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf","2011-06-02 00:00:00",
27293,1,21267,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf","2011-11-21 00:00:00",
36522,2,21267,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf","2011-11-21 00:00:00",
4847,1,21267,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf","2014-04-08 00:00:00",
36523,2,21267,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf","2014-04-08 00:00:00",
27294,1,21267,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf","2015-02-05 00:00:00",
36524,2,21267,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf","2015-02-05 00:00:00",
48741,1,21267,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s041,021267Orig1s053,021630Orig1s031ltr.pdf","2017-06-16 00:00:00",
48763,2,21267,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf","2017-06-19 00:00:00",
49158,2,21267,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf","2017-07-31 00:00:00",
49188,1,21267,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s043,021267Orig1s054,021630Orig1s032ltr.pdf","2017-08-02 00:00:00",
23640,10,21268,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
27295,1,21268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_Approv.pdf","2001-11-01 00:00:00",
36525,2,21268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf","2001-11-01 00:00:00",
42066,3,21268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_Teveten.cfm","2002-03-05 00:00:00",
27296,1,21268,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf","2003-10-17 00:00:00",
27297,1,21268,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21268scm006ltr.pdf","2003-07-10 00:00:00",
4848,1,21268,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021268s009ltr.pdf","2005-07-15 00:00:00",
4849,1,21268,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf","2011-05-25 00:00:00",
14813,2,21268,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf","2011-05-23 00:00:00",
4850,1,21268,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf","2011-05-25 00:00:00",
14814,2,21268,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf","2011-05-23 00:00:00",
27298,1,21268,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf","2012-01-23 00:00:00",
36526,2,21268,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf","2012-01-23 00:00:00",
27299,1,21268,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021268Orig1s018ltr.pdf","2012-09-14 00:00:00",
36527,2,21268,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf","2012-09-14 00:00:00",
14815,2,21268,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf","2014-07-24 00:00:00",
27300,1,21268,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021268Orig1s019ltr.pdf","2014-07-24 00:00:00",
4851,1,21269,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021269s001ltr.pdf","2006-04-05 00:00:00",
14816,2,21269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf","2005-02-23 00:00:00",
21561,3,21269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021269_carduraxl_toc.cfm","2008-10-02 00:00:00",
27301,1,21269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021269ltr.pdf","2005-02-23 00:00:00",
4852,1,21269,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021269s011ltr.pdf","2010-03-22 00:00:00",
14817,2,21269,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf","2010-03-17 00:00:00",
27302,1,21269,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021269s012ltr.pdf","2011-07-12 00:00:00",
36528,2,21269,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf","2011-07-12 00:00:00",
4853,1,21269,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021269Orig1s17ltr.pdf","2015-06-10 00:00:00",
14818,2,21269,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf","2015-06-11 00:00:00",
47362,2,21269,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf","2017-02-28 00:00:00",
47446,1,21269,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021269Orig1s018ltr.pdf","2017-03-03 00:00:00",
14819,2,21271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf","2003-04-07 00:00:00",
27303,1,21271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21271ltr.pdf","2003-04-18 00:00:00",
42067,3,21271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-271_Iprivask.cfm","2004-11-22 00:00:00",
4854,1,21271,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021271Orig1s006ltr.pdf","2014-11-12 00:00:00",
14820,2,21271,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf","2014-11-10 00:00:00",
14821,2,21272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf","2002-05-21 00:00:00",
21562,3,21272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-272_Remodulin.cfm","2002-07-31 00:00:00",
27304,1,21272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf","2002-05-21 00:00:00",
21563,3,21272,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf","2011-10-10 00:00:00",
27305,1,21272,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf","2006-01-30 00:00:00",
14822,2,21272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf","2006-03-22 00:00:00",
21564,3,21272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf","2015-11-18 00:00:00",
27306,1,21272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf","2006-03-23 00:00:00",
14823,2,21272,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf","2008-09-19 00:00:00",
27307,1,21272,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf","2008-09-16 00:00:00",
4855,1,21272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf","2008-02-07 00:00:00",
14824,2,21272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf","2008-02-14 00:00:00",
4856,1,21272,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf","2010-01-15 00:00:00",
36529,2,21272,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf","2010-01-12 00:00:00",
27308,1,21272,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf","2011-02-14 00:00:00",
36530,2,21272,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf","2011-02-09 00:00:00",
27309,1,21272,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf","2014-12-30 00:00:00",
45363,2,21272,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf","2016-09-27 00:00:00",
4857,1,21272,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf","2013-10-01 00:00:00",
14825,2,21272,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf","2013-09-27 00:00:00",
27310,1,21272,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf","2013-09-26 00:00:00",
36531,2,21272,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf","2013-09-27 00:00:00",
42068,3,21272,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf","2014-01-16 00:00:00",
55068,2,21272,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf","2018-07-31 00:00:00",
55082,1,21272,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf","2018-08-03 00:00:00",
54538,2,21272,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021272s026lbl.pdf","2018-06-12 00:00:00",
54561,1,21272,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021272Orig1s026ltr.pdf","2018-06-14 00:00:00",
4858,1,21273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021273ltr.pdf","2005-08-31 00:00:00",
21565,3,21273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021273s000TOC.cfm","2007-09-11 00:00:00",
36532,2,21273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf","2005-08-31 00:00:00",
27311,1,21273,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021273s003ltr.pdf","2008-12-31 00:00:00",
14826,2,21273,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf","2010-06-28 00:00:00",
27312,1,21273,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021273s006ltr.pdf","2010-07-01 00:00:00",
14827,2,21275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf","2001-03-16 00:00:00",
27313,1,21275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan0.03percentOpthalmisSolution_approv.pdf","2004-06-08 00:00:00",
42069,3,21275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan.cfm","2001-08-20 00:00:00",
14828,2,21275,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf","2002-08-26 00:00:00",
27314,1,21275,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21275slr006ltr.pdf","2002-08-26 00:00:00",
14829,2,21275,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf","2003-08-28 00:00:00",
27315,1,21275,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf","2003-08-28 00:00:00",
14830,2,21275,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf","2011-03-11 00:00:00",
4859,1,21275,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf","2003-08-28 00:00:00",
36533,2,21275,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf","2003-08-28 00:00:00",
14831,2,21275,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf","2006-06-28 00:00:00",
27316,1,21275,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021275s013LTR.pdf","2006-06-28 00:00:00",
42070,3,21275,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021275_S013_LUMIGAN.pdf","2008-07-30 00:00:00",
27317,1,21275,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf","2003-11-25 00:00:00",
36534,2,21275,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf","2003-12-02 00:00:00",
4860,1,21275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf","2003-11-25 00:00:00",
14832,2,21275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf","2003-12-02 00:00:00",
36535,2,21275,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf","2011-02-08 00:00:00",
4861,1,21275,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021275Orig1s023ltr.pdf","2012-03-19 00:00:00",
36536,2,21275,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf","2012-03-16 00:00:00",
14833,2,21275,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf","2014-09-30 00:00:00",
27318,1,21275,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021275Orig1s026ltr.pdf","2014-10-02 00:00:00",
49169,2,21275,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021275s027lbl.pdf","2017-08-01 00:00:00",
49195,1,21275,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021275Orig1s027ltr.pdf","2017-08-02 00:00:00",
4862,1,21277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox_Approv.PDF","2001-11-30 00:00:00",
14834,2,21277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf","2001-11-30 00:00:00",
21567,3,21277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox.cfm","2004-05-27 00:00:00",
27320,1,21277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21277s001ltr.pdf","2002-05-22 00:00:00",
14835,2,21277,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf","2002-06-12 00:00:00",
27321,1,21277,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf","2002-06-12 00:00:00",
4863,1,21277,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-085s012ltr.pdf","2002-05-16 00:00:00",
36538,2,21277,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf","2002-05-16 00:00:00",
27322,1,21277,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
36539,2,21277,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
4864,1,21277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
14836,2,21277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
42071,3,21277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021277_S007_AVELOX.pdf","2008-02-19 00:00:00",
27323,1,21277,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf","2003-03-10 00:00:00",
36540,2,21277,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf","2003-02-28 00:00:00",
27324,1,21277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf","2003-10-06 00:00:00",
36541,2,21277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf","2003-10-10 00:00:00",
4865,1,21277,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf","2004-05-26 00:00:00",
14837,2,21277,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf","2004-05-27 00:00:00",
21568,3,21277,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021277_S017_AVELOX_TABLETS.pdf","2008-02-19 00:00:00",
4866,1,21277,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr023ltr.pdf","2004-03-10 00:00:00",
14838,2,21277,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf","2004-04-05 00:00:00",
4867,1,21277,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr.pdf","2004-07-30 00:00:00",
36542,2,21277,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf","2004-07-30 00:00:00",
14839,2,21277,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf","2005-06-14 00:00:00",
27325,1,21277,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf","2005-06-14 00:00:00",
4868,1,21277,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf","2005-11-30 00:00:00",
14840,2,21277,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf","2005-11-30 00:00:00",
27326,1,21277,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf","2005-11-30 00:00:00",
36543,2,21277,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf","2005-11-30 00:00:00",
27327,1,21277,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021085s036,021277s030ltr.pdf","2007-06-04 00:00:00",
36544,2,21277,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf","2007-06-04 00:00:00",
27328,1,21277,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021277s031ltr.pdf","2008-02-20 00:00:00",
36545,2,21277,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf","2008-02-25 00:00:00",
4869,1,21277,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf","2008-12-31 00:00:00",
14841,2,21277,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf","2009-01-02 00:00:00",
4870,1,21277,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s040, 021277s034ltr.pdf","2008-10-07 00:00:00",
36546,2,21277,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf","2008-10-09 00:00:00",
4871,1,21277,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035ltr.pdf","2009-06-29 00:00:00",
14842,2,21277,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf","2009-05-15 00:00:00",
27329,1,21277,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf","2009-05-05 00:00:00",
4872,1,21277,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038ltr.pdf","2010-11-02 00:00:00",
36547,2,21277,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021277s038lbl.pdf","2010-10-25 00:00:00",
14843,2,21277,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf","2009-12-02 00:00:00",
27330,1,21277,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf","2010-01-25 00:00:00",
14844,2,21277,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf","2010-03-05 00:00:00",
27331,1,21277,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040ltr.pdf","2010-04-09 00:00:00",
14845,2,21277,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf","2011-03-04 00:00:00",
27332,1,21277,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041ltr.pdf","2011-03-02 00:00:00",
4873,1,21277,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf","2011-10-20 00:00:00",
14846,2,21277,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf","2011-10-20 00:00:00",
27333,1,21277,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049ltr.pdf","2011-08-08 00:00:00",
27334,1,21277,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf","2011-10-20 00:00:00",
36548,2,21277,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf","2011-10-20 00:00:00",
14847,2,21277,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf","2012-09-11 00:00:00",
27335,1,21277,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s055,021277Orig1s052ltr.pdf","2012-08-28 00:00:00",
27336,1,21277,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277Orig1s053ltr.pdf","2012-12-26 00:00:00",
36549,2,21277,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf","2012-12-21 00:00:00",
27337,1,21277,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085Orig1s057ltr.pdf","2013-08-16 00:00:00",
36550,2,21277,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf","2013-08-15 00:00:00",
14848,2,21277,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf","2014-12-03 00:00:00",
27338,1,21277,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277Orig1s055ltr.pdf","2014-11-24 00:00:00",
14849,2,21277,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf","2015-06-05 00:00:00",
27339,1,21277,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277Orig1s056ltr.pdf","2015-05-13 00:00:00",
45488,1,21277,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf","2016-09-30 00:00:00",
47513,2,21277,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf","2017-03-09 00:00:00",
45434,1,21277,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf","2016-09-30 00:00:00",
45435,2,21277,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf","2016-09-30 00:00:00",
14850,2,21277,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf","2016-07-26 00:00:00",
27340,1,21277,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085Orig1s063ltr.pdf","2016-07-26 00:00:00",
47524,8,21277,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021085s061s062,021277s057s058lbl.pdf#page=33","2017-03-13 00:00:00",
14851,2,21278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf","2001-11-13 00:00:00",
21569,3,21278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin.cfm","2001-11-13 00:00:00",
27341,1,21278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_Approv.pdf","2001-11-13 00:00:00",
44110,10,21278,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
14852,2,21278,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf","2006-08-29 00:00:00",
27342,1,21278,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf","2006-09-18 00:00:00",
4874,1,21278,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf","2006-09-18 00:00:00",
14853,2,21278,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf","2006-08-29 00:00:00",
4875,1,21278,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s007ltr.pdf","2007-03-15 00:00:00",
14854,2,21278,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf","2007-03-15 00:00:00",
27343,1,21278,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf","2007-05-01 00:00:00",
36551,2,21278,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf","2007-05-01 00:00:00",
4876,1,21278,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf","2010-11-22 00:00:00",
36552,2,21278,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf","2010-11-19 00:00:00",
4877,1,21278,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf","2010-12-15 00:00:00",
36553,2,21278,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf","2010-12-10 00:00:00",
4878,1,21278,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf","2012-05-04 00:00:00",
36554,2,21278,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf","2012-05-07 00:00:00",
14855,2,21278,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf","2013-06-18 00:00:00",
27344,1,21278,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf","2013-06-12 00:00:00",
27345,1,21278,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf","2013-12-13 00:00:00",
36555,2,21278,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf","2013-12-17 00:00:00",
27346,1,21278,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf","2015-04-20 00:00:00",
36556,2,21278,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf","2015-04-21 00:00:00",
46702,2,21278,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf","2017-01-06 00:00:00",
46752,8,21278,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf#page=14","2017-01-10 00:00:00",
46753,1,21278,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf","2017-01-10 00:00:00",
27347,1,21279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21279ltr.pdf","2003-07-23 00:00:00",
36557,2,21279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf","2004-06-04 00:00:00",
42072,3,21279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021279s000_ForadilTOC.cfm","2005-12-16 00:00:00",
44111,10,21279,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2003-12-09 00:00:00",
4879,1,21281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid_Aprov.pdf","2001-05-03 00:00:00",
14856,2,21281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf","2001-05-03 00:00:00",
42073,3,21281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid.cfm","2001-05-03 00:00:00",
44112,10,21281,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
14857,2,21281,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf","2002-05-03 00:00:00",
27348,1,21281,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf","2002-05-03 00:00:00",
4880,1,21281,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf","2002-12-03 00:00:00",
21570,3,21281,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021281_S004_PREVACID.pdf","2007-11-19 00:00:00",
14858,2,21281,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf","2002-08-30 00:00:00",
27349,1,21281,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf","2002-08-30 00:00:00",
42074,3,21281,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm","2005-06-23 00:00:00",
4881,1,21281,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf","2003-08-15 00:00:00",
14859,2,21281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf","2004-12-21 00:00:00",
21571,3,21281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021281_s014_PREVACID DELAYED REL CAPS.pdf","2008-07-31 00:00:00",
27350,1,21281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf","2004-06-23 00:00:00",
14860,2,21281,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf","2006-04-13 00:00:00",
27351,1,21281,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf","2006-04-13 00:00:00",
4882,1,21281,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf","2007-07-05 00:00:00",
14861,2,21281,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf","2007-06-27 00:00:00",
27352,1,21281,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf","2008-04-23 00:00:00",
27353,1,21281,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf","2008-10-29 00:00:00",
36558,2,21281,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf","2008-11-07 00:00:00",
4883,1,21281,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf","2009-11-12 00:00:00",
36559,2,21281,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf","2009-08-13 00:00:00",
4884,1,21282,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21282scf001ltr.pdf","2002-12-18 00:00:00",
21572,3,21282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-282_Mucinex.cfm","2002-11-25 00:00:00",
27354,1,21282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21282ltr.pdf","2002-07-12 00:00:00",
36560,2,21282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21282lbl.pdf","2002-07-12 00:00:00",
4885,1,21282,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021282s011ltr.pdf","2006-09-18 00:00:00",
27355,1,21282,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021282s016ltr.pdf","2006-11-22 00:00:00",
27356,1,21282,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf","2007-09-07 00:00:00",
36561,2,21282,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf","2007-09-07 00:00:00",
27357,1,21282,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021282s025ltr.pdf","2008-08-22 00:00:00",
4886,1,21282,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021282s029ltr.pdf","2009-04-07 00:00:00",
27358,1,21282,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620Orig1s029ltr.pdf","2014-03-07 00:00:00",
4887,1,21282,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf","2014-03-07 00:00:00",
48917,2,21282,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282Orig1s048lbl.pdf","2017-07-06 00:00:00",
48920,1,21282,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021282Orig1s48ltr.pdf","2017-07-06 00:00:00",
54607,2,21282,"SUPPL",49,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282s049lbl.pdf","2018-06-19 00:00:00",
4888,1,21283,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20665se1-016,21283se1-001ltr.pdf","2002-08-14 00:00:00",
14862,2,21283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf","2003-05-05 00:00:00",
21573,3,21283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021283_ORIGINAL_APPROVAL_PACKAGE.PDF","2007-06-22 00:00:00",
36562,2,21283,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf","2002-08-14 00:00:00",
42075,3,21283,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s001_Diovan.cfm","2002-08-14 00:00:00",
44113,10,21283,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm","2011-12-22 00:00:00",
53434,20,21283,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021283_Valsartan_Clinical_PREA.pdf","1900-01-01 00:00:00",
53435,18,21283,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021283_Valsartan_ClinpharmBPCA.pdf","1900-01-01 00:00:00",
53436,17,21283,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021283_Valsartan_Statistical_PREA.pdf","1900-01-01 00:00:00",
14863,2,21283,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf","2002-04-05 00:00:00",
21574,3,21283,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s002_Diovan.cfm","2002-04-05 00:00:00",
27359,1,21283,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21283s2ltr.pdf","2002-04-05 00:00:00",
36563,2,21283,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20665S004_DIOVAN_PRNTLBL.PDF","2006-06-06 00:00:00",
42076,3,21283,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm","2006-06-06 00:00:00",
14864,2,21283,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf","2005-08-08 00:00:00",
27360,1,21283,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021283s011ltr.pdf","2005-08-08 00:00:00",
42077,3,21283,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021283_S011_DIOVANTOC.cfm","2007-03-31 00:00:00",
4889,1,21283,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21283s012ltr.pdf","2004-12-06 00:00:00",
36564,2,21283,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21283s012lbl.pdf","2004-12-03 00:00:00",
14865,2,21283,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf","2006-12-04 00:00:00",
27361,1,21283,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021283s018ltr.pdf","2006-12-04 00:00:00",
4890,1,21283,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s021ltr.pdf","2007-08-22 00:00:00",
42078,3,21283,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s021.pdf","2012-03-02 00:00:00",
4891,1,21283,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s024ltr.pdf","2008-01-09 00:00:00",
36565,2,21283,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021283s024lbl.pdf","2007-12-03 00:00:00",
42079,3,21283,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s024.pdf","2012-03-02 00:00:00",
4892,1,21283,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021283s027ltr.pdf","2009-06-17 00:00:00",
36566,2,21283,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021283s027lbl.pdf","2009-06-22 00:00:00",
27362,1,21283,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s032ltr.pdf","2011-06-07 00:00:00",
36567,2,21283,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s032lbl.pdf","2011-06-07 00:00:00",
4893,1,21283,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s033ltr.pdf","2011-12-14 00:00:00",
14866,2,21283,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf","2011-12-12 00:00:00",
4894,1,21283,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s035ltr.pdf","2012-02-29 00:00:00",
36568,2,21283,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s035lbl.pdf","2012-03-06 00:00:00",
27363,1,21283,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf","2012-01-23 00:00:00",
36569,2,21283,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s036lbl.pdf","2012-01-23 00:00:00",
14867,2,21283,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf","2012-07-30 00:00:00",
27364,1,21283,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf","2012-07-30 00:00:00",
4895,1,21283,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s039ltr.pdf","2012-10-09 00:00:00",
36570,2,21283,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s039lbl.pdf","2012-10-05 00:00:00",
14868,2,21283,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf","2014-03-19 00:00:00",
27365,1,21283,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf","2014-03-19 00:00:00",
4896,1,21283,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf","2014-03-19 00:00:00",
14869,2,21283,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf","2014-03-19 00:00:00",
4897,1,21283,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s044ltr.pdf","2014-10-01 00:00:00",
36571,2,21283,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s044lbl.pdf","2014-09-30 00:00:00",
4898,1,21283,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021283Orig1s046ltr.pdf","2015-07-28 00:00:00",
14870,2,21283,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021283s046lbl.pdf","2015-07-30 00:00:00",
47106,2,21283,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021283s50lbl.pdf","2017-02-06 00:00:00",
47126,1,21283,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021283Orig1s050ltr.pdf","2017-02-07 00:00:00",
23641,10,21284,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
27366,1,21284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21284ltr.pdf","2002-06-05 00:00:00",
36572,2,21284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21284lbl.pdf","2002-06-05 00:00:00",
42080,3,21284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-284_Ritalin.cfm","2002-11-20 00:00:00",
4899,1,21284,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21284scm004ltr.pdf","2004-04-20 00:00:00",
4900,1,21284,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
14871,2,21284,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
4901,1,21284,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf","2006-08-11 00:00:00",
14872,2,21284,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf","2006-08-09 00:00:00",
4902,1,21284,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021284s010ltr.pdf","2010-04-29 00:00:00",
14873,2,21284,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s010lbl.pdf","2010-05-07 00:00:00",
14874,2,21284,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf","2007-05-01 00:00:00",
27367,1,21284,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf","2007-05-01 00:00:00",
14875,2,21284,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s017lbl.pdf","2010-11-17 00:00:00",
27368,1,21284,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf","2010-11-18 00:00:00",
4903,1,21284,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf","2010-12-15 00:00:00",
36573,2,21284,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s018lbl.pdf","2010-12-10 00:00:00",
14876,2,21284,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s019lbl.pdf","2013-06-11 00:00:00",
27369,1,21284,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf","2013-06-11 00:00:00",
4904,1,21284,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021284Orig1s020ltr.pdf","2013-05-07 00:00:00",
14877,2,21284,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s020lbl.pdf","2013-05-06 00:00:00",
4905,1,21284,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf","2013-12-16 00:00:00",
14878,2,21284,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s023lbl.pdf","2013-12-17 00:00:00",
4906,1,21284,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021284Orig1s025ltr.pdf","2014-11-10 00:00:00",
36574,2,21284,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021284Orig1s025lbl.pdf","2014-12-19 00:00:00",
4907,1,21284,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf","2015-04-21 00:00:00",
36575,2,21284,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf","2015-04-21 00:00:00",
46704,2,21284,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021284s034lbl.pdf","2017-01-06 00:00:00",
46827,1,21284,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf","2017-01-13 00:00:00",
46828,8,21284,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021284s034lbl.pdf#page=18","2017-01-13 00:00:00",
14879,2,21285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21285lbl.pdf","2001-05-29 00:00:00",
27370,1,21285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal_Approv.pdf","2001-05-29 00:00:00",
42081,3,21285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal.cfm","2002-04-30 00:00:00",
44609,16,21285,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-03-16 00:00:00",
4908,1,21285,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf","2002-04-01 00:00:00",
27371,1,21285,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr.pdf","2005-03-30 00:00:00",
36576,2,21285,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf","2005-03-30 00:00:00",
4909,1,21285,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008rel2_ltr.pdf","2005-11-01 00:00:00",
36577,2,21285,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf","2005-10-28 00:00:00",
14880,2,21285,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
27372,1,21285,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
4910,1,21285,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
36578,2,21285,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4911,1,21285,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf","2007-09-06 00:00:00",
27373,1,21285,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
36579,2,21285,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4912,1,21285,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
36580,2,21285,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
4913,1,21285,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
14881,2,21285,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
14882,2,21285,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
27374,1,21285,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
4914,1,21285,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021ltr.pdf","2009-05-04 00:00:00",
14883,2,21285,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf","2009-05-12 00:00:00",
14884,2,21285,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf","2011-03-21 00:00:00",
27375,1,21285,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf","2011-03-08 00:00:00",
27376,1,21285,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285Orig1s023ltr.pdf","2013-02-12 00:00:00",
36581,2,21285,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf","2013-02-12 00:00:00",
4915,1,21285,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025ltr.pdf","2011-11-14 00:00:00",
4916,1,21285,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285Orig1s027ltr.pdf","2014-07-08 00:00:00",
14885,2,21285,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf","2014-07-08 00:00:00",
4917,1,21285,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285Orig1s030ltr.pdf","2014-06-10 00:00:00",
36582,2,21285,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf","2014-06-10 00:00:00",
47667,1,21285,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1s036,021285Orig1s031ltr.pdf","2017-03-24 00:00:00",
47727,2,21285,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021285s031lbl.pdf","2017-03-28 00:00:00",
50461,2,21285,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s041,021285s034lbl.pdf","2017-11-20 00:00:00",
50490,1,21285,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1ss041,021285Orig1s034ltr.pdf","2017-11-27 00:00:00",
50491,1,21285,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1ss041,021285Orig1s034ltr.pdf","2017-11-27 00:00:00",
53246,2,21285,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf","2018-03-23 00:00:00",
53247,8,21285,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26","2018-03-23 00:00:00",
53500,1,21285,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021014Orig1s042,021285Orig1s035ltr.pdf","2018-03-28 00:00:00",
4918,1,21286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286.pdf","2002-04-25 00:00:00",
14886,2,21286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf","2002-04-25 00:00:00",
21575,3,21286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286_Benicar.cfm","2002-07-05 00:00:00",
27377,1,21286,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286slr001ltr.pdf","2002-10-25 00:00:00",
53353,20,21286,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021286_Olmesartan_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53354,18,21286,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021286_Olmesartan_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53355,17,21286,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021286_Olmesartan_Statistical_BPCA.pdf","1900-01-01 00:00:00",
4919,1,21286,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21286slr002ltr.pdf","2003-02-12 00:00:00",
27378,1,21286,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21286s006ltr.pdf","2004-11-16 00:00:00",
4920,1,21286,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021286s010ltr.pdf","2005-07-15 00:00:00",
14887,2,21286,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf","2005-07-15 00:00:00",
21576,3,21286,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021286Orig1s010.pdf","2015-07-21 00:00:00",
4921,1,21286,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021286s012ltr.pdf","2007-10-04 00:00:00",
14888,2,21286,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf","2010-02-16 00:00:00",
27379,1,21286,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021286s018ltr.pdf","2010-02-17 00:00:00",
4922,1,21286,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s019ltr.pdf","2011-05-24 00:00:00",
36583,2,21286,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf","2011-05-23 00:00:00",
4923,1,21286,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s020ltr.pdf","2011-06-07 00:00:00",
36584,2,21286,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf","2011-06-06 00:00:00",
27380,1,21286,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s021ltr.pdf","2012-02-17 00:00:00",
36585,2,21286,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf","2012-02-17 00:00:00",
4924,1,21286,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s023ltr.pdf","2012-04-02 00:00:00",
36586,2,21286,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf","2012-03-30 00:00:00",
27381,1,21286,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s025ltr.pdf","2012-10-03 00:00:00",
36587,2,21286,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf","2012-10-02 00:00:00",
27382,1,21286,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s026ltr_r.pdf","2012-12-11 00:00:00",
36588,2,21286,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf","2012-12-13 00:00:00",
14889,2,21286,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf","2013-07-05 00:00:00",
27383,1,21286,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021286Orig1s027ltr.pdf","2013-07-05 00:00:00",
4925,1,21286,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s030ltr.pdf","2014-06-17 00:00:00",
14890,2,21286,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf","2014-06-17 00:00:00",
27384,1,21286,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s031ltr.pdf","2014-06-30 00:00:00",
36589,2,21286,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf","2014-06-30 00:00:00",
4926,1,21286,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s032ltr.pdf","2014-09-24 00:00:00",
36590,2,21286,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf","2014-09-26 00:00:00",
45773,2,21286,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021286s036lbl.pdf","2016-11-01 00:00:00",
45778,1,21286,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021286Orig1s036ltr.pdf","2016-11-02 00:00:00",
14891,2,21287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf","2003-06-22 00:00:00",
27385,1,21287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287ltr.pdf","2003-06-22 00:00:00",
27386,1,21287,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287slr001ltr.pdf","2003-07-28 00:00:00",
42082,3,21287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_uroxatral_toc.cfm","2003-09-09 00:00:00",
42083,3,21287,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_S001_UROXATRALTOC.cfml","2007-01-10 00:00:00",
4927,1,21287,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s005ltr.pdf","2006-03-23 00:00:00",
14892,2,21287,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf","2006-03-22 00:00:00",
14893,2,21287,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf","2006-11-22 00:00:00",
27387,1,21287,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s007ltr.pdf","2006-11-22 00:00:00",
4928,1,21287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021287s008ltr.pdf","2007-04-09 00:00:00",
14894,2,21287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf","2007-03-31 00:00:00",
4929,1,21287,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s009ltr.pdf","2008-05-09 00:00:00",
14895,2,21287,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf","2008-09-19 00:00:00",
27388,1,21287,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s011ltr.pdf","2008-09-23 00:00:00",
14896,2,21287,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf","2009-05-25 00:00:00",
27389,1,21287,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021287s013ltr.pdf","2009-05-27 00:00:00",
14897,2,21287,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf","2010-04-19 00:00:00",
27390,1,21287,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s014ltr.pdf","2010-04-13 00:00:00",
4930,1,21287,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s016ltr.pdf","2010-12-21 00:00:00",
14898,2,21287,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf","2010-12-16 00:00:00",
51193,23,21287,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21287_alfuzosin_Original_WR.pdf","2006-02-21 00:00:00",
51194,25,21287,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21287_alfuzosin_Amendment_1.pdf","2006-06-15 00:00:00",
51200,26,21287,"SUPPL",16,"0","https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM226771.pdf","2008-10-17 00:00:00",
53166,20,21287,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21287s016_Alfuzosin_clinicalltr.pdf","1900-01-01 00:00:00",
53167,18,21287,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21287s016_Alfuzosin_Cllinpharmltr.pdf","1900-01-01 00:00:00",
53168,17,21287,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21287s016_Alfuzosin_Statisticalltr.pdf","1900-01-01 00:00:00",
14899,2,21287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf","2013-06-04 00:00:00",
27391,1,21287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021287Orig1s017ltr.pdf","2013-05-31 00:00:00",
14900,2,21287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf","2014-04-22 00:00:00",
27392,1,21287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021287Orig1s018ltr.pdf","2014-08-06 00:00:00",
54212,1,21287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021287Orig1s021ltr.pdf","2018-05-16 00:00:00",
54235,2,21287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021287s021lbl.pdf","2018-05-17 00:00:00",
4931,1,21288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21288ltr.pdf","2001-06-29 00:00:00",
21577,3,21288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-288_Trelstar.cfm","2002-01-07 00:00:00",
36591,2,21288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21288lbl.pdf","2001-06-29 00:00:00",
44114,10,21288,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
27393,1,21288,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021288s002,020715s006ltr.pdf","2005-10-25 00:00:00",
4932,1,21288,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016, 021288s013ltr.pdf","2008-04-16 00:00:00",
4933,1,21288,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf","2011-01-20 00:00:00",
14901,2,21288,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf","2011-01-20 00:00:00",
27394,1,21288,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,022437s003ltr.pdf","2011-05-24 00:00:00",
36592,2,21288,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf","2011-05-23 00:00:00",
4934,1,21288,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf","2013-03-15 00:00:00",
36593,2,21288,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf","2013-03-15 00:00:00",
14902,2,21288,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf","2014-07-15 00:00:00",
27395,1,21288,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288Orig1s028,022437Orig1s008ltr.pdf","2014-07-15 00:00:00",
4935,1,21289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21289ltr.pdf","2002-05-06 00:00:00",
36594,2,21289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle_prntlbl.pdf","2002-05-06 00:00:00",
42084,3,21289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle.cfm","2002-05-06 00:00:00",
4936,1,21289,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021289Orig1s019ltr.pdf","2014-02-21 00:00:00",
14903,2,21289,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf","2014-02-20 00:00:00",
4937,1,21290,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8-001ltr.pdf","2003-10-06 00:00:00",
14904,2,21290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf","2001-11-20 00:00:00",
14905,2,21290,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf","2003-10-10 00:00:00",
21578,3,21290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer.cfm","2001-11-20 00:00:00",
23990,14,21290,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=61","2013-02-04 00:00:00",
27396,1,21290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer_Approv.pdf","2001-11-20 00:00:00",
42085,3,21290,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-290S001_Tracleer.cfm","2003-12-15 00:00:00",
27397,1,21290,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21290s004ltr.pdf","2004-12-02 00:00:00",
4938,1,21290,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf","2005-12-06 00:00:00",
14906,2,21290,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf","2005-12-05 00:00:00",
4939,1,21290,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf","2005-12-06 00:00:00",
36595,2,21290,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf","2005-12-05 00:00:00",
4940,1,21290,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s010ltr.pdf","2007-02-23 00:00:00",
14907,2,21290,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf","2007-02-21 00:00:00",
27398,1,21290,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s011ltr.pdf","2007-06-04 00:00:00",
4941,1,21290,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s012ltr.pdf","2009-08-13 00:00:00",
24190,21,21290,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf","2009-08-11 00:00:00",
36596,2,21290,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf","2009-08-11 00:00:00",
4942,1,21290,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s014ltr.pdf","2009-02-18 00:00:00",
14908,2,21290,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf","2009-02-20 00:00:00",
14909,2,21290,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf","2009-03-20 00:00:00",
27399,1,21290,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s015ltr.pdf","2009-03-24 00:00:00",
15122,2,21290,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf","2009-09-17 00:00:00",
27400,1,21290,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s016ltr.pdf","2009-08-20 00:00:00",
27401,1,21290,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021290s018ltr.pdf","2010-02-25 00:00:00",
27402,1,21290,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021290s019ltr.pdf","2011-02-14 00:00:00",
36597,2,21290,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf","2011-02-09 00:00:00",
4943,1,21290,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s022ltr.pdf","2012-10-09 00:00:00",
36598,2,21290,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf","2012-10-05 00:00:00",
15123,2,21290,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf","2013-07-03 00:00:00",
27403,1,21290,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021290Orig1s025ltr.pdf","2013-07-05 00:00:00",
4944,1,21290,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf","2015-12-09 00:00:00",
36599,2,21290,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf","2015-12-08 00:00:00",
4945,1,21290,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf","2015-12-09 00:00:00",
15124,2,21290,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf","2015-12-08 00:00:00",
46449,1,21290,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s030ltr.pdf","2016-12-21 00:00:00",
45572,1,21290,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s033ltr.pdf","2016-10-21 00:00:00",
45578,2,21290,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf","2016-10-21 00:00:00",
49684,2,21290,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021290s034lbl.pdf","2017-09-07 00:00:00",
49685,8,21290,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021290s034lbl.pdf#page=30","2017-09-07 00:00:00",
49711,1,21290,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s034ltr.pdf","2017-09-11 00:00:00",
49671,1,21290,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s035,209279Orig1s001Ltr.pdf","2017-12-29 00:00:00",
4946,1,21292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21292ltr.pdf","2002-05-31 00:00:00",
15125,2,21292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf","2002-05-31 00:00:00",
21579,3,21292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-292_Novothyrox.cfm","2004-06-29 00:00:00",
4947,1,21292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021292s002ltr.pdf","2009-04-01 00:00:00",
36600,2,21292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf","2009-04-03 00:00:00",
55496,2,21292,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf","2018-09-18 00:00:00",
55502,1,21292,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf","2018-09-18 00:00:00",
55497,2,21292,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf","2018-09-18 00:00:00",
55503,1,21292,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf","2018-09-18 00:00:00",
55498,2,21292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf","2018-09-18 00:00:00",
55504,1,21292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf","2018-09-18 00:00:00",
4948,1,21297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21297ltr.pdf","2002-02-08 00:00:00",
15126,2,21297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21297lbl.pdf","2002-02-08 00:00:00",
42086,3,21297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-297_Clarinex.cfm","2002-04-30 00:00:00",
4949,1,21299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21299ltr.pdf","2004-06-18 00:00:00",
4950,1,21299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Approv.pdf","2004-06-18 00:00:00",
4951,1,21299,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21299slr001ltr.pdf","2003-08-28 00:00:00",
15127,2,21299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf","2004-06-18 00:00:00",
23642,10,21299,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
36601,2,21299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf","2004-06-18 00:00:00",
42087,3,21299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299_Paroxetine.cfm","2004-06-18 00:00:00",
42088,3,21299,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021299_S001_PEXEVA_TABLETS.pdf","2007-09-26 00:00:00",
27404,1,21299,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21299s007ltr.pdf","2004-08-31 00:00:00",
27405,1,21299,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21299s013ltr.pdf","2005-01-13 00:00:00",
36602,2,21299,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21299s013lbl.pdf","2005-01-13 00:00:00",
4952,1,21299,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf","2006-12-28 00:00:00",
36603,2,21299,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf","2006-12-14 00:00:00",
15128,2,21299,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf","2006-12-14 00:00:00",
27406,1,21299,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf","2006-12-28 00:00:00",
4953,1,21299,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf","2006-12-28 00:00:00",
36604,2,21299,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf","2006-12-14 00:00:00",
27407,1,21299,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s019ltr.pdf","2007-08-07 00:00:00",
36605,2,21299,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s019lbl.pdf","2007-08-06 00:00:00",
27408,1,21299,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s020ltr.pdf","2007-10-10 00:00:00",
36606,2,21299,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s020lbl.pdf","2007-10-10 00:00:00",
4954,1,21299,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021299s021ltr.pdf","2008-03-07 00:00:00",
15129,2,21299,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021299s021lbl.pdf","2008-03-07 00:00:00",
15130,2,21299,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021299s022lbl.pdf","2010-02-04 00:00:00",
27409,1,21299,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021299s022ltr.pdf","2010-02-05 00:00:00",
4955,1,21299,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021299s023ltr.pdf","2009-02-03 00:00:00",
15131,2,21299,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021299s023lbl.pdf","2009-02-04 00:00:00",
4956,1,21299,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021299s024ltr.pdf","2011-04-29 00:00:00",
36607,2,21299,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021299s024lbl.pdf","2011-04-29 00:00:00",
27410,1,21299,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf","2012-12-21 00:00:00",
4957,1,21299,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf","2012-12-21 00:00:00",
27411,1,21299,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf","2012-12-21 00:00:00",
4958,1,21299,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021299Orig1s032ltr.pdf","2014-07-24 00:00:00",
15132,2,21299,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf","2014-07-23 00:00:00",
46697,2,21299,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf","2017-01-06 00:00:00",
46749,8,21299,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf#page=38","2017-01-10 00:00:00",
46750,1,21299,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021299Orig1s033ltr.pdf","2017-01-10 00:00:00",
4959,1,21300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21300ltr.pdf","2004-09-03 00:00:00",
4960,1,21300,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
36608,2,21300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21300lbl.pdf","2004-09-03 00:00:00",
42089,3,21300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021300s000_ClarinexTOC.cfm","2006-07-25 00:00:00",
27412,1,21300,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
27413,1,21300,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
27414,1,21300,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf","2010-12-28 00:00:00",
4961,1,21300,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf","2014-04-24 00:00:00",
15133,2,21300,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf","2014-04-25 00:00:00",
4962,1,21301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21301ltr.pdf","2001-05-25 00:00:00",
21580,3,21301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-301_Levoxyl.cfm","2002-01-07 00:00:00",
36609,2,21301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21301lbl.pdf","2001-05-25 00:00:00",
4963,1,21301,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21301slr002ltr.pdf","2002-07-17 00:00:00",
27415,1,21301,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21301scm006ltr.pdf","2003-08-06 00:00:00",
27416,1,21301,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21301s014ltr.pdf","2005-03-10 00:00:00",
36610,2,21301,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21301s014lbl.pdf","2005-03-10 00:00:00",
4964,1,21301,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021301s026ltr.pdf","2008-07-10 00:00:00",
15134,2,21301,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf","2008-07-09 00:00:00",
15135,2,21301,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf","2011-03-21 00:00:00",
21581,3,21301,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021301_s028_levoxyl tablets.pdf","2011-02-15 00:00:00",
4965,1,21302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_ELIDEL_Approv.pdf","2001-12-13 00:00:00",
36611,2,21302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21302lbl.pdf","2001-12-13 00:00:00",
42090,3,21302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_Elidel.cfm","2001-12-13 00:00:00",
43739,8,21302,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf","2011-01-13 00:00:00",
27417,1,21302,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21302scp004ltr.pdf","2003-10-17 00:00:00",
36612,2,21302,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21302scp004_elidel_lbl.pdf","2003-10-17 00:00:00",
15136,2,21302,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21302s005lbl.pdf","2004-12-03 00:00:00",
27418,1,21302,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21302s005ltr.pdf","2004-12-02 00:00:00",
4966,1,21302,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021302s011ltr.pdf","2006-01-30 00:00:00",
36613,2,21302,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021302s011lbl.pdf","2006-01-19 00:00:00",
4967,1,21302,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021302s012ltr.pdf","2007-08-14 00:00:00",
15137,2,21302,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021302s012lbl.pdf","2007-08-14 00:00:00",
27419,1,21302,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021302s014ltr.pdf","2010-07-23 00:00:00",
36614,2,21302,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021302s014lbl.pdf","2010-07-22 00:00:00",
4968,1,21302,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021302Orig1s018ltr.pdf","2014-04-02 00:00:00",
15138,2,21302,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf","2014-04-01 00:00:00",
4969,1,21303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall_Approv.pdf","2001-10-11 00:00:00",
4970,1,21303,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21303s001ltr.pdf","2002-05-22 00:00:00",
15139,2,21303,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21303s1lbl.pdf","2002-05-22 00:00:00",
21582,3,21303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall.cfm","2004-05-25 00:00:00",
21583,3,21303,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021303_S001_AdderallTOC.cfm","2007-06-22 00:00:00",
23643,10,21303,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm","2005-04-15 00:00:00",
36615,2,21303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21303lbl.pdf","2001-10-11 00:00:00",
15140,2,21303,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021303s005lbl.pdf","2005-02-07 00:00:00",
27420,1,21303,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21303s005ltr.pdf","2004-08-12 00:00:00",
48426,3,21303,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021303Orig1s005.pdf","2017-05-17 00:00:00",
15141,2,21303,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021303s009lbl.pdf","2005-07-26 00:00:00",
27421,1,21303,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021303s009ltr.pdf","2005-07-26 00:00:00",
48425,3,21303,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021303Orig1s009.pdf","2017-05-17 00:00:00",
52044,20,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303s009_amphetamine (mixed salts)_Adderall-MedRev.pdf","1900-01-01 00:00:00",
52045,23,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303_amphetamine(mixed salts)_Adderall_XR_5-6-03_orig.pdf","1900-01-01 00:00:00",
52046,25,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303_amphetamine(mixed salts)_Adderall_XR_WR amend_9-17-03.pdf","1900-01-01 00:00:00",
52047,41,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303_amphetamine(mixed salts)_Adderall_XR amend_9-16-04_WR.pdf","1900-01-01 00:00:00",
52048,18,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303s009_amphetamine (mixed salts)_Adderall-ClinPharmRev.pdf","1900-01-01 00:00:00",
52049,17,21303,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021303s009_amphetamine (mixed salts)_Adderall-StatsRev.pdf","1900-01-01 00:00:00",
15142,2,21303,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021303s010lbl.pdf","2006-06-20 00:00:00",
27422,1,21303,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021303s010LTR.pdf","2006-06-20 00:00:00",
15143,2,21303,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf","2006-07-27 00:00:00",
27423,1,21303,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf","2006-07-27 00:00:00",
4971,1,21303,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021303s015ltr.pdf","2007-05-29 00:00:00",
15144,2,21303,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf","2007-05-29 00:00:00",
27424,1,21303,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf","2008-11-13 00:00:00",
15145,2,21303,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf","2010-11-17 00:00:00",
27425,1,21303,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf","2010-11-18 00:00:00",
4972,1,21303,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf","2010-11-18 00:00:00",
36616,2,21303,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf","2010-11-17 00:00:00",
27426,1,21303,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021303s023ltr.pdf","2012-02-10 00:00:00",
36617,2,21303,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023lbl.pdf","2012-02-09 00:00:00",
4973,1,21303,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s024ltr.pdf","2013-06-18 00:00:00",
15146,2,21303,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s024lbl.pdf","2013-06-18 00:00:00",
27427,1,21303,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s025ltr.pdf","2013-03-11 00:00:00",
36618,2,21303,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s025lbl.pdf","2013-03-12 00:00:00",
27428,1,21303,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s026ltr.pdf","2013-12-05 00:00:00",
36619,2,21303,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf","2013-12-04 00:00:00",
4974,1,21303,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021303Orig1s027ltr.pdf","2014-07-25 00:00:00",
15147,2,21303,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021303s027lbl.pdf","2014-07-28 00:00:00",
54907,2,21303,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf","2018-07-17 00:00:00",
54931,1,21303,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021303Orig1s029ltr.pdf","2018-07-20 00:00:00",
27429,1,21303,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021303Orig1s031ltr.pdf","2015-04-21 00:00:00",
36620,2,21303,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021303s031lbl.pdf","2015-04-21 00:00:00",
46769,2,21303,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021303s032lbl.pdf","2017-01-09 00:00:00",
46845,8,21303,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021303s032lbl.pdf#page=15","2017-01-17 00:00:00",
46846,1,21303,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021303Orig1s032,021977Orig1s043ltr.pdf","2017-01-17 00:00:00",
4975,1,21304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21304ltr.pdf","2001-03-29 00:00:00",
4976,1,21304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21304se1-001ltr.pdf","2003-09-25 00:00:00",
15148,2,21304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf","2001-03-29 00:00:00",
15149,2,21304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf","2003-09-25 00:00:00",
21584,3,21304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21304_Valcyte.cfm","2004-04-12 00:00:00",
21585,3,21304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021304_S001_VALCYTE.pdf","2007-11-19 00:00:00",
51497,20,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21304 valganciclovir clinical prea.pdf","1900-01-01 00:00:00",
51498,18,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21304 valganciclovir clinpharm prea.pdf","1900-01-01 00:00:00",
52380,23,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019661, 021304_Valganciclovir_Tab_2_WR_6-21-01.pdf","1900-01-01 00:00:00",
52381,25,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019661, 021304_Valganciclovir_Tab_3_amend_11-6-01.pdf","1900-01-01 00:00:00",
52382,26,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019661, 021304_Valganciclovir_Tab_4_amend_12-29-04.pdf","1900-01-01 00:00:00",
52385,27,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019661, 021304_Valganciclovir_Tab_5_amend_6-1-07.pdf","1900-01-01 00:00:00",
52386,28,21304,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019661, 021304_Valganciclovir_Tab_6_amend_3-20-08l.pdf","1900-01-01 00:00:00",
4977,1,21304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021304s004ltr.pdf","2006-02-02 00:00:00",
36621,2,21304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf","2006-02-02 00:00:00",
4978,1,21304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf","2009-09-01 00:00:00",
15150,2,21304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf","2009-08-30 00:00:00",
21586,3,21304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.cfm","2010-05-27 00:00:00",
24191,21,21304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf","2010-05-27 00:00:00",
27430,1,21304,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf","2010-08-10 00:00:00",
36622,2,21304,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf","2010-08-10 00:00:00",
27431,1,21304,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf","2013-04-01 00:00:00",
36623,2,21304,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf","2013-04-01 00:00:00",
4979,1,21304,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf","2015-04-24 00:00:00",
36624,2,21304,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf","2015-04-28 00:00:00",
48825,1,21304,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021304Orig1s012,022257Orig1s007ltr.pdf","2017-06-26 00:00:00",
48832,2,21304,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf","2017-06-26 00:00:00",
55098,1,21304,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021304Orig1s014,022257Orig1s009ltr.pdf","2018-08-03 00:00:00",
55102,2,21304,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf","2018-08-03 00:00:00",
4980,1,21305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305ltr.pdf","2003-01-24 00:00:00",
4981,1,21305,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305slr001ltr.pdf","2003-08-15 00:00:00",
15151,2,21305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21305_Sodium-Iodide_lbl.pdf","2003-01-24 00:00:00",
21587,3,21305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021305_sodiumiodide.cfm","2003-06-26 00:00:00",
4982,1,21305,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21305s002ltr.pdf","2004-12-02 00:00:00",
4983,1,21305,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021305s003ltr.pdf","2005-05-20 00:00:00",
15152,2,21305,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021305s003lbl.pdf","2005-05-20 00:00:00",
15153,2,21305,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021305s005lbl.pdf","2006-01-10 00:00:00",
27432,1,21305,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s005ltr.pdf","2006-01-20 00:00:00",
4984,1,21305,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s010ltr.pdf","2006-10-26 00:00:00",
27433,1,21305,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021305s011_LTR.pdf","2007-04-25 00:00:00",
36625,2,21305,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021305s011lbl.pdf","2007-04-20 00:00:00",
4985,1,21305,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021305s016ltr.pdf","2008-03-04 00:00:00",
36626,2,21305,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021305s016lbl.pdf","2008-03-05 00:00:00",
27434,1,21305,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s025ltr.pdf","2011-09-28 00:00:00",
36627,2,21305,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s025lbl.pdf","2011-09-29 00:00:00",
4986,1,21305,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s027ltr.pdf","2011-10-05 00:00:00",
15154,2,21305,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s027lbl.pdf","2011-10-03 00:00:00",
4987,1,21305,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s041ltr.pdf","2016-06-21 00:00:00",
15155,2,21305,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s041lbl.pdf","2016-06-21 00:00:00",
4988,1,21305,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s042ltr.pdf","2016-07-12 00:00:00",
15156,2,21306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf","2010-07-06 00:00:00",
23992,14,21306,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2010-08-05 00:00:00",
27435,1,21306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021306s000ltr.pdf","2010-07-02 00:00:00",
27436,1,21306,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf","2011-07-07 00:00:00",
36628,2,21306,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf","2011-07-06 00:00:00",
42091,3,21306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306_butrans_toc.cfm","2011-09-26 00:00:00",
44640,21,21306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306Orig1s000SumR.pdf","2011-09-26 00:00:00",
15157,2,21306,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf","2011-07-06 00:00:00",
27437,1,21306,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf","2011-07-07 00:00:00",
27438,1,21306,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021306Orig1s008ltr.pdf","2012-07-11 00:00:00",
36629,2,21306,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf","2012-07-12 00:00:00",
27439,1,21306,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s012ltr.pdf","2013-04-16 00:00:00",
15158,2,21306,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf","2014-07-02 00:00:00",
27440,1,21306,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf","2014-07-01 00:00:00",
15159,2,21306,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf","2013-07-30 00:00:00",
27441,1,21306,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s016ltr.pdf","2013-07-29 00:00:00",
4989,1,21306,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s018ltr.pdf","2014-04-17 00:00:00",
15160,2,21306,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf","2014-04-16 00:00:00",
4990,1,21306,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf","2014-07-01 00:00:00",
36630,2,21306,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf","2014-07-02 00:00:00",
4991,1,21306,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s020ltr.pdf","2014-08-20 00:00:00",
27442,1,21306,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021306Orig1s022ltr.pdf","2015-07-06 00:00:00",
27443,1,21306,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s023ltr.pdf","2016-04-22 00:00:00",
46280,1,21306,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s024ltr.pdf","2016-12-20 00:00:00",
46356,2,21306,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf","2016-12-21 00:00:00",
45464,1,21306,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s026ltr.pdf","2016-10-04 00:00:00",
50073,2,21306,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf","2017-10-18 00:00:00",
50074,8,21306,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf#page=40","2017-10-18 00:00:00",
50081,1,21306,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s027ltr.pdf","2017-10-18 00:00:00",
52070,20,21306,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/193_21306S27 buprenorphine clinical prea.pdf","1900-01-01 00:00:00",
52071,18,21306,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/194_21306S27 buprenorphine clinpharm prea.pdf","1900-01-01 00:00:00",
48591,2,21306,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306Orig1s030ltr.pdf","2017-05-31 00:00:00",
49487,1,21306,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s031ltr.pdf","2017-08-21 00:00:00",
55680,1,21306,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf","2018-10-01 00:00:00",
55681,1,21306,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf","2018-10-01 00:00:00",
4992,1,21307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin_Approv.pdf","2001-12-07 00:00:00",
21588,3,21307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin.cfm","2002-03-26 00:00:00",
36631,2,21307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21307lbl.pdf","2001-12-07 00:00:00",
4993,1,21307,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021307s004ltr.pdf","2006-04-07 00:00:00",
27444,1,21307,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021307s012ltr.pdf","2011-04-04 00:00:00",
4994,1,21307,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021307s013ltr.pdf","2012-05-04 00:00:00",
27445,1,21307,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021307Orig1s014ltr.pdf","2014-12-18 00:00:00",
4995,1,21307,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021307Orig1s015ltr.pdf","2015-12-22 00:00:00",
15161,2,21307,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021307Orig1s015lbl.pdf","2015-12-22 00:00:00",
15162,2,21308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf","2003-05-07 00:00:00",
21589,3,21308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-308_Monistat.cfm","2004-06-09 00:00:00",
27446,1,21308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21308ltr.pdf","2004-06-09 00:00:00",
27447,1,21308,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308scp004ltr.pdf","2004-06-09 00:00:00",
4996,1,21308,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308slr005ltr.pdf","2004-06-09 00:00:00",
4997,1,21308,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21308scp008ltr.pdf","2003-12-08 00:00:00",
21590,3,21308,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021308_S009_MONISTAT 1.pdf","2007-11-19 00:00:00",
27448,1,21308,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21308s009ltr.pdf","2004-10-05 00:00:00",
36632,2,21308,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021308Orig1s009lbl.pdf","2004-10-05 00:00:00",
27449,1,21308,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21308s010ltr.pdf","2005-04-06 00:00:00",
49512,2,21308,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021308Orig1s010lbl.pdf","2017-08-22 00:00:00",
21591,3,21310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21310.pdf","2005-07-15 00:00:00",
15163,2,21312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21312lbl.pdf","2002-06-26 00:00:00",
27450,1,21312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21312ltr.pdf","2002-06-26 00:00:00",
42092,3,21312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-312_Clarinex.cfm","2003-11-06 00:00:00",
4998,1,21312,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21312slr002ltr.pdf","2004-06-01 00:00:00",
27451,1,21312,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21312slr004,21165slr006ltr.pdf","2004-02-03 00:00:00",
15164,2,21312,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021312s006lbl.pdf","2006-12-26 00:00:00",
27452,1,21312,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
4999,1,21312,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021312s007ltr.pdf","2005-07-21 00:00:00",
15165,2,21312,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021312s007lbl.pdf","2005-07-21 00:00:00",
21592,3,21312,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021312_s007_clarinex red-tabs.pdf","2011-02-15 00:00:00",
27453,1,21312,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
5000,1,21312,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf","2006-12-28 00:00:00",
5001,1,21312,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf","2010-12-28 00:00:00",
27454,1,21312,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf","2014-04-24 00:00:00",
36634,2,21312,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf","2014-04-25 00:00:00",
5002,1,21313,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021313s001ltr.pdf","2007-07-24 00:00:00",
15166,2,21313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021313s000lbl.pdf","2006-02-07 00:00:00",
15167,2,21313,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021313s001lbl.pdf","2007-07-24 00:00:00",
27455,1,21313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021313s000ltr.pdf","2006-02-08 00:00:00",
42093,3,21313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021313s000TOC.cfm","2008-07-09 00:00:00",
5003,1,21313,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021313s002ltr.pdf","2010-01-05 00:00:00",
36635,2,21313,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021313s002lbl.pdf","2010-01-12 00:00:00",
27456,1,21313,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021313Orig1s005ltr.pdf","2014-03-10 00:00:00",
36636,2,21313,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021313s005lbl.pdf","2014-03-10 00:00:00",
52500,2,21313,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s009lbl.pdf","2018-02-07 00:00:00",
52515,1,21313,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s009ltr.pdf","2018-02-08 00:00:00",
53750,2,21313,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf","2018-04-20 00:00:00",
53780,1,21313,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s010,021605Orig1s013ltr.pdf","2018-04-23 00:00:00",
21593,3,21314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm","2005-11-30 00:00:00",
27457,1,21314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21314ltr.pdf","2004-06-07 00:00:00",
36637,2,21314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf","2003-04-09 00:00:00",
15168,2,21314,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf","2014-11-18 00:00:00",
27458,1,21314,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021314Orig1s004ltr.pdf","2014-10-29 00:00:00",
5004,1,21314,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021314Orig1s005ltr.pdf","2016-07-12 00:00:00",
5005,1,21316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316ltr.pdf","2002-06-26 00:00:00",
5006,1,21316,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316se1-001ltr.pdf","2004-05-28 00:00:00",
15169,2,21316,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf","2002-09-11 00:00:00",
21594,3,21316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm","2003-04-30 00:00:00",
36638,2,21316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf","2002-06-26 00:00:00",
42094,3,21316,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_S001_ALTOCOR_AP.pdf","2007-07-09 00:00:00",
5007,1,21316,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr005ltr.pdf","2003-08-28 00:00:00",
5008,1,21316,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr006ltr.pdf","2003-09-30 00:00:00",
36639,2,21316,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf","2003-09-30 00:00:00",
42095,3,21316,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021316_S006_ALTOCAR_TABLETS_AP.pdf","2007-04-30 00:00:00",
27459,1,21316,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21316s010ltr.pdf","2004-07-21 00:00:00",
36640,2,21316,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf","2004-07-21 00:00:00",
5009,1,21316,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021316s018ltr.pdf","2007-02-12 00:00:00",
15170,2,21316,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf","2012-04-27 00:00:00",
27460,1,21316,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316s026ltr.pdf","2012-05-02 00:00:00",
5010,1,21316,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s028ltr.pdf","2012-12-27 00:00:00",
15171,2,21316,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf","2012-12-28 00:00:00",
15172,2,21316,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf","2012-11-02 00:00:00",
27461,1,21316,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s029ltr.pdf","2012-11-05 00:00:00",
27462,1,21316,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021316Orig1s031ltr.pdf","2014-05-01 00:00:00",
36641,2,21316,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf","2014-05-02 00:00:00",
49269,2,21316,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021316s034lbl.pdf","2017-08-08 00:00:00",
49279,1,21316,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021316Orig1s034ltr.pdf","2017-08-08 00:00:00",
52795,2,21316,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021316s035lbl.pdf","2018-03-02 00:00:00",
52805,1,21316,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021316Orig1s035ltr.pdf","2018-03-02 00:00:00",
5011,1,21317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21317ltr.pdf","2001-10-18 00:00:00",
15173,2,21317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21317lbl.pdf","2001-10-18 00:00:00",
42096,3,21317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21317_Bayer.cfm","2001-10-18 00:00:00",
15174,2,21318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf","2001-11-26 00:00:00",
21595,3,21318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm","2004-03-24 00:00:00",
23253,8,21318,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088604.pdf","2003-12-17 00:00:00",
27463,1,21318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21318.pdf","2001-11-26 00:00:00",
5012,1,21318,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318slr002ltr.pdf","2004-06-07 00:00:00",
15175,2,21318,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf","2004-06-07 00:00:00",
27464,1,21318,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318s004ltr.pdf","2004-09-07 00:00:00",
36642,2,21318,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf","2004-09-07 00:00:00",
15176,2,21318,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf","2007-05-29 00:00:00",
27465,1,21318,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021318s009ltr.pdf","2007-05-29 00:00:00",
5013,1,21318,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf","2009-07-23 00:00:00",
36643,2,21318,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf","2009-07-23 00:00:00",
5014,1,21318,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s015ltr.pdf","2008-03-04 00:00:00",
15177,2,21318,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf","2008-03-05 00:00:00",
5015,1,21318,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s016ltr.pdf","2008-06-30 00:00:00",
42097,3,21318,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021318Orig1s016.pdf","2011-10-10 00:00:00",
5016,1,21318,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021318s026ltr.pdf","2011-08-12 00:00:00",
27466,1,21318,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021318s027ltr.pdf","2012-03-15 00:00:00",
5017,1,21318,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf","2013-09-04 00:00:00",
15178,2,21318,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf","2013-09-09 00:00:00",
48200,1,21318,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021318Orig1s051ltr.pdf","2017-05-02 00:00:00",
5018,1,21319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen_approv.PDF","2001-11-20 00:00:00",
5019,1,21319,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21319se1-001ltr.pdf","2002-10-09 00:00:00",
21596,3,21319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm","2001-11-20 00:00:00",
36644,2,21319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf","2001-11-20 00:00:00",
36645,2,21319,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf","2002-10-09 00:00:00",
44115,10,21319,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm","2011-12-20 00:00:00",
27467,1,21319,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319slr005ltr.pdf","2004-03-19 00:00:00",
5020,1,21319,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s007ltr.pdf","2004-08-06 00:00:00",
15179,2,21319,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf","2004-08-06 00:00:00",
15180,2,21319,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf","2004-09-15 00:00:00",
27468,1,21319,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s008ltr.pdf","2004-09-15 00:00:00",
27469,1,21319,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021319s009rev2.pdf","2006-01-06 00:00:00",
5021,1,21319,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319se1-014ltr.pdf","2008-06-23 00:00:00",
15181,2,21319,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf","2008-06-26 00:00:00",
24192,21,21319,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-014_SUMR.pdf","2008-07-17 00:00:00",
5022,1,21319,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319s015ltr.pdf","2008-04-02 00:00:00",
15182,2,21319,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf","2008-04-01 00:00:00",
5023,1,21319,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s018ltr.pdf","2010-06-18 00:00:00",
36646,2,21319,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf","2010-06-24 00:00:00",
27470,1,21319,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s022ltr.pdf","2010-09-13 00:00:00",
36647,2,21319,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf","2010-09-10 00:00:00",
5024,1,21319,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf","2011-06-10 00:00:00",
36648,2,21319,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf","2011-06-10 00:00:00",
15183,2,21319,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf","2011-06-10 00:00:00",
27471,1,21319,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf","2011-06-10 00:00:00",
27472,1,21319,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021319s027ltr.pdf","2012-06-29 00:00:00",
36649,2,21319,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf","2012-06-28 00:00:00",
15184,2,21319,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf","2013-05-01 00:00:00",
27473,1,21319,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf","2013-05-02 00:00:00",
15185,2,21319,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf","2013-05-01 00:00:00",
27474,1,21319,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf","2013-05-02 00:00:00",
27475,1,21320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21320ltr.pdf","2003-12-02 00:00:00",
36650,2,21320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf","2003-12-02 00:00:00",
42098,3,21320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-320_Plenaxis.cfm","2004-03-08 00:00:00",
5025,1,21320,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021320s002ltr.pdf","2005-09-14 00:00:00",
15186,2,21320,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf","2005-09-14 00:00:00",
15187,2,21321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf","2003-04-09 00:00:00",
23254,8,21321,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135933.pdf","2009-11-18 00:00:00",
23994,14,21321,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=18","2011-03-25 00:00:00",
27476,1,21321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21321ltr.pdf","2004-06-03 00:00:00",
42099,3,21321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21321_Extraneal.cfm","2003-04-25 00:00:00",
5026,1,21321,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s008ltr.pdf","2005-05-25 00:00:00",
5027,1,21321,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s009ltr.pdf","2005-05-25 00:00:00",
5028,1,21321,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21321s010ltr.pdf","2004-12-30 00:00:00",
36651,2,21321,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf","2004-12-30 00:00:00",
5029,1,21321,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021321s013ltr.pdf","2007-03-06 00:00:00",
5030,1,21321,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s017ltr.pdf","2009-04-15 00:00:00",
36652,2,21321,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf","2009-04-16 00:00:00",
5031,1,21321,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s018ltr.pdf","2009-02-03 00:00:00",
15188,2,21321,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf","2011-03-11 00:00:00",
27477,1,21321,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf","2011-03-10 00:00:00",
5032,1,21321,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf","2011-03-10 00:00:00",
36653,2,21321,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf","2011-03-11 00:00:00",
5033,1,21321,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s028ltr.pdf","2014-12-11 00:00:00",
5034,1,21321,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s029ltr.pdf","2014-02-27 00:00:00",
5035,1,21321,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021321Orig1s032ltr.pdf","2015-10-21 00:00:00",
15189,2,21321,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf","2015-10-22 00:00:00",
46230,2,21321,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021321s034lbl.pdf","2016-12-20 00:00:00",
46470,1,21321,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s034ltr.pdf","2016-12-22 00:00:00",
45638,1,21321,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s035ltr.pdf","2016-10-25 00:00:00",
5036,1,21322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21322ltr.pdf","2004-10-15 00:00:00",
21597,3,21322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021322s000_LuverisTOC.cfm","2005-11-30 00:00:00",
36654,2,21322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21322lbl.pdf","2004-10-15 00:00:00",
5037,1,21323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323ltr.pdf","2002-08-14 00:00:00",
15190,2,21323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21323lbl.pdf","2002-08-14 00:00:00",
23644,10,21323,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053342.htm","2005-07-29 00:00:00",
27478,1,21323,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323se8-001and21440ltr.pdf","2002-08-29 00:00:00",
36655,2,21323,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf","2004-06-08 00:00:00",
42100,3,21323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-323_Lexapro.cfm","2004-04-12 00:00:00",
42101,3,21323,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm","2004-04-12 00:00:00",
53258,20,21323,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21323_escitalopram_clinical_PREA.pdf","1900-01-01 00:00:00",
53259,18,21323,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21323_Escitalopram_clinpharm_PREA.pdf","1900-01-01 00:00:00",
53260,17,21323,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21323_Escitalopram_statistical_PREA.pdf","1900-01-01 00:00:00",
5038,1,21323,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf","2003-12-22 00:00:00",
21598,3,21323,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf","2007-07-06 00:00:00",
36656,2,21323,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf","2003-12-22 00:00:00",
15191,2,21323,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf","2003-12-22 00:00:00",
21599,3,21323,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf","2007-07-06 00:00:00",
27479,1,21323,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf","2003-12-22 00:00:00",
27480,1,21323,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21323s014,21365s007ltr.pdf","2005-01-13 00:00:00",
27481,1,21323,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf","2004-05-26 00:00:00",
5039,1,21323,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf","2005-02-23 00:00:00",
15192,2,21323,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021323s025lbl.pdf","2007-08-03 00:00:00",
27482,1,21323,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf","2007-08-07 00:00:00",
27483,1,21323,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s028,s029,021365s018,s019ltr.pdf","2008-09-19 00:00:00",
36657,2,21323,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf","2008-09-19 00:00:00",
27484,1,21323,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s029, 021365s019ltr.pdf","2008-10-21 00:00:00",
27485,1,21323,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf","2009-03-24 00:00:00",
36658,2,21323,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf","2009-03-25 00:00:00",
42102,3,21323,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf","2012-01-27 00:00:00",
5040,1,21323,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf","2009-03-24 00:00:00",
21600,3,21323,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf","2012-01-27 00:00:00",
36659,2,21323,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf","2009-03-25 00:00:00",
27486,1,21323,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf","2009-02-03 00:00:00",
36660,2,21323,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf","2009-02-04 00:00:00",
5041,1,21323,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s033,021365s024ltr.pdf","2011-05-16 00:00:00",
15193,2,21323,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf","2011-05-16 00:00:00",
15194,2,21323,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf","2011-03-11 00:00:00",
27487,1,21323,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s035,021365s025ltr.pdf","2011-03-16 00:00:00",
5042,1,21323,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf","2012-12-05 00:00:00",
36661,2,21323,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021323s040lbl.pdf","2012-12-03 00:00:00",
27488,1,21323,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021323Orig1s044,021365Orig1s032ltr.pdf","2014-11-03 00:00:00",
36662,2,21323,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf","2014-11-04 00:00:00",
54156,18,21323,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21323_Escitalopram_clinpharm_PREA.pdf","1900-01-01 00:00:00",
54158,17,21323,"SUPPL",44,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21323_Escitalopram_statistical_PREA.pdf","1900-01-01 00:00:00",
5043,1,21323,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf","2014-07-10 00:00:00",
36663,2,21323,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf","2014-07-21 00:00:00",
46682,2,21323,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf","2017-01-06 00:00:00",
46781,1,21323,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf","2017-01-11 00:00:00",
46782,8,21323,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24","2017-01-11 00:00:00",
5044,1,21324,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs001ltr.pdf","2004-06-03 00:00:00",
21601,3,21324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm","2001-10-02 00:00:00",
23071,6,21324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324PPIlbl.pdf","2003-05-07 00:00:00",
27489,1,21324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort_Approv.pdf","2001-10-02 00:00:00",
36664,2,21324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324lbl.pdf","2001-10-02 00:00:00",
52050,20,21324,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21324 budesonide Entocort_clinical prea.pdf","1900-01-01 00:00:00",
52053,17,21324,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21324 budesonide_Entocort_ statistical prea.pdf","1900-01-01 00:00:00",
27490,1,21324,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs003ltr.pdf","2004-06-03 00:00:00",
5045,1,21324,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21324scm004ltr.pdf","2003-03-26 00:00:00",
5046,1,21324,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021324s005ltr.pdf","2005-05-03 00:00:00",
36665,2,21324,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021324s005lbl.pdf","2005-05-03 00:00:00",
5047,1,21324,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021324s008ltr.pdf","2009-06-24 00:00:00",
15195,2,21324,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf","2009-06-24 00:00:00",
15196,2,21324,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf","2011-12-23 00:00:00",
27491,1,21324,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021324s009ltr.pdf","2011-12-22 00:00:00",
5048,1,21324,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf","2016-05-03 00:00:00",
15197,2,21324,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf","2016-05-03 00:00:00",
52051,20,21324,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21324 budesonide Entocort_clinical prea.pdf","1900-01-01 00:00:00",
27492,1,21324,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf","2016-05-03 00:00:00",
36666,2,21324,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf","2016-05-03 00:00:00",
50098,2,21324,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021324s016lbl.pdf","2017-10-19 00:00:00",
50108,1,21324,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021324Orig1s016ltr.pdf","2017-10-19 00:00:00",
5049,1,21330,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21330ltr.pdf","2002-10-31 00:00:00",
21602,3,21330,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-330_Commit.cfm","2004-06-29 00:00:00",
5050,1,21330,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21330scf002ltr.pdf","2004-02-27 00:00:00",
15198,2,21330,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21330scf002_committ_lbl.pdf","2004-03-03 00:00:00",
52733,3,21330,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021330Orig1s002.pdf","2018-02-27 00:00:00",
15199,2,21330,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s003lbl.pdf","2005-11-01 00:00:00",
27493,1,21330,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s003ltr.pdf","2005-11-01 00:00:00",
5051,1,21330,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s004ltr.pdf","2005-11-30 00:00:00",
36667,2,21330,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s004lbl.pdf","2005-11-30 00:00:00",
52734,3,21330,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021330Orig1s004.pdf","2018-02-27 00:00:00",
5052,1,21330,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021330s005ltr.pdf","2006-09-18 00:00:00",
15200,2,21330,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf","2006-09-15 00:00:00",
5053,1,21330,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021330s007ltr.pdf","2008-05-28 00:00:00",
52735,3,21330,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021330Orig1s007.pdf","2018-02-27 00:00:00",
5054,1,21330,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s008ltr.pdf","2010-01-15 00:00:00",
27494,1,21330,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s009ltr.pdf","2010-08-31 00:00:00",
27495,1,21330,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021330s013ltr.pdf","2012-05-29 00:00:00",
52737,3,21330,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021330Orig1s013.pdf","2018-02-27 00:00:00",
48854,2,21330,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1S014.pdf","2017-06-28 00:00:00",
48855,3,21330,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021330Orig1S014.pdf","2017-06-28 00:00:00",
15201,2,21330,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330s015lbl.pdf","2013-08-12 00:00:00",
27496,1,21330,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s015ltr.pdf","2013-08-08 00:00:00",
5055,1,21330,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s016ltr.pdf","2013-10-29 00:00:00",
15202,2,21330,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1s016lbl.pdf","2013-11-07 00:00:00",
5056,1,21330,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021330Orig1s017ltr.pdf","2014-08-15 00:00:00",
36668,2,21330,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021330Orig1s017lbl.pdf","2014-08-25 00:00:00",
15203,2,21330,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s018lbl.pdf","2015-05-20 00:00:00",
27497,1,21330,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s018ltr.pdf","2015-05-20 00:00:00",
5057,1,21330,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s019ltr.pdf","2015-10-02 00:00:00",
36669,2,21330,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330s019lbl.pdf","2015-10-22 00:00:00",
5058,1,21330,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s020ltr.pdf","2015-08-10 00:00:00",
15204,2,21330,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s020lbl.pdf","2015-08-10 00:00:00",
5059,1,21332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021332ltr.pdf","2005-03-18 00:00:00",
23256,8,21332,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf","2007-02-28 00:00:00",
36670,2,21332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf","2005-03-18 00:00:00",
42103,3,21332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin.cfm","2005-06-14 00:00:00",
27498,1,21332,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021332s006ltr.pdf","2007-10-04 00:00:00",
36671,2,21332,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf","2007-09-26 00:00:00",
5060,1,21332,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf","2014-06-30 00:00:00",
15205,2,21332,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf","2014-07-01 00:00:00",
5061,1,21332,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021332s010ltr.pdf","2008-08-06 00:00:00",
27499,1,21332,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf","2014-06-30 00:00:00",
36672,2,21332,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf","2014-07-01 00:00:00",
27500,1,21332,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021332s020ltr.pdf","2012-01-05 00:00:00",
5062,1,21332,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s023ltr.pdf","2015-02-27 00:00:00",
15206,2,21332,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf","2015-03-03 00:00:00",
27501,1,21332,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s024ltr.pdf","2015-08-11 00:00:00",
27502,1,21332,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s025ltr.pdf","2015-04-13 00:00:00",
36673,2,21332,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf","2015-03-24 00:00:00",
47544,1,21332,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021332Orig1s026ltr.pdf","2017-03-14 00:00:00",
5063,1,21333,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21333slr001ltr.pdf","2003-09-25 00:00:00",
27503,1,21333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-333ltr.pdf","2002-09-16 00:00:00",
36674,2,21333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21333lbl.pdf","2002-09-16 00:00:00",
36675,2,21333,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21333slr001_Minirin_lbl.pdf","2003-09-25 00:00:00",
42104,3,21333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021333s000_MinirinTOC.cfm","2006-07-25 00:00:00",
44116,10,21333,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2007-12-04 00:00:00",
5064,1,21333,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021333Orig1s007ltr.pdf","2013-11-12 00:00:00",
15207,2,21333,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021333s007lbl.pdf","2013-11-15 00:00:00",
54383,1,21333,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2018/021333Orig1s010ltr.pdf","2018-05-31 00:00:00",
54391,2,21333,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021333s010lbl.pdf","2018-05-31 00:00:00",
5065,1,21334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_Approv.pdf","2004-05-27 00:00:00",
15208,2,21334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_prntlbl.pdf","2003-05-07 00:00:00",
21603,3,21334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm","2004-05-27 00:00:00",
5066,1,21335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21335ltr.pdf","2001-05-10 00:00:00",
15209,2,21335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf","2001-05-10 00:00:00",
21604,3,21335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21335_Gleevec.cfm","2001-05-10 00:00:00",
21605,3,21335,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s001_Gleevec.cfm","2003-07-08 00:00:00",
27504,1,21335,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21335s001ltr.pdf","2002-02-01 00:00:00",
36676,2,21335,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335s1lbl.pdf","2002-02-01 00:00:00",
44117,10,21335,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110502.htm","2003-12-09 00:00:00",
36677,2,21335,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf","2003-04-09 00:00:00",
21606,3,21335,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm","2004-08-09 00:00:00",
27505,1,21335,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf","2003-07-23 00:00:00",
36678,2,21335,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf","2003-05-20 00:00:00",
5067,1,21335,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335S004_Gleevec_Approv.pdf","2004-06-04 00:00:00",
36679,2,21335,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf","2002-12-20 00:00:00",
42105,3,21335,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s004_Gleevec.cfm","2003-07-08 00:00:00",
5068,1,21335,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21335slr006ltr.pdf","2003-11-25 00:00:00",
42106,3,21335,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335S006_Gleevec_Approv.pdf","2004-09-29 00:00:00",
5069,1,21336,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021336s001ltr.pdf","2008-02-14 00:00:00",
21607,3,21336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm","2007-09-10 00:00:00",
23645,10,21336,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
27506,1,21336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf","2006-03-03 00:00:00",
36680,2,21336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf","2006-03-03 00:00:00",
15210,2,21336,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf","2007-07-31 00:00:00",
27507,1,21336,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021336s002ltr.pdf","2007-08-02 00:00:00",
5070,1,21336,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf","2014-09-16 00:00:00",
36681,2,21336,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf","2014-09-30 00:00:00",
27508,1,21336,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf","2014-09-16 00:00:00",
51652,20,21336,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21336_selegiline_Clinical_1_PREA.pdf","1900-01-01 00:00:00",
51653,20,21336,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21336_selegiline_Clinical_2_PREA.pdf","1900-01-01 00:00:00",
51654,59,21336,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21336_selegiline_Secondary_Clinical_1_PREA.pdf","1900-01-01 00:00:00",
51656,59,21336,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21336_selegiline_Secondary_Clinical_2_PREA.pdf","1900-01-01 00:00:00",
27509,1,21336,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021336Orig1s011ltr.pdf","2015-04-01 00:00:00",
36682,2,21336,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf","2015-04-01 00:00:00",
49003,1,21336,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021336Orig1s014ltr.pdf","2017-07-17 00:00:00",
49012,2,21336,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf","2017-07-18 00:00:00",
49013,8,21336,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf#page=34","2017-07-18 00:00:00",
5071,1,21337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21337ltr.pdf","2001-11-09 00:00:00",
21608,3,21337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21337_Invanz.cfm","2001-11-09 00:00:00",
36683,2,21337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21337lbl.pdf","2001-11-09 00:00:00",
51847,20,21337,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021337_ertapenem-InVanz-MedRev.pdf","1900-01-01 00:00:00",
51848,23,21337,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021337_ertapenem_Invanz_WR_orig.pdf","1900-01-01 00:00:00",
51849,18,21337,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021337_ertapenem-InVanz-ClinPharmRev.pdf","1900-01-01 00:00:00",
51850,17,21337,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021337_ertapenem-InVanz-StatRev.pdf","1900-01-01 00:00:00",
27510,1,21337,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr013ltr.pdf","2004-05-04 00:00:00",
5072,1,21337,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr014ltr.pdf","2004-05-26 00:00:00",
27511,1,21337,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337s015ltr.pdf","2004-09-10 00:00:00",
27512,1,21337,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21337s017ltr.pdf","2005-01-26 00:00:00",
5073,1,21337,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s018ltr.pdf","2005-05-20 00:00:00",
36684,2,21337,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf","2005-05-20 00:00:00",
27513,1,21337,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s019ltr.pdf","2005-10-19 00:00:00",
36685,2,21337,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s019lbl.pdf","2005-10-19 00:00:00",
5074,1,21337,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021337s021LTR.pdf","2006-08-14 00:00:00",
36686,2,21337,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021337s021lbl.pdf","2006-08-11 00:00:00",
42107,3,21337,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021337Orig1s021.pdf","2014-01-16 00:00:00",
5075,1,21337,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021337s026ltr.pdf","2007-11-19 00:00:00",
5076,1,21337,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021337s028ltr.pdf","2008-03-26 00:00:00",
36687,2,21337,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021337s028lbl.pdf","2008-03-27 00:00:00",
5077,1,21337,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s030ltr.pdf","2010-01-25 00:00:00",
36688,2,21337,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s030lbl.pdf","2009-12-15 00:00:00",
5078,1,21337,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021337s031ltr.pdf","2011-07-25 00:00:00",
15211,2,21337,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021337s031lbl.pdf","2011-07-25 00:00:00",
5079,1,21337,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s033ltr.pdf","2009-11-10 00:00:00",
15212,2,21337,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s033lbl.pdf","2009-10-14 00:00:00",
15213,2,21337,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021337s034lbl.pdf","2010-05-28 00:00:00",
27514,1,21337,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021337s034ltr.pdf","2010-05-27 00:00:00",
15214,2,21337,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s037lbl.pdf","2012-02-22 00:00:00",
5080,1,21337,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021337s038ltr.pdf","2012-03-05 00:00:00",
15215,2,21337,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s038lbl.pdf","2012-03-07 00:00:00",
27515,1,21337,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021337Orig1s041ltr.pdf","2013-07-26 00:00:00",
36689,2,21337,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021337s041lbl.pdf","2013-07-30 00:00:00",
5081,1,21337,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021337Orig1s042ltr.pdf","2014-10-02 00:00:00",
15216,2,21337,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf","2014-10-02 00:00:00",
49727,2,21337,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021337Orig1s045lbl.pdf","2017-09-13 00:00:00",
49809,1,21337,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021337Orig1s045ltr.pdf","2017-09-20 00:00:00",
55480,1,21337,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021337Orig1s046ltr.pdf","2018-09-14 00:00:00",
55524,2,21337,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021337s046lbl.pdf","2018-09-19 00:00:00",
5082,1,21338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338s000_Approv.pdf","2008-01-16 00:00:00",
15217,2,21338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf","2006-05-24 00:00:00",
23996,14,21338,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=346","2015-07-02 00:00:00",
42108,3,21338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338_toc.cfm","2008-01-16 00:00:00",
5083,1,21338,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s005ltr.pdf","2015-05-04 00:00:00",
15218,2,21338,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021338s005lbl.pdf","2015-05-06 00:00:00",
27516,1,21338,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s006ltr.pdf","2015-11-16 00:00:00",
46282,1,21338,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021338Orig1s007ltr.pdf","2016-12-20 00:00:00",
46355,2,21338,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021338s007lbl.pdf","2016-12-21 00:00:00",
47829,1,21338,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021338Orig1s009ltr.pdf","2017-04-03 00:00:00",
15219,2,21341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf","2001-11-16 00:00:00",
23646,10,21341,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2003-12-09 00:00:00",
27517,1,21341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra_Approv.pdf","2001-11-16 00:00:00",
42109,3,21341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra.cfm","2002-05-30 00:00:00",
5084,1,21341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21341slr002ltr.pdf","2002-11-01 00:00:00",
42110,3,21341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021341_S002_BEXTRATOC.cfml","2007-01-10 00:00:00",
27518,1,21341,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341se8-003ltr.pdf","2004-04-29 00:00:00",
36690,2,21341,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf","2004-05-04 00:00:00",
27519,1,21341,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341ltr.pdf","2004-12-02 00:00:00",
36691,2,21341,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf","2004-12-03 00:00:00",
5085,1,21342,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21342scs001ltr.pdf","2003-12-11 00:00:00",
15220,2,21342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21342lbl.pdf","2002-03-01 00:00:00",
21609,3,21342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-342_Levothyroxine.cfm","2002-06-19 00:00:00",
27520,1,21342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-342_Levothyroxine%20Sodium_Approv.pdf","2002-03-01 00:00:00",
36692,2,21342,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21342scs001_Levo-T_lbl.pdf","2003-12-11 00:00:00",
5086,1,21342,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21342scs002ltr.pdf","2003-08-28 00:00:00",
36693,2,21342,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21342scs002_levoT_lbl.pdf","2003-08-28 00:00:00",
5087,1,21342,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21342se4-003ltr.pdf","2004-06-24 00:00:00",
42111,3,21342,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021342_s003_Levo.pdf","2005-05-13 00:00:00",
5088,1,21342,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21342se4-004ltr.pdf","2004-06-24 00:00:00",
42112,3,21342,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021342_s004_Levo.pdf","2005-05-13 00:00:00",
15221,2,21342,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf","2008-06-12 00:00:00",
27521,1,21342,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021342s008,s014ltr.pdf","2008-06-13 00:00:00",
27522,1,21342,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021342s008,s014ltr.pdf","2008-06-13 00:00:00",
36694,2,21342,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf","2008-06-12 00:00:00",
15222,2,21342,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021342s016lbl.pdf","2009-06-22 00:00:00",
27523,1,21342,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021342s016ltr.pdf","2009-06-17 00:00:00",
27524,1,21342,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021342s020ltr.pdf","2011-03-11 00:00:00",
50624,1,21342,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021342s023ltr.pdf","2017-12-07 00:00:00",
50625,2,21342,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021342s023lbl.pdf","2017-12-07 00:00:00",
5089,1,21343,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343s001ltr.pdf","2002-04-01 00:00:00",
21610,3,21343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.cfm","2002-01-23 00:00:00",
23647,10,21343,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
27525,1,21343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343ltr.pdf","2002-01-23 00:00:00",
36695,2,21343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21343lbl.pdf","2002-01-23 00:00:00",
5090,1,21343,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21343slr002ltr.pdf","2003-07-08 00:00:00",
27526,1,21343,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf","2004-01-14 00:00:00",
5091,1,21343,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf","2007-11-19 00:00:00",
36696,2,21343,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf","2007-11-13 00:00:00",
27527,1,21343,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf","2010-10-13 00:00:00",
36697,2,21343,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf","2010-10-12 00:00:00",
15223,2,21343,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf","2011-01-20 00:00:00",
27528,1,21343,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf","2011-01-20 00:00:00",
5092,1,21343,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf","2011-04-11 00:00:00",
36698,2,21343,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf","2011-04-11 00:00:00",
5093,1,21343,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf","2013-03-01 00:00:00",
15224,2,21343,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf","2013-03-01 00:00:00",
5094,1,21343,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf","2014-10-14 00:00:00",
36699,2,21343,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf","2014-10-15 00:00:00",
15225,2,21343,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf","2016-03-03 00:00:00",
27529,1,21343,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf","2016-03-02 00:00:00",
44988,3,21343,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021343Orig1s033.pdf","2016-02-29 00:00:00",
5095,1,21344,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21344se8-001ltr.pdf","2004-01-14 00:00:00",
27530,1,21344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21344.pdf","2002-04-25 00:00:00",
36700,2,21344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf","2002-04-25 00:00:00",
36701,2,21344,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21344se8-001_faslodex_lbl.pdf","2004-01-15 00:00:00",
42113,3,21344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-344_FulvestrantFaslodex.cfm","2002-04-25 00:00:00",
27531,1,21344,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021344s004ltr.pdf","2005-08-08 00:00:00",
36702,2,21344,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021344s004lbl.pdf","2005-08-08 00:00:00",
5096,1,21344,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf","2010-09-13 00:00:00",
15226,2,21344,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf","2010-09-10 00:00:00",
5097,1,21344,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf","2010-09-13 00:00:00",
15227,2,21344,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf","2010-09-10 00:00:00",
15228,2,21344,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s013lbl.pdf","2011-05-23 00:00:00",
27532,1,21344,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s013ltr.pdf","2011-05-19 00:00:00",
51923,20,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344s013_ fulvestrant CDTLclinical prea.pdf","2011-02-01 00:00:00",
51924,20,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344s013_fulvestrant clinical prea.pdf","2011-02-01 00:00:00",
51925,18,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344s013_fulvestrant clinpharm prea.pdf","2011-02-01 00:00:00",
51926,17,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344s013_fulvestrant statistical prea.pdf","2011-02-01 00:00:00",
51927,23,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344_fulvestrant_Original_WR.pdf","2011-02-01 00:00:00",
51928,25,21344,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21344_fulvestrant_ Amendment_1.pdf","2011-02-01 00:00:00",
5098,1,21344,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf","2011-09-29 00:00:00",
36703,2,21344,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s014lbl.pdf","2011-09-26 00:00:00",
27533,1,21344,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf","2011-09-29 00:00:00",
36704,2,21344,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s015lbl.pdf","2011-09-26 00:00:00",
15229,2,21344,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s018lbl.pdf","2012-07-25 00:00:00",
27534,1,21344,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s018ltr.pdf","2012-07-17 00:00:00",
15230,2,21344,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf","2012-11-08 00:00:00",
27535,1,21344,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf","2012-11-13 00:00:00",
5099,1,21344,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf","2012-11-13 00:00:00",
36705,2,21344,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf","2012-11-08 00:00:00",
5100,1,21344,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s025ltr.pdf","2016-03-03 00:00:00",
36706,2,21344,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s025lbl.pdf","2016-03-03 00:00:00",
5101,1,21344,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s026ltr.pdf","2016-03-04 00:00:00",
15231,2,21344,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf","2016-03-04 00:00:00",
52653,3,21344,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021344Orig1s026.pdf","2018-02-15 00:00:00",
5102,1,21344,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s027ltr.pdf","2016-05-20 00:00:00",
36707,2,21344,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s027lbl.pdf","2016-05-23 00:00:00",
5103,1,21344,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s029ltr.pdf","2016-07-13 00:00:00",
15232,2,21344,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s029lbl.pdf","2016-07-13 00:00:00",
48429,3,21344,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021344Orig1s029.pdf","2017-05-17 00:00:00",
45731,1,21344,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s031ltr.pdf","2016-10-31 00:00:00",
46995,1,21344,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s033ltr.pdf","2017-01-27 00:00:00",
52788,2,21344,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344Orig1s033.pdf","2018-03-01 00:00:00",
49551,1,21344,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s034ltr.pdf","2017-08-28 00:00:00",
49557,2,21344,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf","2017-08-28 00:00:00",
50412,2,21344,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s035lbl.pdf","2017-11-15 00:00:00",
50420,1,21344,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s035ltr.pdf","2017-11-15 00:00:00",
54777,1,21344,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021344Orig1s036Ltr.pdf","2018-07-06 00:00:00",
54914,2,21344,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021344s036lbl.pdf","2018-07-19 00:00:00",
5104,1,21345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra_Approv.pdf","2001-12-07 00:00:00",
15233,2,21345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21345lbl.pdf","2001-12-07 00:00:00",
15234,2,21345,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21345slr001_arixtra_lbl.pdf","2002-12-04 00:00:00",
27536,1,21345,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21345slr001ltr.pdf","2002-12-04 00:00:00",
42114,3,21345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra.cfm","2004-05-27 00:00:00",
15235,2,21345,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21345se1-002_arixtra_lbl.pdf","2003-06-22 00:00:00",
27537,1,21345,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21345se1-002ltr.pdf","2003-06-22 00:00:00",
15236,2,21345,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf","2004-06-01 00:00:00",
27538,1,21345,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf","2004-06-01 00:00:00",
5105,1,21345,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf","2004-06-01 00:00:00",
15237,2,21345,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf","2004-06-01 00:00:00",
5106,1,21345,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021345s010ltr.pdf","2005-05-27 00:00:00",
36708,2,21345,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021345s010lbl.pdf","2005-05-27 00:00:00",
27539,1,21345,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021345s018ltr.pdf","2008-10-21 00:00:00",
15238,2,21345,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf","2009-09-18 00:00:00",
27540,1,21345,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s019ltr.pdf","2009-11-25 00:00:00",
15239,2,21345,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf","2010-04-04 00:00:00",
27541,1,21345,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021345s023ltr.pdf","2010-03-31 00:00:00",
15240,2,21345,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s025lbl.pdf","2009-12-30 00:00:00",
27542,1,21345,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s025ltr.pdf","2009-12-31 00:00:00",
5107,1,21345,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021345Orig1s030ltr.pdf","2013-09-13 00:00:00",
36709,2,21345,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021345s030lbl.pdf","2013-09-17 00:00:00",
5108,1,21345,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021345Orig1s032ltr.pdf","2014-07-17 00:00:00",
36710,2,21345,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021345s032lbl.pdf","2014-07-17 00:00:00",
49461,2,21345,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021345s035lbl.pdf","2017-08-18 00:00:00",
49485,1,21345,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021345Orig1s035ltr.pdf","2017-08-21 00:00:00",
21611,3,21346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21346_RisperdalTOC.cfm","2005-06-16 00:00:00",
23648,10,21346,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-20 00:00:00",
27543,1,21346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21346ltr.pdf","2003-11-28 00:00:00",
5109,1,21346,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s009ltr.pdf","2006-10-23 00:00:00",
15241,2,21346,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf","2005-08-19 00:00:00",
27544,1,21346,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf","2005-08-19 00:00:00",
27545,1,21346,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s011LTR.pdf","2006-08-04 00:00:00",
15242,2,21346,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf","2006-09-21 00:00:00",
27546,1,21346,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s013ltr.pdf","2006-09-25 00:00:00",
27547,1,21346,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s015ltr.pdf","2007-04-20 00:00:00",
36711,2,21346,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf","2007-04-20 00:00:00",
5110,1,21346,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s020ltr.pdf","2007-03-15 00:00:00",
15243,2,21346,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf","2007-03-15 00:00:00",
5111,1,21346,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf","2008-10-14 00:00:00",
36712,2,21346,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf","2008-11-07 00:00:00",
15244,2,21346,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf","2008-11-07 00:00:00",
27548,1,21346,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf","2008-10-14 00:00:00",
5112,1,21346,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf","2008-10-14 00:00:00",
36713,2,21346,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf","2008-11-07 00:00:00",
5113,1,21346,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf","2009-05-20 00:00:00",
36714,2,21346,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf","2009-06-07 00:00:00",
5114,1,21346,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf","2008-10-14 00:00:00",
36715,2,21346,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf","2008-11-07 00:00:00",
27549,1,21346,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf","2008-08-19 00:00:00",
5115,1,21346,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf","2009-05-20 00:00:00",
36716,2,21346,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf","2009-06-07 00:00:00",
15245,2,21346,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf","2010-08-30 00:00:00",
27550,1,21346,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf","2010-09-01 00:00:00",
5116,1,21346,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf","2011-12-13 00:00:00",
15246,2,21346,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf","2011-12-13 00:00:00",
5117,1,21346,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf","2009-08-06 00:00:00",
15247,2,21346,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf","2009-08-06 00:00:00",
5118,1,21346,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf","2010-09-01 00:00:00",
36717,2,21346,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf","2010-08-30 00:00:00",
27551,1,21346,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf","2011-08-26 00:00:00",
36718,2,21346,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf","2011-09-02 00:00:00",
27552,1,21346,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf","2011-09-28 00:00:00",
36719,2,21346,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf","2011-09-30 00:00:00",
27553,1,21346,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf","2010-09-01 00:00:00",
36720,2,21346,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf","2010-08-30 00:00:00",
15248,2,21346,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf","2010-08-30 00:00:00",
27554,1,21346,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf","2010-09-01 00:00:00",
5119,1,21346,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf","2010-12-06 00:00:00",
15249,2,21346,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf","2010-12-04 00:00:00",
15250,2,21346,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf","2011-12-13 00:00:00",
27555,1,21346,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf","2011-12-13 00:00:00",
5120,1,21346,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf","2011-06-17 00:00:00",
15251,2,21346,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf","2011-06-16 00:00:00",
5121,1,21346,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf","2011-09-28 00:00:00",
15252,2,21346,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf","2011-09-30 00:00:00",
27556,1,21346,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf","2012-03-13 00:00:00",
15253,2,21346,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf","2014-04-29 00:00:00",
27557,1,21346,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf","2014-05-09 00:00:00",
36721,2,21346,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s052lbl.pdf","2014-06-10 00:00:00",
27558,1,21346,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
36722,2,21346,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf","2016-03-03 00:00:00",
47321,2,21346,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf","2017-02-24 00:00:00",
47423,1,21346,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf","2017-03-02 00:00:00",
55053,1,21346,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf","2018-07-30 00:00:00",
55147,2,21346,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021346s058lbl.pdf","2018-08-09 00:00:00",
21612,3,21348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-348_Zavesca.cfm","2003-12-15 00:00:00",
27559,1,21348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21348ltr.pdf","2003-08-15 00:00:00",
36723,2,21348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf","2003-08-15 00:00:00",
27560,1,21348,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021348s005ltr.pdf","2008-03-04 00:00:00",
36724,2,21348,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf","2008-03-05 00:00:00",
5122,1,21348,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021348s008ltr.pdf","2010-11-29 00:00:00",
36725,2,21348,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf","2010-11-23 00:00:00",
5123,1,21348,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021348Orig1s010ltr.pdf","2014-02-11 00:00:00",
36726,2,21348,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf","2014-02-11 00:00:00",
5124,1,21350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021350ltr.pdf","2005-05-17 00:00:00",
15254,2,21350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021350lbl.pdf","2005-05-17 00:00:00",
42115,3,21350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021350s000TOC.cfm","2007-09-10 00:00:00",
27561,1,21350,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021350s002LTR.pdf","2006-07-13 00:00:00",
36727,2,21350,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021350s002lbl.pdf","2006-07-05 00:00:00",
5125,1,21350,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s005ltr.pdf","2008-01-18 00:00:00",
15255,2,21350,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s005lbl.pdf","2008-01-18 00:00:00",
15256,2,21350,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s008lbl.pdf","2008-11-19 00:00:00",
27562,1,21350,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s008ltr.pdf","2008-11-18 00:00:00",
5126,1,21350,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021350s010ltr.pdf","2012-04-23 00:00:00",
36728,2,21350,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021350s010lbl.pdf","2012-04-20 00:00:00",
5127,1,21350,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021350Orig1s013ltr.pdf","2013-01-17 00:00:00",
36729,2,21350,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021350s013lbl.pdf","2013-01-22 00:00:00",
27563,1,21350,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s014ltr.pdf","2015-04-17 00:00:00",
36730,2,21350,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021350s014lbl.pdf","2015-04-16 00:00:00",
5128,1,21350,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s015ltr.pdf","2015-11-16 00:00:00",
54272,1,21350,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021350Orig1s020ltr.pdf","2018-05-21 00:00:00",
54297,2,21350,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021350s020lbl.pdf","2018-05-22 00:00:00",
15257,2,21351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021351lbl.pdf","2003-02-26 00:00:00",
27564,1,21351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021351Orig1s000Approv.pdf","2003-03-10 00:00:00",
42116,3,21351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-351_Oxytrol.cfm","2005-04-08 00:00:00",
5129,1,21351,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021351s002LTR.pdf","2006-07-13 00:00:00",
36731,2,21351,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021351s002lbl.pdf","2006-07-07 00:00:00",
5130,1,21351,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021351s005ltr.pdf","2011-02-03 00:00:00",
36732,2,21351,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021351s005lbl.pdf","2011-01-31 00:00:00",
5131,1,21351,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf","2012-10-12 00:00:00",
36733,2,21351,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf","2012-10-12 00:00:00",
15258,2,21351,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf","2012-10-12 00:00:00",
27565,1,21351,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf","2012-10-12 00:00:00",
5132,1,21351,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021351Orig1s016ltr.pdf","2015-07-13 00:00:00",
15259,2,21351,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021351s016lbl.pdf","2015-07-13 00:00:00",
50171,2,21351,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf","2017-10-25 00:00:00",
50220,1,21351,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021351Orig1s017,021351Orig1s018ltr.pdf","2017-10-30 00:00:00",
50172,2,21351,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf","2017-10-25 00:00:00",
50221,1,21351,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021351Orig1s017,021351Orig1s018ltr.pdf","2017-10-30 00:00:00",
27566,1,21355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021355ltr.pdf","2005-10-20 00:00:00",
36734,2,21355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf","2005-09-30 00:00:00",
42117,3,21355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021355s000TOC.cfm","2007-09-11 00:00:00",
5133,1,21355,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s002ltr.pdf","2012-03-02 00:00:00",
15260,2,21355,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf","2012-03-01 00:00:00",
5134,1,21355,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s003ltr.pdf","2012-03-02 00:00:00",
15261,2,21355,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf","2012-03-01 00:00:00",
15262,2,21355,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf","2015-07-01 00:00:00",
27567,1,21355,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021355Orig1s006ltr.pdf","2015-07-09 00:00:00",
50262,2,21355,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf","2017-11-02 00:00:00",
5135,1,21356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21356ltr.pdf","2001-10-26 00:00:00",
5136,1,21356,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21356slr001ltr.pdf","2002-12-02 00:00:00",
15263,2,21356,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf","2002-12-02 00:00:00",
21613,3,21356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm","2001-10-26 00:00:00",
36735,2,21356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21356lbl.pdf","2001-10-26 00:00:00",
51676,20,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356 tenofovir clinical prea.pdf","1900-01-01 00:00:00",
51677,18,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356 tenofovir clinpharm prea.pdf","1900-01-01 00:00:00",
51678,17,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356 tenofovir statistical prea.pdf","1900-01-01 00:00:00",
52369,23,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Original_WRltr.pdf","1900-01-01 00:00:00",
52370,25,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_1ltr.pdf","1900-01-01 00:00:00",
52371,26,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_2ltr.pdf","1900-01-01 00:00:00",
52372,27,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_3ltr.pdf","1900-01-01 00:00:00",
52373,28,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_4ltr.pdf","1900-01-01 00:00:00",
52374,29,21356,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_5ltr.pdf","1900-01-01 00:00:00",
15264,2,21356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf","2003-08-28 00:00:00",
27568,1,21356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356se5-003ltr.pdf","2003-08-28 00:00:00",
15265,2,21356,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf","2003-10-16 00:00:00",
27569,1,21356,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr005ltr.pdf","2003-10-16 00:00:00",
5137,1,21356,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr006ltr.pdf","2003-11-25 00:00:00",
15266,2,21356,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf","2003-12-01 00:00:00",
5138,1,21356,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21356slr010ltr.pdf","2004-07-06 00:00:00",
15267,2,21356,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf","2004-07-07 00:00:00",
5139,1,21356,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s011ltr.pdf","2005-05-17 00:00:00",
15268,2,21356,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf","2005-05-17 00:00:00",
5140,1,21356,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021356s016ltr.pdf","2006-03-23 00:00:00",
36736,2,21356,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021356s016lbl.pdf","2006-03-10 00:00:00",
5141,1,21356,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s017ltr.pdf","2005-12-05 00:00:00",
36737,2,21356,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s017lbl.pdf","2005-12-05 00:00:00",
5142,1,21356,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf","2007-05-29 00:00:00",
15269,2,21356,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf","2007-05-29 00:00:00",
27570,1,21356,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s024ltr.pdf","2008-05-21 00:00:00",
5143,1,21356,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s025ltr.pdf","2008-08-13 00:00:00",
15270,2,21356,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf","2008-08-29 00:00:00",
5144,1,21356,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s026ltr.pdf","2008-11-06 00:00:00",
36738,2,21356,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s026lbl.pdf","2008-11-07 00:00:00",
5145,1,21356,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s027ltr.pdf","2009-11-10 00:00:00",
15271,2,21356,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf","2009-10-14 00:00:00",
5146,1,21356,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s028ltr.pdf","2010-01-25 00:00:00",
15272,2,21356,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf","2009-11-13 00:00:00",
27571,1,21356,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s033ltr.pdf","2010-03-29 00:00:00",
36739,2,21356,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s033lbl.pdf","2010-03-26 00:00:00",
5147,1,21356,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s034ltr.pdf","2010-10-13 00:00:00",
15273,2,21356,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf","2010-10-12 00:00:00",
15274,2,21356,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf","2010-10-19 00:00:00",
27572,1,21356,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s035ltr.pdf","2010-10-19 00:00:00",
5148,1,21356,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s037ltr.pdf","2011-09-21 00:00:00",
36740,2,21356,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s037lbl.pdf","2011-09-20 00:00:00",
15275,2,21356,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf","2012-02-01 00:00:00",
27573,1,21356,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356s038ltr.pdf","2012-01-20 00:00:00",
52363,23,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Original_WRltr.pdf","2011-09-06 00:00:00",
52364,25,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_1ltr.pdf","2011-09-06 00:00:00",
52365,26,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_2ltr.pdf","2011-09-06 00:00:00",
52366,27,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_3ltr.pdf","2011-09-06 00:00:00",
52367,28,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_4ltr.pdf","2011-09-06 00:00:00",
52368,29,21356,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21356_tenofovir_Amendment_5ltr.pdf","2011-09-06 00:00:00",
5149,1,21356,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577Orig1s001ltr.pdf","2012-08-09 00:00:00",
36741,2,21356,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf","2012-08-08 00:00:00",
15276,2,21356,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf","2011-11-22 00:00:00",
27574,1,21356,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s041ltr.pdf","2011-11-22 00:00:00",
5150,1,21356,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577Orig1s002ltr.pdf","2012-08-20 00:00:00",
15277,2,21356,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf","2012-08-17 00:00:00",
5151,1,21356,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577Orig1s003ltr.pdf","2013-07-26 00:00:00",
15278,2,21356,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf","2013-07-30 00:00:00",
27575,1,21356,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577Orig1s004ltr.pdf","2013-04-03 00:00:00",
36742,2,21356,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf","2013-04-09 00:00:00",
27576,1,21356,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577Orig1s006ltr.pdf","2013-10-25 00:00:00",
36743,2,21356,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf","2013-10-25 00:00:00",
27577,1,21356,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577Orig1s007ltr.pdf","2015-06-02 00:00:00",
36744,2,21356,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf","2015-06-04 00:00:00",
15279,2,21356,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf","2016-02-18 00:00:00",
27578,1,21356,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577Orig1s009ltr.pdf","2016-02-18 00:00:00",
47913,2,21356,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf","2017-04-10 00:00:00",
47982,1,21356,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021356Orig1s055,022577Orig1s011ltr.pdf","2017-04-12 00:00:00",
55059,1,21356,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021356Orig1s056,022577Orig1s012ltr.pdf","2018-07-30 00:00:00",
55069,2,21356,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf","2018-07-31 00:00:00",
5152,1,21357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf","2004-12-02 00:00:00",
21614,3,21357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.cfm","2005-03-28 00:00:00",
23649,10,21357,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
36745,2,21357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021357lbl.pdf","2004-12-03 00:00:00",
53279,20,21357,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Clinical_PREA.pdf","1900-01-01 00:00:00",
53280,18,21357,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53281,17,21357,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Statistical_PREA.pdf","1900-01-01 00:00:00",
15280,2,21357,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf","2007-09-06 00:00:00",
27579,1,21357,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf","2007-09-06 00:00:00",
15281,2,21357,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.pdf","2009-10-14 00:00:00",
27580,1,21357,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021357s004ltr.pdf","2009-11-10 00:00:00",
5153,1,21357,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s006ltr.pdf","2010-03-22 00:00:00",
15282,2,21357,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s006lbl.pdf","2010-03-18 00:00:00",
5154,1,21357,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s009ltr.pdf","2010-12-22 00:00:00",
15283,2,21357,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s009lbl.pdf","2010-12-20 00:00:00",
5155,1,21357,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf","2012-07-09 00:00:00",
36746,2,21357,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021357s011lbl.pdf","2012-07-10 00:00:00",
5156,1,21357,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf","2013-08-01 00:00:00",
36747,2,21357,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf","2013-08-09 00:00:00",
51343,2,21357,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf","2018-01-19 00:00:00",
51350,8,21357,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf#page=34","2018-01-22 00:00:00",
51870,1,21357,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s014,021358Orig1s013ltr.pdf","2018-01-26 00:00:00",
49768,2,21357,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021357s015lbl.pdf","2017-09-18 00:00:00",
49786,1,21357,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021357Orig1s015ltr.pdf","2017-09-19 00:00:00",
53828,2,21357,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf","2018-04-27 00:00:00",
53899,1,21357,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf","2018-05-01 00:00:00",
53827,2,21357,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf","2018-04-27 00:00:00",
53829,8,21357,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34","2018-04-27 00:00:00",
53900,1,21357,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf","2018-05-01 00:00:00",
21615,3,21358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021358s000_021357s000_MultiHance.cfm","2005-04-17 00:00:00",
27581,1,21358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf","2004-12-02 00:00:00",
36748,2,21358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021358lbl.pdf","2005-01-26 00:00:00",
44118,10,21358,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
5157,1,21358,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf","2007-09-06 00:00:00",
15284,2,21358,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf","2007-09-06 00:00:00",
5158,1,21358,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s008ltr.pdf","2011-02-18 00:00:00",
15285,2,21358,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021358s008lbl.pdf","2011-02-24 00:00:00",
27582,1,21358,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf","2012-07-09 00:00:00",
36749,2,21358,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021358s009lbl.pdf","2012-07-10 00:00:00",
5159,1,21358,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s010ltr.pdf","2011-10-03 00:00:00",
5160,1,21358,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf","2013-08-01 00:00:00",
36750,2,21358,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf","2013-08-09 00:00:00",
51342,2,21358,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf","2018-01-19 00:00:00",
51869,1,21358,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s014,021358Orig1s013ltr.pdf","2018-01-26 00:00:00",
49770,2,21358,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021358s014lbl.pdf","2017-09-18 00:00:00",
49781,1,21358,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021358Origs014ltr.pdf","2017-09-19 00:00:00",
53831,2,21358,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf","2018-04-27 00:00:00",
53902,1,21358,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf","2018-05-01 00:00:00",
53833,2,21358,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf","2018-04-27 00:00:00",
53834,8,21358,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34","2018-04-27 00:00:00",
53904,1,21358,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf","2018-05-01 00:00:00",
15286,2,21359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf","2011-06-30 00:00:00",
21616,3,21359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359_rectiv_toc.cfm","2012-02-29 00:00:00",
24193,21,21359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359Orig1s000SumR.pdf","2012-02-29 00:00:00",
27583,1,21359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021359s000ltr.pdf","2011-06-29 00:00:00",
5161,1,21360,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf","2002-09-20 00:00:00",
21617,3,21360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-360_EfavirenzSustiva.cfm","2002-05-15 00:00:00",
27584,1,21360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21360ltr.pdf","2002-02-01 00:00:00",
36751,2,21360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21360lbl.pdf","2002-02-01 00:00:00",
15287,2,21360,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf","2003-06-22 00:00:00",
27585,1,21360,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf","2003-06-22 00:00:00",
15288,2,21360,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf","2003-06-22 00:00:00",
27586,1,21360,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf","2003-06-22 00:00:00",
27587,1,21360,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf","2003-11-26 00:00:00",
36752,2,21360,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf","2003-12-01 00:00:00",
15289,2,21360,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf","2004-08-25 00:00:00",
27588,1,21360,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf","2004-08-25 00:00:00",
42118,3,21360,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021360_S006_SUSTIVA.pdf","2007-07-20 00:00:00",
15290,2,21360,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf","2004-11-01 00:00:00",
27589,1,21360,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf","2004-10-29 00:00:00",
5162,1,21360,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf","2005-04-28 00:00:00",
36753,2,21360,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf","2005-04-28 00:00:00",
15291,2,21360,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021360s014lbl.pdf","2007-02-05 00:00:00",
21618,3,21360,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf","2007-07-20 00:00:00",
27590,1,21360,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf","2007-02-05 00:00:00",
5163,1,21360,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf","2007-02-02 00:00:00",
36754,2,21360,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf","2007-02-02 00:00:00",
27591,1,21360,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf","2008-08-20 00:00:00",
5164,1,21360,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf","2009-03-12 00:00:00",
15292,2,21360,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf","2009-04-23 00:00:00",
36755,2,21360,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf","2008-08-26 00:00:00",
15293,2,21360,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf","2009-10-01 00:00:00",
27592,1,21360,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf","2009-11-10 00:00:00",
5165,1,21360,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf","2010-04-05 00:00:00",
15294,2,21360,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf","2010-04-04 00:00:00",
5166,1,21360,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf","2010-12-03 00:00:00",
15295,2,21360,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021360s024lbl.pdf","2010-11-29 00:00:00",
5167,1,21360,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf","2011-09-29 00:00:00",
36756,2,21360,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s026lbl.pdf","2011-09-27 00:00:00",
5168,1,21360,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf","2011-12-21 00:00:00",
36757,2,21360,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s028lbl.pdf","2011-12-19 00:00:00",
5169,1,21360,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf","2012-06-26 00:00:00",
15296,2,21360,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf","2012-06-26 00:00:00",
15297,2,21360,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf","2012-08-15 00:00:00",
27593,1,21360,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf","2012-08-15 00:00:00",
5170,1,21360,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf","2013-05-07 00:00:00",
15298,2,21360,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf","2013-05-03 00:00:00",
27594,1,21360,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf","2014-05-27 00:00:00",
36758,2,21360,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf","2014-05-28 00:00:00",
5171,1,21360,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf","2015-04-01 00:00:00",
15299,2,21360,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf","2015-04-02 00:00:00",
5172,1,21360,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf","2016-04-01 00:00:00",
36759,2,21360,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf","2016-04-01 00:00:00",
45193,1,21360,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf","2016-08-31 00:00:00",
45212,2,21360,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf","2016-08-31 00:00:00",
45624,2,21360,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf","2016-10-17 00:00:00",
47053,1,21360,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s042,020972Orig1s054ltr.pdf","2017-01-31 00:00:00",
47060,2,21360,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf","2017-01-30 00:00:00",
50004,2,21360,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf","2017-10-11 00:00:00",
50030,1,21360,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s044,020972Orig1s056ltr.pdf","2017-10-12 00:00:00",
5173,1,21361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21361ltr.pdf","2004-06-01 00:00:00",
36760,2,21361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf","2004-06-01 00:00:00",
42119,3,21361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-361_Xifaxan.cfm","2004-08-27 00:00:00",
15300,2,21361,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf","2007-02-02 00:00:00",
27595,1,21361,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021361s006ltr.pdf","2007-02-12 00:00:00",
5174,1,21361,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s009ltr.pdf","2010-11-18 00:00:00",
15301,2,21361,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf","2010-11-17 00:00:00",
5175,1,21361,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s011ltr.pdf","2010-03-08 00:00:00",
15302,2,21361,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf","2010-03-05 00:00:00",
27596,1,21361,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021361Orig1s012ltr.pdf","2015-05-28 00:00:00",
36761,2,21361,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf","2015-05-29 00:00:00",
5176,1,21361,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021361Orig1s013ltr.pdf","2014-03-14 00:00:00",
15303,2,21361,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf","2014-03-13 00:00:00",
50771,2,21361,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf","2017-12-19 00:00:00",
50789,1,21361,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021361Orig1s023ltr.pdf","2017-12-20 00:00:00",
27597,1,21363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21363ltr.pdf","2002-02-08 00:00:00",
36762,2,21363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21363lbl.pdf","2002-02-08 00:00:00",
42120,3,21363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-363_Clarinex.cfm","2002-04-30 00:00:00",
5177,1,21365,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21365ltr.pdf","2002-11-27 00:00:00",
5178,1,21365,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf","2003-12-22 00:00:00",
15304,2,21365,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf","2003-12-22 00:00:00",
21619,3,21365,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf","2007-07-06 00:00:00",
23650,10,21365,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053342.htm","2005-07-29 00:00:00",
36763,2,21365,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21365_Lexapro_lbl.pdf","2002-11-27 00:00:00",
42121,3,21365,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-365_Lexapro.cfm","2004-06-29 00:00:00",
5179,1,21365,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf","2003-12-22 00:00:00",
15305,2,21365,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf","2003-12-22 00:00:00",
21620,3,21365,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf","2007-07-06 00:00:00",
5180,1,21365,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21323s014,21365s007ltr.pdf","2005-01-13 00:00:00",
5181,1,21365,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf","2004-05-26 00:00:00",
5182,1,21365,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf","2005-02-23 00:00:00",
5183,1,21365,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s028,s029,021365s018,s019ltr.pdf","2008-09-19 00:00:00",
36764,2,21365,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf","2008-09-19 00:00:00",
5184,1,21365,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s029, 021365s019ltr.pdf","2008-10-21 00:00:00",
5185,1,21365,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf","2009-03-24 00:00:00",
15306,2,21365,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf","2009-03-25 00:00:00",
27598,1,21365,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf","2009-03-24 00:00:00",
36765,2,21365,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf","2009-03-25 00:00:00",
5186,1,21365,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf","2009-02-03 00:00:00",
36766,2,21365,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf","2009-02-04 00:00:00",
5187,1,21365,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s033,021365s024ltr.pdf","2011-05-16 00:00:00",
15307,2,21365,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf","2011-05-16 00:00:00",
5188,1,21365,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s035,021365s025ltr.pdf","2011-03-16 00:00:00",
15308,2,21365,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf","2011-03-11 00:00:00",
27599,1,21365,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf","2012-12-05 00:00:00",
36767,2,21365,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021365s030lbl.pdf","2012-12-03 00:00:00",
5189,1,21365,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021323Orig1s044,021365Orig1s032ltr.pdf","2014-11-03 00:00:00",
36768,2,21365,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf","2014-11-04 00:00:00",
27600,1,21365,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf","2014-07-10 00:00:00",
36769,2,21365,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf","2014-07-21 00:00:00",
46681,2,21365,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021365s035lbl.pdf","2017-01-06 00:00:00",
46783,8,21365,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24","2017-01-11 00:00:00",
46784,1,21365,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf","2017-01-11 00:00:00",
15309,2,21366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21366_crestor_lbl.pdf","2003-08-14 00:00:00",
21621,3,21366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm","2004-01-29 00:00:00",
23651,10,21366,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109095.htm","2004-03-24 00:00:00",
27601,1,21366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21366ltr.pdf","2004-01-20 00:00:00",
52890,23,21366,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021366_rosuvastatin_Original_WR.pdf","1900-01-01 00:00:00",
53071,20,21366,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021366_Rosuvastatin_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53072,18,21366,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021366_Rosuvastatin_Cllinpharm_BPCA.pdf","1900-01-01 00:00:00",
53073,17,21366,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021366_Rosuvastatin_Statistical_BPCA.pdf","1900-01-01 00:00:00",
15310,2,21366,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21366slr005lbl.pdf","2005-03-02 00:00:00",
27602,1,21366,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21366s005ltr.pdf","2005-03-03 00:00:00",
23997,14,21366,"SUPPL",10,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf","2011-12-16 00:00:00",
23998,14,21366,"SUPPL",10,"NDA Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf","2011-11-01 00:00:00",
27603,1,21366,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s010ltr.pdf","2007-11-19 00:00:00",
36770,2,21366,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s010lbl.pdf","2007-11-13 00:00:00",
42122,3,21366,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366s010.pdf","2011-09-22 00:00:00",
5190,1,21366,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s011ltr.pdf","2007-07-27 00:00:00",
15311,2,21366,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s011lbl.pdf","2007-07-24 00:00:00",
27604,1,21366,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021366s013ltr.pdf","2008-11-13 00:00:00",
36771,2,21366,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021366s013lbl.pdf","2008-11-07 00:00:00",
27605,1,21366,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s014ltr.pdf","2009-01-26 00:00:00",
36772,2,21366,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s014lbl.pdf","2009-01-29 00:00:00",
27606,1,21366,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s015ltr.pdf","2009-04-01 00:00:00",
36773,2,21366,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s015lbl.pdf","2009-04-03 00:00:00",
5191,1,21366,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s016ltr.pdf","2010-02-12 00:00:00",
24194,21,21366,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016SumR.pdf","2010-07-27 00:00:00",
36774,2,21366,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf","2010-02-08 00:00:00",
42123,3,21366,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016_crestor_toc.cfm","2010-07-27 00:00:00",
15312,2,21366,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s017lbl.pdf","2009-10-21 00:00:00",
27607,1,21366,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s017ltr.pdf","2009-11-25 00:00:00",
52326,23,21366,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021366_rosuvastatin_Original_WR.pdf","2009-07-07 00:00:00",
27608,1,21366,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s018ltr.pdf","2010-01-28 00:00:00",
36775,2,21366,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s018lbl.pdf","2010-01-24 00:00:00",
15313,2,21366,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s021lbl.pdf","2010-11-26 00:00:00",
27609,1,21366,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s021ltr.pdf","2010-11-26 00:00:00",
5192,1,21366,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s024ltr.pdf","2012-02-28 00:00:00",
15314,2,21366,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366Orig1s024Lbl.pdf","2012-02-28 00:00:00",
21622,3,21366,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021366s024.pdf","2012-03-30 00:00:00",
27610,1,21366,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf","2012-11-05 00:00:00",
36776,2,21366,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf","2012-11-02 00:00:00",
15315,2,21366,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s026lbl.pdf","2012-12-21 00:00:00",
27611,1,21366,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s026ltr.pdf","2012-12-26 00:00:00",
5193,1,21366,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf","2012-11-05 00:00:00",
36777,2,21366,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf","2012-11-02 00:00:00",
27612,1,21366,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf","2013-08-08 00:00:00",
36778,2,21366,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf","2013-08-09 00:00:00",
5194,1,21366,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf","2013-08-08 00:00:00",
15316,2,21366,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf","2013-08-09 00:00:00",
27613,1,21366,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021366Orig1s030ltr.pdf","2014-07-10 00:00:00",
36779,2,21366,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021366s030lbl.pdf","2014-08-12 00:00:00",
27614,1,21366,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s031ltr.pdf","2015-11-23 00:00:00",
36780,2,21366,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s031lbl.pdf","2015-11-25 00:00:00",
5195,1,21366,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s032ltr.pdf","2015-06-04 00:00:00",
36781,2,21366,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s032lbl.pdf","2015-06-04 00:00:00",
5196,1,21366,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021366Orig1s033ltr.pdf","2016-05-31 00:00:00",
36782,2,21366,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021366s033lbl.pdf","2016-06-01 00:00:00",
49270,2,21366,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021366s037lbl.pdf","2017-08-08 00:00:00",
49899,1,21366,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021366Orig1s037ltr.pdf","2017-10-01 00:00:00",
5197,1,21367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21367ltr.pdf","2003-03-26 00:00:00",
15317,2,21367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021367lbl.pdf","2003-03-21 00:00:00",
21623,3,21367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021367TOC.cfm","2003-07-16 00:00:00",
5198,1,21367,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21367s002ltr.pdf","2005-03-14 00:00:00",
36783,2,21367,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21367s002lbl.pdf","2005-03-14 00:00:00",
15318,2,21367,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021367s005lbl.pdf","2005-08-19 00:00:00",
27615,1,21367,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021367s005ltr.pdf","2005-08-19 00:00:00",
5199,1,21367,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021367s007ltr.pdf","2007-02-23 00:00:00",
15319,2,21367,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021367s007lbl.pdf","2007-02-21 00:00:00",
15320,2,21367,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021367s009lbl.pdf","2009-05-25 00:00:00",
27616,1,21367,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021367s009ltr.pdf","2009-05-27 00:00:00",
27617,1,21367,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021367Orig1s013ltr.pdf","2014-06-02 00:00:00",
36784,2,21367,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021367s013lbl.pdf","2014-05-30 00:00:00",
49291,2,21367,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf","2017-08-09 00:00:00",
49365,1,21367,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s014,021367Orig1s015ltr.pdf","2017-08-15 00:00:00",
49292,2,21367,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf","2017-08-09 00:00:00",
49366,1,21367,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s014,021367Orig1s015ltr.pdf","2017-08-15 00:00:00",
50321,1,21367,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s016ltr.pdf","2017-11-07 00:00:00",
5200,1,21368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21368ltr.pdf","2003-11-21 00:00:00",
36785,2,21368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf","2003-11-21 00:00:00",
42124,3,21368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-368_Cialis.cfm","2004-03-08 00:00:00",
43569,6,21368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368ppilbl.pdf","2003-11-21 00:00:00",
44119,10,21368,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118686.htm","2005-07-28 00:00:00",
52348,23,21368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021368_tadalafil_Orig_WR.pdf","2017-11-16 00:00:00",
52349,23,21368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021368tadalafilAmend1.pdf","2017-11-16 00:00:00",
52350,26,21368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021368_tadalafil_Amend_2.pdf","2017-11-16 00:00:00",
52351,27,21368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021368_tadalafil_Amend_3.pdf","2017-11-16 00:00:00",
53531,25,21368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021368tadalafilAmend1.pdf","1900-01-01 00:00:00",
5201,1,21368,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf","2005-04-06 00:00:00",
15321,2,21368,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf","2005-04-06 00:00:00",
15322,2,21368,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf","2005-04-06 00:00:00",
27618,1,21368,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf","2005-04-06 00:00:00",
5202,1,21368,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s006ltr.pdf","2005-07-15 00:00:00",
15323,2,21368,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf","2005-07-08 00:00:00",
15324,2,21368,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf","2007-01-24 00:00:00",
27619,1,21368,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s007ltr.pdf","2007-01-25 00:00:00",
15325,2,21368,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf","2006-03-10 00:00:00",
27620,1,21368,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s008ltr.pdf","2006-03-23 00:00:00",
5203,1,21368,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf","2006-10-26 00:00:00",
15326,2,21368,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf","2006-10-25 00:00:00",
15327,2,21368,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf","2006-10-25 00:00:00",
27621,1,21368,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf","2006-10-26 00:00:00",
5204,1,21368,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s011ltr.pdf","2008-01-09 00:00:00",
15328,2,21368,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf","2008-01-08 00:00:00",
5205,1,21368,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s012ltr.pdf","2007-10-22 00:00:00",
15329,2,21368,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf","2007-10-18 00:00:00",
5206,1,21368,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s013ltr.pdf","2008-08-13 00:00:00",
5207,1,21368,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021368s017ltr.pdf","2010-02-16 00:00:00",
15330,2,21368,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf","2010-02-16 00:00:00",
5208,1,21368,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf","2011-10-12 00:00:00",
21624,3,21368,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf","2014-01-17 00:00:00",
36786,2,21368,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf","2011-10-07 00:00:00",
15331,2,21368,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf","2011-10-07 00:00:00",
27622,1,21368,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf","2011-10-12 00:00:00",
5209,1,21368,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021368Orig1s022ltr.pdf","2013-10-11 00:00:00",
36787,2,21368,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf","2013-10-17 00:00:00",
15332,2,21368,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf","2014-05-02 00:00:00",
27623,1,21368,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021368Orig1s023ltr.pdf","2014-04-30 00:00:00",
5210,1,21368,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021368Orig1s026ltr.pdf","2015-09-17 00:00:00",
15333,2,21368,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf","2015-09-23 00:00:00",
5211,1,21368,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021368Orig1s027ltr.pdf","2016-04-26 00:00:00",
36788,2,21368,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf","2016-04-29 00:00:00",
48269,2,21368,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021368s029lbl.pdf","2017-05-08 00:00:00",
48306,1,21368,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021368Orig1s029ltr.pdf","2017-05-09 00:00:00",
52660,2,21368,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf","2018-02-16 00:00:00",
52707,1,21368,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021368Orig1s030ltr.pdf","2018-02-23 00:00:00",
54083,20,21368,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/245_21368S30 tadalafil clinical bpca.pdf","1900-01-01 00:00:00",
54084,18,21368,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/244_21368S30 tadalafil clinpharm bpca.pdf","1900-01-01 00:00:00",
5212,1,21369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21369ltr.pdf","2004-06-23 00:00:00",
42125,3,21369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-369_Codeprex.cfm","2005-04-05 00:00:00",
21625,3,21371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-371_Estrasorb.cfm","2005-01-11 00:00:00",
27624,1,21371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21371ltr.pdf","2003-10-16 00:00:00",
36789,2,21371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf","2003-10-16 00:00:00",
27625,1,21371,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021371Orig1s007ltr.pdf","2015-03-12 00:00:00",
36790,2,21371,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021371s007lbl.pdf","2015-03-12 00:00:00",
50273,2,21371,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf","2017-11-02 00:00:00",
21626,3,21372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-372_Alox.cfm","2004-01-15 00:00:00",
27626,1,21372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21372ltr.pdf","2003-08-06 00:00:00",
36791,2,21372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21372_aloxi_lbl.pdf","2003-08-06 00:00:00",
5213,1,21372,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021372s002ltr.pdf","2005-07-08 00:00:00",
15334,2,21372,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021372s002lbl.pdf","2005-07-07 00:00:00",
5214,1,21372,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021372s005ltr.pdf","2006-09-18 00:00:00",
36792,2,21372,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021372s005lbl.pdf","2006-08-29 00:00:00",
15335,2,21372,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021372s006lbl.pdf","2007-09-04 00:00:00",
27627,1,21372,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021372s006ltr.pdf","2007-09-04 00:00:00",
5215,1,21372,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf","2008-03-05 00:00:00",
21627,3,21372,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm","2009-12-12 00:00:00",
24195,21,21372,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf","2009-12-12 00:00:00",
36793,2,21372,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf","2008-03-05 00:00:00",
5216,1,21372,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021372s008, s010ltr.pdf","2008-03-05 00:00:00",
15336,2,21372,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021372s008s010lbl.pdf","2008-03-05 00:00:00",
42126,3,21372,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm","2009-12-12 00:00:00",
44641,21,21372,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010_SumR.pdf","2009-12-12 00:00:00",
27628,1,21372,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s017ltr.pdf","2014-02-11 00:00:00",
36794,2,21372,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s017lbl.pdf","2014-02-07 00:00:00",
5217,1,21372,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf","2014-06-02 00:00:00",
51538,20,21372,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinical 18 bpca.pdf","1900-01-01 00:00:00",
15337,2,21372,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s018s019lbl.pdf","2014-05-28 00:00:00",
27629,1,21372,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s018,s019ltr.pdf","2014-06-02 00:00:00",
51537,20,21372,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinical bpca.pdf","1900-01-01 00:00:00",
51539,18,21372,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinpharm bpca.pdf","1900-01-01 00:00:00",
51540,17,21372,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron statistical prea.pdf","1900-01-01 00:00:00",
5218,1,21372,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021372Orig1s020ltr.pdf","2014-09-23 00:00:00",
15338,2,21372,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf","2014-09-22 00:00:00",
15339,2,21373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf","2002-04-18 00:00:00",
27630,1,21373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21373ltr.pdf","2002-04-18 00:00:00",
27631,1,21373,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf","2004-06-01 00:00:00",
42127,3,21373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Childrens%20Advil.cfm","2002-04-18 00:00:00",
27632,1,21373,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf","2005-01-13 00:00:00",
5219,1,21373,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf","2006-04-07 00:00:00",
5220,1,21373,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf","2008-12-11 00:00:00",
5221,1,21373,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf","2009-05-27 00:00:00",
27633,1,21373,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf","2010-08-26 00:00:00",
47863,2,21373,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf","2017-04-05 00:00:00",
47868,1,21373,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf","2017-04-05 00:00:00",
5222,1,21374,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21374SLR001ltr.pdf","2003-10-22 00:00:00",
15340,2,21374,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf","2003-10-22 00:00:00",
27634,1,21374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21374ltr.pdf","2002-05-30 00:00:00",
36795,2,21374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf","2002-05-30 00:00:00",
42128,3,21374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-374_Ibuprofen.cfm","2004-05-26 00:00:00",
27635,1,21374,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021374s004ltr.pdf","2006-04-20 00:00:00",
27636,1,21374,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021374s005ltr.pdf","2005-12-15 00:00:00",
27637,1,21374,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021374s007ltr.pdf","2008-06-24 00:00:00",
5223,1,21374,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021374s008ltr.pdf","2009-05-27 00:00:00",
27638,1,21374,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021374s009ltr.pdf","2011-03-16 00:00:00",
47813,2,21374,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf","2017-04-03 00:00:00",
47816,1,21374,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021374Orig1s011ltr.pdf","2017-04-03 00:00:00",
5224,1,21375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert_Approv.pdf","2004-05-26 00:00:00",
36796,2,21375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021375lbl.pdf","2003-04-09 00:00:00",
42129,3,21375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert.cfm","2004-03-24 00:00:00",
27639,1,21375,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021375s002ltr.pdf","2005-08-23 00:00:00",
5225,1,21378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021378ltr.pdf","2004-12-02 00:00:00",
21628,3,21378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021378s000_CombunoxTOC.cfm","2005-11-30 00:00:00",
23258,8,21378,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf","2009-11-16 00:00:00",
36797,2,21378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021378lbl.pdf","2004-12-02 00:00:00",
5226,1,21378,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021378s002ltr.pdf","2006-03-23 00:00:00",
36798,2,21378,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021378s002lbl.pdf","2006-03-10 00:00:00",
15341,2,21378,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021378s005lbl.pdf","2007-06-27 00:00:00",
27640,1,21378,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021378s005ltr.pdf","2007-07-05 00:00:00",
36799,2,21378,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf","2010-09-07 00:00:00",
5227,1,21379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21379ltr.pdf","2002-07-24 00:00:00",
15342,2,21379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf","2002-07-24 00:00:00",
23652,10,21379,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
42130,3,21379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-379_Eligard.cfm","2002-07-24 00:00:00",
5228,1,21379,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf","2004-06-03 00:00:00",
42131,3,21379,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021379_s002_ELIGARD.pdf","2008-07-31 00:00:00",
15343,2,21379,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf","2007-11-13 00:00:00",
27641,1,21379,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf","2007-11-19 00:00:00",
5229,1,21379,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf","2010-10-13 00:00:00",
15344,2,21379,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf","2010-10-12 00:00:00",
5230,1,21379,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf","2011-01-20 00:00:00",
15345,2,21379,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf","2011-01-20 00:00:00",
27642,1,21379,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf","2011-04-11 00:00:00",
36800,2,21379,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf","2011-04-11 00:00:00",
27643,1,21379,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf","2013-03-01 00:00:00",
36801,2,21379,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf","2013-03-01 00:00:00",
5231,1,21379,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf","2014-10-14 00:00:00",
15346,2,21379,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf","2014-10-15 00:00:00",
15347,2,21379,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf","2016-03-03 00:00:00",
27644,1,21379,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf","2016-03-02 00:00:00",
27645,1,21385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21385ltr.pdf","2003-12-16 00:00:00",
36802,2,21385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21385_Ertaczo_lbl.pdf","2003-12-10 00:00:00",
42132,3,21385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-385_Ertaczo.cfm","2004-03-08 00:00:00",
5232,1,21385,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021385s003ltr.pdf","2005-11-30 00:00:00",
5233,1,21385,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021385Orig1s005ltr.pdf","2014-01-23 00:00:00",
36803,2,21385,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021385s005lbl.pdf","2014-01-23 00:00:00",
5234,1,21386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf","2004-07-01 00:00:00",
5235,1,21386,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf","2004-03-02 00:00:00",
15348,2,21386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf","2004-07-01 00:00:00",
36804,2,21386,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf","2004-03-25 00:00:00",
42133,3,21386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm","2004-07-01 00:00:00",
44120,10,21386,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2004-03-25 00:00:00",
27646,1,21386,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021386s004ltr.pdf","2011-02-09 00:00:00",
36805,2,21386,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf","2011-02-09 00:00:00",
5236,1,21387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21387ltr.pdf","2003-07-06 00:00:00",
21629,3,21387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-387_Pravagard.cfm","2004-01-29 00:00:00",
36806,2,21387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21387_pravigard_lbl.pdf","2003-07-08 00:00:00",
5237,1,21388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21388ltr.pdf","2003-12-19 00:00:00",
36807,2,21388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf","2003-12-17 00:00:00",
42134,3,21388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-388_SterileTalc.cfm","2004-05-06 00:00:00",
5238,1,21388,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021388Orig1s002ltr.pdf","2014-06-17 00:00:00",
36808,2,21388,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf","2014-06-17 00:00:00",
15349,2,21392,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021392lbl.pdf","2003-02-06 00:00:00",
21630,3,21392,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-392_CardizemTOC.cfm","2005-06-27 00:00:00",
15350,2,21392,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21392se1-002_cardizem_lbl.pdf","2004-04-05 00:00:00",
21631,3,21392,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXENTED_AP.pdf","2007-07-06 00:00:00",
27647,1,21392,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21392se1-002ltr.pdf","2004-04-07 00:00:00",
5239,1,21392,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021392s010ltr.pdf","2007-05-01 00:00:00",
15351,2,21392,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021392s010lbl.pdf","2007-05-01 00:00:00",
27648,1,21392,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021392s014ltr.pdf","2010-11-30 00:00:00",
36809,2,21392,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021392s014lbl.pdf","2010-11-22 00:00:00",
15352,2,21392,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021392s019lbl.pdf","2015-04-14 00:00:00",
27649,1,21392,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021392Orig1s019ltr.pdf","2015-03-25 00:00:00",
45917,1,21392,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021392Orig1s020ltr.pdf","2016-11-22 00:00:00",
45937,2,21392,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021392s020lbl.pdf","2016-11-21 00:00:00",
5240,1,21393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021393,021394ltr.pdf","2006-01-19 00:00:00",
15353,2,21393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf","2006-01-05 00:00:00",
42135,3,21393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm","2006-09-07 00:00:00",
27650,1,21393,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021393s005ltr.pdf","2008-06-16 00:00:00",
27651,1,21393,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021393s006ltr.pdf","2009-05-27 00:00:00",
5241,1,21393,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021393s007ltr.pdf","2011-04-21 00:00:00",
27652,1,21393,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021393Orig1s012ltr.pdf","2013-03-21 00:00:00",
36810,2,21393,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf","2013-03-22 00:00:00",
47830,1,21393,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021393Orig1s014ltr.pdf","2017-04-03 00:00:00",
47860,2,21393,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf","2017-04-05 00:00:00",
54072,1,21393,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21393Orig1s017ltr.pdf","2018-05-10 00:00:00",
54316,2,21393,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf","2018-05-23 00:00:00",
21632,3,21394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm","2006-09-07 00:00:00",
27653,1,21394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021393,021394ltr.pdf","2006-01-19 00:00:00",
36811,2,21394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf","2006-01-05 00:00:00",
27654,1,21394,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021394s010ltr.pdf","2008-06-13 00:00:00",
5242,1,21394,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021394s012ltr.pdf","2009-05-27 00:00:00",
27655,1,21394,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021394s014ltr.pdf","2011-04-28 00:00:00",
27656,1,21394,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021394s015ltr.pdf","2010-09-07 00:00:00",
47819,1,21394,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s021ltr.pdf","2017-04-03 00:00:00",
47862,2,21394,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf","2017-04-05 00:00:00",
49074,1,21394,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s023ltr.pdf","2017-07-25 00:00:00",
49084,2,21394,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf","2017-07-26 00:00:00",
53765,1,21394,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s025ltr.pdf","2018-04-20 00:00:00",
53789,2,21394,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf","2018-04-23 00:00:00",
5243,1,21395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395ltr.pdf","2004-03-16 00:00:00",
15354,2,21395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395_spiriva_lbl.pdf","2004-03-03 00:00:00",
21633,3,21395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm","2004-05-06 00:00:00",
23653,10,21395,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107272.htm","2004-07-13 00:00:00",
27657,1,21395,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395s001ltr.pdf","2004-08-25 00:00:00",
36812,2,21395,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395s001lbl.pdf","2004-08-25 00:00:00",
27658,1,21395,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s007ltr.pdf","2006-09-25 00:00:00",
36813,2,21395,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s007lbl.pdf","2006-09-21 00:00:00",
5244,1,21395,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf","2006-12-28 00:00:00",
15355,2,21395,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf","2006-12-14 00:00:00",
5245,1,21395,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s014ltr.pdf","2009-03-19 00:00:00",
15356,2,21395,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s014lbl.pdf","2009-03-19 00:00:00",
15357,2,21395,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf","2006-12-14 00:00:00",
27659,1,21395,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf","2006-12-28 00:00:00",
27660,1,21395,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s022ltr.pdf","2008-06-25 00:00:00",
27661,1,21395,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s027ltr.pdf","2008-11-18 00:00:00",
36814,2,21395,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021395s027lbl.pdf","2008-11-18 00:00:00",
15358,2,21395,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s029lbl.pdf","2009-12-18 00:00:00",
27662,1,21395,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s029ltr.pdf","2009-12-24 00:00:00",
42136,3,21395,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021395Orig1s029.pdf","2013-06-03 00:00:00",
5246,1,21395,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021395s033ltr.pdf","2011-08-01 00:00:00",
15359,2,21395,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf","2011-07-29 00:00:00",
5247,1,21395,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021395Orig1s040ltr.pdf","2015-12-14 00:00:00",
15360,2,21395,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf","2015-12-15 00:00:00",
5248,1,21395,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021395Orig1s044ltr.pdf","2016-06-24 00:00:00",
52255,2,21395,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021395s048lbl.pdf","2018-02-01 00:00:00",
52280,1,21395,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021395Orig1s048ltr.pdf","2018-02-02 00:00:00",
21634,3,21396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-396_Prempro.cfm","2005-04-15 00:00:00",
27663,1,21396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21396ltr.pdf","2003-06-08 00:00:00",
36815,2,21396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21396_prempro_lbl.pdf","2003-06-08 00:00:00",
21635,3,21397,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-424_Neurontin.cfm","2004-05-06 00:00:00",
24145,16,21397,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
27664,1,21397,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Approv.pdf","2004-06-09 00:00:00",
36816,2,21397,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Prntlbl.pdf","2004-06-09 00:00:00",
24196,21,21398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000_SumR.pdf","2008-07-22 00:00:00",
27665,1,21398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021398s000ltr.pdf","2007-11-08 00:00:00",
42137,3,21398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000TOC.cfm","2008-04-22 00:00:00",
53201,20,21398,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021398s000_Brimonidine-timolol_clinical_PREA.pdf","1900-01-01 00:00:00",
53202,18,21398,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021398s000_Brimonidine-timolol_clinpharm_PREA.pdf","1900-01-01 00:00:00",
53203,17,21398,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021398s000_Brimonidine-timolol_statistical_PREA.pdf","1900-01-01 00:00:00",
5249,1,21398,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021398Orig1s006ltr.pdf","2012-10-15 00:00:00",
15361,2,21398,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf","2012-10-12 00:00:00",
27666,1,21398,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021398Orig1s007ltr.pdf","2015-10-16 00:00:00",
36817,2,21398,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf","2015-10-22 00:00:00",
21636,3,21399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021399_iressa.cfm","2003-07-15 00:00:00",
27667,1,21399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-399_IRESSA_Approv.pdf","2004-06-07 00:00:00",
36818,2,21399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021399lbl.pdf","2003-05-05 00:00:00",
15362,2,21399,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21399slr003_Iressa_lbl.pdf","2004-05-07 00:00:00",
27668,1,21399,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399slr003ltr.pdf","2004-05-07 00:00:00",
5250,1,21399,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399s005ltr.pdf","2004-12-02 00:00:00",
5251,1,21399,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021399s008ltr.pdf","2005-06-21 00:00:00",
15363,2,21399,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021399s008lbl.pdf","2005-06-17 00:00:00",
5252,1,21400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21400ltr.pdf","2003-08-28 00:00:00",
21637,3,21400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm","2003-10-29 00:00:00",
36819,2,21400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21400_levitra_lbl.pdf","2003-08-28 00:00:00",
44121,10,21400,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106517.htm","2007-10-18 00:00:00",
15364,2,21400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s002lbl.pdf","2005-05-17 00:00:00",
27669,1,21400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s002ltr.pdf","2005-05-17 00:00:00",
5253,1,21400,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s004ltr.pdf","2005-07-15 00:00:00",
36820,2,21400,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s004lbl.pdf","2005-07-08 00:00:00",
5254,1,21400,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s008ltr.pdf","2007-04-20 00:00:00",
15365,2,21400,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s008lbl.pdf","2007-04-09 00:00:00",
5255,1,21400,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s010ltr.pdf","2007-10-22 00:00:00",
36821,2,21400,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s010lbl.pdf","2007-10-18 00:00:00",
5256,1,21400,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s011ltr.pdf","2008-03-21 00:00:00",
15366,2,21400,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021400s011lbl.pdf","2008-03-20 00:00:00",
5257,1,21400,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s012ltr.pdf","2008-05-21 00:00:00",
15367,2,21400,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021400s013lbl.pdf","2011-11-30 00:00:00",
27670,1,21400,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021400s013ltr.pdf","2011-11-28 00:00:00",
15368,2,21400,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021400s016lbl.pdf","2013-08-06 00:00:00",
27671,1,21400,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021400Orig1s016ltr.pdf","2013-08-05 00:00:00",
15369,2,21400,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf","2014-05-02 00:00:00",
27672,1,21400,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021400Orig1s017ltr.pdf","2014-04-30 00:00:00",
15370,2,21400,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/21400s019lbl.pdf","2015-09-23 00:00:00",
27673,1,21400,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021400Orig1s019ltr.pdf","2015-09-17 00:00:00",
49447,2,21400,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021400s020lbl.pdf","2017-08-17 00:00:00",
49570,1,21400,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021400Orig1s020ltr.pdf","2017-08-29 00:00:00",
15371,2,21402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21402lbl.pdf","2002-07-24 00:00:00",
27674,1,21402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21402ltr.pdf","2002-07-24 00:00:00",
42138,3,21402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-402_Synthroid.cfm","2002-11-25 00:00:00",
36822,2,21402,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s011lbl.pdf","2008-06-05 00:00:00",
15372,2,21402,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021402s017lbl.pdf","2008-07-15 00:00:00",
27675,1,21402,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021402s017ltr.pdf","2008-07-15 00:00:00",
5258,1,21402,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021402s020ltr.pdf","2012-10-02 00:00:00",
15373,2,21402,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021402s020lbl.pdf","2014-01-15 00:00:00",
47324,2,21402,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf","2017-02-24 00:00:00",
47413,1,21402,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf","2017-03-02 00:00:00",
47325,2,21402,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021402s024s028lbl.pdf","2017-02-24 00:00:00",
47414,1,21402,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021402Orig1s024,s028ltr.pdf","2017-03-02 00:00:00",
15374,2,21406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021406lbl.pdf","2005-08-15 00:00:00",
21638,3,21406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021406s000TOC.cfm","2007-05-09 00:00:00",
27676,1,21406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021406ltr.pdf","2005-08-19 00:00:00",
27677,1,21406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021406s003LTR.pdf","2006-05-01 00:00:00",
36823,2,21406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021406s003lbl.pdf","2006-05-01 00:00:00",
5259,1,21406,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021406s007ltr.pdf","2007-02-12 00:00:00",
15375,2,21406,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021406s008lbl.pdf","2009-06-24 00:00:00",
27678,1,21406,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021406s008ltr.pdf","2009-06-26 00:00:00",
15376,2,21406,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021406s016lbl.pdf","2011-08-16 00:00:00",
27679,1,21406,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021406s016ltr.pdf","2011-08-17 00:00:00",
27680,1,21406,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf","2014-07-10 00:00:00",
5260,1,21406,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf","2014-07-10 00:00:00",
36824,2,21406,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021406s017s022lbl.pdf","2014-07-11 00:00:00",
5261,1,21408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21408ltr.pdf","2002-10-21 00:00:00",
15377,2,21408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21408lbl.pdf","2002-10-17 00:00:00",
42139,3,21408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021408_s00MentextcTOC.cfm","2006-01-31 00:00:00",
5262,1,21409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21409ltr.pdf","2002-07-26 00:00:00",
15378,2,21409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409lbl.pdf","2002-07-26 00:00:00",
21639,3,21409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-409_Singulair.cfm","2004-11-22 00:00:00",
23654,10,21409,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm","2008-08-12 00:00:00",
5263,1,21409,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21409se1-003ltr.pdf","2003-01-23 00:00:00",
15379,2,21409,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409se1-003_singulair_lbl.pdf","2003-04-09 00:00:00",
5264,1,21409,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf","2003-10-09 00:00:00",
21640,3,21409,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf","2007-07-09 00:00:00",
36825,2,21409,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf","2004-06-17 00:00:00",
5265,1,21409,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf","2003-12-23 00:00:00",
15380,2,21409,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf","2003-12-29 00:00:00",
21641,3,21409,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021409_S007_SINGULAIR_TABLETS_AP.pdf","2007-07-06 00:00:00",
27681,1,21409,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf","2004-11-17 00:00:00",
36826,2,21409,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf","2004-11-17 00:00:00",
5266,1,21409,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf","2005-07-29 00:00:00",
36827,2,21409,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf","2005-07-29 00:00:00",
27682,1,21409,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf","2005-12-06 00:00:00",
36828,2,21409,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf","2005-12-05 00:00:00",
27683,1,21409,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf","2005-05-27 00:00:00",
36829,2,21409,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf","2005-05-27 00:00:00",
27684,1,21409,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf","2007-04-20 00:00:00",
36830,2,21409,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf","2007-04-20 00:00:00",
27685,1,21409,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf","2005-06-29 00:00:00",
36831,2,21409,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf","2005-06-29 00:00:00",
27686,1,21409,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf","2006-05-22 00:00:00",
36832,2,21409,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf","2006-05-22 00:00:00",
15381,2,21409,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf","2006-12-14 00:00:00",
27687,1,21409,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf","2006-12-28 00:00:00",
5267,1,21409,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf","2008-03-11 00:00:00",
15382,2,21409,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf","2008-03-13 00:00:00",
5268,1,21409,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf","2008-04-22 00:00:00",
36833,2,21409,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf","2008-06-05 00:00:00",
5269,1,21409,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf","2008-04-28 00:00:00",
36834,2,21409,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021409s026lbl.pdf","2008-04-29 00:00:00",
27688,1,21409,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf","2009-01-30 00:00:00",
36835,2,21409,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf","2009-02-04 00:00:00",
27689,1,21409,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf","2009-11-10 00:00:00",
36836,2,21409,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf","2009-08-28 00:00:00",
5270,1,21409,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf","2010-04-29 00:00:00",
36837,2,21409,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021409s029lbl.pdf","2010-04-28 00:00:00",
5271,1,21409,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf","2010-08-16 00:00:00",
15383,2,21409,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf","2010-08-19 00:00:00",
27690,1,21409,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf","2011-05-03 00:00:00",
36838,2,21409,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf","2011-04-29 00:00:00",
5272,1,21409,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf","2012-03-28 00:00:00",
15384,2,21409,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf","2012-03-26 00:00:00",
5273,1,21409,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf","2011-12-21 00:00:00",
15385,2,21409,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf","2011-12-20 00:00:00",
27691,1,21409,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf","2012-10-22 00:00:00",
36839,2,21409,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf","2012-10-22 00:00:00",
5274,1,21409,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf","2012-10-02 00:00:00",
15386,2,21409,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf","2012-09-28 00:00:00",
27692,1,21409,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf","2013-03-22 00:00:00",
36840,2,21409,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf","2013-03-26 00:00:00",
5275,1,21409,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf","2013-12-31 00:00:00",
15387,2,21409,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf","2013-12-31 00:00:00",
5276,1,21409,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf","2014-11-28 00:00:00",
15388,2,21409,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf","2014-12-19 00:00:00",
46163,1,21409,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020829Orig1s069,020830Orig1s071,021409Orig1s047ltr.pdf","2016-12-15 00:00:00",
46172,2,21409,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf","2016-12-15 00:00:00",
5277,1,21410,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21410scf001ltr.pdf","2003-08-28 00:00:00",
15389,2,21410,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21410scf001_avandamet_lbl.pdf","2003-08-28 00:00:00",
23655,10,21410,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2008-02-21 00:00:00",
27693,1,21410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21410ltr.pdf","2000-05-09 00:00:00",
36841,2,21410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21410lbl.pdf","2002-10-10 00:00:00",
42140,3,21410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021410_avandamet.cfm","2003-04-30 00:00:00",
15390,2,21410,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf","2004-05-27 00:00:00",
27694,1,21410,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf","2004-05-26 00:00:00",
5278,1,21410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf","2004-05-26 00:00:00",
36842,2,21410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf","2004-05-27 00:00:00",
5279,1,21410,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf","2005-03-01 00:00:00",
36843,2,21410,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21410s009lbl.pdf","2005-01-11 00:00:00",
42141,3,21410,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia%20Tabs.pdf","2009-09-14 00:00:00",
5280,1,21410,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s010LTR.pdf","2006-05-22 00:00:00",
36844,2,21410,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s010lbl.pdf","2006-05-22 00:00:00",
5281,1,21410,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s013LTR.pdf","2006-04-21 00:00:00",
36845,2,21410,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s013lbl.pdf","2006-04-20 00:00:00",
15391,2,21410,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s016lbl.pdf","2007-02-02 00:00:00",
27695,1,21410,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s016ltr.pdf","2007-02-12 00:00:00",
5282,1,21410,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s019ltr.pdf","2007-05-01 00:00:00",
36846,2,21410,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s019lbl.pdf","2007-04-25 00:00:00",
15392,2,21410,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s022lbl.pdf","2007-09-26 00:00:00",
27696,1,21410,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s022ltr.pdf","2007-09-25 00:00:00",
5283,1,21410,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s023ltr.pdf","2007-08-22 00:00:00",
36847,2,21410,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s023lbl.pdf","2007-08-22 00:00:00",
5284,1,21410,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021410s025ltr.pdf","2008-12-04 00:00:00",
15393,2,21410,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf","2008-12-04 00:00:00",
5285,1,21410,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf","2011-02-03 00:00:00",
36848,2,21410,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf","2011-02-04 00:00:00",
15394,2,21410,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027lbl.pdf","2011-05-17 00:00:00",
27697,1,21410,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf","2011-05-24 00:00:00",
15395,2,21410,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029lbl.pdf","2011-11-16 00:00:00",
27698,1,21410,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf","2011-11-21 00:00:00",
5286,1,21410,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf","2012-06-04 00:00:00",
36849,2,21410,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021410s030lbl.pdf","2012-06-06 00:00:00",
27699,1,21410,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf","2013-01-30 00:00:00",
5287,1,21410,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf","2013-09-19 00:00:00",
5288,1,21410,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf","2014-05-08 00:00:00",
15396,2,21410,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf","2014-05-12 00:00:00",
27700,1,21410,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf","2014-05-08 00:00:00",
36850,2,21410,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf","2014-05-12 00:00:00",
15397,2,21410,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf","2014-05-12 00:00:00",
27701,1,21410,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf","2014-05-08 00:00:00",
5289,1,21410,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf","2015-12-17 00:00:00",
47929,2,21410,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf","2017-04-11 00:00:00",
47932,8,21410,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38","2017-04-11 00:00:00",
47950,1,21410,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021410s040ltr.pdf","2017-04-12 00:00:00",
5290,1,21411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21411ltr.pdf","2002-11-26 00:00:00",
15398,2,21411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21411_strattera_lbl.pdf","2002-11-26 00:00:00",
21642,3,21411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021411_S001_STRATTERA_CAPSULES_AP.pdf","2007-07-06 00:00:00",
23656,10,21411,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107912.htm","2005-09-30 00:00:00",
27702,1,21411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21411slr001ltr.pdf","2003-01-17 00:00:00",
36851,2,21411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21411slr001_strattera_lbl.pdf","2003-01-17 00:00:00",
42142,3,21411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-411_Strattera.cfm","2003-03-07 00:00:00",
5291,1,21411,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf","2005-02-03 00:00:00",
27703,1,21411,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf","2007-05-01 00:00:00",
36852,2,21411,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf","2007-05-01 00:00:00",
5292,1,21411,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411se1-005ltr.pdf","2008-05-09 00:00:00",
44642,21,21411,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021411se1-005_SUMR.pdf","2008-07-17 00:00:00",
27704,1,21411,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s008ltr.pdf","2005-05-27 00:00:00",
27705,1,21411,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s010ltr.pdf","2005-02-17 00:00:00",
27706,1,21411,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf","2005-02-03 00:00:00",
27707,1,21411,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf","2007-05-01 00:00:00",
36853,2,21411,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf","2007-05-01 00:00:00",
5293,1,21411,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf","2007-05-01 00:00:00",
36854,2,21411,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf","2007-05-01 00:00:00",
27708,1,21411,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s014ltr.pdf","2005-11-18 00:00:00",
5294,1,21411,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf","2007-05-01 00:00:00",
36855,2,21411,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf","2007-05-01 00:00:00",
15399,2,21411,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf","2006-10-23 00:00:00",
27709,1,21411,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021411s018ltr.pdf","2006-10-23 00:00:00",
5295,1,21411,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s019ltr.pdf","2007-10-04 00:00:00",
36856,2,21411,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s019lbl.pdf","2007-10-04 00:00:00",
5296,1,21411,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf","2007-05-01 00:00:00",
15400,2,21411,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf","2007-05-01 00:00:00",
5297,1,21411,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf","2008-07-25 00:00:00",
15401,2,21411,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf","2008-07-29 00:00:00",
27710,1,21411,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf","2008-07-25 00:00:00",
36857,2,21411,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf","2008-07-29 00:00:00",
5298,1,21411,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf","2008-07-25 00:00:00",
36858,2,21411,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf","2008-07-29 00:00:00",
27711,1,21411,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf","2009-06-16 00:00:00",
36859,2,21411,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf","2009-06-04 00:00:00",
15402,2,21411,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf","2009-06-04 00:00:00",
27712,1,21411,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf","2009-06-16 00:00:00",
15403,2,21411,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf","2010-07-31 00:00:00",
27713,1,21411,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021411s032ltr.pdf","2010-07-30 00:00:00",
5299,1,21411,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s034ltr.pdf","2012-07-09 00:00:00",
15404,2,21411,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf","2012-07-10 00:00:00",
5300,1,21411,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021411s035ltr.pdf","2011-03-10 00:00:00",
15405,2,21411,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf","2011-03-07 00:00:00",
27714,1,21411,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411Orig1s036ltr.pdf","2012-08-20 00:00:00",
36860,2,21411,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036lbl.pdf","2012-09-12 00:00:00",
5301,1,21411,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s039ltr.pdf","2012-06-18 00:00:00",
15406,2,21411,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf","2012-06-18 00:00:00",
5302,1,21411,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf","2013-08-06 00:00:00",
15407,2,21411,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf","2013-08-05 00:00:00",
15408,2,21411,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf","2013-08-05 00:00:00",
27715,1,21411,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf","2013-08-06 00:00:00",
15409,2,21411,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf","2014-02-21 00:00:00",
27716,1,21411,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021411Orig1s044ltr.pdf","2014-02-21 00:00:00",
5303,1,21411,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s045ltr.pdf","2013-12-09 00:00:00",
15410,2,21411,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf","2013-12-05 00:00:00",
15411,2,21411,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf","2015-05-29 00:00:00",
27717,1,21411,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s046ltr.pdf","2015-05-28 00:00:00",
5304,1,21411,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s047ltr.pdf","2015-04-20 00:00:00",
15412,2,21411,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf","2015-04-21 00:00:00",
48485,2,21411,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf","2017-05-22 00:00:00",
48486,8,21411,"SUPPL",48,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf#page=19","2017-05-22 00:00:00",
48504,1,21411,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021411Orig1s048ltr.pdf","2017-05-24 00:00:00",
5305,1,21412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021412s000ltr.pdf","2007-05-01 00:00:00",
27718,1,21412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021412TAltr.pdf","2005-05-27 00:00:00",
36861,2,21412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf","2007-05-01 00:00:00",
42143,3,21412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021412_tovalt_odt_toc.cfm","2009-04-14 00:00:00",
5306,1,21415,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021415s001ltr.pdf","2005-06-07 00:00:00",
15413,2,21415,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021415s001lbl.pdf","2005-06-07 00:00:00",
21643,3,21415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021415s000_MetvixiaTOC.cfm","2006-03-21 00:00:00",
27719,1,21415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21415ltr.pdf","2004-07-30 00:00:00",
36862,2,21415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21415lbl.pdf","2004-07-30 00:00:00",
27720,1,21415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021415s003ltr.pdf","2008-06-30 00:00:00",
36863,2,21415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021415s003lbl.pdf","2008-06-30 00:00:00",
27721,1,21415,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021415Orig1s004ltr.pdf","2012-11-23 00:00:00",
36864,2,21415,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf","2012-11-28 00:00:00",
5307,1,21416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21416ltr.pdf","2003-09-25 00:00:00",
27722,1,21416,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21416s001ltr.pdf","2004-09-15 00:00:00",
36865,2,21416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf","2003-09-25 00:00:00",
42144,3,21416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-416_Rythmol.cfm","2004-02-11 00:00:00",
27723,1,21416,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021416s007ltr.pdf","2010-11-03 00:00:00",
36866,2,21416,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf","2010-10-29 00:00:00",
15414,2,21416,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf","2011-04-15 00:00:00",
27724,1,21416,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021416s010ltr.pdf","2011-04-19 00:00:00",
15415,2,21416,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf","2014-06-23 00:00:00",
21644,3,21417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin.cfm","2003-09-25 00:00:00",
27725,1,21417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21417ltr.pdf","2003-07-28 00:00:00",
36867,2,21417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin_prntlbl.pdf","2004-06-14 00:00:00",
5308,1,21419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21419ltr.pdf","2002-12-19 00:00:00",
5309,1,21419,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf","2007-06-14 00:00:00",
15416,2,21419,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf","2007-06-12 00:00:00",
23657,10,21419,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
42145,3,21419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-419_Methylin.cfm","2004-10-26 00:00:00",
5310,1,21419,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf","2006-08-14 00:00:00",
36868,2,21419,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf","2006-08-11 00:00:00",
5311,1,21419,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf","2010-10-20 00:00:00",
15417,2,21419,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf","2010-10-18 00:00:00",
5312,1,21419,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf","2013-06-18 00:00:00",
15418,2,21419,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf","2013-06-18 00:00:00",
5313,1,21419,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf","2013-12-24 00:00:00",
15419,2,21419,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s007lbl.pdf","2013-12-17 00:00:00",
5314,1,21419,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf","2015-04-20 00:00:00",
36869,2,21419,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf","2015-04-21 00:00:00",
46708,2,21419,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf","2017-01-06 00:00:00",
46829,8,21419,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf#page=12","2017-01-13 00:00:00",
46830,1,21419,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021419Orig1s014,021475Orig1s010ltr.pdf","2017-01-13 00:00:00",
24146,16,21423,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
27726,1,21423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Approv.pdf","2004-06-09 00:00:00",
36870,2,21423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Prntlbl.pdf","2004-06-09 00:00:00",
42146,3,21423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-424_Neurontin.cfm","2004-05-06 00:00:00",
5315,1,21424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Approv.pdf","2004-06-09 00:00:00",
24147,16,21424,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
36871,2,21424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397.pdf_Neurontin_Prntlbl.pdf","2004-06-09 00:00:00",
42147,3,21424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-424_Neurontin.cfm","2004-05-06 00:00:00",
5316,1,21425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21425ltr.pdf","2002-09-20 00:00:00",
5317,1,21425,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21425slr001ltr.pdf","2004-06-29 00:00:00",
15420,2,21425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf","2002-09-20 00:00:00",
21645,3,21425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm","2003-06-26 00:00:00",
5318,1,21425,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21425scp006ltr.pdf","2004-03-16 00:00:00",
36872,2,21425,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf","2004-04-05 00:00:00",
5319,1,21425,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021425s012ltr.pdf","2007-09-06 00:00:00",
15421,2,21425,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf","2007-09-04 00:00:00",
5320,1,21425,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021425s017ltr.pdf","2010-06-29 00:00:00",
36873,2,21425,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf","2010-07-01 00:00:00",
27727,1,21425,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf","2010-01-20 00:00:00",
15422,2,21425,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf","2012-05-07 00:00:00",
5321,1,21425,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf","2015-07-10 00:00:00",
36874,2,21425,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf","2015-07-09 00:00:00",
47886,2,21425,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021425s026lbl.pdf","2017-04-07 00:00:00",
47959,1,21425,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s042,021425Orig1s026ltr.pdf","2017-04-12 00:00:00",
53601,2,21425,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021425s028lbl.pdf","2018-04-04 00:00:00",
53602,1,21425,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425s028ltr.pdf","2018-04-05 00:00:00",
54078,1,21425,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425Orig1s029ltr.pdf","2018-05-10 00:00:00",
21646,3,21426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.cfm","2007-06-11 00:00:00",
27728,1,21426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021426s000LTR.pdf","2006-06-01 00:00:00",
36875,2,21426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf","2006-05-31 00:00:00",
27729,1,21426,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s002ltr.pdf","2008-01-18 00:00:00",
36876,2,21426,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf","2008-01-18 00:00:00",
42148,3,21426,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s002.pdf","2012-10-12 00:00:00",
5322,1,21426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s004ltr.pdf","2008-08-25 00:00:00",
21647,3,21426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf","2012-10-12 00:00:00",
36877,2,21426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf","2008-08-26 00:00:00",
5323,1,21426,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021426s006ltr.pdf","2009-03-27 00:00:00",
15423,2,21426,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf","2009-03-26 00:00:00",
21648,3,21426,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf","2013-05-02 00:00:00",
27730,1,21426,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf","2010-04-28 00:00:00",
36878,2,21426,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf","2010-05-03 00:00:00",
5324,1,21426,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf","2010-04-28 00:00:00",
15424,2,21426,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf","2010-05-03 00:00:00",
42149,3,21426,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s008.pdf","2013-05-10 00:00:00",
5325,1,21426,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf","2010-08-31 00:00:00",
36879,2,21426,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf","2010-08-27 00:00:00",
15425,2,21426,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf","2011-07-25 00:00:00",
27731,1,21426,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s017ltr.pdf","2011-07-27 00:00:00",
15426,2,21426,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf","2011-04-15 00:00:00",
27732,1,21426,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s018ltr.pdf","2011-04-15 00:00:00",
47256,2,21426,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf","2017-02-16 00:00:00",
27733,1,21426,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021426Orig1s028ltr.pdf","2014-09-03 00:00:00",
36880,2,21426,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf","2014-09-03 00:00:00",
46159,1,21426,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021426Orig1s034ltr.pdf","2016-12-15 00:00:00",
46185,2,21426,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf","2016-12-14 00:00:00",
5326,1,21427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21427ltr.pdf","2004-08-10 00:00:00",
15427,2,21427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf","2004-08-10 00:00:00",
23658,10,21427,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114966.htm","2005-07-29 00:00:00",
42150,3,21427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021427_s000_Cymbalta.cfm","2004-10-08 00:00:00",
52438,18,21427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427 duloxetine clinical prea.pdf","1900-01-01 00:00:00",
52439,17,21427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycycline statistical prea.pdf","1900-01-01 00:00:00",
52895,20,21427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427 duloxetine clinical bpca.pdf","1900-01-01 00:00:00",
53532,18,21427,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427 duloxetine clinpharm bpca.pdf","1900-01-01 00:00:00",
5327,1,21427,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21427s002ltr.pdf","2005-02-23 00:00:00",
5328,1,21427,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021427s007LTR.pdf","2006-06-14 00:00:00",
27734,1,21427,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf","2007-03-06 00:00:00",
36881,2,21427,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf","2007-02-26 00:00:00",
5329,1,21427,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf","2007-03-06 00:00:00",
15428,2,21427,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf","2007-02-26 00:00:00",
15429,2,21427,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf","2006-09-21 00:00:00",
5330,1,21427,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf","2007-03-06 00:00:00",
15430,2,21427,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf","2007-02-26 00:00:00",
5331,1,21427,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf","2007-12-03 00:00:00",
15431,2,21427,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf","2007-12-03 00:00:00",
42151,3,21427,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf","2011-10-10 00:00:00",
5332,1,21427,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf","2007-12-03 00:00:00",
36882,2,21427,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf","2007-12-03 00:00:00",
42152,3,21427,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf","2011-10-10 00:00:00",
15432,2,21427,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf","2007-08-03 00:00:00",
27735,1,21427,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
5333,1,21427,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf","2009-03-24 00:00:00",
36883,2,21427,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf","2009-03-20 00:00:00",
5334,1,21427,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf","2009-03-24 00:00:00",
15433,2,21427,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf","2009-03-20 00:00:00",
15434,2,21427,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf","2009-03-20 00:00:00",
27736,1,21427,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf","2009-03-24 00:00:00",
15435,2,21427,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf","2009-02-04 00:00:00",
27737,1,21427,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s029ltr.pdf","2009-02-03 00:00:00",
5335,1,21427,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s030ltr.pdf","2009-11-27 00:00:00",
36884,2,21427,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030lbl.pdf","2009-11-23 00:00:00",
5336,1,21427,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s031ltr.pdf","2011-03-08 00:00:00",
36885,2,21427,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s031lbl.pdf","2011-03-07 00:00:00",
27738,1,21427,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf","2012-08-28 00:00:00",
36886,2,21427,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf","2012-08-30 00:00:00",
15436,2,21427,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf","2011-04-15 00:00:00",
27739,1,21427,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s036ltr.pdf","2011-04-15 00:00:00",
27740,1,21427,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf","2014-11-28 00:00:00",
36887,2,21427,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf","2014-12-03 00:00:00",
27741,1,21427,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf","2012-08-28 00:00:00",
36888,2,21427,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf","2012-08-30 00:00:00",
15437,2,21427,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf","2011-09-07 00:00:00",
21649,3,21427,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021427Orig1s039.pdf","2012-05-09 00:00:00",
27742,1,21427,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s039ltr.pdf","2011-09-07 00:00:00",
5337,1,21427,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf","2012-10-22 00:00:00",
36889,2,21427,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf","2012-10-22 00:00:00",
5338,1,21427,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf","2012-10-22 00:00:00",
15438,2,21427,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf","2012-10-22 00:00:00",
51517,23,21427,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427_duloxetine_Original_WR.pdf","2006-06-23 00:00:00",
51518,25,21427,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427_duloxetine_ Amendment_1.pdf","2009-09-22 00:00:00",
51519,26,21427,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM311213.pdf","2009-11-02 00:00:00",
52441,20,21427,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427 duloxetine clinical prea.pdf","1900-01-01 00:00:00",
52443,17,21427,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21427 duloxetine statistical bpca.pdf","1900-01-01 00:00:00",
5339,1,21427,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf","2014-11-28 00:00:00",
36890,2,21427,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf","2014-12-03 00:00:00",
27743,1,21427,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf","2014-10-21 00:00:00",
36891,2,21427,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf","2014-10-21 00:00:00",
5340,1,21427,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf","2014-10-21 00:00:00",
36892,2,21427,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf","2014-10-21 00:00:00",
15439,2,21427,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf","2014-07-28 00:00:00",
27744,1,21427,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s045ltr.pdf","2014-07-21 00:00:00",
5341,1,21427,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021427Orig1s046ltr.pdf","2015-06-22 00:00:00",
15440,2,21427,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf","2015-06-19 00:00:00",
45196,2,21427,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021427s048lbl.pdf","2016-09-02 00:00:00",
45197,1,21427,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021427Orig1s048ltr.pdf","2016-09-02 00:00:00",
46686,2,21427,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf","2017-01-06 00:00:00",
46734,8,21427,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf#page=32","2017-01-10 00:00:00",
46735,1,21427,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021427Orig1s049ltr.pdf","2017-01-10 00:00:00",
50806,2,21427,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s050lbl.pdf","2017-12-21 00:00:00",
50896,1,21427,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021427Orig1s050ltr.pdf","2017-12-27 00:00:00",
5342,1,21428,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf","2003-08-15 00:00:00",
15441,2,21428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf","2002-08-30 00:00:00",
23659,10,21428,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
27745,1,21428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf","2002-08-30 00:00:00",
42153,3,21428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm","2005-06-23 00:00:00",
21650,3,21428,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID DELAYED RELEASE CAPS.pdf","2008-07-31 00:00:00",
27746,1,21428,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf","2004-06-23 00:00:00",
36893,2,21428,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf","2004-12-21 00:00:00",
5343,1,21428,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf","2006-04-13 00:00:00",
36894,2,21428,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf","2006-04-13 00:00:00",
5344,1,21428,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf","2007-07-05 00:00:00",
15442,2,21428,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf","2007-06-27 00:00:00",
5345,1,21428,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf","2008-04-23 00:00:00",
15443,2,21428,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf","2008-11-07 00:00:00",
27747,1,21428,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf","2008-10-29 00:00:00",
15444,2,21428,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf","2009-08-13 00:00:00",
27748,1,21428,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf","2009-11-12 00:00:00",
5346,1,21428,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf","2010-05-17 00:00:00",
36895,2,21428,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf","2010-05-17 00:00:00",
15445,2,21428,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf","2010-09-10 00:00:00",
5347,1,21428,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf","2011-06-03 00:00:00",
36896,2,21428,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf","2011-06-07 00:00:00",
15446,2,21428,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf","2011-11-01 00:00:00",
27749,1,21428,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076,021428s023ltr.pdf","2011-10-31 00:00:00",
5348,1,21428,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf","2011-05-25 00:00:00",
36897,2,21428,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf","2011-05-26 00:00:00",
5349,1,21428,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf","2012-10-02 00:00:00",
36898,2,21428,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf","2012-10-01 00:00:00",
5350,1,21428,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf","2012-05-09 00:00:00",
15447,2,21428,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf","2012-05-07 00:00:00",
27750,1,21428,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf","2015-12-18 00:00:00",
36899,2,21428,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf","2015-12-17 00:00:00",
27751,1,21428,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf","2014-12-24 00:00:00",
36900,2,21428,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf","2014-12-29 00:00:00",
45663,1,21428,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf","2016-10-26 00:00:00",
45713,2,21428,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf","2016-10-31 00:00:00",
50101,1,21428,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020406Orig1s083,021428Orig1s031ltr.pdf","2017-10-19 00:00:00",
50184,2,21428,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf","2017-10-25 00:00:00",
53695,1,21428,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s084,021428Orig1s032ltr.pdf","2018-04-16 00:00:00",
53708,2,21428,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf","2018-04-17 00:00:00",
54518,2,21428,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf","2018-06-11 00:00:00",
54573,1,21428,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf","2018-06-14 00:00:00",
54516,8,21428,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38","2018-06-11 00:00:00",
54517,2,21428,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf","2018-06-11 00:00:00",
54572,1,21428,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf","2018-06-14 00:00:00",
5351,1,21430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf","2006-05-26 00:00:00",
23660,10,21430,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107296.htm","2006-06-06 00:00:00",
23999,14,21430,"ORIG",1,"REMS","http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM222649.pdf","2012-03-09 00:00:00",
36901,2,21430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430lbl.pdf","2006-05-26 00:00:00",
42154,3,21430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021430s000TOC.cfm","2008-10-03 00:00:00",
27752,1,21431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21431ltr.pdf","2004-07-30 00:00:00",
36902,2,21431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf","2004-07-30 00:00:00",
42155,3,21431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-431_Campral.cfm","2004-10-18 00:00:00",
27753,1,21431,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021431s013ltr.pdf","2010-12-15 00:00:00",
36903,2,21431,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf","2010-12-13 00:00:00",
15448,2,21431,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf","2012-01-30 00:00:00",
27754,1,21431,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021431s015ltr.pdf","2012-02-01 00:00:00",
21651,3,21433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.cfm","2005-12-06 00:00:00",
27755,1,21433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21433ltr.pdf","2004-05-26 00:00:00",
36904,2,21433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf","2004-05-27 00:00:00",
27756,1,21433,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s004ltr.pdf","2006-03-03 00:00:00",
36905,2,21433,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf","2006-03-03 00:00:00",
15449,2,21433,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf","2006-01-05 00:00:00",
27757,1,21433,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021433s005rev2.pdf","2006-01-18 00:00:00",
5352,1,21433,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s006ltr.pdf","2006-10-27 00:00:00",
36906,2,21433,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf","2006-10-26 00:00:00",
5353,1,21433,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021433s011ltr.pdf","2008-07-02 00:00:00",
36907,2,21433,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf","2008-07-09 00:00:00",
5354,1,21433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021433s015ltr.pdf","2010-11-08 00:00:00",
36908,2,21433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf","2010-11-03 00:00:00",
5355,1,21433,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021433s019ltr.pdf","2014-12-03 00:00:00",
36909,2,21433,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf","2011-08-05 00:00:00",
27758,1,21433,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021433Orig1s022ltr.pdf","2013-07-22 00:00:00",
36910,2,21433,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf","2013-07-23 00:00:00",
5356,1,21433,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s025ltr.pdf","2014-11-17 00:00:00",
15450,2,21433,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf","2014-11-20 00:00:00",
27759,1,21433,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s026ltr.pdf","2014-12-12 00:00:00",
36911,2,21433,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf","2014-12-11 00:00:00",
5357,1,21433,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s031ltr.pdf","2016-08-01 00:00:00",
15451,2,21433,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf","2016-08-02 00:00:00",
45508,1,21433,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s032ltr.pdf","2016-10-06 00:00:00",
45593,2,21433,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s032lbl.pdf","2016-10-07 00:00:00",
49027,2,21433,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021433s033lbl.pdf","2017-07-20 00:00:00",
49039,1,21433,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020833Orig1s033,021433Orig1s033ltr.pdf","2017-07-21 00:00:00",
27760,1,21434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21434ltr.pdf","2004-06-30 00:00:00",
27761,1,21434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18276slr038,039,21434slr001ltr.pdf","2004-04-07 00:00:00",
36912,2,21434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021434lbl.pdf","2003-03-06 00:00:00",
42156,3,21434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-434_Xanax.cfm","2004-12-07 00:00:00",
42157,3,21434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021434_S001_Xanax_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
5358,1,21434,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s044,021434s006ltr.pdf","2011-06-03 00:00:00",
15452,2,21434,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf","2011-06-07 00:00:00",
5359,1,21434,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s045,021434s007ltr.pdf","2011-08-26 00:00:00",
15453,2,21434,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021434s007lbl.pdf","2011-08-24 00:00:00",
46242,2,21434,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf","2016-12-20 00:00:00",
46466,1,21434,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018276Orig1s052,021434Orig1s016ltr.pdf","2016-12-22 00:00:00",
46633,8,21434,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf#page=24","2016-12-30 00:00:00",
27762,1,21435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21435ltr.pdf","2003-11-28 00:00:00",
5360,1,21436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21436se1-001ltr.pdf","2003-09-09 00:00:00",
15454,2,21436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21436se1-001_abilify_lbl.pdf","2003-09-09 00:00:00",
21652,3,21436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S001_ABILIFY_TABLETS.pdf","2007-09-24 00:00:00",
27763,1,21436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21436ltr.pdf","2002-11-15 00:00:00",
36913,2,21436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21436_Abilify_lbl.pdf","2002-11-15 00:00:00",
42158,3,21436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify.cfm","2003-03-07 00:00:00",
44122,10,21436,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
51771,17,21436,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436s017_aripiprazole_Abilify-StatsRev.pdf","1900-01-01 00:00:00",
51772,23,21436,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436s000_aripiprazole_WR.pdf","1900-01-01 00:00:00",
51773,20,21436,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436s017_aripiprazole_Abilify-MedRev.pdf","1900-01-01 00:00:00",
51774,18,21436,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436s017_aripiprazole_Abilify-ClinPharmRev.pdf","1900-01-01 00:00:00",
15455,2,21436,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21436s002lbl.pdf","2004-10-04 00:00:00",
21653,3,21436,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021436Orig1s002.pdf","2013-05-10 00:00:00",
27764,1,21436,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21436s002ltr.pdf","2004-10-04 00:00:00",
42159,3,21436,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S004_ABILIFY_TABLETS.pdf","2007-09-24 00:00:00",
15456,2,21436,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf","2005-03-03 00:00:00",
27765,1,21436,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf","2005-03-03 00:00:00",
5361,1,21436,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21436slr006ltr.pdf","2004-04-20 00:00:00",
15457,2,21436,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21436slr006_abilify_lbl.pdf","2004-05-03 00:00:00",
21654,3,21436,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021436Orig1s007.pdf","2013-08-06 00:00:00",
27766,1,21436,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021713s004,021436s007ltr.pdf","2005-06-23 00:00:00",
36914,2,21436,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf","2005-06-23 00:00:00",
15458,2,21436,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf","2005-03-03 00:00:00",
27767,1,21436,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf","2005-03-03 00:00:00",
27768,1,21436,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s010,021713s006ltr.pdf","2006-02-22 00:00:00",
36915,2,21436,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf","2006-02-22 00:00:00",
27769,1,21436,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf","2006-10-23 00:00:00",
36916,2,21436,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf","2006-10-23 00:00:00",
5362,1,21436,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s014, 021713s009ltr.pdf","2006-09-20 00:00:00",
36917,2,21436,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf","2006-09-20 00:00:00",
5363,1,21436,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf","2007-10-04 00:00:00",
36918,2,21436,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf","2007-09-26 00:00:00",
27770,1,21436,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf","2007-11-08 00:00:00",
36919,2,21436,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf","2007-11-07 00:00:00",
42160,3,21436,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436Orig1s017.pdf","2012-03-14 00:00:00",
51237,23,21436,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436_aripiprazole_Abilify_WR21103rev2_dw.pdf","2003-02-11 00:00:00",
15459,2,21436,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf","2007-11-19 00:00:00",
21655,3,21436,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018TOC.cfm","2009-08-20 00:00:00",
24197,21,21436,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018_SumR.pdf","2009-08-20 00:00:00",
27771,1,21436,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf","2007-11-19 00:00:00",
5364,1,21436,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf","2008-05-14 00:00:00",
24198,21,21436,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
42161,3,21436,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021436Orig1s019_s020_s022.pdf","2012-01-27 00:00:00",
24199,21,21436,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
27772,1,21436,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf","2008-05-14 00:00:00",
42162,3,21436,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/021436Orig1s019_s020_s022.pdf","2012-01-27 00:00:00",
5365,1,21436,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf","2008-02-29 00:00:00",
15460,2,21436,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf","2008-02-28 00:00:00",
51236,23,21436,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436_aripiprazole_Abilify_WR21103rev2_dw.pdf","2003-02-11 00:00:00",
24200,21,21436,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
27773,1,21436,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf","2008-05-14 00:00:00",
42163,3,21436,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/021436Orig1s019_s020_s022.pdf","2012-01-27 00:00:00",
5366,1,21436,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf","2008-03-07 00:00:00",
5367,1,21436,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf","2008-08-19 00:00:00",
15461,2,21436,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf","2008-08-26 00:00:00",
5368,1,21436,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s027ltr.pdf","2009-11-27 00:00:00",
15462,2,21436,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s027lbl.pdf","2009-11-23 00:00:00",
42164,3,21436,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021436Orig1s027.pdf","2014-06-16 00:00:00",
27774,1,21436,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf","2009-07-24 00:00:00",
36920,2,21436,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf","2009-07-23 00:00:00",
5369,1,21436,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf","2011-02-18 00:00:00",
36921,2,21436,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf","2011-02-24 00:00:00",
27775,1,21436,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pd","2010-12-03 00:00:00",
36922,2,21436,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf","2010-12-02 00:00:00",
5370,1,21436,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf","2010-12-07 00:00:00",
36923,2,21436,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf","2010-12-03 00:00:00",
5371,1,21436,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf","2011-03-08 00:00:00",
15463,2,21436,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf","2011-03-07 00:00:00",
27776,1,21436,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf","2012-02-27 00:00:00",
36924,2,21436,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf","2012-02-24 00:00:00",
15464,2,21436,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf","2014-06-10 00:00:00",
27777,1,21436,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf","2014-07-11 00:00:00",
51604,17,21436,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole statistical prea.pdf","1900-01-01 00:00:00",
51605,20,21436,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole clinical prea.pdf","1900-01-01 00:00:00",
15465,2,21436,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf","2013-08-09 00:00:00",
27778,1,21436,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf","2013-08-05 00:00:00",
21656,3,21436,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021436Orig1s038.pdf","2016-04-20 00:00:00",
27779,1,21436,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf","2014-12-15 00:00:00",
36925,2,21436,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf","2014-12-15 00:00:00",
15466,2,21436,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf","2016-01-22 00:00:00",
21657,3,21436,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021436Orig1s040.pdf","2016-07-28 00:00:00",
27780,1,21436,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf","2016-01-20 00:00:00",
45086,2,21436,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf","2016-08-18 00:00:00",
45238,1,21436,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf","2016-08-18 00:00:00",
45787,3,21436,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021436Orig1s041.pdf","2016-11-02 00:00:00",
47330,2,21436,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf","2017-02-24 00:00:00",
47424,1,21436,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf","2017-03-02 00:00:00",
49284,8,21436,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83","2017-08-08 00:00:00",
5372,1,21437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21437ltr.pdf","2002-09-27 00:00:00",
36926,2,21437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf","2002-09-27 00:00:00",
42165,3,21437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-437_Inspra.cfm","2004-06-07 00:00:00",
5373,1,21437,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21437se1-002ltr.pdf","2003-10-07 00:00:00",
15467,2,21437,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf","2003-10-10 00:00:00",
21658,3,21437,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm","2004-09-09 00:00:00",
5374,1,21437,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s005ltr.pdf","2008-02-04 00:00:00",
36927,2,21437,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf","2008-01-31 00:00:00",
51713,23,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437_eplerenone_WR81704_BPCA.pdf","2004-08-17 00:00:00",
51714,25,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437_eplerenone_WR32103_BPCA.pdf","2003-03-21 00:00:00",
51715,26,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437_eplerenone_WR100104_BPCA.pdf","2004-10-01 00:00:00",
51716,27,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437_eplerenone_WR6706_BPCA.pdf","2006-06-07 00:00:00",
51717,55,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437s005_eplerenone_WR_BPCA.pdf","2007-10-19 00:00:00",
52934,17,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437S005_Eplerenone_Statistical_BPCA.pdf","2007-10-19 00:00:00",
52935,18,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437S005_Eplerenone_Clinpharm_BPCA.pdf","2007-10-19 00:00:00",
52936,20,21437,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021437S005_Eplerenone_Clinical_BPCA.pdf","2007-10-19 00:00:00",
15468,2,21437,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf","2008-05-19 00:00:00",
27781,1,21437,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s006ltr.pdf","2008-05-09 00:00:00",
5375,1,21437,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.pdf","2012-07-13 00:00:00",
5376,1,21437,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf","2012-06-26 00:00:00",
15469,2,21437,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf","2012-07-13 00:00:00",
15470,2,21437,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf","2012-06-26 00:00:00",
15471,2,21437,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf","2013-05-21 00:00:00",
27782,1,21437,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021437Orig1s011ltr.pdf","2013-05-21 00:00:00",
5377,1,21437,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021437Orig1s013ltr.pdf","2016-05-05 00:00:00",
36928,2,21437,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf","2016-05-05 00:00:00",
54384,1,21437,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021437Orig1s015ltr.pdf","2018-05-31 00:00:00",
54393,2,21437,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf","2018-05-31 00:00:00",
27783,1,21438,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21438ltr.pdf","2003-04-15 00:00:00",
36929,2,21438,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf","2004-06-07 00:00:00",
42166,3,21438,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran.cfm","2003-07-08 00:00:00",
5378,1,21438,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21438s005ltr.pdf","2004-10-29 00:00:00",
5379,1,21438,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021438s01ltr_rc.pdf","2008-01-09 00:00:00",
36930,2,21438,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf","2008-01-08 00:00:00",
5380,1,21438,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021438s012ltr.pdf","2010-01-05 00:00:00",
15472,2,21438,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf","2010-01-12 00:00:00",
27784,1,21438,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf","2010-12-21 00:00:00",
36931,2,21438,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf","2010-12-16 00:00:00",
5381,1,21438,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf","2010-12-21 00:00:00",
15473,2,21438,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf","2010-12-16 00:00:00",
27785,1,21438,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021438Orig1s016ltr.pdf","2013-11-20 00:00:00",
36932,2,21438,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf","2013-11-22 00:00:00",
21659,3,21440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm","2004-04-12 00:00:00",
27786,1,21440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323se8-001and21440ltr.pdf","2002-08-29 00:00:00",
36933,2,21440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf","2004-06-08 00:00:00",
44123,10,21440,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053342.htm","2005-07-29 00:00:00",
5382,1,21441,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21441slr001ltr.pdf","2004-07-14 00:00:00",
27787,1,21441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil%20Allergy-Sinus_Approv.pdf","2004-05-26 00:00:00",
36934,2,21441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21441_Advil_lbl.pdf","2003-04-09 00:00:00",
36935,2,21441,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21441slr001_advil_lbl.pdf","2004-07-14 00:00:00",
42167,3,21441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil.cfm","2004-04-21 00:00:00",
5383,1,21441,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021441s005ltr.pdf","2006-03-01 00:00:00",
27788,1,21441,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021441s008ltr.pdf","2008-06-24 00:00:00",
27789,1,21441,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021441s009ltr.pdf","2009-05-27 00:00:00",
5384,1,21441,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021441s011ltr.pdf","2010-09-07 00:00:00",
48048,2,21441,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021441Orig1s012lbl.pdf","2017-04-17 00:00:00",
48058,1,21441,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021441Orig1s012ltr.pdf","2017-04-18 00:00:00",
15474,2,21443,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf","2004-05-19 00:00:00",
27790,1,21443,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21443ltr.pdf","2004-05-26 00:00:00",
42168,3,21443,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021443s000_EnjuviaTOC.cfm","2006-07-27 00:00:00",
15475,2,21443,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf","2007-04-25 00:00:00",
27791,1,21443,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s004ltr.pdf","2007-05-01 00:00:00",
27792,1,21443,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s005ltr.pdf","2007-05-01 00:00:00",
27793,1,21443,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021443Orig1s009ltr.pdf","2015-07-09 00:00:00",
36936,2,21443,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf","2015-07-01 00:00:00",
50271,2,21443,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021443s010lbl.pdf","2017-11-02 00:00:00",
23661,10,21444,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-20 00:00:00",
27794,1,21444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444ltr.pdf","2003-05-29 00:00:00",
36937,2,21444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021444lbl.pdf","2003-04-07 00:00:00",
42169,3,21444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021444_risperdal.cfm","2003-07-15 00:00:00",
5385,1,21444,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
36938,2,21444,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
15476,2,21444,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf","2003-12-11 00:00:00",
27795,1,21444,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf","2003-12-11 00:00:00",
5386,1,21444,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf","2003-09-25 00:00:00",
42170,3,21444,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021444_S004_RISPERDAL_TABLETS.pdf","2008-02-19 00:00:00",
5387,1,21444,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf","2003-11-28 00:00:00",
27796,1,21444,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf","2003-11-25 00:00:00",
15477,2,21444,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
27797,1,21444,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
42171,3,21444,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
5388,1,21444,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21444s012ltr.pdf","2004-12-29 00:00:00",
15478,2,21444,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21444s012lbl.pdf","2004-12-29 00:00:00",
5389,1,21444,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf","2006-10-18 00:00:00",
15479,2,21444,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf","2006-10-11 00:00:00",
21660,3,21444,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf","2013-06-03 00:00:00",
5390,1,21444,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf","2005-08-19 00:00:00",
36939,2,21444,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf","2005-08-19 00:00:00",
5391,1,21444,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
21661,3,21444,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
36940,2,21444,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
15480,2,21444,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf","2007-08-23 00:00:00",
27798,1,21444,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf","2007-08-22 00:00:00",
42172,3,21444,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm","2011-12-14 00:00:00",
27799,1,21444,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf","2008-08-19 00:00:00",
5392,1,21444,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
36941,2,21444,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf","2010-08-30 00:00:00",
27800,1,21444,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf","2009-08-06 00:00:00",
36942,2,21444,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf","2009-07-21 00:00:00",
5393,1,21444,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
36943,2,21444,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf","2010-08-30 00:00:00",
15481,2,21444,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf","2011-08-25 00:00:00",
27801,1,21444,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf","2011-08-26 00:00:00",
15482,2,21444,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
27802,1,21444,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
5394,1,21444,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
36944,2,21444,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf","2010-08-30 00:00:00",
15483,2,21444,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf","2010-08-30 00:00:00",
27803,1,21444,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf","2010-09-07 00:00:00",
15484,2,21444,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf","2010-12-04 00:00:00",
27804,1,21444,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf","2010-12-06 00:00:00",
27805,1,21444,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf","2011-06-17 00:00:00",
36945,2,21444,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf","2011-06-16 00:00:00",
5395,1,21444,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf","2012-08-03 00:00:00",
36946,2,21444,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf","2012-08-03 00:00:00",
5396,1,21444,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf","2011-09-28 00:00:00",
36947,2,21444,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf","2011-09-30 00:00:00",
5397,1,21444,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf","2012-03-13 00:00:00",
15485,2,21444,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf","2014-04-29 00:00:00",
27806,1,21444,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf","2014-05-09 00:00:00",
5398,1,21444,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
15486,2,21444,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf","2016-03-03 00:00:00",
47318,2,21444,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf","2017-02-24 00:00:00",
47422,1,21444,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf","2017-03-02 00:00:00",
55052,1,21444,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf","2018-07-30 00:00:00",
55146,2,21444,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf","2018-08-09 00:00:00",
15487,2,21445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf","2002-10-25 00:00:00",
21662,3,21445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm","2003-02-03 00:00:00",
21663,3,21445,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf","2008-02-19 00:00:00",
27807,1,21445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21445ltr.pdf","2002-10-25 00:00:00",
27808,1,21445,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf","2004-07-28 00:00:00",
36948,2,21445,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf","2004-07-28 00:00:00",
44124,10,21445,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079524.htm","2008-01-25 00:00:00",
53276,20,21445,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021445_Ezetimibe_Clinical_BPCA_rev2_cd_SPONSOR_REVISED_7-16-08.pdf","1900-01-01 00:00:00",
53277,18,21445,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021445_Ezetimibe_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53278,17,21445,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021445_Ezetimibe_Statistical_BPCA.pdf","1900-01-01 00:00:00",
15488,2,21445,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf","2004-07-28 00:00:00",
27809,1,21445,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf","2004-07-28 00:00:00",
42173,3,21445,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf","2008-02-19 00:00:00",
5399,1,21445,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf","2004-07-28 00:00:00",
21664,3,21445,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf","2008-02-19 00:00:00",
36949,2,21445,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf","2004-07-28 00:00:00",
27810,1,21445,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s006ltr.pdf","2004-09-27 00:00:00",
27811,1,21445,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s007ltr.pdf","2005-03-10 00:00:00",
36950,2,21445,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf","2005-03-10 00:00:00",
5400,1,21445,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s011ltr.pdf","2005-03-29 00:00:00",
15489,2,21445,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf","2005-03-29 00:00:00",
5401,1,21445,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf","2006-03-23 00:00:00",
15490,2,21445,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf","2006-03-22 00:00:00",
5402,1,21445,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s013LTR.pdf","2006-05-25 00:00:00",
36951,2,21445,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf","2006-05-24 00:00:00",
5403,1,21445,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s014ltr.pdf","2006-01-30 00:00:00",
36952,2,21445,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf","2006-01-27 00:00:00",
5404,1,21445,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf","2006-03-23 00:00:00",
36953,2,21445,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf","2006-03-22 00:00:00",
5405,1,21445,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s016ltr.pdf","2006-11-06 00:00:00",
15491,2,21445,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf","2006-11-06 00:00:00",
15492,2,21445,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf","2007-12-14 00:00:00",
27812,1,21445,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021445s018ltr.pdf","2008-01-09 00:00:00",
5406,1,21445,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s019ltr.pdf","2008-02-13 00:00:00",
15493,2,21445,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf","2008-02-14 00:00:00",
27813,1,21445,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf","2008-06-09 00:00:00",
36954,2,21445,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf","2008-06-12 00:00:00",
51734,25,21445,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021445_Ezetimibe_Amendment 1_WR.pdf","2004-11-23 00:00:00",
5407,1,21445,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf","2008-06-09 00:00:00",
15494,2,21445,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf","2008-06-12 00:00:00",
5408,1,21445,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s025ltr.pdf","2009-02-04 00:00:00",
36955,2,21445,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf","2009-02-04 00:00:00",
5409,1,21445,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf","2009-11-25 00:00:00",
15495,2,21445,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf","2009-07-23 00:00:00",
15496,2,21445,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf","2009-07-23 00:00:00",
27814,1,21445,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf","2009-11-25 00:00:00",
5410,1,21445,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021445s030ltr.pdf","2011-08-12 00:00:00",
15497,2,21445,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf","2011-08-12 00:00:00",
15498,2,21445,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf","2012-01-25 00:00:00",
27815,1,21445,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021445s033ltr.pdf","2012-01-30 00:00:00",
27816,1,21445,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021445Orig1s037ltr.pdf","2014-10-14 00:00:00",
36956,2,21445,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf","2014-10-30 00:00:00",
21665,3,21446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm","2005-07-18 00:00:00",
24148,16,21446,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2005-11-30 00:00:00",
27817,1,21446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21446ltr.pdf","2005-01-11 00:00:00",
15499,2,21446,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf","2006-02-22 00:00:00",
27818,1,21446,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf","2006-03-01 00:00:00",
5411,1,21446,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf","2006-03-01 00:00:00",
36957,2,21446,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf","2006-02-22 00:00:00",
27819,1,21446,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s006ltr.pdf","2006-11-06 00:00:00",
5412,1,21446,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021446s010ltr.pdf","2007-07-05 00:00:00",
36958,2,21446,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf","2007-06-27 00:00:00",
5413,1,21446,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf","2009-05-04 00:00:00",
15500,2,21446,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf","2009-05-12 00:00:00",
27820,1,21446,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf","2009-05-04 00:00:00",
36959,2,21446,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf","2009-05-12 00:00:00",
5414,1,21446,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf","2010-01-06 00:00:00",
36960,2,21446,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf","2010-01-08 00:00:00",
5415,1,21446,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021446s021ltr.pdf","2010-10-19 00:00:00",
36961,2,21446,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf","2010-10-25 00:00:00",
27821,1,21446,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf","2011-04-29 00:00:00",
36962,2,21446,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf","2011-04-29 00:00:00",
15501,2,21446,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf","2011-04-29 00:00:00",
27822,1,21446,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf","2011-04-29 00:00:00",
27823,1,21446,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf","2011-08-26 00:00:00",
36963,2,21446,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf","2011-08-30 00:00:00",
5416,1,21446,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf","2011-06-29 00:00:00",
15502,2,21446,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf","2011-07-07 00:00:00",
5417,1,21446,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021446s028ltr.pdf","2012-06-21 00:00:00",
21666,3,21446,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.cfm","2012-07-06 00:00:00",
24201,21,21446,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028SumR.pdf","2012-07-06 00:00:00",
36964,2,21446,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf","2012-06-21 00:00:00",
15503,2,21446,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf","2013-12-24 00:00:00",
27824,1,21446,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf","2013-12-26 00:00:00",
27825,1,21446,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf","2016-03-11 00:00:00",
36965,2,21446,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf","2016-03-15 00:00:00",
46515,2,21446,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf","2016-12-22 00:00:00",
46528,1,21446,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s032, 022488Orig1s011ltr.pdf","2016-12-23 00:00:00",
50038,8,21446,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf#page=50","2017-10-12 00:00:00",
51599,20,21446,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/56_21446 22488 pregabalin clinical prea.pdf","1900-01-01 00:00:00",
51600,18,21446,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/57_21446 22488 pregabalin clinpharm prea.pdf","1900-01-01 00:00:00",
51601,17,21446,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/58_21446 22488 pregabalin statistical prea.pdf","1900-01-01 00:00:00",
54022,2,21446,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf","2018-05-04 00:00:00",
54023,8,21446,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54","2018-05-04 00:00:00",
54039,1,21446,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021446Orig1s035,022488Orig1s013ltr.pdf","2018-05-08 00:00:00",
15504,2,21447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21447lbl.pdf","2002-08-29 00:00:00",
21667,3,21447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-447_Zanaflex.cfm","2004-03-24 00:00:00",
27826,1,21447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21447ltr.pdf","2003-05-30 00:00:00",
5418,1,21447,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf","2006-08-04 00:00:00",
15505,2,21447,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf","2006-08-04 00:00:00",
5419,1,21447,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s005ltr.pdf","2013-03-11 00:00:00",
27827,1,21447,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s011,020397Orig1s026ltr.pdf","2013-11-08 00:00:00",
36966,2,21447,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf","2013-11-08 00:00:00",
5420,1,21449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21449ltr.pdf","2002-09-20 00:00:00",
15506,2,21449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21449lbl.pdf","2002-09-20 00:00:00",
21668,3,21449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-449_Hepsera.cfm","2004-06-07 00:00:00",
53157,20,21449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021449S011_Adefovir_Clinical_Review_BPCA.pdf","1900-01-01 00:00:00",
53158,18,21449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021449S011_Adefovir_Clinpharm_Review_BPCA.pdf","1900-01-01 00:00:00",
53159,17,21449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021449S011_Adefovir_Statistical_Review_BPCA.pdf","1900-01-01 00:00:00",
5421,1,21449,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21449s003ltr.pdf","2004-08-25 00:00:00",
15507,2,21449,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21449s003lbl.pdf","2004-08-25 00:00:00",
27828,1,21449,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s005LTR.pdf","2006-05-02 00:00:00",
36967,2,21449,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s005lbl.pdf","2006-05-02 00:00:00",
15508,2,21449,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s006lbl.pdf","2006-10-23 00:00:00",
27829,1,21449,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s006ltr.pdf","2006-10-23 00:00:00",
27830,1,21449,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s009ltr.pdf","2006-09-25 00:00:00",
36968,2,21449,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s009lbl.pdf","2006-09-21 00:00:00",
5422,1,21449,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021449s011ltr.pdf","2008-01-09 00:00:00",
15509,2,21449,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021449s011lbl.pdf","2007-12-27 00:00:00",
5423,1,21449,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021449s016ltr.pdf","2009-11-25 00:00:00",
36969,2,21449,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021449s016lbl.pdf","2009-10-21 00:00:00",
15510,2,21449,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s018lbl.pdf","2012-03-01 00:00:00",
27831,1,21449,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449s018ltr.pdf","2012-03-02 00:00:00",
5424,1,21449,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449Orig1s020ltr.pdf","2012-11-30 00:00:00",
36970,2,21449,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s020lbl.pdf","2012-11-30 00:00:00",
5425,1,21450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21450ltr.pdf","2003-09-30 00:00:00",
5426,1,21450,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21450slr001ltr.pdf","2004-07-06 00:00:00",
15511,2,21450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21450_zomig_lbl.pdf","2003-10-10 00:00:00",
21669,3,21450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-450_Zomig.cfm","2005-04-15 00:00:00",
23662,10,21450,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm","2007-01-17 00:00:00",
51499,20,21450,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21450 zolmitriptan clinical prea.pdf","1900-01-01 00:00:00",
51500,17,21450,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21450 zolmitriptan statistical prea.pdf","1900-01-01 00:00:00",
53447,20,21450,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021450s005_Zolmitriptan_Clinical_PREA.pdf","1900-01-01 00:00:00",
53448,18,21450,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021450s005_Zolmitriptan_Clinpharm.pdf","1900-01-01 00:00:00",
53449,17,21450,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21450s005_Zolmitriptan_Statistical.pdf","1900-01-01 00:00:00",
5427,1,21450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021450s005ltr.pdf","2008-10-21 00:00:00",
27832,1,21450,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021450Orig1s007ltr.pdf","2013-09-17 00:00:00",
36971,2,21450,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021450s007lbl.pdf","2013-09-16 00:00:00",
5428,1,21450,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021450Orig1s008ltr.pdf","2015-06-16 00:00:00",
36972,2,21450,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021450s008lbl.pdf","2015-06-15 00:00:00",
5429,1,21451,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21451ltr.pdf","2003-12-23 00:00:00",
15512,2,21451,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf","2003-12-29 00:00:00",
42174,3,21451,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021451s000_OraqixTOC.cfm","2006-09-07 00:00:00",
5430,1,21451,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s005ltr.pdf","2010-04-20 00:00:00",
36973,2,21451,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s005lbl.pdf","2010-04-19 00:00:00",
27833,1,21451,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s007ltr.pdf","2010-09-29 00:00:00",
36974,2,21451,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s007lbl.pdf","2010-09-27 00:00:00",
27834,1,21451,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021451Orig1s008ltr.pdf","2012-08-10 00:00:00",
36975,2,21451,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021451s008lbl.pdf","2012-08-09 00:00:00",
5431,1,21453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21453ltr.pdf","2002-12-31 00:00:00",
21670,3,21453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021453_s000_ZeritTOC.cfm","2006-06-08 00:00:00",
36976,2,21453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf","2003-04-09 00:00:00",
5432,1,21453,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21453slr003ltr.pdf","2004-06-07 00:00:00",
36977,2,21453,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf","2004-06-07 00:00:00",
27835,1,21453,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21453s004ltr.pdf","2005-01-21 00:00:00",
36978,2,21453,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf","2005-01-21 00:00:00",
5433,1,21454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21454ltr.pdf","2002-10-31 00:00:00",
15513,2,21454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf","2002-10-31 00:00:00",
23266,8,21454,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188475.pdf","2009-10-30 00:00:00",
24000,14,21454,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=56","2015-07-07 00:00:00",
42175,3,21454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-454_Testim.cfm","2005-01-11 00:00:00",
5434,1,21454,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021454s008ltr.pdf","2009-10-26 00:00:00",
15514,2,21454,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf","2009-10-01 00:00:00",
27836,1,21454,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021454s014ltr.pdf","2011-11-28 00:00:00",
36979,2,21454,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf","2011-11-30 00:00:00",
27837,1,21454,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021454Orig1s016ltr.pdf","2013-09-04 00:00:00",
36980,2,21454,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf","2013-09-09 00:00:00",
27838,1,21454,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s020ltr.pdf","2014-05-06 00:00:00",
15515,2,21454,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf","2014-06-23 00:00:00",
27839,1,21454,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s021ltr.pdf","2014-06-23 00:00:00",
5435,1,21454,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021454Orig1s023ltr.pdf","2015-05-12 00:00:00",
15516,2,21454,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf","2015-05-13 00:00:00",
45673,1,21454,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021454Orig1s024ltr.pdf","2016-10-27 00:00:00",
45747,2,21454,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021454s024lbl.pdf","2016-11-01 00:00:00",
5436,1,21455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21455ltr.pdf","2003-06-08 00:00:00",
5437,1,21455,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21455s001ltr.pdf","2005-03-28 00:00:00",
15517,2,21455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf","2003-05-29 00:00:00",
15518,2,21455,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf","2005-03-25 00:00:00",
23072,6,21455,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001ppi.pdf","2005-03-25 00:00:00",
42176,3,21455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-455_Boniva.cfm","2003-07-02 00:00:00",
44125,10,21455,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2003-12-09 00:00:00",
5438,1,21455,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021455s003LTR.pdf","2006-06-20 00:00:00",
15519,2,21455,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf","2007-02-21 00:00:00",
27840,1,21455,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021455s005ltr.pdf","2007-02-23 00:00:00",
27841,1,21455,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021455s007ltr.pdf","2008-11-28 00:00:00",
42177,3,21455,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021455Orig1s007.pdf","2015-03-11 00:00:00",
5439,1,21455,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021455s009ltr.pdf","2010-01-15 00:00:00",
15520,2,21455,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf","2010-01-08 00:00:00",
15521,2,21455,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf","2011-01-31 00:00:00",
27842,1,21455,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s011ltr.pdf","2011-02-02 00:00:00",
27843,1,21455,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s013ltr.pdf","2011-07-06 00:00:00",
5440,1,21455,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf","2013-04-24 00:00:00",
15522,2,21455,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf","2013-04-23 00:00:00",
27844,1,21455,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf","2013-04-24 00:00:00",
36981,2,21455,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf","2013-04-23 00:00:00",
27845,1,21455,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021455Orig1s018ltr.pdf","2014-12-18 00:00:00",
36982,2,21455,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf","2014-12-19 00:00:00",
15523,2,21455,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf","2015-03-24 00:00:00",
27846,1,21455,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s019ltr.pdf","2015-03-19 00:00:00",
5441,1,21455,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s020ltr.pdf","2015-04-13 00:00:00",
36983,2,21455,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf","2015-04-10 00:00:00",
46095,2,21455,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf","2016-12-07 00:00:00",
46097,8,21455,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19","2016-12-08 00:00:00",
46098,1,21455,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021455Orig1s021ltr.pdf","2016-12-08 00:00:00",
5442,1,21456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf","2004-05-25 00:00:00",
21671,3,21456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm","2003-04-25 00:00:00",
23663,10,21456,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
36984,2,21456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf","2004-05-25 00:00:00",
5443,1,21457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21457ltr.pdf","2004-11-08 00:00:00",
5444,1,21457,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s001ltr.pdf","2005-05-04 00:00:00",
21672,3,21457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.cfm","2007-04-30 00:00:00",
36985,2,21457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf","2004-11-08 00:00:00",
36986,2,21457,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf","2005-05-04 00:00:00",
27847,1,21457,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf","2005-11-30 00:00:00",
36987,2,21457,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf","2005-11-30 00:00:00",
23958,12,21457,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021457s003Exclultr.pdf","2006-02-08 00:00:00",
36988,2,21457,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf","2007-01-17 00:00:00",
5445,1,21457,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf","2005-11-30 00:00:00",
36989,2,21457,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf","2005-11-30 00:00:00",
27848,1,21457,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021457s013ltr.pdf","2008-09-17 00:00:00",
36990,2,21457,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf","2008-09-19 00:00:00",
5446,1,21457,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s021ltr.pdf","2010-08-20 00:00:00",
15524,2,21457,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf","2010-08-19 00:00:00",
27849,1,21457,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s022ltr.pdf","2010-12-15 00:00:00",
15525,2,21457,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf","2012-11-29 00:00:00",
5447,1,21460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21460ltr.pdf","2002-10-21 00:00:00",
36991,2,21460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21460lbl.pdf","2002-10-21 00:00:00",
42178,3,21460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021460_metaglip.cfm","2003-04-30 00:00:00",
27850,1,21460,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021460s005ltr.pdf","2007-07-05 00:00:00",
36992,2,21460,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021460s005lbl.pdf","2007-06-27 00:00:00",
27851,1,21460,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021460s007ltr.pdf","2008-08-20 00:00:00",
36993,2,21460,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021460s007lbl.pdf","2008-08-26 00:00:00",
27852,1,21460,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021460s008ltr.pdf","2009-11-25 00:00:00",
36994,2,21460,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021460s008lbl.pdf","2009-09-18 00:00:00",
15526,2,21460,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021460s009lbl.pdf","2011-02-04 00:00:00",
27853,1,21460,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021460s009ltr.pdf","2011-02-03 00:00:00",
5448,1,21460,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021460Orig1s010ltr.pdf","2013-10-16 00:00:00",
36995,2,21460,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021460s010lbl.pdf","2013-10-22 00:00:00",
5449,1,21462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf","2004-02-05 00:00:00",
5450,1,21462,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf","2004-08-25 00:00:00",
15527,2,21462,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf","2004-08-19 00:00:00",
23073,6,21462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462ppilbl.pdf","2004-02-05 00:00:00",
23664,10,21462,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110261.htm","2005-04-15 00:00:00",
36996,2,21462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf","2004-02-05 00:00:00",
42179,3,21462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-462_Alimta.cfm","2004-03-28 00:00:00",
44477,14,21462,"ORIG",1,"Questions and Answers","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110262.htm","2004-02-05 00:00:00",
53389,20,21462,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21462 pemetrexed clinical bpca.pdf","1900-01-01 00:00:00",
53390,18,21462,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21462 pemetrexed clinpharm bpca.pdf","1900-01-01 00:00:00",
53391,17,21462,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21462 pemetrexed statistical bpca.pdf","1900-01-01 00:00:00",
15528,2,21462,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf","2006-08-04 00:00:00",
27854,1,21462,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021462s004LTR.pdf","2006-08-04 00:00:00",
27855,1,21462,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s006ltr.pdf","2007-02-12 00:00:00",
36997,2,21462,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf","2007-02-21 00:00:00",
15529,2,21462,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf","2007-09-11 00:00:00",
27856,1,21462,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s012ltr.pdf","2007-09-11 00:00:00",
27857,1,21462,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021462s015ltr.pdf","2008-10-01 00:00:00",
36998,2,21462,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf","2008-09-26 00:00:00",
42180,3,21462,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021462s015.pdf","2011-09-22 00:00:00",
15530,2,21462,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf","2009-07-09 00:00:00",
27858,1,21462,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf","2009-07-08 00:00:00",
27859,1,21462,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf","2009-07-08 00:00:00",
36999,2,21462,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf","2009-07-06 00:00:00",
5451,1,21462,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf","2009-07-08 00:00:00",
37000,2,21462,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf","2009-07-09 00:00:00",
27860,1,21462,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf","2011-11-22 00:00:00",
37001,2,21462,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf","2011-11-23 00:00:00",
5452,1,21462,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf","2011-11-22 00:00:00",
37002,2,21462,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf","2011-11-25 00:00:00",
5453,1,21462,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf","2011-11-22 00:00:00",
15531,2,21462,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf","2011-11-25 00:00:00",
5454,1,21462,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s033ltr.pdf","2011-03-23 00:00:00",
37003,2,21462,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf","2011-03-21 00:00:00",
5455,1,21462,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s039ltr.pdf","2012-10-18 00:00:00",
15532,2,21462,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf","2012-10-17 00:00:00",
15533,2,21462,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf","2012-06-05 00:00:00",
27861,1,21462,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462s040ltr.pdf","2012-06-07 00:00:00",
37004,2,21462,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf","2013-01-22 00:00:00",
27862,1,21462,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s043ltr.pdf","2012-11-14 00:00:00",
37005,2,21462,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf","2012-11-15 00:00:00",
5456,1,21462,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf","2013-09-13 00:00:00",
15534,2,21462,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf","2013-09-17 00:00:00",
50019,2,21462,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf","2017-10-12 00:00:00",
50020,1,21462,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021462Orig1s050ltr.pdf","2017-10-12 00:00:00",
54436,2,21462,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf","2018-06-05 00:00:00",
54438,1,21462,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s051ltr.pdf","2018-06-05 00:00:00",
53756,1,21462,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s052ltr.pdf","2018-04-20 00:00:00",
5457,1,21463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021463s000ltr.pdf","2011-01-07 00:00:00",
21673,3,21463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm","2011-09-16 00:00:00",
23268,8,21463,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239932.pdf","2011-01-13 00:00:00",
24202,21,21463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463Orig1s000SumR.pdf","2011-09-16 00:00:00",
37006,2,21463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021463s000lbl.pdf","2011-01-11 00:00:00",
44478,14,21463,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=20","2011-01-07 00:00:00",
15535,2,21463,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf","2013-09-11 00:00:00",
27863,1,21463,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021463Orig1s010ltr.pdf","2013-09-11 00:00:00",
27864,1,21463,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s012ltr.pdf","2014-03-25 00:00:00",
37007,2,21463,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf","2014-03-25 00:00:00",
15536,2,21463,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf","2014-06-23 00:00:00",
27865,1,21463,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s014ltr.pdf","2014-06-23 00:00:00",
27866,1,21463,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s015ltr.pdf","2014-08-01 00:00:00",
27867,1,21463,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021463Orig1s017ltr.pdf","2015-05-13 00:00:00",
37008,2,21463,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf","2015-05-13 00:00:00",
45761,2,21463,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s018lbl.pdf","2016-11-01 00:00:00",
45674,1,21463,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021463Orig1s019ltr.pdf","2016-10-27 00:00:00",
45754,2,21463,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s019lbl.pdf","2016-11-01 00:00:00",
27868,1,21464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21464,21466ltr.pdf","2003-11-25 00:00:00",
37009,2,21464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021466lbl.pdf","2003-12-02 00:00:00",
42181,3,21464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021464s000_021466s000_VfendTOC.cfm","2005-10-06 00:00:00",
15537,2,21466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021466lbl.pdf","2003-12-08 00:00:00",
27869,1,21466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21464,21466ltr.pdf","2003-11-25 00:00:00",
42182,3,21466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021464s000_021466s000_VfendTOC.cfm","2005-11-07 00:00:00",
5458,1,21468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21468ltr.pdf","2004-10-29 00:00:00",
15538,2,21468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21468lbl.pdf","2004-11-01 00:00:00",
21674,3,21468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-468_Fosrenol.cfm","2005-01-28 00:00:00",
21675,3,21468,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s004_fosrenol.pdf","2011-01-04 00:00:00",
27870,1,21468,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021468s005ltr.pdf","2006-03-23 00:00:00",
42183,3,21468,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s005_fosrenol.pdf","2011-01-04 00:00:00",
27871,1,21468,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s010ltr.pdf","2008-04-11 00:00:00",
5459,1,21468,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s011ltr.pdf","2008-10-28 00:00:00",
5460,1,21468,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf","2011-04-29 00:00:00",
15539,2,21468,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf","2011-04-29 00:00:00",
27872,1,21468,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf","2011-04-29 00:00:00",
37010,2,21468,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf","2011-04-29 00:00:00",
5461,1,21468,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s016ltr.pdf","2011-09-07 00:00:00",
15540,2,21468,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf","2011-09-07 00:00:00",
15541,2,21468,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018lbl.pdf","2012-11-02 00:00:00",
27873,1,21468,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021468Orig1s018ltr.pdf","2012-11-05 00:00:00",
43753,8,21468,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018mg.pdf","2012-11-02 00:00:00",
27874,1,21468,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021468Orig1s019ltr.pdf","2014-09-26 00:00:00",
37011,2,21468,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021468s019lbl.pdf","2014-09-26 00:00:00",
5462,1,21468,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021468Orig1s020,204734Orig1s001ltr.pdf","2016-02-26 00:00:00",
37012,2,21468,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf","2016-02-26 00:00:00",
5463,1,21470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea_Approv.pdf","2004-06-04 00:00:00",
21676,3,21470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea.cfm","2004-03-24 00:00:00",
37013,2,21470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021470lbl.pdf","2002-12-24 00:00:00",
5464,1,21470,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021470s003ltr.pdf","2005-05-17 00:00:00",
37014,2,21470,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021470s003lbl.pdf","2005-05-17 00:00:00",
15542,2,21470,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021470s005lbl.pdf","2010-10-25 00:00:00",
27875,1,21470,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021470s005ltr.pdf","2010-11-03 00:00:00",
15543,2,21470,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021470s007lbl.pdf","2013-01-07 00:00:00",
27876,1,21470,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021470Orig1s007ltr.pdf","2012-12-21 00:00:00",
5465,1,21470,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470Orig1s010ltr.pdf","2015-04-06 00:00:00",
15544,2,21470,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s010lbl.pdf","2015-04-07 00:00:00",
15545,2,21470,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s012lbl.pdf","2016-01-11 00:00:00",
27877,1,21470,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470s012ltr.pdf","2016-01-11 00:00:00",
45001,1,21470,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021470Orig1s013ltr.pdf","2016-08-05 00:00:00",
45022,2,21470,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021470s013lbl.pdf","2016-08-05 00:00:00",
5466,1,21471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021471s000LTR.pdf","2006-10-13 00:00:00",
21677,3,21471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021471s000TOC.cfm","2008-07-09 00:00:00",
37015,2,21471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021471lbl.pdf","2006-10-11 00:00:00",
5467,1,21471,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021471s004ltr.pdf","2008-01-23 00:00:00",
15546,2,21472,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21472slr001_ibuprofen_lbl.pdf","2004-02-03 00:00:00",
27878,1,21472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21472ltr.pdf","2002-10-18 00:00:00",
27879,1,21472,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21472slr001ltr.pdf","2004-02-02 00:00:00",
42184,3,21472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-472_Ibuprofen.cfm","2004-11-22 00:00:00",
15547,2,21472,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021472s005lbl.pdf","2006-03-14 00:00:00",
27880,1,21472,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021472s005ltr.pdf","2006-03-14 00:00:00",
27881,1,21472,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021472s006ltr.pdf","2006-01-19 00:00:00",
5468,1,21472,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021472s007ltr.pdf","2006-12-28 00:00:00",
27882,1,21472,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021472s011ltr.pdf","2009-02-23 00:00:00",
27883,1,21472,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021472s012ltr.pdf","2009-04-21 00:00:00",
5469,1,21472,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021472s013ltr.pdf","2010-05-03 00:00:00",
47574,2,21472,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021472Orig1s014lbl.pdf","2017-03-17 00:00:00",
47594,1,21472,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021472Orig1s014ltr.pdf","2017-03-20 00:00:00",
5470,1,21473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21473ltr.pdf","2002-12-13 00:00:00",
15548,2,21473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21473_ciproXR_lbl.pdf","2002-12-16 00:00:00",
24001,14,21473,"ORIG",1,"ReviewApproval","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021473Orig1s000Approv.pdf","2016-02-03 00:00:00",
42185,3,21473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-473_Cipro.cfm","2003-11-06 00:00:00",
21678,3,21473,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S005_CIPRO.pdf","2007-07-09 00:00:00",
27884,1,21473,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf","2004-07-21 00:00:00",
37016,2,21473,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf","2004-07-21 00:00:00",
5471,1,21473,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf","2004-07-21 00:00:00",
15549,2,21473,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf","2004-07-21 00:00:00",
21679,3,21473,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S006_CIPRO.pdf","2007-07-09 00:00:00",
21680,3,21473,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S007_CIPRO.pdf","2007-07-09 00:00:00",
27885,1,21473,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf","2004-07-21 00:00:00",
37017,2,21473,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf","2004-07-21 00:00:00",
21681,3,21473,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S009_CIPRO.pdf","2007-07-09 00:00:00",
27886,1,21473,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021473s009ltr.pdf","2005-05-20 00:00:00",
37018,2,21473,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021473s009lbl.pdf","2005-05-20 00:00:00",
27887,1,21473,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf","2005-11-18 00:00:00",
37019,2,21473,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf","2005-11-17 00:00:00",
42186,3,21473,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S013_CIPRO.pdf","2007-07-09 00:00:00",
5472,1,21473,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf","2007-07-05 00:00:00",
37020,2,21473,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021473s022lbl.pdf","2007-06-27 00:00:00",
5473,1,21473,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021473s023ltr.pdf","2008-01-23 00:00:00",
37021,2,21473,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021473s023lbl.pdf","2008-01-23 00:00:00",
5474,1,21473,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s049,020780s026,021473s024ltr.pdf","2008-10-07 00:00:00",
15550,2,21473,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf","2008-10-09 00:00:00",
5475,1,21473,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020780s028,021473s025ltr.pdf","2009-05-07 00:00:00",
15551,2,21473,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf","2009-05-11 00:00:00",
27888,1,21473,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf","2009-06-30 00:00:00",
5476,1,21473,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s027ltr.pdf","2011-11-21 00:00:00",
15552,2,21473,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s027lbl.pdf","2011-11-16 00:00:00",
27889,1,21473,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf","2011-03-02 00:00:00",
37022,2,21473,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf","2011-03-04 00:00:00",
27890,1,21473,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s031ltr.pdf","2011-06-15 00:00:00",
37023,2,21473,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s031lbl.pdf","2011-06-14 00:00:00",
5477,1,21473,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf","2011-08-08 00:00:00",
27891,1,21473,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf","2011-10-20 00:00:00",
37024,2,21473,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf","2011-11-04 00:00:00",
5478,1,21473,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s034ltr.pdf","2013-01-31 00:00:00",
37025,2,21473,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s034lbl.pdf","2013-02-01 00:00:00",
15553,2,21473,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s035lbl.pdf","2013-08-15 00:00:00",
27892,1,21473,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s035ltr.pdf","2013-08-16 00:00:00",
27893,1,21473,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021473Orig1s036ltr.pdf","2015-02-02 00:00:00",
37026,2,21473,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021473s036lbl.pdf","2015-02-03 00:00:00",
5479,1,21473,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf","2016-07-26 00:00:00",
15554,2,21473,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021473s037lbl.pdf","2016-07-26 00:00:00",
49089,2,21473,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021473s038lbl.pdf","2017-07-27 00:00:00",
49090,8,21473,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021473s038lbl.pdf#page=27","2017-07-27 00:00:00",
49109,1,21473,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021473Orig1s038ltr.pdf","2017-07-28 00:00:00",
21682,3,21475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021475s000_MethylinTOC.cfm","2006-07-25 00:00:00",
23665,10,21475,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
37027,2,21475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21475_methylin_lbl.pdf","2003-04-17 00:00:00",
5480,1,21475,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf","2006-08-14 00:00:00",
15555,2,21475,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf","2006-08-11 00:00:00",
5481,1,21475,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf","2007-06-14 00:00:00",
37028,2,21475,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf","2007-06-12 00:00:00",
5482,1,21475,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf","2010-10-20 00:00:00",
37029,2,21475,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021475s005lbl.pdf","2010-10-18 00:00:00",
5483,1,21475,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf","2013-06-18 00:00:00",
37030,2,21475,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s006lbl.pdf","2013-06-18 00:00:00",
15556,2,21475,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s007lbl.pdf","2013-12-17 00:00:00",
27894,1,21475,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf","2013-12-24 00:00:00",
5484,1,21475,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf","2015-04-20 00:00:00",
37031,2,21475,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf","2015-04-21 00:00:00",
46709,2,21475,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf","2017-01-06 00:00:00",
46831,1,21475,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021419Orig1s014,021475Orig1s010ltr.pdf","2017-01-13 00:00:00",
46832,8,21475,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf#page=13","2017-01-13 00:00:00",
5485,1,21476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021476ltr.pdf","2004-12-30 00:00:00",
15557,2,21476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf","2004-12-30 00:00:00",
42187,3,21476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta.cfm","2005-04-27 00:00:00",
43756,8,21476,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134691.pdf","2009-11-19 00:00:00",
44126,10,21476,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
5486,1,21476,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s005ltr.pdf","2008-01-30 00:00:00",
37032,2,21476,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf","2008-01-30 00:00:00",
5487,1,21476,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s008ltr.pdf","2008-01-30 00:00:00",
15558,2,21476,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf","2008-01-30 00:00:00",
5488,1,21476,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021476s012ltr.pdf","2009-04-10 00:00:00",
15559,2,21476,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf","2009-04-16 00:00:00",
5489,1,21476,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476s021ltr.pdf","2012-01-31 00:00:00",
5490,1,21476,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf","2012-10-12 00:00:00",
15560,2,21476,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf","2012-10-12 00:00:00",
5491,1,21476,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf","2012-10-12 00:00:00",
15561,2,21476,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf","2012-10-12 00:00:00",
51728,23,21476,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21476_eszopiclone_Original_WR.pdf","2006-08-02 00:00:00",
51729,25,21476,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21476_eszopiclone_Amendment_1.pdf","2010-04-13 00:00:00",
52483,20,21476,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21476 eszopiclone clinical bpca.pdf","1900-01-01 00:00:00",
52484,18,21476,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21476 eszopiclone clinpharm bpca.pdf","1900-01-01 00:00:00",
5492,1,21476,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s028ltr.pdf","2014-02-10 00:00:00",
15562,2,21476,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf","2014-02-06 00:00:00",
5493,1,21476,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s030ltr.pdf","2014-05-20 00:00:00",
37033,2,21476,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf","2014-05-16 00:00:00",
5494,1,21478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-478_Zovirax_Approv.pdf","2004-07-01 00:00:00",
37034,2,21478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21478_zovirax_lbl.pdf","2003-04-09 00:00:00",
42188,3,21478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-478_Zovirax.cfm","2003-07-08 00:00:00",
21683,3,21478,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021478_S003_Zovirax_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
27895,1,21478,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21478scp003ltr.pdf","2004-02-02 00:00:00",
5495,1,21478,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021478Orig1s007ltr.pdf","2014-04-03 00:00:00",
15563,2,21478,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021478s007lbl.pdf","2014-04-02 00:00:00",
53727,3,21478,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/21478Orig1s008.pdf","2018-04-18 00:00:00",
15564,2,21479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf","2006-06-20 00:00:00",
21684,3,21479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm","2009-01-15 00:00:00",
27896,1,21479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021479s000LTR.pdf","2006-06-20 00:00:00",
5496,1,21479,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf","2009-01-06 00:00:00",
15565,2,21479,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf","2009-01-06 00:00:00",
27897,1,21479,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf","2009-01-06 00:00:00",
37035,2,21479,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf","2009-01-06 00:00:00",
5497,1,21479,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021479Orig1s005ltr.pdf","2014-08-01 00:00:00",
15566,2,21479,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf","2014-08-19 00:00:00",
5498,1,21481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21481ltr.pdf","2003-03-20 00:00:00",
37036,2,21481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021481lbl.pdf","2003-03-18 00:00:00",
42189,3,21481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021481_fuzeon_review.cfm","2003-07-23 00:00:00",
27898,1,21481,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21481s002ltr.pdf","2004-10-18 00:00:00",
37037,2,21481,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21481s002lbl.pdf","2004-10-18 00:00:00",
5499,1,21481,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s006ltr.pdf","2005-07-08 00:00:00",
15567,2,21481,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s006lbl.pdf","2005-07-07 00:00:00",
5500,1,21481,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s007ltr.pdf","2005-08-16 00:00:00",
37038,2,21481,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s007lbl.pdf","2005-08-15 00:00:00",
27899,1,21481,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s010LTR.pdf","2006-10-02 00:00:00",
37039,2,21481,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s010lbl.pdf","2006-10-02 00:00:00",
5501,1,21481,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021481s011ltr.pdf","2007-01-25 00:00:00",
37040,2,21481,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021481s011lbl.pdf","2007-01-24 00:00:00",
27900,1,21481,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s012ltr.pdf","2006-12-28 00:00:00",
37041,2,21481,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s012lbl.pdf","2006-12-28 00:00:00",
5502,1,21481,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021481s015ltr.pdf","2008-12-24 00:00:00",
5503,1,21481,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021481s017ltr.pdf","2009-12-31 00:00:00",
37042,2,21481,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021481s017lbl.pdf","2010-01-04 00:00:00",
5504,1,21481,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021481s020ltr.pdf","2011-05-03 00:00:00",
37043,2,21481,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021481s020lbl.pdf","2011-04-29 00:00:00",
15568,2,21481,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021481s025lbl.pdf","2012-08-22 00:00:00",
27901,1,21481,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021481Orig1s025ltr.pdf","2012-08-15 00:00:00",
5505,1,21481,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021481Orig1s027ltr.pdf","2013-11-06 00:00:00",
37044,2,21481,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021481s027lbl.pdf","2013-11-01 00:00:00",
5506,1,21481,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021481Orig1s030ltr.pdf","2015-12-03 00:00:00",
15569,2,21481,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021481s030lbl.pdf","2015-12-08 00:00:00",
5507,1,21483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021483s000ltr.pdf","2006-04-05 00:00:00",
23666,10,21483,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2006-04-05 00:00:00",
42190,3,21483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021483s000TOC.cfm","2007-06-29 00:00:00",
5508,1,21483,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021483s003ltr.pdf","2009-11-24 00:00:00",
15570,2,21483,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021483s003lbl.pdf","2009-09-18 00:00:00",
15571,2,21483,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf","2010-12-04 00:00:00",
27902,1,21483,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf","2010-12-07 00:00:00",
27903,1,21483,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf","2013-07-05 00:00:00",
37045,2,21483,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf","2013-07-05 00:00:00",
27904,1,21483,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf","2013-03-05 00:00:00",
37046,2,21483,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf","2013-03-04 00:00:00",
5509,1,21483,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf","2013-08-16 00:00:00",
15572,2,21483,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf","2013-08-15 00:00:00",
15573,2,21483,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf","2014-12-11 00:00:00",
27905,1,21483,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf","2014-12-11 00:00:00",
5510,1,21483,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf","2015-08-24 00:00:00",
15574,2,21483,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf","2015-09-14 00:00:00",
47312,2,21483,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf","2017-02-24 00:00:00",
47418,1,21483,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020825Orig1s056,021483Orig1s015,020919Orig1s044ltr.pdf","2017-03-02 00:00:00",
15575,2,21484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21484_Bravelle_lbl.pdf","2003-04-09 00:00:00",
21685,3,21484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021484_bravelle.cfm","2003-05-08 00:00:00",
27906,1,21484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-484_Bravelle_Approv.pdf","2004-05-28 00:00:00",
5511,1,21485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21485ltr.pdf","2003-06-22 00:00:00",
15576,2,21485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21485_stalevo_lbl.pdf","2003-06-22 00:00:00",
21686,3,21485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm","2004-03-24 00:00:00",
44127,10,21485,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206513.htm","2010-08-09 00:00:00",
15577,2,21485,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf","2009-02-04 00:00:00",
15578,2,21485,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf","2009-03-23 00:00:00",
27907,1,21485,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf","2009-03-05 00:00:00",
27908,1,21485,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf","2009-02-03 00:00:00",
15579,2,21485,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021485s011lbl.pdf","2007-08-03 00:00:00",
27909,1,21485,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/0214855s011ltr.pdf","2007-08-07 00:00:00",
5512,1,21485,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf","2009-03-05 00:00:00",
5513,1,21485,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf","2009-02-03 00:00:00",
37047,2,21485,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf","2009-02-04 00:00:00",
37048,2,21485,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf","2009-03-23 00:00:00",
5514,1,21485,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s016ltr.pdf","2008-09-03 00:00:00",
37049,2,21485,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf","2008-08-29 00:00:00",
5515,1,21485,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s017ltr.pdf","2008-10-01 00:00:00",
37050,2,21485,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s017lbl.pdf","2008-10-03 00:00:00",
5516,1,21485,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf","2010-10-13 00:00:00",
15580,2,21485,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021485s20lbl.pdf","2010-10-11 00:00:00",
27910,1,21485,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf","2014-07-24 00:00:00",
37051,2,21485,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf","2014-07-23 00:00:00",
5517,1,21485,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf","2014-07-24 00:00:00",
37052,2,21485,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf","2014-07-23 00:00:00",
5518,1,21485,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf","2016-02-24 00:00:00",
15581,2,21485,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf","2016-02-25 00:00:00",
15582,2,21485,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf","2016-02-23 00:00:00",
55736,1,21485,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021485Orig1s038ltr.pdf","2018-10-01 00:00:00",
21687,3,21486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021486s000TOC.cfm","2007-06-04 00:00:00",
27911,1,21486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21486ltr.pdf","2004-10-29 00:00:00",
37053,2,21486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21486lbl.pdf","2004-11-01 00:00:00",
15583,2,21487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf","2003-10-20 00:00:00",
27912,1,21487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21487ltr.pdf","2003-10-22 00:00:00",
42191,3,21487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-487_Namenda.cfm","2003-12-31 00:00:00",
27913,1,21487,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21487s002ltr.pdf","2004-09-29 00:00:00",
27914,1,21487,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s004ltr.pdf","2005-05-03 00:00:00",
5519,1,21487,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s006ltr.pdf","2005-05-20 00:00:00",
27915,1,21487,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf","2006-04-21 00:00:00",
5520,1,21487,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf","2006-10-13 00:00:00",
5521,1,21487,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487s010ltr.pdf021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf","2013-10-25 00:00:00",
37054,2,21487,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf","2013-10-25 00:00:00",
5522,1,21487,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf","2013-10-25 00:00:00",
15584,2,21487,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf","2013-10-25 00:00:00",
15585,2,21487,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf","2013-10-25 00:00:00",
27916,1,21487,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf","2013-10-25 00:00:00",
21688,3,21488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021488_eligard.cfm","2003-05-08 00:00:00",
23667,10,21488,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
27917,1,21488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-488_Eligard_Approv.pdf","2004-06-03 00:00:00",
37055,2,21488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021488lbl.pdf","2003-02-13 00:00:00",
5523,1,21488,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf","2004-01-14 00:00:00",
5524,1,21488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf","2007-11-19 00:00:00",
37056,2,21488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf","2007-11-13 00:00:00",
15586,2,21488,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf","2010-10-12 00:00:00",
27918,1,21488,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf","2010-10-13 00:00:00",
15587,2,21488,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf","2011-01-20 00:00:00",
27919,1,21488,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf","2011-01-20 00:00:00",
15588,2,21488,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf","2011-04-11 00:00:00",
27920,1,21488,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf","2011-04-11 00:00:00",
15589,2,21488,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf","2013-03-01 00:00:00",
27921,1,21488,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf","2013-03-01 00:00:00",
5525,1,21488,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf","2014-10-14 00:00:00",
37057,2,21488,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf","2014-10-15 00:00:00",
5526,1,21488,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf","2016-03-02 00:00:00",
37058,2,21488,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf","2016-03-03 00:00:00",
5527,1,21489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21489ltr.pdf","2003-10-16 00:00:00",
5528,1,21489,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf","2007-09-06 00:00:00",
21689,3,21489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.cfm","2006-07-25 00:00:00",
37059,2,21489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21489_proHance_lbl.pdf","2003-10-16 00:00:00",
37060,2,21489,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf","2007-09-06 00:00:00",
44128,10,21489,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2006-06-09 00:00:00",
5529,1,21489,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf","2010-12-22 00:00:00",
15590,2,21489,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021489s002lbl.pdf","2010-12-20 00:00:00",
27922,1,21489,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf","2013-08-16 00:00:00",
37061,2,21489,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf","2013-08-15 00:00:00",
5530,1,21489,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021489Orig1s004ltr.pdf","2014-07-24 00:00:00",
15591,2,21489,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021489s004lbl.pdf","2014-07-24 00:00:00",
49774,2,21489,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021489s005lbl.pdf","2017-09-19 00:00:00",
49780,1,21489,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021489Orig1s005ltr.pdf","2017-09-19 00:00:00",
53845,2,21489,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf","2018-04-27 00:00:00",
53846,8,21489,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf#page=1","2018-04-27 00:00:00",
53895,1,21489,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020131Orig1s028,021489Orig1s006Ltr.pdf","2018-05-01 00:00:00",
5531,1,21490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21490ltr.pdf","2003-11-28 00:00:00",
21690,3,21490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm","2005-02-02 00:00:00",
37062,2,21490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf","2003-11-14 00:00:00",
5532,1,21490,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021490s005ltr.pdf","2007-02-12 00:00:00",
15592,2,21490,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf","2007-02-02 00:00:00",
5533,1,21490,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021490s007ltr.pdf","2008-01-15 00:00:00",
15593,2,21490,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf","2008-01-18 00:00:00",
45416,2,21490,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf","2016-09-29 00:00:00",
45528,1,21490,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021490Orig1s010ltr.pdf","2016-10-12 00:00:00",
49300,2,21490,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf","2017-08-09 00:00:00",
49377,1,21490,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021490Orig1s019ltr.pdf","2017-08-15 00:00:00",
5534,1,21492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21492ltr.pdf","2002-08-09 00:00:00",
5535,1,21492,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21492slr001ltr.pdf","2004-06-03 00:00:00",
21691,3,21492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-492_Eloxatin.cfm","2002-08-09 00:00:00",
37063,2,21492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21492lbl.pdf","2002-08-09 00:00:00",
44129,10,21492,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113746.htm","2003-04-22 00:00:00",
5536,1,21492,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492se1-002ltr.pdf","2004-01-12 00:00:00",
15594,2,21492,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21492se1-002_eloxatin_lbl.pdf","2004-01-15 00:00:00",
21692,3,21492,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021492_s002_EloxatinTOC.cfm","2006-03-24 00:00:00",
5537,1,21492,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf","2004-11-08 00:00:00",
37064,2,21492,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf","2004-11-05 00:00:00",
15595,2,21492,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf","2004-11-05 00:00:00",
27923,1,21492,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf","2004-11-08 00:00:00",
27924,1,21492,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf","2006-03-14 00:00:00",
37065,2,21492,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf","2006-03-14 00:00:00",
15596,2,21492,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021492s008lbl.pdf","2007-01-16 00:00:00",
27925,1,21492,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021492s008_ltr.pdf","2007-01-16 00:00:00",
52149,20,21492,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021492s008_oxaliplatin_Eloxatin-MedRev.pdf","1900-01-01 00:00:00",
52150,18,21492,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021492s008_oxaliplatin_Eloxatin-ClinPharmRev.pdf","1900-01-01 00:00:00",
52151,17,21492,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021492s008_oxaliplatin_Eloxatin-StatsRev.pdf","1900-01-01 00:00:00",
52152,23,21492,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021492_oxaliplatin_Eloxatin_WRltr.pdf","1900-01-01 00:00:00",
52153,25,21492,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021492_oxaliplatin_Eloxatin_WR amend.pdf","1900-01-01 00:00:00",
27926,1,21492,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf","2008-05-28 00:00:00",
5538,1,21492,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf","2009-03-17 00:00:00",
15597,2,21492,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf","2009-03-26 00:00:00",
15598,2,21492,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021492s012lbl.pdf","2011-12-28 00:00:00",
27927,1,21492,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf","2012-01-03 00:00:00",
5539,1,21492,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021492Orig1s013ltr.pdf","2012-10-16 00:00:00",
37066,2,21492,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021492s013lbl.pdf","2012-10-15 00:00:00",
5540,1,21492,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021492Orig1s014ltr.pdf","2015-10-06 00:00:00",
37067,2,21492,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021492s014lbl.pdf","2015-10-06 00:00:00",
27928,1,21493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21493ltr.pdf","2003-04-01 00:00:00",
37068,2,21493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21493_Zymar_lbl.pdf","2003-04-01 00:00:00",
42192,3,21493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021493_Zymar.cfm","2005-05-02 00:00:00",
5541,1,21493,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf","2005-06-21 00:00:00",
15599,2,21493,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf","2005-06-21 00:00:00",
27929,1,21493,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf","2005-06-21 00:00:00",
37069,2,21493,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf","2005-06-21 00:00:00",
51929,20,21493,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021493_Gatifloxacin_Clinical_BPCA.pdf","2009-05-19 00:00:00",
51930,18,21493,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021493_Gatifloxacin_Clinpharm_BPCA.pdf","2009-05-19 00:00:00",
51931,17,21493,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021493_Gatifloxacin_Statistical_BPCA.pdf","2009-05-19 00:00:00",
51932,23,21493,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021493_gatifloxacin_Original_WR.pdf","2009-05-19 00:00:00",
51933,28,21493,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021493_gatifloxacin_Amendment.pdf","2009-05-19 00:00:00",
5542,1,21493,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021493Orig1s010ltr.pdf","2015-05-22 00:00:00",
37070,2,21493,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021493s010lbl.pdf","2015-05-27 00:00:00",
47632,2,21493,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021493s011lbl.pdf","2017-03-22 00:00:00",
47683,1,21493,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021493Orig1s011ltr.pdf","2017-03-24 00:00:00",
54221,20,21493,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103_21493 gatifloxacin clinical bpca.pdf","2017-03-21 00:00:00",
5543,1,21494,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21494s001ltr.pdf","2005-03-23 00:00:00",
21693,3,21494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021494s000_AxidTOC.cfm","2006-09-27 00:00:00",
27930,1,21494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21494ltr.pdf","2004-06-01 00:00:00",
37071,2,21494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21494_axid_lbl.pdf","2004-06-01 00:00:00",
37072,2,21494,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21494s001lbl.pdf","2005-03-23 00:00:00",
21694,3,21496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21496_Duocaine.cfm","2003-11-06 00:00:00",
27931,1,21496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21496ltr.pdf","2003-06-08 00:00:00",
37073,2,21496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21496_duocaine_lbl.pdf","2003-09-17 00:00:00",
5544,1,21497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf","2004-07-21 00:00:00",
15600,2,21497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf","2004-07-21 00:00:00",
15601,2,21497,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf","2016-07-13 00:00:00",
27932,1,21497,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf","2016-07-12 00:00:00",
42193,3,21497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm","2004-10-08 00:00:00",
5545,1,21498,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf","2004-07-21 00:00:00",
15602,2,21498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21498_Alinia_lbl.pdf","2002-11-22 00:00:00",
21695,3,21498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-498_Alinia.cfm","2003-04-25 00:00:00",
21696,3,21498,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm","2004-10-08 00:00:00",
27933,1,21498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21498ltr.pdf","2002-11-22 00:00:00",
37074,2,21498,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf","2004-07-21 00:00:00",
5546,1,21498,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021498s003ltr.pdf","2005-06-21 00:00:00",
21697,3,21498,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm","2007-10-02 00:00:00",
37075,2,21498,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021498s003lbl.pdf","2005-06-16 00:00:00",
5547,1,21498,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf","2016-07-12 00:00:00",
37076,2,21498,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf","2016-07-13 00:00:00",
27934,1,21500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21500ltr.pdf","2003-07-08 00:00:00",
37077,2,21500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21500_emtriva_lbl.pdf","2003-07-08 00:00:00",
42194,3,21500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021500_emtriva_toc.cfm","2003-09-09 00:00:00",
5548,1,21500,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s002ltr.pdf","2005-06-14 00:00:00",
5549,1,21500,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s003ltr.pdf","2005-12-13 00:00:00",
15603,2,21500,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021500s003lbl.pdf","2005-12-13 00:00:00",
5550,1,21500,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021896s001,021500s007ltr.pdf","2007-01-08 00:00:00",
15604,2,21500,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf","2006-12-28 00:00:00",
5551,1,21500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s010, 021896s004ltr.pdf","2008-04-09 00:00:00",
15605,2,21500,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf","2008-04-16 00:00:00",
5552,1,21500,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s011,021896s005ltr.pdf","2008-05-21 00:00:00",
5553,1,21500,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021500s018,021896s015ltr.pdf","2011-11-22 00:00:00",
37078,2,21500,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf","2011-11-29 00:00:00",
15606,2,21500,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf","2012-07-23 00:00:00",
27935,1,21500,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf","2012-07-25 00:00:00",
5554,1,21500,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021500Orig1s021,021896Orig1s018ltr.pdf","2013-04-03 00:00:00",
15607,2,21500,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf","2013-04-09 00:00:00",
47915,2,21500,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf","2017-04-10 00:00:00",
21698,3,21501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021501_capital_soleil_toc.cfm","2009-05-27 00:00:00",
27936,1,21501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021501s000LTR.pdf","2006-10-05 00:00:00",
27937,1,21501,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s001ltr.pdf","2007-05-01 00:00:00",
37079,2,21501,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s001lbl.pdf","2007-04-25 00:00:00",
15608,2,21501,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s003lbl.pdf","2007-06-07 00:00:00",
27938,1,21501,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s003ltr.pdf","2007-06-07 00:00:00",
5555,1,21502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502ltr.pdf","2006-07-25 00:00:00",
21699,3,21502,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s001lbl.pdf","2006-12-26 00:00:00",
27939,1,21502,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s001ltr.pdf","2006-12-28 00:00:00",
42195,3,21502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s000_AntheliosTOC.cfm","2006-09-15 00:00:00",
5556,1,21502,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s002ltr.pdf","2006-12-28 00:00:00",
37080,2,21502,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s002lbl.pdf","2006-12-14 00:00:00",
5557,1,21502,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s003ltr.pdf","2006-12-28 00:00:00",
15609,2,21502,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s003lbl.pdf","2006-12-26 00:00:00",
15610,2,21502,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s004_LBL.pdf","2007-01-17 00:00:00",
27940,1,21502,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s004ltr.pdf","2007-01-25 00:00:00",
5558,1,21502,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s006ltr.pdf","2007-03-15 00:00:00",
37081,2,21502,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s006lbl.pdf","2007-03-15 00:00:00",
5559,1,21503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21503ltr.pdf","2003-05-29 00:00:00",
15611,2,21503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021503lbl.pdf","2003-05-06 00:00:00",
15612,2,21503,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf","2004-04-05 00:00:00",
21700,3,21503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021503s000_ViraceptTOC.cfm","2005-12-16 00:00:00",
21701,3,21503,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021503_S001_VIRACEPT.pdf","2007-08-06 00:00:00",
27941,1,21503,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf","2004-03-24 00:00:00",
15613,2,21503,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf","2003-08-28 00:00:00",
27942,1,21503,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf","2003-08-29 00:00:00",
5560,1,21503,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf","2004-06-07 00:00:00",
15614,2,21503,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf","2004-06-07 00:00:00",
5561,1,21503,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf","2005-10-20 00:00:00",
15615,2,21503,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf","2005-09-30 00:00:00",
21702,3,21503,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021503_S006_VIRACEPT.pdf","2007-08-06 00:00:00",
27943,1,21503,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf","2007-01-08 00:00:00",
37082,2,21503,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf","2006-12-28 00:00:00",
15616,2,21503,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf","2007-08-02 00:00:00",
15617,2,21503,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf","2008-02-14 00:00:00",
27944,1,21503,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021503s011ltr.pdf","2008-02-14 00:00:00",
5562,1,21503,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf","2008-11-26 00:00:00",
15618,2,21503,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
27945,1,21503,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
5563,1,21503,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf","2010-04-28 00:00:00",
37083,2,21503,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf","2010-05-03 00:00:00",
15619,2,21503,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf","2011-03-04 00:00:00",
27946,1,21503,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf","2011-02-28 00:00:00",
27947,1,21503,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf","2012-04-11 00:00:00",
37084,2,21503,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf","2012-04-09 00:00:00",
5564,1,21503,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf","2012-02-27 00:00:00",
15620,2,21503,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf","2012-02-24 00:00:00",
15621,2,21503,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf","2013-06-04 00:00:00",
27948,1,21503,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf","2013-05-31 00:00:00",
15622,2,21503,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf","2015-04-07 00:00:00",
27949,1,21503,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf","2015-03-31 00:00:00",
45302,2,21503,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf","2016-09-20 00:00:00",
45359,1,21503,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf","2016-09-22 00:00:00",
21703,3,21504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021504s000_LidositeTOC.cfm","2006-10-23 00:00:00",
27950,1,21504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21504ltr.pdf","2005-06-24 00:00:00",
37085,2,21504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21504_lidoSite_lbl.pdf","2005-06-24 00:00:00",
5565,1,21504,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021504s003ltr.pdf","2005-06-21 00:00:00",
21704,3,21505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/0221505_s000_Keppra.cfm","2004-11-01 00:00:00",
27951,1,21505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21505ltr.pdf","2003-07-28 00:00:00",
44130,10,21505,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2007-03-28 00:00:00",
27952,1,21505,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf","2004-10-29 00:00:00",
27953,1,21505,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr.pdf","2004-10-29 00:00:00",
27954,1,21505,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021505s006_021035s038ltr.pdf","2006-01-30 00:00:00",
15623,2,21505,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf","2005-06-23 00:00:00",
27955,1,21505,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021035s040,021505s007ltr.pdf","2005-06-23 00:00:00",
5566,1,21505,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf","2006-08-18 00:00:00",
37086,2,21505,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf","2006-08-18 00:00:00",
5567,1,21505,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057, 021505s013ltr.pdf","2007-03-23 00:00:00",
15624,2,21505,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf","2007-03-23 00:00:00",
5568,1,21505,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf","2007-09-25 00:00:00",
27956,1,21505,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
37087,2,21505,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
5569,1,21505,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
15625,2,21505,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
27957,1,21505,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf","2009-05-04 00:00:00",
37088,2,21505,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf","2009-05-13 00:00:00",
27958,1,21505,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf","2009-05-04 00:00:00",
37089,2,21505,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf","2009-05-13 00:00:00",
5570,1,21505,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
15626,2,21505,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
5571,1,21505,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf","2011-12-21 00:00:00",
37090,2,21505,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf","2011-12-20 00:00:00",
27959,1,21505,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf","2011-08-12 00:00:00",
27960,1,21505,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
37091,2,21505,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf","2013-07-30 00:00:00",
27961,1,21505,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf","2014-03-11 00:00:00",
37092,2,21505,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021505s031lbl.pdf","2014-03-10 00:00:00",
27962,1,21505,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf","2015-03-12 00:00:00",
37093,2,21505,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf","2015-03-12 00:00:00",
5572,1,21505,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf","2014-08-11 00:00:00",
15627,2,21505,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf","2014-08-08 00:00:00",
45707,1,21505,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf","2016-10-28 00:00:00",
45765,2,21505,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021035s096,021505s036lbl.pdf","2016-11-01 00:00:00",
48111,2,21505,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s099,021505s038lbl.pdf","2017-04-25 00:00:00",
48145,1,21505,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf","2017-04-27 00:00:00",
50175,2,21505,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf","2017-10-25 00:00:00",
50176,8,21505,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf#page=28","2017-10-25 00:00:00",
50217,1,21505,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf","2017-10-30 00:00:00",
5573,1,21506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21506,21754ltr.pdf","2005-03-18 00:00:00",
21705,3,21506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-506_Mycamine.cfm","2005-08-24 00:00:00",
37094,2,21506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf","2005-03-18 00:00:00",
44479,14,21506,"ORIG",1,"Package Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl_2.pdf","2005-03-18 00:00:00",
15628,2,21506,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf","2006-06-28 00:00:00",
27963,1,21506,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021506s004ltr.pdf","2006-07-03 00:00:00",
15629,2,21506,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021506s008lbl.pdf","2008-01-24 00:00:00",
27964,1,21506,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021506s008ltr.pdf","2008-01-24 00:00:00",
5574,1,21506,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021506s009ltr.pdf","2007-08-07 00:00:00",
37095,2,21506,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021506s009lbl.pdf","2007-08-07 00:00:00",
5575,1,21506,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf","2011-06-10 00:00:00",
15630,2,21506,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf","2011-06-27 00:00:00",
5576,1,21506,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf","2011-06-10 00:00:00",
37096,2,21506,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf","2011-06-27 00:00:00",
27965,1,21506,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s014ltr.pdf","2013-04-24 00:00:00",
37097,2,21506,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s014lbl.pdf","2013-04-23 00:00:00",
5577,1,21506,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s015ltr.pdf","2013-06-24 00:00:00",
15631,2,21506,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s015lbl.pdf","2013-06-25 00:00:00",
51373,20,21506,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine clinical bpca.pdf","1900-01-01 00:00:00",
51374,18,21506,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine clinpharm bpca.pdf","1900-01-01 00:00:00",
51375,17,21506,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine statistical bpca.pdf","1900-01-01 00:00:00",
45175,2,21506,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021506s019lbl.pdf","2016-08-26 00:00:00",
5578,1,21507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21507ltr.pdf","2003-11-28 00:00:00",
42196,3,21507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21507_PrevacidTOC.cfm","2005-06-23 00:00:00",
43759,8,21507,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf","2007-02-20 00:00:00",
44131,10,21507,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
5579,1,21507,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021507s004ltr.pdf","2006-04-13 00:00:00",
15632,2,21507,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf","2006-09-01 00:00:00",
37098,2,21507,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf","2006-09-01 00:00:00",
27966,1,21507,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021507s008ltr.pdf","2008-10-23 00:00:00",
27967,1,21507,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021507s009ltr.pdf","2009-11-10 00:00:00",
37099,2,21507,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf","2009-08-13 00:00:00",
15633,2,21511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf","2002-12-03 00:00:00",
21706,3,21511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-511_Copegus.cfm","2004-08-10 00:00:00",
27968,1,21511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21511ltr.pdf","2002-12-03 00:00:00",
53394,20,21511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinical prea-Dawn.pdf","1900-01-01 00:00:00",
53395,18,21511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinpharm prea.pdf","1900-01-01 00:00:00",
53396,17,21511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinical prea-Dawn (1).pdf","1900-01-01 00:00:00",
5580,1,21511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21511slr002ltr.pdf","2004-05-07 00:00:00",
15634,2,21511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21511slr002_copegus_lbl.pdf","2004-05-07 00:00:00",
15635,2,21511,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s005lbl.pdf","2005-03-03 00:00:00",
27969,1,21511,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s005ltr.pdf","2005-03-03 00:00:00",
5581,1,21511,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006ltr.pdf","2005-08-24 00:00:00",
15636,2,21511,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s006lbl.pdf","2005-08-24 00:00:00",
24002,14,21511,"SUPPL",6,"Release 2 Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease2_ltr.pdf","2005-11-01 00:00:00",
24003,14,21511,"SUPPL",6,"Release Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease_ltr.pdf","2005-09-22 00:00:00",
27970,1,21511,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s007ltr.pdf","2005-08-19 00:00:00",
37100,2,21511,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s007lbl.pdf","2005-08-19 00:00:00",
5582,1,21511,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s008ltr.pdf","2005-06-23 00:00:00",
27971,1,21511,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s012ltr.pdf","2005-11-30 00:00:00",
37101,2,21511,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s012lbl.pdf","2005-11-30 00:00:00",
5583,1,21511,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021511s014ltr.pdf","2007-07-05 00:00:00",
37102,2,21511,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021511s014lbl.pdf","2007-06-27 00:00:00",
27972,1,21511,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021511s015ltr.pdf","2008-04-22 00:00:00",
5584,1,21511,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf","2009-05-07 00:00:00",
27973,1,21511,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf","2009-05-07 00:00:00",
27974,1,21511,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s018ltr.pdf","2010-03-08 00:00:00",
37103,2,21511,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s018lbl.pdf","2010-03-05 00:00:00",
5585,1,21511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s019ltr.pdf","2010-06-15 00:00:00",
37104,2,21511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s019lbl.pdf","2010-06-24 00:00:00",
15637,2,21511,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s020lbl.pdf","2010-10-12 00:00:00",
27975,1,21511,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s020ltr.pdf","2010-10-13 00:00:00",
27976,1,21511,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s021ltr.pdf","2010-12-22 00:00:00",
37105,2,21511,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s021lbl.pdf","2010-12-22 00:00:00",
15638,2,21511,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s022lbl.pdf","2011-08-11 00:00:00",
27977,1,21511,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf","2011-08-11 00:00:00",
27978,1,21511,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf","2011-08-26 00:00:00",
37106,2,21511,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf","2011-08-24 00:00:00",
27979,1,21511,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s024ltr.pdf","2011-05-11 00:00:00",
27980,1,21511,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021511Orig1s026ltr.pdf","2013-02-08 00:00:00",
37107,2,21511,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021511s026lbl.pdf","2013-02-08 00:00:00",
5586,1,21511,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021511Orig1s029ltr.pdf","2015-08-12 00:00:00",
37108,2,21511,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf","2015-08-12 00:00:00",
46117,8,21511,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf#page=27","2016-12-09 00:00:00",
27981,1,21512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21512ltr.pdf","2004-06-25 00:00:00",
37109,2,21512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21512_loratadine_lbl.pdf","2004-06-25 00:00:00",
42197,3,21512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021512s000TOC.cfm","2007-06-04 00:00:00",
5587,1,21513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021513ltr.pdf","2004-12-29 00:00:00",
15639,2,21513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf","2004-12-29 00:00:00",
21707,3,21513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm","2005-02-08 00:00:00",
5588,1,21513,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021513s002ltr.pdf","2005-10-25 00:00:00",
15640,2,21513,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf","2005-10-25 00:00:00",
5589,1,21513,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s004ltr.pdf","2008-04-22 00:00:00",
15641,2,21513,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf","2008-06-05 00:00:00",
5590,1,21513,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s005ltrCorrectedCopy.pdf","2008-12-19 00:00:00",
37110,2,21513,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf","2009-01-02 00:00:00",
27982,1,21513,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021513s006ltr.pdf","2010-10-25 00:00:00",
37111,2,21513,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf","2010-10-19 00:00:00",
15642,2,21513,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf","2011-04-18 00:00:00",
27983,1,21513,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021513s007ltr.pdf","2011-04-20 00:00:00",
15643,2,21513,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf","2012-01-26 00:00:00",
27984,1,21513,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513s008ltr.pdf","2012-01-18 00:00:00",
5591,1,21513,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513Orig1s010ltr.pdf","2012-03-19 00:00:00",
15644,2,21513,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf","2012-03-16 00:00:00",
5592,1,21514,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s001ltr.pdf","2006-08-04 00:00:00",
15645,2,21514,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021514s001lbl.pdf","2006-08-04 00:00:00",
21708,3,21514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021514_daytrana_toc.cfm","2008-11-14 00:00:00",
27985,1,21514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s000ltr.pdf","2006-04-13 00:00:00",
44132,10,21514,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
53332,20,21514,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21514_Methylphenidate_Clinical_PREA.pdf","1900-01-01 00:00:00",
53333,18,21514,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21514_Methylphenidate_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53334,17,21514,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21514_Methylphenidate_Statistical_PREA.pdf","1900-01-01 00:00:00",
54055,20,21514,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21514_Methylphenidate_ClinicalMTL_PREA.pdf","1900-01-01 00:00:00",
37112,2,21514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf","2008-02-14 00:00:00",
5593,1,21514,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021514s005ltr.pdf","2007-05-07 00:00:00",
37113,2,21514,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021514s005lbl.pdf","2007-05-07 00:00:00",
37114,2,21514,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf","2008-02-14 00:00:00",
15646,2,21514,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf","2008-02-14 00:00:00",
27986,1,21514,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021514s008ltr.pdf","2009-12-24 00:00:00",
37115,2,21514,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021514s008lbl.pdf","2009-12-16 00:00:00",
27987,1,21514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf","2010-07-02 00:00:00",
5594,1,21514,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf","2010-07-02 00:00:00",
15647,2,21514,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s009s010lbl.pdf","2010-07-06 00:00:00",
27988,1,21514,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s011ltr.pdf","2010-10-20 00:00:00",
37116,2,21514,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s011lbl.pdf","2010-10-18 00:00:00",
27989,1,21514,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s015ltr.pdf","2013-06-07 00:00:00",
37117,2,21514,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s015lbl.pdf","2013-06-07 00:00:00",
15648,2,21514,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf","2013-12-17 00:00:00",
27990,1,21514,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s017ltr.pdf","2013-12-16 00:00:00",
15649,2,21514,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s022lbl.pdf","2015-04-21 00:00:00",
27991,1,21514,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s022ltr.pdf","2015-04-20 00:00:00",
27992,1,21514,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s023ltr.pdf","2015-08-18 00:00:00",
37118,2,21514,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf","2015-08-17 00:00:00",
52739,3,21514,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021514Orig1s023.pdf","2018-02-27 00:00:00",
45106,2,21514,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021514s024lbl.pdf","2016-08-23 00:00:00",
45151,1,21514,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021514Orig1s024ltr.pdf","2016-08-19 00:00:00",
46717,2,21514,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s025lbl.pdf","2017-01-06 00:00:00",
46776,8,21514,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s025lbl.pdf#page=25","2017-01-10 00:00:00",
46777,1,21514,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021514Orig1s025ltr.pdf","2017-01-10 00:00:00",
50354,1,21514,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021514Orig1s028ltr.pdf","2017-11-09 00:00:00",
50409,2,21514,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf","2017-11-14 00:00:00",
5595,1,21515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf","2003-09-09 00:00:00",
23668,10,21515,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
37119,2,21515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21515_wellbutrin_lbl.pdf","2003-09-09 00:00:00",
42198,3,21515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021515_Wellbutrin.cfm","2005-04-27 00:00:00",
5596,1,21515,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21515s002ltr.pdf","2004-10-29 00:00:00",
21709,3,21515,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm","2007-06-29 00:00:00",
27993,1,21515,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf","2004-06-01 00:00:00",
15650,2,21515,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf","2005-01-13 00:00:00",
27994,1,21515,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf","2005-01-13 00:00:00",
15651,2,21515,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf","2006-06-14 00:00:00",
27995,1,21515,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf","2006-06-14 00:00:00",
27996,1,21515,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf","2006-03-03 00:00:00",
5597,1,21515,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf","2006-07-13 00:00:00",
37120,2,21515,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf","2006-07-05 00:00:00",
27997,1,21515,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf","2006-06-14 00:00:00",
37121,2,21515,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf","2006-06-14 00:00:00",
15652,2,21515,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021515s020lbl.pdf","2007-08-03 00:00:00",
27998,1,21515,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf","2007-08-07 00:00:00",
15653,2,21515,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s022lbl.pdf","2010-05-28 00:00:00",
27999,1,21515,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021515s022ltr.pdf","2010-05-27 00:00:00",
15654,2,21515,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf","2009-07-09 00:00:00",
28000,1,21515,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf","2009-07-08 00:00:00",
28001,1,21515,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf","2009-07-08 00:00:00",
37122,2,21515,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf","2009-07-09 00:00:00",
15655,2,21515,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf","2011-07-27 00:00:00",
28002,1,21515,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf","2011-07-28 00:00:00",
5598,1,21515,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf","2011-07-28 00:00:00",
37123,2,21515,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf","2011-07-27 00:00:00",
28003,1,21515,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021515Orig1s028ltr.pdf","2012-08-03 00:00:00",
5599,1,21515,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf","2015-01-07 00:00:00",
37124,2,21515,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf","2015-01-05 00:00:00",
5600,1,21515,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf","2015-01-07 00:00:00",
15656,2,21515,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf","2015-01-05 00:00:00",
15657,2,21515,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s032lbl.pdf","2014-07-15 00:00:00",
28004,1,21515,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s032ltr.pdf","2014-07-15 00:00:00",
45188,1,21515,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021515Orig1s034ltr.pdf","2016-08-30 00:00:00",
45206,2,21515,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021515s034lbl.pdf","2016-08-30 00:00:00",
48257,2,21515,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021515s036lbl.pdf","2017-05-05 00:00:00",
48258,8,21515,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021515s036lbl.pdf#page=28","2017-05-05 00:00:00",
48299,1,21515,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021515Orig1s036,022108Orig1s014ltr.pdf","2017-05-09 00:00:00",
5601,1,21516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21516ltr.pdf","2004-06-10 00:00:00",
15658,2,21516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21516_istalol_lbl.pdf","2004-06-10 00:00:00",
21710,3,21516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021516s000_IstalolTOC.cfm","2006-01-31 00:00:00",
15659,2,21516,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021516s005lbl.pdf","2013-06-17 00:00:00",
28005,1,21516,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021516Orig1s005ltr.pdf","2013-06-19 00:00:00",
15660,2,21518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21518lbl.pdf","2004-12-03 00:00:00",
28006,1,21518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21518ltr.pdf","2004-12-02 00:00:00",
42199,3,21518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-518_VesiCare.cfm","2005-02-08 00:00:00",
51592,20,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/166_209529 solifenacin clinical bpca.pdf","2017-07-20 00:00:00",
51593,18,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/167_209529 solifenacin clinpharm bpca.pdf","2017-07-20 00:00:00",
51594,17,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/168_209529 solifenacin statistical bpca.pdf","2017-07-20 00:00:00",
52343,23,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021518_solifenacin_Orig_WR.pdf","2017-07-20 00:00:00",
52344,25,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021518_solifenacin_Amend_1.pdf","2017-07-20 00:00:00",
52345,26,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021518_solifenacin_Amend_2.pdf","2017-07-20 00:00:00",
52346,27,21518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021518_solifenacin_Amend_3.pdf","2017-07-20 00:00:00",
5602,1,21518,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021518s003ltr.pdf","2007-07-24 00:00:00",
15661,2,21518,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021518s003lbl.pdf","2007-07-16 00:00:00",
15662,2,21518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s004lbl.pdf","2008-02-14 00:00:00",
28007,1,21518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s004ltr.pdf","2008-02-14 00:00:00",
28008,1,21518,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s006ltr.pdf","2008-10-30 00:00:00",
5603,1,21518,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s007ltr.pdf","2008-11-21 00:00:00",
37125,2,21518,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s007lbl.pdf","2008-11-19 00:00:00",
5604,1,21518,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021518s008ltr.pdf","2010-07-14 00:00:00",
15663,2,21518,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021518s008lbl.pdf","2010-07-01 00:00:00",
5605,1,21518,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021518s010ltr.pdf","2011-03-14 00:00:00",
37126,2,21518,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021518s010lbl.pdf","2011-03-11 00:00:00",
28009,1,21518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s011ltr.pdf","2012-06-12 00:00:00",
37127,2,21518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s011lbl.pdf","2012-06-11 00:00:00",
28010,1,21518,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s012ltr.pdf","2012-01-19 00:00:00",
37128,2,21518,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s012lbl.pdf","2012-01-23 00:00:00",
5606,1,21518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s013ltr.pdf","2012-07-17 00:00:00",
37129,2,21518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518S013lbl.pdf","2012-07-25 00:00:00",
5607,1,21518,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s014ltr.pdf","2012-08-06 00:00:00",
37130,2,21518,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s014lbl.pdf","2012-08-06 00:00:00",
5608,1,21518,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s015ltr.pdf","2013-04-01 00:00:00",
37131,2,21518,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s015lbl.pdf","2013-04-01 00:00:00",
5609,1,21518,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s016ltr.pdf","2013-10-11 00:00:00",
37132,2,21518,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s016lbl.pdf","2013-10-17 00:00:00",
5610,1,21519,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf","2009-02-27 00:00:00",
15664,2,21519,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf","2009-03-17 00:00:00",
21711,3,21519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519_luvox_toc.cfm","2008-11-10 00:00:00",
24203,21,21519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519s000_SumR.pdf","2008-11-10 00:00:00",
28011,1,21519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021519s000ltr.pdf","2008-01-09 00:00:00",
37133,2,21519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf","2007-12-27 00:00:00",
44133,10,21519,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm","2012-02-13 00:00:00",
5611,1,21519,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021519s002ltr.pdf","2011-03-21 00:00:00",
15665,2,21519,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf","2011-03-21 00:00:00",
15666,2,21519,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf","2012-12-03 00:00:00",
28012,1,21519,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021519Orig1s003ltr.pdf","2012-12-03 00:00:00",
5612,1,21519,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021519Orig1s008ltr.pdf","2014-07-23 00:00:00",
37134,2,21519,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf","2014-07-29 00:00:00",
46693,2,21519,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf","2017-01-06 00:00:00",
46747,8,21519,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf#page=30","2017-01-10 00:00:00",
46748,1,21519,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021519Orig1s009ltr.pdf","2017-01-10 00:00:00",
15667,2,21520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf","2004-01-02 00:00:00",
28013,1,21520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21520ltr.pdf","2004-01-02 00:00:00",
42200,3,21520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21520_SymbyaxTOC.cfm","2005-06-16 00:00:00",
43570,6,21520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520ppi.pdf","2004-01-16 00:00:00",
44134,10,21520,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2007-05-09 00:00:00",
28014,1,21520,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21520s005ltr.pdf","2005-02-23 00:00:00",
28015,1,21520,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf","2007-04-20 00:00:00",
37135,2,21520,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf","2007-04-20 00:00:00",
5613,1,21520,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021520s009ltr.pdf","2006-12-28 00:00:00",
37136,2,21520,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s009lbl.pdf","2006-12-04 00:00:00",
5614,1,21520,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf","2007-04-20 00:00:00",
15668,2,21520,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf","2007-04-20 00:00:00",
48927,2,21520,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s011lbl.pdf","2017-07-07 00:00:00",
15669,2,21520,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s012lbl.pdf","2009-03-20 00:00:00",
21712,3,21520,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021520Orig1s012.pdf","2013-05-10 00:00:00",
15670,2,21520,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf","2007-08-03 00:00:00",
28016,1,21520,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
5615,1,21520,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf","2007-08-07 00:00:00",
15671,2,21520,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf","2007-08-03 00:00:00",
5616,1,21520,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s016ltr.pdf","2008-03-19 00:00:00",
15672,2,21520,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s016lbl.pdf","2008-03-19 00:00:00",
5617,1,21520,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s017ltr.pdf","2008-03-24 00:00:00",
37138,2,21520,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s017lbl.pdf","2008-03-24 00:00:00",
5618,1,21520,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s020ltr.pdf","2008-08-19 00:00:00",
15673,2,21520,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s022lbl.pdf","2009-09-22 00:00:00",
5619,1,21520,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s023ltr.pdf","2010-02-01 00:00:00",
37139,2,21520,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s023lbl.pdf","2010-01-29 00:00:00",
5620,1,21520,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,s028ltr.pdf","2011-04-25 00:00:00",
37140,2,21520,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf","2011-04-26 00:00:00",
5621,1,21520,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf","2010-12-07 00:00:00",
37141,2,21520,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf","2010-12-04 00:00:00",
5622,1,21520,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,028ltr.pdf","2011-04-25 00:00:00",
15674,2,21520,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf","2011-04-26 00:00:00",
5623,1,21520,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf","2010-12-07 00:00:00",
15675,2,21520,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf","2010-12-04 00:00:00",
28017,1,21520,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf","2011-06-27 00:00:00",
37142,2,21520,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf","2011-06-29 00:00:00",
5624,1,21520,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf","2011-06-27 00:00:00",
15676,2,21520,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf","2011-06-29 00:00:00",
28018,1,21520,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s033ltr.pdf","2011-10-05 00:00:00",
37143,2,21520,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s33lbl.pdf","2011-10-05 00:00:00",
28019,1,21520,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf","2014-12-23 00:00:00",
37144,2,21520,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s034lbl.pdf","2015-01-09 00:00:00",
5625,1,21520,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf","2013-01-07 00:00:00",
37145,2,21520,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf","2013-01-07 00:00:00",
5626,1,21520,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf","2013-01-07 00:00:00",
15677,2,21520,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf","2013-01-07 00:00:00",
28020,1,21520,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
37146,2,21520,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf","2013-07-30 00:00:00",
15678,2,21520,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021520s038lbl.pdf","2012-08-08 00:00:00",
28021,1,21520,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021520Orig1s038ltr.pdf","2012-08-09 00:00:00",
5627,1,21520,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf","2013-07-30 00:00:00",
37147,2,21520,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf","2013-07-30 00:00:00",
51422,20,21520,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21520s039 Symbyax clinical prea.pdf","1900-01-01 00:00:00",
51423,18,21520,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21520s039 Symbyax Clinpharm prea.pdf","1900-01-01 00:00:00",
51425,17,21520,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21520s039 Symbyax Statistical PREA.pdf","1900-01-01 00:00:00",
52972,61,21520,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21520s039 Symbyax clinphram addendum prea.pdf","1900-01-01 00:00:00",
5628,1,21520,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s040ltr.pdf","2013-08-08 00:00:00",
15679,2,21520,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s040lbl.pdf","2013-08-09 00:00:00",
5629,1,21520,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf","2014-10-15 00:00:00",
37148,2,21520,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s041lbl.pdf","2014-10-15 00:00:00",
47721,2,21520,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s042lbl.pdf","2017-03-27 00:00:00",
47755,1,21520,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf","2017-03-29 00:00:00",
5630,1,21520,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf","2014-07-24 00:00:00",
15680,2,21520,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s045lbl.pdf","2014-07-23 00:00:00",
45536,1,21520,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf","2016-10-14 00:00:00",
45983,2,21520,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021520s046lbl.pdf","2016-12-01 00:00:00",
46700,2,21520,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s047lbl.pdf","2017-01-06 00:00:00",
46822,1,21520,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf","2017-01-13 00:00:00",
47400,1,21520,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021520Orig1s048,s049ltr.pdf","2017-03-02 00:00:00",
47341,2,21520,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s049lbl.pdf","2017-02-27 00:00:00",
47401,1,21520,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021520Orig1s048,s049ltr.pdf","2017-03-02 00:00:00",
53470,2,21520,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021520s050lbl.pdf","2018-03-28 00:00:00",
53471,8,21520,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021520s050lbl.pdf#page=42","2018-03-28 00:00:00",
53519,1,21520,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021520Orig1s050ltr.pdf","2018-03-29 00:00:00",
5631,1,21524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021524ltr.pdf","2005-06-07 00:00:00",
15681,2,21524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021524lbl.pdf","2005-06-07 00:00:00",
21713,3,21524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021524s000TOC.cfm","2007-07-18 00:00:00",
5632,1,21524,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s003ltr.pdf","2007-03-23 00:00:00",
15682,2,21524,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s003lbl.pdf","2007-03-23 00:00:00",
28022,1,21524,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s004ltr.pdf","2007-10-22 00:00:00",
37149,2,21524,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s004lbl.pdf","2007-10-22 00:00:00",
5633,1,21524,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524s010ltr.pdf","2012-03-05 00:00:00",
5634,1,21524,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524Orig1s011ltr.pdf","2012-05-18 00:00:00",
52641,1,21524,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021524Orig1s012ltr.pdf","2018-02-14 00:00:00",
5635,1,21524,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s014ltr.pdf","2014-03-26 00:00:00",
15683,2,21524,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s014lbl.pdf","2014-03-26 00:00:00",
5636,1,21524,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s015ltr.pdf","2014-07-28 00:00:00",
37150,2,21524,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s015lbl.pdf","2014-07-29 00:00:00",
49726,2,21524,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021524Orig1s017lbl.pdf","2017-09-13 00:00:00",
49810,1,21524,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021524Orig1s017ltr.pdf","2017-09-20 00:00:00",
15684,2,21525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf","2004-06-14 00:00:00",
21714,3,21525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020415s012_021525_PhotofrinTOC.cfm","2006-07-25 00:00:00",
28023,1,21525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf","2004-06-14 00:00:00",
5637,1,21526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021526s000ltr.pdf","2006-02-08 00:00:00",
21715,3,21526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa.cfm","2006-04-06 00:00:00",
37151,2,21526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf","2006-02-07 00:00:00",
15685,2,21526,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf","2007-12-27 00:00:00",
28024,1,21526,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021526s002ltr.pdf","2008-01-09 00:00:00",
5638,1,21526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021526s004ltr.pdf","2008-11-06 00:00:00",
21716,3,21526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021526Orig1s004TOC.cfm","2015-01-16 00:00:00",
37152,2,21526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf","2008-11-07 00:00:00",
5639,1,21526,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021526s007ltr.pdf","2009-03-27 00:00:00",
15686,2,21526,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf","2009-03-26 00:00:00",
21717,3,21526,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021526Orig1s007.pdf","2014-08-05 00:00:00",
28025,1,21526,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021526s012ltr.pdf","2010-09-28 00:00:00",
37153,2,21526,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf","2010-09-29 00:00:00",
5640,1,21526,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s014ltr.pdf","2011-07-13 00:00:00",
15687,2,21526,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf","2011-07-11 00:00:00",
5641,1,21526,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s018ltr.pdf","2011-12-28 00:00:00",
37154,2,21526,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf","2011-12-23 00:00:00",
5642,1,21526,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021526Orig1s022ltr.pdf","2012-07-30 00:00:00",
37155,2,21526,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf","2012-07-26 00:00:00",
5643,1,21526,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s025ltr.pdf","2013-11-15 00:00:00",
15688,2,21526,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf","2013-11-14 00:00:00",
28026,1,21526,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s026ltr.pdf","2013-12-20 00:00:00",
37156,2,21526,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf","2013-12-23 00:00:00",
28027,1,21526,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021526Orig1s028ltr.pdf","2015-12-16 00:00:00",
37157,2,21526,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf","2015-12-17 00:00:00",
15689,2,21526,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf","2016-01-07 00:00:00",
28028,1,21526,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021526Orig1s029ltr.pdf","2016-01-07 00:00:00",
5644,1,21527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21527ltr.pdf","2004-12-02 00:00:00",
15690,2,21527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf","2004-12-03 00:00:00",
21718,3,21527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021527s000TOC.cfm","2007-01-23 00:00:00",
28029,1,21527,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527S003ltr.pdf","2006-04-05 00:00:00",
5645,1,21527,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527s005_ltr.pdf","2006-09-15 00:00:00",
15691,2,21527,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf","2006-09-15 00:00:00",
28030,1,21527,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021527s011ltr.pdf","2008-10-22 00:00:00",
5646,1,21527,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021527s016ltr.pdf","2010-12-28 00:00:00",
15692,2,21527,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf","2010-12-26 00:00:00",
28031,1,21527,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021527s019ltr.pdf","2011-10-12 00:00:00",
37158,2,21527,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf","2011-10-12 00:00:00",
5647,1,21527,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021527Orig1s021ltr.pdf","2012-08-31 00:00:00",
15693,2,21527,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf","2012-08-31 00:00:00",
5648,1,21528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21528ltr.pdf","2003-06-08 00:00:00",
15694,2,21528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf","2003-06-08 00:00:00",
42201,3,21528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21528_Acular.cfm","2003-11-06 00:00:00",
5649,1,21528,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021528s005ltr.pdf","2008-12-04 00:00:00",
15695,2,21528,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf","2016-06-01 00:00:00",
5650,1,21529,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021529s001ltr.pdf","2007-01-25 00:00:00",
28032,1,21529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf","2006-07-21 00:00:00",
37159,2,21529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf","2006-07-21 00:00:00",
42202,3,21529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021529_implanon_toc.cfm","2009-11-19 00:00:00",
5651,1,21529,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021529s004ltr.pdf","2009-02-23 00:00:00",
37160,2,21529,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf","2009-02-20 00:00:00",
5652,1,21529,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021529s006ltr.pdf","2012-02-03 00:00:00",
37161,2,21529,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf","2012-02-06 00:00:00",
5653,1,21529,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021529s007ltr.pdf","2011-05-19 00:00:00",
37162,2,21529,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf","2011-05-16 00:00:00",
37163,2,21529,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf","2014-07-09 00:00:00",
28033,1,21529,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf","2013-10-01 00:00:00",
37164,2,21529,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf","2013-10-01 00:00:00",
5654,1,21529,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021529Orig1s011ltr.pdf","2015-08-21 00:00:00",
15696,2,21529,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf","2015-08-20 00:00:00",
28034,1,21529,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf","2016-03-16 00:00:00",
37165,2,21529,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf","2016-03-15 00:00:00",
48491,2,21529,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf","2017-05-23 00:00:00",
48501,1,21529,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021529Orig1s015ltr.pdf","2017-05-23 00:00:00",
5655,1,21530,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf","2005-08-15 00:00:00",
15697,2,21530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21530_mobic_lbl.pdf","2004-06-01 00:00:00",
21719,3,21530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021530s000_MobicTOC.cfm","2006-03-21 00:00:00",
28035,1,21530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21530ltr.pdf","2004-06-01 00:00:00",
37166,2,21530,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf","2005-08-15 00:00:00",
43767,8,21530,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf","2009-11-19 00:00:00",
15698,2,21530,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf","2005-08-15 00:00:00",
28036,1,21530,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf","2005-08-15 00:00:00",
5656,1,21530,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf","2007-02-02 00:00:00",
37167,2,21530,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf","2007-02-02 00:00:00",
15699,2,21530,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf","2008-06-30 00:00:00",
28037,1,21530,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf","2008-07-01 00:00:00",
28038,1,21530,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf","2010-04-29 00:00:00",
37168,2,21530,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021530s007lbl.pdf","2010-04-28 00:00:00",
15700,2,21530,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf","2010-08-01 00:00:00",
28039,1,21530,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf","2010-08-03 00:00:00",
5657,1,21530,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf","2011-08-05 00:00:00",
37169,2,21530,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf","2011-08-05 00:00:00",
15701,2,21530,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021530s011lbl.pdf","2012-03-05 00:00:00",
28040,1,21530,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf","2012-03-12 00:00:00",
5658,1,21530,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf","2016-05-12 00:00:00",
15702,2,21530,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf","2016-05-11 00:00:00",
28041,1,21530,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf","2016-05-12 00:00:00",
37170,2,21530,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf","2016-05-11 00:00:00",
45204,2,21530,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021530s016lbl.pdf","2016-09-01 00:00:00",
45226,1,21530,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021530Orig1s016ltr.pdf","2016-09-01 00:00:00",
5659,1,21532,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21532s001ltr.pdf","2004-11-16 00:00:00",
21720,3,21532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021532_benicar_toc.cfm","2003-09-10 00:00:00",
28042,1,21532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21532ltr.pdf","2003-06-08 00:00:00",
37171,2,21532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf","2003-06-08 00:00:00",
28043,1,21532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021532s004ltr.pdf","2005-07-15 00:00:00",
37172,2,21532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf","2005-07-15 00:00:00",
5660,1,21532,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021532s008ltr.pdf","2007-11-19 00:00:00",
5661,1,21532,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf","2011-05-05 00:00:00",
15703,2,21532,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf","2011-05-05 00:00:00",
5662,1,21532,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf","2011-05-05 00:00:00",
15704,2,21532,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf","2011-05-05 00:00:00",
28044,1,21532,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021532Orig1s015ltr.pdf","2016-02-12 00:00:00",
37173,2,21532,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf","2016-02-18 00:00:00",
5663,1,21532,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532s016ltr.pdf","2012-01-20 00:00:00",
37174,2,21532,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf","2012-01-30 00:00:00",
15705,2,21532,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf","2012-09-20 00:00:00",
28045,1,21532,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s020ltr.pdf","2012-09-24 00:00:00",
5664,1,21532,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s021ltr_r.pdf","2012-12-11 00:00:00",
15706,2,21532,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf","2012-12-14 00:00:00",
5665,1,21532,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021532Orig1s022ltr.pdf","2013-07-05 00:00:00",
37175,2,21532,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf","2013-07-05 00:00:00",
15707,2,21532,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf","2014-06-17 00:00:00",
28046,1,21532,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s024ltr.pdf","2014-06-17 00:00:00",
5666,1,21532,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s025ltr.pdf","2014-06-30 00:00:00",
15708,2,21532,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf","2014-06-30 00:00:00",
5667,1,21532,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s026ltr.pdf","2014-09-24 00:00:00",
15709,2,21532,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf","2014-09-26 00:00:00",
15710,2,21535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf","2003-07-28 00:00:00",
21721,3,21535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-535_Clobex.cfm","2004-06-14 00:00:00",
28047,1,21535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21535ltr.pdf","2003-07-28 00:00:00",
15711,2,21535,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535s002lbl.pdf","2012-08-20 00:00:00",
28048,1,21535,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s002ltr.pdf","2012-08-20 00:00:00",
5668,1,21535,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf","2012-12-03 00:00:00",
15712,2,21535,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf","2014-01-14 00:00:00",
5669,1,21536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021536ltr.pdf","2005-06-21 00:00:00",
15713,2,21536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf","2005-06-21 00:00:00",
21722,3,21536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021-536_LevemirTOC.cfm","2005-07-26 00:00:00",
5670,1,21536,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021536s015ltr.pdf","2007-05-29 00:00:00",
15714,2,21536,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf","2007-05-29 00:00:00",
21723,3,21536,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021536Orig1s015.pdf","2011-10-28 00:00:00",
28049,1,21536,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
28050,1,21536,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf","2008-09-09 00:00:00",
28051,1,21536,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf","2009-05-13 00:00:00",
5671,1,21536,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536Orig1s028ltr.pdf","2012-11-07 00:00:00",
15715,2,21536,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf","2012-11-05 00:00:00",
15716,2,21536,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s029lbl.pdf","2012-01-30 00:00:00",
28052,1,21536,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s029ltr.pdf","2012-02-01 00:00:00",
28053,1,21536,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf","2015-02-27 00:00:00",
37176,2,21536,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf","2015-03-03 00:00:00",
15717,2,21536,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536Orig1s033lbl.pdf","2013-11-19 00:00:00",
21724,3,21536,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021536Orig1s033.pdf","2014-08-01 00:00:00",
28054,1,21536,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s033ltr.pdf","2013-11-07 00:00:00",
5672,1,21536,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s035ltr.pdf","2013-03-12 00:00:00",
37177,2,21536,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf","2013-03-12 00:00:00",
5673,1,21536,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s037ltr.pdf","2012-04-02 00:00:00",
15718,2,21536,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf","2012-03-29 00:00:00",
5674,1,21536,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s039ltr.pdf","2012-05-02 00:00:00",
15719,2,21536,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf","2012-05-01 00:00:00",
5675,1,21536,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s041ltr.pdf","2012-05-22 00:00:00",
15720,2,21536,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf","2012-05-22 00:00:00",
5676,1,21536,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s044ltr.pdf","2013-04-16 00:00:00",
15721,2,21536,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf","2013-04-16 00:00:00",
28055,1,21536,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021536Orig1s048ltr.pdf","2014-02-27 00:00:00",
28056,1,21536,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s050ltr.pdf","2015-01-26 00:00:00",
37178,2,21536,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s050lbl.pdf","2015-02-13 00:00:00",
5677,1,21536,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf","2015-02-27 00:00:00",
15722,2,21536,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf","2015-03-03 00:00:00",
28057,1,21537,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21537ltr.pdf","2003-07-28 00:00:00",
42203,3,21537,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021537_Ciprodex.cfm","2005-05-02 00:00:00",
21725,3,21537,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021537Orig1s008.pdf","2015-08-25 00:00:00",
15723,2,21537,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf","2015-12-15 00:00:00",
28058,1,21537,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021537Orig1s012ltr.pdf","2015-12-14 00:00:00",
5678,1,21538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021538s000ltr.pdf","2008-01-25 00:00:00",
24204,21,21538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538s000_SumR.pdf","2010-02-24 00:00:00",
37179,2,21538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf","2008-01-30 00:00:00",
42204,3,21538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538_accretropin_toc.cfm","2010-02-24 00:00:00",
53407,20,21538,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021538_Somatropin_Clinical_PREA.pdf","1900-01-01 00:00:00",
53408,18,21538,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021538_Somatropin_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53409,17,21538,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021538_Somatropin_Statistical_PREA.pdf","1900-01-01 00:00:00",
46160,1,21538,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021538Orig1s002ltr.pdf","2016-12-15 00:00:00",
46182,2,21538,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021538s002lbl.pdf","2016-12-14 00:00:00",
5679,1,21539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539ltr.pdf","2004-02-02 00:00:00",
15724,2,21539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-acetylcysteine_lbl.pdf","2004-02-03 00:00:00",
28059,1,21539,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr001ltr.pdf","2004-04-29 00:00:00",
37180,2,21539,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr001_acetadote_lbl.pdf","2004-05-04 00:00:00",
42205,3,21539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-539_Acetadote.cfm","2004-10-18 00:00:00",
15725,2,21539,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr002_acetadote_lbl.pdf","2004-05-04 00:00:00",
28060,1,21539,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr002ltr.pdf","2004-05-03 00:00:00",
5680,1,21539,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021539s004ltr.pdf","2006-02-22 00:00:00",
37181,2,21539,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021539s004lbl.pdf","2006-02-22 00:00:00",
5681,1,21539,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021539s005ltr.pdf","2008-12-19 00:00:00",
15726,2,21539,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf","2013-06-11 00:00:00",
28061,1,21539,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021539Orig1s012ltr.pdf","2013-06-06 00:00:00",
5682,1,21539,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021539Orig1s015ltr.pdf","2016-08-02 00:00:00",
37182,2,21539,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021539s015lbl.pdf","2016-08-02 00:00:00",
46959,2,21539,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021539s016lbl.pdf","2017-01-24 00:00:00",
46987,1,21539,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021539Orig1s016ltr.pdf","2017-01-27 00:00:00",
21726,3,21540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021540S000_Caduet.cfm","2004-08-05 00:00:00",
28062,1,21540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf","2004-02-03 00:00:00",
37183,2,21540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21540_caduet_lbl.pdf","2004-02-03 00:00:00",
28063,1,21540,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf","2004-09-29 00:00:00",
37184,2,21540,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21540s003lbl.pdf","2004-09-29 00:00:00",
15727,2,21540,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021540s006lbl.pdf","2006-08-29 00:00:00",
28064,1,21540,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s006ltr.pdf","2006-09-18 00:00:00",
28065,1,21540,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s008ltr.pdf","2006-04-20 00:00:00",
37185,2,21540,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021540s008lbl.pdf","2006-04-14 00:00:00",
28066,1,21540,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s009ltr.pdf","2007-09-25 00:00:00",
37186,2,21540,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021540s009lbl.pdf","2007-09-26 00:00:00",
28067,1,21540,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s011ltr.pdf","2007-09-25 00:00:00",
37187,2,21540,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021540s011lbl.pdf","2007-09-26 00:00:00",
28068,1,21540,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021540s014ltr.pdf","2008-06-02 00:00:00",
15728,2,21540,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021540s018lbl.pdf","2009-07-23 00:00:00",
28069,1,21540,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021540s018ltr.pdf","2009-11-24 00:00:00",
15729,2,21540,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021540s019lbl.pdf","2010-02-23 00:00:00",
28070,1,21540,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021540s019ltr.pdf","2010-02-23 00:00:00",
28071,1,21540,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026ltr.pdf","2012-07-30 00:00:00",
37188,2,21540,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s023s026lbl.pdf","2012-07-30 00:00:00",
28072,1,21540,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026ltr.pdf","2012-07-30 00:00:00",
37189,2,21540,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s023s026lbl.pdf","2012-07-30 00:00:00",
5683,1,21540,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s028ltr.pdf","2012-11-06 00:00:00",
37190,2,21540,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s028lbl.pdf","2012-11-02 00:00:00",
5684,1,21540,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021540Orig1s030,s031ltr.pdf","2013-11-12 00:00:00",
15730,2,21540,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021540s030s031lbl.pdf","2013-11-13 00:00:00",
5685,1,21540,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021540Orig1s030,s031ltr.pdf","2013-11-12 00:00:00",
37191,2,21540,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021540s030s031lbl.pdf","2013-11-13 00:00:00",
15731,2,21540,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021540s034lbl.pdf","2014-05-28 00:00:00",
28073,1,21540,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021540Orig1s034ltr.pdf","2014-05-27 00:00:00",
5686,1,21540,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021540Orig1s036ltr.pdf","2015-03-25 00:00:00",
15732,2,21540,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s036lbl.pdf","2015-03-27 00:00:00",
15733,2,21540,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s037lbl.pdf","2015-03-27 00:00:00",
28074,1,21540,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021540Orig1s037ltr.pdf","2015-02-19 00:00:00",
50260,2,21540,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021540s038lbl.pdf","2017-11-02 00:00:00",
48841,1,21540,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021540Origs039ltr.pdf","2017-06-27 00:00:00",
48847,2,21540,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021540s039lbl.pdf","2017-06-27 00:00:00",
54357,1,21540,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021540Orig1s041ltr.pdf","2018-05-29 00:00:00",
54364,2,21540,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021540s041lbl.pdf","2018-05-29 00:00:00",
55488,1,21540,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021540Orig1s042s043ltr.pdf","2018-09-14 00:00:00",
55525,2,21540,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021540s042s043lbl.pdf","2018-09-19 00:00:00",
55489,1,21540,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021540Orig1s042s043ltr.pdf","2018-09-14 00:00:00",
55526,2,21540,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021540s042s043lbl.pdf","2018-09-19 00:00:00",
5687,1,21543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543ltr.pdf","2003-06-22 00:00:00",
5688,1,21543,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543slr001ltr.pdf","2003-11-28 00:00:00",
15734,2,21543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21543_striant_lbl.pdf","2003-06-22 00:00:00",
42206,3,21543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-543_Striant.cfm","2004-10-26 00:00:00",
15735,2,21543,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21543s002lbl.pdf","2004-11-08 00:00:00",
28075,1,21543,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21543s002ltr.pdf","2004-11-08 00:00:00",
5689,1,21543,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s009ltr.pdf","2014-03-25 00:00:00",
37192,2,21543,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s009lbl.pdf","2014-03-25 00:00:00",
15736,2,21543,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s010lbl.pdf","2014-06-23 00:00:00",
28076,1,21543,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s010ltr.pdf","2014-06-23 00:00:00",
28077,1,21543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021543Orig1s011ltr.pdf","2015-05-13 00:00:00",
37193,2,21543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021543s011lbl.pdf","2015-05-13 00:00:00",
45675,1,21543,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021543Orig1s012ltr.pdf","2016-10-27 00:00:00",
45753,2,21543,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021543s012lbl.pdf","2016-11-01 00:00:00",
15737,2,21544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf","2003-09-25 00:00:00",
21727,3,21544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-544_Seasonale.cfm","2004-03-24 00:00:00",
28078,1,21544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21544ltr.pdf","2003-09-25 00:00:00",
47814,1,21544,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf","2017-04-03 00:00:00",
47842,2,21544,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf","2017-04-03 00:00:00",
47815,1,21544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf","2017-04-03 00:00:00",
47843,2,21544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf","2017-04-03 00:00:00",
49330,2,21544,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s013lbl.pdf","2017-08-10 00:00:00",
49376,1,21544,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s013ltr.pdf","2017-08-15 00:00:00",
5690,1,21545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021545ltr.pdf","2004-12-29 00:00:00",
15738,2,21545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021545lbl.pdf","2004-12-29 00:00:00",
21728,3,21545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021545s000TOC.cfm","2007-02-20 00:00:00",
15739,2,21545,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s006lbl.pdf","2007-05-01 00:00:00",
28079,1,21545,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s006ltr.pdf","2007-05-01 00:00:00",
5691,1,21545,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf","2007-06-14 00:00:00",
37194,2,21545,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf","2007-06-12 00:00:00",
5692,1,21545,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf","2007-06-14 00:00:00",
37195,2,21545,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf","2007-06-12 00:00:00",
28080,1,21545,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021545s013ltr.pdf","2010-12-10 00:00:00",
37196,2,21545,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021545s013lbl.pdf","2010-12-08 00:00:00",
5693,1,21546,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21546ltr.pdf","2003-08-06 00:00:00",
15740,2,21546,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21546_rebetol_lbl.pdf","2004-06-14 00:00:00",
28081,1,21546,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf","2010-01-20 00:00:00",
37197,2,21546,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf","2009-11-16 00:00:00",
42207,3,21546,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-546_Rebetol.cfm","2005-04-08 00:00:00",
43768,8,21546,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089017.pdf","2007-02-20 00:00:00",
5694,1,21546,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002ltr.pdf","2010-11-03 00:00:00",
37198,2,21546,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf","2010-10-29 00:00:00",
5695,1,21546,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004ltr.pdf","2011-05-10 00:00:00",
28082,1,21546,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546Orig1s006ltr.pdf","2013-02-08 00:00:00",
37199,2,21546,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf","2013-02-08 00:00:00",
5696,1,21546,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546Orig1s007ltr.pdf","2013-06-04 00:00:00",
15741,2,21546,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf","2013-06-04 00:00:00",
28083,1,21546,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546Orig1s008ltr.pdf","2013-11-18 00:00:00",
37200,2,21546,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf","2013-11-22 00:00:00",
15742,2,21546,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf","2015-05-27 00:00:00",
28084,1,21546,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546Orig1s009ltr.pdf","2015-05-22 00:00:00",
5697,1,21548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21548ltr.pdf","2003-10-27 00:00:00",
15743,2,21548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21548_levixa_lbl.pdf","2003-10-27 00:00:00",
21729,3,21548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-548_Lexiva.cfm","2004-10-26 00:00:00",
5698,1,21548,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21548s002ltr.pdf","2004-12-02 00:00:00",
15744,2,21548,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21548s002lbl.pdf","2004-12-03 00:00:00",
15745,2,21548,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s004lbl.pdf","2005-06-14 00:00:00",
28085,1,21548,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s004ltr.pdf","2005-06-14 00:00:00",
5699,1,21548,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s005ltr.pdf","2005-11-18 00:00:00",
15746,2,21548,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s005lbl.pdf","2005-11-17 00:00:00",
5700,1,21548,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s007ltr.pdf","2006-03-23 00:00:00",
15747,2,21548,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s007lbl.pdf","2006-03-14 00:00:00",
28086,1,21548,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s008ltr.pdf","2006-05-16 00:00:00",
37201,2,21548,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s008lbl.pdf","2006-05-16 00:00:00",
5701,1,21548,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s009LTR.pdf","2006-08-09 00:00:00",
15748,2,21548,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s009lbl.pdf","2006-08-09 00:00:00",
15749,2,21548,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s010lbl.pdf","2007-02-21 00:00:00",
28087,1,21548,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s010ltr.pdf","2007-02-12 00:00:00",
5702,1,21548,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s011ltr.pdf","2006-11-22 00:00:00",
15750,2,21548,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s011lbl.pdf","2006-11-16 00:00:00",
5703,1,21548,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s013ltr.pdf","2007-10-22 00:00:00",
15751,2,21548,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s013lbl.pdf","2007-10-15 00:00:00",
5704,1,21548,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s014ltr.pdf","2008-01-09 00:00:00",
15752,2,21548,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s014lbl.pdf","2007-12-14 00:00:00",
5705,1,21548,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s015ltr.pdf","2008-01-09 00:00:00",
15753,2,21548,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s015lbl.pdf","2007-12-27 00:00:00",
5706,1,21548,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s016ltr.pdf","2008-02-22 00:00:00",
15754,2,21548,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s016lbl.pdf","2008-02-25 00:00:00",
15755,2,21548,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf","2008-03-07 00:00:00",
28088,1,21548,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017, 022116s001ltr.pdf","2008-03-07 00:00:00",
28089,1,21548,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019, 022116s003ltr.pdf","2008-05-05 00:00:00",
5707,1,21548,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004ltr.pdf","2009-04-20 00:00:00",
15756,2,21548,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf","2009-09-18 00:00:00",
28090,1,21548,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005ltr.pdf","2009-10-26 00:00:00",
5708,1,21548,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024, 022116s008ltr.pdf","2010-04-29 00:00:00",
37202,2,21548,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf","2010-05-03 00:00:00",
15757,2,21548,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf","2011-05-16 00:00:00",
28091,1,21548,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010ltr.pdf","2011-05-16 00:00:00",
15758,2,21548,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf","2012-05-01 00:00:00",
28092,1,21548,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf","2012-05-02 00:00:00",
51613,23,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_Fosamprenavir_ Original_WR.pdf","2012-01-10 00:00:00",
51614,25,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_ Fosamprenavir_WR_Amendment 1.pdf","2012-01-10 00:00:00",
51615,26,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_Fosamprenavir_WR_ Amendment 2.pdf","2012-01-10 00:00:00",
51616,27,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_Fosamprenavir_ WR_Amendment 3.pdf","2012-01-10 00:00:00",
51617,28,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_Fosamprenavir_WR_ Amendment 4.pdf","2012-01-10 00:00:00",
51618,29,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021548_022116_Fosamprenavir_ WR_Amendment 5.pdf","2012-01-10 00:00:00",
52955,18,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21548 fosamprenavir clinpharm bpca-prea.pdf","2012-01-10 00:00:00",
52956,20,21548,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21548 fosamprenavir clinical bpca-prea.pdf","2012-01-10 00:00:00",
5709,1,21548,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013ltr.pdf","2012-02-27 00:00:00",
15759,2,21548,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf","2012-02-22 00:00:00",
15760,2,21548,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf","2013-02-14 00:00:00",
28093,1,21548,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf","2013-02-14 00:00:00",
5710,1,21548,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116Orig1s019ltr.pdf","2015-07-20 00:00:00",
15761,2,21548,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf","2015-07-22 00:00:00",
5711,1,21548,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf","2015-04-01 00:00:00",
37203,2,21548,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf","2015-04-02 00:00:00",
15762,2,21548,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf","2016-03-23 00:00:00",
28094,1,21548,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf","2016-03-24 00:00:00",
45334,1,21548,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf","2016-09-20 00:00:00",
45383,2,21548,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023_21548-s39lbl.pdf","2016-09-27 00:00:00",
50601,2,21548,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021548s040lbledt.pdf","2017-12-05 00:00:00",
50602,1,21548,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021548s040ltr.pdf","2017-12-05 00:00:00",
28095,1,21549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21549ltr.pdf","2003-03-28 00:00:00",
37204,2,21549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf","2003-03-28 00:00:00",
42208,3,21549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-549_Emend.cfm","2003-07-06 00:00:00",
5712,1,21549,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549slr002ltr.pdf","2004-01-22 00:00:00",
21730,3,21549,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021549_S002_EMEND.pdf","2007-11-19 00:00:00",
5713,1,21549,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s004ltr.pdf","2004-12-30 00:00:00",
37205,2,21549,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf","2004-12-30 00:00:00",
28096,1,21549,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s007ltr.pdf","2004-12-29 00:00:00",
37206,2,21549,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf","2004-12-29 00:00:00",
5714,1,21549,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s008ltr.pdf","2005-11-01 00:00:00",
21731,3,21549,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021549Orig1S008.pdf","2012-03-02 00:00:00",
37207,2,21549,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf","2005-11-01 00:00:00",
5715,1,21549,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s009ltr.pdf","2005-06-14 00:00:00",
15763,2,21549,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf","2005-06-14 00:00:00",
15764,2,21549,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf","2006-07-03 00:00:00",
28097,1,21549,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.pdf","2006-07-13 00:00:00",
5716,1,21549,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s011rev1.pdf","2006-06-12 00:00:00",
37208,2,21549,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s011lbl.pdf","2006-06-14 00:00:00",
15765,2,21549,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf","2007-11-19 00:00:00",
28098,1,21549,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021549s012ltr.pdf","2007-11-19 00:00:00",
28099,1,21549,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s014ltr.pdf","2009-07-23 00:00:00",
37209,2,21549,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s014lbl.pdf","2009-07-23 00:00:00",
28100,1,21549,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021549s015ltr.pdf","2008-11-21 00:00:00",
37210,2,21549,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021549s015lbl.pdf","2008-11-19 00:00:00",
5717,1,21549,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s016ltr.pdf","2009-02-04 00:00:00",
15766,2,21549,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf","2009-02-04 00:00:00",
5718,1,21549,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021549s017ltr.pdf","2010-03-25 00:00:00",
15767,2,21549,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf","2010-03-26 00:00:00",
5719,1,21549,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s019ltr.pdf","2013-03-22 00:00:00",
37211,2,21549,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf","2013-03-26 00:00:00",
28101,1,21549,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021549Orig1s021ltr.pdf","2012-07-11 00:00:00",
37212,2,21549,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021549s021lbl.pdf","2012-07-10 00:00:00",
5720,1,21549,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf","2013-03-29 00:00:00",
15768,2,21549,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf","2013-04-01 00:00:00",
15769,2,21549,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf","2014-08-13 00:00:00",
28102,1,21549,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf","2014-08-14 00:00:00",
5721,1,21549,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021549Orig1s025ltr.pdf","2015-09-01 00:00:00",
15770,2,21549,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf","2015-09-03 00:00:00",
51530,20,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinical prea.pdf","1900-01-01 00:00:00",
51581,58,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinical addendum prea.pdf","1900-01-01 00:00:00",
51583,60,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant DD clinical prea.pdf","1900-01-01 00:00:00",
51585,18,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinpharm prea.pdf","1900-01-01 00:00:00",
51587,62,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinpharm addendum prea.pdf","1900-01-01 00:00:00",
51589,17,21549,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant statisical prea.pdf","1900-01-01 00:00:00",
48616,2,21549,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf","2017-06-01 00:00:00",
48635,1,21549,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021549Orig1s027,207865Orig1s001ltr.pdf","2017-06-02 00:00:00",
15771,2,21551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21551_halflytely_lbl.pdf","2004-05-27 00:00:00",
28103,1,21551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21551ltr.pdf","2004-05-26 00:00:00",
42209,3,21551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021551s000_HalfLytelyTOC.cfm","2005-12-01 00:00:00",
43769,8,21551,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf","2010-07-30 00:00:00",
53285,20,21551,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21551_HLB_Clinical_PREA.pdf","1900-01-01 00:00:00",
53286,18,21551,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21551_HLB_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53287,17,21551,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21551_HLB_Statistical_PREA.pdf","1900-01-01 00:00:00",
5722,1,21551,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21551s003ltr.pdf","2005-03-03 00:00:00",
15772,2,21551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021551s005lbl.pdf","2006-05-22 00:00:00",
28104,1,21551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021551s005ltr.pdf","2006-05-21 00:00:00",
5723,1,21551,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021551s006ltr.pdf","2007-09-26 00:00:00",
37213,2,21551,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021551s006lbl.pdf","2007-09-26 00:00:00",
5724,1,21551,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021551s013ltr.pdf","2010-07-23 00:00:00",
15773,2,21551,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021551s013lbl.pdf","2010-07-19 00:00:00",
5725,1,21551,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021551s016ltr.pdf","2011-07-12 00:00:00",
21732,3,21554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554s000_CirpoXRTOC.cfm","2005-12-01 00:00:00",
28105,1,21554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21554ltr.pdf","2003-09-09 00:00:00",
37214,2,21554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21554_ciproXR_lbl.pdf","2003-09-09 00:00:00",
44480,14,21554,"ORIG",1,"Review/Approval","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554Orig1s000Approv.pdf","2016-02-03 00:00:00",
5726,1,21555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21555ltr.pdf","2002-10-07 00:00:00",
5727,1,21555,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021555s001ltr.pdf","2005-05-17 00:00:00",
15774,2,21555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf","2002-10-07 00:00:00",
42210,3,21555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-555_Chloraprep.cfm","2005-01-11 00:00:00",
28106,1,21555,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021555s003ltr.pdf","2009-06-16 00:00:00",
5728,1,21555,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s011,021555s005rev2.pdf","2006-01-06 00:00:00",
28107,1,21555,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021555s007ltr.pdf","2006-12-28 00:00:00",
28108,1,21555,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021555s009ltr.pdf","2007-08-14 00:00:00",
37215,2,21555,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf","2007-08-14 00:00:00",
5729,1,21555,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021555s015ltr.pdf","2010-07-23 00:00:00",
5730,1,21555,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf","2012-08-17 00:00:00",
15775,2,21555,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf","2014-01-15 00:00:00",
5731,1,21555,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Origs030,021555Orig1s017ltr.pdf","2012-08-17 00:00:00",
37216,2,21555,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf","2014-01-15 00:00:00",
5732,1,21555,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020832Orig1s031,021555Orig1s018ltr.pdf","2013-10-11 00:00:00",
37217,2,21555,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf","2013-11-20 00:00:00",
28109,1,21555,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020832Orig1s034,021555Orig1s019ltr.pdf","2014-07-01 00:00:00",
37218,2,21555,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf","2014-07-31 00:00:00",
50913,2,21555,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020ltr.pdf","2017-12-27 00:00:00",
49755,1,21555,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21555Orig1s024ltr.pdf","2017-09-12 00:00:00",
49823,2,21555,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf","2017-09-21 00:00:00",
5733,1,21559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21559ltr.pdf","2003-06-22 00:00:00",
21733,3,21559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-559_Infuvite.cfm","2004-08-09 00:00:00",
37219,2,21559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21559_infuvite_lbl.pdf","2003-06-22 00:00:00",
28110,1,21559,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21559s005ltr.pdf","2004-07-21 00:00:00",
28111,1,21559,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021559s009ltr.pdf","2009-01-21 00:00:00",
37220,2,21559,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021559s009lbl.pdf","2009-01-16 00:00:00",
28112,1,21559,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021559Orig1s015ltr.pdf","2012-12-05 00:00:00",
37221,2,21559,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021559s015lbl.pdf","2012-12-05 00:00:00",
15776,2,21559,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021163s032,021559s025lbl.pdf","2016-03-22 00:00:00",
28113,1,21559,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021163Orig1s032,021559Orig1s025ltr.pdf","2016-03-21 00:00:00",
21734,3,21560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000_zortress_toc.cfm","2010-06-16 00:00:00",
24205,21,21560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000sumr.pdf","2010-06-16 00:00:00",
28114,1,21560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021560s000ltr.pdf","2010-04-29 00:00:00",
37222,2,21560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf","2010-05-03 00:00:00",
28115,1,21560,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021560s004ltr.pdf","2011-11-28 00:00:00",
5734,1,21560,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021560Orig1s006ltr.pdf","2013-02-20 00:00:00",
15777,2,21560,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf","2013-02-20 00:00:00",
5735,1,21560,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s007ltr.pdf","2012-04-27 00:00:00",
37223,2,21560,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf","2012-05-01 00:00:00",
5736,1,21560,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s008ltr.pdf","2012-10-04 00:00:00",
37224,2,21560,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf","2012-10-04 00:00:00",
5737,1,21560,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560s009ltr.pdf","2012-05-04 00:00:00",
28116,1,21560,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s011ltr.pdf","2015-01-28 00:00:00",
37225,2,21560,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf","2015-01-30 00:00:00",
5738,1,21560,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s018ltr.pdf","2015-11-09 00:00:00",
37226,2,21560,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf","2015-11-12 00:00:00",
45546,1,21560,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021560Orig1s019ltr.pdf","2016-10-14 00:00:00",
45622,2,21560,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf","2016-10-17 00:00:00",
51060,1,21560,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021560Orig1s020ltr.pdf","2018-01-17 00:00:00",
51068,2,21560,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s020lbl.pdf","2018-01-17 00:00:00",
51078,2,21560,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf","2018-01-18 00:00:00",
51079,8,21560,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf#page=32","2018-01-18 00:00:00",
15778,2,21563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21563lbl.pdf","2004-09-03 00:00:00",
21735,3,21563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021563s000_ClarinexTOC.cfm","2006-07-10 00:00:00",
28117,1,21563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21563ltr.pdf","2004-09-03 00:00:00",
28118,1,21563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021165s014,021300s011,021312s011,021563s001ltr.pdf","2010-12-28 00:00:00",
37227,2,21563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021165s014lbl.pdf","2012-07-27 00:00:00",
5739,1,21563,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf","2014-04-24 00:00:00",
15779,2,21563,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf","2014-04-25 00:00:00",
5740,1,21565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf","2003-10-14 00:00:00",
15780,2,21565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf","2003-10-17 00:00:00",
42211,3,21565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.cfm","2003-12-31 00:00:00",
28119,1,21565,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf","2005-08-19 00:00:00",
37228,2,21565,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf","2005-08-16 00:00:00",
15781,2,21565,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf","2011-12-23 00:00:00",
28120,1,21565,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf","2011-12-22 00:00:00",
15782,2,21566,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf","2005-04-12 00:00:00",
28121,1,21566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21566ltr.pdf","2004-06-01 00:00:00",
28122,1,21566,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021566s001ltr.pdf","2005-04-12 00:00:00",
37229,2,21566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21566_prevacid_lb.pdf","2004-06-01 00:00:00",
42212,3,21566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021566s000_PrevacidTOC.cfm","2006-03-21 00:00:00",
44135,10,21566,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
5741,1,21566,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021566s002ltr.pdf","2007-01-08 00:00:00",
28123,1,21566,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021566s004ltr.pdf","2007-05-29 00:00:00",
28124,1,21566,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021566s005ltr.pdf","2009-11-10 00:00:00",
37230,2,21566,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021566s005lbl.pdf","2009-08-13 00:00:00",
5742,1,21567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21567ltr.pdf","2003-08-06 00:00:00",
5743,1,21567,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567slr001ltr.pdf","2004-03-19 00:00:00",
37231,2,21567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21567_reyataz_lbl.pdf","2003-07-08 00:00:00",
37232,2,21567,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567slr001_reyataz_lbl.pdf","2004-04-05 00:00:00",
42213,3,21567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021567_reyataz_toc.cfm","2003-09-09 00:00:00",
5744,1,21567,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567se2-002ltr.pdf","2004-07-07 00:00:00",
15783,2,21567,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567se2-002_reyataz_lbl.pdf","2004-07-07 00:00:00",
5745,1,21567,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567s004ltr.pdf","2004-10-08 00:00:00",
37233,2,21567,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567s004lbl.pdf","2004-10-08 00:00:00",
15784,2,21567,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021567s005lbl.pdf","2005-07-21 00:00:00",
28125,1,21567,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021567s005ltr.pdf","2005-07-21 00:00:00",
28126,1,21567,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s007ltr.pdf","2006-01-30 00:00:00",
37234,2,21567,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s007lbl.pdf","2006-01-25 00:00:00",
28127,1,21567,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf","2006-08-14 00:00:00",
37235,2,21567,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf","2006-08-11 00:00:00",
5746,1,21567,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s009ltr.pdf","2006-10-23 00:00:00",
37236,2,21567,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf","2006-10-18 00:00:00",
15785,2,21567,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf","2006-08-11 00:00:00",
28128,1,21567,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf","2006-08-14 00:00:00",
28129,1,21567,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s012LTR.pdf","2007-03-31 00:00:00",
37237,2,21567,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s012lbl.pdf","2007-03-31 00:00:00",
15786,2,21567,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s014lbl.pdf","2008-01-08 00:00:00",
28130,1,21567,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s014ltr.pdf","2008-01-09 00:00:00",
28131,1,21567,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s015ltr.pdf","2008-03-28 00:00:00",
37238,2,21567,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s015lbl.pdf","2008-03-27 00:00:00",
5747,1,21567,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s016ltr.pdf","2008-08-20 00:00:00",
37239,2,21567,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s016lbl.pdf","2008-08-26 00:00:00",
28132,1,21567,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s017ltr.pdf","2008-10-02 00:00:00",
37240,2,21567,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s017lbl.pdf","2008-10-03 00:00:00",
15787,2,21567,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s018lbl.pdf","2008-02-25 00:00:00",
28133,1,21567,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s018ltr.pdf","2008-02-22 00:00:00",
15788,2,21567,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021567s019lbl.pdf","2009-11-23 00:00:00",
21736,3,21567,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021567Orig1s019.pdf","2014-08-05 00:00:00",
28134,1,21567,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021567s019ltr.pdf","2010-01-25 00:00:00",
28135,1,21567,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s022ltr.pdf","2010-01-28 00:00:00",
37241,2,21567,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s022lbl.pdf","2010-01-24 00:00:00",
5748,1,21567,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s023ltr.pdf","2010-04-29 00:00:00",
37242,2,21567,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s023lbl.pdf","2010-05-03 00:00:00",
15789,2,21567,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s025lbl.pdf","2011-02-09 00:00:00",
28136,1,21567,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s025ltr.pdf","2011-02-10 00:00:00",
42214,3,21567,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021567Orig1s025.pdf","2015-07-20 00:00:00",
28137,1,21567,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s026ltr.pdf","2011-10-19 00:00:00",
37243,2,21567,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s026lbl.pdf","2011-10-17 00:00:00",
5749,1,21567,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s027ltr.pdf","2012-02-23 00:00:00",
37244,2,21567,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s027lbl.pdf","2012-02-24 00:00:00",
15790,2,21567,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s028lbl.pdf","2012-03-16 00:00:00",
28138,1,21567,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s028ltr.pdf","2012-03-16 00:00:00",
28139,1,21567,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s031ltr.pdf","2013-02-04 00:00:00",
5750,1,21567,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf","2013-08-20 00:00:00",
37245,2,21567,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf","2013-08-21 00:00:00",
15791,2,21567,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf","2013-08-21 00:00:00",
28140,1,21567,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf","2013-08-20 00:00:00",
15792,2,21567,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf","2014-06-03 00:00:00",
21737,3,21567,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm","2015-04-07 00:00:00",
24206,21,21567,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf","2015-04-07 00:00:00",
28141,1,21567,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf","2014-06-03 00:00:00",
51738,20,21567,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000,021567Orig1s035_Atazanavir_Clinical.pdf","1900-01-01 00:00:00",
51742,18,21567,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinpharm.pdf","1900-01-01 00:00:00",
51743,17,21567,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Statistical.pdf","1900-01-01 00:00:00",
5751,1,21567,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s036ltr.pdf","2015-02-27 00:00:00",
15793,2,21567,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf","2015-04-02 00:00:00",
28142,1,21567,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf","2015-04-01 00:00:00",
28143,1,21567,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf","2015-09-28 00:00:00",
37246,2,21567,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf","2015-12-10 00:00:00",
51248,23,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Orig_WR.pdf","2011-08-02 00:00:00",
51249,25,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Amend_1.pdf","2003-08-25 00:00:00",
51250,40,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Reissue_1.pdf","2006-12-04 00:00:00",
51251,41,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Reissue_2.pdf","2008-05-01 00:00:00",
51252,42,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Reissue_3.pdf","2009-04-29 00:00:00",
51253,43,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Reissue_4.pdf","2011-11-22 00:00:00",
51254,44,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM452756.pdf","2013-01-29 00:00:00",
51255,45,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021567_atazanavir_Reissue_6.pdf","2013-05-20 00:00:00",
51739,20,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir clinical both.pdf","1900-01-01 00:00:00",
51746,18,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir clinpharm both.pdf","1900-01-01 00:00:00",
51747,17,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir statistical both.pdf","1900-01-01 00:00:00",
54094,20,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinical.pdf","1900-01-01 00:00:00",
54095,20,21567,"SUPPL",38,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinical.pdf","1900-01-01 00:00:00",
45307,2,21567,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf","2016-09-15 00:00:00",
45337,1,21567,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf","2016-09-20 00:00:00",
48528,1,21567,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s040,206352Orig1s005ltr.pdf","2017-05-25 00:00:00",
48542,2,21567,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf","2017-05-25 00:00:00",
50140,1,21567,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s041,206352Orig1s006ltr.pdf","2017-10-23 00:00:00",
50165,2,21567,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf","2017-10-24 00:00:00",
53740,2,21567,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf","2018-04-19 00:00:00",
53767,1,21567,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021567Orig1s042,206352Orig1s007ltr.pdf","2018-04-20 00:00:00",
5752,1,21569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021569s000ltr.pdf","2006-08-04 00:00:00",
21738,3,21569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021569s000TOC.cfm","2007-09-11 00:00:00",
37247,2,21569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021569PI.pdf","2006-08-04 00:00:00",
5753,1,21569,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021569s002ltr.pdf","2008-04-30 00:00:00",
37248,2,21569,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021569s002lbl.pdf","2008-06-12 00:00:00",
37249,2,21569,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021569s003lbl.pdf","2009-10-16 00:00:00",
5754,1,21569,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021569s004ltr.pdf","2012-03-12 00:00:00",
15794,2,21569,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021569s004lbl.pdf","2012-03-06 00:00:00",
5755,1,21571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21571ltr.pdf","2004-03-02 00:00:00",
21739,3,21571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/NDA21-271_Iquix.cfm","2004-10-26 00:00:00",
37250,2,21571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21571_iquix_lbl.pdf","2004-03-03 00:00:00",
15795,2,21571,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021571s006lbl.pdf","2014-12-10 00:00:00",
28144,1,21571,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021571Orig1s006ltr.pdf","2014-12-04 00:00:00",
5756,1,21572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21572ltr.pdf","2003-09-25 00:00:00",
21740,3,21572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-572_Cubicin.cfm","2003-12-15 00:00:00",
37251,2,21572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21572_cubicin_lbl.pdf","2003-09-25 00:00:00",
28145,1,21572,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021572s006ltr.pdf","2005-10-19 00:00:00",
37252,2,21572,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021572s006lbl.pdf","2005-10-19 00:00:00",
5757,1,21572,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s007ltr.pdf","2007-08-22 00:00:00",
37253,2,21572,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s007lbl.pdf","2007-08-22 00:00:00",
5758,1,21572,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s008LTR.pdf","2006-05-26 00:00:00",
15796,2,21572,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf","2006-05-26 00:00:00",
15797,2,21572,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s009lbl.pdf","2006-10-25 00:00:00",
28146,1,21572,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s009ltr.pdf","2006-11-06 00:00:00",
5759,1,21572,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s010ltr.pdf","2007-02-23 00:00:00",
15798,2,21572,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s010lbl.pdf","2007-02-21 00:00:00",
15799,2,21572,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s011lbl.pdf","2007-02-21 00:00:00",
28147,1,21572,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s011ltr.pdf","2007-02-23 00:00:00",
5760,1,21572,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s014ltr.pdf","2007-10-10 00:00:00",
37254,2,21572,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s014lbl.pdf","2007-10-10 00:00:00",
5761,1,21572,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021572s021ltr.pdf","2009-02-13 00:00:00",
28148,1,21572,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
37255,2,21572,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
5762,1,21572,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
37256,2,21572,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
15800,2,21572,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
28149,1,21572,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
28150,1,21572,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
37257,2,21572,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
28151,1,21572,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
37258,2,21572,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
28152,1,21572,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s031ltr.pdf","2010-12-10 00:00:00",
15801,2,21572,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf","2010-12-02 00:00:00",
28153,1,21572,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf","2010-12-06 00:00:00",
15802,2,21572,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf","2010-08-28 00:00:00",
15803,2,21572,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s037lbl.pdf","2012-05-23 00:00:00",
28154,1,21572,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s037ltr.pdf","2012-05-23 00:00:00",
5763,1,21572,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021572s038ltr.pdf","2011-10-04 00:00:00",
15804,2,21572,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021572s038lbl.pdf","2011-10-03 00:00:00",
28155,1,21572,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s039ltr.pdf","2012-06-15 00:00:00",
37259,2,21572,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s039lbl.pdf","2012-06-18 00:00:00",
5764,1,21572,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572Orig1s040ltr.pdf","2012-10-15 00:00:00",
15805,2,21572,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s040lbl.pdf","2012-10-12 00:00:00",
5765,1,21572,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf","2013-11-26 00:00:00",
37260,2,21572,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf","2013-11-26 00:00:00",
28156,1,21572,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf","2013-11-26 00:00:00",
37261,2,21572,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf","2013-11-26 00:00:00",
5766,1,21572,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021572Orig1s046ltr.pdf","2014-11-28 00:00:00",
37262,2,21572,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021572s046lbl.pdf","2014-12-19 00:00:00",
5767,1,21572,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s048ltr.pdf","2015-08-06 00:00:00",
15806,2,21572,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572Orig1s048lbledt.pdf","2015-08-04 00:00:00",
5768,1,21572,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s050ltr.pdf","2015-09-18 00:00:00",
37263,2,21572,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572s050lbl.pdf","2015-12-03 00:00:00",
37264,2,21572,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s052lbl.pdf","2016-07-08 00:00:00",
45788,3,21572,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021572Orig1s052.pdf","2016-11-02 00:00:00",
28157,1,21572,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021572Orig1s053ltr.pdf","2016-07-12 00:00:00",
37265,2,21572,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s053lbl.pdf","2016-07-18 00:00:00",
45789,3,21572,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021572Orig1s053.pdf","2016-11-02 00:00:00",
47789,2,21572,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s055lbl.pdf","2017-03-30 00:00:00",
47831,1,21572,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s055ltr.pdf","2017-04-03 00:00:00",
52592,20,21572,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/181_21572S57 daptomycin clinical prea.pdf","1900-01-01 00:00:00",
52593,18,21572,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/178_21572S57 daptomycin clinpharm addendum prea.pdf","1900-01-01 00:00:00",
49664,2,21572,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s057lbl.pdf","2017-09-05 00:00:00",
49677,1,21572,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s057ltr.pdf","2017-09-06 00:00:00",
52892,18,21572,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/179_21572S57 daptomycin clinpharm prea.pdf","1900-01-01 00:00:00",
52894,20,21572,"SUPPL",57,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/181_21572S57 daptomycin clinical prea.pdf","1900-01-01 00:00:00",
47790,2,21572,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s058lbl.pdf","2017-03-30 00:00:00",
47832,1,21572,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s058ltr.pdf","2017-04-03 00:00:00",
48695,2,21572,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s059lbl.pdf","2017-06-12 00:00:00",
48701,1,21572,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s059ltr.pdf","2017-06-12 00:00:00",
49663,2,21572,"SUPPL",60,"cubicin RF","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s060lblcubicinRF.pdf","2017-09-05 00:00:00",
49676,1,21572,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s060ltr.pdf","2017-09-06 00:00:00",
51736,2,21572,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s060lblcubicin.pdf","2018-01-25 00:00:00",
15807,2,21574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf","2004-05-04 00:00:00",
28158,1,21574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21574ltr.pdf","2004-04-29 00:00:00",
42215,3,21574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021574s000_ForametTOC.cfm","2006-02-08 00:00:00",
5769,1,21574,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021574s005ltr.pdf","2006-02-22 00:00:00",
15808,2,21574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf","2007-04-20 00:00:00",
28159,1,21574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021574s006)_LTR.pdf","2007-04-25 00:00:00",
5770,1,21574,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021574s010ltr.pdf","2008-07-31 00:00:00",
37266,2,21574,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf","2008-08-13 00:00:00",
47928,2,21574,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021574s020lbl.pdf","2017-04-11 00:00:00",
47951,1,21574,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021574Orig1s020ltr.pdf","2017-04-12 00:00:00",
15809,2,21575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21575_fosomax_lbl.pdf","2003-09-25 00:00:00",
21741,3,21575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-575_Fosamax.cfm","2005-04-08 00:00:00",
23286,8,21575,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf","2012-06-29 00:00:00",
23669,10,21575,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
28160,1,21575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21575ltr.pdf","2003-09-25 00:00:00",
28161,1,21575,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf","2004-04-29 00:00:00",
5771,1,21575,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf","2004-03-03 00:00:00",
15810,2,21575,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf","2004-04-05 00:00:00",
21742,3,21575,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf","2007-07-06 00:00:00",
5772,1,21575,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf","2004-04-20 00:00:00",
37267,2,21575,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf","2004-05-03 00:00:00",
42216,3,21575,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021575_s004_FOSAMAX TABS.pdf","2008-07-31 00:00:00",
5773,1,21575,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf","2004-12-08 00:00:00",
15811,2,21575,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf","2004-12-08 00:00:00",
5774,1,21575,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf","2004-12-08 00:00:00",
37268,2,21575,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf","2004-12-08 00:00:00",
28162,1,21575,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007.pdf","2006-01-06 00:00:00",
42217,3,21575,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020560s038_021575s007lbl.pdf","2006-01-05 00:00:00",
28163,1,21575,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf","2005-11-08 00:00:00",
37269,2,21575,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf","2005-11-03 00:00:00",
5775,1,21575,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
15812,2,21575,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
28164,1,21575,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
37270,2,21575,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
5776,1,21575,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
15813,2,21575,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
28165,1,21575,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf","2008-10-09 00:00:00",
37271,2,21575,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf","2008-11-07 00:00:00",
28166,1,21575,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
37272,2,21575,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
28167,1,21575,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf","2012-02-08 00:00:00",
37273,2,21575,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021575s017lbl.pdf","2012-02-06 00:00:00",
15814,2,21575,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf","2010-03-02 00:00:00",
28168,1,21575,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf","2010-03-05 00:00:00",
5777,1,21575,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf","2011-01-28 00:00:00",
15815,2,21575,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf","2011-01-26 00:00:00",
5778,1,21575,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf","2011-07-06 00:00:00",
28169,1,21575,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf","2013-04-23 00:00:00",
37274,2,21575,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf","2013-04-23 00:00:00",
15816,2,21575,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf","2013-12-24 00:00:00",
28170,1,21575,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf","2013-12-26 00:00:00",
28171,1,21575,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf","2015-04-13 00:00:00",
37275,2,21575,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf","2015-04-10 00:00:00",
15817,2,21575,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf","2015-12-01 00:00:00",
28172,1,21575,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf","2015-12-01 00:00:00",
15818,2,21583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf","2004-12-30 00:00:00",
28173,1,21583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf","2004-12-30 00:00:00",
28174,1,21583,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf","2005-05-04 00:00:00",
42218,3,21583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021583s000TOC.cfm","2007-05-09 00:00:00",
5779,1,21583,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s003ltr.pdf","2005-11-18 00:00:00",
15819,2,21583,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf","2005-11-16 00:00:00",
5780,1,21583,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021583s006ltr.pdf","2007-10-10 00:00:00",
15820,2,21583,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf","2007-10-10 00:00:00",
15821,2,21583,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf","2009-07-16 00:00:00",
28175,1,21583,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf","2009-07-17 00:00:00",
52790,1,21583,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021583s17ltr.pdf","2018-03-02 00:00:00",
47082,1,21583,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021583Orig1s023ltr.pdf","2017-02-01 00:00:00",
47088,2,21583,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf","2017-02-01 00:00:00",
5781,1,21583,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021583Orig1s025ltr.pdf","2015-02-02 00:00:00",
15822,2,21583,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf","2015-02-03 00:00:00",
5782,1,21583,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf","2015-01-26 00:00:00",
15823,2,21583,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf","2015-01-29 00:00:00",
46288,2,21583,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf","2016-12-20 00:00:00",
46471,1,21583,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s031ltr.pdf","2016-12-22 00:00:00",
45557,1,21583,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s032ltr.pdf","2016-10-19 00:00:00",
45621,2,21583,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf","2016-10-17 00:00:00",
21744,3,21585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm","2005-12-01 00:00:00",
28177,1,21585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21585ltr.pdf","2004-06-25 00:00:00",
28178,1,21585,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s001ltr.pdf","2005-03-03 00:00:00",
37276,2,21585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21585_mucinex_lbl.pdf","2004-06-25 00:00:00",
5783,1,21585,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf","2005-01-26 00:00:00",
28179,1,21585,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf","2007-09-07 00:00:00",
37277,2,21585,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf","2007-09-07 00:00:00",
28180,1,21585,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021585s025ltr.pdf","2010-12-22 00:00:00",
28181,1,21585,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf","2014-03-07 00:00:00",
50583,1,21585,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021620Orig1s038,021585Orig1s033ltr.pdf","2017-12-01 00:00:00",
50586,2,21585,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021620Orig1s038,021585Orig1s033lbl.pdf","2017-12-04 00:00:00",
5784,1,21586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021586s000LTR.pdf","2006-10-05 00:00:00",
21745,3,21586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000TOC.cfm","2008-08-22 00:00:00",
5785,1,21586,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021586s002ltr.pdf","2010-03-18 00:00:00",
15825,2,21586,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf","2015-06-19 00:00:00",
28182,1,21586,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021586Orig1s005ltr.pdf","2015-06-10 00:00:00",
15826,2,21587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21587_childrens_advil.pdf","2004-03-03 00:00:00",
21746,3,21587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-587_Advil.cfm","2005-04-27 00:00:00",
28183,1,21587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21587ltr.pdf","2004-02-25 00:00:00",
28184,1,21587,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021587s002ltr.pdf","2006-04-07 00:00:00",
47864,2,21587,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021587Orig1s006lbl.pdf","2017-04-05 00:00:00",
5786,1,21588,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf","2003-06-08 00:00:00",
15827,2,21588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf","2003-04-28 00:00:00",
15828,2,21588,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf","2003-05-20 00:00:00",
28185,1,21588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588ltr.pdf","2003-05-29 00:00:00",
42219,3,21588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021588s000_GleevecTOC.cfm","2006-06-07 00:00:00",
42220,3,21588,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm","2004-08-09 00:00:00",
44136,10,21588,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110502.htm","2003-12-09 00:00:00",
5787,1,21588,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se7-002ltr.pdf","2003-12-22 00:00:00",
15829,2,21588,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf","2003-12-08 00:00:00",
42221,3,21588,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-588s002_Gleevec.cfm","2005-04-08 00:00:00",
28186,1,21588,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21588slr003ltr.pdf","2004-06-25 00:00:00",
37278,2,21588,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf","2004-06-25 00:00:00",
15830,2,21588,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf","2005-03-18 00:00:00",
21747,3,21588,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf","2015-05-26 00:00:00",
28187,1,21588,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf","2005-03-18 00:00:00",
28188,1,21588,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf","2005-05-20 00:00:00",
5788,1,21588,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s007ltr.pdf","2005-05-20 00:00:00",
5789,1,21588,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s008ltr.pdf","2005-10-25 00:00:00",
15831,2,21588,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf","2005-10-25 00:00:00",
5790,1,21588,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s009ltr.pdf","2006-11-06 00:00:00",
37279,2,21588,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf","2006-11-06 00:00:00",
5791,1,21588,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s008, s010LTR.pdf","2006-06-02 00:00:00",
37280,2,21588,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf","2006-06-01 00:00:00",
5792,1,21588,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf","2006-10-23 00:00:00",
15832,2,21588,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf","2006-10-23 00:00:00",
21748,3,21588,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf","2006-10-19 00:00:00",
28189,1,21588,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf","2006-10-23 00:00:00",
37281,2,21588,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf","2006-10-23 00:00:00",
42222,3,21588,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s012_gleevic.pdf","2006-10-19 00:00:00",
5793,1,21588,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf","2006-10-23 00:00:00",
15833,2,21588,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf","2006-10-23 00:00:00",
42223,3,21588,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s013_gleevic.pdf","2006-10-19 00:00:00",
5794,1,21588,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf","2006-10-23 00:00:00",
15834,2,21588,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf","2006-10-23 00:00:00",
42224,3,21588,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s014_gleevec.pdf","2006-10-19 00:00:00",
15835,2,21588,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf","2006-09-28 00:00:00",
28190,1,21588,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf","2006-10-02 00:00:00",
51975,20,21588,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021588s016_imatinib_Gleevec-Med&StatsRev.pdf","1900-01-01 00:00:00",
51976,23,21588,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021588s016_imatinib_Orig_WR.pdf","1900-01-01 00:00:00",
51977,18,21588,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021588s016_imatinib_Gleevec-ClinPharmRev.pdf","1900-01-01 00:00:00",
51978,17,21588,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021588s016_imatinib_Gleevec-Med&StatsRev.pdf","1900-01-01 00:00:00",
21749,3,21588,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf","2006-10-19 00:00:00",
28191,1,21588,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf","2006-10-23 00:00:00",
37282,2,21588,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf","2006-10-23 00:00:00",
28192,1,21588,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf","2007-09-25 00:00:00",
37283,2,21588,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf","2007-09-19 00:00:00",
5795,1,21588,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s021ltr.pdf","2008-10-01 00:00:00",
37284,2,21588,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf","2008-09-26 00:00:00",
28193,1,21588,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf","2008-10-01 00:00:00",
37285,2,21588,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf","2008-09-26 00:00:00",
5796,1,21588,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s023ltr.pdf","2008-05-05 00:00:00",
28194,1,21588,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf","2008-10-01 00:00:00",
37286,2,21588,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf","2008-09-26 00:00:00",
5797,1,21588,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s025ltr.pdf","2008-12-29 00:00:00",
28195,1,21588,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf","2009-06-02 00:00:00",
28196,1,21588,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf","2009-02-13 00:00:00",
37287,2,21588,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf","2009-02-12 00:00:00",
5798,1,21588,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf","2009-06-02 00:00:00",
15836,2,21588,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf","2009-06-05 00:00:00",
28197,1,21588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf","2011-04-06 00:00:00",
37288,2,21588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf","2011-04-01 00:00:00",
5799,1,21588,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf","2011-04-06 00:00:00",
37289,2,21588,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf","2011-04-01 00:00:00",
5800,1,21588,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021588s035ltr_cor.pdf","2012-02-03 00:00:00",
15837,2,21588,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf","2012-01-31 00:00:00",
5801,1,21588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s037ltr.pdf","2013-01-30 00:00:00",
37290,2,21588,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf","2013-01-30 00:00:00",
5802,1,21588,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s038ltr.pdf","2013-02-25 00:00:00",
37291,2,21588,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf","2013-02-26 00:00:00",
5803,1,21588,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s039ltr.pdf","2013-10-31 00:00:00",
37292,2,21588,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf","2013-10-31 00:00:00",
5804,1,21588,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021588Orig1s040ltr.pdf","2014-05-22 00:00:00",
37293,2,21588,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf","2014-05-28 00:00:00",
15838,2,21588,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf","2015-02-03 00:00:00",
28198,1,21588,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf","2015-02-02 00:00:00",
45063,1,21588,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf","2016-08-25 00:00:00",
45169,2,21588,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf","2016-08-25 00:00:00",
45064,1,21588,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf","2016-08-25 00:00:00",
45170,2,21588,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf","2016-08-25 00:00:00",
45425,2,21588,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf","2016-09-29 00:00:00",
45472,1,21588,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s047ltr.pdf","2016-10-04 00:00:00",
48097,2,21588,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s049lbl.pdf","2017-04-25 00:00:00",
48142,1,21588,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588Orig1s049ltr.pdf","2017-04-27 00:00:00",
49680,2,21588,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s051lbl.pdf","2017-09-07 00:00:00",
49698,1,21588,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588orig1s051ltr.pdf","2017-09-08 00:00:00",
49920,2,21588,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf","2017-10-03 00:00:00",
49930,1,21588,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588Orig1s052ltr.pdf","2017-10-03 00:00:00",
55270,2,21588,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021588s053lbl.pdf","2018-08-22 00:00:00",
55319,1,21588,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021588Orig1s053ltr.pdf","2018-08-24 00:00:00",
21750,3,21589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021589s000_KemstroTOC.cfm","2006-07-25 00:00:00",
28199,1,21589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21589ltr.pdf","2003-11-05 00:00:00",
37294,2,21589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21589_kemstro_lbl.pdf","2003-11-05 00:00:00",
5805,1,21590,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590ltr.pdf","2004-02-27 00:00:00",
15839,2,21590,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21590_fazaclo_lbl.pdf","2004-03-03 00:00:00",
21751,3,21590,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021590s000_FazacloTOC.cfm","2005-10-06 00:00:00",
24004,14,21590,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
28200,1,21590,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590slr001ltr.pdf","2004-06-23 00:00:00",
28201,1,21590,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590s002ltr.pdf","2004-09-07 00:00:00",
5806,1,21590,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s003ltr.pdf","2005-08-15 00:00:00",
5807,1,21590,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s007ltr.pdf","2005-06-10 00:00:00",
37295,2,21590,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s007lbl.pdf","2005-06-10 00:00:00",
15840,2,21590,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s008lbl.pdf","2005-08-15 00:00:00",
28202,1,21590,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s008ltr.pdf","2005-08-16 00:00:00",
5808,1,21590,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021590s009ltr.pdf","2006-02-22 00:00:00",
37296,2,21590,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021590s009lbl.pdf","2006-02-22 00:00:00",
5809,1,21590,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021590s010ltr.pdf","2007-06-04 00:00:00",
37297,2,21590,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf","2007-06-04 00:00:00",
5810,1,21590,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s011ltr.pdf","2008-07-17 00:00:00",
5811,1,21590,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s013ltr.pdf","2008-08-19 00:00:00",
28203,1,21590,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf","2015-09-16 00:00:00",
37298,2,21590,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf","2015-09-16 00:00:00",
28204,1,21590,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf","2010-07-14 00:00:00",
37299,2,21590,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf","2010-07-12 00:00:00",
5812,1,21590,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf","2010-07-14 00:00:00",
37300,2,21590,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf","2010-07-12 00:00:00",
15841,2,21590,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s017lbl.pdf","2010-09-10 00:00:00",
28205,1,21590,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s017ltr.pdf","2010-09-13 00:00:00",
15842,2,21590,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s018lbl.pdf","2010-12-04 00:00:00",
28206,1,21590,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s018ltr.pdf","2010-12-06 00:00:00",
28207,1,21590,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021590Orig1s021ltr.pdf","2013-07-22 00:00:00",
37301,2,21590,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021590s021lbl.pdf","2013-07-23 00:00:00",
15843,2,21590,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021590s024lbl.pdf","2012-01-09 00:00:00",
28208,1,21590,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021590s024ltr.pdf","2012-01-12 00:00:00",
28209,1,21590,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf","2015-09-16 00:00:00",
37302,2,21590,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf","2015-09-16 00:00:00",
28210,1,21590,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf","2015-10-02 00:00:00",
37303,2,21590,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028lbl.pdf","2015-10-22 00:00:00",
47353,2,21590,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021590s030lbl.pdf","2017-02-27 00:00:00",
47371,1,21590,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021590Orig1s030ltr.pdf","2017-03-02 00:00:00",
5813,1,21591,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21591ltr.pdf","2003-09-25 00:00:00",
5814,1,21591,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21591slr001ltr.pdf","2004-06-07 00:00:00",
15844,2,21591,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21591slr001_riomet_lbl.pdf","2004-06-07 00:00:00",
37304,2,21591,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21591_riomet_lbl.pdf","2003-09-26 00:00:00",
42225,3,21591,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-591_Riomet.cfm","2005-01-11 00:00:00",
28211,1,21591,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021591s003ltr.pdf","2005-10-20 00:00:00",
37305,2,21591,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021591s003lbl.pdf","2005-09-30 00:00:00",
5815,1,21591,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021591s004ltr.pdf","2008-10-23 00:00:00",
37306,2,21591,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021591s004lbl.pdf","2008-11-07 00:00:00",
28212,1,21591,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021591s005ltr.pdf","2010-12-10 00:00:00",
37307,2,21591,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021591s005lbl.pdf","2010-12-06 00:00:00",
47926,2,21591,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021591s010lbl.pdf","2017-04-11 00:00:00",
47952,1,21591,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021591Orig1s010ltr.pdf","2017-04-12 00:00:00",
21752,3,21592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021592_foradil_certihaler_toc.cfm","2008-11-25 00:00:00",
23287,8,21592,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088603.pdf","2007-02-20 00:00:00",
28213,1,21592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021592s000ltr.pdf","2006-12-28 00:00:00",
37308,2,21592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021592lbl.pdf","2006-12-26 00:00:00",
5816,1,21592,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003ltr.pdf","2010-06-03 00:00:00",
15846,2,21592,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf","2010-06-02 00:00:00",
21753,3,21594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-594_Amiodarone.cfm","2004-05-06 00:00:00",
23670,10,21594,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
28214,1,21594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21594ltr.pdf","2004-02-27 00:00:00",
5817,1,21595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21595ltr.pdf","2004-06-01 00:00:00",
15847,2,21595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21595_lbl.pdf","2004-06-01 00:00:00",
15848,2,21595,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21595s001lbl.pdf","2005-03-14 00:00:00",
28215,1,21595,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21595s001ltr.pdf","2005-03-14 00:00:00",
42226,3,21595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-595_Sanctura.cfm","2004-07-08 00:00:00",
28216,1,21595,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s002_ltr.pdf","2006-09-15 00:00:00",
37309,2,21595,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021595s002lbl.pdf","2006-09-12 00:00:00",
28217,1,21595,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s003ltr.pdf","2006-12-28 00:00:00",
15849,2,21595,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021595s005lbl.pdf","2009-06-04 00:00:00",
28218,1,21595,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s006ltr.pdf","2011-09-28 00:00:00",
37310,2,21595,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s006lbl.pdf","2011-09-30 00:00:00",
28219,1,21595,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s007ltr.pdf","2011-02-04 00:00:00",
37311,2,21595,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s007lbl.pdf","2011-02-09 00:00:00",
28220,1,21595,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021595Orig1s008,s009ltr.pdf","2012-07-25 00:00:00",
37312,2,21595,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s008lbl.pdf","2012-07-24 00:00:00",
5818,1,21595,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021595Orig1s008,s009ltr.pdf","2012-07-25 00:00:00",
15850,2,21595,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s009lbl.pdf","2012-07-24 00:00:00",
15851,2,21597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf","2003-12-08 00:00:00",
28221,1,21597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf","2003-12-04 00:00:00",
42227,3,21597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021597s000_ZorbtiveTOC.cfm","2006-06-07 00:00:00",
15852,2,21598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf","2003-04-17 00:00:00",
15853,2,21598,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf","2003-10-10 00:00:00",
28222,1,21598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf","2003-05-29 00:00:00",
28223,1,21598,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf","2003-10-03 00:00:00",
42228,3,21598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-598_Vigamox.cfm","2005-04-08 00:00:00",
51388,20,21598,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/104_21598 moxifloxacin clinical bpca.pdf","1900-01-01 00:00:00",
51389,60,21598,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/105_21598 moxifloxacin DDclinical bpca.pdf","1900-01-01 00:00:00",
15854,2,21598,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf","2004-05-03 00:00:00",
28224,1,21598,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf","2004-04-20 00:00:00",
5819,1,21598,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf","2003-10-03 00:00:00",
37313,2,21598,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf","2003-10-10 00:00:00",
28225,1,21598,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf","2004-07-01 00:00:00",
37314,2,21598,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf","2004-07-01 00:00:00",
5820,1,21598,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021598s017ltr.pdf","2011-10-12 00:00:00",
37315,2,21598,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf","2011-10-12 00:00:00",
47585,1,21598,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021598Orig1s022ltr.pdf","2017-03-20 00:00:00",
47627,2,21598,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf","2017-03-21 00:00:00",
5821,1,21602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21602ltr.pdf","2003-05-16 00:00:00",
37316,2,21602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf","2003-05-13 00:00:00",
42229,3,21602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21602_Velcade.cfm","2003-09-25 00:00:00",
44137,10,21602,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106494.htm","2003-12-12 00:00:00",
5822,1,21602,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21602slr004ltr.pdf","2004-06-01 00:00:00",
5823,1,21602,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21602s006ltr.pdf","2005-03-30 00:00:00",
37317,2,21602,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021602s006lbl.pdf","2005-03-25 00:00:00",
28226,1,21602,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021602s007ltr.pdf","2005-12-15 00:00:00",
28227,1,21602,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s008, s009LTR.pdf","2006-06-02 00:00:00",
37318,2,21602,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s008,s009.pdf","2006-06-01 00:00:00",
5824,1,21602,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s010ltr.pdf","2006-12-28 00:00:00",
15855,2,21602,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s010lbl.pdf","2006-12-08 00:00:00",
21754,3,21602,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021602_s010_velcade.pdf","2011-01-07 00:00:00",
5825,1,21602,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021602s013ltr.pdf","2007-10-15 00:00:00",
15856,2,21602,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021602s013lbl.pdf","2007-10-10 00:00:00",
5826,1,21602,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021602se1-015ltr.pdf","2008-06-24 00:00:00",
21755,3,21602,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021602Orig1s015.pdf","2011-10-10 00:00:00",
37319,2,21602,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021602s015lbl.pdf","2008-06-23 00:00:00",
5827,1,21602,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s018ltr.pdf","2009-05-04 00:00:00",
28228,1,21602,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf","2010-01-05 00:00:00",
37320,2,21602,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf","2010-01-12 00:00:00",
5828,1,21602,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf","2010-01-05 00:00:00",
37321,2,21602,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf","2010-01-12 00:00:00",
15857,2,21602,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021602s023lbl.pdf","2010-12-04 00:00:00",
28229,1,21602,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021602s023ltr.pdf","2010-12-07 00:00:00",
28230,1,21602,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602s027ltr.pdf","2012-01-25 00:00:00",
37322,2,21602,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s027lbl.pdf","2012-01-23 00:00:00",
50607,3,21602,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021602Orig1s027.pdf","2017-12-06 00:00:00",
15858,2,21602,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf","2011-11-04 00:00:00",
28231,1,21602,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021602s029,s030ltr.pdf","2011-11-03 00:00:00",
5829,1,21602,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021602s029,s030ltr.pdf","2011-11-03 00:00:00",
37323,2,21602,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf","2011-11-04 00:00:00",
15859,2,21602,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf","2012-10-26 00:00:00",
28232,1,21602,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602Orig1s031,s032ltr.pdf","2012-10-29 00:00:00",
5830,1,21602,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602Orig1s031,s032ltr.pdf","2012-10-29 00:00:00",
37324,2,21602,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf","2012-10-26 00:00:00",
5831,1,21602,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s038ltr.pdf","2014-08-12 00:00:00",
15860,2,21602,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s038lbl.pdf","2014-08-12 00:00:00",
28233,1,21602,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf","2014-10-09 00:00:00",
37325,2,21602,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s040lbl.pdf","2014-10-09 00:00:00",
28234,1,21602,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021602Orig1s042ltr.pdf","2015-09-16 00:00:00",
37326,2,21602,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021602s042lbl.pdf","2015-09-23 00:00:00",
51263,23,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021602_bortezomib_Orig_WR.pdf","2010-04-27 00:00:00",
51264,25,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021602_bortezomib_Amend_1.pdf","2011-01-26 00:00:00",
51265,26,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021602_bortezomib_Amend_2.pdf","2012-11-13 00:00:00",
52040,20,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21602 bortezomib clinica bpca.pdf","1900-01-01 00:00:00",
52042,18,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21602 bortezomib clinpharm bpca.pdf","1900-01-01 00:00:00",
52043,17,21602,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21602 bortezomib statistical bpca.pdf","1900-01-01 00:00:00",
48694,2,21602,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s043lbl.pdf","2017-06-12 00:00:00",
48702,1,21602,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021602Orig1s043ltr.pdf","2017-06-12 00:00:00",
5832,1,21604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21604ltr.pdf","2004-01-14 00:00:00",
21756,3,21604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021604s000_Childrens_ElixSureTOC.cfm","2006-10-13 00:00:00",
28235,1,21604,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021604s003ltr.pdf","2006-01-20 00:00:00",
37327,2,21604,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021604s003lbl.pdf","2006-01-18 00:00:00",
15861,2,21604,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021604Orig1s004lbl.pdf","2014-08-06 00:00:00",
28236,1,21604,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021604Orig1s004ltr.pdf","2014-04-02 00:00:00",
47568,2,21604,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021604Orig1s005lbl.pdf","2017-03-16 00:00:00",
47601,1,21604,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021604Orig1s005ltr.pdf","2017-03-20 00:00:00",
5833,1,21605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021605ltr.pdf","2005-03-10 00:00:00",
37328,2,21605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf","2005-03-10 00:00:00",
42230,3,21605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021605s000TOC.cfm","2007-05-09 00:00:00",
5834,1,21605,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021605s006ltr.pdf","2010-01-05 00:00:00",
37329,2,21605,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf","2010-01-12 00:00:00",
5835,1,21605,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021605Orig1s012ltr.pdf","2014-03-10 00:00:00",
15862,2,21605,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf","2014-03-10 00:00:00",
53751,2,21605,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf","2018-04-20 00:00:00",
53781,1,21605,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s010,021605Orig1s013ltr.pdf","2018-04-23 00:00:00",
52787,1,21605,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021605Orig1s015ltr.pdf","2018-03-01 00:00:00",
52818,2,21605,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf","2018-03-06 00:00:00",
15863,2,21606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021606lbl.pdf","2005-05-27 00:00:00",
21757,3,21606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021606s000TOC.cfm","2007-01-26 00:00:00",
28237,1,21606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021606ltr.pdf","2005-05-27 00:00:00",
51549,20,21606,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/28_21606 paricalcitol clinical prea.pdf","1900-01-01 00:00:00",
51550,57,21606,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/27_21606 paricalcitol CDTL clinical prea.pdf","1900-01-01 00:00:00",
51551,18,21606,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/29_21606 paricalcitol clinpharm prea.pdf","1900-01-01 00:00:00",
51552,17,21606,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/30_21606 paricalcitol statistical prea.pdf","1900-01-01 00:00:00",
5836,1,21606,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021606s004ltr.pdf","2009-07-07 00:00:00",
37330,2,21606,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021606s004lbl.pdf","2009-07-02 00:00:00",
5837,1,21606,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021606s007ltr.pdf","2010-06-15 00:00:00",
37331,2,21606,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021606s007lbl.pdf","2010-06-14 00:00:00",
5838,1,21606,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021606s009(1)ltr.pdf","2011-04-19 00:00:00",
5839,1,21606,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021606s009ltr.pdf","2011-04-11 00:00:00",
15864,2,21606,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021606s009lbl.pdf","2011-04-07 00:00:00",
5840,1,21606,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021606Orig1s012,s014ltr.pdf","2014-09-03 00:00:00",
37332,2,21606,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf","2014-09-03 00:00:00",
15865,2,21606,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf","2014-09-03 00:00:00",
28238,1,21606,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021606Orig1s012,s014ltr.pdf","2014-09-03 00:00:00",
45563,1,21606,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021606Orig1s016,s017ltr.pdf","2016-10-20 00:00:00",
47275,2,21606,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf","2017-02-22 00:00:00",
45564,1,21606,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021606Orig1s016,s017ltr.pdf","2016-10-20 00:00:00",
47276,2,21606,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf","2017-02-22 00:00:00",
5841,1,21609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21609ltr.pdf","2004-12-30 00:00:00",
37333,2,21609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21609lbl.pdf","2004-12-30 00:00:00",
42231,3,21609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021609s000_EnjuviaTOC.cfm","2006-06-08 00:00:00",
5842,1,21610,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf","2006-08-07 00:00:00",
15866,2,21610,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf","2006-08-04 00:00:00",
44481,14,21610,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2013-05-31 00:00:00",
15867,2,21610,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021610s003lbl.pdf","2007-07-10 00:00:00",
28239,1,21610,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021610s003ltr.pdf","2007-07-16 00:00:00",
5843,1,21610,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s005ltr.pdf","2008-01-18 00:00:00",
15868,2,21610,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf","2008-01-18 00:00:00",
5844,1,21610,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s006ltr.pdf","2008-03-05 00:00:00",
15869,2,21610,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf","2008-03-05 00:00:00",
28240,1,21610,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021610s009ltr.pdf","2010-10-12 00:00:00",
37334,2,21610,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021610s009lbl.pdf","2010-10-04 00:00:00",
5845,1,21610,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s012ltr.pdf","2012-07-11 00:00:00",
15870,2,21610,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s012lbl.pdf","2012-07-12 00:00:00",
15871,2,21610,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf","2012-07-13 00:00:00",
28241,1,21610,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s013ltr.pdf","2012-07-13 00:00:00",
28242,1,21610,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021610Orig1s014ltr.pdf","2013-04-18 00:00:00",
5846,1,21610,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s018ltr.pdf","2014-04-17 00:00:00",
37335,2,21610,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021610s018lbl.pdf","2014-04-16 00:00:00",
5847,1,21610,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s019ltr.pdf","2014-08-20 00:00:00",
5848,1,21610,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021610Orig1s020ltr.pdf","2015-07-06 00:00:00",
28243,1,21610,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s021ltr.pdf","2016-04-22 00:00:00",
46284,1,21610,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s022ltr.pdf","2016-12-20 00:00:00",
46354,2,21610,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf","2016-12-21 00:00:00",
46611,8,21610,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf#page=25","2016-12-30 00:00:00",
45465,1,21610,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s023ltr.pdf","2016-10-04 00:00:00",
48565,1,21610,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021610Orig1s024ltr.pdf","2017-05-30 00:00:00",
55733,1,21610,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021610Orig1s025s026ltr.pdf","2018-10-01 00:00:00",
55734,1,21610,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021610Orig1s025s026ltr.pdf","2018-10-01 00:00:00",
5849,1,21611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021611s000LTR.pdf","2006-06-28 00:00:00",
15872,2,21611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf","2006-06-28 00:00:00",
28244,1,21611,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf","2006-08-07 00:00:00",
37336,2,21611,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf","2006-08-04 00:00:00",
42232,3,21611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021610s000_021611s000TOC.cfm","2008-10-03 00:00:00",
5850,1,21611,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021611s004ltr.pdf","2010-04-22 00:00:00",
5851,1,21611,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021611s005ltr.pdf","2011-02-10 00:00:00",
37337,2,21611,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf","2011-02-09 00:00:00",
5852,1,21611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021611Orig1s007ltr.pdf","2012-07-11 00:00:00",
15873,2,21611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf","2014-05-14 00:00:00",
46287,1,21611,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021611Orig1s010ltr.pdf","2016-12-20 00:00:00",
46353,2,21611,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf","2016-12-21 00:00:00",
46612,8,21611,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf#page=25","2016-12-30 00:00:00",
55682,1,21611,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf","2018-10-01 00:00:00",
55683,1,21611,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf","2018-10-01 00:00:00",
5853,1,21612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/21612s000ltr.pdf","2006-01-24 00:00:00",
15874,2,21612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf","2006-01-24 00:00:00",
42233,3,21612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021612_lipofen_toc.cfm","2008-11-17 00:00:00",
5854,1,21612,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf","2008-12-19 00:00:00",
28245,1,21612,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf","2008-12-19 00:00:00",
5855,1,21612,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021612s007ltr.pdf","2011-11-02 00:00:00",
15875,2,21612,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf","2011-10-31 00:00:00",
28246,1,21612,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf","2013-01-23 00:00:00",
37338,2,21612,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf","2013-01-23 00:00:00",
5856,1,21612,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf","2013-01-23 00:00:00",
15876,2,21612,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf","2013-01-23 00:00:00",
54279,1,21612,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021612Orig1s018ltr.pdf","2018-05-21 00:00:00",
54280,2,21612,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s018lbl.pdf","2018-05-21 00:00:00",
5857,1,21615,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
15877,2,21615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021615lbl.pdf","2004-12-29 00:00:00",
28247,1,21615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021615s000revLTR.pdf","2004-12-29 00:00:00",
42234,3,21615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021615s000_RazadyneTOC.cfm","2005-12-05 00:00:00",
44138,10,21615,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2005-07-29 00:00:00",
5858,1,21615,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf","2005-05-03 00:00:00",
5859,1,21615,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
5860,1,21615,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
28248,1,21615,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf","2006-05-01 00:00:00",
5861,1,21615,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf","2012-03-05 00:00:00",
15878,2,21615,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf","2012-03-06 00:00:00",
28249,1,21615,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf","2012-03-05 00:00:00",
37339,2,21615,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf","2012-03-06 00:00:00",
15879,2,21615,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf","2013-07-11 00:00:00",
28250,1,21615,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf","2013-07-02 00:00:00",
28251,1,21615,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf","2012-03-05 00:00:00",
37340,2,21615,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf","2012-05-01 00:00:00",
28252,1,21615,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf","2015-02-12 00:00:00",
37341,2,21615,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf","2015-02-10 00:00:00",
5862,1,21615,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf","2015-12-17 00:00:00",
37342,2,21615,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf","2015-12-17 00:00:00",
47239,1,21615,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023ltr.pdf","2017-02-16 00:00:00",
47240,2,21615,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf","2017-02-16 00:00:00",
5863,1,21618,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21618ltr.pdf","2004-05-26 00:00:00",
15880,2,21618,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf","2004-05-27 00:00:00",
42235,3,21618,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm","2004-08-30 00:00:00",
5864,1,21618,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021618s003ltr.pdf","2007-05-29 00:00:00",
37343,2,21618,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf","2007-05-29 00:00:00",
5865,1,21620,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf","2005-01-26 00:00:00",
15881,2,21620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21620_mucinex_lbl.pdf","2004-05-04 00:00:00",
28253,1,21620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21620ltr.pdf","2004-05-03 00:00:00",
42236,3,21620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021620s000_MucinexTOC.cfm","2005-10-06 00:00:00",
5866,1,21620,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021620s005ltr.pdf","2006-01-30 00:00:00",
28254,1,21620,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf","2007-09-07 00:00:00",
37344,2,21620,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf","2007-09-07 00:00:00",
5867,1,21620,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021620s021ltr.pdf","2009-04-09 00:00:00",
28255,1,21620,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620Orig1s029ltr.pdf","2014-03-07 00:00:00",
5868,1,21620,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf","2014-03-07 00:00:00",
50584,1,21620,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021620Orig1s038,021585Orig1s033ltr.pdf","2017-12-01 00:00:00",
50585,2,21620,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021620Orig1s038,021585Orig1s033lbl.pdf","2017-12-04 00:00:00",
5869,1,21621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21621ltr.pdf","2004-03-19 00:00:00",
21758,3,21621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-621_Zyrtec.cfm","2004-12-07 00:00:00",
5870,1,21621,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021621s005ltr.pdf","2007-11-19 00:00:00",
21759,3,21621,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm","2008-05-21 00:00:00",
15882,2,21623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf","2005-06-24 00:00:00",
28256,1,21623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021623ltr.pdf","2005-06-24 00:00:00",
42237,3,21623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021623TOC.cfm","2008-03-14 00:00:00",
28257,1,21623,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf","2014-03-13 00:00:00",
37345,2,21623,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf","2014-03-11 00:00:00",
15883,2,21623,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf","2014-03-11 00:00:00",
28258,1,21623,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf","2014-03-13 00:00:00",
5871,1,21624,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21624slr001ltr.pdf","2004-02-27 00:00:00",
21760,3,21624,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021624Orig1s001.pdf","2013-06-03 00:00:00",
37346,2,21624,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21624slr001_methadone_hcl_lbl.pdf","2004-03-03 00:00:00",
46289,1,21624,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021624Orig1s006ltr.pdf","2016-12-20 00:00:00",
46352,2,21624,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021624s006lbl.pdf","2016-12-21 00:00:00",
5872,1,21625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21625ltr.pdf","2004-02-03 00:00:00",
15884,2,21625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21625_MVI_Adult_lbl.pdf","2004-02-03 00:00:00",
21761,3,21625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21625s000_MVI_AdultTOC.cfm","2006-10-25 00:00:00",
5873,1,21625,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021643Orig1s015,021625Orig1s018ltr.pdf","2015-01-23 00:00:00",
37347,2,21625,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021625s018,021643s015lbl.pdf","2015-01-22 00:00:00",
50372,1,21625,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021625Orig1s023,021643Orig1s019ltr.pdf","2017-11-13 00:00:00",
50388,2,21625,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021625s023,021643s019lbl.pdf","2017-11-13 00:00:00",
5874,1,21626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21626ltr.pdf","2003-10-02 00:00:00",
21762,3,21626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-626_Radiogardase.cfm","2003-12-31 00:00:00",
28259,1,21626,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21626scp001ltr.pdf","2004-05-26 00:00:00",
37348,2,21626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021626lbl.pdf","2003-10-02 00:00:00",
15885,2,21626,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf","2008-08-29 00:00:00",
28260,1,21626,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021626s007ltr.pdf","2008-08-27 00:00:00",
37349,2,21626,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021626s010lbl.pdf","2014-08-22 00:00:00",
5875,1,21627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021627ltr.pdf","2005-04-19 00:00:00",
28261,1,21627,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf","2006-10-13 00:00:00",
37350,2,21627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf","2005-04-19 00:00:00",
42238,3,21627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021627s000_NamendaTOC.cfm","2006-10-18 00:00:00",
5876,1,21627,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf","2006-04-21 00:00:00",
28262,1,21627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf","2013-10-25 00:00:00",
37351,2,21627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf","2013-10-25 00:00:00",
15886,2,21627,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf","2014-08-12 00:00:00",
28263,1,21627,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf","2014-08-12 00:00:00",
5877,1,21629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21629ltr.pdf","2004-04-20 00:00:00",
15887,2,21629,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf","2006-01-06 00:00:00",
37352,2,21629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf","2004-04-22 00:00:00",
42239,3,21629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-629_Apidra.cfm","2004-06-29 00:00:00",
53296,20,21629,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021629s015_Insulin Glulisine (Apidra)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53297,18,21629,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021629s015_Insulin Glulisine (Apidra) (NO-AP-LBL)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53298,17,21629,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021629s015_Insulin Glulisine (Apidra)_Statistics_PREA.pdf","1900-01-01 00:00:00",
37353,2,21629,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf","2006-01-06 00:00:00",
5878,1,21629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021629s008ltr.pdf","2009-02-27 00:00:00",
15888,2,21629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf","2009-03-17 00:00:00",
42240,3,21629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021629Orig1s008.pdf","2013-01-28 00:00:00",
15889,2,21629,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021629s010lbl.pdf","2007-04-20 00:00:00",
28264,1,21629,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021629s010ltr.pdf","2007-04-20 00:00:00",
5879,1,21629,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021629s015ltr.pdf","2008-10-28 00:00:00",
37354,2,21629,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf","2008-11-07 00:00:00",
28265,1,21629,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021629Orig1s028ltr.pdf","2013-09-11 00:00:00",
37355,2,21629,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021629s028lbl.pdf","2013-09-09 00:00:00",
5880,1,21629,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021629Orig1s029ltr.pdf","2014-05-19 00:00:00",
15890,2,21629,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf","2014-05-15 00:00:00",
28266,1,21629,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021629Orig1s030ltr.pdf","2015-02-27 00:00:00",
37356,2,21629,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021629s030lbl.pdf","2015-03-03 00:00:00",
5881,1,21630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21630ltr.pdf","2003-12-24 00:00:00",
5882,1,21630,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf","2004-04-29 00:00:00",
15891,2,21630,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf","2004-05-04 00:00:00",
37357,2,21630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21630_vfend_lb.pdf","2003-12-29 00:00:00",
42241,3,21630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021630s000_VfendTOC.cfm","2006-07-25 00:00:00",
42242,3,21630,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm","2007-01-10 00:00:00",
5883,1,21630,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf","2004-12-29 00:00:00",
37358,2,21630,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf","2004-12-29 00:00:00",
42243,3,21630,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021630Orig1s003.pdf","2012-11-09 00:00:00",
5884,1,21630,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf","2005-03-29 00:00:00",
15892,2,21630,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf","2005-03-29 00:00:00",
15893,2,21630,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf","2005-07-08 00:00:00",
28267,1,21630,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf","2005-07-15 00:00:00",
15894,2,21630,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf","2006-01-05 00:00:00",
28268,1,21630,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf","2006-01-19 00:00:00",
5885,1,21630,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf","2006-03-22 00:00:00",
15895,2,21630,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf","2006-03-22 00:00:00",
15896,2,21630,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf","2008-02-14 00:00:00",
28269,1,21630,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021630s009ltr.pdf","2008-02-07 00:00:00",
28270,1,21630,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf","2006-05-22 00:00:00",
37359,2,21630,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf","2006-05-22 00:00:00",
5886,1,21630,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf","2006-12-28 00:00:00",
37360,2,21630,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf","2006-12-04 00:00:00",
28271,1,21630,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf","2008-03-13 00:00:00",
37361,2,21630,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf","2008-03-13 00:00:00",
28272,1,21630,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
37362,2,21630,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
28273,1,21630,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf","2008-06-03 00:00:00",
5887,1,21630,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
15897,2,21630,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
5888,1,21630,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
37363,2,21630,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
15898,2,21630,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf","2010-06-24 00:00:00",
28274,1,21630,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf","2010-06-24 00:00:00",
15899,2,21630,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf","2010-12-26 00:00:00",
28275,1,21630,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf","2010-12-21 00:00:00",
28276,1,21630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf","2010-11-30 00:00:00",
37364,2,21630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021630s023lbl.pdf","2010-11-21 00:00:00",
28277,1,21630,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf","2011-06-02 00:00:00",
37365,2,21630,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf","2011-06-16 00:00:00",
5889,1,21630,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf","2011-11-21 00:00:00",
15900,2,21630,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf","2011-11-21 00:00:00",
28278,1,21630,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf","2014-04-08 00:00:00",
37366,2,21630,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf","2014-04-08 00:00:00",
28279,1,21630,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf","2015-02-05 00:00:00",
37367,2,21630,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf","2015-02-05 00:00:00",
48740,1,21630,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s041,021267Orig1s053,021630Orig1s031ltr.pdf","2017-06-16 00:00:00",
48764,2,21630,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf","2017-06-19 00:00:00",
49159,2,21630,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf","2017-07-31 00:00:00",
49189,1,21630,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s043,021267Orig1s054,021630Orig1s032ltr.pdf","2017-08-02 00:00:00",
15901,2,21632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf","2006-02-28 00:00:00",
21763,3,21632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm","2006-04-14 00:00:00",
28280,1,21632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021948s000,021632s000ltr.pdf","2006-03-01 00:00:00",
5890,1,21632,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s002LTR.pdf","2006-08-09 00:00:00",
15902,2,21632,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf","2006-08-09 00:00:00",
15903,2,21632,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf","2006-11-16 00:00:00",
28281,1,21632,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s003ltr.pdf","2006-11-22 00:00:00",
5891,1,21632,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s004ltr.pdf","2007-02-12 00:00:00",
37368,2,21632,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf","2007-02-21 00:00:00",
28282,1,21632,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s006ltr.pdf","2007-11-19 00:00:00",
37369,2,21632,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf","2007-11-13 00:00:00",
5892,1,21632,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021632s010ltr.pdf","2009-06-16 00:00:00",
37370,2,21632,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf","2009-06-10 00:00:00",
28283,1,21632,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021632Orig1s011ltr.pdf","2012-07-24 00:00:00",
37371,2,21632,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf","2012-07-23 00:00:00",
28284,1,21632,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021632s013ltr.pdf","2010-11-09 00:00:00",
49464,2,21632,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021632s024lbl.pdf","2017-08-18 00:00:00",
49504,1,21632,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021632Orig1s024ltr.pdf","2017-08-22 00:00:00",
50999,1,21632,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021632Orig1s026ltr.pdf","2018-01-09 00:00:00",
51005,2,21632,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021632s026lbl.pdf","2018-01-09 00:00:00",
5893,1,21633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21633ltr.pdf","2004-08-25 00:00:00",
42244,3,21633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021633s000_FemtraceTOC.cfm","2005-12-01 00:00:00",
5894,1,21633,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021633Orig1s005ltr.pdf","2014-08-14 00:00:00",
15904,2,21633,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021633s005lbl.pdf","2014-08-13 00:00:00",
50288,2,21633,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021633s006lbl.pdf","2017-11-03 00:00:00",
15905,2,21636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf","2004-06-16 00:00:00",
28285,1,21636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21636ltr.pdf","2004-06-16 00:00:00",
42245,3,21636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021636s000_ZegeridTOC.cfm","2005-12-06 00:00:00",
44139,10,21636,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
5895,1,21636,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf","2010-01-29 00:00:00",
15906,2,21636,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf","2010-08-05 00:00:00",
15907,2,21636,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf","2010-09-10 00:00:00",
28286,1,21636,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf","2010-09-08 00:00:00",
5896,1,21636,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf","2011-05-25 00:00:00",
37372,2,21636,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf","2011-05-25 00:00:00",
28287,1,21636,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf","2011-12-13 00:00:00",
37373,2,21636,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf","2011-12-13 00:00:00",
28288,1,21636,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf","2012-11-14 00:00:00",
37374,2,21636,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf","2012-11-15 00:00:00",
5897,1,21636,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf","2012-04-23 00:00:00",
15908,2,21636,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf","2012-04-20 00:00:00",
28289,1,21636,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf","2014-03-04 00:00:00",
37375,2,21636,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf","2014-02-27 00:00:00",
5898,1,21636,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf","2014-12-24 00:00:00",
15909,2,21636,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf","2014-12-29 00:00:00",
45666,1,21636,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf","2016-10-26 00:00:00",
45721,2,21636,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf","2016-10-31 00:00:00",
54529,2,21636,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf","2018-06-12 00:00:00",
54530,8,21636,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf#page=26","2018-06-12 00:00:00",
54577,1,21636,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021849Orig1s014,021636Orig1s019ltr.pdf","2018-06-14 00:00:00",
21764,3,21640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase.cfm","2004-08-27 00:00:00",
28290,1,21640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640ltr.pdf","2004-05-07 00:00:00",
28291,1,21640,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s001ltr.pdf","2004-12-29 00:00:00",
37376,2,21640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf","2004-05-07 00:00:00",
37377,2,21640,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf","2004-12-29 00:00:00",
44482,14,21640,"ORIG",1,"Additional App Ltr","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021640_additional_ltr.pdf","2004-10-26 00:00:00",
28292,1,21640,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf","2004-12-06 00:00:00",
37378,2,21640,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf","2004-12-06 00:00:00",
5899,1,21640,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf","2004-12-06 00:00:00",
37379,2,21640,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf","2004-12-06 00:00:00",
28293,1,21640,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021640s016ltr.pdf","2012-04-16 00:00:00",
37380,2,21640,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf","2012-04-17 00:00:00",
54371,1,21640,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021640Orig1s025ltr.pdf","2018-05-30 00:00:00",
54376,2,21640,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021640s025lbl.pdf","2018-05-31 00:00:00",
5900,1,21641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021641s000LTR.pdf","2006-05-21 00:00:00",
21765,3,21641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021641s000_AzilectTOC.cfm","2006-07-24 00:00:00",
37381,2,21641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021641lbl.pdf","2006-05-18 00:00:00",
28294,1,21641,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
37382,2,21641,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
5901,1,21641,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
15910,2,21641,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
28295,1,21641,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
37383,2,21641,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
15911,2,21641,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
28296,1,21641,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
28297,1,21641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
37384,2,21641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
5902,1,21641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
15912,2,21641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
24207,21,21641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008_SumR.pdf","2010-01-22 00:00:00",
42246,3,21641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008TOC.cfm","2010-01-22 00:00:00",
28298,1,21641,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf","2010-01-26 00:00:00",
37385,2,21641,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf","2009-12-10 00:00:00",
5903,1,21641,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf","2014-06-02 00:00:00",
37386,2,21641,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf","2014-05-30 00:00:00",
5904,1,21641,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf","2014-06-02 00:00:00",
15913,2,21641,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf","2014-05-30 00:00:00",
15914,2,21642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf","2005-02-03 00:00:00",
28299,1,21642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021642ltr.pdf","2005-02-03 00:00:00",
42247,3,21642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021642s000_NascobalTOC.cfm","2006-06-16 00:00:00",
28300,1,21642,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021642s002ltr.pdf","2006-09-20 00:00:00",
37387,2,21642,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf","2006-09-18 00:00:00",
28301,1,21642,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021642Orig1s015ltr.pdf","2014-02-07 00:00:00",
37388,2,21642,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf","2014-02-07 00:00:00",
15915,2,21642,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf","2014-06-10 00:00:00",
48859,3,21642,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021642Orig1s020.pdf","2017-06-29 00:00:00",
28302,1,21643,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21643ltr.pdf","2004-02-27 00:00:00",
42248,3,21643,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021643s000_MVI_AdultTOC.cfm","2006-09-07 00:00:00",
28303,1,21643,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021643Orig1s015,021625Orig1s018ltr.pdf","2015-01-23 00:00:00",
37389,2,21643,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021625s018,021643s015lbl.pdf","2015-01-22 00:00:00",
50371,1,21643,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021625Orig1s023,021643Orig1s019ltr.pdf","2017-11-13 00:00:00",
50389,2,21643,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021625s023,021643s019lbl.pdf","2017-11-13 00:00:00",
15916,2,21644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf","2004-03-03 00:00:00",
28304,1,21644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21644ltr.pdf","2004-02-27 00:00:00",
42249,3,21644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-644_Clobex.cfm","2004-12-07 00:00:00",
28305,1,21644,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021644Orig1s002ltr.pdf","2012-08-20 00:00:00",
37390,2,21644,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf","2012-08-20 00:00:00",
5905,1,21644,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf","2012-12-03 00:00:00",
15917,2,21644,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf","2014-01-14 00:00:00",
5906,1,21646,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21646ltr.pdf","2004-02-03 00:00:00",
21766,3,21646,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021646s000_Influvite_PediatricTOC.cfm","2006-09-07 00:00:00",
15918,2,21646,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021646s005lbl.pdf","2009-01-02 00:00:00",
28306,1,21646,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021646s005ltr.pdf","2008-12-19 00:00:00",
5907,1,21646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021646Orig1s014ltr.pdf","2014-07-15 00:00:00",
15919,2,21646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021646s014lbl.pdf","2014-08-04 00:00:00",
28307,1,21646,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021265Orig1s030,021646Orig1s022ltr.pdf","2016-03-21 00:00:00",
37391,2,21646,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021265s030,021646s022lbl.pdf","2016-03-22 00:00:00",
24005,14,21647,"ORIG",1,"FDA Public Health Advisory","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm","2004-09-30 00:00:00",
28308,1,21647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21647ltr.pdf","2004-03-28 00:00:00",
37392,2,21647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21647_vioxx_lbl.pdf","2004-04-05 00:00:00",
42250,3,21647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021647_000_VioxxTOC.cfm","2005-12-16 00:00:00",
44140,10,21647,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm","2004-09-30 00:00:00",
21767,3,21648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.cfm","2007-06-04 00:00:00",
28309,1,21648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21648ltr.pdf","2004-08-31 00:00:00",
37393,2,21648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf","2004-08-31 00:00:00",
5908,1,21648,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s004ltr.pdf","2011-10-03 00:00:00",
37394,2,21648,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf","2011-09-27 00:00:00",
42251,3,21648,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021648Orig1REVs004.pdf","2011-11-02 00:00:00",
28310,1,21648,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s005ltr.pdf","2011-11-22 00:00:00",
37395,2,21648,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf","2011-12-02 00:00:00",
5909,1,21648,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021648Orig1s006ltr.pdf","2012-10-02 00:00:00",
37396,2,21648,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf","2012-09-28 00:00:00",
15920,2,21648,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf","2015-07-30 00:00:00",
28311,1,21648,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021648Orig1s008ltr.pdf","2015-07-29 00:00:00",
46018,2,21648,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021648s009lbl.pdf","2016-12-05 00:00:00",
46047,1,21648,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021648Orig1s009ltr.pdf","2016-12-15 00:00:00",
55300,1,21648,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021648Orig1s011ltr.pdf","2018-08-24 00:00:00",
55334,2,21648,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021648s011lbl.pdf","2018-08-28 00:00:00",
28312,1,21652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21652ltr.pdf","2004-08-05 00:00:00",
37397,2,21652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21652lbl.pdf","2004-08-05 00:00:00",
42252,3,21652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021652s000_EpzicomTOC.cfm","2006-10-25 00:00:00",
5910,1,21652,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021652s003LTR.pdf","2006-08-18 00:00:00",
15921,2,21652,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021652s003lbl.pdf","2006-08-14 00:00:00",
28313,1,21652,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021652s005ltr.pdf","2007-05-09 00:00:00",
37398,2,21652,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021652s005lbl.pdf","2007-05-09 00:00:00",
5911,1,21652,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021652s008ltr.pdf","2009-03-11 00:00:00",
37399,2,21652,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf","2009-03-26 00:00:00",
5912,1,21652,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s010ltr.pdf","2011-02-07 00:00:00",
37400,2,21652,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s010lbl.pdf","2011-02-04 00:00:00",
5913,1,21652,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf","2010-08-10 00:00:00",
5914,1,21652,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf","2011-05-17 00:00:00",
5915,1,21652,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s014ltr.pdf","2011-11-22 00:00:00",
37401,2,21652,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s014lbl.pdf","2011-11-29 00:00:00",
5916,1,21652,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s015ltr.pdf","2012-03-13 00:00:00",
15922,2,21652,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s015lbl.pdf","2012-03-12 00:00:00",
5917,1,21652,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s016ltr.pdf","2012-05-22 00:00:00",
37402,2,21652,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s016lbl.pdf","2012-05-22 00:00:00",
28314,1,21652,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s018ltr.pdf","2015-02-24 00:00:00",
37403,2,21652,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s018lbl.pdf","2015-02-20 00:00:00",
5918,1,21652,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s019ltr.pdf","2015-09-18 00:00:00",
51092,20,21652,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21652 abacavir  lamivudine clinical prea.pdf","1900-01-01 00:00:00",
51093,18,21652,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21652 abacavir  lamivudine clinpharm.pdf","1900-01-01 00:00:00",
51094,17,21652,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21652 abacavir  lamivudine statistical prea.pdf","1900-01-01 00:00:00",
5919,1,21652,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s021ltr.pdf","2015-10-01 00:00:00",
15923,2,21652,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf","2015-10-07 00:00:00",
47614,2,21652,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf","2017-03-21 00:00:00",
47689,1,21652,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021652Orig1s022ltr.pdf","2017-03-24 00:00:00",
53919,1,21652,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021652Orig1s023ltr.pdf","2018-05-01 00:00:00",
54037,2,21652,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf","2018-05-08 00:00:00",
54038,8,21652,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf#page=28","2018-05-08 00:00:00",
15924,2,21654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf","2004-11-16 00:00:00",
28315,1,21654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21654ltr.pdf","2004-11-16 00:00:00",
42253,3,21654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor.cfm","2005-01-11 00:00:00",
5920,1,21654,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s004ltr.pdf","2007-02-12 00:00:00",
37404,2,21654,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf","2007-02-02 00:00:00",
28316,1,21654,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021654s007LTR.pdf","2006-07-13 00:00:00",
5921,1,21654,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s014ltr.pdf","2007-11-08 00:00:00",
44607,15,21654,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s014pi.pdf","2007-11-07 00:00:00",
28317,1,21654,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s015ltr.pdf","2008-01-09 00:00:00",
5922,1,21654,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf","2007-07-05 00:00:00",
21768,3,21654,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm","2009-11-19 00:00:00",
42254,3,21654,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021654Orig1s018.pdf","2011-12-14 00:00:00",
5923,1,21654,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021654s021ltr.pdf","2008-06-06 00:00:00",
15925,2,21654,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf","2008-06-19 00:00:00",
5924,1,21654,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s022ltr.pdf","2009-11-10 00:00:00",
15926,2,21654,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf","2009-09-21 00:00:00",
28318,1,21654,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s023ltr.pdf","2009-04-21 00:00:00",
37405,2,21654,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf","2009-04-23 00:00:00",
5925,1,21654,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021654s030ltr.pdf","2010-12-28 00:00:00",
15927,2,21654,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf","2010-12-26 00:00:00",
5926,1,21654,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021654s033ltr.pdf","2011-09-21 00:00:00",
28319,1,21654,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021654Orig1s034ltr.pdf","2012-09-06 00:00:00",
37406,2,21654,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf","2012-09-06 00:00:00",
5927,1,21654,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf","2013-06-27 00:00:00",
37407,2,21654,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf","2013-07-08 00:00:00",
15928,2,21654,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf","2013-09-17 00:00:00",
5928,1,21654,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021654s041ltr.pdf","2014-05-14 00:00:00",
15929,2,21654,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf","2014-05-14 00:00:00",
15930,2,21656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf","2004-11-08 00:00:00",
28320,1,21656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21656ltr.pdf","2004-11-08 00:00:00",
42255,3,21656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021656s000_TricorTOC.cfm","2006-04-21 00:00:00",
5929,1,21656,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021656s004,s011ltr.pdf","2007-09-25 00:00:00",
5930,1,21656,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021249s019,021656s013ltr.pdf","2008-04-16 00:00:00",
5931,1,21656,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021656s019ltr.pdf","2010-10-25 00:00:00",
15931,2,21656,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf","2010-10-21 00:00:00",
15932,2,21656,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf","2011-09-23 00:00:00",
28321,1,21656,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021656s020ltr.pdf","2011-09-26 00:00:00",
15933,2,21656,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf","2013-02-06 00:00:00",
28322,1,21656,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021656Orig1s023ltr.pdf","2013-02-07 00:00:00",
54275,1,21656,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s007,021656Orig1s026ltr.pdf","2018-05-21 00:00:00",
54295,2,21656,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf","2018-05-22 00:00:00",
37408,2,21656,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s030lbl.pdf","2011-09-23 00:00:00",
5932,1,21658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s000ltr.pdf","2008-01-18 00:00:00",
24208,21,21658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000_SumR.pdf","2009-07-20 00:00:00",
37409,2,21658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf","2008-01-18 00:00:00",
42256,3,21658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000TOC.cfm","2009-07-20 00:00:00",
53204,20,21658,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/r_021658s000_Ciclesonide(Alvesco)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53205,18,21658,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/r_021658s000_Ciclesonide(Alvesco)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53206,17,21658,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/r_021658s000_Ciclesonide(Alvesco)_Statistical_PREA.pdf","1900-01-01 00:00:00",
5933,1,21658,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s002ltr.pdf","2008-12-29 00:00:00",
37410,2,21658,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf","2009-01-02 00:00:00",
15934,2,21658,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf","2012-11-26 00:00:00",
28323,1,21658,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s005ltr.pdf","2012-11-21 00:00:00",
5934,1,21658,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s006ltr.pdf","2012-12-21 00:00:00",
37411,2,21658,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf","2012-12-17 00:00:00",
5935,1,21660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021660ltr.pdf","2005-01-11 00:00:00",
21769,3,21660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21660_AbraxaneTOC.cfm","2005-06-16 00:00:00",
37412,2,21660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf","2005-01-10 00:00:00",
5936,1,21660,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021660s010ltr.pdf","2007-02-23 00:00:00",
37413,2,21660,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf","2007-02-23 00:00:00",
42257,3,21660,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021660Orig1s010.pdf","2012-09-17 00:00:00",
5937,1,21660,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021660s013ltr.pdf","2008-07-07 00:00:00",
37414,2,21660,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf","2008-07-09 00:00:00",
42258,3,21660,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021660Orig1s013.pdf","2012-03-27 00:00:00",
5938,1,21660,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021660s022ltr.pdf","2009-06-30 00:00:00",
21770,3,21660,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021660Orig1s022.pdf","2012-03-27 00:00:00",
37415,2,21660,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf","2009-06-29 00:00:00",
5939,1,21660,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf","2012-01-03 00:00:00",
37416,2,21660,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf","2012-01-26 00:00:00",
28324,1,21660,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf","2012-01-03 00:00:00",
37417,2,21660,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf","2012-01-26 00:00:00",
15935,2,21660,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf","2012-01-26 00:00:00",
28325,1,21660,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf","2012-01-03 00:00:00",
5940,1,21660,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s031ltr.pdf","2012-10-15 00:00:00",
37418,2,21660,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf","2012-10-12 00:00:00",
42259,3,21660,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021660Orig1s031.pdf","2015-03-09 00:00:00",
5941,1,21660,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf","2012-10-03 00:00:00",
37419,2,21660,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf","2012-10-04 00:00:00",
15936,2,21660,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf","2012-10-04 00:00:00",
28326,1,21660,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf","2012-10-03 00:00:00",
15937,2,21660,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf","2013-06-11 00:00:00",
28327,1,21660,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s036ltr.pdf","2013-06-11 00:00:00",
28328,1,21660,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s037ltr.pdf","2013-09-10 00:00:00",
37420,2,21660,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf","2013-09-06 00:00:00",
5942,1,21660,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s038ltr.pdf","2013-10-31 00:00:00",
37421,2,21660,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf","2013-10-31 00:00:00",
5943,1,21660,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021660Orig1s040ltr.pdf","2014-12-12 00:00:00",
15938,2,21660,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf","2015-01-08 00:00:00",
28329,1,21660,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021660Orig1s041ltr.pdf","2015-07-22 00:00:00",
37422,2,21660,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf","2015-07-22 00:00:00",
55203,2,21660,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021660s045lbl.pdf","2018-08-17 00:00:00",
55205,1,21660,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021660Orig1s045Ltr.pdf","2018-08-20 00:00:00",
5944,1,21663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21663ltr.pdf","2004-11-08 00:00:00",
15939,2,21663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf","2004-11-08 00:00:00",
15940,2,21663,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf","2006-03-22 00:00:00",
21771,3,21663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-663_MenopurTOC.cfm","2005-06-27 00:00:00",
28330,1,21663,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf","2006-03-22 00:00:00",
28331,1,21663,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf","2006-03-22 00:00:00",
37423,2,21663,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf","2006-03-22 00:00:00",
5945,1,21663,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021663Orig1s014ltr.pdf","2014-02-21 00:00:00",
15941,2,21663,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf","2014-02-20 00:00:00",
15942,2,21664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf","2005-03-29 00:00:00",
15943,2,21664,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf","2006-01-27 00:00:00",
28332,1,21664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021664ltr.pdf","2005-03-29 00:00:00",
28333,1,21664,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf","2006-01-30 00:00:00",
42260,3,21664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021664s000TOC.cfm","2007-06-29 00:00:00",
28334,1,21664,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf","2009-06-08 00:00:00",
37424,2,21664,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf","2009-06-04 00:00:00",
5946,1,21664,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021664s013ltr.pdf","2010-10-19 00:00:00",
37425,2,21664,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf","2010-10-19 00:00:00",
42261,3,21664,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021664Orig1s013.pdf","2013-08-09 00:00:00",
5947,1,21664,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf","2014-01-28 00:00:00",
15944,2,21664,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf","2014-01-28 00:00:00",
5948,1,21664,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf","2014-01-28 00:00:00",
15945,2,21664,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf","2014-01-28 00:00:00",
15946,2,21665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf","2004-11-01 00:00:00",
28335,1,21665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf","2004-10-29 00:00:00",
28336,1,21665,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf","2005-11-08 00:00:00",
37426,2,21665,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf","2005-11-08 00:00:00",
42262,3,21665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-665_Amphadase.cfm","2005-02-04 00:00:00",
15947,2,21665,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf","2005-11-08 00:00:00",
28337,1,21665,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf","2005-11-08 00:00:00",
5949,1,21665,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021665s005ltr.pdf","2012-06-29 00:00:00",
37427,2,21665,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf","2012-06-29 00:00:00",
15948,2,21667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21677_nutreStore_lbl.pdf","2004-08-19 00:00:00",
42263,3,21667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-667_NutreStroe.cfm","2004-07-08 00:00:00",
15949,2,21667,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021667s003lbl.pdf","2011-03-21 00:00:00",
28338,1,21667,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021667s003ltr.pdf","2011-03-16 00:00:00",
5950,1,21669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021669ltr.pdf","2005-04-28 00:00:00",
21772,3,21669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21669s000TOC.cfm","2007-01-22 00:00:00",
37428,2,21669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021669lbl.pdf","2005-04-28 00:00:00",
28339,1,21669,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s002ltr.pdf","2006-01-20 00:00:00",
15950,2,21669,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf","2006-08-18 00:00:00",
28340,1,21669,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s003LTR.pdf","2006-08-21 00:00:00",
21773,3,21669,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021669_s006_chlorhexidine gluconate.pdf","2011-01-07 00:00:00",
5951,1,21669,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021669s014ltr.pdf","2012-05-23 00:00:00",
5952,1,21669,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021669Orig1s019ltr.pdf","2014-06-25 00:00:00",
15951,2,21669,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf","2014-07-31 00:00:00",
49699,1,21669,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021669Orig1s023ltr.pdf","2017-09-08 00:00:00",
49705,2,21669,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021669Orig1s023lbl.pdf","2017-09-08 00:00:00",
15952,2,21670,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021670lbl.pdf","2004-12-30 00:00:00",
21774,3,21670,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-670_VisionBlue.cfm","2005-03-08 00:00:00",
28341,1,21670,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021670ltr.pdf","2004-12-30 00:00:00",
5953,1,21670,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021670Orig1s005ltr.pdf","2012-11-23 00:00:00",
37429,2,21670,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021670s005lbl.pdf","2012-11-28 00:00:00",
28342,1,21671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671ltr.pdf","2004-05-26 00:00:00",
37430,2,21671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21671_depoDur_lbl.pdf","2004-05-27 00:00:00",
42264,3,21671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021671_s000_DepoDurTOC.cfm","2006-01-31 00:00:00",
28343,1,21671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671s002ltr.pdf","2004-08-12 00:00:00",
5954,1,21671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021671s004LTR.pdf","2006-05-25 00:00:00",
37431,2,21671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021671s004lbl.pdf","2006-05-24 00:00:00",
15953,2,21671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s014_LBL.pdf","2007-01-18 00:00:00",
28344,1,21671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s014ltr.pdf","2007-01-25 00:00:00",
5955,1,21671,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s015ltr.pdf","2007-02-23 00:00:00",
15954,2,21671,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s015lbl.pdf","2007-02-23 00:00:00",
5956,1,21671,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s019ltr.pdf","2008-01-09 00:00:00",
37432,2,21671,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s019lbl.pdf","2007-12-27 00:00:00",
5957,1,21671,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021671s020ltr.pdf","2009-11-10 00:00:00",
37433,2,21671,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021671s020lbl.pdf","2009-10-01 00:00:00",
21775,3,21673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-673_Clolar.cfm","2005-04-05 00:00:00",
28345,1,21673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021673ltr.pdf","2004-12-29 00:00:00",
37434,2,21673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf","2004-12-29 00:00:00",
51825,20,21673,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021673_clofarabine_Clolar-Med&StatsRev.pdf","1900-01-01 00:00:00",
51826,23,21673,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021673_clofarabine_3-7-03_HFD150_orig_WR.pdf","1900-01-01 00:00:00",
51827,25,21673,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021673_clofarabine_10-14-03_HFD150_amend_WR.pdf","1900-01-01 00:00:00",
51828,18,21673,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021673_clofarabine_Clolar-ClinPharmRev.pdf","1900-01-01 00:00:00",
51829,17,21673,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021673_clofarabine_Clolar-Med&StatsRev.pdf","1900-01-01 00:00:00",
28346,1,21673,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf","2008-10-23 00:00:00",
28347,1,21673,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf","2008-10-23 00:00:00",
15955,2,21673,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf","2011-06-14 00:00:00",
28348,1,21673,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021673s010ltr.pdf","2011-06-15 00:00:00",
28349,1,21673,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021673Orig1s022ltr.pdf","2013-01-14 00:00:00",
37435,2,21673,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf","2013-01-11 00:00:00",
5958,1,21673,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021673Orig1s023ltr.pdf","2014-09-17 00:00:00",
15956,2,21673,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf","2014-09-19 00:00:00",
5959,1,21673,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021673Orig1s024ltr.pdf","2015-12-18 00:00:00",
15957,2,21673,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf","2015-12-17 00:00:00",
45734,1,21673,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021673Orig1s025ltr.pdf","2016-10-31 00:00:00",
45749,2,21673,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf","2016-11-01 00:00:00",
5960,1,21674,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21674ltr.pdf","2004-06-10 00:00:00",
15958,2,21674,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf","2004-06-10 00:00:00",
21776,3,21674,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.cfm","2006-01-03 00:00:00",
24006,14,21674,"ORIG",1,"Approved Labeling 10/10/2013","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021674-10-2013lbl.pdf","2015-10-06 00:00:00",
15959,2,21676,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf","2006-03-22 00:00:00",
28350,1,21676,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf","2006-03-23 00:00:00",
42265,3,21676,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021676s000TOC.cfm","2007-08-06 00:00:00",
44141,10,21676,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm","2011-11-16 00:00:00",
5961,1,21676,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021676s002ltr.pdf","2007-02-02 00:00:00",
5962,1,21676,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021676s008ltr.pdf","2011-03-16 00:00:00",
15960,2,21676,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf","2011-03-14 00:00:00",
5963,1,21676,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021676s009ltr.pdf","2010-04-12 00:00:00",
15961,2,21676,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf","2010-04-16 00:00:00",
5964,1,21676,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf","2012-04-12 00:00:00",
37436,2,21676,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf","2012-04-10 00:00:00",
42266,3,21676,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021676Orig1s012.pdf","2016-02-03 00:00:00",
15962,2,21676,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf","2015-06-04 00:00:00",
28351,1,21676,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf","2015-06-03 00:00:00",
49294,2,21676,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021676s019lbl.pdf","2017-08-09 00:00:00",
49375,1,21676,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021676Orig1s019ltr.pdf","2017-08-15 00:00:00",
23671,10,21677,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110261.htm","2005-04-15 00:00:00",
28352,1,21677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf","2004-08-25 00:00:00",
37437,2,21677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf","2004-08-19 00:00:00",
42267,3,21677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021677s000_AlimtaTOC.cfm","2006-06-08 00:00:00",
21777,3,21681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm","2005-02-02 00:00:00",
42268,3,21682,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm","2005-02-02 00:00:00",
28353,1,21684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21684ltr.pdf","2004-06-01 00:00:00",
37438,2,21684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf","2004-06-01 00:00:00",
42269,3,21684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021684s000_GonalTOC.cfm","2006-03-21 00:00:00",
5965,1,21684,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s007ltr.pdf","2008-01-09 00:00:00",
37439,2,21684,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf","2007-12-27 00:00:00",
5966,1,21684,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s008ltr.pdf","2008-01-09 00:00:00",
15963,2,21684,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf","2013-10-18 00:00:00",
15964,2,21687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf","2004-07-28 00:00:00",
21778,3,21687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin.cfm","2004-11-22 00:00:00",
28354,1,21687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21687ltr.pdf","2004-07-28 00:00:00",
28355,1,21687,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s001ltr.pdf","2005-02-17 00:00:00",
44142,10,21687,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm","2008-01-25 00:00:00",
53273,20,21687,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021687s023_Ezetimbe(Vytorin)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53274,18,21687,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021687s023_Ezetimbe(Vytorin)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53275,17,21687,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021687s023_021445s020_Ezetimbe(Vytorin)_Statistical_PREA.pdf","1900-01-01 00:00:00",
28356,1,21687,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21687s002ltr.pdf","2005-03-10 00:00:00",
37440,2,21687,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21687s002lbl.pdf","2005-03-10 00:00:00",
5967,1,21687,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s003ltr.pdf","2005-06-07 00:00:00",
37441,2,21687,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s003lbl.pdf","2005-06-07 00:00:00",
15965,2,21687,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s004lbl.pdf","2005-10-24 00:00:00",
15966,2,21687,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf","2006-03-22 00:00:00",
28357,1,21687,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf","2006-03-23 00:00:00",
28358,1,21687,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s009ltr.pdf","2005-12-15 00:00:00",
37442,2,21687,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s009lbl.pdf","2005-12-15 00:00:00",
5968,1,21687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s010ltr.pdf","2006-10-26 00:00:00",
37443,2,21687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s010lbl.pdf","2006-10-25 00:00:00",
15967,2,21687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s011lbl.pdf","2006-10-05 00:00:00",
28359,1,21687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s011LTR.pdf","2006-10-05 00:00:00",
5969,1,21687,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf","2006-03-23 00:00:00",
37444,2,21687,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf","2006-03-22 00:00:00",
5970,1,21687,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s015LTR.pdf","2006-07-13 00:00:00",
37445,2,21687,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s015lbl.pdf","2006-07-05 00:00:00",
15968,2,21687,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s016lbl.pdf","2006-12-04 00:00:00",
28360,1,21687,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s016ltr.pdf","2006-12-04 00:00:00",
5971,1,21687,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s019ltr.pdf","2007-05-29 00:00:00",
15969,2,21687,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s019lbl.pdf","2007-05-29 00:00:00",
15970,2,21687,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s021lbl.pdf","2007-12-14 00:00:00",
28361,1,21687,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s021ltr.pdf","2008-01-09 00:00:00",
28362,1,21687,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021687s022ltr.pdf","2008-02-14 00:00:00",
37446,2,21687,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021687s022lbl.pdf","2008-02-14 00:00:00",
15971,2,21687,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s029lbl.pdf","2009-01-14 00:00:00",
28363,1,21687,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s029ltr.pdf","2009-01-12 00:00:00",
5972,1,21687,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s030ltr.pdf","2009-02-03 00:00:00",
15972,2,21687,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s030lbl.pdf","2009-02-04 00:00:00",
15973,2,21687,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s032lbl.pdf","2009-11-23 00:00:00",
28364,1,21687,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s032ltr.pdf","2010-01-21 00:00:00",
5973,1,21687,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf","2011-06-08 00:00:00",
15974,2,21687,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf","2011-06-08 00:00:00",
15975,2,21687,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s034lbl.pdf","2010-03-17 00:00:00",
28365,1,21687,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s034ltr.pdf","2010-03-18 00:00:00",
5974,1,21687,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s036ltr.pdf","2010-04-28 00:00:00",
37447,2,21687,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s036lbl.pdf","2010-05-03 00:00:00",
15976,2,21687,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s037lbl.pdf","2010-12-26 00:00:00",
28366,1,21687,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s037ltr.pdf","2010-12-28 00:00:00",
5975,1,21687,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s039ltr.pdf","2012-01-30 00:00:00",
37448,2,21687,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s039lbl.pdf","2012-01-25 00:00:00",
15977,2,21687,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf","2011-06-08 00:00:00",
28367,1,21687,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf","2011-06-08 00:00:00",
15978,2,21687,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s041lbl.pdf","2011-10-12 00:00:00",
28368,1,21687,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s041ltr.pdf","2011-10-12 00:00:00",
42270,3,21687,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021687Orig1s041.pdf","2012-06-06 00:00:00",
15979,2,21687,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s042lbl.pdf","2011-12-02 00:00:00",
28369,1,21687,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s042ltr.pdf","2011-12-05 00:00:00",
5976,1,21687,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s044ltr.pdf","2012-02-29 00:00:00",
15980,2,21687,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s044lbl.pdf","2012-03-06 00:00:00",
5977,1,21687,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf","2012-11-06 00:00:00",
15981,2,21687,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf","2012-11-02 00:00:00",
28370,1,21687,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf","2012-11-06 00:00:00",
37449,2,21687,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf","2012-11-02 00:00:00",
5978,1,21687,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021687Orig1s048ltr.pdf","2013-10-28 00:00:00",
37450,2,21687,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021687s048lbl.pdf","2013-10-31 00:00:00",
28371,1,21687,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s050ltr.pdf","2014-02-28 00:00:00",
37451,2,21687,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021687s050lbl.pdf","2014-03-04 00:00:00",
5979,1,21687,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s051ltr.pdf","2014-10-14 00:00:00",
15982,2,21687,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021687s053lbl.pdf","2015-02-03 00:00:00",
28372,1,21687,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021687Orig1s053ltr.pdf","2015-02-03 00:00:00",
48430,3,21687,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021687Orig1s057.pdf","2017-05-17 00:00:00",
52776,2,21687,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021687s060lbl.pdf","2018-03-01 00:00:00",
52777,1,21687,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021687Orig1s060ltr.pdf","2018-03-01 00:00:00",
5980,1,21688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21688ltr.pdf","2004-03-10 00:00:00",
15983,2,21688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf","2004-04-05 00:00:00",
21779,3,21688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm","2004-05-10 00:00:00",
28373,1,21688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021688s006ltr.pdf","2007-10-10 00:00:00",
37452,2,21688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf","2007-10-10 00:00:00",
5981,1,21688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s008ltr.pdf","2008-03-04 00:00:00",
15984,2,21688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf","2008-03-05 00:00:00",
5982,1,21688,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s009ltr.pdf","2008-05-07 00:00:00",
28374,1,21688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s011ltr.pdf","2008-12-29 00:00:00",
37453,2,21688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf","2009-01-06 00:00:00",
28375,1,21688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021688s013ltr.pdf","2010-01-21 00:00:00",
37454,2,21688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf","2009-11-16 00:00:00",
5983,1,21688,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s015ltr.pdf","2011-03-02 00:00:00",
37455,2,21688,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf","2011-03-04 00:00:00",
5984,1,21688,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s017ltr.pdf","2011-08-03 00:00:00",
37456,2,21688,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf","2011-08-12 00:00:00",
15985,2,21688,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf","2014-11-25 00:00:00",
28376,1,21688,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf","2014-11-24 00:00:00",
5985,1,21688,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf","2014-11-24 00:00:00",
37457,2,21688,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf","2014-11-25 00:00:00",
5986,1,21688,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf","2014-11-24 00:00:00",
37458,2,21688,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf","2014-11-25 00:00:00",
48529,1,21688,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s023ltr.pdf","2017-05-25 00:00:00",
48540,2,21688,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf","2017-05-25 00:00:00",
52566,57,21688,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/160_209962 cinacalcet CDTL clinical  bpca.pdf","1900-01-01 00:00:00",
52567,20,21688,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/161_209962 cinacalcet clinical  bpca.pdf","1900-01-01 00:00:00",
52568,18,21688,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/162_209962 cinacalcet clinpharm bpca.pdf","1900-01-01 00:00:00",
52569,17,21688,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/163_209962 cinacalcet statistical bpca.pdf","1900-01-01 00:00:00",
48389,2,21688,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf","2017-05-17 00:00:00",
48400,1,21688,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s024ltr.pdf","2017-05-17 00:00:00",
28377,1,21689,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021689ltr.pdf","2005-04-06 00:00:00",
37459,2,21689,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021689lbl.pdf","2005-04-06 00:00:00",
42271,3,21689,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021689s000TOC.cfm","2007-08-06 00:00:00",
44143,10,21689,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
53266,20,21689,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21689_Esomeprazole_Clinical_Prea.pdf","1900-01-01 00:00:00",
53267,18,21689,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21689_Esomeprazole_Clinpharm_Prea.pdf","1900-01-01 00:00:00",
5987,1,21689,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s002ltr.pdf","2006-01-20 00:00:00",
37460,2,21689,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s002lbl.pdf","2006-01-13 00:00:00",
28378,1,21689,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s003ltr.pdf","2006-03-01 00:00:00",
37461,2,21689,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689S003lbl.pdf","2006-02-22 00:00:00",
5988,1,21689,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s006ltr.pdf","2006-09-20 00:00:00",
15986,2,21689,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s006lbl.pdf","2006-09-18 00:00:00",
28379,1,21689,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s007ltr.pdf","2006-10-02 00:00:00",
37462,2,21689,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s007lbl.pdf","2006-09-27 00:00:00",
5989,1,21689,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf","2007-05-01 00:00:00",
15987,2,21689,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf","2007-05-01 00:00:00",
15988,2,21689,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf","2007-05-01 00:00:00",
5990,1,21689,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf","2009-01-21 00:00:00",
15989,2,21689,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf","2009-01-16 00:00:00",
28380,1,21689,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf","2009-01-21 00:00:00",
37463,2,21689,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf","2009-01-16 00:00:00",
15990,2,21689,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf","2014-03-05 00:00:00",
28381,1,21689,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s014ltr.pdf","2014-03-06 00:00:00",
28382,1,21689,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf","2010-03-08 00:00:00",
37464,2,21689,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf","2010-03-05 00:00:00",
28383,1,21689,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf","2011-06-27 00:00:00",
37465,2,21689,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s016lbl.pdf","2011-06-29 00:00:00",
5991,1,21689,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021689s017ltr.pdf","2011-05-04 00:00:00",
15991,2,21689,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s017lbl.pdf","2011-04-29 00:00:00",
28384,1,21689,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021689s018ltr.pdf","2010-09-08 00:00:00",
37466,2,21689,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021689s018lbl.pdf","2010-09-10 00:00:00",
28385,1,21689,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf","2011-07-06 00:00:00",
37467,2,21689,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s020lbl.pdf","2011-07-06 00:00:00",
15992,2,21689,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s022lbl.pdf","2012-01-24 00:00:00",
28386,1,21689,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689s022ltr.pdf","2012-01-24 00:00:00",
28387,1,21689,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s025ltr.pdf","2012-10-12 00:00:00",
37468,2,21689,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s025lbl.pdf","2012-10-12 00:00:00",
28388,1,21689,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s026ltr.pdf","2012-10-02 00:00:00",
37469,2,21689,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s026lbl.pdf","2012-10-01 00:00:00",
5992,1,21689,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s027ltr.pdf","2014-04-14 00:00:00",
15993,2,21689,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s027lbl.pdf","2014-04-01 00:00:00",
5993,1,21689,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s028ltr.pdf","2014-02-27 00:00:00",
15994,2,21689,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s028lbl.pdf","2014-03-05 00:00:00",
5994,1,21689,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s030ltr.pdf","2014-12-23 00:00:00",
37470,2,21689,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s030lbl.pdf","2014-12-29 00:00:00",
46478,1,21689,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021689Orig1s031ltr.pdf","2016-12-22 00:00:00",
46493,2,21689,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s031lbl.pdf","2016-12-21 00:00:00",
45653,1,21689,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021689Orig1s032ltr.pdf","2016-10-26 00:00:00",
45712,2,21689,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s032lbl.pdf","2016-10-31 00:00:00",
55183,1,21689,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021689Orig1s033ltr.pdf","2018-08-16 00:00:00",
55365,2,21689,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021689s033lbl.pdf","2018-08-30 00:00:00",
5995,1,21690,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf","2015-05-04 00:00:00",
15995,2,21690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690lbl.pdf","2005-05-13 00:00:00",
15996,2,21690,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf","2015-05-04 00:00:00",
23074,6,21690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690ppi.pdf","2005-05-13 00:00:00",
28389,1,21690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021690ltr.pdf","2005-05-17 00:00:00",
42272,3,21690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021690s000TOC.cfm","2007-08-22 00:00:00",
52087,20,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-MedRev.pdf","1900-01-01 00:00:00",
52088,18,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-ClinPharmRev.pdf","1900-01-01 00:00:00",
52089,17,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021690_norgestimate_OrthoTri-Cyclen-StatRev.pdf","1900-01-01 00:00:00",
52090,23,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_11-12-02_HFD510_orig.pdf","1900-01-01 00:00:00",
52091,25,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_1-15-03_HFD510_amend.pdf","1900-01-01 00:00:00",
52092,26,21690,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/019697_norgestimate_OrthoTri-Cyclen_8-15-03_HFD510_amend2.pdf","1900-01-01 00:00:00",
5996,1,21692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021692ltr.pdf","2005-09-09 00:00:00",
5997,1,21692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021692s001LTR.pdf","2006-06-06 00:00:00",
15997,2,21692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021692lbl.pdf","2005-09-09 00:00:00",
42273,3,21692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021692s000_RalivaTOC.cfm","2006-07-25 00:00:00",
5998,1,21692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021692s002LTR.pdf","2006-08-07 00:00:00",
15998,2,21692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021692s002lbl.pdf","2006-08-04 00:00:00",
28390,1,21692,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021692s005ltr.pdf","2008-02-22 00:00:00",
37471,2,21692,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf","2008-02-25 00:00:00",
15999,2,21692,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021692s005s007lbl.pdf","2008-02-25 00:00:00",
28391,1,21692,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021692s007ltr.pdf","2008-02-22 00:00:00",
5999,1,21692,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021692s009ltr.pdf","2009-03-19 00:00:00",
46291,1,21692,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021692Orig1s013,s014ltr.pdf","2016-12-20 00:00:00",
46350,2,21692,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf","2016-12-21 00:00:00",
46292,1,21692,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021692Orig1s013,s014ltr.pdf","2016-12-20 00:00:00",
46351,2,21692,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021692s013s014lbl.pdf","2016-12-21 00:00:00",
49599,2,21692,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf","2017-08-30 00:00:00",
49600,8,21692,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf#page=36","2017-08-30 00:00:00",
49628,1,21692,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021692Orig1s015ltr.pdf","2017-08-30 00:00:00",
6000,1,21693,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021693s001ltr.pdf","2006-07-21 00:00:00",
16000,2,21693,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf","2005-05-17 00:00:00",
21780,3,21693,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm","2007-08-22 00:00:00",
28392,1,21693,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021693ltr.pdf","2005-05-17 00:00:00",
6001,1,21693,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s002ltr.pdf","2010-09-07 00:00:00",
16001,2,21693,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf","2010-08-28 00:00:00",
6002,1,21693,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s004ltr.pdf","2010-06-29 00:00:00",
16002,2,21693,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf","2010-07-01 00:00:00",
6003,1,21695,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021695s001ltr.pdf","2007-01-23 00:00:00",
16003,2,21695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf","2004-12-03 00:00:00",
21781,3,21695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021695s000_AntaraTOC.cfm","2006-06-08 00:00:00",
28393,1,21695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021695ltr.pdf","2004-12-06 00:00:00",
16004,2,21695,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf","2008-06-19 00:00:00",
28394,1,21695,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021695s006ltr.pdf","2008-06-06 00:00:00",
28395,1,21695,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695s008ltr.pdf","2012-03-05 00:00:00",
37472,2,21695,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s008lbl.pdf","2012-03-06 00:00:00",
16005,2,21695,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf","2013-10-22 00:00:00",
28396,1,21695,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021695Orig1s009ltr.pdf","2013-10-22 00:00:00",
6004,1,21695,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695Orig1s010ltr.pdf","2012-12-26 00:00:00",
16006,2,21695,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf","2012-12-21 00:00:00",
16007,2,21695,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf","2015-09-04 00:00:00",
49719,2,21695,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021695s016lbl.pdf","2017-09-12 00:00:00",
49757,1,21695,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021695Orig1s016ltr.pdf","2017-09-15 00:00:00",
54305,2,21695,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s017lbl.pdf","2018-05-22 00:00:00",
54332,1,21695,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021695Orig1s017ltr.pdf","2018-05-24 00:00:00",
6005,1,21697,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021697s001ltr.pdf","2008-10-14 00:00:00",
28397,1,21697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021697s000.pdf","2006-01-06 00:00:00",
37473,2,21697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021697lbl.pdf","2005-12-30 00:00:00",
37474,2,21697,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021697s001lbl.pdf","2008-11-07 00:00:00",
42274,3,21697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021697s000_VaprisolTOC.cfm","2006-03-24 00:00:00",
6006,1,21697,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021697s002ltr.pdf","2010-06-02 00:00:00",
16217,2,21697,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021697s002lbl.pdf","2010-06-03 00:00:00",
6007,1,21697,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021697s003ltr.pdf","2012-02-03 00:00:00",
16218,2,21697,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021697s003lbl.pdf","2012-02-06 00:00:00",
45549,1,21697,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021697Orig1s005ltr.pdf","2016-10-17 00:00:00",
45620,2,21697,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021697s005lbl.pdf","2016-10-17 00:00:00",
21782,3,21698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.cfm","2007-06-04 00:00:00",
28398,1,21698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21698ltr.pdf","2004-09-03 00:00:00",
37475,2,21698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21698lbl.pdf","2004-09-03 00:00:00",
28399,1,21698,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf","2007-03-15 00:00:00",
6008,1,21698,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s018ltr.pdf","2015-03-13 00:00:00",
16219,2,21698,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf","2015-03-26 00:00:00",
6009,1,21698,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s019ltr.pdf","2015-12-14 00:00:00",
16220,2,21698,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf","2015-12-22 00:00:00",
28400,1,21698,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s020Ltr.pdf","2015-11-23 00:00:00",
37476,2,21698,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s020lbl.pdf","2015-11-25 00:00:00",
28401,1,21698,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s022ltr.pdf","2016-03-22 00:00:00",
37477,2,21698,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698s022lbl.pdf","2016-03-29 00:00:00",
6010,1,21698,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf","2016-08-23 00:00:00",
45160,2,21698,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf","2016-07-27 00:00:00",
45062,1,21698,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s024ltr.pdf","2016-08-26 00:00:00",
45115,2,21698,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf","2016-08-26 00:00:00",
6011,1,21700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021700ltr.pdf","2005-11-30 00:00:00",
37478,2,21700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf","2005-11-30 00:00:00",
42275,3,21700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021700s000TOC.cfm","2007-07-02 00:00:00",
44144,10,21700,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2008-02-21 00:00:00",
28402,1,21700,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf","2006-06-20 00:00:00",
37479,2,21700,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf","2006-06-20 00:00:00",
28403,1,21700,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s003ltr.pdf","2006-10-26 00:00:00",
37480,2,21700,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf","2006-10-25 00:00:00",
6012,1,21700,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf","2006-06-20 00:00:00",
16221,2,21700,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf","2006-06-20 00:00:00",
28404,1,21700,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf","2007-04-09 00:00:00",
28405,1,21700,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s006ltr.pdf","2007-09-25 00:00:00",
28406,1,21700,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s007ltr.pdf","2007-08-22 00:00:00",
37481,2,21700,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf","2007-08-22 00:00:00",
28407,1,21700,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021700s008ltr.pdf","2008-12-04 00:00:00",
37482,2,21700,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf","2008-12-04 00:00:00",
37483,2,21700,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf","2009-12-10 00:00:00",
6013,1,21700,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf","2011-02-03 00:00:00",
16222,2,21700,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf","2011-02-04 00:00:00",
6014,1,21700,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf","2011-05-24 00:00:00",
16223,2,21700,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf","2011-05-17 00:00:00",
6015,1,21700,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf","2011-11-21 00:00:00",
16224,2,21700,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf","2011-11-16 00:00:00",
43770,8,21700,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012MedG.pdf","2011-11-16 00:00:00",
6016,1,21700,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf","2012-06-04 00:00:00",
37484,2,21700,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf","2012-06-06 00:00:00",
6017,1,21700,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf","2013-01-30 00:00:00",
6018,1,21700,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf","2013-09-19 00:00:00",
6019,1,21700,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf","2014-05-08 00:00:00",
16225,2,21700,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf","2014-05-12 00:00:00",
28408,1,21700,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf","2014-05-08 00:00:00",
37485,2,21700,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf","2014-05-12 00:00:00",
28409,1,21700,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf","2014-05-08 00:00:00",
37486,2,21700,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf","2014-05-12 00:00:00",
28410,1,21700,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021700Orig1s021ltr.pdf","2015-03-17 00:00:00",
37487,2,21700,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf","2015-03-19 00:00:00",
28411,1,21700,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf","2015-12-17 00:00:00",
16226,2,21703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021703lbl.pdf","2006-10-26 00:00:00",
28412,1,21703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021703s000ltr.pdf","2006-10-27 00:00:00",
42276,3,21703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021703s000TOC.cfm","2008-04-22 00:00:00",
28413,1,21703,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021703s003ltr.pdf","2008-10-22 00:00:00",
37488,2,21703,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf","2008-11-07 00:00:00",
16227,2,21703,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf","2009-04-28 00:00:00",
6020,1,21703,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021703s008ltr.pdf","2012-04-16 00:00:00",
16228,2,21703,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021703s008lbl.pdf","2012-04-17 00:00:00",
28414,1,21703,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021703Orig1s010ltr.pdf","2013-06-12 00:00:00",
28415,1,21703,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026Orig1s001ltr.pdf","2015-12-17 00:00:00",
37489,2,21703,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf","2015-12-17 00:00:00",
6021,1,21703,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026Orig1s002ltr.pdf","2016-07-22 00:00:00",
37490,2,21703,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf","2016-07-21 00:00:00",
48890,2,21703,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021703s018,207026s004lbl.pdf","2017-07-03 00:00:00",
48905,1,21703,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21703Orig1s018,207026Orig1s004ltr.pdf","2017-07-05 00:00:00",
16229,2,21704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf","2004-10-26 00:00:00",
28416,1,21704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21704ltr.pdf","2004-10-26 00:00:00",
42277,3,21704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021704s000_AllegraTOC.cfm","2005-09-13 00:00:00",
6022,1,21704,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021704s007ltr.pdf","2010-04-19 00:00:00",
16230,2,21704,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf","2010-04-19 00:00:00",
16231,2,21704,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf","2013-11-26 00:00:00",
28417,1,21704,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021704s008ltr.pdf","2011-01-27 00:00:00",
28418,1,21704,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf","2012-02-13 00:00:00",
6023,1,21704,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Org1s011ltr.pdf","2012-08-27 00:00:00",
28419,1,21704,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Orig1s013ltr.pdf","2012-12-11 00:00:00",
37491,2,21704,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf","2013-09-13 00:00:00",
16232,2,21704,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf","2015-06-19 00:00:00",
28420,1,21704,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf","2015-06-10 00:00:00",
16233,2,21704,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf","2016-06-10 00:00:00",
28421,1,21704,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf","2016-06-07 00:00:00",
28422,1,21706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021706ltr.pdf","2004-12-29 00:00:00",
37492,2,21706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf","2004-12-29 00:00:00",
42278,3,21706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021706s000_ZegeridTOC.cfm","2005-10-06 00:00:00",
44145,10,21706,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
6024,1,21708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf","2014-09-16 00:00:00",
16234,2,21708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf","2014-09-30 00:00:00",
23292,8,21708,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf","2007-02-20 00:00:00",
28423,1,21708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf","2006-03-03 00:00:00",
37493,2,21708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf","2006-03-03 00:00:00",
42279,3,21708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm","2007-09-10 00:00:00",
44146,10,21708,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
21783,3,21710,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021710s000_EquetroTOC.cfm","2006-07-05 00:00:00",
28424,1,21710,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021710ltr.pdf","2004-12-10 00:00:00",
37494,2,21710,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021710lbl.pdf","2004-12-10 00:00:00",
28425,1,21710,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021710s003ltr.pdf","2006-12-28 00:00:00",
37495,2,21710,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021710s003lbl.pdf","2006-12-14 00:00:00",
28426,1,21710,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021710s005ltr.pdf","2008-01-09 00:00:00",
6025,1,21710,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021710s006ltr.pdf","2009-05-04 00:00:00",
37496,2,21710,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021710s006lbl.pdf","2009-05-13 00:00:00",
16235,2,21710,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf","2010-10-28 00:00:00",
28427,1,21710,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021710s008ltr.pdf","2010-10-27 00:00:00",
6026,1,21710,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710Orig1s009ltr.pdf","2012-11-14 00:00:00",
16236,2,21710,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009lbl.pdf","2012-11-15 00:00:00",
23293,8,21710,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009mg.pdf","2012-11-15 00:00:00",
45371,1,21710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf","2016-09-26 00:00:00",
45421,2,21710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf","2016-09-29 00:00:00",
45372,1,21710,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf","2016-09-26 00:00:00",
45420,2,21710,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf","2016-09-29 00:00:00",
28430,1,21710,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710s013ltr.pdf","2012-01-31 00:00:00",
21784,3,21711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000TOC.cfm","2009-03-31 00:00:00",
23672,10,21711,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2011-12-21 00:00:00",
28431,1,21711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021711s000ltr.pdf","2009-01-02 00:00:00",
28432,1,21711,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s001ltr.pdf","2010-01-15 00:00:00",
37497,2,21711,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf","2010-01-29 00:00:00",
44643,21,21711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000_SumR.pdf","2009-04-02 00:00:00",
28433,1,21711,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s003ltr.pdf","2010-12-22 00:00:00",
37498,2,21711,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf","2010-12-20 00:00:00",
6027,1,21711,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021711Orig1s004ltr.pdf","2013-08-08 00:00:00",
16237,2,21711,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf","2013-08-09 00:00:00",
6028,1,21712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21712ltr.pdf","2004-09-29 00:00:00",
21785,3,21712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021712s000_TOC.cfm","2007-03-30 00:00:00",
37499,2,21712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21712lbl.pdf","2004-09-29 00:00:00",
28434,1,21713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021713ltr.pdf","2004-12-10 00:00:00",
37500,2,21713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021713lbl.pdf","2004-12-10 00:00:00",
42280,3,21713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021713s000_AbilifyTOC2.cfm","2006-09-27 00:00:00",
44147,10,21713,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
6029,1,21713,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf","2005-03-03 00:00:00",
16238,2,21713,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf","2005-03-03 00:00:00",
6030,1,21713,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021713s004,021436s007ltr.pdf","2005-06-23 00:00:00",
37501,2,21713,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf","2005-06-23 00:00:00",
6031,1,21713,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s010,021713s006ltr.pdf","2006-02-22 00:00:00",
16239,2,21713,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf","2006-02-22 00:00:00",
28435,1,21713,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf","2006-10-23 00:00:00",
37502,2,21713,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf","2006-10-23 00:00:00",
28436,1,21713,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s014, 021713s009ltr.pdf","2006-09-20 00:00:00",
37503,2,21713,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf","2006-09-20 00:00:00",
16240,2,21713,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf","2007-09-26 00:00:00",
28437,1,21713,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf","2007-10-04 00:00:00",
28438,1,21713,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf","2007-11-08 00:00:00",
37504,2,21713,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf","2007-11-07 00:00:00",
16241,2,21713,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf","2007-11-19 00:00:00",
28439,1,21713,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf","2007-11-19 00:00:00",
21786,3,21713,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf","2012-01-27 00:00:00",
24209,21,21713,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
28440,1,21713,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf","2008-05-14 00:00:00",
28441,1,21713,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf","2008-05-14 00:00:00",
42281,3,21713,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf","2012-01-27 00:00:00",
44644,21,21713,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
6032,1,21713,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf","2008-02-29 00:00:00",
16242,2,21713,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf","2008-02-28 00:00:00",
21787,3,21713,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf","2012-01-27 00:00:00",
24210,21,21713,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf","2008-07-17 00:00:00",
28442,1,21713,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf","2008-05-14 00:00:00",
28443,1,21713,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf","2008-03-07 00:00:00",
28444,1,21713,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf","2008-08-19 00:00:00",
37505,2,21713,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf","2008-08-26 00:00:00",
28445,1,21713,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf","2009-07-24 00:00:00",
37506,2,21713,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf","2009-07-23 00:00:00",
6033,1,21713,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf","2011-02-18 00:00:00",
37507,2,21713,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf","2011-02-24 00:00:00",
28446,1,21713,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf","2010-12-03 00:00:00",
37508,2,21713,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf","2010-12-02 00:00:00",
6034,1,21713,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf","2010-12-07 00:00:00",
37509,2,21713,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf","2010-12-03 00:00:00",
6035,1,21713,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf","2011-03-08 00:00:00",
16243,2,21713,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf","2011-03-07 00:00:00",
6036,1,21713,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf","2012-02-27 00:00:00",
16244,2,21713,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf","2012-02-24 00:00:00",
16245,2,21713,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf","2014-06-10 00:00:00",
28447,1,21713,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf","2014-07-11 00:00:00",
51606,20,21713,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole clinical prea.pdf","1900-01-01 00:00:00",
16246,2,21713,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf","2013-08-09 00:00:00",
28448,1,21713,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf","2013-08-05 00:00:00",
28449,1,21713,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf","2014-12-15 00:00:00",
37510,2,21713,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf","2014-12-15 00:00:00",
6037,1,21713,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf","2016-01-20 00:00:00",
16247,2,21713,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf","2016-01-22 00:00:00",
45103,2,21713,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf","2016-08-23 00:00:00",
45148,1,21713,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf","2016-08-18 00:00:00",
47329,2,21713,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf","2017-02-24 00:00:00",
47425,1,21713,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf","2017-03-02 00:00:00",
49285,8,21713,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83","2017-08-08 00:00:00",
6038,1,21716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021716ltr.pdf","2005-11-01 00:00:00",
16248,2,21716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021716lbl.pdf","2005-11-01 00:00:00",
42282,3,21716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021716s000_HydaseTOC.cfm","2005-12-28 00:00:00",
16249,2,21716,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021716s003lbl.pdf","2015-11-12 00:00:00",
28450,1,21716,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021716Orig1s003ltr.pdf","2015-11-09 00:00:00",
6039,1,21717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021717s000ltr.pdf","2006-07-03 00:00:00",
16250,2,21717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021717lbl.pdf","2006-07-03 00:00:00",
42283,3,21717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021717_tradename_toc.cfm","2008-10-15 00:00:00",
28451,1,21717,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021717s002_ltr.pdf","2007-07-05 00:00:00",
37511,2,21717,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021717s002lbl.pdf","2007-07-05 00:00:00",
6040,1,21717,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021717Orig1s005ltr.pdf","2013-11-12 00:00:00",
37512,2,21717,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021717s005lbl.pdf","2013-11-15 00:00:00",
50481,2,21717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf","2017-11-24 00:00:00",
50497,1,21717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021717Orig1s009ltr.pdf","2017-11-27 00:00:00",
6041,1,21719,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021719s001ltr.pdf","2006-10-23 00:00:00",
16251,2,21719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21719lbl.pdf","2004-10-22 00:00:00",
28452,1,21719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21719ltr.pdf","2004-10-22 00:00:00",
37513,2,21719,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021719s001lbl.pdf","2006-10-18 00:00:00",
6042,1,21720,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21720ltr.pdf","2004-10-22 00:00:00",
16252,2,21720,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21720lbl.pdf","2004-10-22 00:00:00",
21788,3,21720,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021720_s000_AriceptTOC.cfm","2006-06-08 00:00:00",
28453,1,21720,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003LTR.pdf","2006-10-18 00:00:00",
37514,2,21720,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf","2006-10-18 00:00:00",
6043,1,21720,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf","2010-11-30 00:00:00",
37515,2,21720,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf","2010-12-01 00:00:00",
28454,1,21720,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690Orig1s031ltr.pdf","2013-04-09 00:00:00",
16253,2,21720,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf","2012-03-09 00:00:00",
28455,1,21720,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pdf","2012-03-05 00:00:00",
6044,1,21720,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf","2012-09-06 00:00:00",
16254,2,21720,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf","2012-09-26 00:00:00",
6045,1,21720,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf","2013-09-10 00:00:00",
37516,2,21720,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf","2013-09-09 00:00:00",
16255,2,21720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf","2015-07-22 00:00:00",
28456,1,21720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf","2015-07-22 00:00:00",
6046,1,21721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21721ltr.pdf","2004-10-29 00:00:00",
16256,2,21721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21721lbl.pdf","2004-11-01 00:00:00",
21789,3,21721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021721s000TOC.cfm","2007-04-20 00:00:00",
43772,8,21721,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf","2009-11-19 00:00:00",
28457,1,21721,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf","2005-08-08 00:00:00",
37517,2,21721,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf","2005-08-08 00:00:00",
6047,1,21721,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf","2004-12-02 00:00:00",
37518,2,21721,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf","2004-12-03 00:00:00",
28458,1,21721,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021721s006ltr.pdf","2006-01-30 00:00:00",
37519,2,21721,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf","2006-01-27 00:00:00",
6048,1,21721,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf","2006-06-28 00:00:00",
37520,2,21721,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf","2006-06-28 00:00:00",
28459,1,21721,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf","2007-09-25 00:00:00",
37521,2,21721,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf","2007-09-19 00:00:00",
6049,1,21721,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf","2007-06-04 00:00:00",
16257,2,21721,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf","2007-06-04 00:00:00",
16258,2,21721,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf","2007-09-19 00:00:00",
28460,1,21721,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf","2007-09-25 00:00:00",
52005,20,21721,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin_ClinicalRev.pdf","1900-01-01 00:00:00",
52006,23,21721,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_orig_5-16-06.pdf","1900-01-01 00:00:00",
52012,25,21721,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634, 020635, 021721_levofloxacin_amend_6-16-06.pdf","1900-01-01 00:00:00",
52013,18,21721,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin_ClinPharmRev2.pdf","1900-01-01 00:00:00",
52018,17,21721,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020634s043, 020635s046, 021721s011_levofloxacin_Levaquin-StatRev.pdf","1900-01-01 00:00:00",
6050,1,21721,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf","2007-05-16 00:00:00",
37522,2,21721,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf","2007-05-16 00:00:00",
6051,1,21721,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf","2007-07-05 00:00:00",
37523,2,21721,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf","2007-06-27 00:00:00",
24211,21,21721,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf","2008-07-16 00:00:00",
28461,1,21721,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf","2008-05-08 00:00:00",
6052,1,21721,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf","2007-11-19 00:00:00",
37524,2,21721,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf","2007-11-19 00:00:00",
6053,1,21721,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf","2007-11-19 00:00:00",
16259,2,21721,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf","2007-11-19 00:00:00",
28462,1,21721,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf","2008-01-09 00:00:00",
37525,2,21721,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf","2007-12-14 00:00:00",
16260,2,21721,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf","2008-06-05 00:00:00",
28463,1,21721,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf","2008-04-18 00:00:00",
28464,1,21721,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf","2008-10-07 00:00:00",
37526,2,21721,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf","2008-10-08 00:00:00",
6054,1,21721,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf","2009-05-05 00:00:00",
37527,2,21721,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf","2009-05-11 00:00:00",
28465,1,21721,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf","2009-03-13 00:00:00",
6055,1,21721,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf","2011-03-03 00:00:00",
37528,2,21721,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf","2011-03-04 00:00:00",
28466,1,21721,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf","2011-06-14 00:00:00",
37529,2,21721,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf","2011-06-14 00:00:00",
21790,3,21721,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm","2015-03-10 00:00:00",
24212,21,21721,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,%20020635Orig1s067,%20021721Orig1s028SumR.pdf","2015-03-10 00:00:00",
28467,1,21721,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf","2012-05-01 00:00:00",
37530,2,21721,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf","2012-04-30 00:00:00",
16261,2,21721,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
21791,3,21721,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf","2012-06-22 00:00:00",
28468,1,21721,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
28469,1,21721,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf","2011-10-13 00:00:00",
37531,2,21721,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf","2011-10-12 00:00:00",
42284,3,21721,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf","2012-06-22 00:00:00",
6056,1,21721,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf","2013-08-16 00:00:00",
37532,2,21721,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf","2013-08-15 00:00:00",
28470,1,21721,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf","2014-05-28 00:00:00",
37533,2,21721,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf","2014-05-28 00:00:00",
6057,1,21721,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf","2016-07-26 00:00:00",
37534,2,21721,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf","2016-07-26 00:00:00",
47151,1,21721,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020634Orig1s068,020635Orig1s074,021721Orig1s035ltr.pdf","2017-02-09 00:00:00",
47161,2,21721,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf","2017-02-10 00:00:00",
21792,3,21723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021723s000_LyricaCapsTOC.cfm","2005-12-02 00:00:00",
28471,1,21723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21723ltr.pdf","2005-01-11 00:00:00",
44610,16,21723,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2005-11-30 00:00:00",
6058,1,21724,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021724ltr.pdf","2005-06-14 00:00:00",
21793,3,21724,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021724s000TOC.cfm","2008-01-23 00:00:00",
44611,16,21724,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2005-11-30 00:00:00",
16262,2,21726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021726lbl.pdf","2005-01-26 00:00:00",
28472,1,21726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021726ltr.pdf","2005-01-26 00:00:00",
42285,3,21726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021726s000_NiravamTOC.cfm","2006-07-25 00:00:00",
16263,2,21726,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021726s006lbl.pdf","2006-02-07 00:00:00",
28473,1,21726,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021726s006ltr.pdf","2006-02-07 00:00:00",
6059,1,21726,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021726s008ltr.pdf","2011-06-24 00:00:00",
16264,2,21726,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf","2011-06-16 00:00:00",
6060,1,21727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21727ltr.pdf","2004-10-04 00:00:00",
16265,2,21727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21727lbl.pdf","2004-10-04 00:00:00",
42286,3,21727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021727s000_OraDiscTOC.cfm","2006-03-21 00:00:00",
23673,10,21729,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
28474,1,21729,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021729s000LTR.pdf","2006-06-12 00:00:00",
28475,1,21729,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf","2006-10-23 00:00:00",
37535,2,21729,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021729lbl.pdf","2006-06-08 00:00:00",
37536,2,21729,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf","2006-10-23 00:00:00",
42287,3,21729,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021729s000TOC.cfm","2007-08-31 00:00:00",
6061,1,21729,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf","2007-10-04 00:00:00",
37537,2,21729,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf","2007-09-26 00:00:00",
6062,1,21729,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf","2007-11-08 00:00:00",
16266,2,21729,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf","2007-11-07 00:00:00",
6063,1,21729,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf","2007-11-19 00:00:00",
37538,2,21729,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf","2007-11-19 00:00:00",
28476,1,21729,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf","2008-05-14 00:00:00",
42288,3,21729,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
44645,21,21729,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
6064,1,21729,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf","2008-05-14 00:00:00",
21794,3,21729,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
24213,21,21729,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
28477,1,21729,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf","2008-02-29 00:00:00",
37539,2,21729,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf","2008-02-28 00:00:00",
24214,21,21729,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
28478,1,21729,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf","2008-05-14 00:00:00",
42289,3,21729,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
6065,1,21729,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf","2008-03-07 00:00:00",
28479,1,21729,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf","2008-08-19 00:00:00",
37540,2,21729,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf","2008-08-26 00:00:00",
16267,2,21729,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf","2009-07-23 00:00:00",
28480,1,21729,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf","2009-07-24 00:00:00",
16268,2,21729,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf","2011-02-24 00:00:00",
28481,1,21729,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf","2011-02-18 00:00:00",
28482,1,21729,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf","2010-12-03 00:00:00",
37541,2,21729,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf","2010-12-02 00:00:00",
6066,1,21729,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf","2010-12-07 00:00:00",
37542,2,21729,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf","2010-12-03 00:00:00",
6067,1,21729,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf","2011-03-08 00:00:00",
16269,2,21729,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf","2011-03-07 00:00:00",
6068,1,21729,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf","2012-02-27 00:00:00",
16270,2,21729,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf","2012-02-24 00:00:00",
6069,1,21729,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf","2014-07-11 00:00:00",
37543,2,21729,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf","2014-06-10 00:00:00",
51607,20,21729,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole clinical prea.pdf","1900-01-01 00:00:00",
6070,1,21729,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf","2013-08-05 00:00:00",
37544,2,21729,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf","2013-08-09 00:00:00",
16271,2,21729,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf","2014-12-15 00:00:00",
28483,1,21729,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf","2014-12-15 00:00:00",
6071,1,21729,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf","2016-01-20 00:00:00",
37545,2,21729,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf","2016-01-22 00:00:00",
45102,2,21729,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf","2016-08-23 00:00:00",
45147,1,21729,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf","2016-08-18 00:00:00",
47328,2,21729,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf","2017-02-24 00:00:00",
47426,1,21729,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf","2017-03-02 00:00:00",
49286,8,21729,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83","2017-08-08 00:00:00",
6072,1,21730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21730ltr.pdf","2005-03-14 00:00:00",
21795,3,21730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.cfm","2006-12-13 00:00:00",
37546,2,21730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf","2005-03-14 00:00:00",
28484,1,21730,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s003ltr.pdf","2006-09-20 00:00:00",
28485,1,21730,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s006ltr.pdf","2006-04-07 00:00:00",
6073,1,21730,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021730s008ltr.pdf","2008-02-07 00:00:00",
16272,2,21730,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf","2008-02-14 00:00:00",
6074,1,21730,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021730Orig1s024ltr.pdf","2012-08-01 00:00:00",
37547,2,21730,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf","2012-07-30 00:00:00",
6075,1,21730,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021730Orig1s033ltr.pdf","2013-09-12 00:00:00",
16273,2,21730,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf","2013-09-11 00:00:00",
16274,2,21730,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf","2015-03-17 00:00:00",
28486,1,21730,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021730Orig1s036ltr.pdf","2015-03-13 00:00:00",
51291,18,21730,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol clinpharm prea.pdf","1900-01-01 00:00:00",
51292,20,21730,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol clinical prea.pdf","1900-01-01 00:00:00",
51293,17,21730,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol statistical prea.pdf","1900-01-01 00:00:00",
47370,2,21730,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021730s039lbl.pdf","2017-02-28 00:00:00",
21796,3,21731,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.cfm","2006-09-27 00:00:00",
23674,10,21731,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
28487,1,21731,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021731s004LTR.pdf","2006-10-05 00:00:00",
6076,1,21731,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf","2007-11-19 00:00:00",
16275,2,21731,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf","2007-11-13 00:00:00",
28488,1,21731,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf","2010-10-13 00:00:00",
37548,2,21731,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf","2010-10-12 00:00:00",
6077,1,21731,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf","2011-01-20 00:00:00",
16276,2,21731,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf","2011-01-20 00:00:00",
28489,1,21731,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf","2011-04-11 00:00:00",
37549,2,21731,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf","2011-04-11 00:00:00",
28490,1,21731,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf","2013-03-01 00:00:00",
37550,2,21731,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf","2013-03-01 00:00:00",
6078,1,21731,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf","2014-10-14 00:00:00",
37551,2,21731,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf","2014-10-15 00:00:00",
6079,1,21731,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf","2016-03-02 00:00:00",
37552,2,21731,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf","2016-03-03 00:00:00",
6080,1,21732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21732ltr.pdf","2004-10-15 00:00:00",
16277,2,21732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21732lbl.pdf","2004-10-15 00:00:00",
21797,3,21732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021732s000_VantasTOC.cfm","2006-07-05 00:00:00",
6081,1,21732,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf","2011-02-10 00:00:00",
37553,2,21732,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf","2011-02-09 00:00:00",
6082,1,21732,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf","2011-02-10 00:00:00",
37554,2,21732,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf","2011-02-09 00:00:00",
6083,1,21732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s007,s010,s012ltr.pdf","2011-02-10 00:00:00",
37555,2,21732,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s007s010s012lbl.pdf","2011-02-09 00:00:00",
16278,2,21732,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021732s013lbl.pdf","2011-01-20 00:00:00",
28491,1,21732,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021732s013ltr.pdf","2011-01-20 00:00:00",
16279,2,21732,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021732s015lbl.pdf","2014-01-10 00:00:00",
6084,1,21732,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021732Orig1s018ltr.pdf","2013-04-09 00:00:00",
37556,2,21732,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021732s018lbl.pdf","2013-04-09 00:00:00",
6085,1,21732,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021732Orig1s019ltr.pdf","2014-07-10 00:00:00",
16280,2,21733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21733lbl.pdf","2004-09-07 00:00:00",
21798,3,21733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021733s000_CymbaltaTOC.cfm","2005-12-06 00:00:00",
28492,1,21733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21733ltr.pdf","2004-09-07 00:00:00",
44148,10,21733,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114966.htm","2005-07-29 00:00:00",
16281,2,21734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.pdf","2005-10-10 00:00:00",
28493,1,21734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021734ltr.pdf","2005-10-20 00:00:00",
42290,3,21734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021734s000TOC.cfm","2007-08-31 00:00:00",
6086,1,21735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21735ltr.pdf","2004-10-05 00:00:00",
16282,2,21735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21735lbl.pdf","2004-10-05 00:00:00",
21799,3,21735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021735s000_TerconazoleTOC.cfm","2006-07-27 00:00:00",
28494,1,21735,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021735s004ltr.pdf","2011-01-05 00:00:00",
37557,2,21735,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021735s004lbl.pdf","2011-01-04 00:00:00",
6087,1,21737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021737ltr.pdf","2005-04-12 00:00:00",
16283,2,21737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf","2005-04-12 00:00:00",
42291,3,21737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021737s000TOC.cfm","2007-01-22 00:00:00",
28495,1,21737,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021737s007ltr.pdf","2007-11-08 00:00:00",
37558,2,21737,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf","2007-11-07 00:00:00",
28496,1,21737,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021737s010ltr.pdf","2008-08-07 00:00:00",
6088,1,21737,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021737s018ltr.pdf","2010-12-03 00:00:00",
6089,1,21737,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021737s019ltr.pdf","2011-06-06 00:00:00",
16284,2,21737,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf","2011-06-07 00:00:00",
28497,1,21738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021738s000ltr.pdf","2007-07-05 00:00:00",
37559,2,21738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021738lbl.pdf","2007-06-14 00:00:00",
42292,3,21738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021738_extina_toc.cfm","2009-01-22 00:00:00",
54692,2,21738,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021738s007lbl.pdf","2018-06-27 00:00:00",
54699,1,21738,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021738Orig1s007ltr.pdf","2018-06-27 00:00:00",
6090,1,21742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021742s000ltr.pdf","2008-01-09 00:00:00",
42293,3,21742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021742s000TOC.cfm","2008-05-02 00:00:00",
6091,1,21742,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021742s007ltr.pdf","2010-02-26 00:00:00",
16285,2,21742,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf","2010-03-03 00:00:00",
16286,2,21742,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf","2011-12-14 00:00:00",
28498,1,21742,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021742s013ltr.pdf","2011-12-15 00:00:00",
50547,2,21742,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf","2017-12-01 00:00:00",
50574,1,21742,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021742Orig1s022ltr.pdf","2017-12-01 00:00:00",
28499,1,21743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21743ltr.pdf","2004-12-02 00:00:00",
37560,2,21743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021743lbl.pdf","2004-11-18 00:00:00",
42294,3,21743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-743_Tarceva.cfm","2005-03-28 00:00:00",
28500,1,21743,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021743s003ltr.pdf","2005-11-03 00:00:00",
37561,2,21743,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021743s003lbl.pdf","2005-11-03 00:00:00",
6092,1,21743,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021743s007ltr.pdf","2007-05-07 00:00:00",
37562,2,21743,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021743s007lbl.pdf","2007-05-01 00:00:00",
28501,1,21743,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf","2008-09-16 00:00:00",
28502,1,21743,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf","2008-09-16 00:00:00",
37563,2,21743,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s010lbl.pdf","2008-09-19 00:00:00",
6093,1,21743,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s011ltr.pdf","2008-09-23 00:00:00",
37564,2,21743,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s011lbl.pdf","2008-09-25 00:00:00",
6094,1,21743,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf","2010-04-20 00:00:00",
16287,2,21743,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf","2010-04-19 00:00:00",
28503,1,21743,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021743s015ltr.pdf","2009-05-05 00:00:00",
37565,2,21743,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021743s015lbl.pdf","2009-05-13 00:00:00",
6095,1,21743,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf","2010-04-20 00:00:00",
16288,2,21743,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf","2010-04-19 00:00:00",
6096,1,21743,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021743s017ltr.pdf","2012-04-19 00:00:00",
16289,2,21743,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021743s017lbl.pdf","2012-04-20 00:00:00",
16290,2,21743,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021743s018lbl.pdf","2013-05-14 00:00:00",
28504,1,21743,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021743Orig1s018ltr.pdf","2013-05-16 00:00:00",
6097,1,21743,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021743Orig1s019ltr.pdf","2014-04-16 00:00:00",
37566,2,21743,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021743s019lbl.pdf","2014-04-16 00:00:00",
6098,1,21743,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021743Orig2s021ltr.pdf","2015-04-29 00:00:00",
16291,2,21743,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021743s021lbl.pdf","2015-04-29 00:00:00",
51718,23,21743,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021743_erlotinib_Orig_WR.pdf","2010-05-07 00:00:00",
51719,25,21743,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021743_erlotinib_Amend_1.pdf","2014-06-23 00:00:00",
52477,20,21743,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21743 erlotinib clinical bpca.pdf","1900-01-01 00:00:00",
52478,18,21743,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21743 erlotinib clinpharm bpca.pdf","1900-01-01 00:00:00",
6099,1,21743,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s023ltr.pdf","2016-05-24 00:00:00",
37567,2,21743,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s023lbl.pdf","2016-05-23 00:00:00",
45552,2,21743,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf","2016-10-18 00:00:00",
45565,1,21743,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s025ltr.pdf","2016-10-20 00:00:00",
45489,1,21743,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s026ltr.pdf","2016-09-30 00:00:00",
47287,2,21743,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf","2017-02-22 00:00:00",
6100,1,21743,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s027ltr.pdf","2016-06-06 00:00:00",
16292,2,21743,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s027lbl.pdf","2016-06-02 00:00:00",
6101,1,21744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021744ltr.pdf","2005-05-20 00:00:00",
24007,14,21744,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239933.pdf","2011-01-13 00:00:00",
37568,2,21744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021744lbl.pdf","2005-05-20 00:00:00",
42295,3,21744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021744s000TOC.cfm","2007-09-11 00:00:00",
52755,8,21744,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Proquin XR.pdf","2018-02-28 00:00:00",
28505,1,21744,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021744s002LTR.pdf","2006-08-21 00:00:00",
37569,2,21744,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021744s002lbl.pdf","2006-08-18 00:00:00",
6102,1,21744,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021744s003ltr.pdf","2007-08-02 00:00:00",
16293,2,21744,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s003lbl.pdf","2007-08-02 00:00:00",
16294,2,21744,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s004lbl.pdf","2007-08-14 00:00:00",
28506,1,21744,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021744s005ltr.pdf","2007-09-06 00:00:00",
37570,2,21744,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s005lbl.pdf","2007-09-06 00:00:00",
6103,1,21744,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s007,s010ltr.pdf","2008-10-23 00:00:00",
28507,1,21744,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s008ltr.pdf","2008-10-08 00:00:00",
37571,2,21744,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021744s008lbl.pdf","2008-10-09 00:00:00",
6104,1,21744,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s007,s010ltr.pdf","2008-10-23 00:00:00",
37572,2,21744,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021744s012lbl.pdf","2009-05-11 00:00:00",
28508,1,21744,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021744s013ltr.pdf","2009-05-13 00:00:00",
6105,1,21744,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021744s014ltr.pdf","2011-01-04 00:00:00",
16295,2,21744,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021744s014lbl.pdf","2011-01-04 00:00:00",
6106,1,21744,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021744s016ltr.pdf","2011-03-03 00:00:00",
16296,2,21744,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021744s016lbl.pdf","2011-03-04 00:00:00",
21800,3,21745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745_ryzolt_toc.cfm","2009-07-06 00:00:00",
28509,1,21745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021745s000ltr.pdf","2009-01-02 00:00:00",
37573,2,21745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021745s000lbl.pdf","2009-01-02 00:00:00",
44646,21,21745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745s000_SumR.pdf","2009-07-06 00:00:00",
6107,1,21746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021746s000ltr.pdf","2012-03-13 00:00:00",
16297,2,21746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf","2012-03-07 00:00:00",
21801,3,21746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000TOC.cfm","2012-04-03 00:00:00",
44647,21,21746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000SumR.pdf","2012-04-03 00:00:00",
16298,2,21747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf","2011-10-12 00:00:00",
24215,21,21747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747Orig1s000SumR.pdf","2012-08-16 00:00:00",
28510,1,21747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021747s000ltr.pdf","2011-10-12 00:00:00",
28511,1,21747,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf","2012-08-31 00:00:00",
37574,2,21747,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf","2012-08-31 00:00:00",
42296,3,21747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747_combivent_toc.cfm","2012-08-16 00:00:00",
16299,2,21747,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf","2014-10-21 00:00:00",
28512,1,21747,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf","2014-10-22 00:00:00",
6108,1,21747,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf","2016-02-01 00:00:00",
16300,2,21747,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf","2016-02-25 00:00:00",
6109,1,21747,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s013ltr.pdf","2016-06-10 00:00:00",
16301,2,21747,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf","2016-06-13 00:00:00",
16302,2,21748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf","2005-06-07 00:00:00",
21802,3,21748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021748s000_GlumetzaTOC.cfm","2006-09-07 00:00:00",
28513,1,21748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021748ltr.pdf","2005-06-07 00:00:00",
6110,1,21748,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021748s002ltr.pdf","2006-11-06 00:00:00",
37575,2,21748,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf","2006-11-06 00:00:00",
28514,1,21748,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021748s005ltr.pdf","2009-06-23 00:00:00",
37576,2,21748,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf","2009-06-22 00:00:00",
28515,1,21748,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021748s008ltr.pdf","2010-03-03 00:00:00",
6111,1,21748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021748s010ltr.pdf","2011-04-19 00:00:00",
37577,2,21748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf","2011-04-15 00:00:00",
47927,2,21748,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf","2017-04-11 00:00:00",
24008,14,21749,"ORIG",1,"Questions and Answers","http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm130314.htm","2004-08-11 00:00:00",
28516,1,21749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf","2004-08-11 00:00:00",
37578,2,21749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021749lbl.pdf","2004-08-11 00:00:00",
42297,3,21749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-749_21-751_Pentetate.cfm","2004-10-20 00:00:00",
44149,10,21749,"ORIG",1,"0","http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm130311.htm","2004-08-11 00:00:00",
6112,1,21749,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf","2005-08-08 00:00:00",
6113,1,21749,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021749Orig1s008ltr.pdf","2013-03-22 00:00:00",
16303,2,21749,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021749s008lbl.pdf","2013-03-26 00:00:00",
6114,1,21751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf","2004-08-11 00:00:00",
16304,2,21751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021751lbl.pdf","2004-08-11 00:00:00",
21803,3,21751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-751_21-749_Pentetate.cfm","2004-10-20 00:00:00",
28517,1,21751,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf","2005-08-08 00:00:00",
6115,1,21751,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021751Orig1s008ltr.pdf","2013-03-22 00:00:00",
37579,2,21751,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf","2013-03-26 00:00:00",
50051,19,21752,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=365","2017-10-12 00:00:00",
6116,1,21752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21752ltr.pdf","2004-08-05 00:00:00",
16305,2,21752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21752lbl.pdf","2004-08-05 00:00:00",
21804,3,21752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_TruvadaTOC.cfm","2006-01-31 00:00:00",
52469,20,21752,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21752 emtricitabine tenofovir disproxil fumarate clinical prea.pdf","1900-01-01 00:00:00",
52470,18,21752,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21752 emtricitabine tenofovir disproxil fumarate clinpharm prea.pdf","1900-01-01 00:00:00",
28518,1,21752,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21752s002ltr.pdf","2005-03-30 00:00:00",
37580,2,21752,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21752s002lbl.pdf","2005-03-30 00:00:00",
42298,3,21752,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021752_S002_TRUVADA.pdf","2008-07-30 00:00:00",
16306,2,21752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021752s005lbl.pdf","2006-03-10 00:00:00",
28519,1,21752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021752s005ltr.pdf","2006-03-23 00:00:00",
28520,1,21752,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021752s006ltr.pdf","2005-10-11 00:00:00",
37581,2,21752,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021752s006lbl.pdf","2005-10-10 00:00:00",
6117,1,21752,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf","2007-05-29 00:00:00",
16307,2,21752,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf","2007-05-29 00:00:00",
28521,1,21752,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s016ltr.pdf","2008-05-21 00:00:00",
6118,1,21752,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s017ltr.pdf","2008-11-07 00:00:00",
16308,2,21752,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021752s017lbl.pdf","2008-11-07 00:00:00",
6119,1,21752,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021752s019ltr.pdf","2010-01-21 00:00:00",
37582,2,21752,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021752s019lbl.pdf","2009-11-19 00:00:00",
16309,2,21752,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021752s027lbl.pdf","2011-07-12 00:00:00",
28522,1,21752,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021752s027ltr.pdf","2011-07-12 00:00:00",
6120,1,21752,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s030ltr.pdf","2012-07-16 00:00:00",
16310,2,21752,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030lbl.pdf","2012-07-16 00:00:00",
21805,3,21752,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752_truvada_toc.cfm","2012-08-02 00:00:00",
44648,21,21752,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030SumR.pdf","2012-08-02 00:00:00",
6121,1,21752,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s031ltr.pdf","2012-07-17 00:00:00",
37583,2,21752,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s031lbl.pdf","2012-07-18 00:00:00",
16311,2,21752,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf","2013-06-17 00:00:00",
28523,1,21752,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s035ltr.pdf","2013-06-19 00:00:00",
6122,1,21752,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s042ltr.pdf","2013-10-25 00:00:00",
37584,2,21752,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s042lbl.pdf","2013-10-25 00:00:00",
28524,1,21752,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s043ltr.pdf","2013-12-17 00:00:00",
37585,2,21752,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s043lbl.pdf","2013-12-17 00:00:00",
6123,1,21752,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021752Orig1s044ltr.pdf","2014-06-19 00:00:00",
28525,1,21752,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s047ltr.pdf","2016-03-14 00:00:00",
37586,2,21752,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf","2016-03-15 00:00:00",
6124,1,21752,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s050ltr.pdf","2016-02-29 00:00:00",
37587,2,21752,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s050lbl.pdf","2016-02-26 00:00:00",
48690,1,21752,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021752Orig1s052ltr.pdf","2017-06-09 00:00:00",
48089,1,21752,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021752Orig1S053ltr.pdf","2017-04-24 00:00:00",
48090,8,21752,"SUPPL",53,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf#page=42","2017-04-24 00:00:00",
48091,2,21752,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf","2017-04-24 00:00:00",
54217,1,21752,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021752Orig1s055ltr.pdf","2018-05-16 00:00:00",
54234,2,21752,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021752s055lbl.pdf","2018-05-17 00:00:00",
6125,1,21753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021753s000ltr.pdf","2007-07-05 00:00:00",
16312,2,21753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf","2007-06-27 00:00:00",
42299,3,21753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021753TOC.cfm","2008-03-14 00:00:00",
28526,1,21753,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021753s002ltr.pdf","2010-09-07 00:00:00",
37588,2,21753,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf","2010-09-07 00:00:00",
16313,2,21753,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf","2012-02-27 00:00:00",
28527,1,21753,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021753Orig1s007ltr.pdf","2014-06-18 00:00:00",
16314,2,21754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf","2005-03-18 00:00:00",
28528,1,21754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21506,21754ltr.pdf","2005-03-18 00:00:00",
42300,3,21754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021754s000_mycamine_TOC.cfm","2007-12-06 00:00:00",
44483,14,21754,"ORIG",1,"Package Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl_2.pdf","2005-03-18 00:00:00",
6126,1,21756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021756ltr.pdf","2004-12-30 00:00:00",
16315,2,21756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021756lbl.pdf","2004-12-30 00:00:00",
21806,3,21756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-756_Macugen.cfm","2005-03-28 00:00:00",
6127,1,21756,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf","2005-11-18 00:00:00",
6128,1,21756,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf","2005-11-18 00:00:00",
16316,2,21756,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf","2006-03-10 00:00:00",
28529,1,21756,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021756s006,s007ltr.pdf","2006-03-23 00:00:00",
37589,2,21756,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf","2006-03-10 00:00:00",
16317,2,21756,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf","2011-10-20 00:00:00",
28530,1,21756,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021756s018ltr.pdf","2011-10-14 00:00:00",
6129,1,21758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758ltr.pdf","2005-02-17 00:00:00",
6130,1,21758,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s001ltr.pdf","2006-03-03 00:00:00",
16318,2,21758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021758lbl.pdf","2005-02-17 00:00:00",
37590,2,21758,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s00lbl.pdf","2006-03-03 00:00:00",
42301,3,21758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021758s000TOC.cfm","2007-07-18 00:00:00",
28531,1,21758,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758s002ltr.pdf","2005-11-30 00:00:00",
28532,1,21758,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s007ltr.pdf","2006-12-28 00:00:00",
37591,2,21758,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s007lbl.pdf","2006-12-26 00:00:00",
28533,1,21758,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s012ltr.pdf","2010-03-10 00:00:00",
37592,2,21758,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s012lbl.pdf","2010-03-09 00:00:00",
16319,2,21758,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s014lbl.pdf","2010-12-30 00:00:00",
28534,1,21758,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s014ltr.pdf","2011-01-05 00:00:00",
6131,1,21758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021758s016ltr.pdf","2011-11-16 00:00:00",
16320,2,21758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021758s016lbl.pdf","2011-11-16 00:00:00",
28535,1,21758,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021758s017ltr.pdf","2012-03-19 00:00:00",
37593,2,21758,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf","2012-03-20 00:00:00",
6132,1,21759,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf","2006-03-14 00:00:00",
16321,2,21759,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf","2006-03-14 00:00:00",
28536,1,21759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021759ltr.pdf","2005-02-03 00:00:00",
37594,2,21759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021759lbl.pdf","2005-02-03 00:00:00",
42302,3,21759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021759s000TOC.cfm","2007-07-02 00:00:00",
28537,1,21759,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf","2008-05-28 00:00:00",
16322,2,21759,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf","2009-03-26 00:00:00",
28538,1,21759,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf","2009-03-17 00:00:00",
16323,2,21759,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf","2011-12-28 00:00:00",
28539,1,21759,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf","2012-01-03 00:00:00",
16324,2,21759,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021759s015lbl.pdf","2012-10-15 00:00:00",
28540,1,21759,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021759Orig1s015ltr.pdf","2012-10-16 00:00:00",
6133,1,21759,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021759Orig1s016ltr.pdf","2013-07-18 00:00:00",
16325,2,21759,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021759s016lbl.pdf","2013-07-17 00:00:00",
6134,1,21759,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021759Orig1s019ltr.pdf","2015-10-06 00:00:00",
37595,2,21759,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021759s019lbledt.pdf","2015-10-07 00:00:00",
21807,3,21762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021762s000_FosamaxTOC.cfm","2006-06-08 00:00:00",
23296,8,21762,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf","2013-05-09 00:00:00",
28541,1,21762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762ltr.pdf","2005-04-12 00:00:00",
28542,1,21762,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762s001ltr.pdf","2005-11-08 00:00:00",
37596,2,21762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762lbl.pdf","2005-04-12 00:00:00",
37597,2,21762,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762s001lbl.pdf","2005-11-08 00:00:00",
44150,10,21762,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
6135,1,21762,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
37598,2,21762,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
6136,1,21762,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf","2007-01-08 00:00:00",
37599,2,21762,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf","2007-01-08 00:00:00",
16326,2,21762,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021762s004lbl.pdf","2007-05-01 00:00:00",
28543,1,21762,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021762s004ltr.pdf","2007-05-01 00:00:00",
16327,2,21762,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf","2010-03-02 00:00:00",
28544,1,21762,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf","2010-03-03 00:00:00",
6137,1,21762,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf","2008-10-09 00:00:00",
16328,2,21762,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf","2008-11-07 00:00:00",
6138,1,21762,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf","2010-03-03 00:00:00",
37600,2,21762,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf","2010-03-02 00:00:00",
16329,2,21762,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf","2010-03-02 00:00:00",
28545,1,21762,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf","2010-03-03 00:00:00",
6139,1,21762,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s013ltr.pdf","2011-01-27 00:00:00",
37601,2,21762,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021762s013lbl.pdf","2011-01-26 00:00:00",
28546,1,21762,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s015ltr.pdf","2011-07-06 00:00:00",
28547,1,21762,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s017ltr.pdf","2013-04-23 00:00:00",
37602,2,21762,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s017lbl.pdf","2013-04-23 00:00:00",
28548,1,21762,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s018ltr.pdf","2013-11-08 00:00:00",
37603,2,21762,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s018lbl.pdf","2013-11-08 00:00:00",
6140,1,21762,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s020ltr.pdf","2015-04-13 00:00:00",
16330,2,21762,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s020lbl.pdf","2015-04-10 00:00:00",
6141,1,21762,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s021ltr.pdf","2015-12-01 00:00:00",
37604,2,21762,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s021lbl.pdf","2015-12-02 00:00:00",
21808,3,21763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021763s000TOC.cfm","2007-09-10 00:00:00",
28549,1,21763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021763ltr.pdf","2006-01-19 00:00:00",
37605,2,21763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021763lbl.pdf","2006-01-06 00:00:00",
16331,2,21764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021764lbl.pdf","2006-05-24 00:00:00",
28550,1,21764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021764s000LTR.pdf","2006-05-25 00:00:00",
42303,3,21764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021764s000TOC.cfm","2008-02-22 00:00:00",
28551,1,21764,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021764s002ltr.pdf","2010-08-06 00:00:00",
37606,2,21764,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021764s002lbl.pdf","2010-08-10 00:00:00",
6142,1,21764,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021764s005ltr.pdf","2012-03-28 00:00:00",
37607,2,21764,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021764s005lbl.pdf","2012-03-28 00:00:00",
21809,3,21765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021765s000TOC.cfm","2007-04-20 00:00:00",
28552,1,21765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21765ltr.pdf","2004-03-28 00:00:00",
37608,2,21765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf","2004-04-05 00:00:00",
16332,2,21765,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf","2006-01-06 00:00:00",
28553,1,21765,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021765s004ltr.pdf","2006-01-19 00:00:00",
16333,2,21765,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf","2007-07-06 00:00:00",
28554,1,21765,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021765s007_ltr.pdf","2007-07-10 00:00:00",
6143,1,21768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21768ltr.pdf","2004-08-06 00:00:00",
16334,2,21768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21768lbl.pdf","2004-08-06 00:00:00",
21810,3,21768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021768s000_FludeoxyglucoseTOC.cfm","2006-07-28 00:00:00",
28555,1,21768,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021768s002ltr.pdf","2007-01-08 00:00:00",
16335,2,21770,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021770lbl.pdf","2005-08-23 00:00:00",
28556,1,21770,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021770ltr.pdf","2005-08-23 00:00:00",
28557,1,21770,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021770s001ltr.pdf","2006-04-20 00:00:00",
42304,3,21770,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021770s000TOC.cfm","2007-06-04 00:00:00",
6144,1,21770,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf","2010-08-16 00:00:00",
37609,2,21770,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf","2010-08-28 00:00:00",
28558,1,21773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021773ltr.pdf","2005-05-03 00:00:00",
37610,2,21773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf","2005-05-03 00:00:00",
42305,3,21773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm","2005-08-04 00:00:00",
43778,8,21773,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf","2009-11-18 00:00:00",
44151,10,21773,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm","2009-11-02 00:00:00",
6145,1,21773,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf","2007-01-08 00:00:00",
16336,2,21773,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf","2006-12-28 00:00:00",
16337,2,21773,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf","2006-10-13 00:00:00",
28559,1,21773,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s004LTR.pdf","2006-10-18 00:00:00",
16338,2,21773,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf","2006-11-06 00:00:00",
28560,1,21773,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s005ltr.pdf","2006-11-06 00:00:00",
28561,1,21773,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf","2007-01-08 00:00:00",
37611,2,21773,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf","2006-12-28 00:00:00",
6146,1,21773,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021773s007ltr.pdf","2007-02-23 00:00:00",
37612,2,21773,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf","2007-02-16 00:00:00",
6147,1,21773,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
16339,2,21773,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
16340,2,21773,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf","2008-06-19 00:00:00",
28562,1,21773,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s010ltr.pdf","2008-06-20 00:00:00",
6148,1,21773,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
37613,2,21773,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
28563,1,21773,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s012ltr.pdf","2008-01-18 00:00:00",
37614,2,21773,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf","2008-01-15 00:00:00",
16341,2,21773,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
28564,1,21773,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
16342,2,21773,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
28565,1,21773,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
6149,1,21773,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
37615,2,21773,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
16343,2,21773,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-04 00:00:00",
28566,1,21773,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
28567,1,21773,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf","2010-08-20 00:00:00",
28568,1,21773,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s028ltr.pdf","2010-11-18 00:00:00",
37616,2,21773,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf","2010-11-17 00:00:00",
6150,1,21773,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf","2011-10-24 00:00:00",
16344,2,21773,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf","2011-11-04 00:00:00",
16345,2,21773,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf","2011-11-04 00:00:00",
28569,1,21773,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf","2011-10-24 00:00:00",
6151,1,21773,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s031ltr.pdf","2011-08-10 00:00:00",
6152,1,21773,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021773Orig1s036ltr.pdf","2014-11-26 00:00:00",
16346,2,21773,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf","2014-11-26 00:00:00",
28570,1,21773,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021773Orig1s040ltr.pdf","2015-02-27 00:00:00",
37617,2,21773,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf","2015-03-03 00:00:00",
6153,1,21774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021774ltr.pdf","2005-09-08 00:00:00",
16347,2,21774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf","2005-09-08 00:00:00",
21811,3,21774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021774s000_AmbienTOC.cfm","2006-06-07 00:00:00",
23675,10,21774,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
6154,1,21774,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf","2008-01-09 00:00:00",
37618,2,21774,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf","2008-01-08 00:00:00",
48860,3,21774,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021774Orig1s003.pdf","2017-06-29 00:00:00",
6155,1,21774,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf","2008-01-09 00:00:00",
16348,2,21774,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf","2008-01-08 00:00:00",
16349,2,21774,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf","2008-01-08 00:00:00",
28571,1,21774,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf","2008-01-09 00:00:00",
16350,2,21774,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf","2008-01-08 00:00:00",
28572,1,21774,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf","2008-01-09 00:00:00",
28573,1,21774,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf","2008-01-09 00:00:00",
37619,2,21774,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf","2008-01-08 00:00:00",
6156,1,21774,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021774s010ltr.pdf","2010-04-19 00:00:00",
37620,2,21774,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf","2010-04-19 00:00:00",
16351,2,21774,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf","2013-04-23 00:00:00",
21812,3,21774,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf","2013-09-30 00:00:00",
28574,1,21774,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf","2013-04-24 00:00:00",
6157,1,21774,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf","2013-04-24 00:00:00",
16352,2,21774,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf","2013-04-23 00:00:00",
21813,3,21774,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf","2013-09-30 00:00:00",
6158,1,21774,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf","2014-10-09 00:00:00",
37621,2,21774,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf","2014-10-09 00:00:00",
45055,1,21774,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf","2016-08-12 00:00:00",
45056,2,21774,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf","2016-08-11 00:00:00",
46023,2,21774,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf","2016-12-05 00:00:00",
46052,1,21774,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf","2016-12-06 00:00:00",
46083,8,21774,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf#page=24","2016-12-06 00:00:00",
47472,2,21774,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf","2017-03-06 00:00:00",
47499,1,21774,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf","2017-03-08 00:00:00",
55501,1,21774,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf","2018-09-18 00:00:00",
55513,2,21774,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf","2018-09-18 00:00:00",
6159,1,21775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021775s000ltr.pdf","2008-05-28 00:00:00",
6160,1,21775,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s001ltr.pdf","2009-02-19 00:00:00",
16353,2,21775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021775lbl.pdf","2008-05-28 00:00:00",
21814,3,21775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021775_ENTEREGTOC.cfm","2008-07-18 00:00:00",
24010,14,21775,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=15","2008-05-28 00:00:00",
44649,21,21775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021775s000_SUMR.pdf","2008-07-17 00:00:00",
6161,1,21775,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s004ltr.pdf","2010-01-21 00:00:00",
37622,2,21775,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021775s004lbl.pdf","2009-11-19 00:00:00",
6162,1,21775,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s007ltr.pdf","2012-10-02 00:00:00",
28575,1,21775,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s008ltr.pdf","2012-10-23 00:00:00",
37623,2,21775,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021775s008lbl.pdf","2012-10-22 00:00:00",
28576,1,21775,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021775Orig1s010ltr.pdf","2013-10-21 00:00:00",
37624,2,21775,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021775s010lbl.pdf","2013-10-22 00:00:00",
6163,1,21775,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021775Orig1s013ltr.pdf","2016-05-20 00:00:00",
6164,1,21777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021777s000ltr.pdf","2007-02-12 00:00:00",
16354,2,21777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021777lbl.pdf","2007-02-02 00:00:00",
21815,3,21777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021777s000TOC.cfm","2008-05-06 00:00:00",
6165,1,21777,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021777s003ltr.pdf","2008-03-26 00:00:00",
6166,1,21777,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s006,s009ltr.pdf","2013-06-11 00:00:00",
16355,2,21777,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s006s009lbl.pdf","2013-06-11 00:00:00",
6167,1,21777,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777s006,s009ltr.pdf","2013-06-11 00:00:00",
37625,2,21777,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777Orig1s006s009lbl.pdf","2013-06-11 00:00:00",
6168,1,21777,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021777Orig1s012ltr.pdf","2013-04-16 00:00:00",
37626,2,21777,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021777s012lbl.pdf","2013-04-16 00:00:00",
28577,1,21777,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021777Orig1s014ltr.pdf","2016-05-27 00:00:00",
37627,2,21777,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021777s014lbl.pdf","2016-06-01 00:00:00",
21816,3,21778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021778s000TOC.cfm","2007-07-02 00:00:00",
28578,1,21778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021778ltr.pdf","2005-07-08 00:00:00",
37628,2,21778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021778lbl.pdf","2005-07-07 00:00:00",
28579,1,21778,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf","2007-03-23 00:00:00",
37629,2,21778,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf","2007-03-23 00:00:00",
16356,2,21778,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf","2007-03-23 00:00:00",
28580,1,21778,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf","2007-03-23 00:00:00",
28581,1,21778,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021778s007ltr.pdf","2008-08-19 00:00:00",
6169,1,21778,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021778s008ltr.pdf","2010-07-28 00:00:00",
37630,2,21778,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021778s008lbl.pdf","2010-07-30 00:00:00",
6170,1,21778,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021778Orig1s016ltr.pdf","2013-05-16 00:00:00",
16357,2,21778,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021778s016lbl.pdf","2013-05-21 00:00:00",
28582,1,21778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021778Orig1s018ltr.pdf","2014-09-23 00:00:00",
37631,2,21778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021778s018lbl.pdf","2014-09-22 00:00:00",
6171,1,21779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf","2005-01-11 00:00:00",
16358,2,21779,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf","2005-08-31 00:00:00",
28583,1,21779,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf","2005-08-31 00:00:00",
37632,2,21779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf","2005-01-11 00:00:00",
42306,3,21779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-779_Ventavis.cfm","2005-03-28 00:00:00",
28584,1,21779,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf","2005-08-31 00:00:00",
37633,2,21779,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf","2005-08-31 00:00:00",
28585,1,21779,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s003ltr.pdf","2005-12-15 00:00:00",
37634,2,21779,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf","2005-12-15 00:00:00",
6172,1,21779,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s006ltr.pdf","2008-03-07 00:00:00",
16359,2,21779,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf","2008-03-05 00:00:00",
28586,1,21779,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s008ltr.pdf","2008-09-23 00:00:00",
37635,2,21779,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf","2008-09-25 00:00:00",
21817,3,21779,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021779Orig1s009.pdf","2011-10-10 00:00:00",
28587,1,21779,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021779s009ltr.pdf","2010-01-27 00:00:00",
37636,2,21779,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf","2009-09-22 00:00:00",
28588,1,21779,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021779s010ltr.pdf","2010-04-23 00:00:00",
37637,2,21779,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf","2010-05-03 00:00:00",
6173,1,21779,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021779s012ltr.pdf","2011-02-14 00:00:00",
37638,2,21779,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf","2011-02-09 00:00:00",
6174,1,21779,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021779Orig1s013ltr.pdf","2012-05-02 00:00:00",
37639,2,21779,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf","2012-05-01 00:00:00",
28589,1,21779,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021779Orig1s014ltr_corrected.pdf","2013-11-25 00:00:00",
37640,2,21779,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf","2013-11-26 00:00:00",
50069,2,21779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021779s018lbl.pdf","2017-10-17 00:00:00",
50093,1,21779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021779Orig1s018ltr.pdf","2017-10-18 00:00:00",
6175,1,21780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021780s000ltr.pdf","2006-11-06 00:00:00",
42307,3,21780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021780_nitromist_toc.cfm","2008-10-28 00:00:00",
28590,1,21780,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021780s003ltr.pdf","2011-03-11 00:00:00",
37641,2,21780,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021780s003lbl.pdf","2011-03-11 00:00:00",
6176,1,21780,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021780Orig1s007ltr.pdf","2016-06-14 00:00:00",
16360,2,21780,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021780s007lbl.pdf","2016-06-13 00:00:00",
6177,1,21782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782ltr.pdf","2005-07-26 00:00:00",
23676,10,21782,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109091.htm","2005-08-30 00:00:00",
28591,1,21782,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782s001ltr.pdf","2005-08-23 00:00:00",
37642,2,21782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782lbl.pdf","2005-07-26 00:00:00",
37643,2,21782,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782s001lbl.pdf","2005-08-23 00:00:00",
42308,3,21782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021782s000_RozeremTOC.cfm","2005-10-20 00:00:00",
6178,1,21782,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf","2012-03-05 00:00:00",
6179,1,21782,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf","2008-10-23 00:00:00",
16361,2,21782,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf","2008-11-07 00:00:00",
6180,1,21782,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf","2008-10-23 00:00:00",
37644,2,21782,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf","2008-11-07 00:00:00",
16362,2,21782,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf","2008-11-07 00:00:00",
28592,1,21782,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf","2008-10-23 00:00:00",
23298,8,21782,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011Medguide.pdf","2010-11-12 00:00:00",
28593,1,21782,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021782s011ltr.pdf","2010-11-15 00:00:00",
37645,2,21782,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011lbl.pdf","2010-11-12 00:00:00",
28594,1,21782,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf","2012-03-05 00:00:00",
6181,1,21782,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf","2012-03-05 00:00:00",
28595,1,21782,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021782s015ltr.pdf","2011-08-05 00:00:00",
16363,2,21785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021785lbl.pdf","2004-12-30 00:00:00",
16364,2,21785,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
21818,3,21785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021785s000_InviraseTOC.cfm","2006-09-27 00:00:00",
23075,6,21785,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf","2005-11-04 00:00:00",
23299,8,21785,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf","2010-10-13 00:00:00",
28596,1,21785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021785ltr.pdf","2004-12-30 00:00:00",
28597,1,21785,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
6182,1,21785,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf","2005-09-14 00:00:00",
37646,2,21785,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf","2005-09-14 00:00:00",
42309,3,21785,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021785_S002_FORTOVASE.pdf","2007-07-27 00:00:00",
43571,6,21785,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf","2005-11-04 00:00:00",
28598,1,21785,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s024, 021785s003ltr.pdf","2007-04-09 00:00:00",
37647,2,21785,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf","2007-04-06 00:00:00",
6183,1,21785,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s025,021785s004ltr.pdf","2007-07-16 00:00:00",
16365,2,21785,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf","2007-07-16 00:00:00",
16366,2,21785,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf","2010-01-24 00:00:00",
28599,1,21785,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s027,021785s006ltr.pdf","2010-01-26 00:00:00",
6184,1,21785,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s032,021785s009ltr.pdf","2010-04-29 00:00:00",
16367,2,21785,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf","2010-05-07 00:00:00",
28600,1,21785,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s033,021785s010ltr.pdf","2010-10-12 00:00:00",
37648,2,21785,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf","2010-10-12 00:00:00",
6185,1,21785,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628Orig1s034,021785Orig1s011ltr.pdf","2012-12-04 00:00:00",
16368,2,21785,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf","2012-12-04 00:00:00",
6186,1,21785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020628s037,021785s014ltr.pdf","2011-05-31 00:00:00",
6187,1,21785,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628s038,021785s015ltr.pdf","2012-02-27 00:00:00",
16369,2,21785,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf","2012-02-22 00:00:00",
28601,1,21785,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s039,021785Orig1s016ltr.pdf","2015-04-22 00:00:00",
37649,2,21785,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf","2015-04-28 00:00:00",
28602,1,21785,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s041,021785Orig1s017ltr.pdf","2016-03-02 00:00:00",
37650,2,21785,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf","2016-03-03 00:00:00",
16370,2,21785,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf","2015-04-02 00:00:00",
28603,1,21785,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s042,21785Orig1s018ltr.pdf","2015-03-31 00:00:00",
16371,2,21785,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf","2015-12-17 00:00:00",
28604,1,21785,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s043,021785Orig1s019ltr.pdf","2015-12-17 00:00:00",
45342,1,21785,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s045,021785Orig1s021ltr.pdf","2016-09-20 00:00:00",
45382,2,21785,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf","2016-09-23 00:00:00",
53055,2,21785,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf","2018-03-19 00:00:00",
53067,1,21785,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020628Orig1s046,021785Orig1s022ltr.pdf","2018-03-20 00:00:00",
16372,2,21788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021788lbl.pdf","2008-12-03 00:00:00",
28605,1,21788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021788s000ltr.pdf","2008-12-02 00:00:00",
42310,3,21788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021788_synthetic_conjugated_estrogens_toc.cfm","2009-04-22 00:00:00",
6188,1,21789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789ltr.pdf","2005-07-08 00:00:00",
6189,1,21789,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789s001ltr.pdf","2005-11-18 00:00:00",
16373,2,21789,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf","2005-11-18 00:00:00",
37651,2,21789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf","2005-07-07 00:00:00",
42311,3,21789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021789s000_MetrogelTOC.cfm","2006-09-26 00:00:00",
16374,2,21789,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf","2010-03-17 00:00:00",
28606,1,21789,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021789s003ltr.pdf","2010-03-09 00:00:00",
6190,1,21789,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021789s004ltr.pdf","2011-10-24 00:00:00",
16375,2,21789,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf","2011-11-04 00:00:00",
42312,3,21789,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021789Orig1s004.pdf","2012-10-12 00:00:00",
16376,2,21790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021790lbl.pdf","2006-05-04 00:00:00",
28607,1,21790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021790s000LTR.pdf","2006-05-05 00:00:00",
42313,3,21790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_DacogenTOC.cfm","2006-06-16 00:00:00",
52603,20,21790,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021790_decitabine_clinical_bpca.pdf","1900-01-01 00:00:00",
52604,18,21790,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021790_decitabine_clinpharm_bpca.pdf","1900-01-01 00:00:00",
28608,1,21790,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021790s006ltr.pdf","2010-03-18 00:00:00",
37652,2,21790,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021790s006lbl.pdf","2010-03-18 00:00:00",
16377,2,21790,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf","2015-09-04 00:00:00",
6191,1,21793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021793ltr.pdf","2005-06-14 00:00:00",
21819,3,21793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021793s000TOC.cfm","2007-07-18 00:00:00",
37653,2,21793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf","2005-06-14 00:00:00",
6192,1,21793,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf","2009-07-06 00:00:00",
16378,2,21793,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf","2009-09-22 00:00:00",
42314,3,21793,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021793_s004a_reglan tablets.pdf","2011-02-15 00:00:00",
6193,1,21793,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf","2009-10-26 00:00:00",
6194,1,21793,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021793s007ltr.pdf","2010-09-21 00:00:00",
37654,2,21793,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf","2010-09-10 00:00:00",
16379,2,21793,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf","2010-11-26 00:00:00",
28609,1,21793,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf","2010-11-22 00:00:00",
6195,1,21793,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s009ltr.pdf","2011-08-05 00:00:00",
6196,1,21793,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s011ltr.pdf","2011-11-30 00:00:00",
37655,2,21793,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf","2011-12-02 00:00:00",
43781,8,21793,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf","2011-12-02 00:00:00",
6197,1,21794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021794ltr.pdf","2005-07-15 00:00:00",
21820,3,21794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021794s000TOC.cfm","2007-09-13 00:00:00",
37656,2,21794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf","2005-07-08 00:00:00",
6198,1,21794,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf","2008-03-18 00:00:00",
37657,2,21794,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf","2008-03-17 00:00:00",
37658,2,21794,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf","2009-04-03 00:00:00",
28610,1,21794,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf","2015-07-13 00:00:00",
37659,2,21794,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf","2015-07-24 00:00:00",
54277,1,21794,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021794Orig1s016ltr.pdf","2018-05-21 00:00:00",
54283,2,21794,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf","2018-05-22 00:00:00",
23677,10,21795,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm","2008-05-14 00:00:00",
24216,21,21795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021795s000_SumR.pdf","2009-08-26 00:00:00",
28611,1,21795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021795s000ltr.pdf","2008-05-14 00:00:00",
42315,3,21795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021795_desmopressin_acetate.cfm","2009-08-26 00:00:00",
53225,20,21795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021795_Desmopressin_Clinical_PREA.pdf","1900-01-01 00:00:00",
53226,18,21795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021795_Desmopressin_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
6199,1,21797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf","2005-03-31 00:00:00",
6200,1,21797,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf","2007-03-06 00:00:00",
21821,3,21797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.cfm","2005-07-12 00:00:00",
37660,2,21797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf","2005-03-31 00:00:00",
37661,2,21797,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf","2007-02-26 00:00:00",
52474,20,21797,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21797 entecavir clinical bpca.pdf","1900-01-01 00:00:00",
52475,18,21797,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21797 entecavir clinpharm bpca.pdf","1900-01-01 00:00:00",
52476,17,21797,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21797 entecavir statistical bpca.pdf","1900-01-01 00:00:00",
6201,1,21797,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf","2007-03-31 00:00:00",
16380,2,21797,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf","2007-03-31 00:00:00",
16381,2,21797,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf","2007-07-27 00:00:00",
28612,1,21797,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf","2007-07-27 00:00:00",
16382,2,21797,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf","2008-08-13 00:00:00",
28613,1,21797,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf","2008-07-31 00:00:00",
28614,1,21797,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf","2008-06-06 00:00:00",
6202,1,21797,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf","2009-07-22 00:00:00",
37662,2,21797,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf","2009-07-24 00:00:00",
28615,1,21797,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf","2009-02-27 00:00:00",
37663,2,21797,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf","2009-03-17 00:00:00",
37664,2,21797,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf","2010-10-29 00:00:00",
6203,1,21797,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.pdf","2011-01-04 00:00:00",
37665,2,21797,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s011lbl.pdf","2010-12-28 00:00:00",
6204,1,21797,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf","2012-10-15 00:00:00",
37666,2,21797,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf","2012-10-15 00:00:00",
16383,2,21797,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf","2012-10-15 00:00:00",
28616,1,21797,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf","2012-10-15 00:00:00",
6205,1,21797,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf","2013-12-20 00:00:00",
37667,2,21797,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf","2013-12-23 00:00:00",
6206,1,21797,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf","2014-03-21 00:00:00",
37668,2,21797,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf","2014-03-25 00:00:00",
51703,23,21797,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Original_WR.pdf","2006-11-28 00:00:00",
51705,25,21797,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_1.pdf","2007-04-23 00:00:00",
51707,26,21797,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_2.pdf","2010-06-28 00:00:00",
51711,27,21797,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_3.pdf","2013-05-31 00:00:00",
54710,1,21797,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s19_21798Orig11s021ltr.pdf","2018-06-27 00:00:00",
54813,2,21797,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s019lbl.pdf","2018-07-07 00:00:00",
6207,1,21798,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf","2007-03-06 00:00:00",
16384,2,21798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf","2005-03-31 00:00:00",
28617,1,21798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf","2005-03-31 00:00:00",
37669,2,21798,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf","2007-02-26 00:00:00",
42316,3,21798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.cfm","2005-12-06 00:00:00",
6208,1,21798,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf","2007-03-31 00:00:00",
16385,2,21798,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf","2007-03-31 00:00:00",
6209,1,21798,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf","2007-07-27 00:00:00",
37670,2,21798,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf","2007-07-27 00:00:00",
6210,1,21798,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf","2008-07-31 00:00:00",
37671,2,21798,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf","2008-08-13 00:00:00",
6211,1,21798,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf","2008-06-06 00:00:00",
6212,1,21798,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf","2009-07-22 00:00:00",
16386,2,21798,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf","2009-07-24 00:00:00",
6213,1,21798,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf","2009-02-27 00:00:00",
16387,2,21798,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf","2009-03-17 00:00:00",
16388,2,21798,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf","2010-10-29 00:00:00",
28618,1,21798,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.pdf","2011-01-04 00:00:00",
37672,2,21798,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021798s012lbl.pdf","2010-12-28 00:00:00",
16389,2,21798,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf","2012-10-15 00:00:00",
28619,1,21798,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf","2012-10-15 00:00:00",
6214,1,21798,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf","2012-10-15 00:00:00",
37673,2,21798,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf","2012-10-15 00:00:00",
16390,2,21798,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf","2013-12-23 00:00:00",
28620,1,21798,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf","2013-12-20 00:00:00",
16391,2,21798,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf","2014-03-25 00:00:00",
28621,1,21798,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf","2014-03-21 00:00:00",
51704,23,21798,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Original_WR.pdf","2006-11-28 00:00:00",
51706,25,21798,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_1.pdf","2007-04-23 00:00:00",
51708,26,21798,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_2.pdf","2010-06-28 00:00:00",
51712,27,21798,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021797_021798_entecavir_Amendment_3.pdf","2013-05-31 00:00:00",
54709,1,21798,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s19_21798Orig11s021ltr.pdf","2018-06-27 00:00:00",
54814,2,21798,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf","2018-07-06 00:00:00",
16392,2,21799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021799lbl.pdf","2005-08-15 00:00:00",
28622,1,21799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021799ltr.pdf","2005-08-16 00:00:00",
42317,3,21799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021799s000TOC.cfm","2008-07-09 00:00:00",
43782,8,21799,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192698.pdf","2009-12-03 00:00:00",
6215,1,21799,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021799s006ltr.pdf","2007-10-04 00:00:00",
16393,2,21799,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021799s006lbl.pdf","2007-10-10 00:00:00",
6216,1,21799,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021799s008ltr.pdf","2008-11-18 00:00:00",
16394,2,21799,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf","2008-11-17 00:00:00",
6217,1,21799,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s011ltr.pdf","2010-06-17 00:00:00",
16395,2,21799,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf","2010-06-24 00:00:00",
28623,1,21799,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s013ltr.pdf","2009-12-31 00:00:00",
6218,1,21799,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s014ltr.pdf","2010-01-25 00:00:00",
37674,2,21799,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021799s014lbl.pdf","2009-11-23 00:00:00",
6219,1,21799,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s015ltr.pdf","2010-01-29 00:00:00",
16396,2,21799,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021799s016lbl.pdf","2011-04-18 00:00:00",
28624,1,21799,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021799s016ltr.pdf","2011-04-19 00:00:00",
6220,1,21799,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s021ltr.pdf","2013-02-26 00:00:00",
37675,2,21799,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s021lbl.pdf","2013-02-26 00:00:00",
6221,1,21799,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021799s022ltr.pdf","2012-05-24 00:00:00",
28625,1,21799,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s023ltr.pdf","2013-04-16 00:00:00",
37676,2,21799,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s023lbl.pdf","2013-04-16 00:00:00",
16397,2,21799,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021799s024lbl.pdf","2014-07-03 00:00:00",
28626,1,21799,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021799Orig1s024ltr.pdf","2014-07-03 00:00:00",
6222,1,21802,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf","2006-04-13 00:00:00",
16398,2,21802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf","2005-06-07 00:00:00",
16399,2,21802,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf","2006-04-12 00:00:00",
21822,3,21802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021802s000TOC.cfm","2007-07-02 00:00:00",
23678,10,21802,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-10 00:00:00",
28627,1,21802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021802ltr.pdf","2005-06-07 00:00:00",
53227,20,21802,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21802_ focalin_ clinical_ prea.pdf","1900-01-01 00:00:00",
53228,18,21802,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21802_ focalin_ clinpharm_ prea.pdf","1900-01-01 00:00:00",
53229,17,21802,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21802_ focalin_ statistical_ prea .pdf","1900-01-01 00:00:00",
6223,1,21802,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf","2006-08-04 00:00:00",
16400,2,21802,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf","2006-08-04 00:00:00",
28628,1,21802,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf","2006-04-13 00:00:00",
37677,2,21802,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf","2006-04-12 00:00:00",
28629,1,21802,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf","2006-08-04 00:00:00",
37678,2,21802,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf","2006-08-04 00:00:00",
6224,1,21802,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf","2007-05-01 00:00:00",
37679,2,21802,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf","2007-05-01 00:00:00",
28630,1,21802,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021802s012ltr.pdf","2008-10-22 00:00:00",
6225,1,21802,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s014,s016ltr.pdf","2009-12-11 00:00:00",
37680,2,21802,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf","2009-10-30 00:00:00",
6226,1,21802,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s016ltr.pdf021802s014,s016ltr.pdf","2009-12-11 00:00:00",
16401,2,21802,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf","2009-10-30 00:00:00",
16402,2,21802,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf","2010-05-07 00:00:00",
28631,1,21802,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s017ltr.pdf","2010-05-07 00:00:00",
6227,1,21802,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf","2010-11-22 00:00:00",
16403,2,21802,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf","2010-11-19 00:00:00",
37681,2,21802,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf","2011-11-29 00:00:00",
6228,1,21802,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf","2012-05-04 00:00:00",
16404,2,21802,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf","2012-05-07 00:00:00",
28632,1,21802,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf","2013-06-12 00:00:00",
37682,2,21802,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf","2013-06-18 00:00:00",
6229,1,21802,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf","2013-12-13 00:00:00",
37683,2,21802,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf","2013-12-17 00:00:00",
6230,1,21802,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf","2015-04-20 00:00:00",
16405,2,21802,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf","2015-04-21 00:00:00",
46703,2,21802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf","2017-01-06 00:00:00",
46754,1,21802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf","2017-01-10 00:00:00",
46755,8,21802,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf#page=17","2017-01-10 00:00:00",
21823,3,21806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021806s000TOC.cfm","2007-06-29 00:00:00",
28633,1,21806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021806ltr.pdf","2005-05-25 00:00:00",
37684,2,21806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021806lbl.pdf","2005-05-25 00:00:00",
28634,1,21806,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021806s003ltr.pdf","2011-02-10 00:00:00",
37685,2,21806,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021806s003lbl.pdf","2011-02-09 00:00:00",
16406,2,21807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf","2005-11-01 00:00:00",
21824,3,21807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021807s000TOC.cfm","2007-09-10 00:00:00",
28635,1,21807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021807ltr.pdf","2005-11-01 00:00:00",
43783,8,21807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lblMG.pdf","2007-02-21 00:00:00",
55618,2,21807,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf","2018-09-26 00:00:00",
55619,8,21807,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf#page=36","2018-09-26 00:00:00",
55745,1,21807,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021807Orig1s005ltr.pdf","2018-10-01 00:00:00",
6231,1,21810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021810s000ltr.pdf","2008-08-28 00:00:00",
16407,2,21810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf","2008-08-29 00:00:00",
42318,3,21810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810_novolog_mix_toc.cfm","2009-08-13 00:00:00",
44650,21,21810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810S000_SumR.pdf","2009-08-13 00:00:00",
50470,2,21810,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf","2017-11-22 00:00:00",
6232,1,21810,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021810Orig1s004ltr.pdf","2013-03-12 00:00:00",
37686,2,21810,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf","2013-03-12 00:00:00",
6233,1,21810,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021810Orig1s010ltr.pdf","2015-02-27 00:00:00",
16408,2,21810,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf","2015-03-03 00:00:00",
6234,1,21812,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s001LTR.pdf","2006-05-24 00:00:00",
21825,3,21812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021812s000TOC.cfm","2008-05-06 00:00:00",
28636,1,21812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s000ltr.pdf","2006-01-30 00:00:00",
37687,2,21812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021812s000LBL.pdf","2006-01-27 00:00:00",
6235,1,21812,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021812Orig1s009ltr.pdf","2014-03-04 00:00:00",
16409,2,21812,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf","2014-03-27 00:00:00",
28637,1,21812,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021812Orig1s010ltr.pdf","2013-12-17 00:00:00",
37688,2,21812,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021812Orig1s010lbl.pdf","2014-01-13 00:00:00",
16410,2,21812,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf","2015-02-17 00:00:00",
28638,1,21812,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021812Orig1s011ltr.pdf","2015-02-12 00:00:00",
6236,1,21813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021813s000ltr.pdf","2006-12-28 00:00:00",
6237,1,21813,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021813s001ltr.pdf","2008-02-29 00:00:00",
16411,2,21813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf","2006-12-26 00:00:00",
24217,21,21813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813s000_SumR.pdf","2009-06-09 00:00:00",
42319,3,21813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813_elestrin_toc.cfm","2009-06-09 00:00:00",
6238,1,21813,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021813s003ltr.pdf","2012-02-29 00:00:00",
37689,2,21813,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf","2012-02-28 00:00:00",
16412,2,21813,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf","2014-03-04 00:00:00",
50270,2,21813,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021813s006lbl.pdf","2017-11-02 00:00:00",
21826,3,21814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21814_000_AptivusTOC.cfm","2005-09-02 00:00:00",
28639,1,21814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021814ltr.pdf","2005-06-24 00:00:00",
28640,1,21814,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf","2006-08-18 00:00:00",
37690,2,21814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf","2005-06-23 00:00:00",
37691,2,21814,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf","2006-08-14 00:00:00",
53415,20,21814,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021814_Tipranavir_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53416,18,21814,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021814_Tipranavir_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53417,17,21814,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021814_Tipranavir_Statistical_BPCA.pdf","1900-01-01 00:00:00",
16413,2,21814,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf","2006-08-14 00:00:00",
28641,1,21814,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf","2006-08-18 00:00:00",
16414,2,21814,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf","2007-10-10 00:00:00",
28642,1,21814,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s003ltr.pdf","2007-10-10 00:00:00",
6239,1,21814,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s004ltr.pdf","2007-05-29 00:00:00",
21827,3,21814,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm","2010-05-12 00:00:00",
24218,21,21814,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf","2010-05-12 00:00:00",
28643,1,21814,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf","2008-06-26 00:00:00",
37692,2,21814,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf","2008-06-26 00:00:00",
6240,1,21814,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf","2009-06-24 00:00:00",
37693,2,21814,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf","2009-06-24 00:00:00",
28644,1,21814,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf","2010-05-03 00:00:00",
37694,2,21814,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf","2010-05-07 00:00:00",
6241,1,21814,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf","2010-09-07 00:00:00",
16415,2,21814,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf","2010-08-16 00:00:00",
6242,1,21814,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf","2011-04-07 00:00:00",
16416,2,21814,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf","2011-04-06 00:00:00",
28645,1,21814,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf","2012-02-27 00:00:00",
37695,2,21814,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf","2012-02-22 00:00:00",
28646,1,21814,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf","2014-04-08 00:00:00",
37696,2,21814,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf","2014-04-08 00:00:00",
6243,1,21814,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf","2015-04-01 00:00:00",
37697,2,21814,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf","2015-04-07 00:00:00",
45343,1,21814,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf","2016-09-20 00:00:00",
45375,2,21814,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf","2016-09-23 00:00:00",
54716,2,21814,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf","2018-06-28 00:00:00",
54857,1,21814,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022292Orig1s010,021814Orig1s018ltr.pdf","2018-07-06 00:00:00",
6244,1,21817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021817s000ltr.pdf","2007-04-20 00:00:00",
16417,2,21817,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s001lbl.pdf","2008-06-19 00:00:00",
21828,3,21817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021817TOC.cfm","2008-03-14 00:00:00",
24219,21,21817,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021817se1-001_SUMR.pdf","2008-07-17 00:00:00",
28647,1,21817,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s001ltr.pdf","2008-06-06 00:00:00",
37698,2,21817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021817lbl.pdf","2007-04-20 00:00:00",
6245,1,21817,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s002ltr.pdf","2008-12-31 00:00:00",
37699,2,21817,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s002lbl.pdf","2009-01-06 00:00:00",
6246,1,21817,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s003ltr.pdf","2009-03-19 00:00:00",
37700,2,21817,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s003lbl.pdf","2009-04-21 00:00:00",
28648,1,21817,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s004ltr.pdf","2009-06-10 00:00:00",
37701,2,21817,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s004lbl.pdf","2009-06-10 00:00:00",
28649,1,21817,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s006ltr.pdf","2011-03-10 00:00:00",
37702,2,21817,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s006lbl.pdf","2011-03-11 00:00:00",
6247,1,21817,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s009ltr.pdf","2011-01-27 00:00:00",
37703,2,21817,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s009lbl.pdf","2011-01-26 00:00:00",
16418,2,21817,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf","2011-09-01 00:00:00",
21829,3,21817,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021817Orig1s012.pdf","2013-01-24 00:00:00",
28650,1,21817,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s012ltr.pdf","2011-09-01 00:00:00",
6248,1,21817,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s013ltr.pdf","2011-08-17 00:00:00",
6249,1,21817,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021817Orig1s015ltr.pdf","2013-04-24 00:00:00",
16419,2,21817,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021817s015lbl.pdf","2013-04-23 00:00:00",
28651,1,21817,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s020ltr.pdf","2015-02-02 00:00:00",
37704,2,21817,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s020lbl.pdf","2015-02-19 00:00:00",
6250,1,21817,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s021ltr.pdf","2015-05-11 00:00:00",
37705,2,21817,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s021lbl.pdf","2015-04-19 00:00:00",
28652,1,21817,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021817Orig1s022ltr.pdf","2016-04-15 00:00:00",
37706,2,21817,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021817s022lbl.pdf","2016-04-15 00:00:00",
48936,2,21817,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf","2017-07-10 00:00:00",
48946,1,21817,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021817Orig1s027ltr.pdf","2017-07-11 00:00:00",
48959,8,21817,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf#page=25","2017-07-12 00:00:00",
6251,1,21818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021818ltr.pdf","2005-06-21 00:00:00",
21830,3,21818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm","2007-10-02 00:00:00",
37707,2,21818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021818lbl.pdf","2005-06-16 00:00:00",
6252,1,21821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021821ltr.pdf","2005-06-21 00:00:00",
16420,2,21821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf","2005-06-17 00:00:00",
21831,3,21821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-821_Tygacil.cfm","2005-08-24 00:00:00",
44152,10,21821,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm224383.htm","2011-12-21 00:00:00",
28653,1,21821,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf","2006-07-21 00:00:00",
6253,1,21821,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf","2006-07-21 00:00:00",
6254,1,21821,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s006ltr.pdf","2007-02-02 00:00:00",
6255,1,21821,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s007ltr.pdf","2007-04-09 00:00:00",
37708,2,21821,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf","2007-04-06 00:00:00",
28654,1,21821,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s010ltr.pdf","2007-05-29 00:00:00",
37709,2,21821,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf","2007-05-29 00:00:00",
28655,1,21821,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf","2009-02-03 00:00:00",
6256,1,21821,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf","2009-03-25 00:00:00",
16421,2,21821,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf","2009-03-25 00:00:00",
28656,1,21821,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf","2009-02-03 00:00:00",
37710,2,21821,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf","2009-02-04 00:00:00",
16422,2,21821,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf","2009-02-10 00:00:00",
28657,1,21821,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s016ltr.pdf","2009-02-13 00:00:00",
28658,1,21821,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf","2009-03-25 00:00:00",
37711,2,21821,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf","2009-03-25 00:00:00",
6257,1,21821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf","2009-03-25 00:00:00",
16423,2,21821,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf","2009-03-25 00:00:00",
16424,2,21821,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf","2009-02-04 00:00:00",
28659,1,21821,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf","2009-02-03 00:00:00",
28660,1,21821,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf","2010-07-23 00:00:00",
37712,2,21821,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf","2010-07-19 00:00:00",
6258,1,21821,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s022ltr.pdf","2009-06-30 00:00:00",
6259,1,21821,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf","2010-07-23 00:00:00",
37713,2,21821,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf","2010-07-16 00:00:00",
6260,1,21821,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf","2013-10-01 00:00:00",
21832,3,21821,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s026.pdf","2014-01-16 00:00:00",
37714,2,21821,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf","2013-09-27 00:00:00",
6261,1,21821,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf","2010-07-23 00:00:00",
37715,2,21821,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf","2010-07-19 00:00:00",
6262,1,21821,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf","2013-10-01 00:00:00",
21833,3,21821,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s031.pdf","2014-01-16 00:00:00",
37716,2,21821,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf","2013-09-27 00:00:00",
28661,1,21821,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s037ltr.pdf","2013-05-28 00:00:00",
37717,2,21821,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf","2013-05-24 00:00:00",
16425,2,21821,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf","2016-06-01 00:00:00",
28662,1,21821,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s039ltr.pdf","2016-06-01 00:00:00",
6263,1,21821,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s042ltr.pdf","2016-06-30 00:00:00",
37718,2,21821,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s042lbl.pdf","2016-07-14 00:00:00",
6264,1,21821,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s043ltr.pdf","2016-01-21 00:00:00",
37719,2,21821,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf","2016-01-26 00:00:00",
53703,2,21821,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021821s045lbl.pdf","2018-04-17 00:00:00",
53716,1,21821,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021821Orig1s045ltr.pdf","2018-04-17 00:00:00",
28663,1,21822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021822s000ltr.pdf","2008-06-26 00:00:00",
37720,2,21822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021822LBL.pdf","2008-06-26 00:00:00",
42320,3,21822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021822_aptivus_toc.cfm","2010-04-21 00:00:00",
44651,21,21822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021822s000Sumr.pdf","2010-04-21 00:00:00",
6265,1,21823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021823ltr.pdf","2005-08-19 00:00:00",
21834,3,21823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021823orig1s000.pdf","2015-12-01 00:00:00",
37721,2,21823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf","2005-08-15 00:00:00",
44153,10,21823,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
16426,2,21823,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf","2006-01-25 00:00:00",
28664,1,21823,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf","2006-01-30 00:00:00",
6266,1,21823,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s003LTR.pdf","2006-06-28 00:00:00",
6267,1,21823,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s004_LTR.pdf","2006-09-18 00:00:00",
37722,2,21823,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf","2006-08-23 00:00:00",
6268,1,21823,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf","2011-01-27 00:00:00",
16427,2,21823,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf","2011-01-26 00:00:00",
6269,1,21823,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf","2011-01-27 00:00:00",
37723,2,21823,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf","2011-01-26 00:00:00",
6270,1,21823,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s008ltr.pdf","2011-08-24 00:00:00",
16428,2,21823,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf","2013-04-23 00:00:00",
28665,1,21823,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021823Orig1s009ltr.pdf","2013-04-24 00:00:00",
6271,1,21823,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s010ltr.pdf","2015-03-27 00:00:00",
37724,2,21823,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf","2015-03-27 00:00:00",
28666,1,21823,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s011ltr.pdf","2015-04-13 00:00:00",
37725,2,21823,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf","2015-04-10 00:00:00",
46086,8,21823,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27","2016-12-07 00:00:00",
6272,1,21825,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021825s001ltr.pdf","2012-04-24 00:00:00",
21835,3,21825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000TOC.cfm","2011-11-30 00:00:00",
28667,1,21825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021825Orig1s000ltr.pdf","2011-10-14 00:00:00",
37726,2,21825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf","2011-10-14 00:00:00",
37727,2,21825,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021825s001lbl.pdf","2012-04-24 00:00:00",
44652,21,21825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000SumR.pdf","2011-12-02 00:00:00",
52746,8,21825,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Ferriprox021825s001lbl.pdf","2018-02-28 00:00:00",
6273,1,21825,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021825Orig1s003ltr.pdf","2015-02-26 00:00:00",
37728,2,21825,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf","2015-03-02 00:00:00",
16429,2,21829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829lbl.pdf","2007-05-10 00:00:00",
21836,3,21829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021829s000TOC.cfm","2007-07-02 00:00:00",
23076,6,21829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829ppi.pdf","2007-05-10 00:00:00",
28668,1,21829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021829s000ltr.pdf","2007-05-16 00:00:00",
28669,1,21829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf","2012-04-04 00:00:00",
37729,2,21829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s001lbl.pdf","2012-04-02 00:00:00",
44991,3,21829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf","2012-04-02 00:00:00",
6274,1,21829,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf","2012-04-04 00:00:00",
37730,2,21829,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s002lbl.pdf","2012-04-02 00:00:00",
44992,3,21829,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf","2012-04-02 00:00:00",
16430,2,21829,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021829s007lbl.pdf","2015-03-02 00:00:00",
28670,1,21829,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021829Orig1s007ltr.pdf","2015-02-27 00:00:00",
21837,3,21830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021830TOC.cfm","2009-05-15 00:00:00",
24220,21,21830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.pdf","2008-07-17 00:00:00",
28671,1,21830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf","2008-06-03 00:00:00",
37731,2,21830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf","2008-06-12 00:00:00",
28672,1,21830,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf","2009-04-27 00:00:00",
37732,2,21830,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf","2009-04-28 00:00:00",
28673,1,21830,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf","2010-05-28 00:00:00",
37733,2,21830,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf","2012-05-14 00:00:00",
28674,1,21830,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf","2013-10-21 00:00:00",
37734,2,21830,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf","2013-10-22 00:00:00",
51334,18,21830,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021830s006 mesalamine clinical prea.pdf","1900-01-01 00:00:00",
51335,17,21830,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021830s006 mesalamine statistical prea.pdf","1900-01-01 00:00:00",
51336,18,21830,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19651Origs024_ mesalamine clinpharm PREA.pdf","1900-01-01 00:00:00",
6275,1,21830,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf","2016-05-06 00:00:00",
16431,2,21830,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf","2016-05-06 00:00:00",
49125,1,21830,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf","2017-07-28 00:00:00",
49139,2,21830,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf","2017-07-28 00:00:00",
53742,2,21830,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021830s012lbl.pdf","2018-04-19 00:00:00",
53769,1,21830,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021830Orig1s012ltr.pdf","2018-04-23 00:00:00",
6276,1,21832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021832ltr.pdf","2005-07-08 00:00:00",
16432,2,21835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf","2005-11-01 00:00:00",
21838,3,21835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021835s000TOC.cfm","2007-07-03 00:00:00",
28675,1,21835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021835ltr.pdf","2005-11-01 00:00:00",
28676,1,21835,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf","2011-01-14 00:00:00",
37735,2,21835,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf","2011-01-14 00:00:00",
6277,1,21835,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf","2011-01-14 00:00:00",
37736,2,21835,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf","2011-01-14 00:00:00",
16433,2,21835,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf","2012-09-11 00:00:00",
28677,1,21835,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s006ltr.pdf","2012-09-10 00:00:00",
16434,2,21835,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf","2012-08-20 00:00:00",
28678,1,21835,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s007ltr.pdf","2012-08-20 00:00:00",
28679,1,21837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021837s000,022177s000ltr.pdf","2008-03-24 00:00:00",
28680,1,21838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021838s000TAltr.pdf","2007-03-15 00:00:00",
6278,1,21839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf","2005-09-08 00:00:00",
16435,2,21839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf","2005-08-31 00:00:00",
42321,3,21839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021839_IncrelexTOC.cfm","2005-10-12 00:00:00",
16436,2,21839,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf","2011-02-24 00:00:00",
28681,1,21839,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021839s007ltr.pdf","2011-02-18 00:00:00",
28682,1,21839,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839Origs010ltr.pdf","2012-09-17 00:00:00",
37737,2,21839,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf","2012-09-14 00:00:00",
28683,1,21839,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839s012ltr.pdf","2012-06-15 00:00:00",
37738,2,21839,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf","2012-06-18 00:00:00",
28684,1,21839,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021839Orig1s016ltr.pdf","2014-06-05 00:00:00",
37739,2,21839,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf","2014-06-04 00:00:00",
6279,1,21839,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021839Orig1s017ltr.pdf","2016-03-16 00:00:00",
16437,2,21839,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf","2016-03-17 00:00:00",
6280,1,21840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021840s000LTR.pdf","2006-05-26 00:00:00",
16438,2,21840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf","2006-05-26 00:00:00",
42322,3,21840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021840s000TOC.cfm","2008-07-09 00:00:00",
28685,1,21840,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021840s008ltr.pdf","2010-08-09 00:00:00",
37740,2,21840,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021840s008lbl.pdf","2010-07-29 00:00:00",
49331,2,21840,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021840s011lbl.pdf","2017-08-10 00:00:00",
49380,1,21840,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021840Orig1s011ltr.pdf","2017-08-15 00:00:00",
16439,2,21842,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf","2006-09-01 00:00:00",
23077,6,21842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842ppi.pdf","2005-08-30 00:00:00",
28687,1,21842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021842ltr.pdf","2005-08-31 00:00:00",
28688,1,21842,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021842s001ltr.pdf","2006-09-18 00:00:00",
37741,2,21842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf","2005-08-30 00:00:00",
42323,3,21842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021842s000TOC.cfm","2007-01-22 00:00:00",
44154,10,21842,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
6281,1,21842,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf","2006-11-07 00:00:00",
37742,2,21842,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf","2006-11-06 00:00:00",
28689,1,21842,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf","2006-10-02 00:00:00",
28690,1,21842,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021842s005ltr.pdf","2007-10-04 00:00:00",
37743,2,21842,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf","2007-09-26 00:00:00",
16440,2,21842,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf","2009-01-06 00:00:00",
28691,1,21842,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s007ltr.pdf","2009-01-06 00:00:00",
28692,1,21842,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf","2012-05-18 00:00:00",
37744,2,21842,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf","2012-05-22 00:00:00",
28693,1,21842,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s009ltr.pdf","2009-10-26 00:00:00",
6282,1,21842,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf","2012-05-18 00:00:00",
16441,2,21842,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf","2012-05-22 00:00:00",
6283,1,21842,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s011ltr.pdf","2009-11-25 00:00:00",
16442,2,21842,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf","2009-10-23 00:00:00",
28694,1,21842,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021842s012ltr.pdf","2010-08-11 00:00:00",
6284,1,21842,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
37745,2,21842,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf","2011-08-04 00:00:00",
16443,2,21842,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf","2011-08-04 00:00:00",
28695,1,21842,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
28696,1,21842,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf","2012-05-22 00:00:00",
6285,1,21842,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021842Orig1s019ltr.pdf","2014-08-19 00:00:00",
37746,2,21842,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf","2014-08-20 00:00:00",
46138,1,21842,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf","2016-12-13 00:00:00",
46730,2,21842,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf","2017-01-09 00:00:00",
46143,1,21842,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf","2016-12-14 00:00:00",
46729,2,21842,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf","2017-01-09 00:00:00",
50861,2,21842,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf","2017-12-26 00:00:00",
50862,8,21842,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41","2017-12-26 00:00:00",
50916,1,21842,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021842Orig1s022ltr.pdf","2017-12-27 00:00:00",
16444,2,21844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021844lbl.pdf","2006-10-23 00:00:00",
28697,1,21844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021844s000ltr.pdf","2006-10-23 00:00:00",
42324,3,21844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021844_desonate_toc.cfm","2008-09-05 00:00:00",
6286,1,21844,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021844s002ltr.pdf","2010-01-05 00:00:00",
16445,2,21844,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021844s002lbl.pdf","2010-01-12 00:00:00",
6287,1,21844,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021844Orig1s008ltr.pdf","2014-07-24 00:00:00",
16446,2,21844,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021844s008lbl.pdf","2014-07-24 00:00:00",
6288,1,21845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845ltr.pdf","2005-06-07 00:00:00",
21839,3,21845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021845s000_RevatioTOC.cfm","2005-12-02 00:00:00",
28698,1,21845,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845s001ltr.pdf","2005-11-18 00:00:00",
37747,2,21845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021845lbl.pdf","2005-06-07 00:00:00",
44155,10,21845,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm","2014-06-20 00:00:00",
24140,15,21845,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021845s002PI.pdf","2006-08-04 00:00:00",
28699,1,21845,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s002ltr.pdf","2006-08-04 00:00:00",
6289,1,21845,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s003_ltr.pdf","2006-07-21 00:00:00",
6290,1,21845,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021845s004ltr.pdf","2008-01-09 00:00:00",
16447,2,21845,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf","2007-12-27 00:00:00",
28700,1,21845,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s005ltr.pdf","2009-02-19 00:00:00",
37748,2,21845,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf","2009-02-20 00:00:00",
6291,1,21845,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s006ltr.pdf","2009-05-13 00:00:00",
16448,2,21845,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf","2009-05-11 00:00:00",
6292,1,21845,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf","2010-11-22 00:00:00",
16449,2,21845,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf","2010-11-26 00:00:00",
6293,1,21845,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021845Orig1s008ltr.pdf","2012-09-05 00:00:00",
37749,2,21845,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf","2012-08-31 00:00:00",
28701,1,21845,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf","2014-03-13 00:00:00",
37750,2,21845,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf","2014-03-13 00:00:00",
28702,1,21845,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
37751,2,21845,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
6294,1,21845,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
16450,2,21845,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
28703,1,21845,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf","2014-03-07 00:00:00",
37752,2,21845,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf","2014-03-07 00:00:00",
6295,1,21845,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf","2015-04-29 00:00:00",
37753,2,21845,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf","2015-05-12 00:00:00",
52259,2,21845,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021845s018lbl.pdf","2018-02-02 00:00:00",
52301,1,21845,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021845Orig1s018ltr.pdf","2018-02-02 00:00:00",
49267,2,21845,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021845s20_022473s11_203109s11lbl.pdf","2017-08-08 00:00:00",
6296,1,21846,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021846s098ltr.pdf","2007-05-29 00:00:00",
37754,2,21846,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021846s098lbl.pdf","2007-05-29 00:00:00",
6297,1,21846,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021846s099ltr.pdf","2007-11-08 00:00:00",
28704,1,21846,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021846s101ltr.pdf","2008-07-23 00:00:00",
37755,2,21846,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021846s101lbl.pdf","2008-07-22 00:00:00",
6298,1,21849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021849s000ltr.pdf","2006-03-03 00:00:00",
21840,3,21849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021849TOC.cfm","2008-05-07 00:00:00",
23679,10,21849,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
37756,2,21849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021849s000lbl.pdf","2006-03-03 00:00:00",
21841,3,21849,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021849Orig1s002.pdf","2011-10-10 00:00:00",
28705,1,21849,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021849s002ltr.pdf","2008-01-09 00:00:00",
37757,2,21849,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf","2008-01-08 00:00:00",
6299,1,21849,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf","2010-01-29 00:00:00",
6300,1,21849,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf","2010-09-08 00:00:00",
16451,2,21849,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf","2010-09-10 00:00:00",
16452,2,21849,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf","2011-05-25 00:00:00",
28706,1,21849,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf","2011-05-25 00:00:00",
28707,1,21849,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf","2011-12-13 00:00:00",
37758,2,21849,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf","2011-12-15 00:00:00",
6301,1,21849,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf","2012-11-14 00:00:00",
16453,2,21849,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf","2012-11-15 00:00:00",
16454,2,21849,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf","2012-04-20 00:00:00",
28708,1,21849,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf","2012-04-23 00:00:00",
28709,1,21849,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf","2014-03-04 00:00:00",
37759,2,21849,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf","2014-02-27 00:00:00",
6302,1,21849,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf","2014-12-24 00:00:00",
16455,2,21849,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf","2014-12-29 00:00:00",
45665,1,21849,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf","2016-10-26 00:00:00",
45720,2,21849,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf","2016-10-31 00:00:00",
54531,8,21849,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf#page=26","2018-06-12 00:00:00",
54532,2,21849,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf","2018-06-12 00:00:00",
54576,1,21849,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021849Orig1s014,021636Orig1s019ltr.pdf","2018-06-14 00:00:00",
6303,1,21850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021850s000ltr.pdf","2006-04-05 00:00:00",
21842,3,21850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021850s000TOC.cfm","2007-02-05 00:00:00",
23680,10,21850,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
6304,1,21850,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf","2010-01-29 00:00:00",
37760,2,21850,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021850s002lbl.pdf","2010-01-24 00:00:00",
16456,2,21850,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf","2010-09-10 00:00:00",
28710,1,21850,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf","2010-09-08 00:00:00",
28711,1,21852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021852s000ltr.pdf","2006-01-20 00:00:00",
37761,2,21852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf","2006-01-13 00:00:00",
42325,3,21852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852TOC.cfm","2008-03-24 00:00:00",
28712,1,21852,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021852s002ltr.pdf","2007-10-04 00:00:00",
37762,2,21852,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf","2007-10-04 00:00:00",
6305,1,21852,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021852s006ltr.pdf","2010-04-02 00:00:00",
37763,2,21852,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf","2010-04-04 00:00:00",
28713,1,21852,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021852Orig1s012ltr.pdf","2012-12-04 00:00:00",
37764,2,21852,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf","2012-12-03 00:00:00",
6306,1,21852,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s015ltr.pdf","2014-12-30 00:00:00",
16457,2,21852,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf","2015-01-08 00:00:00",
52077,20,21852,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21852s015_ calcipotriene betamethasone clinical prea.pdf","1900-01-01 00:00:00",
52078,18,21852,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21852s015_ calcipotriene betamethasone clinpharm prea.pdf","1900-01-01 00:00:00",
6307,1,21852,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s016ltr.pdf","2014-07-29 00:00:00",
16458,2,21852,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf","2014-07-29 00:00:00",
6308,1,21853,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf","2007-07-05 00:00:00",
42326,3,21853,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm","2009-11-19 00:00:00",
28714,1,21854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021854s000ltr.pdf","2007-03-15 00:00:00",
6309,1,21855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021855ltr.pdf","2005-08-08 00:00:00",
21843,3,21855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021855s000TOC.cfm","2007-06-04 00:00:00",
37765,2,21855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.pdf","2005-08-08 00:00:00",
47547,1,21855,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021855Orig1s006ltr.pdf","2017-03-14 00:00:00",
47567,2,21855,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf","2017-03-16 00:00:00",
16459,2,21856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021856lbl.pdf","2009-02-20 00:00:00",
24221,21,21856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_SumR.pdf","2009-04-07 00:00:00",
28715,1,21856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021856s000ltr.pdf","2009-02-18 00:00:00",
42327,3,21856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000TOC.cfm","2009-04-07 00:00:00",
6310,1,21856,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021856s003ltr.pdf","2011-02-03 00:00:00",
16460,2,21856,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021856s003lbl.pdf","2011-02-04 00:00:00",
16461,2,21856,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021856s006lbl.pdf","2012-11-02 00:00:00",
28716,1,21856,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021856Orig1s006ltr.pdf","2012-11-06 00:00:00",
49426,2,21856,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf","2017-08-16 00:00:00",
49568,1,21856,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021856Orig1s011ltr.pdf","2017-08-29 00:00:00",
52496,2,21856,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021856s012lbl.pdf","2018-02-07 00:00:00",
52516,1,21856,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021856Orig1s012ltr.pdf","2018-02-08 00:00:00",
6311,1,21858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s000ltr.pdf","2006-01-10 00:00:00",
6312,1,21858,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s001LTR.pdf","2006-08-09 00:00:00",
16462,2,21858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf","2006-01-10 00:00:00",
16463,2,21858,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf","2006-08-09 00:00:00",
21844,3,21858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021858s000TOC.cfm","2007-05-09 00:00:00",
44156,10,21858,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
6313,1,21858,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021858s004ltr.pdf","2007-02-23 00:00:00",
28717,1,21858,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf","2013-04-24 00:00:00",
37766,2,21858,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf","2013-04-23 00:00:00",
16464,2,21858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf","2011-01-26 00:00:00",
28718,1,21858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s009ltr.pdf","2011-01-27 00:00:00",
28719,1,21858,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s010ltr.pdf","2011-08-12 00:00:00",
28720,1,21858,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s012ltr.pdf","2011-07-07 00:00:00",
28721,1,21858,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf","2013-04-24 00:00:00",
37767,2,21858,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf","2013-04-23 00:00:00",
6314,1,21858,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf","2013-04-24 00:00:00",
16465,2,21858,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf","2013-04-23 00:00:00",
6315,1,21858,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s019ltr.pdf","2015-03-19 00:00:00",
37768,2,21858,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf","2015-03-19 00:00:00",
6316,1,21858,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s020ltr.pdf","2015-04-13 00:00:00",
37769,2,21858,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf","2015-04-10 00:00:00",
46105,1,21858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021858Orig1s022ltr.pdf","2016-12-09 00:00:00",
46141,2,21858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf","2016-12-13 00:00:00",
46648,8,21858,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18","2017-01-03 00:00:00",
6317,1,21859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021859ltr.pdf","2005-12-13 00:00:00",
16466,2,21859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021859lbl.pdf","2005-12-13 00:00:00",
42328,3,21859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021859_s000_HylenexTOC.cfm","2006-01-03 00:00:00",
28722,1,21859,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021859s002LTR.pdf","2006-06-12 00:00:00",
16467,2,21859,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021859s005lbl.pdf","2008-10-09 00:00:00",
28723,1,21859,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021859s005ltr.pdf","2008-10-06 00:00:00",
6318,1,21859,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021859s006ltr.pdf","2010-01-25 00:00:00",
16468,2,21859,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021859s006lbl.pdf","2009-12-15 00:00:00",
6319,1,21859,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s009ltr.pdf","2012-03-05 00:00:00",
16469,2,21859,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf","2012-03-20 00:00:00",
6320,1,21859,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s015ltr.pdf","2012-03-23 00:00:00",
16470,2,21859,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s015lbl.pdf","2012-03-23 00:00:00",
6321,1,21859,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021859Orig1s023ltr.pdf","2016-01-25 00:00:00",
37770,2,21859,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021859s023lbl.pdf","2016-01-26 00:00:00",
45045,8,21860,"APPL",0,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf","2016-08-24 00:00:00",
45046,10,21860,"APPL",0,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2016-08-24 00:00:00",
6322,1,21860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021860s000LTR.pdf","2006-05-22 00:00:00",
16471,2,21860,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s001lbl.pdf","2007-04-09 00:00:00",
28724,1,21860,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s001ltr.pdf","2007-04-09 00:00:00",
37771,2,21860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021860lbl.pdf","2006-05-22 00:00:00",
42329,3,21860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021860_sarafem_toc.cfm","2008-09-05 00:00:00",
44157,10,21860,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
28725,1,21860,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s002ltr.pdf","2007-12-03 00:00:00",
37772,2,21860,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s002lbl.pdf","2007-12-03 00:00:00",
28726,1,21860,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021860s005ltr.pdf","2009-04-27 00:00:00",
37773,2,21860,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021860s005lbl.pdf","2009-04-28 00:00:00",
16472,2,21860,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf","2013-07-08 00:00:00",
28727,1,21860,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf","2013-07-08 00:00:00",
6323,1,21860,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf","2013-07-08 00:00:00",
37774,2,21860,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf","2013-07-08 00:00:00",
16473,2,21860,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf","2013-07-08 00:00:00",
28728,1,21860,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf","2013-07-08 00:00:00",
28729,1,21860,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf","2013-07-08 00:00:00",
37775,2,21860,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf","2013-07-08 00:00:00",
6324,1,21860,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021860Orig1s010ltr.pdf","2014-12-02 00:00:00",
16474,2,21860,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021860s010lbl.pdf","2014-12-03 00:00:00",
46721,2,21860,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf","2017-01-06 00:00:00",
46798,8,21860,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf#page=33","2017-01-11 00:00:00",
46799,1,21860,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021860Orig1s011ltr.pdf","2017-01-11 00:00:00",
6325,1,21861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021861s000ltr.pdf","2008-04-22 00:00:00",
37776,2,21861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021861lbl.pdf","2008-04-23 00:00:00",
42330,3,21861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021861s000TOC.cfm","2010-03-19 00:00:00",
53356,20,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021861_Olopatadine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53357,20,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21861 patanase clinical both.pdf","1900-01-01 00:00:00",
53358,18,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021861_Olopatadine_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53359,17,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021861_Olopatadine_Statistical_PREA.pdf","1900-01-01 00:00:00",
53360,18,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21861 patanase clinpharm both.pdf","1900-01-01 00:00:00",
53361,17,21861,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21861 patanase statistical both.pdf","1900-01-01 00:00:00",
28730,1,21861,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021861s002ltr.pdf","2010-01-26 00:00:00",
37777,2,21861,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021861s002lbl.pdf","2009-12-02 00:00:00",
28731,1,21861,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021861s008ltr.pdf","2010-04-05 00:00:00",
37778,2,21861,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021861s008lbl.pdf","2010-04-04 00:00:00",
6326,1,21861,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021861s009ltr.pdf","2012-02-27 00:00:00",
37779,2,21861,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021861s009lbl.pdf","2012-02-24 00:00:00",
6327,1,21861,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021861Orig1s011ltr.pdf","2015-10-28 00:00:00",
16475,2,21861,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021861s011lbl.pdf","2015-11-04 00:00:00",
6328,1,21862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021862ltr.pdf","2005-08-23 00:00:00",
16476,2,21862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf","2005-08-23 00:00:00",
42331,3,21862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021862s000_NevanacTOC.cfm","2005-10-06 00:00:00",
37780,2,21862,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021862s002lbl.pdf","2008-06-12 00:00:00",
6329,1,21862,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021862s008ltr.pdf","2011-07-05 00:00:00",
16477,2,21862,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf","2011-06-27 00:00:00",
50781,1,21862,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021862Orig1s013ltr.pdf","2017-12-20 00:00:00",
50832,2,21862,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf","2017-12-22 00:00:00",
6330,1,21864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021864s000ltr.pdf","2007-05-29 00:00:00",
16478,2,21864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021864lbl.pdf","2007-05-29 00:00:00",
21845,3,21864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021864_lybrel_toc.cfm","2008-12-22 00:00:00",
6331,1,21864,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021864s002ltr.pdf","2008-09-19 00:00:00",
16479,2,21864,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021864s002lbl.pdf","2008-09-19 00:00:00",
6332,1,21864,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021864Orig1s007ltr.pdf","2016-06-21 00:00:00",
37781,2,21864,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021864s007lbl.pdf","2016-06-21 00:00:00",
6333,1,21866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021866s000ltr.pdf","2006-09-25 00:00:00",
21846,3,21866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021866TOC.cfm","2008-08-11 00:00:00",
24222,21,21866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021866s000_SumR.pdf","2008-08-12 00:00:00",
37782,2,21866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021866lbl.pdf","2006-09-21 00:00:00",
44158,10,21866,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
16480,2,21866,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf","2007-09-26 00:00:00",
28732,1,21866,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf","2007-10-04 00:00:00",
16481,2,21866,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf","2010-02-14 00:00:00",
28733,1,21866,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf","2010-02-14 00:00:00",
6334,1,21866,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf","2007-11-08 00:00:00",
16482,2,21866,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf","2007-11-07 00:00:00",
28734,1,21866,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf","2007-11-19 00:00:00",
37783,2,21866,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf","2007-11-19 00:00:00",
6335,1,21866,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf","2008-05-14 00:00:00",
42332,3,21866,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
44653,21,21866,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
21847,3,21866,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
28735,1,21866,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf","2008-05-14 00:00:00",
44654,21,21866,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
6336,1,21866,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf","2008-02-29 00:00:00",
16483,2,21866,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf","2008-02-28 00:00:00",
28736,1,21866,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf","2008-05-14 00:00:00",
42333,3,21866,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf","2012-01-27 00:00:00",
44655,21,21866,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf","2008-07-17 00:00:00",
28737,1,21866,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf","2008-03-07 00:00:00",
28738,1,21866,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf","2008-08-19 00:00:00",
37784,2,21866,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf","2008-08-26 00:00:00",
28739,1,21866,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf","2009-07-24 00:00:00",
37785,2,21866,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf","2009-07-23 00:00:00",
28740,1,21866,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021866s015ltr.pdf","2010-02-17 00:00:00",
6337,1,21866,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf","2011-02-18 00:00:00",
37786,2,21866,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf","2011-02-24 00:00:00",
6338,1,21866,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf","2010-12-03 00:00:00",
37787,2,21866,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf","2010-12-02 00:00:00",
16484,2,21866,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf","2010-12-03 00:00:00",
28741,1,21866,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf","2010-12-07 00:00:00",
28742,1,21866,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf","2011-03-08 00:00:00",
37788,2,21866,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf","2011-03-07 00:00:00",
28743,1,21866,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf","2012-02-27 00:00:00",
37789,2,21866,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf","2012-02-24 00:00:00",
6339,1,21866,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf","2014-07-11 00:00:00",
37790,2,21866,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf","2014-06-10 00:00:00",
51608,20,21866,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole clinical prea.pdf","1900-01-01 00:00:00",
6340,1,21866,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf","2013-08-05 00:00:00",
37791,2,21866,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf","2013-08-09 00:00:00",
6341,1,21866,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf","2014-12-15 00:00:00",
16485,2,21866,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf","2014-12-15 00:00:00",
6342,1,21866,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf","2016-01-20 00:00:00",
37792,2,21866,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf","2016-01-22 00:00:00",
45052,2,21866,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf","2016-08-23 00:00:00",
45053,1,21866,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf","2016-08-18 00:00:00",
47327,2,21866,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf","2017-02-24 00:00:00",
47427,1,21866,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf","2017-03-02 00:00:00",
49287,8,21866,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83","2017-08-08 00:00:00",
6343,1,21868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021868s000ltr.pdf","2006-02-02 00:00:00",
21848,3,21868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021868_exubera_toc.cfm","2008-10-03 00:00:00",
23306,8,21868,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088594.pdf","2006-01-27 00:00:00",
37793,2,21868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021868lbl.pdf","2006-01-27 00:00:00",
6344,1,21868,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021868s016, s017ltr.pdf","2008-10-02 00:00:00",
16486,2,21868,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021868s016s017lbl.pdf","2008-10-03 00:00:00",
16487,2,21868,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021868s016s017lbl.pdf","2008-10-03 00:00:00",
28744,1,21868,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021868s016, s017ltr.pdf","2008-10-02 00:00:00",
6345,1,21870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021870ltr.pdf","2005-08-23 00:00:00",
21849,3,21870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021870s000TOC.cfm","2007-07-18 00:00:00",
37794,2,21870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021870lbl.pdf","2005-08-23 00:00:00",
6346,1,21870,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021870s004ltr.pdf","2010-08-20 00:00:00",
37795,2,21870,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021870s004lbl.pdf","2010-08-20 00:00:00",
16488,2,21870,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021870s005lbl.pdf","2011-01-06 00:00:00",
28745,1,21870,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021870s005ltr.pdf","2011-01-07 00:00:00",
16489,2,21870,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021870s007lbl.pdf","2012-01-23 00:00:00",
28746,1,21870,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021870s007ltr.pdf","2012-01-20 00:00:00",
6347,1,21871,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021871s000ltr.pdf","2006-03-01 00:00:00",
16490,2,21871,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf","2006-02-23 00:00:00",
42334,3,21871,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021871TOC.cfm","2008-03-24 00:00:00",
45110,2,21871,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf","2016-08-23 00:00:00",
45154,1,21871,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021871Orig1s001ltr.pdf","2016-08-22 00:00:00",
49303,2,21871,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021871s008lbl.pdf","2017-08-09 00:00:00",
49379,1,21871,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021871Orig1s008ltr.pdf","2017-08-15 00:00:00",
21850,3,21872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021872s000TOC.cfm","2008-02-22 00:00:00",
23681,10,21872,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2007-03-28 00:00:00",
37796,2,21872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf","2006-08-04 00:00:00",
6348,1,21872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf","2007-09-25 00:00:00",
16491,2,21872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf","2007-09-19 00:00:00",
28747,1,21872,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf","2007-09-25 00:00:00",
37797,2,21872,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf","2007-09-19 00:00:00",
6349,1,21872,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021872s005ltr.pdf","2008-05-21 00:00:00",
16492,2,21872,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf","2012-12-07 00:00:00",
6350,1,21872,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
37798,2,21872,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf","2013-07-30 00:00:00",
6351,1,21872,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
16493,2,21872,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf","2013-07-30 00:00:00",
6352,1,21872,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf","2014-03-11 00:00:00",
16494,2,21872,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf","2014-03-10 00:00:00",
6353,1,21872,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021872Orig1s016ltr.pdf","2014-11-03 00:00:00",
16495,2,21872,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf","2014-11-04 00:00:00",
28748,1,21872,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf","2015-03-12 00:00:00",
37799,2,21872,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf","2015-03-12 00:00:00",
6354,1,21872,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf","2014-08-11 00:00:00",
37800,2,21872,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf","2014-08-08 00:00:00",
16496,2,21872,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf","2016-04-27 00:00:00",
28749,1,21872,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021872Orig1s021ltr.pdf","2016-04-25 00:00:00",
45708,1,21872,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf","2016-10-28 00:00:00",
45764,2,21872,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s022lbl.pdf","2016-11-01 00:00:00",
48112,2,21872,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s023lbl.pdf","2017-04-25 00:00:00",
48144,1,21872,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf","2017-04-27 00:00:00",
50174,2,21872,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s024lbl.pdf","2017-10-25 00:00:00",
50218,1,21872,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf","2017-10-30 00:00:00",
6355,1,21873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021873s000LTR.pdf","2006-10-13 00:00:00",
16497,2,21873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021873lbl.pdf","2006-10-05 00:00:00",
21851,3,21873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021873_yaz_toc.cfm","2008-10-03 00:00:00",
21852,3,21875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.cfm","2009-03-05 00:00:00",
23307,8,21875,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231717.pdf","2013-07-26 00:00:00",
28750,1,21875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf","2007-07-05 00:00:00",
37801,2,21875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf","2007-06-27 00:00:00",
16498,2,21875,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf","2010-10-25 00:00:00",
28751,1,21875,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf","2010-10-25 00:00:00",
28752,1,21875,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf","2009-04-01 00:00:00",
16499,2,21875,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf","2010-10-25 00:00:00",
28753,1,21875,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf","2010-10-25 00:00:00",
6356,1,21875,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf","2013-07-02 00:00:00",
37802,2,21875,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf","2013-07-15 00:00:00",
16500,2,21875,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf","2010-10-25 00:00:00",
28754,1,21875,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf","2010-10-25 00:00:00",
28755,1,21875,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf","2012-01-19 00:00:00",
6357,1,21875,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf","2012-01-19 00:00:00",
6358,1,21875,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf","2015-04-17 00:00:00",
16501,2,21875,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf","2015-04-16 00:00:00",
47134,2,21875,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf","2017-02-07 00:00:00",
47154,1,21875,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf","2017-02-09 00:00:00",
6359,1,21876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf","2013-04-10 00:00:00",
16502,2,21876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf","2013-04-16 00:00:00",
21853,3,21876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000TOC.cfm","2014-03-25 00:00:00",
44656,21,21876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf","2014-03-25 00:00:00",
16503,2,21876,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf","2013-09-30 00:00:00",
28756,1,21876,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf","2014-12-17 00:00:00",
54635,1,21876,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021876Orig1s013ltr.pdf","2018-06-21 00:00:00",
54672,2,21876,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf","2018-06-21 00:00:00",
6360,1,21877,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021877ltr.pdf","2005-11-01 00:00:00",
16504,2,21877,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf","2009-12-16 00:00:00",
28757,1,21877,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf","2009-12-24 00:00:00",
37803,2,21877,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021877lbl.pdf","2005-11-01 00:00:00",
42335,3,21877,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021877_s000_ArranonTOC.cfm","2006-01-06 00:00:00",
6361,1,21877,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf","2009-12-24 00:00:00",
37804,2,21877,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf","2009-12-16 00:00:00",
16505,2,21877,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf","2012-02-06 00:00:00",
28758,1,21877,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021877s005ltr.pdf","2012-02-07 00:00:00",
54778,1,21877,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021877Orig1s008ltr.pdf","2018-07-06 00:00:00",
16506,2,21878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021878lbl.pdf","2005-10-24 00:00:00",
28759,1,21878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021878ltr.pdf","2005-10-25 00:00:00",
42336,3,21878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021878s000_LevemirTOC.cfm","2006-10-25 00:00:00",
16507,2,21879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf","2010-10-29 00:00:00",
21854,3,21879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000TOC.cfm","2011-06-09 00:00:00",
24223,21,21879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000SumR.pdf","2011-06-09 00:00:00",
28760,1,21879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf","2010-11-03 00:00:00",
6362,1,21879,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021879Orig1s005ltr.pdf","2015-01-21 00:00:00",
16508,2,21879,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf","2015-01-22 00:00:00",
21855,3,21880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021880s000_RevlimidTOC.cfm","2006-02-08 00:00:00",
23682,10,21880,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109337.htm","2005-12-28 00:00:00",
24011,14,21880,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=46","2010-08-16 00:00:00",
28761,1,21880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021880rev2.pdf","2006-01-06 00:00:00",
28762,1,21880,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf","2006-07-13 00:00:00",
37805,2,21880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf","2005-12-28 00:00:00",
37806,2,21880,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf","2006-07-03 00:00:00",
28763,1,21880,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf","2009-03-03 00:00:00",
37807,2,21880,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf","2009-02-24 00:00:00",
6363,1,21880,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s013ltr.pdf","2010-08-09 00:00:00",
16509,2,21880,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf","2010-08-10 00:00:00",
6364,1,21880,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf","2009-03-03 00:00:00",
37808,2,21880,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf","2009-02-24 00:00:00",
16510,2,21880,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf","2009-02-24 00:00:00",
28764,1,21880,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf","2009-03-03 00:00:00",
16511,2,21880,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf","2010-10-19 00:00:00",
28765,1,21880,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s018ltr.pdf","2010-10-19 00:00:00",
6365,1,21880,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021880s023ltr.pdf","2011-12-28 00:00:00",
16512,2,21880,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf","2011-12-23 00:00:00",
6366,1,21880,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s028ltr.pdf","2012-03-14 00:00:00",
37809,2,21880,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf","2012-03-12 00:00:00",
6367,1,21880,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf","2013-02-12 00:00:00",
16513,2,21880,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf","2013-02-12 00:00:00",
28766,1,21880,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s031ltr.pdf","2012-05-11 00:00:00",
37810,2,21880,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf","2012-05-10 00:00:00",
28767,1,21880,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf","2013-02-12 00:00:00",
37811,2,21880,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf","2013-02-12 00:00:00",
28768,1,21880,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s034ltr.pdf","2013-06-06 00:00:00",
37812,2,21880,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf","2013-06-05 00:00:00",
6368,1,21880,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s035ltr.pdf","2013-11-18 00:00:00",
6369,1,21880,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s038ltr.pdf","2013-11-07 00:00:00",
37813,2,21880,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf","2013-11-04 00:00:00",
16514,2,21880,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf","2014-09-19 00:00:00",
28769,1,21880,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf","2014-09-16 00:00:00",
6370,1,21880,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf","2014-09-16 00:00:00",
37814,2,21880,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf","2014-09-19 00:00:00",
16515,2,21880,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf","2015-02-24 00:00:00",
28770,1,21880,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf","2015-02-19 00:00:00",
6371,1,21880,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s044ltr.pdf","2015-09-15 00:00:00",
6372,1,21880,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s045ltr.pdf","2015-10-29 00:00:00",
28771,1,21880,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s046ltr.pdf","2015-12-02 00:00:00",
6373,1,21880,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021880Orig1s047ltr.pdf","2016-04-26 00:00:00",
47289,2,21880,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s049lbl.pdf","2017-02-22 00:00:00",
47298,1,21880,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s049ltr.pdf","2017-02-23 00:00:00",
48868,1,21880,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s050ltr.pdf","2017-06-29 00:00:00",
49773,2,21880,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s051lbl.pdf","2017-09-18 00:00:00",
49787,1,21880,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s051ltr.pdf","2017-09-19 00:00:00",
50543,2,21880,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf","2017-11-30 00:00:00",
50573,1,21880,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s052,021880Orig1s053ltr.pdf","2017-12-01 00:00:00",
50544,2,21880,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf","2017-11-30 00:00:00",
50572,1,21880,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s052,021880Orig1s053ltr.pdf","2017-12-01 00:00:00",
50947,1,21880,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s055ltr.pdf","2017-12-29 00:00:00",
50953,2,21880,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf","2018-01-02 00:00:00",
50954,8,21880,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf#page=42","2018-01-02 00:00:00",
6374,1,21881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021881s000LTR.pdf","2006-08-07 00:00:00",
21856,3,21881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021881_moviprep_toc.cfm","2008-09-05 00:00:00",
23311,8,21881,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM253840.pdf","2013-09-20 00:00:00",
37815,2,21881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021881lbl.pdf","2006-08-04 00:00:00",
28772,1,21881,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021881s003ltr.pdf","2008-02-07 00:00:00",
6375,1,21881,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021881s008ltr.pdf","2011-05-03 00:00:00",
37816,2,21881,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021881s008lbl.pdf","2011-04-29 00:00:00",
6376,1,21881,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021881s010ltr.pdf","2010-11-04 00:00:00",
37817,2,21881,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021881s010lbl.pdf","2010-11-02 00:00:00",
6377,1,21881,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021881Orig1s012ltr.pdf","2012-08-30 00:00:00",
37818,2,21881,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021881s012lbl.pdf","2012-08-31 00:00:00",
28773,1,21881,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s015ltr.pdf","2013-09-13 00:00:00",
37819,2,21881,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s015lbl.pdf","2013-09-17 00:00:00",
28774,1,21881,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s016ltr.pdf","2013-12-19 00:00:00",
37820,2,21881,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s016lbl.pdf","2013-12-19 00:00:00",
21857,3,21882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021882_s000_ExjadeTOC.cfm","2006-01-10 00:00:00",
28775,1,21882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021882ltr.pdf","2005-11-08 00:00:00",
37821,2,21882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf","2005-11-03 00:00:00",
16516,2,21882,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf","2007-04-25 00:00:00",
28776,1,21882,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s002lltr.pdf","2007-05-01 00:00:00",
28777,1,21882,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s003ltr.pdf","2008-01-09 00:00:00",
37822,2,21882,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf","2008-01-08 00:00:00",
6378,1,21882,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021882s004ltr.pdf","2008-10-08 00:00:00",
16517,2,21882,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf","2008-10-09 00:00:00",
6379,1,21882,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s006ltr.pdf","2009-04-27 00:00:00",
16518,2,21882,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf","2009-04-28 00:00:00",
6380,1,21882,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s007ltr.pdf","2009-03-10 00:00:00",
28778,1,21882,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021882s010ltr.pdf","2010-02-05 00:00:00",
37823,2,21882,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf","2010-02-04 00:00:00",
28779,1,21882,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s011ltr.pdf","2011-04-13 00:00:00",
37824,2,21882,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf","2011-04-11 00:00:00",
6381,1,21882,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s012ltr.pdf","2011-08-12 00:00:00",
16519,2,21882,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf","2011-08-11 00:00:00",
28780,1,21882,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021882Orig1s014ltr.pdf","2012-09-18 00:00:00",
37825,2,21882,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf","2012-09-20 00:00:00",
6382,1,21882,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf","2013-01-25 00:00:00",
37826,2,21882,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf","2013-01-24 00:00:00",
52605,20,21882,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21882 deferasirox clinical prea.pdf","1900-01-01 00:00:00",
52606,18,21882,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21882 deferasirox clinpharm prea.pdf","1900-01-01 00:00:00",
52607,17,21882,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21882 deferasirox statistical prea.pdf","1900-01-01 00:00:00",
28781,1,21882,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf","2013-01-25 00:00:00",
16520,2,21882,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf","2013-06-04 00:00:00",
28782,1,21882,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s017ltr.pdf","2013-05-31 00:00:00",
6383,1,21882,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s019ltr.pdf","2013-10-22 00:00:00",
37827,2,21882,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf","2013-10-21 00:00:00",
6384,1,21882,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021882Orig1s021ltr.pdf","2015-07-24 00:00:00",
16521,2,21882,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf","2015-07-24 00:00:00",
45071,1,21882,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021882Orig1s024ltr.pdf","2016-08-17 00:00:00",
45080,2,21882,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf","2016-08-12 00:00:00",
54176,2,21882,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s025lbl.pdf","2018-05-14 00:00:00",
54195,1,21882,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s025ltr.pdf","2018-05-15 00:00:00",
52680,2,21882,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s026lbl.pdf","2018-02-22 00:00:00",
52704,1,21882,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s026ltr.pdf","2018-02-23 00:00:00",
6385,1,21883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021883Orig1s000ltr.pdf","2014-05-27 00:00:00",
16522,2,21883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf","2014-05-27 00:00:00",
21858,3,21883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000TOC.cfm","2014-06-25 00:00:00",
24224,21,21883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000SumR.pdf","2014-06-25 00:00:00",
28783,1,21883,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021883Orig1s002ltr.pdf","2015-12-22 00:00:00",
16523,2,21883,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf","2016-01-26 00:00:00",
28784,1,21883,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021883Orig1s003ltr.pdf","2016-01-21 00:00:00",
54994,1,21883,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021883Orig1s007ltr.pdf","2018-07-26 00:00:00",
55412,2,21883,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf","2018-09-07 00:00:00",
6386,1,21884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021884ltr.pdf","2005-12-15 00:00:00",
21859,3,21884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021884_s000_IplexTOC.cfm","2006-01-20 00:00:00",
28785,1,21884,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021884s001ltr.pdf","2007-03-06 00:00:00",
37828,2,21884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf","2005-12-15 00:00:00",
37829,2,21884,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021884s001lbl.pdf","2007-03-07 00:00:00",
42337,3,21884,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021884Orig1s001.pdf","2014-08-05 00:00:00",
6387,1,21884,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021884s002ltr.pdf","2006-09-25 00:00:00",
6388,1,21885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021885rev2.pdf","2006-01-06 00:00:00",
37830,2,21885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021885lbl.pdf","2006-01-05 00:00:00",
42338,3,21885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021885s000TOC.cfm","2007-07-02 00:00:00",
6389,1,21887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021887s000ltr.pdf","2007-02-12 00:00:00",
16524,2,21887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf","2007-02-08 00:00:00",
42339,3,21887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021887s000TOC.cfm","2007-04-10 00:00:00",
28786,1,21887,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021887s002ltr.pdf","2010-09-27 00:00:00",
6390,1,21887,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s004ltr.pdf","2011-02-14 00:00:00",
6391,1,21887,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s005ltr.pdf","2011-03-14 00:00:00",
16525,2,21887,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021887Orig1s006lbl.pdf","2014-08-05 00:00:00",
28787,1,21887,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021887Orig1s006ltr.pdf","2014-06-18 00:00:00",
28788,1,21887,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021887Orig1s008ltr.pdf","2016-05-27 00:00:00",
37831,2,21887,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021887Orig1s008lbl.pdf","2016-05-26 00:00:00",
48393,2,21887,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021887Orig1s009lbl.pdf","2017-05-17 00:00:00",
48401,1,21887,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021887Orig1s009ltr.pdf","2017-05-17 00:00:00",
28789,1,21891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021891s000ltr.pdf","2006-09-18 00:00:00",
37832,2,21891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021891lbl.pdf","2006-09-15 00:00:00",
42340,3,21891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021891s000TOC.cfm","2008-07-09 00:00:00",
6392,1,21891,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s004ltr.pdf","2008-10-23 00:00:00",
28790,1,21891,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s005ltr.pdf","2008-10-09 00:00:00",
6393,1,21891,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021891s008ltr.pdf","2010-06-29 00:00:00",
6394,1,21891,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021891Orig1s018ltr.pdf","2014-07-28 00:00:00",
37833,2,21891,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021891Orig1s018lbl.pdf","2014-07-29 00:00:00",
6395,1,21891,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021891Orig1s020ltr.pdf","2015-12-29 00:00:00",
16526,2,21891,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021891Orig1s020lbl.pdf","2016-02-11 00:00:00",
6396,1,21891,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021891Orig1s021ltr.pdf","2016-04-07 00:00:00",
16527,2,21891,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021891Orig1s021lbl.pdf","2016-04-11 00:00:00",
48524,1,21891,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021891Orig1s023ltr.pdf","2017-05-25 00:00:00",
48536,2,21891,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021891Orig1s023lbl.pdf","2017-05-25 00:00:00",
52696,1,21891,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021891Orig1s026ltr.pdf","2018-02-23 00:00:00",
53020,2,21891,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s026lbl.pdf","2018-03-15 00:00:00",
54945,1,21891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021891Orig1s027Ltr.pdf","2018-07-23 00:00:00",
55110,2,21891,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021891Orig1s027Lbl.pdf","2018-08-03 00:00:00",
6397,1,21892,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021892s001ltr.pdf","2007-09-25 00:00:00",
28791,1,21892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021892s000ltr.pdf","2006-03-23 00:00:00",
37834,2,21892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021892s000lbl.pdf","2006-03-22 00:00:00",
42341,3,21892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021892_osmoprep_toc.cfm","2008-09-05 00:00:00",
6398,1,21892,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021892s002ltr.pdf","2008-12-19 00:00:00",
21860,3,21892,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021892Orig1s003.pdf","2011-10-10 00:00:00",
28792,1,21892,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf","2009-03-27 00:00:00",
37835,2,21892,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s003lbl.pdf","2009-03-26 00:00:00",
16528,2,21892,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf","2009-10-14 00:00:00",
28793,1,21892,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf","2009-11-25 00:00:00",
16529,2,21892,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006lbl.pdf","2012-10-09 00:00:00",
23314,8,21892,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf","2012-10-09 00:00:00",
28794,1,21892,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021892Orig1s006ltr.pdf","2012-10-10 00:00:00",
28795,1,21892,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf","2011-12-14 00:00:00",
6399,1,21894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021894s000ltr.pdf","2008-08-21 00:00:00",
21861,3,21894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000TOC.cfm","2008-10-09 00:00:00",
24225,21,21894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000_SumR.pdf","2008-10-09 00:00:00",
28796,1,21894,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf","2010-01-27 00:00:00",
37836,2,21894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021894lbl.pdf","2008-08-26 00:00:00",
28797,1,21894,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf","2010-01-27 00:00:00",
16530,2,21894,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s004lbl.pdf","2011-07-07 00:00:00",
28798,1,21894,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s004ltr.pdf","2011-07-07 00:00:00",
6400,1,21894,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s005ltr.pdf","2011-05-06 00:00:00",
37837,2,21894,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf","2011-05-05 00:00:00",
6401,1,21894,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021894Orig1s007ltr.pdf","2012-08-27 00:00:00",
28799,1,21894,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021894Orig1s009ltr.pdf","2013-08-05 00:00:00",
16531,2,21894,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021894s010lbl.pdf","2015-06-04 00:00:00",
28800,1,21894,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s010ltr.pdf","2015-06-04 00:00:00",
6402,1,21894,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s012ltr.pdf","2015-08-27 00:00:00",
49802,1,21894,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021894Orig1s013ltr.pdf","2017-09-19 00:00:00",
49815,2,21894,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf","2017-09-21 00:00:00",
49816,8,21894,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf#page=24","2017-09-21 00:00:00",
6403,1,21896,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021896s001,021500s007ltr.pdf","2007-01-08 00:00:00",
16532,2,21896,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf","2006-12-28 00:00:00",
21862,3,21896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021896s000TOC.cfm","2007-07-18 00:00:00",
28801,1,21896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021896ltr.pdf","2005-10-20 00:00:00",
37838,2,21896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021896lbl.pdf","2005-09-30 00:00:00",
51842,20,21896,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021896s000_emtricitabine_Emtriva-MedRev (2005).pdf","1900-01-01 00:00:00",
51843,23,21896,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021896_emtricitabine_emtriva_WR.pdf","1900-01-01 00:00:00",
51844,18,21896,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021896s000_emtricitabine_Emtriva-ClinPharmRev (2005).pdf","1900-01-01 00:00:00",
51845,17,21896,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021896s000_emtricitabine_Emtriva-StatsRev (2005).pdf","1900-01-01 00:00:00",
28802,1,21896,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s010, 021896s004ltr.pdf","2008-04-09 00:00:00",
37839,2,21896,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf","2008-04-16 00:00:00",
6404,1,21896,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s011,021896s005ltr.pdf","2008-05-21 00:00:00",
16533,2,21896,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf","2011-11-29 00:00:00",
28803,1,21896,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021500s018,021896s015ltr.pdf","2011-11-22 00:00:00",
16534,2,21896,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021896s016lbl.pdf","2012-07-24 00:00:00",
28804,1,21896,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf","2012-07-25 00:00:00",
6405,1,21896,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021500Orig1s021,021896Orig1s018ltr.pdf","2013-04-03 00:00:00",
16535,2,21896,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf","2013-04-09 00:00:00",
47914,2,21896,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021500s028,021896s025lbl.pdf","2017-04-10 00:00:00",
6406,1,21897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021897s000LTR.pdf","2006-04-21 00:00:00",
21863,3,21897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm","2008-01-16 00:00:00",
24012,14,21897,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=67","2010-10-13 00:00:00",
37840,2,21897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf","2006-04-14 00:00:00",
43796,8,21897,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf","2010-03-31 00:00:00",
44159,10,21897,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103334.htm","2008-08-12 00:00:00",
16536,2,21897,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf","2007-11-07 00:00:00",
28805,1,21897,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021897s003ltr.pdf","2007-11-08 00:00:00",
6407,1,21897,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf","2010-03-25 00:00:00",
16537,2,21897,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf","2010-03-26 00:00:00",
6408,1,21897,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf","2010-03-25 00:00:00",
16538,2,21897,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf","2010-03-26 00:00:00",
28806,1,21897,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s015ltr.pdf","2010-10-13 00:00:00",
37841,2,21897,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf","2010-10-13 00:00:00",
6409,1,21897,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf","2013-07-31 00:00:00",
37842,2,21897,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf","2014-06-12 00:00:00",
6410,1,21897,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf","2013-07-31 00:00:00",
37843,2,21897,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf","2014-06-12 00:00:00",
6411,1,21897,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021897Orig1s029Ltr.pdf","2015-12-29 00:00:00",
37844,2,21897,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf","2015-12-10 00:00:00",
44485,14,21897,"SUPPL",29,"REMS","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897Orig1s029Rems.pdf","2015-12-29 00:00:00",
6412,1,21897,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021897Orig1s032ltr.pdf","2016-05-19 00:00:00",
16539,2,21902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf","2006-11-06 00:00:00",
16540,2,21902,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf","2007-06-04 00:00:00",
28807,1,21902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf","2006-11-06 00:00:00",
28808,1,21902,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf","2007-06-07 00:00:00",
42342,3,21902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.cfm","2007-01-08 00:00:00",
6413,1,21902,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf","2008-01-09 00:00:00",
16541,2,21902,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf","2007-12-27 00:00:00",
6414,1,21902,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf","2008-09-23 00:00:00",
16542,2,21902,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf","2008-09-19 00:00:00",
6415,1,21902,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf","2012-11-21 00:00:00",
37845,2,21902,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf","2012-11-26 00:00:00",
6416,1,21902,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf","2013-03-04 00:00:00",
21864,3,21903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/21-903s000TOC.cfm","2008-04-22 00:00:00",
37846,2,21903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021903lbl.pdf","2006-04-14 00:00:00",
6417,1,21903,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021903s003ltr.pdf","2008-09-16 00:00:00",
6418,1,21903,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021903s004ltr.pdf","2009-12-31 00:00:00",
16543,2,21903,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021903s004lbl.pdf","2010-01-04 00:00:00",
6419,1,21903,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021903Orig1s008ltr.pdf","2013-12-05 00:00:00",
37847,2,21903,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021903s008lbl.pdf","2013-12-04 00:00:00",
6420,1,21903,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021903Orig1s009ltr.pdf","2016-01-15 00:00:00",
16544,2,21903,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021903s009lbl.pdf","2016-01-26 00:00:00",
50068,2,21903,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021903s010lbl.pdf","2017-10-17 00:00:00",
50092,1,21903,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021903Orig1s010ltr.pdf","2017-10-18 00:00:00",
6421,1,21905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021905s000_LTR.pdf","2007-04-25 00:00:00",
21865,3,21905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021905_valtropin_toc.cfm","2009-05-27 00:00:00",
37848,2,21905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021905lbl.pdf","2007-04-20 00:00:00",
6422,1,21906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021906ltr.pdf","2005-11-01 00:00:00",
37849,2,21906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021906lbl.pdf","2005-11-01 00:00:00",
42343,3,21906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021906s000TOC.cfm","2007-07-18 00:00:00",
16545,2,21906,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf","2007-04-25 00:00:00",
28809,1,21906,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf","2007-04-25 00:00:00",
28810,1,21906,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf","2007-01-08 00:00:00",
37850,2,21906,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf","2006-12-28 00:00:00",
16546,2,21906,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf","2007-03-07 00:00:00",
28811,1,21906,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf","2007-03-07 00:00:00",
6423,1,21906,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf","2007-07-05 00:00:00",
37851,2,21906,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf","2007-07-05 00:00:00",
16547,2,21906,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf","2007-11-19 00:00:00",
28812,1,21906,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf","2007-11-19 00:00:00",
28813,1,21906,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf","2007-10-04 00:00:00",
37852,2,21906,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf","2007-09-26 00:00:00",
28814,1,21906,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf","2008-06-24 00:00:00",
37853,2,21906,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf","2008-06-26 00:00:00",
6424,1,21906,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf","2009-04-10 00:00:00",
16548,2,21906,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf","2009-04-16 00:00:00",
28815,1,21906,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf","2008-10-08 00:00:00",
37854,2,21906,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf","2008-10-09 00:00:00",
6425,1,21906,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf","2009-04-24 00:00:00",
16549,2,21906,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf","2009-04-23 00:00:00",
6426,1,21906,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf","2010-02-05 00:00:00",
16550,2,21906,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf","2010-02-04 00:00:00",
6427,1,21906,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf","2010-05-03 00:00:00",
37855,2,21906,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf","2010-05-07 00:00:00",
28816,1,21906,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf","2010-06-16 00:00:00",
37856,2,21906,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s026lbl.pdf","2010-06-15 00:00:00",
6428,1,21906,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf","2011-03-01 00:00:00",
37857,2,21906,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf","2011-03-04 00:00:00",
6429,1,21906,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf","2011-05-10 00:00:00",
6430,1,21906,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf","2012-04-24 00:00:00",
16551,2,21906,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf","2012-04-24 00:00:00",
16552,2,21906,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf","2012-02-22 00:00:00",
28817,1,21906,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf","2012-02-27 00:00:00",
28818,1,21906,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf","2012-05-18 00:00:00",
37858,2,21906,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf","2012-05-17 00:00:00",
28819,1,21906,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf","2013-01-22 00:00:00",
37859,2,21906,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf","2013-01-22 00:00:00",
28820,1,21906,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf","2013-11-08 00:00:00",
37860,2,21906,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf","2013-11-08 00:00:00",
6431,1,21906,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf","2015-01-29 00:00:00",
37861,2,21906,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf","2015-01-30 00:00:00",
28821,1,21906,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf","2015-07-06 00:00:00",
37862,2,21906,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf","2015-07-01 00:00:00",
16553,2,21906,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf","2015-04-02 00:00:00",
28822,1,21906,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf","2015-04-01 00:00:00",
6432,1,21906,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf","2015-11-17 00:00:00",
16554,2,21906,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf","2015-11-12 00:00:00",
45946,1,21906,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s052,021906Orig1s046ltr.pdf","2016-11-23 00:00:00",
45968,2,21906,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s052_021906s046lbl.pdf","2016-11-29 00:00:00",
45321,2,21906,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf","2016-09-16 00:00:00",
45332,1,21906,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf","2016-09-20 00:00:00",
48732,2,21906,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s054,021906s049lbl.pdf","2017-06-16 00:00:00",
48744,1,21906,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021251Orig1s054,021906s049ltr.pdf","2017-06-16 00:00:00",
50076,2,21906,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf","2017-10-18 00:00:00",
50077,8,21906,"SUPPL",50,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51","2017-10-18 00:00:00",
50083,1,21906,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/212906Orig1s050,021251Orig1s055ltr.pdf","2017-10-18 00:00:00",
21866,3,21908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021908s000_AmitizaTOC.cfm","2006-03-24 00:00:00",
28823,1,21908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021908s000ltr.pdf","2006-02-02 00:00:00",
37863,2,21908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf","2006-02-02 00:00:00",
28824,1,21908,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021908s004ltr.pdf","2007-05-29 00:00:00",
37864,2,21908,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf","2007-05-29 00:00:00",
6433,1,21908,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021908se1-005ltr.pdf","2008-05-05 00:00:00",
16555,2,21908,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf","2008-05-02 00:00:00",
24226,21,21908,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021908se1-005_SUMR.pdf","2008-07-17 00:00:00",
42344,3,21908,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021908s005TOC.cfm","2010-05-03 00:00:00",
16556,2,21908,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf","2011-03-04 00:00:00",
21867,3,21908,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021908Orig1s008.pdf","2012-11-09 00:00:00",
28825,1,21908,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021908s008ltr.pdf","2011-03-01 00:00:00",
16557,2,21908,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf","2012-11-26 00:00:00",
28826,1,21908,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021908Orig1s010ltr.pdf","2012-11-28 00:00:00",
42345,3,21908,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021908Orig1s010.pdf","2013-08-06 00:00:00",
6434,1,21908,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021908Orig1s011ltr.pdf","2013-04-24 00:00:00",
16558,2,21908,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf","2013-04-23 00:00:00",
42346,3,21908,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021908Orig1s011.pdf","2015-08-21 00:00:00",
45543,1,21908,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021908Orig1s013ltr.pdf","2016-10-14 00:00:00",
45750,2,21908,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf","2016-11-01 00:00:00",
49204,2,21908,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf","2017-08-02 00:00:00",
49216,1,21908,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021908Orig1s015ltr.pdf","2017-08-02 00:00:00",
53862,2,21908,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf","2018-04-27 00:00:00",
53906,1,21908,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021908Orig1s016Ltr.pdf","2018-05-01 00:00:00",
16559,2,21909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf","2007-07-30 00:00:00",
28827,1,21909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021909s000_ltr.pdf","2007-07-30 00:00:00",
42347,3,21909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021909_allegra_toc.cfm","2009-03-12 00:00:00",
28828,1,21909,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021909s003ltr.pdf","2011-01-27 00:00:00",
37865,2,21909,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf","2013-11-26 00:00:00",
6435,1,21909,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021909Orig1s006ltr.pdf","2012-08-27 00:00:00",
16560,2,21909,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf","2013-11-21 00:00:00",
28829,1,21909,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021909Orig1s007ltr.pdf","2013-04-30 00:00:00",
6436,1,21909,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021909Orig1s010ltr.pdf","2016-06-14 00:00:00",
37866,2,21909,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf","2016-06-17 00:00:00",
21868,3,21910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021910s000TOC.cfm","2008-05-07 00:00:00",
28830,1,21910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021910s000ltr.pdf","2006-08-04 00:00:00",
37867,2,21910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021910lbl.pdf","2006-07-27 00:00:00",
16561,2,21910,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021910s005lbl.pdf","2012-06-26 00:00:00",
28831,1,21910,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021910s005ltr.pdf","2012-06-25 00:00:00",
28832,1,21911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021911s000ltr.pdf","2008-11-18 00:00:00",
37868,2,21911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf","2008-11-17 00:00:00",
42348,3,21911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_TOC.cfm","2009-02-19 00:00:00",
44657,21,21911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_SumR.pdf","2009-02-19 00:00:00",
6437,1,21911,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021911s004ltr.pdf","2009-11-24 00:00:00",
16562,2,21911,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf","2010-11-08 00:00:00",
28833,1,21911,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021911s005ltr.pdf","2010-11-10 00:00:00",
6438,1,21911,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf","2011-03-08 00:00:00",
16563,2,21911,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf","2011-03-07 00:00:00",
28834,1,21911,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf","2011-06-03 00:00:00",
6439,1,21911,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf","2015-02-17 00:00:00",
37869,2,21911,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf","2015-03-03 00:00:00",
52327,23,21911,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021911_rufinamide_Orig_WR.pdf","2015-01-13 00:00:00",
52328,25,21911,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021911_rufinamide_Amend.pdf","2015-01-13 00:00:00",
16564,2,21911,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf","2015-07-01 00:00:00",
28835,1,21911,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf","2015-06-26 00:00:00",
46112,8,21911,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf#page=18","2016-12-09 00:00:00",
16565,2,21912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf","2006-10-11 00:00:00",
21869,3,21912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm","2009-04-14 00:00:00",
24227,21,21912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf","2009-04-14 00:00:00",
28836,1,21912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf","2006-10-13 00:00:00",
28837,1,21912,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf","2008-01-09 00:00:00",
37870,2,21912,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf","2008-01-08 00:00:00",
44160,10,21912,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2007-02-20 00:00:00",
28838,1,21912,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf","2011-07-18 00:00:00",
37871,2,21912,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf","2011-07-18 00:00:00",
6440,1,21912,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf","2010-06-03 00:00:00",
16566,2,21912,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf","2010-06-02 00:00:00",
6441,1,21912,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf","2011-02-07 00:00:00",
16567,2,21912,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf","2011-02-24 00:00:00",
23322,8,21912,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015MedG.pdf","2011-02-24 00:00:00",
28839,1,21912,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf","2011-02-18 00:00:00",
6442,1,21912,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf","2011-09-07 00:00:00",
6443,1,21912,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf","2012-08-13 00:00:00",
28840,1,21912,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf","2012-08-13 00:00:00",
6444,1,21912,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf","2014-03-04 00:00:00",
37872,2,21912,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf","2014-03-04 00:00:00",
21870,3,21918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021918_cetraxal_toc.cfm","2009-10-06 00:00:00",
24228,21,21918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021918s000_SumR_P1.pdf","2009-10-06 00:00:00",
28841,1,21918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021918s000ltr.pdf","2009-05-06 00:00:00",
37873,2,21918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021918lbl.pdf","2009-05-11 00:00:00",
53210,20,21918,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022124_Ciclesonide_Clinical_PREA.pdf","1900-01-01 00:00:00",
53211,18,21918,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022124_Ciclesonide_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53212,17,21918,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021918s000_Ciprofloxacin_Statistical_PREA.pdf","1900-01-01 00:00:00",
28842,1,21919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf","2009-11-18 00:00:00",
37874,2,21919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf","2009-11-18 00:00:00",
42349,3,21919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021919_byetta_toc.cfm","2010-08-20 00:00:00",
43799,8,21919,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf","2009-11-18 00:00:00",
6445,1,21920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021920s000ltr.pdf","2006-03-01 00:00:00",
16568,2,21920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf","2006-02-28 00:00:00",
23683,10,21920,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2006-03-02 00:00:00",
42350,3,21920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021920s000TOC.cfm","2008-02-22 00:00:00",
6446,1,21920,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s010ltr.pdf","2009-04-21 00:00:00",
6447,1,21920,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s011ltr.pdf","2009-07-17 00:00:00",
37875,2,21920,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf","2009-07-24 00:00:00",
28843,1,21920,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021920s013ltr.pdf","2010-08-16 00:00:00",
6448,1,21920,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021920s017ltr.pdf","2012-06-15 00:00:00",
6449,1,21920,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021920Orig1s018ltr.pdf","2013-04-03 00:00:00",
37876,2,21920,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf","2013-11-25 00:00:00",
47573,2,21920,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf","2017-03-17 00:00:00",
47595,1,21920,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021920Orig1s019ltr.pdf","2017-03-20 00:00:00",
21871,3,21923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021923_s000_NexavarTOC.cfm","2006-02-08 00:00:00",
28844,1,21923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021923ltr.pdf","2006-01-19 00:00:00",
37877,2,21923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021923lbl.pdf","2006-01-06 00:00:00",
6450,1,21923,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s003ltr.pdf","2007-03-15 00:00:00",
6451,1,21923,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf","2007-11-26 00:00:00",
37878,2,21923,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf","2007-11-19 00:00:00",
28845,1,21923,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf","2007-11-26 00:00:00",
37879,2,21923,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf","2007-11-19 00:00:00",
6452,1,21923,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf","2007-11-26 00:00:00",
16569,2,21923,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf","2007-11-19 00:00:00",
6453,1,21923,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf","2007-11-26 00:00:00",
37880,2,21923,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf","2007-11-19 00:00:00",
6454,1,21923,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf","2010-11-03 00:00:00",
37881,2,21923,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf","2010-10-28 00:00:00",
16570,2,21923,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf","2010-10-28 00:00:00",
28846,1,21923,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf","2010-11-03 00:00:00",
6455,1,21923,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s011ltr.pdf","2011-03-25 00:00:00",
16571,2,21923,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s011lbl.pdf","2011-03-28 00:00:00",
16572,2,21923,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf","2011-10-20 00:00:00",
28847,1,21923,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s012ltr.pdf","2011-10-17 00:00:00",
6456,1,21923,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021923Origs013ltr.pdf","2012-08-27 00:00:00",
6457,1,21923,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s014ltr.pdf","2013-06-12 00:00:00",
16573,2,21923,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s014lbl.pdf","2013-06-18 00:00:00",
16574,2,21923,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf","2013-10-31 00:00:00",
28848,1,21923,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s015ltr.pdf","2013-10-31 00:00:00",
6458,1,21923,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s016ltr.pdf","2013-11-25 00:00:00",
37882,2,21923,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s016lbl.pdf","2013-11-22 00:00:00",
50914,1,21923,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021923Orig1s018ltr.pdf","2017-12-27 00:00:00",
50929,2,21923,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021923s018lbl.pdf","2017-12-27 00:00:00",
6459,1,21924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021924s000ltr.pdf","2006-10-23 00:00:00",
16575,2,21924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf","2006-10-18 00:00:00",
42351,3,21924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021924s000TOC.cfm","2008-09-04 00:00:00",
6460,1,21924,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021924s002ltr.pdf","2008-01-09 00:00:00",
16576,2,21924,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf","2007-12-27 00:00:00",
6461,1,21924,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021924s006ltr.pdf","2012-03-12 00:00:00",
37883,2,21924,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf","2012-03-06 00:00:00",
50648,2,21924,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf","2017-12-11 00:00:00",
6462,1,21925,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s001ltr.pdf","2007-02-12 00:00:00",
21872,3,21925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021925_duetact_toc.cfm","2008-09-04 00:00:00",
23684,10,21925,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2007-08-15 00:00:00",
28849,1,21925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021925s000LTR.pdf","2006-08-04 00:00:00",
37884,2,21925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf","2006-08-04 00:00:00",
37885,2,21925,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf","2007-02-23 00:00:00",
16577,2,21925,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf","2007-09-07 00:00:00",
28850,1,21925,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s002ltr.pdf","2007-09-11 00:00:00",
16578,2,21925,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf","2007-10-04 00:00:00",
28851,1,21925,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s003ltr.pdf","2007-10-04 00:00:00",
28852,1,21925,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s004ltr.pdf","2007-10-04 00:00:00",
37886,2,21925,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf","2007-09-26 00:00:00",
16579,2,21925,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf","2009-01-06 00:00:00",
28853,1,21925,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s005ltr.pdf","2009-01-06 00:00:00",
16580,2,21925,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf","2013-11-14 00:00:00",
28854,1,21925,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf","2013-11-14 00:00:00",
6463,1,21925,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s007ltr.pdf","2009-10-26 00:00:00",
6464,1,21925,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021925s008ltr.pdf","2010-09-28 00:00:00",
37887,2,21925,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf","2010-09-29 00:00:00",
16581,2,21925,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf","2011-08-04 00:00:00",
28855,1,21925,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
6465,1,21925,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
37888,2,21925,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf","2011-08-04 00:00:00",
6466,1,21925,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf","2012-05-22 00:00:00",
16582,2,21925,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf","2013-11-14 00:00:00",
28856,1,21925,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf","2013-11-14 00:00:00",
28857,1,21925,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021925Orig1s015ltr.pdf","2015-03-17 00:00:00",
37889,2,21925,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf","2015-03-19 00:00:00",
46140,1,21925,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021925Orig1s016ltr.pdf","2016-12-13 00:00:00",
50859,2,21925,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf","2017-12-26 00:00:00",
50860,8,21925,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf#page=39","2017-12-26 00:00:00",
50917,1,21925,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021925Orig1s017ltr.pdf","2017-12-27 00:00:00",
6467,1,21926,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s001ltr.pdf","2008-10-23 00:00:00",
21873,3,21926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000TOC.cfm","2008-08-29 00:00:00",
28858,1,21926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s000Revisedltr.pdf","2008-04-22 00:00:00",
43801,8,21926,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089804.pdf","2009-12-04 00:00:00",
44658,21,21926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000_SumR.pdf","2008-08-29 00:00:00",
51671,20,21926,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21926 sumatriptan naproxen clinical bpca.pdf","1900-01-01 00:00:00",
51673,18,21926,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21926 sumatriptan naproxen clinpharm bpca.pdf","1900-01-01 00:00:00",
51674,17,21926,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21926 sumatriptan naproxen statistical bpca.pdf","1900-01-01 00:00:00",
51675,61,21926,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21926 sumatriptan naproxen statistical addendum bpca.pdf","1900-01-01 00:00:00",
28859,1,21926,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s002ltr.pdf","2011-11-16 00:00:00",
37890,2,21926,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021926s002lbl.pdf","2011-11-14 00:00:00",
6468,1,21926,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021926s005ltr.pdf","2012-03-05 00:00:00",
16583,2,21926,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021926s005lbl.pdf","2012-03-20 00:00:00",
28860,1,21926,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s006ltr.pdf","2011-09-26 00:00:00",
37891,2,21926,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021926s010lbl.pdf","2014-05-15 00:00:00",
16584,2,21926,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf","2015-05-21 00:00:00",
28861,1,21926,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021926Orig1s012ltr.pdf","2015-05-19 00:00:00",
37892,2,21926,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf","2015-05-21 00:00:00",
52347,23,21926,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021926_sumatriptan_naproxen_Orig_WR.pdf","2015-04-16 00:00:00",
6469,1,21926,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021926Orig1s013ltr.pdf","2016-05-11 00:00:00",
16585,2,21926,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021926s013lbl.pdf","2016-05-11 00:00:00",
6470,1,21928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021928s000ltr.pdf","2006-05-16 00:00:00",
16586,2,21928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021928lbl.pdf","2006-05-16 00:00:00",
21874,3,21928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021928_s000_ChantixTOC.cfm","2006-06-16 00:00:00",
23685,10,21928,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm","2006-09-01 00:00:00",
53437,18,21928,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021928 varenicline_chantix_clinpharm_PREA.pdf","1900-01-01 00:00:00",
28862,1,21928,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021928s003ltr.pdf","2007-11-26 00:00:00",
37893,2,21928,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021928s003lbl.pdf","2007-11-26 00:00:00",
16587,2,21928,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s007lbl.pdf","2008-02-01 00:00:00",
28863,1,21928,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s007ltr.pdf","2008-02-04 00:00:00",
6471,1,21928,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s008ltr.pdf","2008-05-21 00:00:00",
16588,2,21928,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s008lbl.pdf","2008-05-16 00:00:00",
6472,1,21928,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s011ltr.pdf","2009-11-24 00:00:00",
37894,2,21928,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf","2009-10-21 00:00:00",
6473,1,21928,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf","2009-07-08 00:00:00",
16589,2,21928,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf","2009-07-09 00:00:00",
6474,1,21928,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf","2009-11-25 00:00:00",
37895,2,21928,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf","2009-07-09 00:00:00",
6475,1,21928,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf","2010-04-27 00:00:00",
37896,2,21928,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf","2010-05-03 00:00:00",
6476,1,21928,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s015ltr.pdf","2010-02-17 00:00:00",
6477,1,21928,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf","2010-04-27 00:00:00",
37897,2,21928,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf","2010-05-03 00:00:00",
28864,1,21928,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s018ltr.pdf","2011-02-24 00:00:00",
28865,1,21928,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf","2011-07-22 00:00:00",
37898,2,21928,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf","2011-07-22 00:00:00",
6478,1,21928,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf","2011-07-22 00:00:00",
16590,2,21928,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf","2011-07-22 00:00:00",
28866,1,21928,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf","2011-07-22 00:00:00",
37899,2,21928,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf","2011-07-22 00:00:00",
16591,2,21928,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s023lbl.pdf","2010-12-22 00:00:00",
28867,1,21928,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s023ltr.pdf","2010-12-22 00:00:00",
6479,1,21928,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s024ltr.pdf","2011-07-06 00:00:00",
28868,1,21928,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s025ltr.pdf","2011-11-14 00:00:00",
37900,2,21928,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s025lbl.pdf","2011-11-10 00:00:00",
6480,1,21928,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928s028ltr.pdf","2012-01-25 00:00:00",
16592,2,21928,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s028lbl.pdf","2012-01-24 00:00:00",
16593,2,21928,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf","2013-02-21 00:00:00",
28869,1,21928,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021928Orig1s030ltr_repl.pdf","2013-03-15 00:00:00",
16594,2,21928,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s031lbl.pdf","2012-12-13 00:00:00",
28870,1,21928,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928Orig1s031ltr.pdf","2012-12-13 00:00:00",
16595,2,21928,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf","2014-09-22 00:00:00",
28871,1,21928,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf","2014-09-24 00:00:00",
16596,2,21928,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf","2014-10-16 00:00:00",
28872,1,21928,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf","2014-10-16 00:00:00",
6481,1,21928,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf","2014-10-16 00:00:00",
16597,2,21928,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf","2014-10-16 00:00:00",
6482,1,21928,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf","2014-09-24 00:00:00",
37901,2,21928,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf","2014-09-22 00:00:00",
6483,1,21928,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf","2014-10-16 00:00:00",
37902,2,21928,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf","2014-10-16 00:00:00",
6484,1,21928,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf","2014-09-24 00:00:00",
37903,2,21928,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf","2014-09-22 00:00:00",
45079,2,21928,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf","2016-08-17 00:00:00",
45127,1,21928,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf","2016-08-12 00:00:00",
46266,2,21928,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s040lbl.pdf","2016-12-20 00:00:00",
46450,1,21928,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s040ltr.pdf","2016-12-21 00:00:00",
45078,2,21928,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf","2016-08-17 00:00:00",
45126,1,21928,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf","2016-08-12 00:00:00",
50091,1,21928,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021928Orig1s042ltr.pdf","2017-10-18 00:00:00",
50094,2,21928,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021928Orig1s042lbl.pdf","2017-10-18 00:00:00",
54415,2,21928,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf","2018-06-01 00:00:00",
54427,1,21928,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021928Orig1s045s046ltr.pdf","2018-06-04 00:00:00",
54416,2,21928,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf","2018-06-01 00:00:00",
54417,8,21928,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf#page=22","2018-06-01 00:00:00",
54428,1,21928,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021928Orig1s045s046ltr.pdf","2018-06-04 00:00:00",
6485,1,21929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021929ltr.pdf","2006-07-21 00:00:00",
23686,10,21929,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2007-02-21 00:00:00",
37904,2,21929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021929lbl.pdf","2006-07-21 00:00:00",
42352,3,21929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021929_symbicort_toc.cfm","2008-10-30 00:00:00",
16598,2,21929,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s004lbl.pdf","2007-11-07 00:00:00",
28873,1,21929,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s004ltr.pdf","2007-11-08 00:00:00",
6486,1,21929,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s006ltr.pdf","2007-11-08 00:00:00",
37905,2,21929,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s006lbl.pdf","2007-11-07 00:00:00",
16599,2,21929,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021929s010lbl.pdf","2008-07-16 00:00:00",
28874,1,21929,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021929s010ltr.pdf","2008-07-17 00:00:00",
6487,1,21929,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021929s012ltr.pdf","2009-03-03 00:00:00",
16600,2,21929,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf","2009-04-03 00:00:00",
42353,3,21929,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021929Orig1s012.pdf","2012-03-02 00:00:00",
47032,2,21929,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf","2017-01-27 00:00:00",
47047,1,21929,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s013ltr.pdf","2017-01-31 00:00:00",
51266,23,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021929_WR_Orig.pdf","2011-01-28 00:00:00",
51267,25,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021929_WR_Amend_1.pdf","2011-05-05 00:00:00",
51268,26,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021929_WR_Amend_2.pdf","2012-04-06 00:00:00",
51269,27,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021929_WR_Amend_3.pdf","2015-03-09 00:00:00",
51270,28,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021929_WR_Amend_4.pdf","2015-10-19 00:00:00",
52065,20,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/79_21929 budesonide formoterol fumarate dehydrate clinical prea.pdf","1900-01-01 00:00:00",
52067,18,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/80_21929 budesonide formoterol fumarate dehydrate clinpharm prea.pdf","1900-01-01 00:00:00",
52069,17,21929,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/81_21929 budesonide formoterol fumarate dehydrate statistical prea.pdf","1900-01-01 00:00:00",
28875,1,21929,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s019ltr.pdf","2011-02-18 00:00:00",
16601,2,21929,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf","2010-06-28 00:00:00",
28876,1,21929,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021929s021ltr.pdf","2010-06-29 00:00:00",
6488,1,21929,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s028ltr.pdf","2011-08-22 00:00:00",
28877,1,21929,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021929Orig1s033ltr.pdf","2012-07-25 00:00:00",
49720,2,21929,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf","2017-09-12 00:00:00",
49721,8,21929,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf#page=46","2017-09-12 00:00:00",
49749,1,21929,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s041ltr.pdf","2017-09-15 00:00:00",
50829,2,21929,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s042lbl.pdf","2017-12-21 00:00:00",
50926,1,21929,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s042ltr.pdf","2017-12-27 00:00:00",
6489,1,21936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021936Orig1s000ltr.pdf","2014-09-26 00:00:00",
37906,2,21936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021936s000lbl.pdf","2014-09-26 00:00:00",
42354,3,21936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000TOC.cfm","2015-07-02 00:00:00",
44659,21,21936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000SumR.pdf","2015-07-02 00:00:00",
51570,20,21936,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/88_21936 tiotropium clinical prea.pdf","1900-01-01 00:00:00",
51571,18,21936,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/89_21936 tiotropium clinpharm prea.pdf","1900-01-01 00:00:00",
51572,17,21936,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/90_21936 tiotropium statistical prea.pdf","1900-01-01 00:00:00",
52375,23,21936,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021936_tiotropium_Orig_WR.pdf","1900-01-01 00:00:00",
28878,1,21936,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s003ltr.pdf","2016-01-20 00:00:00",
37907,2,21936,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s003lbl.pdf","2016-02-17 00:00:00",
6490,1,21936,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s005ltr.pdf","2016-06-10 00:00:00",
16602,2,21936,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s005lbl.pdf","2016-06-13 00:00:00",
47252,2,21936,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021936s007lbl.pdf","2017-02-16 00:00:00",
16603,2,21937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf","2006-07-12 00:00:00",
21875,3,21937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm","2006-12-13 00:00:00",
28879,1,21937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021937s000ltr.pdf","2006-07-21 00:00:00",
28880,1,21937,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s006ltr.pdf","2008-02-20 00:00:00",
37908,2,21937,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf","2008-02-25 00:00:00",
28881,1,21937,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s007ltr.pdf","2008-03-04 00:00:00",
37909,2,21937,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf","2008-03-05 00:00:00",
28882,1,21937,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s009ltr.pdf","2008-06-09 00:00:00",
37910,2,21937,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf","2008-06-12 00:00:00",
28883,1,21937,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s011ltr.pdf","2008-10-23 00:00:00",
6491,1,21937,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s012ltr.pdf","2010-01-15 00:00:00",
37911,2,21937,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf","2010-01-08 00:00:00",
6492,1,21937,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s019ltr.pdf","2010-08-11 00:00:00",
16604,2,21937,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf","2010-08-10 00:00:00",
6493,1,21937,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021937s023ltr.pdf","2011-09-20 00:00:00",
37912,2,21937,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf","2011-09-20 00:00:00",
6494,1,21937,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021937s025ltr.pdf","2012-06-18 00:00:00",
16605,2,21937,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf","2012-06-18 00:00:00",
28884,1,21937,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s027ltr.pdf","2013-04-23 00:00:00",
37913,2,21937,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf","2013-04-19 00:00:00",
6495,1,21937,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s031ltr.pdf","2013-10-25 00:00:00",
16606,2,21937,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf","2013-10-25 00:00:00",
6496,1,21937,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s034ltr.pdf","2015-01-26 00:00:00",
37914,2,21937,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf","2015-01-29 00:00:00",
6497,1,21937,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s037ltr.pdf","2015-11-23 00:00:00",
37915,2,21937,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf","2015-12-03 00:00:00",
6498,1,21937,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021937Orig1s039ltr.pdf","2016-02-12 00:00:00",
37916,2,21937,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf","2016-02-18 00:00:00",
47916,2,21937,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021937s041lbl.pdf","2017-04-10 00:00:00",
47979,1,21937,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021937Orig1s041ltr.pdf","2017-04-12 00:00:00",
55031,2,21937,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021937s043lbl.pdf","2018-07-27 00:00:00",
55036,1,21937,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021937Orig1s043Ltr.pdf","2018-07-30 00:00:00",
21876,3,21938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.cfm","2006-04-06 00:00:00",
28885,1,21938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021938s000ltr.pdf","2006-01-30 00:00:00",
37917,2,21938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf","2006-01-26 00:00:00",
43802,8,21938,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219111.pdf","2010-07-16 00:00:00",
16607,2,21938,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf","2007-02-05 00:00:00",
21877,3,21938,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s002_sutent.pdf","2007-02-02 00:00:00",
28886,1,21938,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
21878,3,21938,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s003_sutent.pdf","2007-02-02 00:00:00",
28887,1,21938,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
37918,2,21938,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf","2007-02-02 00:00:00",
6499,1,21938,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
16608,2,21938,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf","2007-02-05 00:00:00",
21879,3,21938,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s004_sutent.pdf","2007-02-02 00:00:00",
21880,3,21938,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s005_sutent.pdf","2007-02-02 00:00:00",
28888,1,21938,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
37919,2,21938,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf","2007-02-05 00:00:00",
6500,1,21938,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf","2010-09-22 00:00:00",
37920,2,21938,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf","2010-09-22 00:00:00",
16609,2,21938,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf","2010-09-22 00:00:00",
28889,1,21938,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf","2010-09-22 00:00:00",
6501,1,21938,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf","2010-09-22 00:00:00",
37921,2,21938,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf","2010-09-22 00:00:00",
16610,2,21938,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf","2009-04-03 00:00:00",
28890,1,21938,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021938s009ltr.pdf","2009-04-03 00:00:00",
6502,1,21938,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf","2010-07-06 00:00:00",
37922,2,21938,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf","2010-07-06 00:00:00",
16611,2,21938,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf","2010-07-06 00:00:00",
28891,1,21938,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf","2010-07-06 00:00:00",
28892,1,21938,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf","2011-05-25 00:00:00",
37923,2,21938,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf","2011-05-20 00:00:00",
43555,5,21938,"SUPPL",13,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256237.htm","2011-05-20 00:00:00",
16612,2,21938,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf","2010-07-06 00:00:00",
28893,1,21938,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf","2010-07-06 00:00:00",
6503,1,21938,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf","2010-07-06 00:00:00",
37924,2,21938,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf","2010-07-06 00:00:00",
6504,1,21938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf","2011-05-25 00:00:00",
16613,2,21938,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf","2011-05-20 00:00:00",
6505,1,21938,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf","2011-05-25 00:00:00",
37925,2,21938,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf","2011-05-20 00:00:00",
28894,1,21938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf","2012-04-24 00:00:00",
37926,2,21938,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf","2012-04-24 00:00:00",
6506,1,21938,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf","2012-04-24 00:00:00",
16614,2,21938,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf","2012-04-24 00:00:00",
28895,1,21938,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf","2012-11-19 00:00:00",
37927,2,21938,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf","2012-11-19 00:00:00",
6507,1,21938,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf","2012-11-19 00:00:00",
16615,2,21938,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf","2012-11-19 00:00:00",
6508,1,21938,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf","2012-11-19 00:00:00",
37928,2,21938,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf","2012-11-19 00:00:00",
16616,2,21938,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf","2013-09-09 00:00:00",
28896,1,21938,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf","2013-09-04 00:00:00",
28897,1,21938,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf","2013-09-04 00:00:00",
37929,2,21938,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf","2013-09-09 00:00:00",
6509,1,21938,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s026ltr.pdf","2014-06-12 00:00:00",
6510,1,21938,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s027ltr.pdf","2014-12-23 00:00:00",
37930,2,21938,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021938s027lbl.pdf","2014-12-23 00:00:00",
28898,1,21938,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf","2015-04-27 00:00:00",
37931,2,21938,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf","2015-04-28 00:00:00",
6511,1,21938,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf","2015-04-27 00:00:00",
16617,2,21938,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf","2015-04-28 00:00:00",
28899,1,21938,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s031ltr.pdf","2015-11-17 00:00:00",
37932,2,21938,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s031lbl.pdf","2015-11-19 00:00:00",
50435,2,21938,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021938s033lbl.pdf","2017-11-16 00:00:00",
50448,1,21938,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021938Orig1s033ltr.pdf","2017-11-17 00:00:00",
6512,1,21939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021939s000_TALTRd.pdf","2010-03-11 00:00:00",
28900,1,21943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021943s000_ltr.pdf","2006-03-23 00:00:00",
28901,1,21944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021944s000LTR.pdf","2006-08-04 00:00:00",
6513,1,21945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021945s000ltr.pdf","2011-02-10 00:00:00",
21881,3,21945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945_makena_toc.cfm","2012-10-31 00:00:00",
37933,2,21945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021945s000lbl.pdf","2011-02-03 00:00:00",
44660,21,21945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945Orig1s000SumR.pdf","2012-10-31 00:00:00",
53290,20,21945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021945_Makena_Clinical_PREA.pdf","1900-01-01 00:00:00",
53291,18,21945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021945_Makena_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
53292,17,21945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021945_Makena_Statistical_PREA.pdf","1900-01-01 00:00:00",
6514,1,21945,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021945Orig1s005ltr.pdf","2013-09-17 00:00:00",
16618,2,21945,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021945s005lbl.pdf","2013-09-16 00:00:00",
49440,2,21945,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021945s008lbl.pdf","2017-08-17 00:00:00",
49490,1,21945,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021945Orig1s008ltr.pdf","2017-08-21 00:00:00",
52648,2,21945,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s012lbl.pdf","2018-02-15 00:00:00",
52649,1,21945,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021945Orig1s012ltr.pdf","2018-02-15 00:00:00",
55073,21,21945,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945Orig1s012SumR.pdf","2018-08-02 00:00:00",
16619,2,21946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021946lbl.pdf","2006-08-04 00:00:00",
21882,3,21946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021946s000TOC.cfm","2008-09-04 00:00:00",
28902,1,21946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021946s000LTR.pdf","2006-08-04 00:00:00",
16620,2,21946,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf","2009-01-06 00:00:00",
6515,1,21946,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021946s003ltr.pdf","2010-01-05 00:00:00",
16621,2,21946,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021946s003lbl.pdf","2010-01-04 00:00:00",
16622,2,21946,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021946s004lbl.pdf","2010-12-06 00:00:00",
28903,1,21946,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021946s004ltr.pdf","2010-12-10 00:00:00",
6516,1,21946,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021946s005ltr.pdf","2012-05-14 00:00:00",
37934,2,21946,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021946s005lbl.pdf","2012-05-16 00:00:00",
6517,1,21947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021947s000ltr.pdf","2006-10-02 00:00:00",
6518,1,21947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s001ltr.pdf","2007-05-01 00:00:00",
23687,10,21947,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113690.htm","2007-09-26 00:00:00",
37935,2,21947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021947lbl.pdf","2006-09-26 00:00:00",
37936,2,21947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s001lbl.pdf","2007-05-01 00:00:00",
42355,3,21947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021947s000FentoraTOC.cfm","2007-12-06 00:00:00",
44487,14,21947,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2011-12-30 00:00:00",
16623,2,21947,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf","2007-03-07 00:00:00",
28904,1,21947,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf","2007-03-07 00:00:00",
6519,1,21947,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021947s006ltr.pdf","2008-02-14 00:00:00",
16624,2,21947,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021947s006lbl.pdf","2008-02-14 00:00:00",
16625,2,21947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021947s008lbl.pdf","2013-02-26 00:00:00",
28905,1,21947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s008ltr.pdf","2013-02-25 00:00:00",
28906,1,21947,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947Orig1s009ltr.pdf","2011-07-21 00:00:00",
37937,2,21947,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf","2011-07-21 00:00:00",
6520,1,21947,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021947s010ltr.pdf","2010-01-25 00:00:00",
16626,2,21947,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021947s010lbl.pdf","2009-12-11 00:00:00",
6521,1,21947,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s011ltr.pdf","2011-01-25 00:00:00",
16627,2,21947,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s011lbl.pdf","2011-01-24 00:00:00",
6522,1,21947,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s013ltr.pdf","2012-01-03 00:00:00",
37938,2,21947,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s013lbl.pdf","2011-12-28 00:00:00",
16628,2,21947,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf","2012-06-11 00:00:00",
28907,1,21947,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021947s015ltr.pdf","2012-06-07 00:00:00",
28908,1,21947,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s017ltr.pdf","2013-11-12 00:00:00",
47996,2,21947,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf","2017-04-12 00:00:00",
47997,8,21947,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf#page=20","2017-04-12 00:00:00",
48027,1,21947,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021947Orig1s019ltr.pdf","2017-04-14 00:00:00",
28909,1,21947,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021947Orig1s022ltr.pdf","2014-12-30 00:00:00",
46293,1,21947,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021947Orig1s024,s025ltr.pdf","2016-12-20 00:00:00",
46348,2,21947,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf","2016-12-21 00:00:00",
46294,1,21947,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021947Orig1s024,s025ltr.pdf","2016-12-20 00:00:00",
46349,2,21947,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf","2016-12-21 00:00:00",
49712,1,21947,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021947Orig1s027ltr.pdf","2017-09-11 00:00:00",
16629,2,21948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf","2006-02-28 00:00:00",
21883,3,21948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm","2006-04-14 00:00:00",
28910,1,21948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021948s000,021632s000ltr.pdf","2006-03-01 00:00:00",
6523,1,21949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021949s000ltr.pdf","2006-07-21 00:00:00",
6524,1,21949,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021949s001ltr.pdf","2007-02-23 00:00:00",
16630,2,21949,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s001lbl.pdf","2007-02-23 00:00:00",
37939,2,21949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021949lbl.pdf","2006-07-13 00:00:00",
42356,3,21949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021949_budesonide_toc.cfm","2008-11-17 00:00:00",
6525,1,21949,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021949s002ltr.pdf","2007-07-05 00:00:00",
16631,2,21949,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s002lbl.pdf","2007-06-27 00:00:00",
6526,1,21949,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021949s003ltr.pdf","2008-04-16 00:00:00",
16632,2,21949,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s003lbl.pdf","2008-04-16 00:00:00",
6527,1,21949,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021949s004ltr.pdf","2008-06-19 00:00:00",
37940,2,21949,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s004lbl.pdf","2008-06-18 00:00:00",
6528,1,21949,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021949s006ltr.pdf","2010-07-08 00:00:00",
16633,2,21949,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021949s006lbl.pdf","2010-07-06 00:00:00",
6529,1,21951,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s001ltr.pdf","2014-07-31 00:00:00",
16634,2,21951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf","2012-05-29 00:00:00",
28911,1,21951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021951s000ltr.pdf","2012-05-30 00:00:00",
37941,2,21951,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf","2014-07-31 00:00:00",
42357,3,21951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021951_absorica_toc.cfm","2013-05-24 00:00:00",
44488,14,21951,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2013-06-21 00:00:00",
6530,1,21951,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s003ltr.pdf","2014-08-19 00:00:00",
16635,2,21951,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf","2014-08-20 00:00:00",
6531,1,21951,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021951Orig1s005ltr.pdf","2015-09-08 00:00:00",
37942,2,21951,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf","2015-09-08 00:00:00",
6532,1,21951,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s007ltr.pdf","2016-02-05 00:00:00",
28912,1,21951,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s008ltr.pdf","2016-07-12 00:00:00",
48779,1,21951,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021951Orig1s010ltr.pdf","2017-06-20 00:00:00",
54003,1,21951,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s011ltr.pdf","2018-05-03 00:00:00",
54015,2,21951,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf","2018-05-04 00:00:00",
53806,1,21951,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s012ltr.pdf","2018-04-24 00:00:00",
55471,1,21951,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s014ltr.pdf","2018-09-13 00:00:00",
55624,2,21951,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf","2018-09-27 00:00:00",
55625,8,21951,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf#page=12","2018-09-20 00:00:00",
6533,1,21952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021952s000ltr.pdf","2008-06-19 00:00:00",
24229,21,21952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021952s000_SUMR.pdf","2008-07-17 00:00:00",
42358,3,21952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021952_claritin_toc.cfm","2009-08-27 00:00:00",
6534,1,21952,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021952s003ltr.pdf","2009-04-10 00:00:00",
6535,1,21952,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021952Orig1s012ltr.pdf","2015-12-10 00:00:00",
37943,2,21952,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf","2015-12-11 00:00:00",
53775,1,21952,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s014ltr.pdf","2018-04-23 00:00:00",
53790,2,21952,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf","2018-04-23 00:00:00",
54439,1,21952,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s015ltr.pdf","2018-06-05 00:00:00",
54465,2,21952,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf","2018-06-06 00:00:00",
54700,1,21952,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s016ltr.pdf","2018-06-27 00:00:00",
54744,2,21952,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf","2018-07-04 00:00:00",
54948,1,21952,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s017Ltr.pdf","2018-07-23 00:00:00",
55109,2,21952,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf","2018-08-03 00:00:00",
6536,1,21956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021956s000ltr.pdf","2006-09-18 00:00:00",
6537,1,21956,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf","2011-03-07 00:00:00",
16636,2,21956,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf","2011-03-07 00:00:00",
21884,3,21956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021956s000TOC.cfm","2008-05-07 00:00:00",
37944,2,21956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021956lbl.pdf","2006-08-29 00:00:00",
28913,1,21956,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf","2011-03-07 00:00:00",
37945,2,21956,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf","2011-03-07 00:00:00",
6538,1,21956,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s003ltr.pdf","2011-12-22 00:00:00",
37946,2,21956,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s003lbl.pdf","2011-12-19 00:00:00",
6539,1,21956,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021956Orig1s004ltr.pdf","2014-10-22 00:00:00",
37947,2,21956,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021956s004lbl.pdf","2014-10-21 00:00:00",
49439,2,21956,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021956s010lbl.pdf","2017-08-17 00:00:00",
49491,1,21956,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021956Orig1s010ltr.pdf","2017-08-21 00:00:00",
21885,3,21957,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021957_nexium_toc.cfm","2008-09-05 00:00:00",
28914,1,21957,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021957s000ltr.pdf","2006-10-26 00:00:00",
28915,1,21957,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf","2008-01-18 00:00:00",
37948,2,21957,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021957lbl.pdf","2007-03-27 00:00:00",
44161,10,21957,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
6540,1,21957,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf","2009-01-21 00:00:00",
16637,2,21957,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf","2009-01-16 00:00:00",
28916,1,21957,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021957s004ltr.pdf","2011-12-28 00:00:00",
37949,2,21957,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021957s004lbl2.pdf","2011-12-23 00:00:00",
28917,1,21957,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021957s005ltr.pdf","2010-09-23 00:00:00",
37950,2,21957,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021957s005lbl.pdf","2009-06-24 00:00:00",
53264,20,21957,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021957se5-004_se8-005_Esomeprazole (Nexium)_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53265,18,21957,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021957se5-004_se8-005_Esomeprazole (Nexium)_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
28918,1,21957,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf","2010-03-08 00:00:00",
37951,2,21957,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf","2010-03-05 00:00:00",
6541,1,21957,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf","2011-06-27 00:00:00",
37952,2,21957,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf","2011-06-29 00:00:00",
16638,2,21957,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf","2010-09-10 00:00:00",
28919,1,21957,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf","2010-09-09 00:00:00",
16639,2,21957,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf","2011-07-06 00:00:00",
28920,1,21957,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf","2011-07-06 00:00:00",
16640,2,21957,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf","2012-01-24 00:00:00",
28921,1,21957,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf","2012-01-24 00:00:00",
6542,1,21957,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf","2012-10-11 00:00:00",
37953,2,21957,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf","2012-10-12 00:00:00",
6543,1,21957,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf","2012-10-02 00:00:00",
37954,2,21957,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf","2012-10-01 00:00:00",
28922,1,21957,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf","2012-11-29 00:00:00",
37955,2,21957,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf","2012-12-10 00:00:00",
16641,2,21957,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf","2014-04-01 00:00:00",
28923,1,21957,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf","2014-03-28 00:00:00",
6544,1,21957,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf","2014-02-27 00:00:00",
16642,2,21957,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf","2014-03-05 00:00:00",
28924,1,21957,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf","2014-12-24 00:00:00",
37956,2,21957,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf","2014-12-29 00:00:00",
46479,1,21957,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021957Orig1s018,021153Orig1s051,022101Orig1s015ltr.pdf","2016-12-22 00:00:00",
46487,2,21957,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf","2016-12-21 00:00:00",
45662,1,21957,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf","2016-10-26 00:00:00",
45695,2,21957,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf","2016-10-28 00:00:00",
54500,2,21957,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf","2018-06-11 00:00:00",
54501,8,21957,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33","2018-06-11 00:00:00",
54566,1,21957,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021153Orig1s053,022101Orig1s017,021957Orig1s020ltr.pdf","2018-06-14 00:00:00",
6545,1,21958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021958s000LTR.pdf","2006-07-27 00:00:00",
16643,2,21958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf","2006-07-27 00:00:00",
21886,3,21958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021958TOC.cfm","2008-07-08 00:00:00",
28925,1,21958,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021958s002ltr.pdf","2010-01-15 00:00:00",
28926,1,21958,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021958s003ltr.pdf","2012-03-26 00:00:00",
37957,2,21959,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021959lbl.pdf","2006-06-02 00:00:00",
42359,3,21959,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021959TOC.cfm","2008-07-08 00:00:00",
6546,1,21959,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021959s003ltr.pdf","2009-05-05 00:00:00",
16644,2,21959,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf","2009-05-11 00:00:00",
16645,2,21959,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf","2010-07-31 00:00:00",
28927,1,21959,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021959s004ltr.pdf","2010-07-30 00:00:00",
28928,1,21961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021961s000ltr.pdf","2007-10-10 00:00:00",
37958,2,21961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021961lbl.pdf","2007-10-10 00:00:00",
42360,3,21961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021961_simvastatin_toc.cfm","2009-02-02 00:00:00",
44162,10,21961,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
28929,1,21963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021963s000ltr.pdf","2006-10-23 00:00:00",
37959,2,21963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021963lbl.pdf","2006-10-18 00:00:00",
42361,3,21963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021963TOC.cfm","2008-03-14 00:00:00",
6547,1,21963,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf","2008-06-30 00:00:00",
37960,2,21963,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf","2008-06-30 00:00:00",
28930,1,21964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021964s000ltr.pdf","2008-04-28 00:00:00",
42362,3,21964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021964s000TOC.cfm","2008-06-03 00:00:00",
6548,1,21964,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021964s006ltr.pdf","2010-01-21 00:00:00",
16646,2,21964,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021964s006lbl.pdf","2009-11-23 00:00:00",
16647,2,21964,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021964s009lbl.pdf","2010-07-30 00:00:00",
28931,1,21964,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021964s009ltr.pdf","2010-07-28 00:00:00",
16648,2,21964,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021964s010lbl.pdf","2014-09-30 00:00:00",
28932,1,21964,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021964Orig1s010ltr.pdf","2014-10-02 00:00:00",
16649,2,21964,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021964s011lbl.pdf","2013-08-27 00:00:00",
28933,1,21964,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021964Orig1s011ltr.pdf","2013-08-27 00:00:00",
48437,2,21964,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf","2017-05-18 00:00:00",
48459,1,21964,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s017,208271Orig1s001ltr.pdf","2017-05-19 00:00:00",
49219,2,21964,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf","2017-08-03 00:00:00",
49222,8,21964,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29","2017-08-03 00:00:00",
49562,1,21964,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s018;208271Orig1s002ltr.pdf","2017-08-29 00:00:00",
52966,2,21964,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf","2018-03-15 00:00:00",
52979,1,21964,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021964Orig1s019,208271Orig1s003ltr.pdf","2018-03-15 00:00:00",
6549,1,21968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021968s000ltr.pdf","2006-01-30 00:00:00",
37961,2,21968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf","2006-01-26 00:00:00",
42363,3,21968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.cfm","2006-04-06 00:00:00",
6550,1,21968,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
16650,2,21968,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf","2007-02-05 00:00:00",
21887,3,21968,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s002_sutent.pdf","2007-02-02 00:00:00",
16651,2,21968,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf","2007-02-05 00:00:00",
28934,1,21968,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
42364,3,21968,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s003_sutent.pdf","2007-02-02 00:00:00",
6551,1,21968,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
21888,3,21968,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s004_sutent.pdf","2007-02-02 00:00:00",
37962,2,21968,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf","2007-02-05 00:00:00",
16652,2,21968,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf","2007-02-05 00:00:00",
21889,3,21968,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s005_sutent.pdf","2007-02-02 00:00:00",
28935,1,21968,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
28936,1,21968,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf","2007-02-12 00:00:00",
37963,2,21968,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf","2007-02-05 00:00:00",
42365,3,21968,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s006_sutent.pdf","2007-02-02 00:00:00",
28937,1,21969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021969s000TAltr.pdf","2006-12-04 00:00:00",
6552,1,21971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021971s000TAltr.pdf","2007-02-12 00:00:00",
28938,1,21972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021972s000taltr.pdf","2007-08-14 00:00:00",
28939,1,21974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021974s000_TA_ltr.pdf","2007-01-25 00:00:00",
16653,2,21976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf","2006-06-28 00:00:00",
16654,2,21976,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf","2006-11-22 00:00:00",
21890,3,21976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021976s000_SprycelTOC.cfm","2006-09-06 00:00:00",
28940,1,21976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s000LTR.pdf","2006-06-27 00:00:00",
28941,1,21976,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s001ltr.pdf","2006-12-04 00:00:00",
44163,10,21976,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109402.htm","2006-12-08 00:00:00",
52598,20,21976,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21976 darunavir clinical prea.pdf","1900-01-01 00:00:00",
52599,18,21976,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21976 darunavir clinpharm prea.pdf","1900-01-01 00:00:00",
6553,1,21976,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf","2008-03-11 00:00:00",
37964,2,21976,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf","2008-03-12 00:00:00",
28942,1,21976,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf","2008-03-11 00:00:00",
37965,2,21976,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf","2008-03-12 00:00:00",
28943,1,21976,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s005ltr.pdf","2008-02-27 00:00:00",
37966,2,21976,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf","2008-02-26 00:00:00",
6554,1,21976,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s006ltr.pdf","2008-10-23 00:00:00",
6555,1,21976,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s007ltr.pdf","2008-10-23 00:00:00",
16655,2,21976,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf","2008-11-07 00:00:00",
16656,2,21976,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf","2009-01-02 00:00:00",
28944,1,21976,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s009ltr.pdf","2008-12-29 00:00:00",
6556,1,21976,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s010ltr.pdf","2009-06-17 00:00:00",
37967,2,21976,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf","2009-06-22 00:00:00",
6557,1,21976,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s011ltr.pdf","2009-06-17 00:00:00",
16657,2,21976,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf","2009-06-22 00:00:00",
6558,1,21976,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf","2010-02-05 00:00:00",
16658,2,21976,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf","2010-02-04 00:00:00",
28945,1,21976,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf","2010-02-05 00:00:00",
37968,2,21976,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf","2010-02-04 00:00:00",
16659,2,21976,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf","2010-05-03 00:00:00",
28946,1,21976,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s016ltr.pdf","2010-04-29 00:00:00",
6559,1,21976,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s017ltr.pdf","2010-12-15 00:00:00",
16660,2,21976,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf","2010-12-13 00:00:00",
6560,1,21976,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021976s018ltr.pdf","2011-10-24 00:00:00",
37969,2,21976,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf","2011-10-25 00:00:00",
16661,2,21976,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf","2011-12-23 00:00:00",
28947,1,21976,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf","2011-12-27 00:00:00",
51504,23,21976,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021976_Prezista_Original_WRltr.pdf","2006-11-17 00:00:00",
51506,25,21976,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021976_Prezista_Amendment_1ltr.pdf","2007-08-16 00:00:00",
6561,1,21976,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s021ltr.pdf","2012-02-15 00:00:00",
37970,2,21976,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf","2012-02-14 00:00:00",
6562,1,21976,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s022ltr.pdf","2012-02-23 00:00:00",
16662,2,21976,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf","2012-02-24 00:00:00",
37971,2,21976,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf","2012-11-15 00:00:00",
16663,2,21976,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf","2012-06-06 00:00:00",
28948,1,21976,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf","2012-06-07 00:00:00",
6563,1,21976,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf","2013-04-25 00:00:00",
16664,2,21976,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf","2013-04-29 00:00:00",
28949,1,21976,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf","2013-02-04 00:00:00",
37972,2,21976,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf","2013-02-06 00:00:00",
6564,1,21976,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf","2013-02-04 00:00:00",
16665,2,21976,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf","2013-02-06 00:00:00",
16666,2,21976,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf","2013-02-26 00:00:00",
28950,1,21976,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf","2013-02-26 00:00:00",
6565,1,21976,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf","2013-11-08 00:00:00",
16667,2,21976,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf","2013-11-08 00:00:00",
16668,2,21976,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf","2014-04-08 00:00:00",
28951,1,21976,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf","2014-04-08 00:00:00",
6566,1,21976,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf","2015-05-28 00:00:00",
37973,2,21976,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf","2015-05-29 00:00:00",
16669,2,21976,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf","2015-04-02 00:00:00",
28952,1,21976,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf","2015-04-01 00:00:00",
28953,1,21976,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf","2016-06-21 00:00:00",
37974,2,21976,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf","2016-06-21 00:00:00",
45309,2,21976,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf","2016-09-15 00:00:00",
45335,1,21976,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf","2016-09-20 00:00:00",
48793,1,21976,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021976Orig1s045,202895Orig1s020ltr.pdf","2017-06-22 00:00:00",
48895,2,21976,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf","2017-07-05 00:00:00",
52100,1,21976,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021976Orig1s047,202895Orig1s021ltr.pdf","2018-01-30 00:00:00",
52423,2,21976,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf","2018-02-06 00:00:00",
55420,2,21976,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf","2018-09-10 00:00:00",
55441,1,21976,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202895Orig1s51,021976Orig1s022Ltr.pdf","2018-09-12 00:00:00",
6567,1,21977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s000ltr.pdf","2007-03-06 00:00:00",
16670,2,21977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf","2007-02-26 00:00:00",
28954,1,21977,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021977s001ltr.pdf","2008-04-25 00:00:00",
37975,2,21977,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021977s001lbl.pdf","2008-06-05 00:00:00",
42366,3,21977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021977s000TOC.cfm","2007-04-05 00:00:00",
44164,10,21977,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
53325,20,21977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977 lisdexamfetamine clinical prea.pdf","1900-01-01 00:00:00",
53326,20,21977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977_lisdexamfetamine_clinical_PREA .pdf","1900-01-01 00:00:00",
53327,17,21977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977 lisdexamfetamine statistical prea.pdf","1900-01-01 00:00:00",
53328,17,21977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977_lisdexamfetamine_statistical_PREA.pdf","1900-01-01 00:00:00",
6568,1,21977,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s002.pdf","2008-01-09 00:00:00",
16671,2,21977,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977s002lbl.pdf","2007-12-14 00:00:00",
6569,1,21977,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf","2009-05-29 00:00:00",
16672,2,21977,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf","2009-05-25 00:00:00",
28955,1,21977,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf","2009-05-29 00:00:00",
37976,2,21977,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf","2009-05-25 00:00:00",
6570,1,21977,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf","2008-11-13 00:00:00",
28956,1,21977,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf","2010-04-08 00:00:00",
37977,2,21977,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf","2010-04-05 00:00:00",
28957,1,21977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s012ltr.pdf","2011-03-21 00:00:00",
37978,2,21977,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s012lbl.pdf","2011-03-21 00:00:00",
6571,1,21977,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s013ltr.pdf","2010-01-28 00:00:00",
37979,2,21977,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s013lbl.pdf","2009-12-11 00:00:00",
16673,2,21977,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf","2010-04-05 00:00:00",
28958,1,21977,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf","2010-04-08 00:00:00",
6572,1,21977,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf","2010-11-15 00:00:00",
16674,2,21977,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf","2010-11-12 00:00:00",
28959,1,21977,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf","2010-11-15 00:00:00",
37980,2,21977,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf","2010-11-12 00:00:00",
6573,1,21977,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf","2010-11-15 00:00:00",
16675,2,21977,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf","2010-11-12 00:00:00",
16676,2,21977,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf","2010-11-12 00:00:00",
28960,1,21977,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf","2010-11-15 00:00:00",
6574,1,21977,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977s022ltr.pdf","2012-02-03 00:00:00",
37981,2,21977,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s022lbl.pdf","2012-02-01 00:00:00",
6575,1,21977,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s023ltr.pdf","2011-09-06 00:00:00",
37982,2,21977,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s023lbl.pdf","2011-09-02 00:00:00",
16677,2,21977,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf","2012-11-26 00:00:00",
28961,1,21977,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf","2012-11-21 00:00:00",
6576,1,21977,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf","2012-11-21 00:00:00",
16678,2,21977,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf","2012-11-26 00:00:00",
28962,1,21977,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf","2012-11-21 00:00:00",
37983,2,21977,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf","2012-11-26 00:00:00",
16679,2,21977,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s027lbledt.pdf","2013-04-29 00:00:00",
28963,1,21977,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s027ltr.pdf","2013-04-30 00:00:00",
51314,20,21977,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977s027 lisdexamfetamine clinical prea.pdf","1900-01-01 00:00:00",
51315,17,21977,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21977s027 lisdexamfetamine statistical prea.pdf","1900-01-01 00:00:00",
6577,1,21977,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s028ltr.pdf","2013-06-18 00:00:00",
37984,2,21977,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s028lbl.pdf","2013-06-18 00:00:00",
16680,2,21977,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s030lbl.pdf","2013-12-12 00:00:00",
28964,1,21977,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s030ltr.pdf","2013-12-10 00:00:00",
6578,1,21977,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf","2014-07-23 00:00:00",
37985,2,21977,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf","2014-07-30 00:00:00",
16681,2,21977,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf","2014-07-30 00:00:00",
28965,1,21977,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf","2014-07-23 00:00:00",
16682,2,21977,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf","2014-11-20 00:00:00",
28966,1,21977,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s033ltr.pdf","2014-11-17 00:00:00",
49174,2,21977,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf","2017-08-01 00:00:00",
49177,8,21977,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/ 021977s034,208510s002lbl.pdf#page=38","2017-08-01 00:00:00",
49198,1,21977,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s034,208510Orig1s002ltr.pdf","2017-08-02 00:00:00",
6579,1,21977,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf","2015-02-02 00:00:00",
16683,2,21977,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf","2015-02-03 00:00:00",
21891,3,21977,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s036.pdf","2015-05-14 00:00:00",
21892,3,21977,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s037.pdf","2015-05-14 00:00:00",
28967,1,21977,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf","2015-02-02 00:00:00",
37986,2,21977,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf","2015-02-03 00:00:00",
16684,2,21977,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s039lbl.pdf","2015-04-21 00:00:00",
28968,1,21977,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s039ltr.pdf","2015-04-20 00:00:00",
45558,1,21977,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf","2016-10-19 00:00:00",
45619,2,21977,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf","2016-10-17 00:00:00",
45559,1,21977,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf","2016-10-19 00:00:00",
45618,2,21977,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf","2016-10-17 00:00:00",
46768,2,21977,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s043lbl.pdf","2017-01-09 00:00:00",
46848,1,21977,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021303Orig1s032,021977Orig1s043ltr.pdf","2017-01-17 00:00:00",
47045,1,21977,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s044ltr.pdf","2017-01-31 00:00:00",
47092,2,21977,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s044lbl.pdf","2017-01-31 00:00:00",
48487,2,21977,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf","2017-05-23 00:00:00",
48500,1,21977,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Origs045,208510Orig1s001ltr.pdf","2017-05-23 00:00:00",
6580,1,21978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021978s000ltr.pdf","2006-09-20 00:00:00",
16685,2,21978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021978lbl.pdf","2006-09-20 00:00:00",
21893,3,21978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978_verdeso_toc.cfm","2008-09-05 00:00:00",
44661,21,21978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978s000_SumR.pdf","2008-09-05 00:00:00",
16686,2,21978,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021978s007lbl.pdf","2010-05-03 00:00:00",
28969,1,21978,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021978s007ltr.pdf","2010-04-28 00:00:00",
6581,1,21978,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021978s009ltr.pdf","2011-08-26 00:00:00",
37987,2,21978,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021978s009lbl.pdf","2011-08-22 00:00:00",
28970,1,21978,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021978Orig1s010ltr.pdf","2013-04-03 00:00:00",
37988,2,21978,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021978s010lbl.pdf","2013-04-09 00:00:00",
16687,2,21980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021980s000lbl.pdf","2007-01-23 00:00:00",
28971,1,21980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021980s000ltr.pdf","2006-04-05 00:00:00",
42367,3,21980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021980s000TOC.cfm","2008-02-22 00:00:00",
6582,1,21980,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021980Orig1s004ltr.pdf","2016-02-04 00:00:00",
37989,2,21980,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021980s004lbl.pdf","2016-02-11 00:00:00",
6583,1,21983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021983s000LTR.pdf","2006-10-02 00:00:00",
21894,3,21983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021983_duodote_toc.cfm","2009-07-15 00:00:00",
49997,2,21983,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf","2017-10-10 00:00:00",
50013,1,21983,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021983Orig1s023ltr.pdf","2017-10-11 00:00:00",
51749,57,21983,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/190_21983s23 pralidoxime atropine CDTL clinical prea.pdf","1900-01-01 00:00:00",
51750,20,21983,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/191_21983s23 pralidoxime atropine clinical prea.pdf","1900-01-01 00:00:00",
51751,18,21983,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/192_21983s23 pralidoxime atropine clinpharm prea.pdf","1900-01-01 00:00:00",
16688,2,21985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021985lbl.pdf","2007-03-07 00:00:00",
28972,1,21985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s000ltr.pdf","2007-03-15 00:00:00",
42368,3,21985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000TOC.cfm","2007-04-30 00:00:00",
44165,10,21985,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm","2012-11-23 00:00:00",
28973,1,21985,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s002ltr.pdf","2007-08-14 00:00:00",
6584,1,21985,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s004ltr.pdf","2008-02-20 00:00:00",
28974,1,21985,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s006ltr.pdf","2008-05-21 00:00:00",
6585,1,21985,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021985s008ltr.pdf","2010-01-25 00:00:00",
16689,2,21985,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021985s008lbl.pdf","2009-11-16 00:00:00",
6586,1,21985,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021985s012ltr.pdf","2010-08-10 00:00:00",
16690,2,21985,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021985s012lbl.pdf","2010-08-04 00:00:00",
28975,1,21985,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s014ltr.pdf","2011-02-14 00:00:00",
37990,2,21985,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s014lbl.pdf","2011-02-11 00:00:00",
6587,1,21985,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s019ltr.pdf","2011-10-17 00:00:00",
16691,2,21985,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf","2011-10-20 00:00:00",
28976,1,21985,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s021ltr.pdf","2012-01-31 00:00:00",
37991,2,21985,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s021lbl.pdf","2012-01-31 00:00:00",
28977,1,21985,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s022ltrC.pdf","2012-02-07 00:00:00",
37992,2,21985,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985Orig1s022LBL.pdf","2012-02-06 00:00:00",
28978,1,21985,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s023ltr.pdf","2012-04-18 00:00:00",
37993,2,21985,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s023lbl.pdf","2012-04-16 00:00:00",
28979,1,21985,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985Orig1s024ltr.pdf","2012-10-02 00:00:00",
37994,2,21985,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s024lbl.pdf","2012-10-01 00:00:00",
6588,1,21985,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021985Orig1s025ltr.pdf","2013-11-07 00:00:00",
37995,2,21985,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021985s025lbl.pdf","2013-11-04 00:00:00",
37996,2,21985,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021985s026lbl.pdf","2014-03-19 00:00:00",
6589,1,21985,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s027ltr.pdf","2015-04-01 00:00:00",
37997,2,21985,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s027lbl.pdf","2015-04-02 00:00:00",
6590,1,21985,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s028ltr.pdf","2015-12-23 00:00:00",
16692,2,21985,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s028lbl.pdf","2015-12-28 00:00:00",
45832,1,21985,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021985Orig1s031ltr.pdf","2016-11-18 00:00:00",
45851,2,21985,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021985s031lbl.pdf","2016-11-08 00:00:00",
50422,1,21985,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021985Orig1s034ltr.pdf","2017-11-15 00:00:00",
50518,2,21985,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021985s034lbl.pdf","2017-11-29 00:00:00",
52971,25,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021985_aliskiren_Amend_1.pdf","2009-03-13 00:00:00",
52973,26,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021985_aliskiren_Amend_2.pdf","2012-08-06 00:00:00",
52974,27,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021985_aliskiren_Amend_3.pdf","2016-08-09 00:00:00",
52975,23,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021985_aliskiren_Orig_WR.pdf","2008-05-13 00:00:00",
53026,57,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206_210709 aliskiren CDTL clinical bpca.pdf","2016-08-09 00:00:00",
53027,18,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207_210709 aliskiren clin and clinpharm bpca.pdf","2016-08-09 00:00:00",
53028,17,21985,"SUPPL",34,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208_210709 aliskiren statistical bpca.pdf","2016-08-09 00:00:00",
16693,2,21986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf","2006-07-03 00:00:00",
21895,3,21986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.cfm","2006-09-06 00:00:00",
21896,3,21986,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf","2011-09-22 00:00:00",
28980,1,21986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021986s000ltr.pdf","2006-07-03 00:00:00",
28981,1,21986,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf","2007-11-19 00:00:00",
6591,1,21986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf","2007-11-19 00:00:00",
37998,2,21986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf","2007-11-13 00:00:00",
42369,3,21986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf","2011-09-22 00:00:00",
6592,1,21986,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf","2008-06-03 00:00:00",
6593,1,21986,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021986s004ltr.pdf","2009-05-29 00:00:00",
16694,2,21986,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf","2009-05-25 00:00:00",
28982,1,21986,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf","2010-08-09 00:00:00",
37999,2,21986,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf","2010-07-31 00:00:00",
16695,2,21986,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf","2010-10-28 00:00:00",
28983,1,21986,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s007ltr.pdf","2010-11-03 00:00:00",
6594,1,21986,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s008ltr.pdf","2010-11-03 00:00:00",
38000,2,21986,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf","2010-10-28 00:00:00",
28984,1,21986,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf","2011-10-13 00:00:00",
38001,2,21986,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf","2011-10-12 00:00:00",
6595,1,21986,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf","2011-10-13 00:00:00",
16696,2,21986,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf","2011-10-12 00:00:00",
28985,1,21986,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021986Orig1s013ltr.pdf","2013-06-18 00:00:00",
38002,2,21986,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf","2013-06-17 00:00:00",
6596,1,21986,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021986Orig1s014ltr.pdf","2014-04-14 00:00:00",
38003,2,21986,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf","2014-05-12 00:00:00",
6597,1,21986,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf","2015-08-14 00:00:00",
16697,2,21986,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf","2015-08-13 00:00:00",
28986,1,21986,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf","2015-08-14 00:00:00",
38004,2,21986,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf","2015-08-13 00:00:00",
45426,2,21986,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf","2016-09-29 00:00:00",
45490,1,21986,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021986Orig1s018ltr.pdf","2016-09-30 00:00:00",
49354,2,21986,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf","2017-08-14 00:00:00",
49412,1,21986,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s019ltr.pdf","2017-08-15 00:00:00",
50407,2,21986,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf","2017-11-14 00:00:00",
50427,1,21986,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s020ltr.pdf","2017-11-15 00:00:00",
28987,1,21988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021988TAltr.pdf","2007-03-06 00:00:00",
6598,1,21990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021990s000TAltr.pdf","2007-01-08 00:00:00",
6599,1,21990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf","2007-07-05 00:00:00",
38005,2,21990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf","2007-06-25 00:00:00",
42370,3,21990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021990_exforge_toc.cfm","2008-10-03 00:00:00",
6600,1,21990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021990s003ltr.pdf","2008-07-25 00:00:00",
38006,2,21990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021990s003lbl.pdf","2008-07-24 00:00:00",
48427,3,21990,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021990Orig1s003.pdf","2017-05-17 00:00:00",
6601,1,21990,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021990s007ltr.pdf","2010-04-05 00:00:00",
38007,2,21990,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021990s007lbl.pdf","2010-04-04 00:00:00",
16698,2,21990,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s013lbl.pdf","2011-06-07 00:00:00",
28988,1,21990,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s013ltr.pdf","2011-06-03 00:00:00",
16699,2,21990,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s014lbl.pdf","2011-12-13 00:00:00",
28989,1,21990,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s014ltr.pdf","2011-12-14 00:00:00",
6602,1,21990,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s016ltr.pdf","2011-11-02 00:00:00",
38008,2,21990,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s016lbl.pdf","2011-10-31 00:00:00",
6603,1,21990,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf","2012-01-20 00:00:00",
38009,2,21990,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s017lbl.pdf","2012-01-30 00:00:00",
28990,1,21990,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s018ltr.pdf","2012-10-02 00:00:00",
38010,2,21990,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s018lbl.pdf","2012-10-01 00:00:00",
16700,2,21990,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s019lbl.pdf","2012-12-10 00:00:00",
28991,1,21990,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s019ltr.pdf","2012-11-29 00:00:00",
28992,1,21990,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf","2014-03-19 00:00:00",
6604,1,21990,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf","2014-03-19 00:00:00",
38011,2,21990,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s020s021lbl.pdf","2014-03-19 00:00:00",
6605,1,21990,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s024ltr.pdf","2014-09-25 00:00:00",
16701,2,21990,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s024lbl.pdf","2014-09-26 00:00:00",
6606,1,21990,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021990Orig1s026ltr.pdf","2015-07-30 00:00:00",
16702,2,21990,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021990s026lbl.pdf","2015-07-30 00:00:00",
6607,1,21991,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021991s000ltr.pdf","2006-10-13 00:00:00",
6608,1,21991,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021991s001ltr.pdf","2008-07-24 00:00:00",
16703,2,21991,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021991lbl.pdf","2006-10-11 00:00:00",
16704,2,21991,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021991s001lbl.pdf","2008-07-23 00:00:00",
21897,3,21991,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021991s000_ZolinzaTOC.cfm","2006-11-20 00:00:00",
28993,1,21991,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021991s002ltr.pdf","2011-11-17 00:00:00",
38012,2,21991,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021991s002lbl.pdf","2011-11-15 00:00:00",
28994,1,21991,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021991s004ltr.pdf","2009-11-10 00:00:00",
38013,2,21991,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021991s004lbl.pdf","2009-10-01 00:00:00",
6609,1,21991,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
6610,1,21991,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021991Orig1s008ltr.pdf","2015-12-22 00:00:00",
6611,1,21992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021992s000ltr.pdf","2008-03-05 00:00:00",
16705,2,21992,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf","2009-11-05 00:00:00",
28995,1,21992,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf","2009-11-24 00:00:00",
38014,2,21992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021992lbl.pdf","2008-03-05 00:00:00",
42371,3,21992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021992s000TOC.cfm","2008-06-13 00:00:00",
28996,1,21992,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s004ltr.pdf","2009-02-03 00:00:00",
38015,2,21992,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s004lbl.pdf","2009-02-04 00:00:00",
28997,1,21992,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s005ltr.pdf","2009-04-29 00:00:00",
38016,2,21992,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s005lbl.pdf","2009-04-28 00:00:00",
16706,2,21992,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf","2009-09-18 00:00:00",
28998,1,21992,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf","2009-11-24 00:00:00",
6612,1,21992,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf","2009-11-24 00:00:00",
38017,2,21992,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf","2009-09-18 00:00:00",
28999,1,21992,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s008ltr.pdf","2010-01-25 00:00:00",
6613,1,21992,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s009ltr.pdf","2010-01-25 00:00:00",
38018,2,21992,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s009lbl.pdf","2009-11-17 00:00:00",
6614,1,21992,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s011ltr.pdf","2010-02-22 00:00:00",
38019,2,21992,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s011lbl.pdf","2010-02-17 00:00:00",
16707,2,21992,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s013lbl.pdf","2010-10-18 00:00:00",
29000,1,21992,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s013ltr.pdf","2010-10-20 00:00:00",
16708,2,21992,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s015lbl.pdf","2010-07-12 00:00:00",
29001,1,21992,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s015ltr.pdf","2010-07-14 00:00:00",
6615,1,21992,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s017ltr.pdf","2010-09-09 00:00:00",
16709,2,21992,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s017lbl.pdf","2010-09-10 00:00:00",
6616,1,21992,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s019ltr.pdf","2011-01-25 00:00:00",
16710,2,21992,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s019lbl.pdf","2011-01-10 00:00:00",
16711,2,21992,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s020lbl.pdf","2011-01-31 00:00:00",
29002,1,21992,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s020ltr.pdf","2011-02-03 00:00:00",
6617,1,21992,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s021ltr.pdf","2011-03-07 00:00:00",
16712,2,21992,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s021lbl.pdf","2011-03-07 00:00:00",
6618,1,21992,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s022ltr.pdf","2011-04-13 00:00:00",
16713,2,21992,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s022lbl.pdf","2011-04-11 00:00:00",
29003,1,21992,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992s030ltr.pdf","2012-03-12 00:00:00",
38020,2,21992,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s030lbl.pdf","2012-03-09 00:00:00",
6619,1,21992,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s031ltr.pdf","2013-12-13 00:00:00",
38021,2,21992,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s031lbl.pdf","2013-12-11 00:00:00",
6620,1,21992,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf","2013-02-19 00:00:00",
38022,2,21992,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf","2013-02-20 00:00:00",
6621,1,21992,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992Orig1s034ltr.pdf","2012-12-11 00:00:00",
38023,2,21992,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s034lbl.pdf","2012-12-10 00:00:00",
6622,1,21992,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf","2013-03-15 00:00:00",
38024,2,21992,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf","2013-02-20 00:00:00",
29004,1,21992,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s037ltr.pdf","2013-12-24 00:00:00",
38025,2,21992,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s037lbl.pdf","2013-12-24 00:00:00",
29005,1,21992,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s039ltr.pdf","2014-11-14 00:00:00",
38026,2,21992,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992Orig1s039lbl.pdf","2014-11-17 00:00:00",
6623,1,21992,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s040ltr.pdf","2014-07-21 00:00:00",
38027,2,21992,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992s040lbl.pdf","2014-07-29 00:00:00",
52429,2,21992,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021992s042lbl.pdf","2018-02-06 00:00:00",
52517,1,21992,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021992Orig1s042ltr.pdf","2018-02-08 00:00:00",
54149,20,21992,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/258_021992s042 desvenlaxafine clinical both.pdf","1900-01-01 00:00:00",
54150,18,21992,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/256_021992s042 desvenlaxafine clinpharm both.pdf","1900-01-01 00:00:00",
54151,62,21992,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/255_021992s042 desvenlaxafine clinical addendum both.pdf","1900-01-01 00:00:00",
54152,17,21992,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/257_021992s042 desvenlaxafine statistical both.pdf","1900-01-01 00:00:00",
45061,1,21992,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021992Orig1s043ltr.pdf","2016-08-26 00:00:00",
45174,2,21992,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021992s043lbl.pdf","2016-08-26 00:00:00",
46689,2,21992,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s044lbl.pdf","2017-01-06 00:00:00",
50800,2,21992,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf","2017-12-21 00:00:00",
50801,8,21992,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf#page=35","2017-12-21 00:00:00",
50899,1,21992,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021992Orig1s046ltr.pdf","2017-12-27 00:00:00",
29006,1,21993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021993s000ltr.pdf","2006-12-14 00:00:00",
38028,2,21993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf","2006-12-14 00:00:00",
42372,3,21993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021993_claritin_toc.cfm","2008-10-03 00:00:00",
6624,1,21993,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021993s004ltr.pdf","2008-10-23 00:00:00",
6625,1,21993,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf","2014-07-24 00:00:00",
38029,2,21993,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf","2014-07-29 00:00:00",
29007,1,21993,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf","2015-11-27 00:00:00",
38030,2,21993,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf","2015-12-01 00:00:00",
54971,1,21993,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf","2018-07-25 00:00:00",
55107,2,21993,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf","2018-08-03 00:00:00",
6626,1,21994,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021994s000ltr.pdf","2006-09-25 00:00:00",
16714,2,21994,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021994lbl.pdf","2006-09-25 00:00:00",
29008,1,21994,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021994s001ltr.pdf","2010-09-02 00:00:00",
38031,2,21994,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021994s001lbl.pdf","2010-09-07 00:00:00",
42373,3,21994,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021994s000TOC.cfm","2008-05-07 00:00:00",
16715,2,21994,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021994s006lbl.pdf","2011-09-12 00:00:00",
29009,1,21994,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021994s006ltr.pdf","2011-09-12 00:00:00",
49861,1,21994,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021994Orig1s012ltr.pdf","2017-09-26 00:00:00",
49864,2,21994,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf","2017-09-26 00:00:00",
6627,1,21995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021995s000ltr.pdf","2006-10-23 00:00:00",
38032,2,21995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf","2006-10-18 00:00:00",
42374,3,21995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.cfm","2006-12-13 00:00:00",
44166,10,21995,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm","2013-04-29 00:00:00",
6628,1,21995,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf","2007-10-22 00:00:00",
29010,1,21995,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf","2007-10-22 00:00:00",
29011,1,21995,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf","2007-10-22 00:00:00",
29012,1,21995,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf","2007-10-22 00:00:00",
29013,1,21995,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s007ltr.pdf","2008-07-23 00:00:00",
38033,2,21995,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf","2008-07-23 00:00:00",
29014,1,21995,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s009ltr.pdf","2008-10-23 00:00:00",
29015,1,21995,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf","2010-03-05 00:00:00",
38034,2,21995,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf","2010-03-02 00:00:00",
6629,1,21995,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf","2010-03-05 00:00:00",
16716,2,21995,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf","2010-03-02 00:00:00",
29016,1,21995,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf","2010-03-05 00:00:00",
38035,2,21995,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf","2010-03-02 00:00:00",
6630,1,21995,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021995s013ltr.pdf","2010-01-14 00:00:00",
21898,3,21995,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021995Orig1s013.pdf","2015-03-11 00:00:00",
38036,2,21995,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf","2010-01-12 00:00:00",
6631,1,21995,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf","2010-03-05 00:00:00",
16717,2,21995,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf","2010-03-02 00:00:00",
42375,3,21995,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021995Orig1s014.pdf","2015-03-11 00:00:00",
16718,2,21995,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf","2010-09-29 00:00:00",
29017,1,21995,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf","2010-09-29 00:00:00",
29018,1,21995,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
6632,1,21995,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021995s017ltr.pdf","2011-04-19 00:00:00",
16719,2,21995,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf","2011-04-18 00:00:00",
29019,1,21995,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf","2010-09-29 00:00:00",
38037,2,21995,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf","2010-09-29 00:00:00",
16720,2,21995,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf","2012-02-27 00:00:00",
6633,1,21995,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995s023ltr.pdf","2012-03-27 00:00:00",
16721,2,21995,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf","2012-03-27 00:00:00",
16722,2,21995,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf","2012-10-22 00:00:00",
29020,1,21995,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995Orig1s025ltr.pdf","2012-10-22 00:00:00",
6634,1,21995,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s027ltr_replacement.pdf","2013-02-08 00:00:00",
38038,2,21995,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf","2013-02-08 00:00:00",
38039,2,21995,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf","2013-10-22 00:00:00",
6635,1,21995,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s029ltr.pdf","2013-08-22 00:00:00",
38040,2,21995,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf","2013-08-21 00:00:00",
29021,1,21995,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s032ltr.pdf","2015-03-12 00:00:00",
38041,2,21995,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf","2015-03-12 00:00:00",
6636,1,21995,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf","2015-04-29 00:00:00",
38042,2,21995,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf","2015-05-04 00:00:00",
29022,1,21995,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf","2015-09-01 00:00:00",
38043,2,21995,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf","2015-09-04 00:00:00",
46918,2,21995,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf","2017-01-18 00:00:00",
46948,1,21995,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s038ltr.pdf","2017-01-24 00:00:00",
49348,2,21995,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf","2017-08-14 00:00:00",
49405,1,21995,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf","2017-08-15 00:00:00",
52554,2,21995,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf","2018-02-12 00:00:00",
52560,8,21995,"SUPPL",42,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf#page=24","2018-02-12 00:00:00",
52633,1,21995,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf","2018-02-14 00:00:00",
6637,1,21996,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021996s000ltr.pdf","2006-12-28 00:00:00",
29023,1,21996,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021996s001_LTR.pdf","2007-04-25 00:00:00",
38044,2,21996,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021996s001lbl.pdf","2007-04-20 00:00:00",
42376,3,21996,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021996_alaway_toc.cfm","2008-10-03 00:00:00",
6638,1,21996,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021996Orig1s008ltr.pdf","2015-02-12 00:00:00",
16723,2,21996,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021996Orig1s008lbl.pdf","2015-02-17 00:00:00",
6639,1,21997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021997s000ltr.pdf","2009-03-19 00:00:00",
16724,2,21997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021997lbl.pdf","2009-03-26 00:00:00",
21899,3,21997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.cfm","2009-06-12 00:00:00",
23336,8,21997,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135937.pdf","2009-11-18 00:00:00",
44662,21,21997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.cfm","2009-06-12 00:00:00",
6640,1,21997,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021997s002ltr.pdf","2010-12-21 00:00:00",
6641,1,21997,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021997s003ltr.pdf","2011-09-20 00:00:00",
6642,1,21997,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021997Orig1s005ltr.pdf","2013-04-24 00:00:00",
38045,2,21997,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021997s005lbl.pdf","2013-04-23 00:00:00",
6643,1,21997,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021997Orig1s006ltr.pdf","2014-10-30 00:00:00",
38046,2,21997,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf","2014-11-04 00:00:00",
24230,21,21998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf","2009-11-24 00:00:00",
29024,1,21998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf","2009-07-13 00:00:00",
38047,2,21998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf","2009-07-13 00:00:00",
42377,3,21998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998_planb_onestep_toc.cfm","2009-11-24 00:00:00",
53317,20,21998,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21998 levonorgestrel clinical prea.pdf","1900-01-01 00:00:00",
53318,20,21998,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21998 DD Clinical Review PREA.pdf","1900-01-01 00:00:00",
53319,18,21998,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21998 levonorgestrel clinpharm prea.pdf","1900-01-01 00:00:00",
53320,18,21998,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21998 clinpharm add Review_Prea.pdf","1900-01-01 00:00:00",
53321,17,21998,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21998 levonorgestrel statistical prea.pdf","1900-01-01 00:00:00",
6644,1,21998,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s002ltr.pdf","2013-05-02 00:00:00",
38048,2,21998,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf","2013-09-24 00:00:00",
42378,3,21998,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021998Orig1s002.pdf","2015-11-17 00:00:00",
6645,1,21998,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s003ltr.pdf","2013-06-24 00:00:00",
16725,2,21998,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf","2013-06-21 00:00:00",
49413,2,21998,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021998Orig1s004lbl.pdf","2017-08-15 00:00:00",
49414,1,21998,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021998Orig1s004ltr.pdf","2017-08-15 00:00:00",
6646,1,21999,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf","2008-01-09 00:00:00",
23688,10,21999,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
29025,1,21999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021999s000_ltr.pdf","2006-12-28 00:00:00",
38049,2,21999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf","2006-12-28 00:00:00",
38050,2,21999,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf","2008-01-08 00:00:00",
42379,3,21999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021999s000_TOC.cfm","2007-03-30 00:00:00",
53362,20,21999,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21999 Paliperidone clinical prea.pdf","1900-01-01 00:00:00",
53363,18,21999,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21999 Paliperidone Clinpharm Prea.pdf","1900-01-01 00:00:00",
53364,17,21999,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21999 paliperidone statistical prea.pdf","1900-01-01 00:00:00",
29026,1,21999,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf","2008-01-09 00:00:00",
42380,3,21999,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021999Orig1s004.pdf","2014-08-05 00:00:00",
29027,1,21999,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf","2008-08-28 00:00:00",
38051,2,21999,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf","2008-08-29 00:00:00",
6647,1,21999,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s006ltr.pdf","2008-09-05 00:00:00",
38052,2,21999,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf","2008-09-05 00:00:00",
29028,1,21999,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s007ltr.pdf","2008-05-21 00:00:00",
29029,1,21999,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf","2008-08-28 00:00:00",
38053,2,21999,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf","2008-08-29 00:00:00",
6648,1,21999,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s010ltr.pdf","2008-08-19 00:00:00",
38054,2,21999,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf","2008-08-26 00:00:00",
16726,2,21999,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf","2009-11-04 00:00:00",
29030,1,21999,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf","2009-08-06 00:00:00",
38055,2,21999,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf","2009-08-04 00:00:00",
6649,1,21999,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf","2009-08-06 00:00:00",
16727,2,21999,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf","2009-08-04 00:00:00",
6650,1,21999,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s015ltr.pdf","2009-07-23 00:00:00",
16728,2,21999,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf","2009-07-23 00:00:00",
6651,1,21999,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s017ltr.pdf","2011-02-18 00:00:00",
16729,2,21999,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf","2011-02-24 00:00:00",
16730,2,21999,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf","2010-03-05 00:00:00",
29031,1,21999,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s018ltr.pdf","2010-03-11 00:00:00",
29032,1,21999,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf","2011-04-11 00:00:00",
38056,2,21999,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf","2011-04-07 00:00:00",
16731,2,21999,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf","2010-12-04 00:00:00",
29033,1,21999,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s023ltr.pdf","2010-12-07 00:00:00",
6652,1,21999,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf","2011-04-11 00:00:00",
16732,2,21999,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf","2011-04-07 00:00:00",
29034,1,21999,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf","2014-05-01 00:00:00",
38057,2,21999,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf","2014-05-02 00:00:00",
16733,2,21999,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf","2016-03-03 00:00:00",
29035,1,21999,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
47315,2,21999,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf","2017-02-24 00:00:00",
47407,1,21999,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf","2017-03-02 00:00:00",
49462,2,21999,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s034lbl.pdf","2017-08-18 00:00:00",
49484,1,21999,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s034ltr.pdf","2017-08-21 00:00:00",
55054,1,21999,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf","2018-07-30 00:00:00",
55562,2,21999,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021999s035lbl.pdf","2018-09-21 00:00:00",
16734,2,22000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf","2007-01-18 00:00:00",
29036,1,22000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022000s000ltr.pdf","2007-01-25 00:00:00",
42381,3,22000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022000s000TOC.cfm","2007-08-31 00:00:00",
38058,2,22000,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf","2009-12-10 00:00:00",
16735,2,22000,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf","2010-09-23 00:00:00",
29037,1,22000,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022000s003ltr.pdf","2010-09-27 00:00:00",
6653,1,22000,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022000s005ltr.pdf","2011-07-18 00:00:00",
38059,2,22000,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf","2011-07-18 00:00:00",
42382,3,22000,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf","2015-03-09 00:00:00",
29038,1,22000,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf","2013-08-12 00:00:00",
38060,2,22000,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf","2013-08-12 00:00:00",
6654,1,22000,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s009ltr.pdf","2013-08-29 00:00:00",
16736,2,22000,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf","2013-09-24 00:00:00",
6655,1,22000,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf","2013-08-12 00:00:00",
16737,2,22000,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf","2013-08-12 00:00:00",
16738,2,22000,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf","2013-12-17 00:00:00",
29039,1,22000,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s011ltr.pdf","2013-12-17 00:00:00",
16739,2,22000,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf","2014-10-21 00:00:00",
29040,1,22000,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022000Orig1s013ltr.pdf","2014-10-21 00:00:00",
49523,2,22000,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s015lbl.pdf","2017-08-24 00:00:00",
49538,1,22000,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022000Orig1s015ltr.pdf","2017-08-25 00:00:00",
49127,1,22000,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf","2017-07-28 00:00:00",
49143,2,22000,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s016lbl.pdf","2017-07-31 00:00:00",
54329,1,22000,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022000Orig1s017ltr.pdf","2018-05-24 00:00:00",
54340,2,22000,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022000s017lbl.pdf","2018-05-25 00:00:00",
16740,2,22001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022001lbl.pdf","2007-01-08 00:00:00",
29041,1,22001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022001s000ltr.pdf","2007-01-08 00:00:00",
42383,3,22001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022001s000TOC.cfm","2008-10-03 00:00:00",
29042,1,22003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022003ltr.pdf","2006-09-20 00:00:00",
38061,2,22003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022003lbl.pdf","2006-09-18 00:00:00",
42384,3,22003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022003s000_NoxafilTOC.cfm","2006-11-09 00:00:00",
51541,20,22003,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/8_22003 posaconazole clinical prea.pdf","1900-01-01 00:00:00",
51542,18,22003,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/7_22003 posaconazole clinpharm prea.pdf","1900-01-01 00:00:00",
6656,1,22003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf","2008-05-21 00:00:00",
29043,1,22003,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf","2008-05-21 00:00:00",
29044,1,22003,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022003s007ltr.pdf","2009-02-23 00:00:00",
38062,2,22003,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022003s007lbl.pdf","2009-02-20 00:00:00",
16741,2,22003,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf","2010-09-10 00:00:00",
29045,1,22003,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf","2010-09-13 00:00:00",
6657,1,22003,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf","2012-06-25 00:00:00",
38063,2,22003,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf","2012-06-22 00:00:00",
6658,1,22003,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf","2012-06-25 00:00:00",
16742,2,22003,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf","2012-06-22 00:00:00",
16743,2,22003,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003Orig1s016lbl.pdf","2015-07-22 00:00:00",
29046,1,22003,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s016ltr.pdf","2015-07-16 00:00:00",
29047,1,22003,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
38064,2,22003,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
16744,2,22003,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
29048,1,22003,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
45295,1,22003,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf","2016-09-15 00:00:00",
46970,2,22003,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf","2017-01-24 00:00:00",
50983,1,22003,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf","2018-01-08 00:00:00",
51007,2,22003,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf","2018-01-09 00:00:00",
6659,1,22004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022004s000ltr.pdf","2006-10-26 00:00:00",
21900,3,22004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022004s000TOC.cfm","2006-12-22 00:00:00",
38065,2,22004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022004lbl.pdf","2006-10-23 00:00:00",
6660,1,22004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022004s002ltr.pdf","2007-11-26 00:00:00",
16745,2,22004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022004s002lbl.pdf","2007-11-26 00:00:00",
6661,1,22004,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s005ltr.pdf","2010-05-12 00:00:00",
38066,2,22004,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022004s005lbl.pdf","2010-05-17 00:00:00",
6662,1,22004,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s007ltr.pdf","2010-05-12 00:00:00",
16746,2,22004,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022004s013lbl.pdf","2013-03-26 00:00:00",
29049,1,22004,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022004Orig1s013ltr.pdf","2013-03-26 00:00:00",
6663,1,22004,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022004Orig1s015ltr.pdf","2016-03-21 00:00:00",
21901,3,22006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000TOC.cfm","2009-10-16 00:00:00",
24013,14,22006,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=48","2011-02-02 00:00:00",
24231,21,22006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000_SumR.pdf","2009-10-16 00:00:00",
29050,1,22006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022006s000ltr.pdf","2009-08-26 00:00:00",
53552,20,22006,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_CLINICAL_BPCA.pdf","1900-01-01 00:00:00",
53553,18,22006,"ORIG",1,"0","https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM374644.pdf","1900-01-01 00:00:00",
53554,17,22006,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_STATISTICAL_BPCA.pdf","1900-01-01 00:00:00",
16747,2,22006,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022006s002lbl.pdf","2011-01-25 00:00:00",
29051,1,22006,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002ltr.pdf","2011-01-24 00:00:00",
16748,2,22006,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf","2012-12-14 00:00:00",
6664,1,22006,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
16749,2,22006,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
29052,1,22006,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
38067,2,22006,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
6665,1,22006,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf","2013-10-29 00:00:00",
16750,2,22006,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf","2013-10-31 00:00:00",
6666,1,22006,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006Orig1s014ltr.pdf","2014-04-04 00:00:00",
38068,2,22006,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf","2014-04-04 00:00:00",
6667,1,22006,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006Orig1s015ltr.pdf","2016-06-23 00:00:00",
38069,2,22006,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf","2016-06-27 00:00:00",
29053,1,22006,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006Orig1s016ltr.pdf","2015-09-22 00:00:00",
38070,2,22006,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf","2015-09-23 00:00:00",
6668,1,22006,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022006Orig1s017ltr.pdf","2015-11-04 00:00:00",
16751,2,22006,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022006Orig1s017lbl.pdf","2015-11-04 00:00:00",
48196,1,22006,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s016,022006Orig1s018ltr.pdf","2017-05-02 00:00:00",
48225,2,22006,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf","2017-05-02 00:00:00",
50214,1,22006,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s017,022006Orig1s019ltr.pdf","2017-10-30 00:00:00",
55280,8,22006,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26","2018-08-23 00:00:00",
55281,2,22006,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf","2018-08-23 00:00:00",
55321,1,22006,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020427Orig1s018,022006Orig1s020ltr.pdf","2018-08-27 00:00:00",
6669,1,22007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000TAltr.pdf","2007-05-01 00:00:00",
16752,2,22007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf","2008-03-28 00:00:00",
21902,3,22007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022007_perforomist_toc.cfm","2009-03-19 00:00:00",
23338,8,22007,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf","2010-06-04 00:00:00",
29054,1,22007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000ltr.pdf","2007-05-31 00:00:00",
44167,10,22007,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2008-04-01 00:00:00",
29055,1,22007,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022007s004ltr.pdf","2010-06-03 00:00:00",
38071,2,22007,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf","2010-06-02 00:00:00",
29056,1,22007,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022007s005ltr.pdf","2011-02-07 00:00:00",
29057,1,22007,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007s006ltr.pdf","2012-01-17 00:00:00",
38072,2,22007,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf","2012-01-23 00:00:00",
6670,1,22007,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf","2012-10-02 00:00:00",
29058,1,22007,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf","2012-10-02 00:00:00",
50550,2,22007,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022007s012lbl.pdf","2017-12-01 00:00:00",
50571,1,22007,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022007Orig1s012ltr.pdf","2017-12-01 00:00:00",
6671,1,22008,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s001ltr.pdf","2008-11-03 00:00:00",
16753,2,22008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf","2008-07-09 00:00:00",
16754,2,22008,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf","2008-11-07 00:00:00",
21903,3,22008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022008_requip_toc.cfm","2008-12-29 00:00:00",
29059,1,22008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr.pdf","2008-06-20 00:00:00",
29060,1,22008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr_FINAL.pdf","2008-07-08 00:00:00",
16755,2,22008,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf","2009-04-16 00:00:00",
29061,1,22008,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022008s002ltr.pdf","2009-04-16 00:00:00",
29062,1,22008,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf","2014-09-02 00:00:00",
38073,2,22008,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf","2014-09-03 00:00:00",
6672,1,22008,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf","2014-09-02 00:00:00",
16756,2,22008,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf","2014-09-03 00:00:00",
6673,1,22008,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf","2014-09-02 00:00:00",
16757,2,22008,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf","2014-09-03 00:00:00",
29063,1,22008,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf","2014-09-02 00:00:00",
38074,2,22008,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf","2014-09-03 00:00:00",
47663,1,22008,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022008Orig1s009ltr.pdf","2017-03-24 00:00:00",
47699,2,22008,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022008s009lbl.pdf","2017-03-24 00:00:00",
6674,1,22009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s000ltr.pdf","2008-04-02 00:00:00",
21904,3,22009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009_avobenzone_ecamsule_octocrylene_titanium_dioxide_cream_toc.cfm","2010-01-13 00:00:00",
24232,21,22009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009s000_SumR.pdf","2010-01-13 00:00:00",
29064,1,22009,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s001ltr.pdf","2008-10-23 00:00:00",
53288,20,22009,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022009_Ecamsule-Anthelios_Clinical_PREA_june.pdf","1900-01-01 00:00:00",
53289,18,22009,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022009_Ecamsule-Anthelios_ClinPharm_PREA_june.pdf","1900-01-01 00:00:00",
6675,1,22009,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022009s004ltr.pdf","2010-04-13 00:00:00",
6676,1,22010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022010s000ltr.pdf","2006-04-07 00:00:00",
42385,3,22010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022010_septocaine_toc.cfm","2008-09-05 00:00:00",
16758,2,22011,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s001lbl.pdf","2009-02-04 00:00:00",
21905,3,22011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/22011s000TOC.cfm","2006-12-22 00:00:00",
29065,1,22011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022011s000ltr.pdf","2006-10-27 00:00:00",
29066,1,22011,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s001ltr.pdf","2009-01-26 00:00:00",
38075,2,22011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022011lbl.pdf","2006-10-26 00:00:00",
6677,1,22011,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s002ltr.pdf","2009-05-13 00:00:00",
16759,2,22011,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s002lbl.pdf","2009-05-13 00:00:00",
6678,1,22011,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001ltr.pdf","2010-03-08 00:00:00",
16760,2,22011,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf","2010-03-09 00:00:00",
6679,1,22011,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006ltr.pdf","2010-09-16 00:00:00",
16761,2,22011,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf","2010-10-04 00:00:00",
29067,1,22011,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006ltr.pdf","2011-04-01 00:00:00",
38076,2,22011,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf","2011-04-01 00:00:00",
38077,2,22011,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s010lbl.pdf","2013-01-28 00:00:00",
6680,1,22011,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008ltr.pdf","2011-05-10 00:00:00",
6681,1,22011,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009ltr.pdf","2012-01-03 00:00:00",
16762,2,22011,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf","2011-12-23 00:00:00",
29068,1,22011,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022011Orig1s013,022154Orig1s010ltr.pdf","2013-01-30 00:00:00",
38078,2,22011,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf","2013-01-28 00:00:00",
53525,1,22011,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022011Orig1s021,022154Orig1s018ltr.pdf","2018-03-29 00:00:00",
53562,2,22011,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf","2018-04-01 00:00:00",
53563,8,22011,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf#page=17","2018-04-01 00:00:00",
16763,2,22012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022012lbl.pdf","2006-10-23 00:00:00",
16764,2,22012,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s001lbl.pdf","2007-07-24 00:00:00",
21906,3,22012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022012s000TOC.cfm","2007-07-27 00:00:00",
29069,1,22012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022012s000ltr.pdf","2006-10-23 00:00:00",
29070,1,22012,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s001ltr.pdf","2007-07-24 00:00:00",
16765,2,22012,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s003lbl.pdf","2007-08-06 00:00:00",
29071,1,22012,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s003ltr.pdf","2007-08-07 00:00:00",
6682,1,22012,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s004ltr.pdf","2007-10-22 00:00:00",
38079,2,22012,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s004lbl.pdf","2007-10-22 00:00:00",
29072,1,22012,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf","2009-06-26 00:00:00",
38080,2,22012,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf","2009-06-29 00:00:00",
16766,2,22012,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022012s011lbl.pdf","2009-01-06 00:00:00",
29073,1,22012,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022012s011ltr.pdf","2008-12-31 00:00:00",
6683,1,22012,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf","2009-06-26 00:00:00",
16767,2,22012,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf","2009-06-29 00:00:00",
29074,1,22012,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf","2011-02-02 00:00:00",
38081,2,22012,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s016lbl.pdf","2011-01-31 00:00:00",
6684,1,22012,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf","2011-01-07 00:00:00",
38082,2,22012,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf","2011-01-10 00:00:00",
6685,1,22012,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf","2011-01-18 00:00:00",
38083,2,22012,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf","2011-01-10 00:00:00",
6686,1,22012,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf","2011-07-07 00:00:00",
38084,2,22012,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s020lbl.pdf","2011-07-07 00:00:00",
16768,2,22012,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022012s021lbl.pdf","2015-10-08 00:00:00",
29075,1,22012,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022012Orig1s021ltr.pdf","2015-11-04 00:00:00",
49745,2,22012,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022012s022lbl.pdf","2017-09-15 00:00:00",
49788,1,22012,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022012Orig1s022ltr.pdf","2017-09-19 00:00:00",
6687,1,22013,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s000ltr.pdf","2007-01-25 00:00:00",
16769,2,22013,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022013lbl.pdf","2007-01-16 00:00:00",
21907,3,22013,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022013_oluxe_toc.cfm","2008-10-03 00:00:00",
29076,1,22013,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s001ltr.pdf","2007-07-24 00:00:00",
6688,1,22013,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022013s005ltr.pdf","2010-11-18 00:00:00",
38085,2,22013,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022013s005lbl.pdf","2010-11-12 00:00:00",
16770,2,22013,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022013s009lbl.pdf","2013-04-30 00:00:00",
29077,1,22013,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022013Orig1s009ltr.pdf","2013-04-24 00:00:00",
54213,1,22013,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022013Orig1s013ltr.pdf","2018-05-16 00:00:00",
54243,2,22013,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022013s013lbl.pdf","2018-05-17 00:00:00",
16771,2,22014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022014lbl.pdf","2007-07-30 00:00:00",
16772,2,22014,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022014s001lbl.pdf","2008-04-16 00:00:00",
23689,10,22014,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220264.htm","2010-08-09 00:00:00",
29078,1,22014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022014s000ltr.pdf","2007-07-31 00:00:00",
29079,1,22014,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s001ltr.pdf","2008-04-16 00:00:00",
42386,3,22014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014_evamist_toc.cfm","2009-04-22 00:00:00",
44663,21,22014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014s000_SumR.pdf","2009-04-22 00:00:00",
29080,1,22014,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s005ltr.pdf","2008-11-03 00:00:00",
29081,1,22014,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022014Orig1s006ltr.pdf","2014-03-13 00:00:00",
38086,2,22014,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022014s006lbl.pdf","2014-03-13 00:00:00",
29082,1,22014,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022014s009ltr.pdf","2011-10-31 00:00:00",
38087,2,22014,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022014s009lbl.pdf","2011-11-01 00:00:00",
50276,2,22014,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022014s013lbl.pdf","2017-11-02 00:00:00",
21908,3,22015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_TOC.cfm","2007-06-22 00:00:00",
29083,1,22015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022015s000ltr.pdf","2006-10-13 00:00:00",
29084,1,22015,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s002ltr.pdf","2008-11-21 00:00:00",
6689,1,22015,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s003ltr.pdf","2008-12-04 00:00:00",
6690,1,22015,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022015s006ltr.pdf","2010-05-07 00:00:00",
6691,1,22015,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022015Orig1s012ltr.pdf","2012-03-19 00:00:00",
29085,1,22015,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022015Orig1s020ltr.pdf","2014-08-06 00:00:00",
38088,2,22015,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022015Orig1s020lbl.pdf","2014-08-04 00:00:00",
16773,2,22015,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s023lbl.pdf","2015-11-04 00:00:00",
29086,1,22015,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s023ltr.pdf","2015-11-04 00:00:00",
6692,1,22015,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s024ltr.pdf","2015-11-16 00:00:00",
16774,2,22015,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s024lbl.pdf","2015-11-19 00:00:00",
45476,1,22015,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s025ltr.pdf","2016-10-05 00:00:00",
45586,2,22015,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s025lbl.pdf","2016-10-11 00:00:00",
45637,1,22015,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s026ltr.pdf","2016-10-25 00:00:00",
45643,2,22015,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s026lbl.pdf","2016-10-27 00:00:00",
49973,1,22015,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022015Orig1s027ltr.pdf","2017-10-06 00:00:00",
50096,2,22015,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022015Orig1s027lbl.pdf","2017-10-18 00:00:00",
53864,1,22015,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s029ltr.pdf","2018-04-27 00:00:00",
54005,2,22015,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s029lbl.pdf","2018-05-03 00:00:00",
54045,1,22015,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s030ltr.pdf","2018-05-08 00:00:00",
54053,2,22015,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s030lbl.pdf","2018-05-08 00:00:00",
55220,1,22015,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s0333Ltr.pdf","2018-08-20 00:00:00",
55331,2,22015,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s0333Lbl.pdf","2018-08-27 00:00:00",
6693,1,22016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022016s000ltr.pdf","2007-03-07 00:00:00",
21909,3,22016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022016_vaprisol_toc.cfm","2008-11-03 00:00:00",
47650,2,22018,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022018Lbl.pdf","2017-03-23 00:00:00",
47694,1,22018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022018Orig1s000ltr.pdf","2017-03-24 00:00:00",
48814,3,22018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022018Orig1s000TOC.cfm","2017-06-23 00:00:00",
48815,21,22018,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022018Orig1s000SumR.pdf","2017-06-23 00:00:00",
6695,1,22020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022020s000ltr.pdf","2007-11-19 00:00:00",
23690,10,22020,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
38089,2,22020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022020lbl.pdf","2007-11-19 00:00:00",
42387,3,22020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020_protonix_toc.cfm","2009-03-31 00:00:00",
44664,21,22020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020s000_SumR.pdf","2009-03-31 00:00:00",
53378,20,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53379,18,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53380,17,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_Statistical_BPCA.pdf","1900-01-01 00:00:00",
53381,57,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_DDSummary_BPCA.pdf","1900-01-01 00:00:00",
53382,60,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_DDSummary_BPCA.pdf","1900-01-01 00:00:00",
53383,58,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_ClinicalAddendum_BPCA.pdf","1900-01-01 00:00:00",
54079,58,22020,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022020_Pantoprazole_ClinicalAddendum_BPCA.pdf","1900-01-01 00:00:00",
29087,1,22020,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf","2009-11-25 00:00:00",
38090,2,22020,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf","2009-11-16 00:00:00",
6696,1,22020,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf","2010-09-08 00:00:00",
16776,2,22020,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf","2010-09-10 00:00:00",
6697,1,22020,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf","2011-10-31 00:00:00",
38091,2,22020,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf","2011-11-01 00:00:00",
6698,1,22020,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf","2011-05-25 00:00:00",
16777,2,22020,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf","2011-05-25 00:00:00",
16778,2,22020,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf","2012-10-15 00:00:00",
29088,1,22020,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf","2012-10-11 00:00:00",
16779,2,22020,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022020s007lbl.pdf","2012-05-15 00:00:00",
16780,2,22020,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf","2013-12-11 00:00:00",
29089,1,22020,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf","2013-12-13 00:00:00",
29090,1,22020,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf","2014-12-24 00:00:00",
38092,2,22020,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf","2014-12-29 00:00:00",
45659,1,22020,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf","2016-10-26 00:00:00",
45717,2,22020,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf","2016-10-31 00:00:00",
50839,2,22020,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf","2017-12-22 00:00:00",
50878,1,22020,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf","2017-12-27 00:00:00",
48939,1,22020,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Origs053,022020Orig1s015ltr.pdf","2017-07-10 00:00:00",
48955,2,22020,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf","2017-07-12 00:00:00",
48956,8,22020,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf#page=30","2017-07-12 00:00:00",
54505,2,22020,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054,022020s016,020988s060lbl.pdf","2018-06-11 00:00:00",
54570,1,22020,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf","2018-06-14 00:00:00",
6699,1,22021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022021s000ltr.pdf","2007-03-07 00:00:00",
23691,10,22021,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
29091,1,22021,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s052,022021s001ltr.pdf","2009-03-06 00:00:00",
38093,2,22021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022021lbl.pdf","2007-03-07 00:00:00",
42388,3,22021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022021TOC.cfm","2008-03-14 00:00:00",
29092,1,22021,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s054,022021s005ltr.pdf","2009-02-18 00:00:00",
6700,1,22021,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022021s006ltr.pdf","2010-01-20 00:00:00",
38094,2,22021,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022021s006lbl.pdf","2009-11-23 00:00:00",
6701,1,22021,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022021s007ltr.pdf","2011-08-08 00:00:00",
16781,2,22021,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022021s007lbl.pdf","2011-08-12 00:00:00",
6702,1,22021,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022021s008ltr.pdf","2012-01-23 00:00:00",
16782,2,22021,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022021s008lbl.pdf","2012-01-23 00:00:00",
6703,1,22023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022023s000ltr.pdf","2008-01-29 00:00:00",
16783,2,22023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf","2008-01-30 00:00:00",
21910,3,22023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000TOC.cfm","2009-04-22 00:00:00",
6704,1,22023,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf","2010-03-25 00:00:00",
38095,2,22023,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf","2010-03-26 00:00:00",
16784,2,22023,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf","2010-03-26 00:00:00",
29093,1,22023,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf","2010-03-25 00:00:00",
29094,1,22023,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s004ltr.pdf","2010-11-18 00:00:00",
38096,2,22023,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf","2010-11-17 00:00:00",
42389,3,22023,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022023Orig1s004.pdf","2014-01-17 00:00:00",
29095,1,22023,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf","2010-03-25 00:00:00",
38097,2,22023,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf","2010-03-26 00:00:00",
6705,1,22023,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022023Orig1s006ltr.pdf","2016-02-03 00:00:00",
38098,2,22023,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbledt.pdf","2017-02-07 00:00:00",
16785,2,22023,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf","2013-03-26 00:00:00",
29096,1,22023,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022023Orig1s007ltr.pdf","2013-03-22 00:00:00",
6706,1,22023,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022023Orig1s009ltr.pdf","2012-07-11 00:00:00",
16786,2,22023,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf","2012-07-10 00:00:00",
6707,1,22023,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf","2013-03-29 00:00:00",
38099,2,22023,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf","2013-04-01 00:00:00",
6708,1,22023,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf","2014-08-14 00:00:00",
16787,2,22023,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf","2014-08-13 00:00:00",
47207,2,22023,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s014lbl.pdf","2017-02-15 00:00:00",
52644,3,22023,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022023Orig1s014.pdf","2018-02-14 00:00:00",
48618,2,22023,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s015lbl.pdf","2017-06-01 00:00:00",
48636,1,22023,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s015ltr.pdf","2017-06-02 00:00:00",
49361,1,22023,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022023Orig1s016ltr.pdf","2017-08-15 00:00:00",
49423,2,22023,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022023s016lbl.pdf","2017-08-15 00:00:00",
53609,2,22023,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s017lbl.pdf","2018-04-05 00:00:00",
53610,1,22023,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023s017ltr.pdf","2018-04-05 00:00:00",
53456,2,22023,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022023s018lbl.pdf","2018-03-27 00:00:00",
53509,1,22023,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022023Orig1s018ltr.pdf","2018-03-29 00:00:00",
6709,1,22024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022024s000ltr.pdf","2009-05-14 00:00:00",
6710,1,22024,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022024Orig1s001ltr.pdf","2013-11-14 00:00:00",
16788,2,22024,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf","2013-11-14 00:00:00",
21911,3,22024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022024_actoplus_met_xr_toc.cfm","2010-03-25 00:00:00",
23692,10,22024,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
38100,2,22024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf","2009-07-08 00:00:00",
6711,1,22024,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022024s002ltr.pdf","2010-12-28 00:00:00",
16789,2,22024,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf","2010-12-26 00:00:00",
29097,1,22024,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
38101,2,22024,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf","2011-08-04 00:00:00",
6712,1,22024,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf","2011-08-04 00:00:00",
16790,2,22024,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf","2011-08-04 00:00:00",
6713,1,22024,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf","2012-05-22 00:00:00",
46139,1,22024,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf","2016-12-13 00:00:00",
46144,1,22024,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf","2016-12-14 00:00:00",
46190,2,22024,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022024s013lbl.pdf","2016-12-15 00:00:00",
50857,2,22024,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf","2017-12-26 00:00:00",
50858,8,22024,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf#page=41","2017-12-26 00:00:00",
50919,1,22024,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022024Orig1s014ltr.pdf","2017-12-27 00:00:00",
6714,1,22025,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s001ltr.pdf","2009-02-18 00:00:00",
16791,2,22025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022025lbl.pdf","2007-09-10 00:00:00",
29098,1,22025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022025s000_ltr.pdf","2007-09-11 00:00:00",
38102,2,22025,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s001lbl.pdf","2009-02-12 00:00:00",
42390,3,22025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025_totect_toc.cfm","2009-11-24 00:00:00",
44665,21,22025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025s000_SumR.pdf","2009-11-24 00:00:00",
16792,2,22025,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s005lbl.pdf","2009-09-21 00:00:00",
29099,1,22025,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s005ltr.pdf","2009-11-10 00:00:00",
29100,1,22025,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022025s011ltr.pdf","2011-03-10 00:00:00",
29101,1,22025,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022025Orig1s013ltr.pdf","2013-04-30 00:00:00",
38103,2,22025,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022025s013lbl.pdf","2013-04-29 00:00:00",
49057,2,22025,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022025s015lbl.pdf","2017-07-25 00:00:00",
52523,2,22025,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s016lbl.pdf","2018-02-09 00:00:00",
52543,1,22025,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022025Orig1s016ltr.pdf","2018-02-09 00:00:00",
6715,1,22026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022026s000ltr2.pdf","2007-10-04 00:00:00",
16793,2,22026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022026lbl.pdf","2007-10-04 00:00:00",
24233,21,22026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022026s000_SumR.pdf","2009-02-02 00:00:00",
42391,3,22026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022026_amlodipine_toc.cfm","2009-02-02 00:00:00",
6716,1,22027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022027s000ltr.pdf","2006-10-23 00:00:00",
6717,1,22027,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf","2010-09-13 00:00:00",
38104,2,22027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022027lbl.pdf","2006-10-23 00:00:00",
38105,2,22027,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf","2010-09-10 00:00:00",
42392,3,22027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022027_noxafil_toc.cfm","2008-09-05 00:00:00",
38106,2,22027,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf","2012-06-22 00:00:00",
16794,2,22027,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf","2012-06-22 00:00:00",
29102,1,22027,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf","2012-06-25 00:00:00",
6718,1,22028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022028s000ltr.pdf","2008-02-25 00:00:00",
16795,2,22028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022028lbl.pdf","2008-02-25 00:00:00",
42393,3,22028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028_cosyntropin_toc.cfm","2009-08-03 00:00:00",
44666,21,22028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028s000_SumR.pdf","2009-08-03 00:00:00",
54177,2,22028,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022028s005lbl.pdf","2018-05-14 00:00:00",
54196,1,22028,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022028Orig1s005ltr.pdf","2018-05-15 00:00:00",
29103,1,22029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022029s000ltr.pdf","2008-02-26 00:00:00",
42394,3,22029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029TOC.cfm","2010-05-03 00:00:00",
44667,21,22029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029s000sumr.pdf","2010-05-03 00:00:00",
29104,1,22029,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022029s002ltr.pdf","2008-08-25 00:00:00",
6719,1,22029,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022029s003ltr.pdf","2009-06-24 00:00:00",
16796,2,22029,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf","2009-06-29 00:00:00",
6720,1,22029,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022029s007ltr.pdf","2010-09-15 00:00:00",
6721,1,22029,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022029s009ltr.pdf","2011-06-07 00:00:00",
29105,1,22029,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022029Orig1s011ltr.pdf","2012-11-07 00:00:00",
38107,2,22029,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022029Orig1s011lbl.pdf","2014-01-15 00:00:00",
6722,1,22029,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022029Orig1s012ltr.pdf","2013-04-01 00:00:00",
51352,20,22029,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22029 methyl salicylate clinical prea.pdf","1900-01-01 00:00:00",
51353,20,22029,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22029 methyl salicylate clinical2 prea.pdf","1900-01-01 00:00:00",
51354,18,22029,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22029 methyl salicylate clinpharm prea.pdf","1900-01-01 00:00:00",
51355,17,22029,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22029 methy salicylate statistical prea.pdf","1900-01-01 00:00:00",
6723,1,22029,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022029Orig1s014ltr.pdf","2014-02-04 00:00:00",
16797,2,22029,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf","2014-02-14 00:00:00",
16798,2,22030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022030lbl.pdf","2008-11-07 00:00:00",
29106,1,22030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022030s000ltr.pdf","2008-11-07 00:00:00",
42395,3,22030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022030s000TOC.cfm","2009-02-26 00:00:00",
44668,21,22030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022030s000_SumR.pdf","2009-02-26 00:00:00",
6724,1,22030,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022030s004ltr.pdf","2010-04-08 00:00:00",
38108,2,22030,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022030s004lbl.pdf","2010-04-04 00:00:00",
16799,2,22030,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s006lbl.pdf","2011-11-18 00:00:00",
29107,1,22030,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s006ltr.pdf","2011-11-03 00:00:00",
6725,1,22030,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s007ltr.pdf","2011-02-14 00:00:00",
16800,2,22030,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s007lbl.pdf","2011-02-11 00:00:00",
29108,1,22030,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s008ltr.pdf","2012-01-03 00:00:00",
38109,2,22030,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s008lbl.pdf","2012-01-06 00:00:00",
6726,1,22030,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022030Orig1s009ltr.pdf","2012-08-03 00:00:00",
16801,2,22030,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022030s009lbl.pdf","2012-08-02 00:00:00",
50361,2,22030,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022030s014lbl.pdf","2017-11-13 00:00:00",
50428,1,22030,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022030Orig1s014ltr.pdf","2017-11-15 00:00:00",
6727,1,22032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000TAltr.pdf","2007-07-05 00:00:00",
21912,3,22032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032_omeprazole_toc.cfm","2009-05-28 00:00:00",
29109,1,22032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000ltr.pdf","2008-01-09 00:00:00",
44669,21,22032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032s000_SumR.pdf","2009-05-28 00:00:00",
6728,1,22032,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003GenAdviceltr.pdf","2009-07-23 00:00:00",
16802,2,22032,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf","2009-07-24 00:00:00",
29110,1,22032,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003ltr.pdf","2009-04-07 00:00:00",
29111,1,22032,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022032s008ltr.pdf","2010-07-23 00:00:00",
6729,1,22032,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022032s012ltr.pdf","2011-07-05 00:00:00",
29112,1,22032,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032s016ltr.pdf","2012-04-11 00:00:00",
6730,1,22032,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s019ltr.pdf","2012-09-11 00:00:00",
6731,1,22032,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s020ltr.pdf","2012-10-30 00:00:00",
16803,2,22032,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf","2014-01-15 00:00:00",
29113,1,22032,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022032Orig1s021ltr.pdf","2013-08-20 00:00:00",
38110,2,22032,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf","2013-09-19 00:00:00",
29114,1,22032,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s024ltr.pdf","2015-03-10 00:00:00",
38111,2,22032,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf","2015-03-12 00:00:00",
6732,1,22032,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s029ltr.pdf","2015-06-12 00:00:00",
16804,2,22032,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf","2015-06-19 00:00:00",
6733,1,22032,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022032Orig1s032ltr.pdf","2016-02-11 00:00:00",
38112,2,22032,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf","2016-02-11 00:00:00",
50295,1,22032,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s037ltr.pdf","2017-11-06 00:00:00",
50362,2,22032,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s037lbl.pdf","2017-11-13 00:00:00",
50411,2,22032,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s038lbl.pdF","2017-11-14 00:00:00",
50429,1,22032,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s038ltr.pdf","2017-11-15 00:00:00",
6734,1,22033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022033s000ltr.pdf","2008-03-04 00:00:00",
16805,2,22033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022033lbl.pdf","2008-03-05 00:00:00",
21913,3,22033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033TOC.cfm","2008-08-11 00:00:00",
23693,10,22033,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm","2012-02-13 00:00:00",
24234,21,22033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033s000_SumR.pdf","2008-08-11 00:00:00",
6735,1,22033,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf","2009-02-27 00:00:00",
38113,2,22033,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022033s002lbl.pdf","2009-03-17 00:00:00",
16806,2,22033,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf","2011-05-09 00:00:00",
29115,1,22033,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf","2011-05-11 00:00:00",
16807,2,22033,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s006lbl.pdf","2011-05-09 00:00:00",
29116,1,22033,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf","2011-05-11 00:00:00",
6736,1,22033,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf","2011-05-11 00:00:00",
16808,2,22033,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s007lbl.pdf","2011-05-09 00:00:00",
29117,1,22033,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022033Orig1s009ltr.pdf","2012-12-04 00:00:00",
38114,2,22033,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022033s009lbl.pdf","2012-12-04 00:00:00",
6737,1,22033,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022033Orig1s010ltr.pdf","2014-07-24 00:00:00",
38115,2,22033,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022033s010lbl.pdf","2014-07-23 00:00:00",
46720,2,22033,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf","2017-01-06 00:00:00",
46796,8,22033,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26","2017-01-11 00:00:00",
46797,1,22033,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022033Orig1s011ltr.pdf","2017-01-11 00:00:00",
21914,3,22036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036s000_silenor_toc.cfm","2011-02-11 00:00:00",
23341,8,22036,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf","2010-03-31 00:00:00",
29118,1,22036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022036s000ltr.pdf","2010-03-22 00:00:00",
29119,1,22036,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022036s001ltr.pdf","2012-01-20 00:00:00",
38116,2,22036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf","2010-03-18 00:00:00",
44670,21,22036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036Orig1s000SumR.pdf","2011-02-11 00:00:00",
6738,1,22037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022037s000ltr.pdf","2009-09-10 00:00:00",
24235,21,22037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037s000sumr.pdf","2010-07-09 00:00:00",
38117,2,22037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022037lbl.pdf","2009-10-01 00:00:00",
42396,3,22037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037_intuniv_toc.cfm","2010-07-09 00:00:00",
54112,20,22037,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037_guanfacine_Clinical_PREA.pdf","1900-01-01 00:00:00",
54113,20,22037,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037_guanfacine_DDmemo_PREA.pdf","1900-01-01 00:00:00",
54114,20,22037,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037_guanfacine_DD memo1_PREA.pdf","1900-01-01 00:00:00",
54115,18,22037,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037_guanfacine_cliinpharm_PREA.pdf","1900-01-01 00:00:00",
54116,17,22037,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037_guanfacine_Statistical_PREA.pdf","1900-01-01 00:00:00",
29120,1,22037,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s002ltr.pdf","2011-03-02 00:00:00",
38118,2,22037,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s002lbl.pdf","2011-03-04 00:00:00",
29121,1,22037,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s006ltr.pdf","2011-06-10 00:00:00",
38119,2,22037,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s006lbl.pdf","2011-06-10 00:00:00",
6739,1,22037,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s008ltr.pdf","2013-02-25 00:00:00",
16809,2,22037,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s008lbl.pdf","2013-02-21 00:00:00",
29122,1,22037,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s009ltr.pdf","2013-08-27 00:00:00",
38120,2,22037,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s009lbl.pdf","2013-08-27 00:00:00",
29123,1,22037,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022037Orig1s010ltr.pdf","2014-11-20 00:00:00",
38121,2,22037,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022037s010lbl.pdf","2014-11-20 00:00:00",
51164,20,22037,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine clinical both (2).pdf","1900-01-01 00:00:00",
51165,57,22037,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine CDTL clinical both.pdf","1900-01-01 00:00:00",
51166,18,22037,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine clinpharm both (1).pdf","1900-01-01 00:00:00",
51167,17,22037,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine statistical both.pdf","1900-01-01 00:00:00",
51938,23,22037,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022037_guanfacine_Original_WR.pdf","2014-10-17 00:00:00",
6740,1,22037,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022037Orig1s011ltr.pdf","2015-03-19 00:00:00",
16810,2,22037,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022037s011lbl.pdf","2015-03-19 00:00:00",
51156,20,22037,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 S011 guanfacine clinical prea.pdf","1900-01-01 00:00:00",
51158,18,22037,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 S011 guanfacine clinpharm prea.pdf","1900-01-01 00:00:00",
51159,17,22037,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 S011 guanfacine statistical prea.pdf","1900-01-01 00:00:00",
6741,1,22037,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022037Orig1s013ltr.pdf","2016-07-12 00:00:00",
16811,2,22037,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022037s013lbl.pdf","2016-07-08 00:00:00",
50513,2,22037,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022037s014lbl.pdf","2017-11-28 00:00:00",
50555,1,22037,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022037Orig1s014ltr.pdf","2017-12-01 00:00:00",
52878,2,22037,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022037s016lbl.pdf","2018-03-08 00:00:00",
53000,1,22037,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022037Orig1s016ltr.pdf","2018-03-15 00:00:00",
16812,2,22038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022038lbl.pdf","2007-06-07 00:00:00",
24236,21,22038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_SUMR.pdf","2009-12-30 00:00:00",
29124,1,22038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022038s000ltr.pdf","2007-06-07 00:00:00",
42397,3,22038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_divigel_toc.cfm","2009-12-30 00:00:00",
6742,1,22038,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022038s002ltr.pdf","2012-05-31 00:00:00",
38122,2,22038,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022038s002lbl.pdf","2012-06-06 00:00:00",
50268,2,22038,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022038s003lbl.pdf","2017-11-02 00:00:00",
55215,1,22038,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022038Orig1s004ltr.pdf","2018-08-20 00:00:00",
55258,2,22038,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022038s004lbl.pdf","2018-08-21 00:00:00",
6743,1,22041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022041s000_LTR.pdf","2007-03-26 00:00:00",
16813,2,22041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf","2006-12-19 00:00:00",
21915,3,22041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022041_cyanokit_toc.cfm","2008-12-12 00:00:00",
29125,1,22041,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s004ltr.pdf","2010-10-19 00:00:00",
38123,2,22041,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s004lbl.pdf","2010-10-19 00:00:00",
16814,2,22041,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf","2009-06-10 00:00:00",
29126,1,22041,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022041s005ltr.pdf","2009-06-16 00:00:00",
16815,2,22041,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf","2010-03-03 00:00:00",
29127,1,22041,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s007ltr.pdf","2010-02-26 00:00:00",
38124,2,22041,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf","2011-04-11 00:00:00",
16816,2,22041,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf","2011-04-11 00:00:00",
6744,1,22042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025ltr.pdf","2007-09-25 00:00:00",
16817,2,22042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf","2007-09-14 00:00:00",
42398,3,22042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022042_evista_toc.cfm","2009-03-12 00:00:00",
43814,8,22042,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf","2009-11-18 00:00:00",
6745,1,22043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022043s000ltr.pdf","2007-05-01 00:00:00",
16818,2,22043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022043lbl.pdf","2007-05-01 00:00:00",
23694,10,22043,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
42399,3,22043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022043_invega_toc.cfm","2009-05-28 00:00:00",
16819,2,22044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022044lbl.pdf","2007-04-06 00:00:00",
21916,3,22044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022044TOC.cfm","2008-07-08 00:00:00",
29128,1,22044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022044s000ltr.pdf","2007-04-09 00:00:00",
44168,10,22044,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm","2013-04-29 00:00:00",
6746,1,22044,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf","2008-01-09 00:00:00",
16820,2,22044,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf","2008-01-08 00:00:00",
6747,1,22044,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, s004ltr.pdf","2008-02-29 00:00:00",
38125,2,22044,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf","2008-02-28 00:00:00",
29129,1,22044,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, 004ltr.pdf","2008-02-29 00:00:00",
38126,2,22044,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf","2008-02-28 00:00:00",
6748,1,22044,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf","2008-01-09 00:00:00",
16821,2,22044,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf","2008-01-08 00:00:00",
29130,1,22044,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf","2008-01-09 00:00:00",
38127,2,22044,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf","2008-01-08 00:00:00",
6749,1,22044,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s007ltr.pdf","2008-05-07 00:00:00",
29131,1,22044,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s009ltr.pdf","2008-10-23 00:00:00",
6750,1,22044,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf","2010-03-04 00:00:00",
16822,2,22044,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf","2010-03-02 00:00:00",
6751,1,22044,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022044s011ltr.pdf","2010-01-14 00:00:00",
38128,2,22044,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022044s011lbl.pdf","2009-12-31 00:00:00",
6752,1,22044,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf","2010-03-04 00:00:00",
16823,2,22044,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf","2010-03-02 00:00:00",
29132,1,22044,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf","2010-03-04 00:00:00",
38129,2,22044,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf","2010-03-02 00:00:00",
29133,1,22044,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf","2010-09-29 00:00:00",
38130,2,22044,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf","2010-09-29 00:00:00",
6753,1,22044,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
6754,1,22044,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016(1)ltr.pdf","2011-05-16 00:00:00",
6755,1,22044,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016ltr.pdf","2011-04-19 00:00:00",
16824,2,22044,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf","2011-04-18 00:00:00",
16825,2,22044,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf","2011-05-16 00:00:00",
6756,1,22044,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf","2010-09-29 00:00:00",
16826,2,22044,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf","2010-09-29 00:00:00",
16827,2,22044,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022lbl.pdf","2012-03-27 00:00:00",
29134,1,22044,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044s022ltr.pdf","2012-03-27 00:00:00",
6757,1,22044,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044Orig1s026ltr.pdf","2012-10-22 00:00:00",
16828,2,22044,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026lbl.pdf","2012-10-22 00:00:00",
29135,1,22044,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Orig1s027ltr.pdf","2013-02-08 00:00:00",
38131,2,22044,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s027lbl.pdf","2013-02-08 00:00:00",
29136,1,22044,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Origs029ltr.pdf","2013-09-24 00:00:00",
38132,2,22044,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s029lbl.pdf","2013-09-17 00:00:00",
29137,1,22044,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf","2015-04-29 00:00:00",
38133,2,22044,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s034lbl.pdf","2015-05-04 00:00:00",
29138,1,22044,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf","2015-09-01 00:00:00",
38134,2,22044,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s035lbl.pdf","2015-09-04 00:00:00",
46922,2,22044,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf","2017-01-18 00:00:00",
46944,1,22044,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022044Orig1s039,s040ltr.pdf","2017-01-24 00:00:00",
46923,2,22044,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s039s040lbl.pdf","2017-01-18 00:00:00",
46943,1,22044,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022044Orig1s039,s040ltr.pdf","2017-01-24 00:00:00",
49350,2,22044,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022044s042lbl.pdf","2017-08-14 00:00:00",
49406,1,22044,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf","2017-08-15 00:00:00",
52555,2,22044,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf","2018-02-12 00:00:00",
52559,8,22044,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf#page=32","2018-02-12 00:00:00",
52634,1,22044,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf","2018-02-14 00:00:00",
6758,1,22045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022045s000ltr.pdf","2007-02-02 00:00:00",
42400,3,22045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022045s000TOC.cfm","2008-02-22 00:00:00",
29139,1,22046,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022046s001ltr.pdf","2006-09-18 00:00:00",
38135,2,22046,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022046s001lbl.pdf","2006-09-01 00:00:00",
16829,2,22046,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf","2012-01-30 00:00:00",
29140,1,22046,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf","2012-02-01 00:00:00",
6759,1,22047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022047Orig1s000ltr.pdf","2011-09-28 00:00:00",
21917,3,22047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022047s000TOC.cfm","2011-09-27 00:00:00",
44169,10,22047,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
29141,1,22047,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s002ltr.pdf","2008-03-17 00:00:00",
38136,2,22047,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s002lbl.pdf","2008-03-17 00:00:00",
6760,1,22047,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf","2008-10-09 00:00:00",
16830,2,22047,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf","2008-11-07 00:00:00",
16831,2,22047,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf","2008-11-07 00:00:00",
29142,1,22047,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf","2008-10-09 00:00:00",
29143,1,22047,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf","2008-10-09 00:00:00",
38137,2,22047,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf","2008-11-07 00:00:00",
6761,1,22047,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s009ltr.pdf","2008-05-28 00:00:00",
21918,3,22047,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022047Orig1s011.pdf","2014-08-01 00:00:00",
29144,1,22047,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf","2009-12-30 00:00:00",
38138,2,22047,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf","2009-12-11 00:00:00",
16832,2,22047,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf","2008-08-29 00:00:00",
29145,1,22047,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s013ltr.pdf","2008-08-13 00:00:00",
6762,1,22047,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf","2009-12-30 00:00:00",
38139,2,22047,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf","2009-12-11 00:00:00",
16833,2,22047,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf","2009-12-11 00:00:00",
29146,1,22047,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf","2009-12-30 00:00:00",
6763,1,22047,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s018ltr.pdf","2008-08-19 00:00:00",
29147,1,22047,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf","2009-12-30 00:00:00",
38140,2,22047,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf","2009-12-11 00:00:00",
16834,2,22047,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf","2009-12-11 00:00:00",
29148,1,22047,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf","2009-12-30 00:00:00",
6764,1,22047,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf","2011-07-12 00:00:00",
38141,2,22047,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf","2011-07-12 00:00:00",
6765,1,22047,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s024ltr.pdf","2011-05-19 00:00:00",
38142,2,22047,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s024lbl.pdf","2011-05-23 00:00:00",
6766,1,22047,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022047s025ltr.pdf","2010-12-07 00:00:00",
38143,2,22047,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022047s025lbl.pdf","2010-12-04 00:00:00",
6767,1,22047,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
16835,2,22047,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf","2013-05-01 00:00:00",
16836,2,22047,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf","2011-07-12 00:00:00",
29149,1,22047,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf","2011-07-12 00:00:00",
6768,1,22047,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s028ltr.pdf","2011-11-14 00:00:00",
6769,1,22047,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
38144,2,22047,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf","2013-05-01 00:00:00",
29150,1,22047,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
38145,2,22047,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf","2013-05-01 00:00:00",
16837,2,22047,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf","2013-05-01 00:00:00",
29151,1,22047,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf","2013-05-02 00:00:00",
16838,2,22047,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf","2013-10-31 00:00:00",
29152,1,22047,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf","2013-10-30 00:00:00",
16839,2,22047,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf","2016-05-25 00:00:00",
6770,1,22047,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf","2016-06-21 00:00:00",
16840,2,22047,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf","2016-06-21 00:00:00",
47306,2,22047,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022047s039lbl.pdf","2017-02-24 00:00:00",
47374,1,22047,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020639Orig1s065,022047Orig1s039ltr.pdf","2017-03-02 00:00:00",
6771,1,22048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022048s000, 022223s000ltr.pdf","2008-01-09 00:00:00",
38146,2,22048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf","2007-12-03 00:00:00",
42401,3,22048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022048s000_022223s000_TOC.cfm","2008-07-08 00:00:00",
53425,20,22048,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022048_Acetonide_Clinical_PREA.pdf","1900-01-01 00:00:00",
53426,18,22048,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022048_Acetonide_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53427,17,22048,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022048_Acetonide_Statistical_PREA.pdf","1900-01-01 00:00:00",
52689,3,22051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022051_veramyst_toc.cfm","2018-02-23 00:00:00",
45883,2,22051,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Orig1s013lbl.pdf","2016-11-10 00:00:00",
47939,2,22051,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014lbl.pdf","2017-04-12 00:00:00",
47956,2,22051,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014ltr.pdf","2017-04-12 00:00:00",
49578,1,22051,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022051Orig1s017ltr.pdf","2017-08-29 00:00:00",
54300,3,22051,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/022051Orig1s017.pdf","2018-05-22 00:00:00",
16847,2,22052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022052lbl.pdf","2007-06-04 00:00:00",
29157,1,22052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022052s000ltr.pdf","2007-06-04 00:00:00",
42402,3,22052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022052_zyflo_toc.cfm","2008-10-03 00:00:00",
6774,1,22052,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005ltr.pdf","2009-11-12 00:00:00",
16848,2,22052,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf","2009-08-28 00:00:00",
6775,1,22052,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022052s009ltr.pdf","2011-12-01 00:00:00",
38147,2,22052,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022052s009lbl.pdf","2011-12-02 00:00:00",
16849,2,22055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf","2007-04-20 00:00:00",
21920,3,22055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022055s000TOC.cfm","2007-05-29 00:00:00",
29158,1,22055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022055s000ltr.pdf","2007-04-20 00:00:00",
53392,20,22055,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22055_retapumulin_clinical_PREA.pdf","1900-01-01 00:00:00",
53393,18,22055,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22055_retapumulin_clinpharm_PREA.pdf","1900-01-01 00:00:00",
29159,1,22055,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022055Orig1s002ltr.pdf","2012-12-27 00:00:00",
38148,2,22055,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf","2012-12-28 00:00:00",
16850,2,22055,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf","2010-10-07 00:00:00",
29160,1,22055,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022055s004ltr.pdf","2010-10-04 00:00:00",
6776,1,22056,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf","2008-12-04 00:00:00",
16851,2,22056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf","2008-03-24 00:00:00",
16852,2,22056,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf","2008-12-04 00:00:00",
23695,10,22056,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
24237,21,22056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf","2010-03-16 00:00:00",
29161,1,22056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022056s000ltr.pdf","2008-03-24 00:00:00",
42403,3,22056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056_prilosec_toc.cfm","2010-03-16 00:00:00",
29162,1,22056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf","2010-03-08 00:00:00",
38149,2,22056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf","2010-03-05 00:00:00",
6777,1,22056,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf","2010-09-08 00:00:00",
16853,2,22056,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf","2010-09-10 00:00:00",
6778,1,22056,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf","2011-07-06 00:00:00",
38150,2,22056,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf","2011-07-06 00:00:00",
6779,1,22056,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf","2011-01-25 00:00:00",
38151,2,22056,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf","2011-01-24 00:00:00",
6780,1,22056,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf","2011-05-25 00:00:00",
38152,2,22056,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf","2011-05-25 00:00:00",
16854,2,22056,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf","2012-02-06 00:00:00",
29163,1,22056,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf","2012-01-24 00:00:00",
16855,2,22056,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf","2012-10-12 00:00:00",
29164,1,22056,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf","2012-10-11 00:00:00",
6781,1,22056,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf","2012-10-02 00:00:00",
16856,2,22056,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf","2012-10-01 00:00:00",
6782,1,22056,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf","2013-05-16 00:00:00",
38153,2,22056,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf","2013-05-21 00:00:00",
16857,2,22056,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf","2014-04-01 00:00:00",
29165,1,22056,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf","2014-04-14 00:00:00",
16858,2,22056,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf","2014-02-27 00:00:00",
29166,1,22056,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf","2014-02-27 00:00:00",
6783,1,22056,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf","2014-12-24 00:00:00",
38154,2,22056,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf","2014-12-29 00:00:00",
6784,1,22056,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022056Orig1s018ltr.pdf","2016-02-04 00:00:00",
38155,2,22056,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf","2016-02-11 00:00:00",
51450,20,22056,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22056 omeprazole clinical prea.pdf","1900-01-01 00:00:00",
51452,18,22056,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22056 omeprazole clinpharm prea.pdf","1900-01-01 00:00:00",
46477,1,22056,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s102,022056Orig1s019ltr.pdf","2016-12-22 00:00:00",
46491,2,22056,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf","2016-12-21 00:00:00",
55460,8,22056,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf#page=34","2018-09-12 00:00:00",
45657,1,22056,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf","2016-10-26 00:00:00",
45715,2,22056,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf","2016-10-31 00:00:00",
55459,8,22056,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34","2018-09-12 00:00:00",
55296,2,22056,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s021lbl.pdf","2018-08-24 00:00:00",
55297,8,22056,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s021lbl.pdf#page=14","2018-08-24 00:00:00",
55318,1,22056,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022056Orig1s021ltr.pdf","2018-08-24 00:00:00",
54523,2,22056,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s022lbl.pdf","2018-06-11 00:00:00",
54583,1,22056,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022056Orig1s022ltr.pdf","2018-06-14 00:00:00",
6785,1,22057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022057s000ltr.pdf","2007-07-05 00:00:00",
6786,1,22057,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022057s001ltr.pdf","2008-02-27 00:00:00",
21921,3,22057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022057_endometrin_toc.cfm","2009-11-19 00:00:00",
38156,2,22057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf","2007-06-27 00:00:00",
38157,2,22057,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf","2008-02-28 00:00:00",
6787,1,22057,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022057s002ltr.pdf","2009-06-08 00:00:00",
6788,1,22058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s000ltr.pdf","2007-05-09 00:00:00",
21922,3,22058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058_supprelin_la_toc.cfm","2008-12-02 00:00:00",
24238,21,22058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022058s000_SumR.pdf","2008-12-02 00:00:00",
29167,1,22058,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022058s001ltr.pdf","2007-11-26 00:00:00",
38158,2,22058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022058lbl.pdf","2007-05-07 00:00:00",
29168,1,22058,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022058s003ltr.pdf","2008-07-08 00:00:00",
38159,2,22058,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022058s003lbl.pdf","2008-07-09 00:00:00",
16859,2,22058,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022058s006lbl.pdf","2011-11-18 00:00:00",
29169,1,22058,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022058s006ltr.pdf","2011-11-02 00:00:00",
38160,2,22058,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s008lbl.pdf","2016-07-13 00:00:00",
6789,1,22058,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022058s009ltr.pdf","2012-04-06 00:00:00",
16860,2,22058,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022058s009lbl.pdf","2012-04-06 00:00:00",
6790,1,22058,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022058Orig1s011ltr.pdf","2013-04-03 00:00:00",
38161,2,22058,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf","2013-04-09 00:00:00",
48471,2,22058,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf","2017-05-19 00:00:00",
48473,8,22058,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf#page=19","2017-05-22 00:00:00",
48492,1,22058,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022058Orig1s014s015ltr.pdf","2017-05-23 00:00:00",
48472,2,22058,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf","2017-05-22 00:00:00",
48474,8,22058,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf#page=19","2017-05-22 00:00:00",
48493,1,22058,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022058Orig1s014s015ltr.pdf","2017-05-23 00:00:00",
6791,1,22059,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s001ltr.pdf","2007-05-01 00:00:00",
16861,2,22059,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf","2007-05-01 00:00:00",
29170,1,22059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s000ltr.pdf","2007-03-15 00:00:00",
38162,2,22059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf","2007-03-13 00:00:00",
42404,3,22059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022059s000TOC.cfm","2007-05-09 00:00:00",
29171,1,22059,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s002ltr.pdf","2007-08-22 00:00:00",
38163,2,22059,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf","2007-08-21 00:00:00",
6792,1,22059,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf","2010-03-09 00:00:00",
16862,2,22059,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf","2010-02-01 00:00:00",
16863,2,22059,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf","2008-07-09 00:00:00",
29172,1,22059,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022059s004ltr.pdf","2008-07-10 00:00:00",
6793,1,22059,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf","2010-03-09 00:00:00",
38164,2,22059,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf","2010-02-01 00:00:00",
6794,1,22059,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s007ltr.pdf","2010-02-05 00:00:00",
16864,2,22059,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf","2010-02-01 00:00:00",
16865,2,22059,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf","2011-08-12 00:00:00",
29173,1,22059,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf","2011-08-15 00:00:00",
29174,1,22059,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf","2011-08-15 00:00:00",
38165,2,22059,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf","2011-08-12 00:00:00",
29175,1,22059,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022059Orig1s013ltr.pdf","2012-02-21 00:00:00",
38166,2,22059,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf","2012-02-17 00:00:00",
16866,2,22059,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf","2013-06-25 00:00:00",
29176,1,22059,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf","2013-06-24 00:00:00",
29177,1,22059,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf","2013-10-22 00:00:00",
38167,2,22059,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf","2013-10-22 00:00:00",
29178,1,22059,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf","2013-10-22 00:00:00",
38168,2,22059,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf","2013-10-22 00:00:00",
16867,2,22059,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf","2013-06-25 00:00:00",
29179,1,22059,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf","2013-06-24 00:00:00",
29180,1,22059,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022059Orig1s020ltr.pdf","2015-04-02 00:00:00",
38169,2,22059,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf","2015-04-01 00:00:00",
16868,2,22059,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf","2015-01-05 00:00:00",
29181,1,22059,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022059Orig1s021ltr.pdf","2014-12-30 00:00:00",
47890,2,22059,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022059s022lbl.pdf","2017-04-05 00:00:00",
47973,1,22059,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022059Orig1s022ltr.pdf","2017-04-12 00:00:00",
6795,1,22061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022061s000ltr.pdf","2008-10-27 00:00:00",
48788,2,22063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf","2017-06-21 00:00:00",
48789,8,22063,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf#page=22","2017-06-21 00:00:00",
48795,1,22063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022063Orig1s000ltr.pdf","2017-06-22 00:00:00",
51377,20,22063,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/149_22063 mixed salts clinical prea.pdf","1900-01-01 00:00:00",
51378,18,22063,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/150_22063 mixed salts clinpharm prea.pdf","1900-01-01 00:00:00",
51379,17,22063,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/151_22063 mixed salts statistical prea.pdf","1900-01-01 00:00:00",
54466,3,22063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022063Orig1s000TOC.cfm","2018-06-06 00:00:00",
6796,1,22064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022064s000ltr.pdf","2008-04-09 00:00:00",
16869,2,22064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf","2008-04-09 00:00:00",
42405,3,22064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064_xyzal_toc.cfm","2008-10-15 00:00:00",
44671,21,22064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064s000_SumR.pdf","2008-10-15 00:00:00",
52313,23,22064,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022064_22157_levocetirizine_Original_WR.pdf","2009-08-25 00:00:00",
53310,20,22064,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022064_Levocetirizine_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53311,18,22064,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022064_Levocetirizine_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
6797,1,22064,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s005ltr.pdf","2008-02-05 00:00:00",
16870,2,22064,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf","2008-02-14 00:00:00",
16871,2,22064,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf","2008-04-01 00:00:00",
29182,1,22064,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s009ltr.pdf","2008-04-02 00:00:00",
6798,1,22064,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf","2009-11-10 00:00:00",
38170,2,22064,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf","2009-10-06 00:00:00",
6799,1,22064,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf","2011-03-10 00:00:00",
16872,2,22064,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf","2011-03-07 00:00:00",
6800,1,22064,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf","2012-09-07 00:00:00",
38171,2,22064,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf","2012-09-11 00:00:00",
6801,1,22064,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf","2013-11-08 00:00:00",
38172,2,22064,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf","2013-11-08 00:00:00",
29183,1,22064,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf","2016-06-24 00:00:00",
38173,2,22064,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf","2016-06-27 00:00:00",
47166,2,22064,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf","2017-02-10 00:00:00",
47234,1,22064,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s031,022157Orig1s014ltr.pdf","2017-02-16 00:00:00",
45856,2,22064,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf","2016-11-09 00:00:00",
45859,1,22064,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s032,022157Orig1s015ltr.pdf","2016-11-09 00:00:00",
48963,2,22064,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf","2017-07-13 00:00:00",
48970,1,22064,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s033,022157Orig1s016ltr.pdf","2017-07-13 00:00:00",
50065,2,22064,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s034lbl.pdf","2017-10-17 00:00:00",
50116,1,22064,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s034ltr.pdf","2017-10-19 00:00:00",
53595,2,22064,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022064s036lbl.pdf","2018-04-03 00:00:00",
53596,1,22064,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022064s036ltr.pdf","2018-04-03 00:00:00",
6802,1,22065,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s001ltr.pdf","2009-03-17 00:00:00",
16873,2,22065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf","2007-10-17 00:00:00",
29184,1,22065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022065s000ltr.pdf","2007-10-22 00:00:00",
38174,2,22065,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf","2009-04-03 00:00:00",
42406,3,22065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022065TOC.cfm","2008-03-24 00:00:00",
16874,2,22065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf","2009-10-07 00:00:00",
29185,1,22065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf","2009-10-13 00:00:00",
6803,1,22065,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf","2009-10-13 00:00:00",
16875,2,22065,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf","2009-10-07 00:00:00",
29186,1,22065,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf","2010-05-17 00:00:00",
38175,2,22065,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf","2010-05-17 00:00:00",
6804,1,22065,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf","2010-05-17 00:00:00",
38176,2,22065,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf","2010-05-17 00:00:00",
6805,1,22065,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022065s006ltr.pdf","2011-10-20 00:00:00",
38177,2,22065,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf","2011-10-20 00:00:00",
51941,23,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Original_WR.pdf","2011-04-05 00:00:00",
51942,25,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Amendment_1.pdf","2011-04-05 00:00:00",
51943,26,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Amendment_2.pdf","2011-04-05 00:00:00",
52937,17,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_statistical_BPCA.pdf","2011-04-05 00:00:00",
52938,18,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_clinpharm_BPCA.pdf","2011-04-05 00:00:00",
52939,20,22065,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_clinical_BPCA.pdf","2011-04-05 00:00:00",
6806,1,22066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022066s000_ltr.pdf","2007-09-07 00:00:00",
16876,2,22066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf","2007-09-07 00:00:00",
21923,3,22066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000TOC.cfm","2008-10-03 00:00:00",
23696,10,22066,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2007-09-24 00:00:00",
44672,21,22066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000_SumR.pdf","2008-10-03 00:00:00",
16877,2,22066,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf","2010-12-20 00:00:00",
29187,1,22066,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf","2010-12-22 00:00:00",
6807,1,22066,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039,%20022066Orig1s004ltr.pdf","2013-08-29 00:00:00",
16878,2,22066,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf","2013-08-28 00:00:00",
6808,1,22066,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf","2012-12-13 00:00:00",
6809,1,22066,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf","2014-11-18 00:00:00",
16879,2,22066,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf","2014-11-20 00:00:00",
53858,2,22066,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf","2018-04-27 00:00:00",
53859,8,22066,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1","2018-04-27 00:00:00",
53893,1,22066,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s046,022066Orig1s008Ltr.pdf","2018-05-01 00:00:00",
6810,1,22067,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s001ltr.pdf","2008-07-01 00:00:00",
16880,2,22067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067lbl.pdf","2008-01-18 00:00:00",
16881,2,22067,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s001lbl.pdf","2008-06-30 00:00:00",
29188,1,22067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s000ltr.pdf","2008-01-23 00:00:00",
42407,3,22067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067_flo-pred_toc.cfm","2010-02-24 00:00:00",
44673,21,22067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022067s000sumr.pdf","2010-02-24 00:00:00",
6811,1,22067,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022067s002ltr.pdf","2008-10-08 00:00:00",
38178,2,22067,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022067s002lbl.pdf","2008-10-09 00:00:00",
6812,1,22067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022067s004ltr.pdf","2010-05-12 00:00:00",
16882,2,22067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022067s004lbl.pdf","2010-05-17 00:00:00",
6813,1,22067,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022067s007ltr.pdf","2011-06-17 00:00:00",
16883,2,22067,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022067s007lbl.pdf","2011-06-16 00:00:00",
6814,1,22068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022068s000ltr.pdf","2007-11-08 00:00:00",
6815,1,22068,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s001ltr.pdf","2010-03-18 00:00:00",
16884,2,22068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf","2007-10-29 00:00:00",
16885,2,22068,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf","2010-03-17 00:00:00",
21924,3,22068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068TOC.cfm","2008-03-14 00:00:00",
44674,21,22068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068s000_SumR.pdf","2008-07-22 00:00:00",
6816,1,22068,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022068s002ltr.pdf","2010-01-21 00:00:00",
16886,2,22068,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022068s002lbl.pdf","2009-09-16 00:00:00",
29189,1,22068,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf","2010-06-22 00:00:00",
38179,2,22068,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf","2010-06-17 00:00:00",
6817,1,22068,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf","2010-06-22 00:00:00",
16887,2,22068,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf","2010-06-17 00:00:00",
29190,1,22068,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s006ltr.pdf","2011-01-20 00:00:00",
38180,2,22068,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s006lbl.pdf","2011-01-14 00:00:00",
16888,2,22068,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s007lbl.pdf","2011-11-01 00:00:00",
29191,1,22068,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068Orig1s007ltr.pdf","2011-11-01 00:00:00",
16889,2,22068,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf","2011-11-25 00:00:00",
29192,1,22068,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf","2011-11-22 00:00:00",
29193,1,22068,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf","2011-11-22 00:00:00",
38181,2,22068,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf","2011-11-25 00:00:00",
6818,1,22068,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068Orig1s011ltr.pdf","2012-12-26 00:00:00",
16890,2,22068,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011lbledt2.pdf","2012-12-21 00:00:00",
29194,1,22068,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068s012ltr.pdf","2012-05-03 00:00:00",
38182,2,22068,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s012lbl.pdf","2012-05-02 00:00:00",
29195,1,22068,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s013ltr.pdf","2013-05-22 00:00:00",
29196,1,22068,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s014ltr_corrected.pdf","2013-06-13 00:00:00",
38183,2,22068,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s014lbledt.pdf","2013-06-18 00:00:00",
29197,1,22068,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s016ltr.pdf","2013-05-28 00:00:00",
16891,2,22068,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s017lbl.pdf","2014-01-23 00:00:00",
29198,1,22068,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s017ltr.pdf","2014-01-23 00:00:00",
29199,1,22068,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s018ltr.pdf","2013-10-01 00:00:00",
38184,2,22068,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s018lbl.pdf","2013-10-01 00:00:00",
29200,1,22068,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s019ltr.pdf","2014-09-29 00:00:00",
38185,2,22068,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s019lbl.pdf","2014-09-30 00:00:00",
6819,1,22068,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s020ltr.pdf","2015-01-28 00:00:00",
38186,2,22068,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s020lbl.pdf","2015-01-30 00:00:00",
6820,1,22068,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s021ltr.pdf","2015-10-16 00:00:00",
38187,2,22068,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s021lbl.pdf","2015-10-22 00:00:00",
45423,2,22068,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022068s023lbl.pdf","2016-09-30 00:00:00",
45424,1,22068,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022068Orig1s023ltr.pdf","2016-09-28 00:00:00",
47297,1,22068,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022068Orig1s024ltr.pdf","2017-02-23 00:00:00",
47334,2,22068,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s024lbl.pdf","2017-02-27 00:00:00",
50847,2,22068,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s026lbl.pdf","2017-12-22 00:00:00",
50965,1,22068,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022068Orig1s026ltr.pdf","2017-12-29 00:00:00",
53086,2,22068,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s027lbl.pdf","2018-03-22 00:00:00",
53144,1,22068,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022068Orig1s027ltr.pdf","2018-03-21 00:00:00",
55268,2,22068,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s029lbl.pdf","2018-08-22 00:00:00",
55269,8,22068,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s029lbl.pdf#page=35","2018-08-22 00:00:00",
55317,1,22068,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022068Orig1s029ltr.pdf","2018-08-24 00:00:00",
6821,1,22070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022070s000_ltr.pdf","2007-07-30 00:00:00",
21925,3,22070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022070_atralin_toc.cfm","2009-03-05 00:00:00",
38188,2,22070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022070lbl.pdf","2007-07-30 00:00:00",
16892,2,22070,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf","2014-09-03 00:00:00",
29201,1,22070,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022070Orig1s003ltr.pdf","2014-09-03 00:00:00",
6822,1,22071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022071s000ltr.pdf","2007-10-04 00:00:00",
21926,3,22071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022071_lamisil_toc.cfm","2009-03-12 00:00:00",
38189,2,22071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022071lbl.pdf","2007-10-04 00:00:00",
53412,20,22071,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022071_Terbinafine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53413,18,22071,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022071_Terbinafine_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53414,17,22071,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022071_Terbinafine_Statistical_PREA.pdf","1900-01-01 00:00:00",
6823,1,22071,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022071s003ltr.pdf","2010-12-07 00:00:00",
38190,2,22071,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022071s003lbl.pdf","2010-12-04 00:00:00",
6824,1,22071,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s004ltr.pdf","2011-03-31 00:00:00",
16893,2,22071,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022071s004lbl.pdf","2011-04-01 00:00:00",
6825,1,22071,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s006ltr.pdf","2011-11-08 00:00:00",
6826,1,22071,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022071s007ltr.pdf","2012-04-25 00:00:00",
16894,2,22071,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022071s007lbl.pdf","2012-04-23 00:00:00",
29202,1,22071,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s009ltr.pdf","2013-06-18 00:00:00",
38191,2,22071,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s009lbl.pdf","2013-06-17 00:00:00",
6827,1,22071,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s010ltr.pdf","2013-10-25 00:00:00",
38192,2,22071,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s010lbl.pdf","2013-10-25 00:00:00",
45230,1,22071,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022071Orig1s011ltr.pdf","2016-08-23 00:00:00",
45512,8,22071,"SUPPL",11,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524717.pdf","2016-10-12 00:00:00",
46947,2,22071,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf","2017-01-24 00:00:00",
46957,1,22071,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020539Orig1s029,022071Orig1s013ltr.pdf","2017-01-24 00:00:00",
6828,1,22072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022072s000ltr.pdf","2006-07-03 00:00:00",
16895,2,22072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022072lbl.pdf","2006-07-03 00:00:00",
29203,1,22072,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf","2008-06-03 00:00:00",
42408,3,22072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.cfm","2006-09-06 00:00:00",
29204,1,22072,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf","2010-08-09 00:00:00",
16896,2,22074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf","2007-09-04 00:00:00",
29205,1,22074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022074s000ltr.pdf","2007-09-04 00:00:00",
42409,3,22074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022074s000TOC.cfm","2007-11-06 00:00:00",
16897,2,22074,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf","2011-03-07 00:00:00",
29206,1,22074,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022074s003ltr.pdf","2011-03-08 00:00:00",
16898,2,22074,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf","2014-10-29 00:00:00",
53719,3,22074,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022074Orig1s004.pdf","2018-04-18 00:00:00",
16899,2,22074,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf","2013-12-03 00:00:00",
29207,1,22074,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022074Orig1s006ltr.pdf","2013-12-05 00:00:00",
53728,3,22074,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/22074Orig1s009.pdf","2018-04-18 00:00:00",
6829,1,22074,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s010ltr.pdf","2014-12-24 00:00:00",
16900,2,22074,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf","2015-01-09 00:00:00",
6830,1,22074,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s011ltr.pdf","2014-12-17 00:00:00",
16901,2,22074,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf","2014-12-16 00:00:00",
49775,2,22074,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf","2017-09-19 00:00:00",
49779,1,22074,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022074Orig1s017ltr.pdf","2017-09-19 00:00:00",
52695,2,22074,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf","2018-02-23 00:00:00",
52723,1,22074,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022074Orig1s018ltr.pdf","2018-02-26 00:00:00",
50937,2,22074,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s020lbl.pdf","2017-12-28 00:00:00",
6831,1,22076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022076s000ltr.pdf","2007-05-29 00:00:00",
16902,2,22076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022076lbl.pdf","2007-05-29 00:00:00",
21927,3,22076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022076_locoid_toc.cfm","2009-12-17 00:00:00",
6832,1,22076,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022076Orig1s005ltr.pdf","2014-10-31 00:00:00",
38193,2,22076,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022076s005lbl.pdf","2014-11-04 00:00:00",
6838,1,22080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022080s000ltr.pdf","2007-08-22 00:00:00",
16909,2,22080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022080lbl.pdf","2007-08-21 00:00:00",
21931,3,22080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022080_reclast_toc.cfm","2008-10-03 00:00:00",
44675,21,22080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022080s000_SumR.pdf","2008-10-03 00:00:00",
6839,1,22081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s000LTR.pdf","2007-07-05 00:00:00",
6840,1,22081,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s001ltr.pdf","2007-12-03 00:00:00",
21932,3,22081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022081s000TOC.cfm","2007-08-21 00:00:00",
23353,8,22081,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf","2009-09-02 00:00:00",
24016,14,22081,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=28","2010-09-01 00:00:00",
38197,2,22081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf","2007-06-27 00:00:00",
16910,2,22081,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf","2008-02-25 00:00:00",
29213,1,22081,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s002ltr.pdf","2008-02-19 00:00:00",
29214,1,22081,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s004ltr.pdf","2008-10-14 00:00:00",
38198,2,22081,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf","2008-11-07 00:00:00",
29215,1,22081,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s008ltr.pdf","2009-06-10 00:00:00",
38199,2,22081,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf","2009-06-10 00:00:00",
16911,2,22081,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf","2009-08-13 00:00:00",
29216,1,22081,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s010ltr.pdf","2009-11-24 00:00:00",
16912,2,22081,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf","2009-07-09 00:00:00",
29217,1,22081,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s011ltr.pdf","2009-07-08 00:00:00",
29218,1,22081,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s012ltr.pdf","2010-10-20 00:00:00",
38200,2,22081,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf","2010-10-25 00:00:00",
6841,1,22081,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081s014ltr.pdf","2012-02-17 00:00:00",
16913,2,22081,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf","2012-02-17 00:00:00",
6842,1,22081,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s016ltr.pdf","2010-08-26 00:00:00",
6843,1,22081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s017ltr.pdf","2011-03-08 00:00:00",
21933,3,22081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022081Orig1s017.pdf","2014-08-01 00:00:00",
38201,2,22081,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf","2011-03-07 00:00:00",
6844,1,22081,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s018ltr.pdf","2011-07-21 00:00:00",
38202,2,22081,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf","2011-07-20 00:00:00",
6845,1,22081,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022081Orig1s019ltr.pdf","2013-08-22 00:00:00",
38203,2,22081,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf","2013-08-21 00:00:00",
29219,1,22081,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081Orig1s022ltr.pdf","2012-10-23 00:00:00",
38204,2,22081,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf","2012-10-22 00:00:00",
29220,1,22081,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s029ltr.pdf","2014-05-06 00:00:00",
38205,2,22081,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf","2014-05-06 00:00:00",
6846,1,22081,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s030ltr.pdf","2014-02-04 00:00:00",
16914,2,22081,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf","2014-02-03 00:00:00",
6847,1,22081,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s032ltr.pdf","2014-10-30 00:00:00",
6848,1,22081,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022081Orig1s033ltr.pdf","2015-10-06 00:00:00",
16915,2,22081,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf","2015-10-08 00:00:00",
46218,1,22081,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022081Orig1s036ltr.pdf","2016-12-19 00:00:00",
49073,1,22081,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022081Orig1s037ltr.pdf","2017-07-25 00:00:00",
49890,1,22081,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022081Orig1s038ltr.pdf","2017-09-29 00:00:00",
16916,2,22083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022083lbl.pdf","2007-07-09 00:00:00",
42410,3,22083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083_exelon_toc.cfm","2009-05-28 00:00:00",
6849,1,22083,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022083s008ltr.pdf","2010-08-31 00:00:00",
16917,2,22083,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022083s008lbl.pdf","2010-09-07 00:00:00",
6850,1,22083,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022083Orig1s016ltr.pdf","2012-09-05 00:00:00",
16918,2,22083,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022083s016lbl.pdf","2012-09-06 00:00:00",
45790,3,22083,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083Orig1s016.pdf","2016-11-02 00:00:00",
6851,1,22083,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022083Orig1s019ltr.pdf","2013-07-01 00:00:00",
38206,2,22083,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022083s019lbl.pdf","2013-07-11 00:00:00",
16919,2,22083,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022083s020lbl.pdf","2015-02-05 00:00:00",
29221,1,22083,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022083Orig1s020ltr.pdf","2015-02-05 00:00:00",
45801,1,22083,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020823s035,021025s023,022083s023ltr.pdf","2016-11-03 00:00:00",
45806,2,22083,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022083s023lbl.pdf","2016-11-04 00:00:00",
6852,1,22085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022085TAltr.pdf","2010-03-22 00:00:00",
6853,1,22087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022087s000ltr.pdf","2009-01-30 00:00:00",
21934,3,22087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022087_vectical_toc.cfm","2009-08-03 00:00:00",
38207,2,22087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022087lbl.pdf","2009-02-04 00:00:00",
44676,21,22087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022087s000_SumR.pdf","2009-08-03 00:00:00",
6854,1,22088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s000ltr.pdf","2007-06-04 00:00:00",
6855,1,22088,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s001ltr.pdf","2007-11-19 00:00:00",
16920,2,22088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088lbl.pdf","2007-06-04 00:00:00",
16921,2,22088,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088s001lbl.pdf","2007-11-19 00:00:00",
42411,3,22088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022088s000TOC.cfm","2007-07-30 00:00:00",
53410,20,22088,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022088_temsirolimus_clinical_bpca.pdf","1900-01-01 00:00:00",
53411,18,22088,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022088_temsirolimus_clinpharm_bpca.pdf","1900-01-01 00:00:00",
29222,1,22088,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38208,2,22088,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
6856,1,22088,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38209,2,22088,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
29223,1,22088,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38210,2,22088,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
6857,1,22088,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s006ltr.pdf","2010-04-29 00:00:00",
16922,2,22088,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s006lbl.pdf","2010-04-28 00:00:00",
6858,1,22088,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38211,2,22088,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
6859,1,22088,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s008ltr.pdf","2010-07-14 00:00:00",
16923,2,22088,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s008lbl.pdf","2010-07-12 00:00:00",
29224,1,22088,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38212,2,22088,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
6860,1,22088,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf","2011-06-27 00:00:00",
38213,2,22088,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf","2011-06-16 00:00:00",
6861,1,22088,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022088s014ltr.pdf","2012-06-04 00:00:00",
38214,2,22088,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf","2012-06-06 00:00:00",
52357,23,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55830_temsirolimus_Original_WR.pdf","2012-02-28 00:00:00",
52358,25,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55830_temsirolimus_Amendment_1.pdf","2012-02-28 00:00:00",
52359,26,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55830_temsirolimus_Amendment_2.pdf","2012-02-28 00:00:00",
52360,27,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22088_temsirolimus_Amendment_3.pdf","2012-02-28 00:00:00",
52361,28,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22088_temsirolimus_Amendment_4.pdf","2012-02-28 00:00:00",
52362,29,22088,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22088_temsirolimus_Amendment_5.pdf","2012-02-28 00:00:00",
29225,1,22088,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s016ltr.pdf","2014-04-08 00:00:00",
38215,2,22088,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s016lbl.pdf","2014-04-08 00:00:00",
16924,2,22088,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s017lbl.pdf","2014-10-09 00:00:00",
29226,1,22088,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s017ltr.pdf","2014-10-09 00:00:00",
16925,2,22088,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf","2015-03-02 00:00:00",
29227,1,22088,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022088Orig1s018ltr.pdf","2015-02-27 00:00:00",
16926,2,22088,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022088s019lbl.pdf","2016-07-28 00:00:00",
29228,1,22088,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022088Orig1s019ltr.pdf","2016-07-28 00:00:00",
48512,1,22088,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022088Orig1s020ltr.pdf","2017-05-24 00:00:00",
48515,2,22088,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022088s020lbl.pdf","2017-05-24 00:00:00",
53465,2,22088,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf","2018-03-27 00:00:00",
53504,1,22088,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022088Orig1s021s023ltr.pdf","2018-03-29 00:00:00",
53466,2,22088,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf","2018-03-27 00:00:00",
53505,1,22088,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022088Orig1s021s023ltr.pdf","2018-03-29 00:00:00",
6862,1,22090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022090s000ltr.pdf","2008-07-15 00:00:00",
23697,10,22090,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm","2011-12-21 00:00:00",
24240,21,22090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000_SumR.pdf","2008-08-19 00:00:00",
38216,2,22090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022090lbl.pdf","2008-07-09 00:00:00",
42412,3,22090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000TOC.cfm","2008-08-19 00:00:00",
51147,20,22090,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022090 gadoxetate clinical prea.pdf","1900-01-01 00:00:00",
51148,18,22090,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022090 gadoxetate clinpharm prea.pdf","1900-01-01 00:00:00",
29229,1,22090,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf","2009-11-19 00:00:00",
6863,1,22090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022090s004ltr.pdf","2010-12-22 00:00:00",
38217,2,22090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022090s004lbl.pdf","2010-12-20 00:00:00",
6864,1,22090,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022090s005ltr.pdf","2011-11-21 00:00:00",
38218,2,22090,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022090s005lbl.pdf","2011-11-21 00:00:00",
6865,1,22090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022090Orig1s008ltr.pdf","2013-10-18 00:00:00",
38219,2,22090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022090s008lbl.pdf","2013-10-18 00:00:00",
6866,1,22090,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022090Orig1s011ltr.pdf","2015-04-01 00:00:00",
38220,2,22090,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022090s011lbl.pdf","2015-04-01 00:00:00",
53856,2,22090,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s014lbl.pdf","2018-04-27 00:00:00",
53907,1,22090,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s014ltredt.pdf","2018-05-01 00:00:00",
55021,2,22090,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf","2018-07-27 00:00:00",
55024,8,22090,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51","2018-07-27 00:00:00",
55037,1,22090,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s015,201277Orig1s015Ltr.pdf","2018-07-30 00:00:00",
6867,1,22096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022096s000ltr.pdf","2010-03-11 00:00:00",
6868,1,22100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022100s000ltr.pdf","2007-10-04 00:00:00",
21935,3,22100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100_azor_toc.cfm","2009-12-17 00:00:00",
38221,2,22100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf","2007-10-04 00:00:00",
29230,1,22100,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022100s002ltr.pdf","2009-05-14 00:00:00",
38222,2,22100,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf","2009-05-13 00:00:00",
29231,1,22100,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022100s003ltr.pdf","2008-08-12 00:00:00",
6869,1,22100,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf","2011-05-24 00:00:00",
38223,2,22100,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf","2011-05-23 00:00:00",
6870,1,22100,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf","2011-05-24 00:00:00",
16927,2,22100,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf","2011-05-23 00:00:00",
29232,1,22100,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s013ltr.pdf","2011-11-16 00:00:00",
38224,2,22100,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf","2011-11-14 00:00:00",
29233,1,22100,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s014ltr.pdf","2011-11-03 00:00:00",
38225,2,22100,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf","2011-10-31 00:00:00",
29234,1,22100,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100s016ltr.pdf","2012-01-20 00:00:00",
38226,2,22100,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf","2012-01-23 00:00:00",
16928,2,22100,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf","2012-10-02 00:00:00",
29235,1,22100,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s019ltr.pdf","2012-10-03 00:00:00",
6871,1,22100,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s020ltr_r.pdf","2012-12-11 00:00:00",
38227,2,22100,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf","2012-12-13 00:00:00",
6872,1,22100,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022100Orig1s022ltr.pdf","2013-07-05 00:00:00",
38228,2,22100,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022100s022lbl.pdf","2013-07-05 00:00:00",
6873,1,22100,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s024ltr.pdf","2014-06-18 00:00:00",
38229,2,22100,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf","2014-06-17 00:00:00",
6874,1,22100,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s025ltr.pdf","2014-07-03 00:00:00",
38230,2,22100,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf","2014-07-03 00:00:00",
6875,1,22100,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s026ltr.pdf","2014-09-24 00:00:00",
16929,2,22100,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf","2014-09-26 00:00:00",
46132,1,22100,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s030ltr.pdf","2016-12-13 00:00:00",
45775,2,22100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022100s032lbl.pdf","2016-11-01 00:00:00",
45779,1,22100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022100Orig1s032ltr.pdf","2016-11-02 00:00:00",
46723,2,22100,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022100s033lbl.pdf","2017-01-06 00:00:00",
46836,1,22100,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022100Orig1s033ltr.pdf","2017-01-13 00:00:00",
6876,1,22101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022101s000ltr.pdf","2008-02-29 00:00:00",
16930,2,22101,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf","2009-01-16 00:00:00",
23698,10,22101,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
29236,1,22101,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf","2009-01-21 00:00:00",
38231,2,22101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022101lbl.pdf","2008-02-28 00:00:00",
42413,3,22101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101_nexium_toc.cfm","2010-03-17 00:00:00",
44677,21,22101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101s000sumr.pdf","2010-03-17 00:00:00",
53261,20,22101,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022101s000_Esmoprazole_Clinical_PREA.pdf","1900-01-01 00:00:00",
53262,18,22101,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022101s000_Esmoprazole_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53263,17,22101,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022101s000_Esomeprazole_Statistic_PREA.pdf","1900-01-01 00:00:00",
29237,1,22101,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf","2009-11-25 00:00:00",
38232,2,22101,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf","2009-10-14 00:00:00",
29238,1,22101,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf","2010-03-08 00:00:00",
38233,2,22101,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf","2010-03-05 00:00:00",
6877,1,22101,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf","2011-06-27 00:00:00",
38234,2,22101,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf","2011-06-29 00:00:00",
6878,1,22101,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf","2010-09-09 00:00:00",
38235,2,22101,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf","2010-09-10 00:00:00",
29239,1,22101,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf","2011-07-06 00:00:00",
38236,2,22101,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf","2011-07-06 00:00:00",
6879,1,22101,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf","2012-01-24 00:00:00",
38237,2,22101,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf","2012-01-24 00:00:00",
6880,1,22101,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf","2012-10-11 00:00:00",
16931,2,22101,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf","2012-10-12 00:00:00",
29240,1,22101,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf","2012-10-02 00:00:00",
38238,2,22101,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf","2012-10-01 00:00:00",
29241,1,22101,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf","2012-11-29 00:00:00",
38239,2,22101,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf","2012-12-10 00:00:00",
6881,1,22101,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf","2014-03-28 00:00:00",
16932,2,22101,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf","2014-04-01 00:00:00",
16933,2,22101,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf","2014-02-27 00:00:00",
29242,1,22101,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf","2014-02-27 00:00:00",
29243,1,22101,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf","2014-12-24 00:00:00",
38240,2,22101,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf","2014-12-29 00:00:00",
46481,1,22101,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021957Orig1s018,021153Orig1s051,022101Orig1s015ltr.pdf","2016-12-22 00:00:00",
46485,2,22101,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf","2016-12-21 00:00:00",
45661,1,22101,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf","2016-10-26 00:00:00",
45694,2,22101,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf","2016-10-28 00:00:00",
54499,2,22101,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf","2018-06-11 00:00:00",
54502,8,22101,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33","2018-06-11 00:00:00",
54567,1,22101,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021153Orig1s053,022101Orig1s017,021957Orig1s020ltr.pdf","2018-06-14 00:00:00",
16934,2,22102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf","2007-08-01 00:00:00",
42414,3,22102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102_calomist_toc.cfm","2009-04-14 00:00:00",
44678,21,22102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102s000_SumR.pdf","2009-04-14 00:00:00",
16935,2,22102,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf","2009-03-25 00:00:00",
29244,1,22102,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022102s003ltr.pdf","2009-03-27 00:00:00",
6882,1,22103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022103s000tr.pdf","2007-08-07 00:00:00",
21936,3,22103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022103s000TOC.cfm","2008-07-11 00:00:00",
38241,2,22103,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022103s002lbl.pdf","2009-06-04 00:00:00",
6883,1,22103,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022103s003ltr.pdf","2011-09-16 00:00:00",
38242,2,22103,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s003lbl.pdf","2011-09-16 00:00:00",
6884,1,22103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022103s004ltr.pdf","2011-02-04 00:00:00",
38243,2,22103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s004lbl.pdf","2011-01-31 00:00:00",
29245,1,22103,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022103Orig1s005ltr.pdf","2012-08-20 00:00:00",
38244,2,22103,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022103s005lbl.pdf","2012-08-20 00:00:00",
6885,1,22104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022104s000ltr.pdf","2008-05-21 00:00:00",
21937,3,22104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104_venlafaxine_hydrochloride_toc.cfm","2009-07-29 00:00:00",
44171,10,22104,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm","2008-05-30 00:00:00",
44679,21,22104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104s000_SumR.pdf","2008-07-17 00:00:00",
16936,2,22104,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf","2009-04-03 00:00:00",
29246,1,22104,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s002ltr.pdf","2009-03-05 00:00:00",
6886,1,22104,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s003ltr.pdf","2009-02-03 00:00:00",
16937,2,22104,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s003lbl.pdf","2009-02-04 00:00:00",
6887,1,22104,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s007ltr.pdf","2012-08-02 00:00:00",
16938,2,22104,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s008lbl.pdf","2012-05-07 00:00:00",
29247,1,22104,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104s008ltr.pdf","2012-05-04 00:00:00",
16939,2,22104,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s009lbl.pdf","2012-12-13 00:00:00",
29248,1,22104,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s009ltr.pdf","2012-12-13 00:00:00",
29249,1,22104,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022104Orig1s010ltr.pdf","2014-07-23 00:00:00",
38245,2,22104,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022104s010lbl.pdf","2014-07-30 00:00:00",
46713,2,22104,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s015lbl.pdf","2017-01-06 00:00:00",
46761,1,22104,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022104Orig1s015ltr.pdf","2017-01-10 00:00:00",
50802,2,22104,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s016lbl.pdf","2017-12-21 00:00:00",
50803,8,22104,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s016lbl.pdf#page=35","2017-12-21 00:00:00",
50898,1,22104,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s005,022104Orig1s016ltr.pdf","2017-12-27 00:00:00",
6888,1,22106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022106s000ltr.pdf","2007-10-22 00:00:00",
16940,2,22106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022106lbl.pdf","2007-10-15 00:00:00",
24241,21,22106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106s000_SumR.pdf","2008-07-22 00:00:00",
42415,3,22106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106TOC.cfm","2008-03-14 00:00:00",
29250,1,22106,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf","2009-04-21 00:00:00",
38246,2,22106,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf","2009-04-23 00:00:00",
38247,2,22106,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s003lbl.pdf","2009-02-12 00:00:00",
6889,1,22106,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf","2009-04-21 00:00:00",
16941,2,22106,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf","2009-04-23 00:00:00",
29251,1,22106,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf","2013-04-16 00:00:00",
38248,2,22106,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s007lbl.pdf","2013-04-15 00:00:00",
6890,1,22106,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf","2013-04-16 00:00:00",
16942,2,22106,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s008lbl.pdf","2013-04-15 00:00:00",
29252,1,22106,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf","2013-04-16 00:00:00",
38249,2,22106,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s009lbl.pdf","2013-04-15 00:00:00",
16943,2,22106,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022106s011lbl.pdf","2012-01-31 00:00:00",
6891,1,22106,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022106Orig1s012ltr.pdf","2014-01-21 00:00:00",
16944,2,22106,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf","2014-01-22 00:00:00",
16945,2,22106,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf","2013-04-15 00:00:00",
29253,1,22106,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf","2013-04-16 00:00:00",
29254,1,22106,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022106Orig1s015ltr.pdf","2015-08-11 00:00:00",
38250,2,22106,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022106s015lbl.pdf","2015-08-11 00:00:00",
6892,1,22107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s000ltr.pdf","2008-01-23 00:00:00",
29255,1,22107,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s001ltr.pdf","2008-07-23 00:00:00",
38251,2,22107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf","2008-01-23 00:00:00",
42416,3,22107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107_tekturna_toc.cfm","2008-10-27 00:00:00",
44680,21,22107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107s000_SumR.pdf","2008-10-27 00:00:00",
6893,1,22107,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022107s002ltr.pdf","2009-07-17 00:00:00",
16946,2,22107,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf","2009-07-24 00:00:00",
6894,1,22107,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s005ltr.pdf","2010-05-24 00:00:00",
38252,2,22107,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf","2010-05-28 00:00:00",
16947,2,22107,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf","2010-08-09 00:00:00",
29256,1,22107,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s007ltr.pdf","2010-08-11 00:00:00",
6895,1,22107,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s009ltr.pdf","2011-02-14 00:00:00",
38253,2,22107,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf","2011-02-11 00:00:00",
6896,1,22107,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s013ltr.pdf","2011-06-16 00:00:00",
38254,2,22107,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf","2011-06-16 00:00:00",
6897,1,22107,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s014ltr.pdf","2011-10-14 00:00:00",
16948,2,22107,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf","2011-10-20 00:00:00",
6898,1,22107,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s016ltr.pdf","2012-02-17 00:00:00",
38255,2,22107,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf","2012-02-17 00:00:00",
6899,1,22107,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s017ltr.pdf","2012-01-30 00:00:00",
38256,2,22107,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf","2012-01-31 00:00:00",
6900,1,22107,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s019ltr.pdf","2012-02-14 00:00:00",
6901,1,22107,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s021ltr.pdf","2012-04-18 00:00:00",
38257,2,22107,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf","2012-04-16 00:00:00",
6902,1,22107,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107Orig1s022ltr.pdf","2012-10-02 00:00:00",
16949,2,22107,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf","2012-10-01 00:00:00",
6903,1,22107,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022107Orig1s023ltr.pdf","2013-11-07 00:00:00",
38258,2,22107,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf","2013-11-04 00:00:00",
16950,2,22107,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf","2014-03-19 00:00:00",
16951,2,22107,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf","2015-04-02 00:00:00",
29257,1,22107,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s025ltr.pdf","2015-04-01 00:00:00",
29258,1,22107,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s026ltr.pdf","2015-12-23 00:00:00",
38259,2,22107,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf","2015-12-28 00:00:00",
45831,1,22107,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022107Orig1s029ltr.pdf","2016-11-08 00:00:00",
45853,2,22107,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf","2016-11-08 00:00:00",
6904,1,22108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022108s000ltr.pdf","2008-04-24 00:00:00",
16952,2,22108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022108lbl.pdf","2008-05-27 00:00:00",
24242,21,22108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000_SumR.pdf","2009-04-07 00:00:00",
42417,3,22108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000TOC.cfm","2009-04-07 00:00:00",
29259,1,22108,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s002ltr.pdf","2011-05-04 00:00:00",
6905,1,22108,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s003ltr.pdf","2011-05-04 00:00:00",
16953,2,22108,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003lbl.pdf","2011-05-02 00:00:00",
16954,2,22108,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf","2011-07-27 00:00:00",
29260,1,22108,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf","2011-07-28 00:00:00",
29261,1,22108,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf","2011-07-28 00:00:00",
38260,2,22108,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf","2011-07-27 00:00:00",
16955,2,22108,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007lbl.pdf","2012-08-15 00:00:00",
29262,1,22108,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022108Orig1s007ltr.pdf","2012-08-17 00:00:00",
6906,1,22108,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf","2015-01-07 00:00:00",
38261,2,22108,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf","2015-01-09 00:00:00",
16956,2,22108,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s011lbl.pdf","2014-07-11 00:00:00",
29263,1,22108,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022108Orig1s011ltr.pdf","2014-07-10 00:00:00",
45187,1,22108,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022108Orig1s012ltr.pdf","2016-08-30 00:00:00",
45216,2,22108,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022108s012lbl.pdf","2016-08-30 00:00:00",
48256,2,22108,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf","2017-05-05 00:00:00",
48259,8,22108,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf#page=28","2017-05-05 00:00:00",
48300,1,22108,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021515Orig1s036,022108Orig1s014ltr.pdf","2017-05-09 00:00:00",
23358,8,22110,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf","2009-09-25 00:00:00",
29264,1,22110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022110s000ltr.pdf","2009-09-16 00:00:00",
38262,2,22110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022110s000lbl.pdf","2009-09-18 00:00:00",
42418,3,22110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000TOC.cfm","2009-11-25 00:00:00",
44681,21,22110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000_SumR.pdf","2009-11-25 00:00:00",
29265,1,22110,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022110s002ltr_corrected.pdf","2011-07-27 00:00:00",
6907,1,22110,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf","2013-06-26 00:00:00",
16957,2,22110,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf","2013-06-25 00:00:00",
16958,2,22110,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf","2014-02-10 00:00:00",
16959,2,22110,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf","2014-03-19 00:00:00",
6908,1,22110,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s010ltr.pdf","2014-11-14 00:00:00",
6909,1,22110,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s011ltr.pdf","2014-12-04 00:00:00",
16960,2,22110,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf","2014-12-10 00:00:00",
6910,1,22110,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s012ltr.pdf","2016-05-09 00:00:00",
16961,2,22110,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf","2016-05-09 00:00:00",
6911,1,22110,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s013ltr.pdf","2016-03-25 00:00:00",
24017,14,22110,"SUPPL",13,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65","2016-03-29 00:00:00",
48549,1,22110,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022110Orig1s014ltr.pdf","2017-05-26 00:00:00",
6912,1,22113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022113s000ltr.pdf","2011-12-28 00:00:00",
42419,3,22113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113_advil_toc.cfm","2012-09-06 00:00:00",
44682,21,22113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113Orig1s000SumR.pdf","2012-09-06 00:00:00",
48171,2,22113,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf","2017-05-01 00:00:00",
48213,1,22113,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022113Orig1s001ltr.pdf","2017-05-02 00:00:00",
52782,1,22113,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s003ltr.pdf","2018-03-01 00:00:00",
53018,2,22113,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf","2018-03-15 00:00:00",
52781,1,22113,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s004ltr.pdf","2018-03-01 00:00:00",
53017,2,22113,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf","2018-03-15 00:00:00",
16962,2,22114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022114lbl.pdf","2007-08-17 00:00:00",
16963,2,22114,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022114s001lbl.pdf","2009-01-14 00:00:00",
21938,3,22114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022114_zingo_toc.cfm","2010-03-02 00:00:00",
29266,1,22114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022114s000ltr.pdf","2007-08-17 00:00:00",
29267,1,22114,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022114s001ltr.pdf","2009-01-12 00:00:00",
6913,1,22115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022115s000ltr.pdf","2009-06-10 00:00:00",
6914,1,22115,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf","2010-04-19 00:00:00",
24243,21,22115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000_SumR.pdf","2010-02-14 00:00:00",
38263,2,22115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022115lbl.pdf","2009-06-10 00:00:00",
38264,2,22115,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf","2010-04-19 00:00:00",
42420,3,22115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000TOC.cfm","2010-02-14 00:00:00",
53302,20,22115,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022115_Lamotrigine_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53303,18,22115,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022115s000_Lamotrigine_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53304,17,22115,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022115_Lamotrigine_Statistical_BPCA.pdf","1900-01-01 00:00:00",
6915,1,22115,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf","2013-12-26 00:00:00",
38265,2,22115,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022115 s003lbl.pdf","2013-12-23 00:00:00",
6916,1,22115,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
16964,2,22115,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf","2015-01-08 00:00:00",
16965,2,22115,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf","2010-04-19 00:00:00",
29268,1,22115,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf","2010-04-19 00:00:00",
29269,1,22115,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s006ltr.pdf","2011-04-28 00:00:00",
38266,2,22115,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf","2011-04-25 00:00:00",
50608,3,22115,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022115Orig1s006.pdf","2017-12-06 00:00:00",
53305,20,22115,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22115s006_ lamotrigine_clinical_prea.pdf","1900-01-01 00:00:00",
53306,18,22115,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22115s006_ lamotrigine_ clinpharm_ prea.pdf","1900-01-01 00:00:00",
53307,17,22115,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22115s006_ lamotrigine_ statistical_ prea.pdf","1900-01-01 00:00:00",
38267,2,22115,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf","2010-10-26 00:00:00",
16966,2,22115,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf","2010-10-26 00:00:00",
29270,1,22115,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
38268,2,22115,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf","2015-03-25 00:00:00",
6917,1,22115,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf","2011-08-08 00:00:00",
38269,2,22115,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s013lbl.pdf","2011-08-05 00:00:00",
6918,1,22115,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
16967,2,22115,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf","2015-01-08 00:00:00",
6919,1,22115,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s015ltr.pdf","2011-06-27 00:00:00",
16968,2,22115,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s015lbl.pdf","2011-06-29 00:00:00",
29271,1,22115,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf","2011-12-02 00:00:00",
38270,2,22115,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s016lbl.pdf","2011-12-08 00:00:00",
16969,2,22115,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022115s017lbl.pdf","2012-08-02 00:00:00",
29272,1,22115,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf","2012-08-02 00:00:00",
6920,1,22115,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
16970,2,22115,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf","2015-03-25 00:00:00",
29273,1,22115,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf","2014-06-12 00:00:00",
38271,2,22115,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s019lbl.pdf","2014-06-30 00:00:00",
54961,1,22115,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf","2018-07-24 00:00:00",
54977,2,22115,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s022lbl.pdf","2018-07-26 00:00:00",
54978,8,22115,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s022lbl.pdf#page=49","2018-07-26 00:00:00",
54756,2,22115,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s023lbl.pdf","2018-07-05 00:00:00",
54844,1,22115,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf","2018-07-06 00:00:00",
6921,1,22116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022116s000ltr.pdf","2007-07-05 00:00:00",
16971,2,22116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022116lbl.pdf","2007-06-18 00:00:00",
16972,2,22116,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf","2008-03-07 00:00:00",
29274,1,22116,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017, 022116s001ltr.pdf","2008-03-07 00:00:00",
42421,3,22116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022116_lexiva_toc.cfm","2009-11-10 00:00:00",
29275,1,22116,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019, 022116s003ltr.pdf","2008-05-05 00:00:00",
6922,1,22116,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004ltr.pdf","2009-04-20 00:00:00",
6923,1,22116,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005ltr.pdf","2009-10-26 00:00:00",
16973,2,22116,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf","2009-09-18 00:00:00",
6924,1,22116,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024, 022116s008ltr.pdf","2010-04-29 00:00:00",
38272,2,22116,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf","2010-05-03 00:00:00",
16974,2,22116,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf","2011-05-16 00:00:00",
29276,1,22116,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010ltr.pdf","2011-05-16 00:00:00",
29277,1,22116,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf","2012-05-02 00:00:00",
38273,2,22116,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf","2012-05-01 00:00:00",
6925,1,22116,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013ltr.pdf","2012-02-27 00:00:00",
38274,2,22116,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf","2012-02-22 00:00:00",
29278,1,22116,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf","2013-02-14 00:00:00",
38275,2,22116,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf","2013-02-14 00:00:00",
6926,1,22116,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116Orig1s019ltr.pdf","2015-07-20 00:00:00",
38276,2,22116,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf","2015-07-22 00:00:00",
16975,2,22116,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf","2015-04-02 00:00:00",
29279,1,22116,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf","2015-04-01 00:00:00",
16976,2,22116,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf","2016-03-23 00:00:00",
29280,1,22116,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf","2016-03-24 00:00:00",
45320,2,22116,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023lbl.pdf","2016-09-16 00:00:00",
45333,1,22116,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf","2016-09-20 00:00:00",
50603,2,22116,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022116s024lbl.pdf","2017-12-05 00:00:00",
50604,1,22116,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022116s024ltr.pdf","2017-12-05 00:00:00",
6927,1,22117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022117s000ltr.pdf","2009-08-26 00:00:00",
16977,2,22117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf","2009-08-26 00:00:00",
21939,3,22117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000TOC.cfm","2009-10-02 00:00:00",
24244,21,22117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000_SumR.pdf","2009-10-02 00:00:00",
44172,10,22117,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-20 00:00:00",
6928,1,22117,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf","2010-09-21 00:00:00",
16978,2,22117,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf","2010-08-30 00:00:00",
29281,1,22117,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf","2010-09-21 00:00:00",
38277,2,22117,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf","2010-08-30 00:00:00",
6929,1,22117,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s007ltr.pdf","2010-12-07 00:00:00",
16979,2,22117,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s007lbl.pdf","2010-12-04 00:00:00",
29282,1,22117,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s009ltr.pdf","2011-10-13 00:00:00",
38278,2,22117,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s009lbl.pdf","2011-10-12 00:00:00",
6930,1,22117,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s010ltr.pdf","2011-08-11 00:00:00",
38279,2,22117,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s010lbl.pdf","2011-08-11 00:00:00",
6931,1,22117,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s011ltr.pdf","2014-10-23 00:00:00",
16980,2,22117,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s011lbl.pdf","2014-10-24 00:00:00",
16981,2,22117,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022117s012lbl.pdf","2013-03-26 00:00:00",
29283,1,22117,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022117Orig1s012ltr.pdf","2013-03-22 00:00:00",
16982,2,22117,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022117s013lbl.pdf","2012-11-08 00:00:00",
29284,1,22117,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022117Orig1s013ltr.pdf","2012-11-09 00:00:00",
29285,1,22117,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf","2014-11-19 00:00:00",
38280,2,22117,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf","2014-11-20 00:00:00",
6932,1,22117,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf","2014-11-19 00:00:00",
16983,2,22117,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf","2014-11-20 00:00:00",
16984,2,22117,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf","2014-11-20 00:00:00",
29286,1,22117,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf","2014-11-19 00:00:00",
6933,1,22117,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf","2015-03-13 00:00:00",
38281,2,22117,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf","2015-03-17 00:00:00",
16985,2,22117,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf","2015-03-17 00:00:00",
29287,1,22117,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf","2015-03-13 00:00:00",
51239,23,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Orig_WR.pdf","2009-09-23 00:00:00",
51241,25,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_1.pdf","2010-06-02 00:00:00",
51243,26,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_2.pdf","2010-10-22 00:00:00",
51245,27,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_3.pdf","2013-08-30 00:00:00",
51247,28,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_4.pdf","2014-02-06 00:00:00",
51727,20,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine clinical2 bpca.pdf","1900-01-01 00:00:00",
51731,18,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine clinpharm bpca.pdf","1900-01-01 00:00:00",
51733,17,22117,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine statistical bpca.pdf","1900-01-01 00:00:00",
29288,1,22117,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf","2015-03-13 00:00:00",
38282,2,22117,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf","2015-03-17 00:00:00",
51238,23,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Orig_WR.pdf","2009-09-23 00:00:00",
51240,25,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_1.pdf","2010-06-02 00:00:00",
51242,26,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_2.pdf","2010-10-22 00:00:00",
51244,27,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_3.pdf","2013-08-30 00:00:00",
51246,28,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022117_asenapine_Amend_4.pdf","2014-02-06 00:00:00",
51726,20,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine clinical bpca.pdf","1900-01-01 00:00:00",
51732,18,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine clinpharm bpca.pdf","1900-01-01 00:00:00",
51735,17,22117,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22117 asenapine statistical bpca.pdf","1900-01-01 00:00:00",
46859,2,22117,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf","2017-01-13 00:00:00",
46940,1,22117,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s020,022117Orig1s021ltr.pdf","2017-01-24 00:00:00",
46858,2,22117,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf","2017-01-13 00:00:00",
46941,1,22117,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s020,022117Orig1s021ltr.pdf","2017-01-24 00:00:00",
47309,2,22117,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s022lbl.pdf","2017-02-24 00:00:00",
47405,1,22117,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s022ltr.pdf","2017-03-02 00:00:00",
6934,1,22118,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022118s001ltr.pdf","2008-03-05 00:00:00",
29289,1,22118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022118s000ltr.pdf","2007-08-14 00:00:00",
38283,2,22118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022118lbl.pdf","2007-08-14 00:00:00",
38284,2,22118,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022118s001lbl.pdf","2008-03-05 00:00:00",
42422,3,22118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022118_fenofibrate_toc.cfm","2008-10-30 00:00:00",
6935,1,22118,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118s003ltr.pdf","2012-03-14 00:00:00",
6936,1,22118,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118Orig1s005ltr.pdf","2012-11-06 00:00:00",
16986,2,22118,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022118s005lbl.pdf","2012-11-06 00:00:00",
54273,1,22118,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022118Orig1s007ltr.pdf","2018-05-21 00:00:00",
54296,2,22118,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022118s007lbl.pdf","2018-05-22 00:00:00",
6937,1,22119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022119s000ltr.pdf","2007-08-27 00:00:00",
21940,3,22119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/22119s000TOC.cfm","2007-10-02 00:00:00",
29290,1,22119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022119s001ltr.pdf","2011-01-07 00:00:00",
38285,2,22119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf","2011-01-06 00:00:00",
42423,3,22119,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022119Orig1s001.pdf","2012-03-02 00:00:00",
16987,2,22122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf","2007-10-22 00:00:00",
24245,21,22122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022122_SumR.pdf","2008-02-22 00:00:00",
29292,1,22122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/02212s000ltr.pdf","2007-10-22 00:00:00",
42424,3,22122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/Voltaren_022122.cfm","2008-02-22 00:00:00",
29293,1,22122,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022122s006ltr.pdf","2009-11-10 00:00:00",
38287,2,22122,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf","2009-10-01 00:00:00",
16988,2,22122,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf","2015-01-05 00:00:00",
29294,1,22122,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022122Orig1s007ltr.pdf","2014-11-28 00:00:00",
16989,2,22122,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf","2016-05-11 00:00:00",
29295,1,22122,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022122Orig1s010ltr.pdf","2016-05-11 00:00:00",
52693,2,22122,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf","2018-02-23 00:00:00",
52694,8,22122,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf#page=22","2018-02-23 00:00:00",
52725,1,22122,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022122Orig1s011ltr.pdf","2018-02-26 00:00:00",
54453,3,22122,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/022122Orig1s011.pdf","2018-06-05 00:00:00",
6938,1,22124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022124s000ltr.pdf","2007-11-26 00:00:00",
16990,2,22124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022124lbl.pdf","2007-11-26 00:00:00",
21942,3,22124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022124_omnaris_toc.cfm","2009-11-12 00:00:00",
24246,21,22124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022124s000_SumR.pdf","2009-11-12 00:00:00",
53207,20,22124,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022124_Ciclesonide_Clinical_PREA.pdf","1900-01-01 00:00:00",
53208,18,22124,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022124_Ciclesonide_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53209,17,22124,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022124_Ciclesonide_Statistical_PREA.pdf","1900-01-01 00:00:00",
16991,2,22127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022127lbl.pdf","2007-10-22 00:00:00",
21943,3,22127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022127s000TOC.cfm","2008-08-29 00:00:00",
24247,21,22127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022127s000_SumR.pdf","2008-08-29 00:00:00",
29296,1,22127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022127s000ltr.pdf","2007-10-22 00:00:00",
16992,2,22127,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf","2011-06-16 00:00:00",
29297,1,22127,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf","2011-06-24 00:00:00",
6939,1,22127,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022127Orig1s011,022318Orig1s005ltr.pdf","2014-11-28 00:00:00",
16993,2,22127,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf","2014-12-17 00:00:00",
16994,2,22127,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf","2016-03-14 00:00:00",
29298,1,22127,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s013,022318Orig1s006ltr.pdf","2016-03-11 00:00:00",
45961,1,22127,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s015, 022318Orig1s008ltr.pdf","2016-11-28 00:00:00",
45996,2,22127,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s015,022318s008lbl.pdf","2016-12-01 00:00:00",
51658,20,22127,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22127 sevelamer clinical prea.pdf","1900-01-01 00:00:00",
51660,18,22127,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/38_22127 sevelamer clinpharm prea.pdf","1900-01-01 00:00:00",
51661,17,22127,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/39_22127 sevelamer statistical prea.pdf","1900-01-01 00:00:00",
6940,1,22128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022128s000ltr.pdf","2007-08-07 00:00:00",
6941,1,22128,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022128s001ltr.pdf","2008-11-28 00:00:00",
16995,2,22128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf","2007-08-07 00:00:00",
42425,3,22128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022128_selzentry_toc.cfm","2007-10-05 00:00:00",
6942,1,22128,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf","2009-11-27 00:00:00",
16996,2,22128,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf","2009-11-23 00:00:00",
6943,1,22128,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022128s004ltr.pdf","2010-06-03 00:00:00",
16997,2,22128,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022128s004lbl.pdf","2010-06-03 00:00:00",
6944,1,22128,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022128s007ltr.pdf","2011-10-25 00:00:00",
38288,2,22128,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022128s007lbl.pdf","2011-10-25 00:00:00",
6945,1,22128,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022128Orig1s009ltr.pdf","2012-08-15 00:00:00",
38289,2,22128,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022128s009lbl.pdf","2012-08-22 00:00:00",
16998,2,22128,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s010lbl.pdf","2013-02-06 00:00:00",
29299,1,22128,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s010ltr.pdf","2013-02-04 00:00:00",
29300,1,22128,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s011ltr.pdf","2013-02-19 00:00:00",
38290,2,22128,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s011lbl.pdf","2013-02-20 00:00:00",
6946,1,22128,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022128Orig1s012ltr.pdf","2014-03-28 00:00:00",
38291,2,22128,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022128s012lbl.pdf","2014-04-01 00:00:00",
16999,2,22128,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf","2015-05-11 00:00:00",
29301,1,22128,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022128Orig1s015ltr.pdf","2015-04-22 00:00:00",
45848,2,22128,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf","2016-11-08 00:00:00",
50201,3,22128,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208984Orig1s000,022128Orig1s017TOC.cfm","2017-10-26 00:00:00",
54915,2,22128,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf","2018-07-19 00:00:00",
54916,8,22128,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43","2018-07-19 00:00:00",
54932,1,22128,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022128Orig1s018,208984Orig1s001Ltr.pdf","2018-07-20 00:00:00",
21944,3,22129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000TOC.cfm","2009-06-01 00:00:00",
24248,21,22129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000_SumR.pdf","2009-06-01 00:00:00",
29302,1,22129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022129s000ltr.pdf","2009-04-16 00:00:00",
38292,2,22129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022129lbl.pdf","2009-04-16 00:00:00",
53187,20,22129,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022129_Benzyl Alcohol_Clinical_PREA.pdf","1900-01-01 00:00:00",
53188,18,22129,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022129_Benzyl Alcohol_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
53189,17,22129,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022129s000_Benzyl Alcohol_Statistical_Prea.pdf","1900-01-01 00:00:00",
6947,1,22129,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022129s002ltr.pdf","2010-06-24 00:00:00",
17000,2,22129,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022129s002lbl.pdf","2010-06-24 00:00:00",
29303,1,22129,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022129Orig1s005ltr.pdf","2012-07-17 00:00:00",
38293,2,22129,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022129s005lbl.pdf","2012-07-30 00:00:00",
21945,3,22134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000TOC.cfm","2010-08-23 00:00:00",
24249,21,22134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000SumR.pdf","2011-02-17 00:00:00",
29304,1,22134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022134s000ltr.pdf","2010-07-30 00:00:00",
29305,1,22134,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022134Orig1s001ltr.pdf","2014-12-05 00:00:00",
38294,2,22134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf","2010-07-31 00:00:00",
38295,2,22134,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf","2014-12-10 00:00:00",
53163,20,22134,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22134_alcaftadine_clinical_PREA.pdf","1900-01-01 00:00:00",
53164,18,22134,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22134_alcaftaine_clinpharm_PREA.pdf","1900-01-01 00:00:00",
53165,17,22134,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22134_alcaftadine_statistical_PREA.pdf","1900-01-01 00:00:00",
6948,1,22134,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022134Orig1s004ltr.pdf","2015-10-02 00:00:00",
17001,2,22134,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf","2015-10-07 00:00:00",
29306,1,22137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022137s000ltr.pdf","2007-09-25 00:00:00",
38296,2,22137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022137lbl.pdf","2007-09-26 00:00:00",
42426,3,22137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022137_fludarabine_toc.cfm","2008-11-17 00:00:00",
17002,2,22137,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf","2011-02-24 00:00:00",
29307,1,22137,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022137s003ltr.pdf","2011-03-02 00:00:00",
29308,1,22138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022138s000,020164s075ltr.pdf","2007-05-29 00:00:00",
38297,2,22138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf","2007-05-29 00:00:00",
42427,3,22138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022138_020164_lovenox_enoxaparin_sodium_toc.cfm","2009-03-24 00:00:00",
44174,10,22138,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm373741.htm","2013-11-07 00:00:00",
52796,2,22141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022141s000lbl.pdf","2018-03-02 00:00:00",
54951,1,22141,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022141Orig1s024ltr.pdf","2018-07-23 00:00:00",
6950,1,22142,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022142Orig1s000ltr.pdf","2018-03-26 00:00:00",
53141,2,22142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022142s000lbl.pdf","2018-03-22 00:00:00",
17003,2,22145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022145lbl.pdf","2007-10-15 00:00:00",
17004,2,22145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf","2009-02-04 00:00:00",
24250,21,22145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_SumR.pdf","2008-02-22 00:00:00",
29309,1,22145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022145s000tr.pdf","2007-10-22 00:00:00",
29310,1,22145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf","2009-02-09 00:00:00",
29311,1,22145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf","2009-02-03 00:00:00",
42428,3,22145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_Isentress.cfm","2008-02-22 00:00:00",
29312,1,22145,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022145s003ltr.pdf","2008-10-28 00:00:00",
38298,2,22145,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022145s003lbl.pdf","2008-11-07 00:00:00",
6951,1,22145,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s004ltr.pdf","2009-07-15 00:00:00",
38299,2,22145,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s004lbl.pdf","2009-07-09 00:00:00",
42429,3,22145,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022145Orig1s004.pdf","2012-04-13 00:00:00",
6952,1,22145,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s006ltr.pdf","2009-01-14 00:00:00",
17005,2,22145,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf","2009-01-14 00:00:00",
29313,1,22145,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf","2010-07-02 00:00:00",
38300,2,22145,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf","2010-07-06 00:00:00",
6953,1,22145,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf","2010-07-02 00:00:00",
17006,2,22145,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf","2010-07-06 00:00:00",
17007,2,22145,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf","2009-11-23 00:00:00",
29314,1,22145,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s013ltr.pdf","2010-01-20 00:00:00",
6954,1,22145,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s014ltr.pdf","2010-04-02 00:00:00",
17008,2,22145,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf","2010-04-04 00:00:00",
6955,1,22145,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf","2011-06-17 00:00:00",
6956,1,22145,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s017ltr.pdf","2011-03-01 00:00:00",
38301,2,22145,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s017lbl.pdf","2011-03-04 00:00:00",
6957,1,22145,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s018ltr.pdf","2011-04-13 00:00:00",
38302,2,22145,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s018lbl.pdf","2011-04-11 00:00:00",
6958,1,22145,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s020ltr.pdf","2011-11-07 00:00:00",
17009,2,22145,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf","2011-11-16 00:00:00",
29315,1,22145,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf","2012-04-02 00:00:00",
38303,2,22145,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf","2012-03-28 00:00:00",
6959,1,22145,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s022ltr.pdf","2011-12-28 00:00:00",
38304,2,22145,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s022lbl.pdf","2011-12-23 00:00:00",
6960,1,22145,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf","2012-04-23 00:00:00",
17010,2,22145,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf","2012-04-20 00:00:00",
29316,1,22145,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf","2012-08-15 00:00:00",
38305,2,22145,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf","2012-08-15 00:00:00",
6961,1,22145,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf","2013-07-02 00:00:00",
17011,2,22145,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf","2013-07-03 00:00:00",
29317,1,22145,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf","2013-04-09 00:00:00",
38306,2,22145,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf","2013-04-09 00:00:00",
17012,2,22145,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf","2013-08-05 00:00:00",
29318,1,22145,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf","2013-08-06 00:00:00",
6962,1,22145,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf","2013-10-25 00:00:00",
29319,1,22145,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf","2013-12-31 00:00:00",
38307,2,22145,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf","2013-12-23 00:00:00",
17013,2,22145,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf","2014-04-10 00:00:00",
29320,1,22145,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf","2014-04-10 00:00:00",
6963,1,22145,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf","2015-02-19 00:00:00",
17014,2,22145,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf","2015-02-20 00:00:00",
6964,1,22145,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf","2015-02-24 00:00:00",
38308,2,22145,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf","2015-02-23 00:00:00",
48579,2,22145,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf","2017-05-31 00:00:00",
48599,1,22145,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022145Orig1s036,203045Orig1s013,205786Orig1s004ltr.pdf","2017-05-31 00:00:00",
51634,57,22145,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/127_22145S036 raltegravir CDTL clinical prea.pdf","1900-01-01 00:00:00",
51635,18,22145,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/128_22145S036 raltegravir clinpharm prea.pdf","1900-01-01 00:00:00",
51636,17,22145,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/129_22145S036 raltegravir statistical prea.pdf","1900-01-01 00:00:00",
52953,20,22145,"SUPPL",36,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022145 raltegravir_Isentress_clinical prea.pdf","1900-01-01 00:00:00",
50474,2,22145,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf","2017-11-24 00:00:00",
50505,1,22145,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205786Orig1s006,022145Orig1s037,203045Orig1s014ltr.pdf","2017-12-06 00:00:00",
52826,2,22145,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf","2018-03-06 00:00:00",
53012,1,22145,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s038,205786Orig1s007,203045Orig2s015ltr.pdf","2018-03-15 00:00:00",
54629,1,22145,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s039ltr.pdf","2018-06-20 00:00:00",
29321,1,22148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022148s000ltr.pdf","2008-06-20 00:00:00",
38309,2,22148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022148lbl.pdf","2008-06-18 00:00:00",
42430,3,22148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022148_cymbalta_toc.cfm","2008-09-05 00:00:00",
44683,21,22148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022148s000_SumR.pdf","2008-08-20 00:00:00",
17015,2,22150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf","2011-08-26 00:00:00",
29322,1,22150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf","2011-08-29 00:00:00",
42431,3,22150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022150_firazyr_toc.cfm","2011-10-03 00:00:00",
17016,2,22150,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf","2013-09-09 00:00:00",
29323,1,22150,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022150Orig1s004ltr.pdf","2013-09-04 00:00:00",
6965,1,22150,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s006ltr.pdf","2015-08-11 00:00:00",
17017,2,22150,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf","2015-08-11 00:00:00",
6966,1,22150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s007ltr.pdf","2015-11-25 00:00:00",
17018,2,22150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf","2015-11-25 00:00:00",
6967,1,22152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022152s000ltr.pdf","2008-07-31 00:00:00",
21946,3,22152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152_stavzor_toc.cfm","2009-08-25 00:00:00",
29324,1,22152,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s001ltr.pdf","2009-02-06 00:00:00",
38310,2,22152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022152lbl.pdf","2008-08-07 00:00:00",
44684,21,22152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152s000_SumR.pdf","2009-08-25 00:00:00",
29325,1,22152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s002ltr.pdf","2009-05-04 00:00:00",
38311,2,22152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022152s002lbl.pdf","2009-05-12 00:00:00",
6968,1,22152,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf","2013-02-28 00:00:00",
17019,2,22152,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf","2013-03-01 00:00:00",
17020,2,22152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf","2013-03-01 00:00:00",
29326,1,22152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf","2013-02-28 00:00:00",
6969,1,22152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s005ltr.pdf","2013-06-18 00:00:00",
17021,2,22152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s005lbl.pdf","2013-06-18 00:00:00",
6970,1,22152,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s006ltr.pdf","2014-03-10 00:00:00",
38312,2,22152,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s006lbl.pdf","2014-03-10 00:00:00",
6971,1,22152,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s007ltr.pdf","2014-09-03 00:00:00",
17022,2,22152,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s007lbl.pdf","2014-09-03 00:00:00",
6972,1,22154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022154s000ltr.pdf","2009-05-06 00:00:00",
6973,1,22154,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001ltr.pdf","2010-03-08 00:00:00",
17023,2,22154,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf","2010-03-09 00:00:00",
21947,3,22154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022154_tyzeka_toc.cfm","2009-11-10 00:00:00",
38313,2,22154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022154lbl.pdf","2009-05-11 00:00:00",
44685,21,22154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022154s000_SumR.pdf","2009-11-10 00:00:00",
17024,2,22154,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf","2010-10-04 00:00:00",
29327,1,22154,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006ltr.pdf","2010-09-16 00:00:00",
17025,2,22154,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf","2011-04-01 00:00:00",
29328,1,22154,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006ltr.pdf","2011-04-01 00:00:00",
29329,1,22154,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008ltr.pdf","2011-05-10 00:00:00",
29330,1,22154,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009ltr.pdf","2012-01-03 00:00:00",
38314,2,22154,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf","2011-12-23 00:00:00",
17026,2,22154,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013,022154s010lbl.pdf","2013-02-12 00:00:00",
29331,1,22154,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022011Orig1s013,022154Orig1s010ltr.pdf","2013-01-30 00:00:00",
53524,1,22154,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022011Orig1s021,022154Orig1s018ltr.pdf","2018-03-29 00:00:00",
53564,2,22154,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf","2018-04-01 00:00:00",
53565,8,22154,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf#page=17","2018-04-01 00:00:00",
6974,1,22155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf","2007-11-26 00:00:00",
42432,3,22155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022155s000TOC.cfm","2008-05-21 00:00:00",
6975,1,22155,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf","2008-08-19 00:00:00",
6976,1,22155,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf","2008-08-19 00:00:00",
6977,1,22155,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s005ltr.pdf","2009-03-05 00:00:00",
6978,1,22155,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf","2009-03-17 00:00:00",
29332,1,22155,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022155s007ltr.pdf","2012-05-24 00:00:00",
6979,1,22155,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf","2014-05-20 00:00:00",
17027,2,22155,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf","2014-05-19 00:00:00",
6980,1,22155,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf","2016-04-18 00:00:00",
38315,2,22155,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf","2016-04-20 00:00:00",
21948,3,22156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156_cleviprex_toc.cfm","2008-09-23 00:00:00",
29333,1,22156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022156s000ltr.pdf","2008-08-08 00:00:00",
44686,21,22156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156s000_SumR.pdf","2008-09-23 00:00:00",
29334,1,22156,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022156s003ltr.pdf","2011-12-14 00:00:00",
38316,2,22156,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf","2011-12-13 00:00:00",
6981,1,22157,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s001ltr.pdf","2008-06-30 00:00:00",
17028,2,22157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157lbl.pdf","2008-01-30 00:00:00",
17029,2,22157,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157s001lbl.pdf","2008-06-30 00:00:00",
29335,1,22157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s000ltr.pdf","2008-01-30 00:00:00",
42433,3,22157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157_xyzal_toc.cfm","2010-04-01 00:00:00",
44687,21,22157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157s000SumR.pdf","2010-04-01 00:00:00",
53312,20,22157,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022157_Levocitirizine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53313,17,22157,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022157_Levocitirizine_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
6982,1,22157,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf","2009-11-10 00:00:00",
17030,2,22157,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf","2009-10-06 00:00:00",
6983,1,22157,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf","2011-03-10 00:00:00",
17031,2,22157,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf","2011-03-07 00:00:00",
29336,1,22157,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf","2012-09-07 00:00:00",
38317,2,22157,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf","2012-09-11 00:00:00",
6984,1,22157,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf","2013-11-08 00:00:00",
17032,2,22157,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf","2013-11-08 00:00:00",
17033,2,22157,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf","2016-06-27 00:00:00",
29337,1,22157,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf","2016-06-24 00:00:00",
47167,2,22157,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf","2017-02-10 00:00:00",
47235,1,22157,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s031,022157Orig1s014ltr.pdf","2017-02-16 00:00:00",
45857,2,22157,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf","2016-11-09 00:00:00",
45860,1,22157,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s032,022157Orig1s015ltr.pdf","2016-11-09 00:00:00",
48964,2,22157,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf","2017-07-13 00:00:00",
48969,1,22157,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s033,022157Orig1s016ltr.pdf","2017-07-13 00:00:00",
50064,2,22157,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022157s017lbl.pdf","2017-10-17 00:00:00",
50109,1,22157,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022157Orig1s017ltr.pdf","2017-10-19 00:00:00",
53593,2,22157,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022157s018lbl.pdf","2018-04-03 00:00:00",
53594,1,22157,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022157s018ltr.pdf","2018-04-03 00:00:00",
6985,1,22159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022159s000ltr.pdf","2008-05-14 00:00:00",
21949,3,22159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022159_oraverse_toc.cfm","2009-08-26 00:00:00",
44688,21,22159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022159s000_SUMR.pdf","2008-07-17 00:00:00",
51462,17,22159,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22159 phentolamine statistical prea.pdf","1900-01-01 00:00:00",
51463,20,22159,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22159 phentolamine clinical prea.pdf","1900-01-01 00:00:00",
17034,2,22159,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf","2016-03-22 00:00:00",
29338,1,22159,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022159Orig1s011ltr.pdf","2016-03-23 00:00:00",
6986,1,22160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022160s000ltr.pdf","2009-10-13 00:00:00",
24251,21,22160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160s000SumR.pdf","2010-05-06 00:00:00",
42434,3,22160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160_oxaliplatin_toc.cfm","2010-05-06 00:00:00",
6987,1,22160,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022160Orig1s004ltr.pdf","2012-08-13 00:00:00",
38318,2,22160,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022160s004lbl.pdf","2012-08-15 00:00:00",
29339,1,22160,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s008ltr.pdf","2013-11-27 00:00:00",
29340,1,22160,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s009ltr.pdf","2013-11-27 00:00:00",
38319,2,22160,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022160s009lbl.pdf","2013-11-26 00:00:00",
6988,1,22160,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022160Orig1s010ltr.pdf","2016-04-22 00:00:00",
38320,2,22160,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022160s010lbl.pdf","2016-04-27 00:00:00",
17035,2,22161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf","2008-04-16 00:00:00",
21950,3,22161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022161s000_LexiscanTOC.cfm","2008-06-02 00:00:00",
23699,10,22161,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm375654.htm","2014-02-07 00:00:00",
29341,1,22161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022161s000ltr.pdf","2008-04-16 00:00:00",
6989,1,22161,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s003ltr.pdf","2009-03-19 00:00:00",
38321,2,22161,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf","2009-04-03 00:00:00",
6990,1,22161,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s004ltr.pdf","2009-12-31 00:00:00",
38322,2,22161,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf","2009-12-30 00:00:00",
29342,1,22161,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf","2011-09-28 00:00:00",
38323,2,22161,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf","2011-09-29 00:00:00",
6991,1,22161,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf","2011-09-28 00:00:00",
38324,2,22161,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf","2011-09-29 00:00:00",
17036,2,22161,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf","2011-09-29 00:00:00",
29343,1,22161,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf","2011-09-28 00:00:00",
6992,1,22161,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s009ltr.pdf","2011-10-04 00:00:00",
17037,2,22161,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf","2011-09-30 00:00:00",
6993,1,22161,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf","2014-01-07 00:00:00",
17038,2,22161,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf","2014-01-10 00:00:00",
29344,1,22161,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.pdf","2014-01-14 00:00:00",
38325,2,22161,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf","2014-01-07 00:00:00",
29345,1,22161,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s012ltr.pdf","2014-09-23 00:00:00",
38326,2,22161,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf","2014-09-22 00:00:00",
46881,2,22161,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022161s013lbl.pdf","2017-01-17 00:00:00",
46905,1,22161,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022161Orig1s013ltr.pdf","2017-01-19 00:00:00",
54400,2,22161,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022161s015lbl.pdf","2018-05-31 00:00:00",
54405,1,22161,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022161Orig1s015ltr.pdf","2018-06-01 00:00:00",
6994,1,22165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf","2009-07-23 00:00:00",
21951,3,22165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000TOC.cfm","2010-05-27 00:00:00",
24252,21,22165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000SumR.pdf","2010-05-27 00:00:00",
29346,1,22165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf","2009-07-23 00:00:00",
38327,2,22165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf","2009-06-22 00:00:00",
38328,2,22165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf","2009-06-22 00:00:00",
42435,3,22165,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000TOC.cfm","2010-05-27 00:00:00",
43829,8,22165,"SUPPL",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM169077.pdf","2009-11-16 00:00:00",
44689,21,22165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000SumR.pdf","2010-05-27 00:00:00",
29347,1,22165,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf","2011-07-25 00:00:00",
6995,1,22165,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf","2016-05-11 00:00:00",
38329,2,22165,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf","2016-05-11 00:00:00",
47629,2,22165,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf","2017-03-21 00:00:00",
47631,8,22165,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf#page=19","2017-03-22 00:00:00",
47693,1,22165,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022165Orig1s012ltr.pdf","2017-03-24 00:00:00",
6996,1,22172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022172s000ltr.pdf","2007-11-19 00:00:00",
17039,2,22172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022172lbl.pdf","2007-11-19 00:00:00",
23700,10,22172,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2007-12-03 00:00:00",
42436,3,22172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022172s000_seroquel_xr_toc.cfm","2010-01-05 00:00:00",
44690,21,22172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022172s000_SumR.pdf","2010-01-05 00:00:00",
17040,2,22173,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf","2009-12-15 00:00:00",
21952,3,22173,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173_zyprexa_relprevv_toc.cfm","2010-07-27 00:00:00",
24018,14,22173,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=74","2010-03-01 00:00:00",
29349,1,22173,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022173s000ltr.pdf","2009-12-29 00:00:00",
44175,10,22173,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
44691,21,22173,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173s000SumR.pdf","2010-07-27 00:00:00",
6997,1,22173,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s002ltr.pdf","2010-05-03 00:00:00",
17041,2,22173,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf","2010-05-07 00:00:00",
6998,1,22173,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf","2010-06-02 00:00:00",
38330,2,22173,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf","2010-06-11 00:00:00",
6999,1,22173,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s004ltr.pdf","2010-07-12 00:00:00",
29350,1,22173,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf","2010-06-02 00:00:00",
38331,2,22173,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf","2010-06-03 00:00:00",
7000,1,22173,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173Orig1s008,s010,s014_r_ltr.pdf","2012-08-07 00:00:00",
38332,2,22173,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf","2012-08-06 00:00:00",
17042,2,22173,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf","2010-12-04 00:00:00",
29351,1,22173,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s009ltr.pdf","2010-12-06 00:00:00",
7001,1,22173,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf","2012-08-07 00:00:00",
17043,2,22173,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf","2012-08-06 00:00:00",
29352,1,22173,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf","2012-08-07 00:00:00",
38333,2,22173,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf","2012-08-06 00:00:00",
7002,1,22173,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf","2014-12-23 00:00:00",
38334,2,22173,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s015lbl.pdf","2015-01-09 00:00:00",
17044,2,22173,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf","2015-07-24 00:00:00",
17045,2,22173,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf","2013-04-01 00:00:00",
29353,1,22173,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022173Orig1s018ltr.pdf","2013-03-29 00:00:00",
7003,1,22173,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022173Orig1s023ltr.pdf","2014-11-03 00:00:00",
38335,2,22173,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s023lbl.pdf","2014-11-04 00:00:00",
29354,1,22173,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022173Orig1s024ltr.pdf","2015-09-18 00:00:00",
45535,1,22173,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf","2016-10-14 00:00:00",
45602,2,22173,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf","2016-10-07 00:00:00",
47348,2,22173,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf","2017-02-27 00:00:00",
47383,1,22173,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
50534,2,22173,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s027lbl.pdf","2017-12-01 00:00:00",
50579,1,22173,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022173Orig1s027ltr.pdf","2017-12-01 00:00:00",
47349,2,22173,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022173s026s028lbl.pdf","2017-02-27 00:00:00",
47382,1,22173,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020592Orig1s068,s069,021086Orig1s044,s045,021253Orig1s057,s058,022173Orig1s026,s028ltr.pdf","2017-03-02 00:00:00",
53478,2,22173,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf","2018-03-28 00:00:00",
53479,8,22173,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf#page=28","2018-03-28 00:00:00",
53521,1,22173,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020592Orig1s071,021086Orig1s046,021253Orig1s059,022173Orig1s029ltr.pdf","2018-03-29 00:00:00",
7004,1,22175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022175s000ltr.pdf","2012-05-22 00:00:00",
17046,2,22175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf","2012-05-22 00:00:00",
42437,3,22175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175_pertzye_toc.cfm","2013-09-26 00:00:00",
44692,21,22175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175Orig1s000SumR.pdf","2013-09-26 00:00:00",
53368,20,22175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022175 pancrelipase_clinical_prea.pdf","1900-01-01 00:00:00",
53369,18,22175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022175 pancrelipase_clinpharm_prea.pdf","1900-01-01 00:00:00",
53370,17,22175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022175 pancrelipase_statistical_prea.pdf","1900-01-01 00:00:00",
45599,2,22175,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022175s003lbl.pdf","2016-10-07 00:00:00",
51458,20,22175,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/31_22175 pancrelipase clinical prea.pdf","1900-01-01 00:00:00",
48961,2,22175,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf","2017-07-13 00:00:00",
48962,8,22175,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf#page=13","2017-07-13 00:00:00",
48985,1,22175,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022175Orig1s004ltr.pdf","2017-07-14 00:00:00",
7005,1,22177,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021837s000,022177s000ltr.pdf","2008-03-24 00:00:00",
29355,1,22180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022180s000ltr.pdf","2009-07-07 00:00:00",
38336,2,22180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf","2009-07-02 00:00:00",
42438,3,22180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000TOC.cfm","2009-11-25 00:00:00",
44693,21,22180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000_SumR.pdf","2009-11-25 00:00:00",
7006,1,22180,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf","2010-11-30 00:00:00",
38337,2,22180,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf","2010-12-01 00:00:00",
29356,1,22180,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf","2010-11-30 00:00:00",
38338,2,22180,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf","2010-12-01 00:00:00",
29357,1,22180,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022180s006ltr.pdf","2011-06-28 00:00:00",
38339,2,22180,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf","2011-06-29 00:00:00",
52398,2,22180,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022180s009lbl.pdf","2018-02-05 00:00:00",
52508,1,22180,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022180Orig1s009ltr.pdf","2018-02-08 00:00:00",
17047,2,22180,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf","2013-12-24 00:00:00",
17048,2,22180,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf","2015-03-19 00:00:00",
29358,1,22180,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf","2015-03-17 00:00:00",
29359,1,22180,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf","2015-03-17 00:00:00",
38340,2,22180,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf","2015-03-19 00:00:00",
50910,1,22180,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022180Orig1s016ltr.pdf","2017-12-27 00:00:00",
50933,2,22180,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022180s016lbl.pdf","2017-12-27 00:00:00",
7007,1,22181,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022181s001ltr.pdf","2008-06-24 00:00:00",
17049,2,22181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf","2007-12-13 00:00:00",
24253,21,22181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181s000_SumR.pdf","2008-07-22 00:00:00",
29360,1,22181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022181s000_ltr.pdf","2007-12-13 00:00:00",
42439,3,22181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181TOC.cfm","2008-03-24 00:00:00",
44436,13,22181,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/sapropterin/qa.htm","2007-12-13 00:00:00",
7008,1,22181,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s009ltr.pdf","2013-12-20 00:00:00",
38341,2,22181,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s009lbl.pdf","2013-12-23 00:00:00",
29361,1,22181,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s010ltr.pdf","2013-12-20 00:00:00",
38342,2,22181,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s010lbl.pdf","2013-12-23 00:00:00",
29362,1,22181,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022181Orig1s013ltr.pdf","2014-04-24 00:00:00",
38343,2,22181,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022181s013lbl.pdf","2015-11-10 00:00:00",
51475,20,22181,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22181s013 sapropterin clinical bpca.pdf","1900-01-01 00:00:00",
51476,18,22181,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22181s013 sapropterin clinpharm bpca.pdf","1900-01-01 00:00:00",
52329,23,22181,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22181_sapropterin_Original_WR.pdf","2014-03-28 00:00:00",
52330,25,22181,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22181_sapropterin_Amendment_1.pdf","2014-03-13 00:00:00",
29363,1,22181,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022181Orig1s014ltr.pdf","2016-06-15 00:00:00",
38344,2,22181,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022181s014lbl.pdf","2016-06-17 00:00:00",
7009,1,22184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf","2010-09-02 00:00:00",
17050,2,22184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022184s000lbl.pdf","2010-09-07 00:00:00",
17051,2,22184,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf","2012-03-16 00:00:00",
21953,3,22184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184_lumigan_toc.cfm","2010-12-08 00:00:00",
29364,1,22184,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022184s001ltr.pdf","2012-03-19 00:00:00",
44694,21,22184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184Orig1s000SumR.pdf","2011-02-17 00:00:00",
29365,1,22184,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022184Orig1s005ltr.pdf","2014-10-02 00:00:00",
38345,2,22184,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf","2014-09-30 00:00:00",
49168,2,22184,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf","2017-07-29 00:00:00",
49196,1,22184,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022184Orig1s006ltr.pdf","2017-08-02 00:00:00",
21954,3,22185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022185_taclonex_scalp_toc.cfm","2009-04-14 00:00:00",
29366,1,22185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022185s000ltr.pdf","2008-05-15 00:00:00",
44695,21,22185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022185s000_SUMR.pdf","2008-07-17 00:00:00",
29367,1,22185,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf","2009-03-24 00:00:00",
29368,1,22185,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf","2012-10-22 00:00:00",
38346,2,22185,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf","2012-10-18 00:00:00",
7010,1,22185,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s012ltr.pdf","2012-12-04 00:00:00",
17052,2,22185,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf","2012-12-04 00:00:00",
7011,1,22185,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf","2013-11-08 00:00:00",
38347,2,22185,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf","2013-11-19 00:00:00",
29369,1,22185,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf","2013-11-08 00:00:00",
38348,2,22185,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf","2013-11-08 00:00:00",
29370,1,22185,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf","2014-09-03 00:00:00",
38349,2,22185,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf","2014-09-03 00:00:00",
52074,20,22185,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22185 talconex clinical prea.pdf","1900-01-01 00:00:00",
52075,18,22185,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22185 talconex clinpharm prea.pdf","1900-01-01 00:00:00",
52076,17,22185,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22185 talconex statistics prea.pdf","1900-01-01 00:00:00",
38350,2,22185,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf","2015-11-04 00:00:00",
17053,2,22185,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf","2014-07-29 00:00:00",
29371,1,22185,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf","2014-07-29 00:00:00",
38351,2,22185,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf","2016-06-23 00:00:00",
29372,1,22186,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022186s000ltr.pdf","2008-08-13 00:00:00",
42440,3,22186,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186_akfluor_toc.cfm","2009-08-26 00:00:00",
44696,21,22186,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186s000_SumR.pdf","2009-08-26 00:00:00",
29373,1,22187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf","2008-01-23 00:00:00",
38352,2,22187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf","2008-01-23 00:00:00",
38353,2,22187,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf","2009-12-02 00:00:00",
42441,3,22187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187TOC.cfm","2008-03-17 00:00:00",
44697,21,22187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187s000_SumR.pdf","2008-07-22 00:00:00",
53270,20,22187,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22187_etravirine_clinical_prea.pdf","1900-01-01 00:00:00",
53271,18,22187,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22187_etravirine_clinpharm_prea.pdf","1900-01-01 00:00:00",
29374,1,22187,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022187s002ltr.pdf","2009-11-10 00:00:00",
38354,2,22187,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf","2009-10-06 00:00:00",
29375,1,22187,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s003ltr.pdf","2010-03-03 00:00:00",
38355,2,22187,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf","2010-03-03 00:00:00",
7012,1,22187,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s006ltr.pdf","2010-12-22 00:00:00",
38356,2,22187,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf","2010-12-26 00:00:00",
17054,2,22187,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf","2010-12-22 00:00:00",
29376,1,22187,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s007ltr.pdf","2010-12-28 00:00:00",
29377,1,22187,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022187s008ltr.pdf","2011-10-12 00:00:00",
38357,2,22187,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf","2011-10-12 00:00:00",
7013,1,22187,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187s009ltr.pdf","2012-03-28 00:00:00",
17055,2,22187,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf","2012-03-26 00:00:00",
17056,2,22187,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf","2012-08-15 00:00:00",
29378,1,22187,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187Orig1s010ltr.pdf","2012-08-15 00:00:00",
7014,1,22187,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf","2013-03-01 00:00:00",
17057,2,22187,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf","2013-03-01 00:00:00",
17058,2,22187,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf","2013-03-01 00:00:00",
29379,1,22187,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf","2013-03-01 00:00:00",
17059,2,22187,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf","2013-03-01 00:00:00",
29380,1,22187,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf","2013-03-01 00:00:00",
7015,1,22187,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022187Orig1s016ltr.pdf","2014-08-21 00:00:00",
38358,2,22187,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf","2014-08-22 00:00:00",
54910,2,22187,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s024lbl.pdf","2018-07-18 00:00:00",
54952,1,22187,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022187Orig1s024ltr.pdf","2018-07-23 00:00:00",
7016,1,22192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022192s000ltr.pdf","2009-05-11 00:00:00",
17060,2,22192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022192lbl.pdf","2009-05-11 00:00:00",
21955,3,22192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm","2009-06-12 00:00:00",
23701,10,22192,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
24254,21,22192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm","2009-06-12 00:00:00",
29381,1,22192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s001ltr.pdf","2010-08-26 00:00:00",
38359,2,22192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s001lbl.pdf","2010-08-27 00:00:00",
29382,1,22192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s002ltr.pdf","2010-12-06 00:00:00",
38360,2,22192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s002lbl.pdf","2010-12-04 00:00:00",
7017,1,22192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s004ltr.pdf","2011-03-24 00:00:00",
17061,2,22192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s004lbl.pdf","2011-03-28 00:00:00",
7018,1,22192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf","2011-09-12 00:00:00",
17062,2,22192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf","2011-09-12 00:00:00",
7019,1,22192,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf","2011-09-12 00:00:00",
38361,2,22192,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf","2011-09-12 00:00:00",
7020,1,22192,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022192Orig1s007ltr.pdf","2013-02-04 00:00:00",
38362,2,22192,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022192s007lbl.pdf","2013-02-01 00:00:00",
7021,1,22192,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022192s009ltr.pdf","2012-01-31 00:00:00",
38363,2,22192,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022192s009lbl.pdf","2012-01-30 00:00:00",
29383,1,22192,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022192Orig1s013ltr.pdf","2014-04-22 00:00:00",
38364,2,22192,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022192s013lbl.pdf","2014-04-22 00:00:00",
17063,2,22192,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s015lbl.pdf","2016-06-01 00:00:00",
29384,1,22192,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s015ltr.pdf","2016-05-27 00:00:00",
7022,1,22192,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s017ltr.pdf","2016-01-06 00:00:00",
17064,2,22192,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf","2016-01-06 00:00:00",
47310,2,22192,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf","2017-02-24 00:00:00",
47402,1,22192,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022192Orig1s018,s021ltr.pdf","2017-03-02 00:00:00",
47311,2,22192,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022192s018s021lbl.pdf","2017-02-24 00:00:00",
47403,1,22192,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022192Orig1s018,s021ltr.pdf","2017-03-02 00:00:00",
7023,1,22193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022193s000ltr.pdf","2008-07-31 00:00:00",
17065,2,22193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022193lbl.pdf","2008-07-29 00:00:00",
24255,21,22193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022193s000_SumR.pdf","2009-09-21 00:00:00",
42442,3,22193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022193_navstel_toc.cfm","2009-09-21 00:00:00",
53183,20,22193,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22193 navstel clinical PREA.pdf","1900-01-01 00:00:00",
53184,18,22193,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22193 navstel clinpharm PREA.pdf","1900-01-01 00:00:00",
17066,2,22195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf","2008-03-24 00:00:00",
21956,3,22195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm","2009-04-01 00:00:00",
24256,21,22195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf","2009-04-01 00:00:00",
29385,1,22195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf","2008-03-19 00:00:00",
7024,1,22195,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022195s002ltr.pdf","2010-01-29 00:00:00",
38365,2,22195,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf","2010-01-29 00:00:00",
7025,1,22195,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022195s005ltr.pdf","2011-10-20 00:00:00",
7026,1,22195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022195s006ltr.pdf","2012-01-25 00:00:00",
17067,2,22195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf","2012-01-23 00:00:00",
29386,1,22195,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022195Orig1s007ltr.pdf","2015-04-22 00:00:00",
38366,2,22195,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf","2015-04-23 00:00:00",
7027,1,22195,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022195Orig1s009ltr.pdf","2014-01-14 00:00:00",
46295,1,22195,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022195Orig1s011ltr.pdf","2016-12-20 00:00:00",
46347,2,22195,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf","2016-12-21 00:00:00",
46617,8,22195,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf#page=26","2016-12-30 00:00:00",
55694,1,22195,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf","2018-10-01 00:00:00",
55695,1,22195,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf","2018-10-01 00:00:00",
17068,2,22196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf","2009-01-06 00:00:00",
23702,10,22196,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2013-04-29 00:00:00",
24257,21,22196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_SumR.pdf","2009-07-22 00:00:00",
29387,1,22196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022196S000ltr.pdf","2008-12-29 00:00:00",
42443,3,22196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000TOC.cfm","2009-07-22 00:00:00",
43835,8,22196,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143465.pdf","2009-12-04 00:00:00",
29388,1,22196,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022196s003ltr.pdf","2010-10-19 00:00:00",
29389,1,22196,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022196s007ltr.pdf","2011-10-03 00:00:00",
17069,2,22198,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf","2008-09-19 00:00:00",
29390,1,22198,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022198s000ltr.pdf","2008-09-16 00:00:00",
42444,3,22198,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022198_sancuso_toc.cfm","2009-09-30 00:00:00",
29391,1,22198,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022198Orig1s003ltr.pdf","2015-10-01 00:00:00",
38367,2,22198,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf","2015-09-29 00:00:00",
7028,1,22198,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022198s005ltr.pdf","2011-09-28 00:00:00",
38368,2,22198,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf","2011-09-29 00:00:00",
29392,1,22198,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022198Orig1s012ltr.pdf","2014-09-23 00:00:00",
38369,2,22198,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf","2014-09-22 00:00:00",
52502,2,22198,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022198s016lbl.pdf","2018-02-07 00:00:00",
7029,1,22200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_corrected_ltr.pdf","2012-01-27 00:00:00",
17070,2,22200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf","2012-01-27 00:00:00",
42445,3,22200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000TOC.cfm","2012-06-12 00:00:00",
44698,21,22200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf","2012-06-12 00:00:00",
7030,1,22200,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf","2014-03-05 00:00:00",
17071,2,22200,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf","2014-03-04 00:00:00",
42446,3,22200,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022200Orig1s008.pdf","2014-08-05 00:00:00",
7031,1,22200,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf","2015-05-05 00:00:00",
7032,1,22200,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf","2014-05-27 00:00:00",
17072,2,22200,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf","2014-05-28 00:00:00",
29393,1,22200,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf","2014-05-27 00:00:00",
38370,2,22200,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf","2014-05-28 00:00:00",
17073,2,22200,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf","2015-03-09 00:00:00",
29394,1,22200,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf","2015-03-06 00:00:00",
7033,1,22200,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf","2015-09-28 00:00:00",
38371,2,22200,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf","2015-10-06 00:00:00",
29395,1,22200,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf","2015-09-28 00:00:00",
38372,2,22200,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf","2015-10-07 00:00:00",
7034,1,22200,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf","2015-09-28 00:00:00",
38373,2,22200,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf","2015-10-07 00:00:00",
7035,1,22200,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf","2015-09-28 00:00:00",
17074,2,22200,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf","2015-10-07 00:00:00",
7036,1,22200,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s019ltr.pdf","2015-03-11 00:00:00",
17075,2,22200,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf","2015-03-27 00:00:00",
7037,1,22200,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf","2015-09-22 00:00:00",
38374,2,22200,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf","2015-09-23 00:00:00",
50143,1,22200,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022200Orig1s025ltr.pdf","2017-10-23 00:00:00",
50154,2,22200,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf","2017-10-24 00:00:00",
50155,8,22200,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf#page=30","2017-10-24 00:00:00",
53591,2,22200,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf","2018-04-03 00:00:00",
53592,1,22200,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022200s026ltr.pdf","2018-04-03 00:00:00",
7038,1,22201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022201s000ltr.pdf","2008-12-30 00:00:00",
17076,2,22201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf","2008-12-29 00:00:00",
24258,21,22201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_SumR.pdf","2009-02-17 00:00:00",
42447,3,22201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_TOC.cfm","2009-02-17 00:00:00",
17077,2,22201,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf","2013-03-08 00:00:00",
29396,1,22201,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s002ltr.pdf","2013-03-06 00:00:00",
29397,1,22201,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s003ltr.pdf","2013-08-20 00:00:00",
38375,2,22201,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s003lbl.pdf","2013-08-21 00:00:00",
7039,1,22201,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s009ltr.pdf","2015-02-27 00:00:00",
17078,2,22201,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf","2015-03-03 00:00:00",
7040,1,22201,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s011ltr.pdf","2015-10-28 00:00:00",
38376,2,22201,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf","2015-11-04 00:00:00",
17079,2,22202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022202lbl.pdf","2009-06-22 00:00:00",
29398,1,22202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022202s000ltr.pdf","2009-06-23 00:00:00",
42448,3,22202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202_zipsor_toc.cfm","2010-04-21 00:00:00",
43836,8,22202,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243355.pdf","2011-02-15 00:00:00",
44699,21,22202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202s000sumr.pdf","2010-04-21 00:00:00",
29399,1,22202,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003s,s004ltr.pdf","2011-05-06 00:00:00",
7041,1,22202,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003,s004ltr.pdf","2011-05-06 00:00:00",
7042,1,22202,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022202Orig1s011ltr.pdf","2016-05-11 00:00:00",
38377,2,22202,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf","2016-05-11 00:00:00",
21957,3,22203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000TOC.cfm","2009-08-14 00:00:00",
29400,1,22203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022203s000ltr.pdf","2008-10-22 00:00:00",
44700,21,22203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000SUMR.cfm","2009-08-14 00:00:00",
17080,2,22203,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf","2009-11-06 00:00:00",
29401,1,22203,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022203s003ltr.pdf","2009-11-24 00:00:00",
7043,1,22203,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022203s006ltr.pdf","2011-01-25 00:00:00",
17081,2,22203,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf","2011-01-25 00:00:00",
7044,1,22203,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022203Orig1s008ltr.pdf","2013-09-04 00:00:00",
38378,2,22203,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022203s008lbl.pdf","2013-09-09 00:00:00",
51758,20,22203,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022203 azelastine clinical prea.pdf","1900-01-01 00:00:00",
51759,17,22203,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022203 azelastine Astepro statistical prea.pdf","1900-01-01 00:00:00",
52887,18,22203,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022203 azelastine clinpharm prea.pdf","1900-01-01 00:00:00",
29402,1,22203,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf","2015-02-24 00:00:00",
38379,2,22203,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf","2015-02-23 00:00:00",
51258,23,22203,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N202236_azelastine_fluticasone_Original_WR.pdf","2013-09-06 00:00:00",
51760,20,22203,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22203s010, 011 azelastine clinical prea.pdf","1900-01-01 00:00:00",
29403,1,22203,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf","2015-02-24 00:00:00",
38380,2,22203,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf","2015-02-23 00:00:00",
51257,23,22203,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N202236_azelastine_fluticasone_Original_WR.pdf","2013-09-06 00:00:00",
55431,2,22203,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022203s015lbl.pdf","2018-09-11 00:00:00",
55442,1,22203,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022203Orig1s015Ltr.pdf","2018-09-12 00:00:00",
7045,1,22204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022204s000ltr.pdf","2009-02-03 00:00:00",
17082,2,22204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022204lbl.pdf","2009-02-04 00:00:00",
42449,3,22204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000_gelnique_toc.cfm","2010-05-13 00:00:00",
44701,21,22204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000SumR.pdf","2010-05-13 00:00:00",
29404,1,22204,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022204s004ltr.pdf","2011-02-04 00:00:00",
38381,2,22204,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022204s004lbl.pdf","2011-01-31 00:00:00",
29405,1,22204,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022204Orig1s006ltr.pdf","2012-10-12 00:00:00",
38382,2,22204,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022204s006lbl.pdf","2012-10-12 00:00:00",
7046,1,22204,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022204Orig1s009ltr.pdf","2015-07-13 00:00:00",
38383,2,22204,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022204s009lbl.pdf","2015-07-13 00:00:00",
50196,2,22204,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022204s010lbl.pdf","2017-10-26 00:00:00",
50230,1,22204,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022204Orig1s010ltr.pdf","2017-10-30 00:00:00",
7047,1,22205,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022205Orig1s001ltr.pdf","2013-12-17 00:00:00",
17083,2,22205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf","2012-02-06 00:00:00",
17084,2,22205,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf","2014-01-13 00:00:00",
24259,21,22205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205Orig1s000SumR.pdf","2013-06-04 00:00:00",
29406,1,22205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022205s000ltr.pdf","2012-02-08 00:00:00",
42450,3,22205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205_giazo_toc.cfm","2013-06-04 00:00:00",
7048,1,22206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022206s000ltr.pdf","2008-10-14 00:00:00",
17085,2,22206,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf","2009-02-20 00:00:00",
29407,1,22206,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022206s001ltr.pdf","2009-02-18 00:00:00",
38384,2,22206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022206lbl.pdf","2008-11-07 00:00:00",
42451,3,22206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000TOC.cfm","2008-11-14 00:00:00",
44702,21,22206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_SumR.pdf","2008-11-17 00:00:00",
17086,2,22206,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf","2010-03-05 00:00:00",
29408,1,22206,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022206s006ltr.pdf","2010-03-08 00:00:00",
7049,1,22206,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022206Orig1s008ltr.pdf","2012-12-19 00:00:00",
17087,2,22206,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf","2012-12-18 00:00:00",
7050,1,22206,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022206Orig1s012ltr.pdf","2013-07-15 00:00:00",
38385,2,22206,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022206s012lbl.pdf","2013-07-17 00:00:00",
24260,21,22207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf","2009-04-01 00:00:00",
29409,1,22207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf","2008-03-19 00:00:00",
38386,2,22207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf","2008-03-24 00:00:00",
42452,3,22207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm","2009-04-01 00:00:00",
7051,1,22207,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022207s002ltr.pdf","2010-04-21 00:00:00",
7052,1,22207,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022207s004ltr.pdf","2012-01-25 00:00:00",
38387,2,22207,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf","2012-01-23 00:00:00",
46296,1,22207,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022207Orig1s006ltr.pdf","2016-12-20 00:00:00",
46346,2,22207,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf","2016-12-21 00:00:00",
55697,1,22207,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
55779,2,22207,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf","2018-10-01 00:00:00",
55781,8,22207,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf#page=25","2018-10-01 00:00:00",
55698,1,22207,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
55778,2,22207,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf","2018-10-01 00:00:00",
55780,8,22207,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf#page=25","2018-10-01 00:00:00",
7053,1,22210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf","2009-09-01 00:00:00",
17088,2,22210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf","2009-08-27 00:00:00",
21958,3,22210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210_zenpep_toc.cfm","2010-06-29 00:00:00",
23365,8,22210,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf","2009-09-02 00:00:00",
44703,21,22210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210s000sumr.pdf","2010-06-29 00:00:00",
51460,20,22210,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22210 Zenpep clinical prea.pdf","1900-01-01 00:00:00",
53376,18,22210,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelipase_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53377,17,22210,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelapse_Statistical_PREA.pdf","1900-01-01 00:00:00",
17089,2,22210,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf","2011-07-14 00:00:00",
17090,2,22210,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf","2011-06-16 00:00:00",
29410,1,22210,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf","2011-06-17 00:00:00",
54071,20,22210,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelapse_Clinical_PREA.pdf","1900-01-01 00:00:00",
29411,1,22210,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf","2011-06-15 00:00:00",
7054,1,22210,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,012ltr.pdf","2013-04-16 00:00:00",
17091,2,22210,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf","2013-04-16 00:00:00",
29412,1,22210,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf","2013-04-16 00:00:00",
38388,2,22210,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf","2013-04-16 00:00:00",
38389,2,22210,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf","2014-03-27 00:00:00",
7055,1,22211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022211s000ltr.pdf","2009-09-21 00:00:00",
17092,2,22211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022211lbl.pdf","2009-09-21 00:00:00",
21959,3,22211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022211_zirgan_toc.cfm","2010-01-05 00:00:00",
24261,21,22211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022211s000_SumR.pdf","2010-01-05 00:00:00",
7056,1,22212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022212s000ltr.pdf","2008-06-24 00:00:00",
7057,1,22212,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022212s001ltr.pdf","2009-03-25 00:00:00",
17093,2,22212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf","2008-06-24 00:00:00",
21960,3,22212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000TOC.cfm","2008-07-25 00:00:00",
44704,21,22212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000_SumR.pdf","2008-07-25 00:00:00",
7058,1,22212,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212s003ltr.pdf","2012-06-15 00:00:00",
17094,2,22212,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf","2012-06-18 00:00:00",
7059,1,22212,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212Orig1s010ltr.pdf","2012-11-28 00:00:00",
38390,2,22212,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf","2012-12-10 00:00:00",
29413,1,22212,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s011ltr.pdf","2013-03-26 00:00:00",
38391,2,22212,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf","2013-03-26 00:00:00",
51514,23,22212,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22212_difluprednate_Original _WR.pdf","2009-02-18 00:00:00",
51515,25,22212,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22212_difluprednate_Amendment_1.pdf","2011-09-12 00:00:00",
52611,20,22212,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22212 difluprednate clinical bpca.pdf","1900-01-01 00:00:00",
52612,18,22212,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22212 defluprednate clinpharm bpca.pdf","1900-01-01 00:00:00",
52613,17,22212,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22212 difluprednate statistical bpca.pdf","1900-01-01 00:00:00",
7060,1,22212,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s012ltr.pdf","2013-05-16 00:00:00",
17095,2,22212,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf","2013-05-21 00:00:00",
17096,2,22212,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf","2016-08-02 00:00:00",
29414,1,22212,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022212Orig1s016ltr.pdf","2016-08-02 00:00:00",
21961,3,22214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022214_arimidex_toc.cfm","2010-03-04 00:00:00",
29415,1,22214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022214s000ltr.pdf","2008-12-11 00:00:00",
53176,20,22214,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022214s000_Anastrozole (Arimidex)_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53177,18,22214,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022214s000_Anastrozole (Arimidex)_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
53178,17,22214,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022214s000_Anastrozole (Arimidex)_Statistical_BPCA.pdf","1900-01-01 00:00:00",
7061,1,22217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022217s000ltr.pdf","2009-10-26 00:00:00",
38392,2,22217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022217lbl.pdf","2009-09-21 00:00:00",
42453,3,22217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022217_valturna_toc.cfm","2010-05-06 00:00:00",
44705,21,22217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022217s000sumr.pdf","2010-05-06 00:00:00",
7062,1,22217,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022217s005ltr.pdf","2010-08-09 00:00:00",
38393,2,22217,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022217s005lbl.pdf","2010-08-10 00:00:00",
7063,1,22217,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s007ltr.pdf","2011-02-14 00:00:00",
17097,2,22217,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s007lbl.pdf","2011-02-11 00:00:00",
7064,1,22217,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s013ltr.pdf","2011-05-05 00:00:00",
38394,2,22217,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s013lbl.pdf","2011-05-05 00:00:00",
29416,1,22217,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s014ltr.pdf","2011-10-17 00:00:00",
38395,2,22217,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s014lbl.pdf","2011-10-20 00:00:00",
29417,1,22217,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s016ltr.pdf","2012-01-30 00:00:00",
38396,2,22217,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s016lbl.pdf","2012-02-07 00:00:00",
29418,1,22217,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s017ltr.pdf","2012-02-06 00:00:00",
38397,2,22217,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s017lbl.pdf","2012-02-06 00:00:00",
29419,1,22217,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s020ltr.pdf","2012-04-27 00:00:00",
38398,2,22217,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s020lbl.pdf","2012-04-26 00:00:00",
7065,1,22219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s000ltr.pdf","2014-03-06 00:00:00",
7066,1,22219,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s001ltr.pdf","2014-06-23 00:00:00",
17098,2,22219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf","2014-03-06 00:00:00",
24019,14,22219,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=313","2014-03-13 00:00:00",
38399,2,22219,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf","2014-06-23 00:00:00",
42454,3,22219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1AveedTOC.cfm","2016-03-28 00:00:00",
52747,8,22219,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/AveedMedGuide.pdf","2018-02-28 00:00:00",
29420,1,22219,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s003ltr.pdf","2015-03-04 00:00:00",
38400,2,22219,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf","2015-03-05 00:00:00",
7067,1,22219,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s005ltr.pdf","2015-05-13 00:00:00",
38401,2,22219,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf","2015-05-13 00:00:00",
46131,1,22219,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s008ltr.pdf","2016-12-13 00:00:00",
45676,1,22219,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s009ltr.pdf","2016-10-27 00:00:00",
45746,2,22219,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022219s009lbl.pdf","2016-11-01 00:00:00",
51904,1,22219,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s010ltr.pdf","2018-01-26 00:00:00",
51908,2,22219,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf","2018-01-26 00:00:00",
55456,1,22219,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s011ltr.pdf","2018-09-12 00:00:00",
17099,2,22220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf","2008-06-19 00:00:00",
21962,3,22220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022220_trivaris_toc.cfm","2009-04-01 00:00:00",
29421,1,22220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022220s000ltr.pdf","2008-06-20 00:00:00",
44706,21,22220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022220s000_SUMR.pdf","2008-07-17 00:00:00",
17100,2,22221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf","2008-10-09 00:00:00",
29422,1,22221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022221s000ltr.pdf","2008-10-09 00:00:00",
42455,3,22221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221_akten_toc.cfm","2009-09-01 00:00:00",
44707,21,22221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221s000_SumR.pdf","2009-09-01 00:00:00",
53322,20,22221,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022221s000_Lidocaine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53323,18,22221,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022221s000_Lidocaine_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53324,17,22221,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022221s000_Lidocaine_Statistical_PREA.pdf","1900-01-01 00:00:00",
17101,2,22221,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf","2012-12-10 00:00:00",
7068,1,22221,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022221Orig1s005ltr.pdf","2014-03-13 00:00:00",
17102,2,22221,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf","2014-03-13 00:00:00",
23366,8,22222,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM296221.pdf","2012-03-15 00:00:00",
29423,1,22222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022222s000ltr.pdf","2012-03-01 00:00:00",
38402,2,22222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022222s000lbl.pdf","2012-03-01 00:00:00",
42456,3,22222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022222_ultresa_toc.cfm","2013-07-26 00:00:00",
44708,21,22222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022222Orig1s000SumR.pdf","2013-07-26 00:00:00",
53371,20,22222,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022222_pancrelipase_PREA.pdf","1900-01-01 00:00:00",
53372,20,22222,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22222_Pancrelpase_Clinical-3_PREA.pdf","1900-01-01 00:00:00",
53373,18,22222,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22222_Pancrelipase_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53374,18,22222,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22222_Pancrelpase_Clinpharm2_PREA.pdf","1900-01-01 00:00:00",
53375,20,22222,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22222_Pancrelipase_Safety 4-2010_PREA.pdf","1900-01-01 00:00:00",
38403,2,22222,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022222s002lbl.pdf","2014-10-02 00:00:00",
29424,1,22223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022048s000, 022223s000ltr.pdf","2008-01-09 00:00:00",
38404,2,22223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf","2007-12-03 00:00:00",
42457,3,22223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022048s000_022223s000_TOC.cfm","2008-07-08 00:00:00",
7069,1,22224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022224s000ltr.pdf","2008-12-19 00:00:00",
21963,3,22224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224_trilipix_toc.cfm","2009-05-28 00:00:00",
24262,21,22224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224s000_SumR.pdf","2009-05-28 00:00:00",
38405,2,22224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022224s000lbl.pdf","2009-01-02 00:00:00",
29425,1,22224,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022224s003ltr.pdf","2010-09-16 00:00:00",
38406,2,22224,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022224s003lbl.pdf","2010-09-20 00:00:00",
29426,1,22224,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s004ltr.pdf","2011-03-16 00:00:00",
17103,2,22224,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf","2011-09-30 00:00:00",
29427,1,22224,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf","2011-10-03 00:00:00",
7070,1,22224,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf","2011-10-03 00:00:00",
38407,2,22224,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf","2011-09-30 00:00:00",
29428,1,22224,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf","2012-09-14 00:00:00",
38408,2,22224,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf","2012-09-06 00:00:00",
7071,1,22224,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf","2012-09-14 00:00:00",
17104,2,22224,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf","2012-09-06 00:00:00",
23368,8,22224,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008mg.pdf","2012-09-06 00:00:00",
7072,1,22224,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022224Orig1s011ltr.pdf","2015-04-28 00:00:00",
38409,2,22224,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022224Orig1s011lbl.pdf","2015-04-27 00:00:00",
54270,1,22224,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022224Orig1s013ltr.pdf","2018-05-21 00:00:00",
54302,2,22224,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s013lbl.pdf","2018-05-22 00:00:00",
17105,2,22225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf","2015-12-16 00:00:00",
21964,3,22225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022225Orig1s000TOC.cfm","2016-02-04 00:00:00",
24263,21,22225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022225Orig1s000SumR.pdf","2016-02-04 00:00:00",
29429,1,22225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022225Orig1s000ltr.pdf","2015-12-16 00:00:00",
45652,1,22225,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022225Orig1s001ltr.pdf","2016-10-26 00:00:00",
29430,1,22226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022226s000ltr.pdf","2008-10-27 00:00:00",
24264,21,22233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233s000Sumr.pdf","2010-05-12 00:00:00",
29431,1,22233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022233s000ltr.pdf","2008-08-27 00:00:00",
38410,2,22233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022233LBL.pdf","2008-08-26 00:00:00",
42458,3,22233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233_aloxi_toc.cfm","2010-05-12 00:00:00",
7073,1,22233,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022233Orig1s005ltr.pdf","2014-09-23 00:00:00",
17106,2,22233,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022233s005lbl.pdf","2014-09-22 00:00:00",
7074,1,22234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022234s000ltr.pdf","2008-08-13 00:00:00",
7075,1,22234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022234s000ltr.pdf","2011-03-11 00:00:00",
17107,2,22234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022234s000lbl.pdf","2011-03-11 00:00:00",
42459,3,22234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234_docetaxel_toc.cfm","2011-12-08 00:00:00",
44709,21,22234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234Orig1s000SumR.pdf","2011-12-08 00:00:00",
17108,2,22234,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf","2014-07-11 00:00:00",
29432,1,22234,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022234Orig1s003ltr.pdf","2014-07-11 00:00:00",
49666,2,22234,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf","2017-09-06 00:00:00",
49874,2,22234,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf","2017-09-28 00:00:00",
49889,1,22234,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022234Orig1s008ltr.pdf","2017-09-29 00:00:00",
55095,1,22234,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s010Ltr.pdf","2018-08-03 00:00:00",
55106,2,22234,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf","2018-08-03 00:00:00",
55620,2,22234,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf","2018-09-26 00:00:00",
55748,1,22234,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s011,202356Orig1s003ltr.pdf","2018-10-01 00:00:00",
7076,1,22235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022235s000ltr.pdf","2008-05-22 00:00:00",
17109,2,22235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf","2008-04-23 00:00:00",
21965,3,22235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022235_luvox_toc.cfm","2009-09-03 00:00:00",
43839,8,22235,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf","2011-04-01 00:00:00",
44176,10,22235,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm","2012-02-13 00:00:00",
44710,21,22235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22235s000_SumR.pdf","2009-09-03 00:00:00",
7077,1,22239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022239s000ltr.pdf","2009-07-20 00:00:00",
17110,2,22239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf","2009-07-23 00:00:00",
21966,3,22239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239_sumavel_dosepro_toc.cfm","2010-06-22 00:00:00",
44711,21,22239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239s000Sumr.pdf","2010-06-22 00:00:00",
29433,1,22239,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022239s002ltr.pdf","2011-07-05 00:00:00",
38411,2,22239,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf","2011-06-27 00:00:00",
17111,2,22239,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf","2016-06-06 00:00:00",
7078,1,22239,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022239Orig1s005ltr.pdf","2013-11-27 00:00:00",
38412,2,22239,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf","2013-12-12 00:00:00",
7079,1,22246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022246s000ltr .pdf","2009-09-09 00:00:00",
17112,2,22246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf","2009-09-18 00:00:00",
23369,8,22246,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187064.pdf","2009-10-19 00:00:00",
29436,1,22246,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022246s001ltr.pdf","2010-11-22 00:00:00",
38415,2,22246,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022246s001lbl.pdf","2010-11-18 00:00:00",
42460,3,22246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246_metozolv_odt_toc.cfm","2010-03-30 00:00:00",
44713,21,22246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246s000_SumR.pdf","2010-03-30 00:00:00",
7080,1,22246,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s005ltr.pdf","2011-09-06 00:00:00",
7081,1,22246,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s006ltr.pdf","2011-09-29 00:00:00",
38416,2,22246,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022246s006lbl.pdf","2011-09-30 00:00:00",
7082,1,22247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf","2013-10-24 00:00:00",
7083,1,22247,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf","2013-10-24 00:00:00",
17113,2,22247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf","2013-11-21 00:00:00",
17114,2,22247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247s000lbl.pdf","2013-10-25 00:00:00",
17115,2,22247,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf","2013-11-21 00:00:00",
42461,3,22247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022247_duavee_toc.cfm","2013-11-15 00:00:00",
17116,2,22247,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022247s002lbl.pdf","2015-10-07 00:00:00",
29437,1,22247,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022247Orig1s002ltr.pdf","2015-09-28 00:00:00",
50269,2,22247,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022247s004lbl.pdf","2017-11-02 00:00:00",
21969,3,22249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/treanda_022249_TOC.cfm","2008-05-08 00:00:00",
29438,1,22249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022249s000ltr.pdf","2008-03-21 00:00:00",
29439,1,22249,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s001ltr.pdf","2009-05-06 00:00:00",
38417,2,22249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022249lbl.pdf","2008-03-20 00:00:00",
38418,2,22249,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf","2009-05-11 00:00:00",
44714,21,22249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22249s000_SumR.pdf","2008-05-08 00:00:00",
7084,1,22249,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s002,022303s000ltr.pdf","2009-04-27 00:00:00",
38419,2,22249,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s002lbl.pdf","2009-04-28 00:00:00",
17117,2,22249,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s005lbl.pdf","2010-03-03 00:00:00",
29440,1,22249,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s005ltr.pdf","2010-03-04 00:00:00",
7085,1,22249,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s006ltr.pdf","2010-12-28 00:00:00",
38420,2,22249,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf","2010-12-26 00:00:00",
7086,1,22249,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022249s012ltr.pdf","2012-06-27 00:00:00",
17118,2,22249,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf","2012-06-27 00:00:00",
51259,23,22249,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022249_bendamustine_Original_WR.pdf","2010-01-19 00:00:00",
51260,25,22249,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022249_bendamustine_Amendment_1.pdf","2010-01-23 00:00:00",
51261,26,22249,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022249_bendamustine_Amendment_2.pdf","2011-07-07 00:00:00",
53185,20,22249,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022249Orig1s012_bendamustine clinical_bpca.pdf","1900-01-01 00:00:00",
53186,18,22249,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022249Orig1s012_bendamustine clinpharm_bpca.pdf","1900-01-01 00:00:00",
17119,2,22249,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s014lbl.pdf","2013-08-29 00:00:00",
29441,1,22249,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022249Orig1s014ltr.pdf","2013-08-29 00:00:00",
17120,2,22249,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf","2013-09-17 00:00:00",
42462,3,22249,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022249Orig1s015.pdf","2014-08-01 00:00:00",
7087,1,22249,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s019ltr.pdf","2015-03-11 00:00:00",
38421,2,22249,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf","2015-03-10 00:00:00",
42463,3,22249,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s019.pdf","2016-07-27 00:00:00",
29442,1,22249,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s020ltr.pdf","2015-11-09 00:00:00",
38422,2,22249,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf","2015-11-12 00:00:00",
7088,1,22249,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s021ltr.pdf","2015-09-04 00:00:00",
38423,2,22249,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s021lbl.pdf","2015-09-02 00:00:00",
42464,3,22249,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s021.pdf","2016-07-27 00:00:00",
45566,1,22249,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022249Orig1s022ltr.pdf","2016-10-20 00:00:00",
45906,2,22249,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022249s022lbl.pdf","2016-10-19 00:00:00",
50782,1,22249,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022249Orig1s023ltr.pdf","2017-12-20 00:00:00",
50836,2,22249,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022249s023lbl.pdf","2017-12-22 00:00:00",
17121,2,22250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf","2010-01-24 00:00:00",
23703,10,22250,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm313009.htm","2012-07-23 00:00:00",
29443,1,22250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdf","2010-01-29 00:00:00",
42465,3,22250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000TOC.cfm","2010-02-23 00:00:00",
7089,1,22250,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022250s002ltr.pdf","2011-11-21 00:00:00",
17122,2,22250,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf","2012-07-23 00:00:00",
7090,1,22250,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s004ltr.pdf","2012-07-24 00:00:00",
38424,2,22250,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf","2012-07-23 00:00:00",
17123,2,22250,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf","2013-01-23 00:00:00",
29444,1,22250,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s006ltr.pdf","2013-01-24 00:00:00",
17124,2,22250,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf","2013-01-11 00:00:00",
29445,1,22250,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s007ltr.pdf","2012-12-26 00:00:00",
29446,1,22250,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdf","2013-06-20 00:00:00",
45547,1,22250,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022250Orig1s013ltr.pdf","2016-10-17 00:00:00",
45617,2,22250,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf","2016-10-17 00:00:00",
46091,8,22250,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf#page=14","2016-12-08 00:00:00",
49915,2,22250,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf","2017-10-03 00:00:00",
49928,1,22250,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf","2017-10-03 00:00:00",
49929,1,22250,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf","2017-10-03 00:00:00",
17125,2,22251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf","2009-07-08 00:00:00",
29447,1,22251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022251s000ltr.pdf","2009-05-13 00:00:00",
29448,1,22251,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf","2013-12-26 00:00:00",
38425,2,22251,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf","2013-12-23 00:00:00",
42466,3,22251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251_lamictal_odt_lamotrigine.cfm","2010-05-27 00:00:00",
44715,21,22251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251s000_SumR.pdf","2010-05-27 00:00:00",
17126,2,22251,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
29449,1,22251,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
17127,2,22251,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
29450,1,22251,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
7091,1,22251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf","2010-11-03 00:00:00",
38426,2,22251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf","2010-10-28 00:00:00",
7092,1,22251,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
17128,2,22251,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
7093,1,22251,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf","2015-01-07 00:00:00",
38427,2,22251,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf","2015-01-05 00:00:00",
7094,1,22251,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf","2011-08-08 00:00:00",
17129,2,22251,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf","2011-08-05 00:00:00",
29451,1,22251,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf","2011-06-02 00:00:00",
17130,2,22251,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf","2011-12-02 00:00:00",
29452,1,22251,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf","2011-12-02 00:00:00",
7095,1,22251,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf","2012-08-02 00:00:00",
17131,2,22251,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf","2012-08-02 00:00:00",
7096,1,22251,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf","2015-03-25 00:00:00",
38428,2,22251,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf","2015-03-25 00:00:00",
29453,1,22251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf","2014-06-12 00:00:00",
38429,2,22251,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s052,020764s045,022251s016lbl.pdf","2014-06-30 00:00:00",
17132,2,22251,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf","2015-05-21 00:00:00",
29454,1,22251,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf","2015-05-20 00:00:00",
51218,20,22251,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22251 lamotrigine clinical prea.pdf","1900-01-01 00:00:00",
51219,18,22251,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22251 lamotrigine clinpharm prea.pdf","1900-01-01 00:00:00",
51220,17,22251,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22251 lamotrigine statistical prea.pdf","1900-01-01 00:00:00",
54962,1,22251,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf","2018-07-24 00:00:00",
54983,2,22251,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf","2018-07-26 00:00:00",
54984,8,22251,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64","2018-07-26 00:00:00",
54757,2,22251,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022251s021lbl.pdf","2018-07-05 00:00:00",
54843,1,22251,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf","2018-07-06 00:00:00",
7097,1,22252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022252s000ltr.pdf","2010-05-12 00:00:00",
17133,2,22252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf","2010-05-17 00:00:00",
17134,2,22252,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf","2012-02-14 00:00:00",
21970,3,22252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1TOC.cfm","2010-06-06 00:00:00",
24265,21,22252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf","2010-06-06 00:00:00",
29455,1,22252,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252s001ltr.pdf","2012-02-15 00:00:00",
7098,1,22252,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252Orig2s000ltr.pdf","2012-03-16 00:00:00",
38430,2,22252,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf","2012-03-16 00:00:00",
53268,20,22252,"ORIG",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22252 Natazia clinical prea.pdf","1900-01-01 00:00:00",
53269,18,22252,"ORIG",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22252 Natazia clinpharm prea.pdf","1900-01-01 00:00:00",
17135,2,22252,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf","2013-08-22 00:00:00",
29456,1,22252,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022252Orig1s003ltr.pdf","2013-08-23 00:00:00",
7099,1,22252,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022252Orig1s004ltr.pdf","2015-08-24 00:00:00",
38431,2,22252,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf","2015-08-25 00:00:00",
7100,1,22253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000, 022254s000ltr.pdf","2008-10-31 00:00:00",
17136,2,22253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022253lbl.pdf","2008-10-29 00:00:00",
21971,3,22253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000TOC.cfm","2008-12-17 00:00:00",
44716,21,22253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf","2008-12-17 00:00:00",
7101,1,22253,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022253s004,022254s001ltr.pdf","2010-01-20 00:00:00",
38432,2,22253,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001lbl.pdf","2009-11-20 00:00:00",
7102,1,22253,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf","2010-05-04 00:00:00",
17137,2,22253,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf","2012-08-28 00:00:00",
7103,1,22253,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf","2013-02-12 00:00:00",
38433,2,22253,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf","2013-02-12 00:00:00",
17138,2,22253,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29457,1,22253,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
7104,1,22253,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
38434,2,22253,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29458,1,22253,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf","2011-08-12 00:00:00",
17139,2,22253,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf","2013-02-06 00:00:00",
29459,1,22253,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf","2013-02-07 00:00:00",
29460,1,22253,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf","2014-01-17 00:00:00",
38435,2,22253,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf","2014-01-17 00:00:00",
7105,1,22253,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf","2013-04-23 00:00:00",
38436,2,22253,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf","2013-04-19 00:00:00",
17140,2,22253,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
29461,1,22253,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
29462,1,22253,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
38437,2,22253,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
7106,1,22253,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf","2014-08-14 00:00:00",
38438,2,22253,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf","2014-08-19 00:00:00",
7107,1,22253,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf","2015-07-13 00:00:00",
17141,2,22253,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf","2015-07-13 00:00:00",
47708,2,22253,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s037,022254s029,022255s021lbl.pdf","2017-03-27 00:00:00",
47751,1,22253,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022253Orig1s037,022254Orig1s029,022255Orig1s021ltr.pdf","2017-03-29 00:00:00",
50325,2,22253,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf","2017-11-07 00:00:00",
50326,8,22253,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20","2017-11-07 00:00:00",
17142,2,22254,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001lbl.pdf","2009-11-20 00:00:00",
24266,21,22254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf","2008-12-17 00:00:00",
29463,1,22254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000, 022254s000ltr.pdf","2008-10-31 00:00:00",
29464,1,22254,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022253s004,022254s001ltr.pdf","2010-01-20 00:00:00",
38439,2,22254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022254lbl.pdf","2008-10-29 00:00:00",
42467,3,22254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000TOC.cfm","2008-12-17 00:00:00",
29465,1,22254,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf","2010-05-04 00:00:00",
38440,2,22254,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf","2012-08-28 00:00:00",
29466,1,22254,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf","2013-02-12 00:00:00",
38441,2,22254,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf","2013-02-12 00:00:00",
17143,2,22254,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29467,1,22254,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
7108,1,22254,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
38442,2,22254,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29468,1,22254,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf","2011-08-12 00:00:00",
17144,2,22254,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf","2013-02-06 00:00:00",
29469,1,22254,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf","2013-02-07 00:00:00",
7109,1,22254,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf","2014-01-17 00:00:00",
38443,2,22254,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf","2014-01-17 00:00:00",
29470,1,22254,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf","2013-04-23 00:00:00",
38444,2,22254,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf","2013-04-19 00:00:00",
17145,2,22254,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
29471,1,22254,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
29472,1,22254,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
38445,2,22254,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
7110,1,22254,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf","2014-08-14 00:00:00",
17146,2,22254,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf","2014-08-13 00:00:00",
29473,1,22254,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf","2015-07-13 00:00:00",
38446,2,22254,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf","2015-07-13 00:00:00",
47706,2,22254,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s037,022254s029,022255s021lbl.pdf","2017-03-27 00:00:00",
47750,1,22254,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022253Orig1s037,022254Orig1s029,022255Orig1s021ltr.pdf","2017-03-29 00:00:00",
50327,2,22254,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf","2017-11-07 00:00:00",
50328,8,22254,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20","2017-11-07 00:00:00",
7111,1,22255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf","2010-05-04 00:00:00",
17147,2,22255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf","2012-08-28 00:00:00",
42468,3,22255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255_vimpat_toc.cfm","2010-12-01 00:00:00",
44717,21,22255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255Orig1s000SumR.pdf","2011-02-17 00:00:00",
7112,1,22255,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf","2013-02-12 00:00:00",
17148,2,22255,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf","2013-02-12 00:00:00",
17149,2,22255,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29474,1,22255,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
7113,1,22255,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf","2013-09-26 00:00:00",
38447,2,22255,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf","2013-09-27 00:00:00",
29475,1,22255,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf","2011-08-12 00:00:00",
7114,1,22255,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf","2013-02-07 00:00:00",
17150,2,22255,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf","2013-02-06 00:00:00",
7115,1,22255,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022255s009ltr.pdf022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf","2014-01-17 00:00:00",
38448,2,22255,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf","2014-01-17 00:00:00",
7116,1,22255,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf","2013-04-23 00:00:00",
17151,2,22255,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf","2013-04-19 00:00:00",
17152,2,22255,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
29476,1,22255,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
29477,1,22255,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf","2014-09-03 00:00:00",
38449,2,22255,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf","2014-09-03 00:00:00",
7117,1,22255,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf","2014-08-14 00:00:00",
17153,2,22255,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf","2014-08-13 00:00:00",
7118,1,22255,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf","2015-07-13 00:00:00",
17154,2,22255,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf","2015-07-13 00:00:00",
47704,2,22255,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s037,022254s029,022255s021lbl.pdf","2017-03-27 00:00:00",
47749,1,22255,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022253Orig1s037,022254Orig1s029,022255Orig1s021ltr.pdf","2017-03-29 00:00:00",
50329,2,22255,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf","2017-11-07 00:00:00",
50330,8,22255,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20","2017-11-07 00:00:00",
7119,1,22256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf","2009-01-14 00:00:00",
7120,1,22256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256s001ltr.pdf","2009-04-21 00:00:00",
17155,2,22256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf","2009-01-14 00:00:00",
38450,2,22256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf","2009-04-23 00:00:00",
42469,3,22256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022256s000TOC.cfm","2009-03-24 00:00:00",
44718,21,22256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2009/022256s000SumR.pdf","2009-01-15 00:00:00",
7121,1,22256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s002ltr.pdf","2010-02-16 00:00:00",
17156,2,22256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf","2010-02-23 00:00:00",
7122,1,22256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s004ltr.pdf","2010-02-16 00:00:00",
17157,2,22256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf","2010-02-16 00:00:00",
29478,1,22256,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s006ltr.pdf","2010-05-21 00:00:00",
38451,2,22256,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf","2010-05-18 00:00:00",
7123,1,22256,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s010ltr.pdf","2011-05-03 00:00:00",
42470,3,22256,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022256Orig1s010.pdf","2013-08-06 00:00:00",
17158,2,22256,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf","2011-11-09 00:00:00",
29479,1,22256,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s011ltr.pdf","2011-11-10 00:00:00",
29480,1,22256,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s012ltr.pdf","2012-11-08 00:00:00",
29481,1,22256,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s013ltr.pdf","2012-12-11 00:00:00",
38452,2,22256,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf","2012-12-07 00:00:00",
29482,1,22256,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf","2013-10-31 00:00:00",
38453,2,22256,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf","2013-10-31 00:00:00",
7124,1,22256,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf","2013-10-31 00:00:00",
38454,2,22256,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf","2013-10-31 00:00:00",
38455,2,22256,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf","2013-06-26 00:00:00",
17159,2,22256,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf","2015-01-30 00:00:00",
29483,1,22256,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022256Orig1s019ltr.pdf","2015-02-02 00:00:00",
45239,1,22256,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s021ltr.pdf","2016-09-06 00:00:00",
45246,2,22256,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf","2016-09-06 00:00:00",
46651,2,22256,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s022lbl.pdf","2017-01-03 00:00:00",
46667,1,22256,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s022ltr.pdf","2017-01-05 00:00:00",
50815,2,22256,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf","2017-12-21 00:00:00",
50816,8,22256,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf#page=30","2017-12-21 00:00:00",
50869,1,22256,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022256Orig1s023ltr.pdf","2017-12-27 00:00:00",
17160,2,22257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf","2009-08-30 00:00:00",
24267,21,22257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf","2010-05-27 00:00:00",
29484,1,22257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf","2009-09-01 00:00:00",
42471,3,22257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.cfm","2010-05-27 00:00:00",
53033,20,22257,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21304 valganciclovir clinical prea.pdf","1900-01-01 00:00:00",
53034,18,22257,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21304 valganciclovir clinpharm prea.pdf","1900-01-01 00:00:00",
7125,1,22257,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf","2010-08-10 00:00:00",
38456,2,22257,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf","2010-08-10 00:00:00",
7126,1,22257,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf","2013-04-01 00:00:00",
17161,2,22257,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf","2013-04-01 00:00:00",
17162,2,22257,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf","2015-04-28 00:00:00",
29485,1,22257,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf","2015-04-24 00:00:00",
48824,1,22257,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021304Orig1s012,022257Orig1s007ltr.pdf","2017-06-26 00:00:00",
48833,2,22257,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf","2017-06-26 00:00:00",
55099,1,22257,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021304Orig1s014,022257Orig1s009ltr.pdf","2018-08-03 00:00:00",
55101,2,22257,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf","2018-08-03 00:00:00",
29486,1,22259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022259Orig1s000ltr.pdf","2015-09-22 00:00:00",
38457,2,22259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022259s000lbl.pdf","2015-09-23 00:00:00",
46063,3,22259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022259Orig1s000TOC.cfm","2016-10-26 00:00:00",
46064,21,22259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022259Orig1s000SumR.pdf","2016-10-26 00:00:00",
7127,1,22260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022260s000ltr.pdf","2008-07-01 00:00:00",
21972,3,22260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260_epoprostenol_toc.cfm","2008-11-06 00:00:00",
44719,21,22260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260s000_SumR.pdf","2008-11-06 00:00:00",
29487,1,22260,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022260s002ltr.pdf","2010-08-30 00:00:00",
38458,2,22260,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf","2010-09-07 00:00:00",
7128,1,22260,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022260s004ltr.pdf","2011-04-01 00:00:00",
38459,2,22260,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022260s004lbl.pdf","2011-04-01 00:00:00",
17163,2,22260,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf","2013-06-05 00:00:00",
48864,3,22260,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022260Orig1s005.pdf","2017-06-29 00:00:00",
17164,2,22262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf","2008-11-07 00:00:00",
24268,21,22262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262s000_SumR.pdf","2009-08-27 00:00:00",
29488,1,22262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022262s000ltr.pdf","2008-10-31 00:00:00",
42472,3,22262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262_loseasonique_toc.cfm","2009-08-27 00:00:00",
49332,2,22262,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262s002lbl.pdf","2017-08-10 00:00:00",
49378,2,22262,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262Orig1s002ltr.pdf","2017-08-15 00:00:00",
7129,1,22264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022264s000ltr.pdf","2009-08-17 00:00:00",
7130,1,22264,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s001ltr.pdf","2010-05-18 00:00:00",
17165,2,22264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf","2009-10-01 00:00:00",
38460,2,22264,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s001lbl.pdf","2010-05-17 00:00:00",
42473,3,22264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264_invega_sustenna_toc.cfm","2010-05-13 00:00:00",
44177,10,22264,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
44720,21,22264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000sumr.pdf","2010-05-13 00:00:00",
7131,1,22264,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s002ltr.pdf","2011-06-24 00:00:00",
38461,2,22264,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s002lbl.pdf","2011-06-16 00:00:00",
7132,1,22264,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s004ltr.pdf","2010-12-07 00:00:00",
38462,2,22264,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s004lbl.pdf","2010-12-04 00:00:00",
29489,1,22264,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022264Orig1s005ltr.pdf","2012-08-30 00:00:00",
38463,2,22264,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022264s005lbl.pdf","2012-08-31 00:00:00",
29490,1,22264,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s006ltr.pdf","2011-09-28 00:00:00",
38464,2,22264,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s006lbl.pdf","2011-09-30 00:00:00",
17166,2,22264,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf","2014-05-02 00:00:00",
29491,1,22264,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf","2014-05-01 00:00:00",
17167,2,22264,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf","2014-12-20 00:00:00",
29492,1,22264,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf","2014-11-14 00:00:00",
29493,1,22264,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf","2014-11-14 00:00:00",
38465,2,22264,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf","2014-12-20 00:00:00",
50849,2,22264,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s015lbl.pdf","2017-12-26 00:00:00",
50924,1,22264,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022264Orig1s015ltr.pdf","2017-12-27 00:00:00",
7133,1,22264,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022264Orig1s018ltr.pdf","2015-06-10 00:00:00",
17168,2,22264,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf","2015-06-11 00:00:00",
7134,1,22264,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
17169,2,22264,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf","2016-03-03 00:00:00",
48738,2,22264,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf","2017-06-16 00:00:00",
48739,1,22264,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022264Orig1s023ltr.pdf","2017-06-16 00:00:00",
47316,2,22264,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s024lbl.pdf","2017-02-24 00:00:00",
47408,1,22264,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf","2017-03-02 00:00:00",
55055,1,22264,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf","2018-07-30 00:00:00",
55563,2,22264,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022264s027lbl.pdf","2018-09-21 00:00:00",
17170,2,22266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf","2009-07-17 00:00:00",
24020,14,22266,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM285397.pdf","2011-12-30 00:00:00",
24021,14,22266,"ORIG",1,"Prescriber Information","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000PrescriberInfo.pdf","2009-07-17 00:00:00",
24022,14,22266,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2009-07-17 00:00:00",
29494,1,22266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf","2009-07-17 00:00:00",
29495,1,22266,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf","2010-07-08 00:00:00",
38466,2,22266,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf","2010-07-12 00:00:00",
42474,3,22266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266_onsolis_toc.cfm","2009-11-05 00:00:00",
44178,10,22266,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm284704.htm","2011-12-22 00:00:00",
44721,21,22266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266s000_SumR_P1.pdf","2009-11-05 00:00:00",
29496,1,22266,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf","2012-01-03 00:00:00",
38467,2,22266,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf","2011-12-28 00:00:00",
7135,1,22266,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022266s009ltr.pdf","2012-06-07 00:00:00",
17171,2,22266,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf","2012-06-11 00:00:00",
7136,1,22266,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022266Orig1s012ltr.pdf","2013-11-08 00:00:00",
29497,1,22266,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022266Orig1s014ltr.pdf","2014-12-30 00:00:00",
38468,2,22266,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf","2015-01-09 00:00:00",
38469,2,22266,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf","2015-08-12 00:00:00",
46297,1,22266,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf","2016-12-20 00:00:00",
46344,2,22266,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf","2016-12-21 00:00:00",
46623,8,22266,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf#page=32","2016-12-30 00:00:00",
46298,1,22266,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf","2016-12-20 00:00:00",
46345,2,22266,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf","2016-12-21 00:00:00",
49713,1,22266,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022266Orig1s019ltr.pdf","2017-09-11 00:00:00",
17172,2,22267,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022267s001lbl.pdf","2009-10-21 00:00:00",
23704,10,22267,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm","2011-12-20 00:00:00",
24269,21,22267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022267s000_SumR.pdf","2009-09-03 00:00:00",
29498,1,22267,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022267s001ltr.pdf","2009-11-24 00:00:00",
38470,2,22267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022267lbl.pdf","2008-03-27 00:00:00",
42475,3,22267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022267_depakote_er_toc.cfm","2009-09-03 00:00:00",
53237,20,22267,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022267_Divalproex_Clinical_PREA.pdf","1900-01-01 00:00:00",
7137,1,22268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022268s000ltr.pdf","2009-04-14 00:00:00",
7138,1,22268,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022268s001ltr.pdf","2010-02-23 00:00:00",
17173,2,22268,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022268s001lbl.pdf","2010-02-23 00:00:00",
21973,3,22268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000TOC.cfm","2009-07-08 00:00:00",
24270,21,22268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000_SumR.pdf","2009-07-08 00:00:00",
38471,2,22268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022268lbl.pdf","2009-04-16 00:00:00",
7139,1,22268,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022268Orig1s003ltr.pdf","2012-08-07 00:00:00",
17174,2,22268,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022268s003lbl.pdf","2012-08-07 00:00:00",
7140,1,22268,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022268Orig1s004ltr.pdf","2013-05-01 00:00:00",
38472,2,22268,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022268s004lbl.pdf","2013-05-01 00:00:00",
29499,1,22268,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022268Orig1s012ltr.pdf","2015-03-20 00:00:00",
38473,2,22268,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022268s012lbl.pdf","2015-03-20 00:00:00",
51001,2,22268,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022268s019lbl.pdf","2018-01-09 00:00:00",
51013,1,22268,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022268Orig1s019ltr.pdf","2018-01-10 00:00:00",
7141,1,22271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022271Orig1s000ltr.pdf","2013-01-30 00:00:00",
21974,3,22271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000TOC.cfm","2013-03-25 00:00:00",
38474,2,22271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf","2013-01-30 00:00:00",
43846,8,22271,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337732.pdf","2013-02-05 00:00:00",
44722,21,22271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf","2013-03-25 00:00:00",
7142,1,22271,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf","2016-04-07 00:00:00",
38475,2,22271,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf","2016-04-07 00:00:00",
7143,1,22271,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf","2015-09-01 00:00:00",
38476,2,22271,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf","2015-09-21 00:00:00",
7144,1,22271,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s009ltr.pdf","2016-05-31 00:00:00",
17175,2,22271,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf","2016-06-01 00:00:00",
46146,1,22271,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s011ltr.pdf","2016-12-14 00:00:00",
46169,2,22271,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf","2016-12-15 00:00:00",
7145,1,22272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s000ltr.pdf","2010-04-09 00:00:00",
17176,2,22272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf","2010-04-06 00:00:00",
21975,3,22272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000TOC.cfm","2010-09-29 00:00:00",
23375,8,22272,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM208530.pdf","2010-04-16 00:00:00",
24023,14,22272,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-04 00:00:00",
44179,10,22272,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm207173.htm","2013-02-15 00:00:00",
44493,14,22272,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2010-08-06 00:00:00",
44723,21,22272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000SumR.pdf","2011-02-17 00:00:00",
51534,20,22272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272 oxycodone clinical bpca.pdf","1900-01-01 00:00:00",
51535,18,22272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272  oxycodone clinpharm bpca.pdf","1900-01-01 00:00:00",
51536,17,22272,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272 oxycodone statistical bpca.pdf","1900-01-01 00:00:00",
7146,1,22272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s005ltr.pdf","2010-07-01 00:00:00",
38477,2,22272,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf","2010-07-01 00:00:00",
7147,1,22272,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s006ltr.pdf","2010-11-22 00:00:00",
38478,2,22272,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf","2010-11-26 00:00:00",
7148,1,22272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022272s009ltr.pdf","2011-10-11 00:00:00",
17177,2,22272,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf","2011-10-12 00:00:00",
7149,1,22272,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s010ltr.pdf","2012-07-11 00:00:00",
38479,2,22272,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf","2012-07-12 00:00:00",
7150,1,22272,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s011ltr.pdf","2012-07-11 00:00:00",
38480,2,22272,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf","2012-07-13 00:00:00",
29500,1,22272,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf","2013-04-16 00:00:00",
38481,2,22272,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf","2013-04-16 00:00:00",
42476,3,22272,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022272Orig1s014TOC.cfm","2013-04-26 00:00:00",
7151,1,22272,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020553Orig1s065,022272Orig1s016ltr.pdf","2013-01-14 00:00:00",
38482,2,22272,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf","2013-01-15 00:00:00",
29501,1,22272,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s017ltr.pdf","2013-04-16 00:00:00",
7152,1,22272,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s022ltr.pdf","2014-04-17 00:00:00",
17178,2,22272,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf","2014-04-16 00:00:00",
17179,2,22272,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf","2014-10-30 00:00:00",
29502,1,22272,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf","2014-10-30 00:00:00",
29503,1,22272,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s024ltr.pdf","2014-08-20 00:00:00",
17180,2,22272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf","2015-08-13 00:00:00",
29504,1,22272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s027ltr.pdf","2015-08-13 00:00:00",
42477,3,22272,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022272Orig1s027TOC.cfm","2015-09-29 00:00:00",
7153,1,22272,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s028ltr.pdf","2015-07-06 00:00:00",
46299,1,22272,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s034ltr.pdf","2016-12-20 00:00:00",
46341,2,22272,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf","2016-12-21 00:00:00",
45466,1,22272,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s036ltr.pdf","2016-10-04 00:00:00",
48567,1,22272,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022272Orig1s037ltr.pdf","2017-05-30 00:00:00",
55630,2,22272,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf","2018-09-27 00:00:00",
55631,8,22272,"SUPPL",39,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf#page=45","2018-09-26 00:00:00",
55758,1,22272,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s039ltr.pdf","2018-10-01 00:00:00",
55700,1,22272,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf","2018-10-01 00:00:00",
55774,2,22272,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf","2018-10-01 00:00:00",
55776,8,22272,"SUPPL",40,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf#page=45","2018-10-01 00:00:00",
55699,1,22272,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf","2018-10-01 00:00:00",
55775,2,22272,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf","2018-10-01 00:00:00",
55777,8,22272,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf#page=45","2018-10-01 00:00:00",
17181,2,22273,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022273s001lbl.pdf","2009-07-23 00:00:00",
21976,3,22273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273_fludarabine_phosphate_toc.cfm","2009-05-28 00:00:00",
24271,21,22273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_SumR.pdf","2009-05-28 00:00:00",
29505,1,22273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022273S000ltr.pdf","2008-12-29 00:00:00",
29506,1,22273,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022273s001ltr.pdf","2009-11-24 00:00:00",
38483,2,22273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022273lbl.pdf","2009-01-02 00:00:00",
17182,2,22275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf","2009-05-25 00:00:00",
21977,3,22275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000TOC.cfm","2009-07-21 00:00:00",
23705,10,22275,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm350203.htm","2013-12-27 00:00:00",
24272,21,22275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000_SumR.pdf","2009-07-21 00:00:00",
29507,1,22275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022275s000ltr.pdf","2009-05-27 00:00:00",
29508,1,22275,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022275s003ltr.pdf","2011-09-28 00:00:00",
7154,1,22275,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275s005ltr.pdf","2012-02-03 00:00:00",
38484,2,22275,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf","2012-02-02 00:00:00",
17183,2,22275,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf","2012-11-19 00:00:00",
29509,1,22275,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s007ltr.pdf","2012-11-19 00:00:00",
7155,1,22275,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s008ltr.pdf","2012-09-17 00:00:00",
17184,2,22275,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf","2013-04-16 00:00:00",
29510,1,22275,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s009ltr.pdf","2013-04-18 00:00:00",
7156,1,22275,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s011ltr.pdf","2013-05-08 00:00:00",
38485,2,22275,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf","2013-05-21 00:00:00",
17185,2,22275,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf","2014-03-04 00:00:00",
29511,1,22275,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022275Orig1s014ltr.pdf","2014-03-05 00:00:00",
48624,2,22275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022275s015lbl.pdf","2017-06-01 00:00:00",
48642,1,22275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022275Orig1s015ltr.pdf","2017-06-05 00:00:00",
53795,2,22275,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbledt.pdf","2018-04-24 00:00:00",
53796,8,22275,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbl.pdf#page=24","2018-04-24 00:00:00",
53807,1,22275,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022275Orig1s016ltr.pdf","2018-04-24 00:00:00",
52436,14,22276,"APPL",0,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/022276_SLCOrderLtr.pdf","2018-02-06 00:00:00",
7157,1,22276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf","2008-07-31 00:00:00",
17186,2,22276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf","2008-07-29 00:00:00",
21978,3,22276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000TOC.cfm","2008-10-09 00:00:00",
44724,21,22276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000_SumR.pdf","2008-10-09 00:00:00",
53936,14,22276,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/022276_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7158,1,22276,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf","2009-01-12 00:00:00",
38486,2,22276,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf","2009-01-14 00:00:00",
7159,1,22276,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s008ltr.pdf","2016-04-11 00:00:00",
17187,2,22276,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf","2016-04-08 00:00:00",
45394,1,22276,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s011ltr.pdf","2016-09-26 00:00:00",
45417,2,22276,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf","2016-09-29 00:00:00",
7160,1,22277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022277s000ltr.pdf","2009-03-05 00:00:00",
21979,3,22277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277_temodar_toc.cfm","2009-11-24 00:00:00",
29512,1,22277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf","2010-04-29 00:00:00",
38487,2,22277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022277lbl.pdf","2009-04-03 00:00:00",
38488,2,22277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022277s001lbl.pdf","2010-04-28 00:00:00",
44725,21,22277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277s000_SumR.pdf","2009-11-24 00:00:00",
17188,2,22277,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf","2011-02-09 00:00:00",
29513,1,22277,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.pdf","2011-06-09 00:00:00",
38489,2,22277,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf","2011-06-07 00:00:00",
29514,1,22277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022277Orig1s007ltr.pdf","2014-05-06 00:00:00",
38490,2,22277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022277s007lbl.pdf","2014-05-06 00:00:00",
7161,1,22277,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s008ltr.pdf","2015-04-03 00:00:00",
38491,2,22277,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s008lbl.pdf","2015-04-07 00:00:00",
17189,2,22277,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf","2015-09-23 00:00:00",
29515,1,22277,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s009ltr.pdf","2015-09-22 00:00:00",
47433,1,22277,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022277Orig1s010ltr.pdf","2017-03-02 00:00:00",
47801,2,22277,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s010lbl.pdf","2017-03-31 00:00:00",
17190,2,22277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf","2016-03-04 00:00:00",
29516,1,22277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022277Orig1s011ltr.pdf","2016-02-16 00:00:00",
49994,2,22277,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s012lbl.pdf","2017-10-10 00:00:00",
50026,1,22277,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022277Orig1s012ltr.pdf","2017-10-12 00:00:00",
7162,1,22278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022278s000ltr.pdf","2009-02-24 00:00:00",
21980,3,22278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022278_membraneblue_toc.cfm","2009-12-16 00:00:00",
38492,2,22278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf","2009-02-24 00:00:00",
7163,1,22278,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022278Orig1s003ltr.pdf","2014-09-17 00:00:00",
38493,2,22278,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf","2014-09-19 00:00:00",
7164,1,22279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022279Orig1s000ltr.pdf","2015-05-21 00:00:00",
17191,2,22279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022279Orig1s000lbl.pdf","2015-05-20 00:00:00",
45612,3,22279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022279Orig1s000TOC.cfm","2016-10-12 00:00:00",
46067,21,22279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022279Orig1s000SumR.pdf","2016-10-20 00:00:00",
46862,2,22279,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022279s001lbl.pdf","2017-01-13 00:00:00",
46935,1,22279,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022279Orig1s001,022424Orig1s001ltr.pdf","2017-01-24 00:00:00",
54758,2,22279,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022279s002lbl.pdf","2018-07-05 00:00:00",
54841,1,22279,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022279Orig1s002,022424Orig1s002ltr.pdf","2018-07-06 00:00:00",
17192,2,22281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf","2009-12-04 00:00:00",
21981,3,22281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022281s000TOC.cfm","2010-02-23 00:00:00",
23706,10,22281,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
29517,1,22281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022281s000ltr.pdf","2009-12-02 00:00:00",
29518,1,22281,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s001ltr.pdf","2010-04-28 00:00:00",
29519,1,22281,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s002ltr.pdf","2010-12-22 00:00:00",
29520,1,22281,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s003ltr.pdf","2010-12-22 00:00:00",
7165,1,22281,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022281s005ltr.pdf","2011-07-28 00:00:00",
17193,2,22281,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf","2012-03-27 00:00:00",
7166,1,22281,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022281Orig1s006ltr.pdf","2012-09-24 00:00:00",
17194,2,22281,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf","2014-01-15 00:00:00",
17195,2,22281,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf","2015-07-10 00:00:00",
29521,1,22281,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022281Orig1s008ltr.pdf","2015-06-11 00:00:00",
47267,1,22281,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s011ltr.pdf","2017-02-21 00:00:00",
47272,2,22281,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s011lbl.pdf","2017-02-21 00:00:00",
50297,1,22281,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s012ltr.pdf","2017-11-06 00:00:00",
50316,2,22281,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s012lbl.pdf","2017-11-07 00:00:00",
29522,1,22282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022282s000ltr.pdf","2011-12-07 00:00:00",
7167,1,22283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022283Orig1s000ltr.pdf","2013-06-28 00:00:00",
7168,1,22283,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022283Orig1s001ltr.pdf","2015-06-12 00:00:00",
21982,3,22283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000TOC.cfm","2014-12-09 00:00:00",
24273,21,22283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000SumR.pdf","2014-12-09 00:00:00",
38494,2,22283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.pdf","2013-09-24 00:00:00",
38495,2,22283,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf","2015-06-18 00:00:00",
50309,1,22283,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022283Orig1s002ltr.pdf","2017-11-06 00:00:00",
50363,2,22283,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022283Orig1s002lbl.pdf","2017-11-13 00:00:00",
7169,1,22285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022285s000ltr.pdf","2008-09-16 00:00:00",
7170,1,22285,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s001ltr.pdf","2009-02-18 00:00:00",
24274,21,22285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_SumR.pdf","2009-01-06 00:00:00",
38496,2,22285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022285lbl.pdf","2008-09-16 00:00:00",
38497,2,22285,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf","2009-02-13 00:00:00",
42478,3,22285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_TOC.cfm","2009-01-06 00:00:00",
44180,10,22285,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-09-19 00:00:00",
7171,1,22285,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf","2009-05-04 00:00:00",
38498,2,22285,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf","2009-05-12 00:00:00",
7172,1,22285,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf","2009-05-04 00:00:00",
38499,2,22285,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf","2009-05-12 00:00:00",
7173,1,22285,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
38500,2,22285,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf","2013-07-30 00:00:00",
7174,1,22285,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf","2011-08-12 00:00:00",
29523,1,22285,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf","2013-07-26 00:00:00",
38501,2,22285,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf","2013-07-30 00:00:00",
7175,1,22285,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf","2014-03-11 00:00:00",
38502,2,22285,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf","2014-03-10 00:00:00",
17196,2,22285,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf","2015-03-12 00:00:00",
29524,1,22285,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf","2015-03-12 00:00:00",
29525,1,22285,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022285Orig1s018ltr.pdf","2014-08-04 00:00:00",
38503,2,22285,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s018lbl.pdf","2014-08-04 00:00:00",
51294,60,22285,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022285_Levetiracetam_BPCA_Division_Director.pdf","1900-01-01 00:00:00",
51295,57,22285,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22285_Levetiracetam_CDTL_PREA_BPCA.pdf","1900-01-01 00:00:00",
51296,20,22285,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22285_Levetiracetam_Clinical_PREA_BPCA.pdf","1900-01-01 00:00:00",
51297,18,22285,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22285_Levetiracetam_ Clinpharm_PREA_BPCA.pdf","1900-01-01 00:00:00",
7176,1,22285,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf","2014-03-11 00:00:00",
38504,2,22285,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf","2014-03-10 00:00:00",
17197,2,22285,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s020lbl.pdf","2014-08-08 00:00:00",
29526,1,22285,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf","2014-08-11 00:00:00",
17198,2,22285,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s022lbl.pdf","2016-04-07 00:00:00",
29527,1,22285,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s022ltr.pdf","2016-04-08 00:00:00",
45705,1,22285,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf","2016-10-28 00:00:00",
45763,2,22285,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s023lbl.pdf","2016-11-01 00:00:00",
48106,2,22285,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s025lbl.pdf","2017-04-25 00:00:00",
48143,1,22285,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf","2017-04-27 00:00:00",
50173,2,22285,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s026lbl.pdf","2017-10-25 00:00:00",
50177,8,22285,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s026lbl.pdf#page=21","2017-10-25 00:00:00",
50219,1,22285,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf","2017-10-30 00:00:00",
7177,1,22287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022287s000ltr.pdf","2009-02-04 00:00:00",
23707,10,22287,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
24275,21,22287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000_SumR.pdf","2009-06-24 00:00:00",
42479,3,22287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000TOC.cfm","2009-06-24 00:00:00",
17199,2,22287,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf","2010-06-24 00:00:00",
29528,1,22287,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s002ltr.pdf","2010-06-24 00:00:00",
7178,1,22287,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s003ltr.pdf","2010-03-25 00:00:00",
17200,2,22287,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf","2010-03-26 00:00:00",
17201,2,22287,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf","2010-03-26 00:00:00",
29529,1,22287,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s004ltr.pdf","2010-03-25 00:00:00",
29530,1,22287,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s005ltr.pdf","2010-09-08 00:00:00",
38505,2,22287,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf","2010-09-10 00:00:00",
29531,1,22287,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s007ltr.pdf","2011-04-11 00:00:00",
38506,2,22287,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf","2011-04-11 00:00:00",
29532,1,22287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287Orig1s008ltr_replace.pdf","2011-06-28 00:00:00",
38507,2,22287,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf","2011-06-27 00:00:00",
7179,1,22287,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s011ltr.pdf","2011-10-31 00:00:00",
17202,2,22287,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf","2011-11-01 00:00:00",
17203,2,22287,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf","2011-05-26 00:00:00",
29533,1,22287,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s012ltr.pdf","2011-05-25 00:00:00",
29534,1,22287,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s014ltr.pdf","2012-10-02 00:00:00",
38508,2,22287,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf","2012-10-01 00:00:00",
29535,1,22287,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s015ltr.pdf","2012-05-09 00:00:00",
38509,2,22287,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf","2012-05-07 00:00:00",
29536,1,22287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022287Orig1s017ltr.pdf","2013-08-22 00:00:00",
38510,2,22287,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf","2013-08-21 00:00:00",
7180,1,22287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022287Orig1s018ltr.pdf","2015-12-18 00:00:00",
38511,2,22287,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf","2015-12-17 00:00:00",
29537,1,22287,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022287Orig1s019ltr.pdf","2014-12-23 00:00:00",
38512,2,22287,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf","2014-12-29 00:00:00",
29538,1,22287,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s020ltr.pdf","2016-02-04 00:00:00",
38513,2,22287,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf","2016-02-11 00:00:00",
29539,1,22287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,022287Orig1s022,022287Orig1s023,208056Orig1s001ltr.pdf","2016-07-12 00:00:00",
38514,2,22287,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf","2016-07-20 00:00:00",
17204,2,22287,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf","2016-07-20 00:00:00",
29540,1,22287,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf","2016-07-12 00:00:00",
7181,1,22287,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf","2016-07-12 00:00:00",
38515,2,22287,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf","2016-07-20 00:00:00",
45866,1,22287,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s025,208056Orig1s003ltr.pdf","2016-11-10 00:00:00",
45871,2,22287,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf","2016-11-10 00:00:00",
50117,1,22287,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022287Orig1s027ltr.pdf","2017-10-19 00:00:00",
50149,2,22287,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022287s027lbl.pdf","2017-10-23 00:00:00",
54508,2,22287,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf","2018-06-11 00:00:00",
54509,8,22287,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf#page=24","2018-06-11 00:00:00",
54578,1,22287,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022287Orig1s029s030ltr.pdf","2018-06-14 00:00:00",
54507,2,22287,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf","2018-06-11 00:00:00",
54510,8,22287,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf#page=24","2018-06-11 00:00:00",
54579,1,22287,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022287Orig1s029s030ltr.pdf","2018-06-14 00:00:00",
7182,1,22288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022288s000ltr.pdf","2009-09-16 00:00:00",
17205,2,22288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf","2009-09-18 00:00:00",
42480,3,22288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000TOC.cfm","2009-10-21 00:00:00",
44726,21,22288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000_SumR.pdf","2009-10-21 00:00:00",
53190,20,22288,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022288_Bepotastine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53191,18,22288,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022288_Bepotastine_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
53192,17,22288,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022288_Bepotastine_Statistical_PREA.pdf","1900-01-01 00:00:00",
7183,1,22288,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022288s003ltr.pdf","2012-06-29 00:00:00",
38516,2,22288,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf","2012-06-29 00:00:00",
52530,2,22288,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf","2018-02-09 00:00:00",
52547,1,22288,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022288Orig1s008ltr.pdf","2018-02-09 00:00:00",
7184,1,22290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022290s000ltr.pdf","2008-09-23 00:00:00",
7185,1,22290,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022290Orig1s001ltr.pdf","2013-03-22 00:00:00",
21983,3,22290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022290s000TOC.cfm","2008-10-23 00:00:00",
24276,21,22290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022290s000_SumR.pdf","2008-10-23 00:00:00",
38517,2,22290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/22290lbl.pdf","2008-09-19 00:00:00",
38518,2,22290,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022290s001lbl.pdf","2013-03-26 00:00:00",
7186,1,22291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022291s000ltr.pdf","2008-11-26 00:00:00",
7187,1,22291,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s001ltr.pdf","2011-03-02 00:00:00",
21984,3,22291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_TOC.cfm","2009-01-14 00:00:00",
38519,2,22291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf","2008-11-21 00:00:00",
38520,2,22291,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf","2011-03-04 00:00:00",
44727,21,22291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_SumR.pdf","2009-01-14 00:00:00",
29541,1,22291,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022291s003ltr.pdf","2010-03-09 00:00:00",
7188,1,22291,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s006ltr.pdf","2011-12-07 00:00:00",
17206,2,22291,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf","2011-12-06 00:00:00",
7189,1,22291,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022291Orig1s008ltr.pdf","2012-11-19 00:00:00",
38521,2,22291,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf","2012-11-19 00:00:00",
7190,1,22291,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s010ltr.pdf","2014-02-12 00:00:00",
17207,2,22291,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf","2014-02-11 00:00:00",
17208,2,22291,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf","2014-04-28 00:00:00",
29542,1,22291,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s011ltr.pdf","2014-04-28 00:00:00",
7191,1,22291,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s012ltr.pdf","2014-08-28 00:00:00",
38522,2,22291,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf","2014-08-27 00:00:00",
7192,1,22291,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s013ltr.pdf","2014-07-17 00:00:00",
7193,1,22291,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s014ltr.pdf","2015-04-08 00:00:00",
38523,2,22291,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf","2015-04-10 00:00:00",
17209,2,22291,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf","2015-06-12 00:00:00",
29543,1,22291,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s015ltr.pdf","2015-06-12 00:00:00",
51699,23,22291,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022291_eltrombopag_Orig_WR.pdf","2010-01-25 00:00:00",
51701,25,22291,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022291_eltrombopag_Amend_1.pdf","2011-11-23 00:00:00",
52448,20,22291,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22291s015 eltrombopag clinical bpca.pdf","1900-01-01 00:00:00",
52449,18,22291,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22291s015 eltrombopag clinpharm bpca.pdf","1900-01-01 00:00:00",
52450,17,22291,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22291s015 eltrombopag statistical bpca.pdf","1900-01-01 00:00:00",
45615,2,22291,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf","2016-10-17 00:00:00",
47518,2,22291,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf","2017-03-10 00:00:00",
47550,1,22291,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291Orig1s017,207027Orig1s002ltr.pdf","2017-03-14 00:00:00",
48932,2,22291,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf","2017-07-10 00:00:00",
49953,2,22291,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s019lbl.pdf","2017-10-05 00:00:00",
49971,1,22291,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291s019ltr.pdf","2017-10-06 00:00:00",
54966,2,22291,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf","2018-07-25 00:00:00",
54967,8,22291,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf#page=29","2018-07-25 00:00:00",
54999,1,22291,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022291Orig1s020,207027Orig1s005Ltr.pdf","2018-07-26 00:00:00",
7194,1,22292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf","2008-06-26 00:00:00",
7195,1,22292,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf","2009-06-24 00:00:00",
17210,2,22292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf","2008-06-26 00:00:00",
38524,2,22292,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf","2009-06-24 00:00:00",
42481,3,22292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm","2010-05-12 00:00:00",
44728,21,22292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf","2010-05-12 00:00:00",
7196,1,22292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf","2010-05-03 00:00:00",
17211,2,22292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf","2010-05-07 00:00:00",
7197,1,22292,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf","2010-09-07 00:00:00",
38525,2,22292,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022292s003lbl.pdf","2010-08-16 00:00:00",
29544,1,22292,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf","2011-04-07 00:00:00",
38526,2,22292,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022292s004lbl.pdf","2011-04-06 00:00:00",
17212,2,22292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf","2012-02-22 00:00:00",
29545,1,22292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf","2012-02-27 00:00:00",
29546,1,22292,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf","2014-04-08 00:00:00",
38527,2,22292,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf","2014-04-08 00:00:00",
29547,1,22292,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf","2015-04-01 00:00:00",
38528,2,22292,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf","2015-04-07 00:00:00",
45344,1,22292,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf","2016-09-20 00:00:00",
45376,2,22292,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf","2016-09-23 00:00:00",
54717,2,22292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022292s010lbl.pdf","2018-06-28 00:00:00",
54856,1,22292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022292Orig1s010,021814Orig1s018ltr.pdf","2018-07-06 00:00:00",
29548,1,22293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022293s000ltr.pdf","2008-09-16 00:00:00",
21985,3,22294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294_zidovudine_toc.cfm","2009-11-10 00:00:00",
29549,1,22294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022294s000ltr.pdf","2009-07-31 00:00:00",
38529,2,22294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022294lbl.pdf","2009-07-30 00:00:00",
44729,21,22294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022294s000_SumR.pdf","2009-11-10 00:00:00",
7198,1,22294,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022294s002ltr.pdf","2011-01-05 00:00:00",
38530,2,22294,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022294s002lbl.pdf","2011-01-04 00:00:00",
7199,1,22295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022295s000ltr.pdf","2009-01-06 00:00:00",
7200,1,22296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022296s000ltr.pdf","2009-07-31 00:00:00",
7201,1,22299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022299s000TAltr.pdf","2010-03-11 00:00:00",
7202,1,22301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022301s000ltr.pdf","2008-11-07 00:00:00",
17213,2,22301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf","2008-11-07 00:00:00",
21986,3,22301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301_apriso_toc.cfm","2009-12-30 00:00:00",
44730,21,22301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301s000_SumR.pdf","2009-12-30 00:00:00",
49144,2,22301,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022301s009lbl.pdf","2017-07-31 00:00:00",
49182,1,22301,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022301Orig1s009ltr.pdf","2017-08-02 00:00:00",
21987,3,22303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022303_treanda_toc.cfm","2009-08-27 00:00:00",
24277,21,22303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022303s000_SumR.pdf","2009-08-27 00:00:00",
29550,1,22303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022303s000ltr.pdf","2008-11-07 00:00:00",
38531,2,22303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022303lbl.pdf","2008-11-03 00:00:00",
17214,2,22304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf","2009-02-04 00:00:00",
21988,3,22304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_TOC.cfm","2009-01-25 00:00:00",
24278,21,22304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_SumR.pdf","2009-01-25 00:00:00",
29551,1,22304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022304s000correctedltr.pdf","2009-01-25 00:00:00",
29552,1,22304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022304s001ltr.pdf","2010-01-20 00:00:00",
38532,2,22304,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf","2009-11-16 00:00:00",
29553,1,22304,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf","2010-11-04 00:00:00",
38533,2,22304,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf","2010-11-01 00:00:00",
7203,1,22304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf","2010-11-04 00:00:00",
17215,2,22304,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf","2010-11-01 00:00:00",
7204,1,22304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf","2013-07-12 00:00:00",
38534,2,22304,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf","2013-07-12 00:00:00",
17216,2,22304,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf","2013-07-12 00:00:00",
29554,1,22304,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf","2013-07-12 00:00:00",
29555,1,22304,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf","2013-07-12 00:00:00",
38535,2,22304,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf","2013-07-12 00:00:00",
17217,2,22304,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf","2013-07-12 00:00:00",
29556,1,22304,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf","2013-07-12 00:00:00",
7205,1,22304,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf","2013-07-12 00:00:00",
38536,2,22304,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf","2013-07-12 00:00:00",
7206,1,22304,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf","2013-11-06 00:00:00",
17218,2,22304,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf","2013-11-01 00:00:00",
29557,1,22304,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf","2013-11-06 00:00:00",
38537,2,22304,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf","2013-11-01 00:00:00",
46331,1,22304,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022304Orig1s016ltr.pdf","2016-12-21 00:00:00",
46340,2,22304,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf","2016-12-21 00:00:00",
46624,8,22304,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf#page=32","2016-12-30 00:00:00",
55684,1,22304,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf","2018-10-01 00:00:00",
55771,2,22304,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf","2018-10-01 00:00:00",
55685,1,22304,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf","2018-10-01 00:00:00",
55772,2,22304,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf","2018-10-01 00:00:00",
55773,8,22304,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf#page=32","2018-10-01 00:00:00",
29558,1,22305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022305s000ltr.pdf","2011-09-16 00:00:00",
42482,3,22305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022305_purwash_toc.cfm","2012-06-26 00:00:00",
44731,21,22305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022305Orig1s000SumR.pdf","2012-06-26 00:00:00",
7207,1,22306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022306s000ltr.pdf","2009-07-09 00:00:00",
38538,2,22306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf","2009-07-09 00:00:00",
42483,3,22306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306_sotalol_hydrochloride_toc.cfm","2010-03-30 00:00:00",
44732,21,22306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306s000SumR.pdf","2010-03-30 00:00:00",
17219,2,22307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf","2009-07-13 00:00:00",
29559,1,22307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022307s000_ltr.pdf","2009-07-13 00:00:00",
29560,1,22307,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s001ltr.pdf","2010-04-22 00:00:00",
38539,2,22307,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf","2010-05-03 00:00:00",
42484,3,22307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000TOC.cfm","2009-07-13 00:00:00",
43849,8,22307,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM238428.pdf","2012-12-05 00:00:00",
44181,10,22307,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm","2014-12-23 00:00:00",
44733,21,22307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000_SumR.pdf","2009-07-13 00:00:00",
51579,20,22307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/15_22307 prasugrel clinical bpca.pdf","1900-01-01 00:00:00",
51580,18,22307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/16_22307 prasugrel clinpharm bpca.pdf","1900-01-01 00:00:00",
51582,17,22307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/17_22307 prasugrel statistical bpca.pdf","1900-01-01 00:00:00",
7208,1,22307,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s002ltr.pdf","2010-12-10 00:00:00",
17220,2,22307,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf","2010-12-06 00:00:00",
7209,1,22307,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022307s003ltr.pdf","2011-09-29 00:00:00",
38540,2,22307,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf","2011-09-30 00:00:00",
29561,1,22307,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307s006ltr.pdf","2012-03-27 00:00:00",
17221,2,22307,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf","2012-12-04 00:00:00",
29562,1,22307,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307Orig1s007ltr.pdf","2012-12-04 00:00:00",
24024,14,22307,"SUPPL",8,"Priority 3 Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008.pdf","2016-07-29 00:00:00",
29563,1,22307,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s008ltr.pdf","2013-10-17 00:00:00",
38541,2,22307,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf","2013-10-18 00:00:00",
42485,3,22307,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008TOC.cfm","2016-02-10 00:00:00",
7210,1,22307,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s010ltr.pdf","2013-11-20 00:00:00",
38542,2,22307,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf","2013-11-22 00:00:00",
29564,1,22307,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022307Orig1s012ltr.pdf","2015-07-10 00:00:00",
38543,2,22307,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf","2015-07-09 00:00:00",
29565,1,22307,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s013ltr.pdf","2016-01-15 00:00:00",
38544,2,22307,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf","2016-02-23 00:00:00",
29566,1,22307,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s014ltr.pdf","2016-07-13 00:00:00",
38545,2,22307,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf","2016-07-13 00:00:00",
52923,2,22307,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022307s015lbl.pdf","2018-03-13 00:00:00",
52995,1,22307,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022307Orig1s015ltr.pdf","2018-03-15 00:00:00",
7211,1,22308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022308s000ltr.pdf","2009-06-02 00:00:00",
38546,2,22308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022308lbl.pdf","2009-06-04 00:00:00",
42486,3,22308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000TOC.cfm","2009-07-10 00:00:00",
44734,21,22308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000_SumR.pdf","2009-07-10 00:00:00",
53193,20,22308,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_Clinical_PREA.pdf","1900-01-01 00:00:00",
53194,18,22308,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
53195,17,22308,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_Statistical_PREA.pdf","1900-01-01 00:00:00",
29567,1,22308,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022308Orig1s003ltr.pdf","2012-09-24 00:00:00",
38547,2,22308,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf","2012-09-20 00:00:00",
53611,2,22308,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf","2018-04-05 00:00:00",
53612,1,22308,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022308s013ltr.pdf","2018-04-05 00:00:00",
45770,19,22309,"APPL",0,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=5","2016-11-02 00:00:00",
7212,1,22309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf","2011-05-05 00:00:00",
21989,3,22309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309_androgel_toc.cfm","2011-11-17 00:00:00",
21990,3,22309,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022309Orig1s001.pdf","2014-01-16 00:00:00",
29568,1,22309,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf","2012-09-10 00:00:00",
38548,2,22309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf","2011-04-29 00:00:00",
38549,2,22309,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf","2012-09-11 00:00:00",
44735,21,22309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000SumR.pdf","2011-11-17 00:00:00",
29569,1,22309,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s007ltr.pdf","2013-03-15 00:00:00",
17222,2,22309,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf","2013-05-20 00:00:00",
29570,1,22309,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s008ltr.pdf","2013-05-22 00:00:00",
7213,1,22309,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf","2014-11-18 00:00:00",
17223,2,22309,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf","2014-11-20 00:00:00",
7214,1,22309,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf","2014-06-23 00:00:00",
38550,2,22309,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf","2014-06-23 00:00:00",
29571,1,22309,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022309Orig1s014ltr.pdf","2015-05-13 00:00:00",
38551,2,22309,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf","2015-05-13 00:00:00",
45677,1,22309,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022309Orig1s017ltr.pdf","2016-10-27 00:00:00",
45741,2,22309,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf","2016-11-01 00:00:00",
17224,2,22310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022310lbl.pdf","2009-01-06 00:00:00",
29572,1,22310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022310s000ltr.pdf","2008-12-29 00:00:00",
42487,3,22310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022310_casodex_toc.cfm","2009-09-30 00:00:00",
53196,20,22310,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022310s000_Bicalutamide_Clinical_BPCA.pdf","1900-01-01 00:00:00",
53197,18,22310,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022310s000_Bicalutamide_ClinPharm_BPCA.pdf","1900-01-01 00:00:00",
53198,17,22310,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022310s000_Bicalutamide_Statistical_.pdf","1900-01-01 00:00:00",
7215,1,22311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022311s000ltr.pdf","2008-12-19 00:00:00",
7216,1,22311,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022311s001ltr.pdf","2010-06-16 00:00:00",
17225,2,22311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf","2009-01-02 00:00:00",
24279,21,22311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000_SumR.pdf","2009-03-24 00:00:00",
38552,2,22311,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf","2010-06-15 00:00:00",
42488,3,22311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000TOC.cfm","2009-03-24 00:00:00",
7217,1,22311,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022311Orig1s013ltr.pdf","2013-06-06 00:00:00",
38553,2,22311,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf","2013-06-11 00:00:00",
17226,2,22311,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf","2014-12-10 00:00:00",
29573,1,22311,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022311Orig1s015ltr.pdf","2014-12-05 00:00:00",
7218,1,22311,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022311Orig1s016ltr.pdf","2015-08-06 00:00:00",
38554,2,22311,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf","2015-08-06 00:00:00",
50599,2,22311,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022311s018lbl.pdf","2017-12-04 00:00:00",
50600,1,22311,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022311s018ltr.pdf","2017-12-04 00:00:00",
7219,1,22312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022312s000ltr.pdf","2012-01-17 00:00:00",
21991,3,22312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312_docetaxel_toc.cfm","2013-05-24 00:00:00",
38555,2,22312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022312s000lbl.pdf","2012-01-12 00:00:00",
44736,21,22312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312Orig1s000SumR.pdf","2013-05-24 00:00:00",
17227,2,22314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf","2009-05-11 00:00:00",
24280,21,22314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000_SumR.pdf","2009-09-02 00:00:00",
29574,1,22314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf","2009-05-14 00:00:00",
42489,3,22314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000TOC.cfm","2009-09-02 00:00:00",
17228,2,22314,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf","2011-06-27 00:00:00",
29575,1,22314,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s005ltr.pdf","2011-06-13 00:00:00",
7220,1,22314,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s007ltr.pdf","2011-12-14 00:00:00",
38556,2,22314,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s007lbl.pdf","2011-12-13 00:00:00",
17229,2,22314,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf","2012-02-17 00:00:00",
29576,1,22314,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314s009ltr.pdf","2012-02-21 00:00:00",
17230,2,22314,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf","2011-10-31 00:00:00",
29577,1,22314,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s011ltr.pdf","2011-11-02 00:00:00",
29578,1,22314,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf","2012-01-20 00:00:00",
17231,2,22314,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf","2012-10-01 00:00:00",
29579,1,22314,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s013ltr.pdf","2012-10-02 00:00:00",
17232,2,22314,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf","2012-12-10 00:00:00",
29580,1,22314,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s014ltr.pdf","2012-11-29 00:00:00",
29581,1,22314,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf","2014-03-19 00:00:00",
38557,2,22314,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf","2014-03-19 00:00:00",
7221,1,22314,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf","2014-03-19 00:00:00",
38558,2,22314,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf","2014-03-19 00:00:00",
38559,2,22314,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s017lbl.pdf","2014-06-10 00:00:00",
29582,1,22314,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s019ltr.pdf","2014-09-25 00:00:00",
38560,2,22314,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s019lbl.pdf","2014-09-26 00:00:00",
7222,1,22314,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022314Orig1s020ltr.pdf","2015-07-30 00:00:00",
17233,2,22314,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf","2015-07-30 00:00:00",
7223,1,22315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022315s000ltr.pdf","2009-06-23 00:00:00",
17234,2,22315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf","2009-06-22 00:00:00",
42490,3,22315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315_ozurdex_toc.cfm","2009-10-29 00:00:00",
44737,21,22315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315s000_SumR.pdf","2009-10-29 00:00:00",
29583,1,22315,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s002ltr.pdf","2010-09-07 00:00:00",
29584,1,22315,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s003ltr.pdf","2010-09-29 00:00:00",
38561,2,22315,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf","2010-09-29 00:00:00",
7224,1,22315,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315s005ltr.pdf","2012-02-29 00:00:00",
38562,2,22315,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf","2012-02-28 00:00:00",
7225,1,22315,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315Orig1s007ltr.pdf","2012-09-10 00:00:00",
38563,2,22315,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf","2012-09-11 00:00:00",
7226,1,22315,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s008ltr.pdf","2014-02-11 00:00:00",
17235,2,22315,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf","2014-02-10 00:00:00",
29585,1,22315,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s009ltr.pdf","2014-06-30 00:00:00",
38564,2,22315,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf","2014-07-01 00:00:00",
48435,3,22315,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022315Orig1s009.pdf","2017-05-17 00:00:00",
29586,1,22315,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s010ltr.pdf","2014-10-01 00:00:00",
38565,2,22315,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf","2014-09-30 00:00:00",
54216,1,22315,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022315Orig1s012ltr.pdf","2018-05-16 00:00:00",
54233,2,22315,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf","2018-05-17 00:00:00",
7227,1,22318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022318s000ltr.pdf","2009-08-17 00:00:00",
21992,3,22318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_renvela_toc.cfm","2011-02-03 00:00:00",
24281,21,22318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_SumR.pdf","2011-02-03 00:00:00",
38566,2,22318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022318lbl.pdf","2009-10-01 00:00:00",
29587,1,22318,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf","2011-06-24 00:00:00",
38567,2,22318,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf","2011-06-16 00:00:00",
7228,1,22318,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022127Orig1s011,022318Orig1s005ltr.pdf","2014-11-28 00:00:00",
38568,2,22318,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf","2014-12-17 00:00:00",
17236,2,22318,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf","2016-03-14 00:00:00",
29588,1,22318,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s013,022318Orig1s006ltr.pdf","2016-03-11 00:00:00",
45962,1,22318,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s015, 022318Orig1s008ltr.pdf","2016-11-28 00:00:00",
45997,2,22318,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s015,022318s008lbl.pdf","2016-12-01 00:00:00",
7229,1,22320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022320s000ltr.pdf","2008-12-19 00:00:00",
24282,21,22320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_SumR.pdf","2010-01-13 00:00:00",
29589,1,22320,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s001ltr.pdf","2011-02-24 00:00:00",
38569,2,22320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf","2009-01-02 00:00:00",
38570,2,22320,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf","2011-02-24 00:00:00",
42491,3,22320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320_epiduo_toc.cfm","2010-01-13 00:00:00",
7230,1,22320,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s002ltr.pdf","2011-12-20 00:00:00",
38571,2,22320,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf","2011-12-20 00:00:00",
7231,1,22320,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022320Orig1s004ltr.pdf","2013-02-04 00:00:00",
38572,2,22320,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf","2013-02-06 00:00:00",
51440,20,22320,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22320 adapalene benzyoyl clinical prea.pdf","1900-01-01 00:00:00",
51441,18,22320,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22320 adapalene benzoyl clinpharm prea.pdf","1900-01-01 00:00:00",
51442,17,22320,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22320 adapalene benzoyl statistical prea.pdf","1900-01-01 00:00:00",
7232,1,22321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf","2009-08-19 00:00:00",
23380,8,22321,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM179172.pdf","2009-09-02 00:00:00",
38573,2,22321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022321s000lbl.pdf","2009-08-18 00:00:00",
42492,3,22321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022321s000TOC.cfm","2010-05-25 00:00:00",
44495,14,22321,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-04 00:00:00",
44496,14,22321,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-07-11 00:00:00",
17237,2,22321,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf","2012-07-12 00:00:00",
29590,1,22321,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022321s007ltr.pdf","2012-07-11 00:00:00",
7233,1,22321,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s010ltr.pdf","2013-04-18 00:00:00",
17238,2,22321,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s012lbl.pdf","2013-06-03 00:00:00",
29591,1,22321,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s012ltr.pdf","2013-06-04 00:00:00",
17239,2,22321,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s013lbl.pdf","2013-11-05 00:00:00",
17240,2,22321,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s016lbl.pdf","2014-10-17 00:00:00",
29592,1,22321,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s016ltr.pdf","2014-10-17 00:00:00",
43556,5,22321,"SUPPL",16,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm","2014-10-17 00:00:00",
7234,1,22321,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s017ltr.pdf","2014-04-17 00:00:00",
17241,2,22321,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf","2014-04-16 00:00:00",
7235,1,22321,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s018ltr.pdf","2014-08-20 00:00:00",
29593,1,22321,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022321Orig1s019ltr.pdf","2015-07-06 00:00:00",
29594,1,22321,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s021ltr.pdf","2016-04-22 00:00:00",
46332,1,22321,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s022ltr.pdf","2016-12-21 00:00:00",
46339,2,22321,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022321s022lbl.pdf","2016-12-21 00:00:00",
45467,1,22321,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s023ltr.pdf","2016-10-04 00:00:00",
48582,1,22321,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022321Orig1s026ltr.pdf","2017-05-31 00:00:00",
55634,2,22321,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf","2018-09-27 00:00:00",
55636,8,22321,"SUPPL",28,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf#page=28","2018-09-27 00:00:00",
55688,1,22321,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022321Orig1s028s029ltr.pdf","2018-10-01 00:00:00",
55635,2,22321,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf","2018-09-27 00:00:00",
55637,8,22321,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf#page=28","2018-09-27 00:00:00",
55689,1,22321,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022321Orig1s028s029ltr.pdf","2018-10-01 00:00:00",
7236,1,22325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022325s000ltr.pdf","2009-01-02 00:00:00",
7237,1,22325,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022325s001ltr.pdf","2010-11-22 00:00:00",
17242,2,22325,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022325s001lbl.pdf","2010-11-18 00:00:00",
21993,3,22325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325_nexterone_toc.cfm","2010-02-17 00:00:00",
24283,21,22325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325s000_SumR.pdf","2010-02-17 00:00:00",
38574,2,22325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022325lbl.pdf","2009-01-02 00:00:00",
50610,3,22325,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022325Orig1s001.pdf","2017-12-06 00:00:00",
29595,1,22325,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022325s002ltr.pdf","2011-12-14 00:00:00",
38575,2,22325,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022325s002lbl.pdf","2011-12-12 00:00:00",
29596,1,22325,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022325Orig1s009ltr.pdf","2015-03-17 00:00:00",
38576,2,22325,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022325s009lbl.pdf","2015-03-17 00:00:00",
45954,1,22325,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022325Orig1s013ltr.pdf","2016-11-23 00:00:00",
46001,2,22325,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022325s013lbl.pdf","2016-12-02 00:00:00",
47678,1,22325,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022325Orig1s014ltr.pdf","2017-03-24 00:00:00",
47703,2,22325,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022325Orig1s014lbl.pdf","2017-03-24 00:00:00",
29597,1,22327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022327s000ltr.pdf","2009-05-22 00:00:00",
42493,3,22327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327_prevacid_24hr_toc.cfm","2009-08-03 00:00:00",
44182,10,22327,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
44738,21,22327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327s000_SumR.pdf","2009-08-03 00:00:00",
7238,1,22327,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s004ltr.pdf","2010-09-20 00:00:00",
7239,1,22327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s008ltr.pdf","2010-12-06 00:00:00",
38577,2,22327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022327Orig1s008lbl.pdf","2013-11-26 00:00:00",
7240,1,22327,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s009ltr.pdf","2010-12-06 00:00:00",
38578,2,22327,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s009lbl.pdf","2013-11-26 00:00:00",
7241,1,22327,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s013ltr.pdf","2011-04-20 00:00:00",
38579,2,22327,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s013lbl.pdf","2013-11-26 00:00:00",
7242,1,22327,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s016ltr.pdf","2011-09-29 00:00:00",
38580,2,22327,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s016lbl.pdf","2013-11-26 00:00:00",
7243,1,22327,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s017ltr.pdf","2011-11-02 00:00:00",
17243,2,22327,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s017lbl.pdf","2013-11-26 00:00:00",
17244,2,22327,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s018lbl.pdf","2013-11-26 00:00:00",
29598,1,22327,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s018ltr.pdf","2012-04-09 00:00:00",
17245,2,22327,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s019lbl.pdf","2013-11-19 00:00:00",
29599,1,22327,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s019ltr.pdf","2012-04-25 00:00:00",
29600,1,22327,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327Orig1s020ltr.pdf","2012-09-24 00:00:00",
38581,2,22327,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s020lbl.pdf","2013-11-26 00:00:00",
29601,1,22327,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022327Orig1s022ltr.pdf","2015-07-09 00:00:00",
38582,2,22327,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022327Orig1s022lbl.pdf","2015-07-02 00:00:00",
47431,1,22327,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022327Orig1s024ltr.pdf","2017-03-02 00:00:00",
47470,2,22327,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s024lbl.pdf","2017-03-06 00:00:00",
50556,1,22327,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022327Orig1s026ltr.pdf","2017-12-01 00:00:00",
50589,2,22327,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022327Orig1s026lbl.pdf","2017-12-04 00:00:00",
7244,1,22328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022328s000ltr.pdf","2011-11-28 00:00:00",
21994,3,22328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000TOC.cfm","2012-09-05 00:00:00",
23381,8,22328,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM281854.pdf","2011-11-29 00:00:00",
23708,10,22328,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2013-04-29 00:00:00",
24284,21,22328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000SumR.pdf","2012-09-05 00:00:00",
38583,2,22328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022328lbl.pdf","2011-11-28 00:00:00",
38584,2,22328,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf","2013-02-08 00:00:00",
17246,2,22328,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf","2015-09-14 00:00:00",
29602,1,22328,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022328Orig1s004ltr.pdf","2015-09-15 00:00:00",
7245,1,22331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022331s000ltr.pdf","2009-10-07 00:00:00",
21995,3,22331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331_jenloga_toc.cfm","2009-11-10 00:00:00",
29603,1,22331,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s001,s002ltr.pdf","2010-10-04 00:00:00",
38585,2,22331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022331lbl.pdf","2009-10-07 00:00:00",
38586,2,22331,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf","2010-10-07 00:00:00",
48433,3,22331,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022331Orig1s001.pdf","2017-05-17 00:00:00",
53216,20,22331,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22331_Clonidine_Clinical_PREA.pdf","1900-01-01 00:00:00",
53218,18,22331,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22331_Clonidine_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53219,17,22331,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22331_Clonidine_Statistical_PREA.pdf","1900-01-01 00:00:00",
17247,2,22331,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf","2010-10-07 00:00:00",
17248,2,22331,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s005lbl.pdf","2010-10-07 00:00:00",
29604,1,22331,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s005ltr.pdf","2010-10-04 00:00:00",
7246,1,22331,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022331Orig1s012ltr.pdf","2013-02-14 00:00:00",
17249,2,22331,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022331s012lbl.pdf","2013-02-14 00:00:00",
45130,1,22331,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022331Orig1s013ltr.pdf","2016-08-16 00:00:00",
45195,2,22331,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022331s013lbl.pdf","2016-08-16 00:00:00",
17250,2,22331,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf","2014-12-16 00:00:00",
29605,1,22331,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022331Orig1s014ltr.pdf","2014-11-21 00:00:00",
29606,1,22331,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022331Orig1s015ltr.pdf","2015-06-10 00:00:00",
38587,2,22331,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022331s015lbl.pdf","2015-06-10 00:00:00",
7247,1,22332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf","2009-05-29 00:00:00",
17251,2,22332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf","2009-05-25 00:00:00",
21996,3,22332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022332_adcirca_toc.cfm","2009-08-03 00:00:00",
7248,1,22332,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022332s003ltr.pdf","2011-02-14 00:00:00",
38588,2,22332,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf","2011-02-09 00:00:00",
29607,1,22332,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022332Orig1s005ltr.pdf","2013-11-25 00:00:00",
38589,2,22332,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf","2013-11-22 00:00:00",
17252,2,22332,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf","2014-05-02 00:00:00",
29608,1,22332,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022332Orig1s006ltr.pdf","2014-04-30 00:00:00",
7249,1,22332,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022332Orig1s007ltr.pdf","2015-04-03 00:00:00",
17253,2,22332,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf","2015-04-07 00:00:00",
48305,1,22332,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022332Orig1s009ltr.pdf","2017-05-09 00:00:00",
48333,2,22332,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf","2017-05-09 00:00:00",
17254,2,22334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf","2009-04-03 00:00:00",
17255,2,22334,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf","2010-05-17 00:00:00",
21997,3,22334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000TOC.cfm","2009-05-15 00:00:00",
24285,21,22334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000_SumR.pdf","2009-05-15 00:00:00",
29609,1,22334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022334s000ltr.pdf","2009-04-03 00:00:00",
29610,1,22334,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s001ltr.pdf","2010-05-18 00:00:00",
51730,23,22334,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022334_everolimus_Original_WR.pdf","2010-04-01 00:00:00",
53272,18,22334,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22334 everolimus clinpharm bpca.pdf","1900-01-01 00:00:00",
54060,20,22334,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22334 everolinus clinical bpca.pdf","1900-01-01 00:00:00",
7250,1,22334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s004ltr.pdf","2010-07-14 00:00:00",
17256,2,22334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf","2010-07-12 00:00:00",
7251,1,22334,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s006ltr.pdf","2010-11-04 00:00:00",
17257,2,22334,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf","2010-11-01 00:00:00",
7252,1,22334,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf","2011-05-10 00:00:00",
17258,2,22334,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf","2011-05-06 00:00:00",
29611,1,22334,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf","2011-05-10 00:00:00",
38590,2,22334,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf","2011-05-06 00:00:00",
17259,2,22334,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf","2012-04-02 00:00:00",
29612,1,22334,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf","2012-04-02 00:00:00",
29613,1,22334,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf","2012-04-02 00:00:00",
38591,2,22334,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf","2012-04-02 00:00:00",
7253,1,22334,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s016ltrRepl.pdf","2012-07-23 00:00:00",
38592,2,22334,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf","2012-07-20 00:00:00",
42494,3,22334,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022334Orig1s016.pdf","2013-10-21 00:00:00",
7254,1,22334,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s017ltr.pdf","2012-05-02 00:00:00",
38593,2,22334,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf","2012-04-26 00:00:00",
7255,1,22334,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s018ltr.pdf","2012-08-31 00:00:00",
17260,2,22334,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf","2012-08-31 00:00:00",
17261,2,22334,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
29614,1,22334,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
7256,1,22334,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf","2013-11-07 00:00:00",
17262,2,22334,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf","2013-11-08 00:00:00",
29615,1,22334,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
38594,2,22334,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
17263,2,22334,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
29616,1,22334,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
7257,1,22334,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf","2014-07-03 00:00:00",
17264,2,22334,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf","2014-07-02 00:00:00",
17265,2,22334,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf","2014-12-19 00:00:00",
29617,1,22334,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s027ltr.pdf","2014-12-19 00:00:00",
7258,1,22334,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s029ltr.pdf","2015-01-26 00:00:00",
17266,2,22334,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf","2015-01-29 00:00:00",
7259,1,22334,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s030ltr.pdf","2015-05-26 00:00:00",
38595,2,22334,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf","2015-05-27 00:00:00",
7260,1,22334,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s031ltr.pdf","2015-09-22 00:00:00",
17267,2,22334,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf","2015-09-23 00:00:00",
7261,1,22334,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf","2016-02-01 00:00:00",
17268,2,22334,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf","2016-02-02 00:00:00",
7262,1,22334,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s034ltr.pdf","2016-02-05 00:00:00",
38596,2,22334,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf","2016-02-11 00:00:00",
7263,1,22334,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s035ltr.pdf","2016-02-23 00:00:00",
7264,1,22334,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s036ltr.pdf","2016-02-29 00:00:00",
38597,2,22334,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf","2016-02-26 00:00:00",
17269,2,22334,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf","2016-06-17 00:00:00",
29618,1,22334,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s038ltr.pdf","2016-06-16 00:00:00",
49868,2,22334,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022334s039lbl.pdf","2017-09-28 00:00:00",
49876,1,22334,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022334Orig1s039ltr.pdf","2017-09-28 00:00:00",
53647,2,22334,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf","2018-04-11 00:00:00",
53655,1,22334,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022334Orig1s040,203985Orig1s013ltr.pdf","2018-04-12 00:00:00",
17270,2,22341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf","2010-01-26 00:00:00",
29619,1,22341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf","2010-01-26 00:00:00",
38598,2,22341,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf","2010-12-26 00:00:00",
42495,3,22341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm","2010-04-06 00:00:00",
29620,1,22341,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf","2011-05-24 00:00:00",
38599,2,22341,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf","2011-05-23 00:00:00",
7265,1,22341,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf","2012-04-09 00:00:00",
38600,2,22341,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf","2012-04-09 00:00:00",
17271,2,22341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf","2012-04-09 00:00:00",
29621,1,22341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf","2012-04-09 00:00:00",
7266,1,22341,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf","2012-04-09 00:00:00",
38601,2,22341,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf","2012-04-09 00:00:00",
17272,2,22341,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf","2012-12-18 00:00:00",
29622,1,22341,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf","2012-12-19 00:00:00",
17273,2,22341,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf","2013-04-17 00:00:00",
29623,1,22341,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf","2013-04-18 00:00:00",
7267,1,22341,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf","2013-06-14 00:00:00",
38602,2,22341,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf","2013-06-18 00:00:00",
29624,1,22341,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf","2014-08-01 00:00:00",
7268,1,22341,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s022ltr.pdf","2015-02-27 00:00:00",
38603,2,22341,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf","2015-03-03 00:00:00",
7269,1,22341,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s023ltr.pdf","2015-03-11 00:00:00",
17274,2,22341,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf","2015-03-26 00:00:00",
29625,1,22341,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf","2015-07-08 00:00:00",
7270,1,22341,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s025ltr.pdf","2016-04-26 00:00:00",
17275,2,22341,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf","2016-04-27 00:00:00",
45358,1,22341,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s026ltr.pdf","2016-09-22 00:00:00",
49547,1,22341,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s027ltr.pdf","2017-08-28 00:00:00",
49554,2,22341,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf","2017-08-28 00:00:00",
49556,8,22341,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf#page=40","2017-08-28 00:00:00",
48119,2,22341,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf","2017-04-26 00:00:00",
48151,1,22341,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s028ltr.pdf","2017-04-27 00:00:00",
49108,1,22341,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s029ltr.pdf","2017-07-28 00:00:00",
7271,1,22342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022342s000ltr.pdf","2009-07-23 00:00:00",
55256,1,22343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022343Orig1s000Ltr.pdf","2018-08-21 00:00:00",
55299,2,22343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022343s000lbl.pdf","2018-08-24 00:00:00",
7272,1,22344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022344s000ltr.pdf","2018-05-23 00:00:00",
54232,2,22344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022344s000lbl.pdf","2018-05-23 00:00:00",
17276,2,22345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf","2011-06-16 00:00:00",
17277,2,22345,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf","2012-03-19 00:00:00",
21998,3,22345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm","2011-07-11 00:00:00",
23709,10,22345,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm350197.htm","2013-11-01 00:00:00",
29627,1,22345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022345s000ltr.pdf","2011-06-15 00:00:00",
29628,1,22345,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022345s001ltr.pdf","2012-03-23 00:00:00",
43853,8,22345,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf","2011-06-17 00:00:00",
44739,21,22345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000SumR.pdf","2011-07-11 00:00:00",
29629,1,22345,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s006ltr.pdf","2013-09-11 00:00:00",
38604,2,22345,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf","2013-09-09 00:00:00",
7273,1,22345,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s007ltr.pdf","2013-06-07 00:00:00",
17278,2,22345,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf","2013-06-11 00:00:00",
7274,1,22345,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s009Ltr.pdf","2015-11-27 00:00:00",
29630,1,22345,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s010ltr.pdf","2015-05-28 00:00:00",
38605,2,22345,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf","2015-05-29 00:00:00",
17279,2,22345,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf","2016-05-23 00:00:00",
29631,1,22345,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022345Orig1s011ltr.pdf","2016-05-24 00:00:00",
7275,1,22346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022346s000ltr.pdf","2009-03-05 00:00:00",
7276,1,22347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022347s000TALtr.pdf","2009-03-24 00:00:00",
24286,21,22348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348s000SumR.pdf","2010-03-11 00:00:00",
29632,1,22348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022348s000ltr.pdf","2009-06-17 00:00:00",
38606,2,22348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022348lbl.pdf","2009-06-22 00:00:00",
42496,3,22348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348_caldolor_toc.cfm","2010-03-11 00:00:00",
7277,1,22348,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s003ltr.pdf","2015-01-28 00:00:00",
7278,1,22348,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s005ltr.pdf","2015-11-23 00:00:00",
17280,2,22348,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022348s005lbl.pdf","2015-11-25 00:00:00",
51168,18,22348,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen clinpharm prea.pdf","1900-01-01 00:00:00",
51169,20,22348,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen clinical prea.pdf","1900-01-01 00:00:00",
51170,60,22348,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348_ibuprofen_DD clinical_PREA.pdf","1900-01-01 00:00:00",
51171,17,22348,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen statistical prea.pdf","1900-01-01 00:00:00",
29633,1,22348,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022348Orig1s010ltr.pdf","2016-05-11 00:00:00",
38607,2,22348,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf","2016-05-11 00:00:00",
21999,3,22350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000TOC.cfm","2009-09-29 00:00:00",
29634,1,22350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf","2009-08-06 00:00:00",
29635,1,22350,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf","2011-02-24 00:00:00",
38608,2,22350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf","2009-08-14 00:00:00",
38609,2,22350,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf","2011-02-24 00:00:00",
44740,21,22350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf","2009-09-29 00:00:00",
7279,1,22350,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf","2011-02-24 00:00:00",
17281,2,22350,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf","2011-02-24 00:00:00",
17282,2,22350,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf","2011-12-23 00:00:00",
29636,1,22350,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s004ltr.pdf","2011-12-22 00:00:00",
29637,1,22350,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s007ltr.pdf","2011-11-17 00:00:00",
38610,2,22350,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf","2011-11-16 00:00:00",
7280,1,22350,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022350s009ltr.pdf","2012-03-15 00:00:00",
7281,1,22350,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022350Orig1s011ltr.pdf","2013-05-29 00:00:00",
17283,2,22350,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf","2013-06-04 00:00:00",
7282,1,22350,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf","2016-04-07 00:00:00",
38611,2,22350,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf","2016-04-07 00:00:00",
7283,1,22350,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf","2015-09-01 00:00:00",
38612,2,22350,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf","2015-09-04 00:00:00",
47359,2,22350,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf","2017-02-28 00:00:00",
47475,8,22350,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf#page=31","2017-03-07 00:00:00",
47498,1,22350,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf","2017-03-08 00:00:00",
46919,2,22350,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s019lbl.pdf","2017-01-18 00:00:00",
46937,1,22350,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s019ltr.pdf","2017-01-24 00:00:00",
7284,1,22351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022351s000ltr.pdf","2009-08-06 00:00:00",
17284,2,22351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf","2009-07-31 00:00:00",
42497,3,22351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351_colcrys_toc.cfm","2010-02-17 00:00:00",
44498,14,22351,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf","2009-08-04 00:00:00",
44741,21,22351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351s000_SumR.pdf","2010-02-17 00:00:00",
54103,18,22351,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202703 colchicine clinical-clinpharm bpca_final.pdf","1900-01-01 00:00:00",
29638,1,22352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022352s000ltr.pdf","2009-08-06 00:00:00",
38613,2,22352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf","2009-07-30 00:00:00",
42498,3,22352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352_colcrys_toc.cfm","2010-02-17 00:00:00",
44742,21,22352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352s000_SumR.pdf","2010-02-17 00:00:00",
17285,2,22352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf","2010-05-07 00:00:00",
29639,1,22352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022352s004ltr.pdf","2010-05-06 00:00:00",
7285,1,22352,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf","2011-07-25 00:00:00",
17286,2,22352,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf","2011-07-25 00:00:00",
29640,1,22352,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf","2011-07-25 00:00:00",
38614,2,22352,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf","2011-07-25 00:00:00",
29641,1,22352,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022352Orig1s017ltr.pdf","2014-08-15 00:00:00",
38615,2,22352,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf","2014-08-15 00:00:00",
7286,1,22352,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022352Orig1s022ltr.pdf","2015-12-18 00:00:00",
17287,2,22352,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf","2015-12-31 00:00:00",
46116,8,22352,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf#page=24","2016-12-09 00:00:00",
7287,1,22353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022353s000ltr.pdf","2009-10-26 00:00:00",
17288,2,22353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf","2009-10-21 00:00:00",
22000,3,22353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353_colcrys_toc.cfm","2010-02-18 00:00:00",
24287,21,22353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353s000_SumR.pdf","2010-02-18 00:00:00",
43855,8,22353,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf","2009-10-30 00:00:00",
44183,10,22353,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm174382.htm","2009-11-24 00:00:00",
7288,1,22356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022356s000ltr.pdf","2010-03-10 00:00:00",
29642,1,22359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022359s000TAltr.pdf","2010-08-09 00:00:00",
7289,1,22360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022360s000ltr.pdf","2009-05-27 00:00:00",
22001,3,22360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360_nicorette_toc.cfm","2009-12-30 00:00:00",
24288,21,22360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360s000_SumR.pdf","2009-12-30 00:00:00",
29643,1,22360,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022360s002ltr.pdf","2011-12-08 00:00:00",
7290,1,22360,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022360Orig1s004ltr.pdf","2012-09-24 00:00:00",
38616,2,22360,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.pdf","2013-04-17 00:00:00",
48856,3,22360,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022360Orig1S005.pdf","2017-06-28 00:00:00",
7291,1,22360,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s006ltr.pdf","2013-05-28 00:00:00",
17289,2,22360,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf","2013-09-24 00:00:00",
17290,2,22360,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf","2013-11-07 00:00:00",
29644,1,22360,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s007ltr.pdf","2013-10-29 00:00:00",
22002,3,22360,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022360Orig1s008.pdf","2015-11-18 00:00:00",
7292,1,22360,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s009ltr.pdf","2015-04-17 00:00:00",
38617,2,22360,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf","2015-04-21 00:00:00",
7293,1,22360,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s010ltr.pdf","2015-10-02 00:00:00",
38618,2,22360,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf","2015-10-22 00:00:00",
54551,1,22360,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022360ORig1s011ltr.pdf","2018-06-14 00:00:00",
54652,2,22360,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022360ORig1s011lbl.pdf","2018-06-21 00:00:00",
7294,1,22362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf","2009-10-26 00:00:00",
17291,2,22362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf","2009-10-07 00:00:00",
24289,21,22362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362s000sumr.pdf","2010-03-31 00:00:00",
42499,3,22362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362_welchol_toc.cfm","2010-03-31 00:00:00",
51485,23,22362,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Original_WR1.pdf","2004-08-31 00:00:00",
51487,25,22362,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_1_WR.pdf","2006-01-19 00:00:00",
51490,26,22362,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_2_WR.pdf","2006-03-28 00:00:00",
51493,27,22362,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021176_colesevelam_Amendment_3_WR.pdf","2007-04-02 00:00:00",
29645,1,22362,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf","2010-09-16 00:00:00",
38619,2,22362,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf","2010-09-20 00:00:00",
17292,2,22362,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022362s007lbl.pdf","2011-07-18 00:00:00",
29646,1,22362,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf","2011-07-19 00:00:00",
17293,2,22362,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf","2012-01-06 00:00:00",
29647,1,22362,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf","2012-01-17 00:00:00",
29648,1,22362,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf","2012-07-13 00:00:00",
38620,2,22362,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf","2012-07-13 00:00:00",
29649,1,22362,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf","2013-07-02 00:00:00",
38621,2,22362,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf","2013-07-02 00:00:00",
29650,1,22362,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf","2013-07-02 00:00:00",
38622,2,22362,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf","2013-07-02 00:00:00",
29651,1,22362,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf","2013-07-02 00:00:00",
38623,2,22362,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf","2013-07-02 00:00:00",
17294,2,22362,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf","2014-01-23 00:00:00",
29652,1,22362,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf","2014-01-23 00:00:00",
7295,1,22363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022363s000ltr.pdf","2009-08-26 00:00:00",
38624,2,22363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022363s000lbl.pdf","2009-08-26 00:00:00",
42500,3,22363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022363s000TOC.cfm","2009-11-23 00:00:00",
7296,1,22363,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022363s002ltr.pdf","2010-06-08 00:00:00",
17295,2,22363,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s005lbl.pdf","2011-06-16 00:00:00",
29653,1,22363,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s005ltr.pdf","2011-06-27 00:00:00",
17296,2,22363,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s006lbl.pdf","2011-08-05 00:00:00",
29654,1,22363,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s006ltr.pdf","2011-08-05 00:00:00",
22003,3,22363,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf","2012-03-30 00:00:00",
29655,1,22363,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf","2012-02-28 00:00:00",
38625,2,22363,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf","2012-02-28 00:00:00",
7297,1,22363,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf","2012-02-28 00:00:00",
17297,2,22363,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf","2012-02-28 00:00:00",
22004,3,22363,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf","2012-04-24 00:00:00",
29656,1,22363,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363Orig1s010ltr.pdf","2012-11-06 00:00:00",
38626,2,22363,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s010lbl.pdf","2012-11-06 00:00:00",
45918,1,22363,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022363Orig1s011ltr.pdf","2016-11-22 00:00:00",
45936,2,22363,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022363s011lbl.pdf","2016-11-21 00:00:00",
29657,1,22363,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022363Orig1s012ltr.pdf","2013-10-18 00:00:00",
38627,2,22363,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022363s012lbl.pdf","2013-10-18 00:00:00",
7298,1,22368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022368s000ltr.pdf","2010-10-12 00:00:00",
22005,3,22368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368_aridol_toc.cfm","2011-05-19 00:00:00",
38628,2,22368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf","2010-10-13 00:00:00",
44743,21,22368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368Orig1s000SumR.pdf","2011-05-19 00:00:00",
53329,20,22368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022368_Mannitol_Clinical_PREA.pdf","1900-01-01 00:00:00",
53330,18,22368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22368_Mannitol_Clinpharm_PREA_REVISED_CD_4-10.11.pdf","1900-01-01 00:00:00",
53331,17,22368,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022368_Mannitol_Statistical_PREA.pdf","1900-01-01 00:00:00",
22006,3,22369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369_latisse_toc.cfm","2009-08-27 00:00:00",
24290,21,22369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369s000_SumR.pdf","2009-08-27 00:00:00",
29658,1,22369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022369s000ltr.pdf","2008-12-31 00:00:00",
38629,2,22369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022369lbl.pdf","2009-01-02 00:00:00",
7299,1,22369,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022369s004ltr.pdf","2011-09-12 00:00:00",
17298,2,22369,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf","2011-09-16 00:00:00",
17299,2,22369,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf","2012-03-29 00:00:00",
38630,2,22369,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022369s007lbl.pdf","2013-03-15 00:00:00",
7300,1,22369,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008s,010ltr.pdf","2014-09-08 00:00:00",
17300,2,22369,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf","2014-09-09 00:00:00",
51891,60,22369,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_Division_Director_PREA.pdf","1900-01-01 00:00:00",
51893,57,22369,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_CDTL_PREA.pdf","1900-01-01 00:00:00",
7301,1,22369,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008,s010ltr.pdf","2014-09-08 00:00:00",
17301,2,22369,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf","2014-09-09 00:00:00",
51892,60,22369,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_Division_Director_PREA.pdf","1900-01-01 00:00:00",
51894,57,22369,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_CDTL_PREA.pdf","1900-01-01 00:00:00",
51895,20,22369,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_Clinical_PREA.pdf","1900-01-01 00:00:00",
51896,17,22369,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_Stats_PREA.pdf","1900-01-01 00:00:00",
51897,17,22369,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22369_Bimatoprost_Stat_Add_PREA.pdf","1900-01-01 00:00:00",
49167,2,22369,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022369s011lbl.pdf","2017-07-29 00:00:00",
49197,1,22369,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022369Orig1s011ltr.pdf","2017-08-02 00:00:00",
7302,1,22370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022370s000ltr.pdf","2009-02-18 00:00:00",
7303,1,22370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022370s000ltr.pdf","2010-05-12 00:00:00",
22007,3,22370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022370s000_tramadol_toc.cfm","2011-02-22 00:00:00",
38631,2,22370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022370s000lbl.pdf","2010-05-17 00:00:00",
46337,2,22370,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf","2016-12-21 00:00:00",
46342,1,22370,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022370Orig1s012,s014ltr.pdf","2016-12-21 00:00:00",
46338,2,22370,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf","2016-12-21 00:00:00",
46343,1,22370,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022370Orig1s012,s014ltr.pdf","2016-12-21 00:00:00",
49603,2,22370,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf","2017-08-30 00:00:00",
49604,8,22370,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf#page=33","2017-08-30 00:00:00",
49641,1,22370,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022370Orig1s015ltr.pdf","2017-08-31 00:00:00",
55597,2,22370,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf","2018-09-24 00:00:00",
55599,8,22370,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf#page=34","2018-09-24 00:00:00",
55690,1,22370,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022370Orig1s016s017ltr.pdf","2018-10-01 00:00:00",
55598,2,22370,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf","2018-09-24 00:00:00",
55600,8,22370,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf#page=34","2018-09-24 00:00:00",
55691,1,22370,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022370Orig1s016s017ltr.pdf","2018-10-01 00:00:00",
24291,21,22372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372Orig1s000SumR.pdf","2011-09-16 00:00:00",
29659,1,22372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022372s000ltr.pdf","2010-08-10 00:00:00",
38632,2,22372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf","2010-08-10 00:00:00",
42501,3,22372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372_suprep_toc.cfm","2011-09-16 00:00:00",
43856,8,22372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000MedGuide.pdf","2010-08-10 00:00:00",
7304,1,22372,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022372s003ltr.pdf","2011-07-12 00:00:00",
17302,2,22372,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf","2012-11-02 00:00:00",
29660,1,22372,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022372Orig1s004ltr.pdf","2012-11-06 00:00:00",
7305,1,22377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022377s000ltr.pdf","2010-07-02 00:00:00",
22008,3,22377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377_alsuma_toc.cfm","2011-05-11 00:00:00",
24292,21,22377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377Orig1s000SumR.pdf","2011-05-11 00:00:00",
38633,2,22377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf","2010-07-06 00:00:00",
29661,1,22377,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf","2014-06-10 00:00:00",
38634,2,22377,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf","2014-06-10 00:00:00",
29662,1,22377,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf","2014-06-10 00:00:00",
38635,2,22377,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf","2014-06-10 00:00:00",
24293,21,22382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382Orig1s000SumR.pdf","2011-05-03 00:00:00",
29663,1,22382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022382s000ltr.pdf","2010-05-21 00:00:00",
38636,2,22382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022382s000lbl.pdf","2010-05-28 00:00:00",
42502,3,22382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382_sprix_toc.cfm","2011-05-03 00:00:00",
29664,1,22382,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022382Orig1s009ltr.pdf","2014-04-22 00:00:00",
38637,2,22382,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022382s009lbl.pdf","2014-04-22 00:00:00",
29665,1,22382,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf","2016-05-10 00:00:00",
38638,2,22382,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf","2016-05-11 00:00:00",
7306,1,22382,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf","2016-05-10 00:00:00",
38639,2,22382,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf","2016-05-11 00:00:00",
51405,2,22382,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf","2018-01-22 00:00:00",
51563,8,22382,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf#page=20","2018-01-24 00:00:00",
51900,1,22382,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022382Orig1s018ltr.pdf","2018-01-26 00:00:00",
7307,1,22383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022383s000ltr.pdf","2011-07-07 00:00:00",
23391,8,22383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf","2011-07-05 00:00:00",
24294,21,22383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000SumR.pdf","2011-08-12 00:00:00",
38640,2,22383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf","2011-07-05 00:00:00",
42503,3,22383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000TOC.cfm","2011-08-12 00:00:00",
7308,1,22383,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s002ltr.pdf","2012-09-27 00:00:00",
38641,2,22383,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf","2012-09-26 00:00:00",
7309,1,22383,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf","2012-12-26 00:00:00",
29666,1,22383,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf","2012-12-26 00:00:00",
17303,2,22386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf","2008-06-26 00:00:00",
29667,1,22386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022386s000ltr.pdf","2008-06-26 00:00:00",
42504,3,22386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386_prandimet_toc.cfm","2009-04-14 00:00:00",
44744,21,22386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386s000_SumR.pdf","2009-04-14 00:00:00",
29668,1,22386,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf","2010-06-04 00:00:00",
38642,2,22386,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf","2010-06-03 00:00:00",
7310,1,22386,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s007ltr.pdf","2012-03-05 00:00:00",
17304,2,22386,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf","2012-03-06 00:00:00",
7311,1,22386,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s008ltr.pdf","2012-04-27 00:00:00",
38643,2,22386,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf","2012-04-26 00:00:00",
50653,2,22386,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf","2017-12-11 00:00:00",
47923,2,22386,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf","2017-04-11 00:00:00",
47949,1,22386,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022386Orig1s018ltr.pdf","2017-04-12 00:00:00",
7312,1,22387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf","2009-08-06 00:00:00",
22009,3,22387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm","2010-04-06 00:00:00",
38644,2,22387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf","2009-07-30 00:00:00",
44499,14,22387,"ORIG",1,"Usage Instructions","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387UsageInstr.pdf","2009-08-05 00:00:00",
29669,1,22387,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf","2011-02-14 00:00:00",
38645,2,22387,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf","2011-02-09 00:00:00",
29670,1,22387,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf","2013-05-02 00:00:00",
38646,2,22387,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf","2013-05-01 00:00:00",
7313,1,22387,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf","2014-05-22 00:00:00",
38647,2,22387,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf","2014-05-28 00:00:00",
7314,1,22387,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf","2016-06-08 00:00:00",
17305,2,22387,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf","2016-06-13 00:00:00",
50139,1,22387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022387Orig1s015ltr.pdf","2017-10-23 00:00:00",
50162,2,22387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s015lbl.pdf","2017-10-24 00:00:00",
7315,1,22393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022393s000ltr.pdf","2009-11-13 00:00:00",
29671,1,22393,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s001ltr.pdf","2011-04-15 00:00:00",
38648,2,22393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022393lbl.pdf","2009-11-06 00:00:00",
38649,2,22393,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf","2011-04-15 00:00:00",
42505,3,22393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000TOC.cfm","2010-01-04 00:00:00",
44745,21,22393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000_SumR.pdf","2010-01-04 00:00:00",
17306,2,22393,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf","2011-06-16 00:00:00",
29672,1,22393,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s004ltr.pdf","2011-06-27 00:00:00",
7316,1,22393,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s006ltr.pdf","2011-10-03 00:00:00",
38650,2,22393,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s006lbl.pdf","2011-09-30 00:00:00",
7317,1,22393,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022393Orig1s011ltr.pdf","2013-06-14 00:00:00",
17307,2,22393,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022393s011lbl.pdf","2013-06-18 00:00:00",
17308,2,22393,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022393s013lbl.pdf","2014-10-16 00:00:00",
29673,1,22393,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022393Orig1s013ltr.pdf","2014-10-21 00:00:00",
7318,1,22393,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022393Orig1s014ltr.pdf","2016-08-01 00:00:00",
38651,2,22393,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf","2016-07-28 00:00:00",
17309,2,22395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf","2009-11-17 00:00:00",
22010,3,22395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395_qutenza_toc.cfm","2010-06-29 00:00:00",
29674,1,22395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022395s000ltr.pdf","2009-11-19 00:00:00",
44746,21,22395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395s000Sumr.pdf","2010-06-29 00:00:00",
7319,1,22396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022396Orig1s000ltr.pdf","2014-12-30 00:00:00",
17310,2,22396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396s000lbledt.pdf","2015-01-08 00:00:00",
42506,3,22396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022396Orig1s000TOC.cfm","2016-02-16 00:00:00",
7320,1,22396,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022396Orig1s003ltr.pdf","2016-05-10 00:00:00",
38652,2,22396,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022396s003lbl.pdf","2016-05-11 00:00:00",
7321,1,22399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022399s000ltr.pdf","2011-04-11 00:00:00",
22011,3,22399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000TOC.cfm","2011-05-16 00:00:00",
23392,8,22399,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250398.pdf","2011-04-07 00:00:00",
38653,2,22399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf","2011-04-07 00:00:00",
44747,21,22399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000SumR.pdf","2011-05-16 00:00:00",
17311,2,22399,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf","2012-06-11 00:00:00",
29675,1,22399,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s003ltr.pdf","2012-06-08 00:00:00",
45791,3,22399,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022399Orig1s003.pdf","2016-11-02 00:00:00",
7322,1,22399,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s004ltr.pdf","2012-04-23 00:00:00",
17312,2,22399,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf","2012-04-20 00:00:00",
7323,1,22399,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s005ltr.pdf","2013-03-29 00:00:00",
38654,2,22399,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf","2013-04-01 00:00:00",
29676,1,22399,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf","2012-12-27 00:00:00",
38655,2,22399,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf","2012-12-28 00:00:00",
7324,1,22399,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf","2012-12-27 00:00:00",
38656,2,22399,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf","2012-12-28 00:00:00",
17313,2,22399,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf","2013-05-09 00:00:00",
29677,1,22399,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s008ltr.pdf","2013-05-07 00:00:00",
17314,2,22401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf","2009-10-16 00:00:00",
24295,21,22401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/22401s000sumr.pdf","2010-03-31 00:00:00",
29678,1,22401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022401s000ltr.pdf","2009-11-02 00:00:00",
42507,3,22401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022401_twynsta_toc.cfm","2010-03-31 00:00:00",
29679,1,22401,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022401s002ltr.pdf","2010-07-29 00:00:00",
38657,2,22401,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf","2010-07-31 00:00:00",
17315,2,22401,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf","2012-01-23 00:00:00",
29680,1,22401,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s004ltr.pdf","2012-01-23 00:00:00",
7325,1,22401,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s005ltr.pdf","2011-06-07 00:00:00",
38658,2,22401,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf","2011-06-06 00:00:00",
7326,1,22401,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf","2012-10-23 00:00:00",
17316,2,22401,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf","2012-10-22 00:00:00",
17317,2,22401,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf","2012-10-22 00:00:00",
29681,1,22401,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf","2012-10-23 00:00:00",
7327,1,22401,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s010ltr.pdf","2011-11-16 00:00:00",
17318,2,22401,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf","2011-11-14 00:00:00",
7328,1,22401,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s011ltr.pdf","2012-04-02 00:00:00",
17319,2,22401,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf","2012-03-30 00:00:00",
29682,1,22401,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s012ltr.pdf","2012-11-16 00:00:00",
38659,2,22401,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf","2012-11-15 00:00:00",
7329,1,22401,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022401Orig1s016ltr.pdf","2014-12-15 00:00:00",
17320,2,22401,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf","2014-12-16 00:00:00",
7330,1,22401,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022401Orig1s018ltr.pdf","2016-01-15 00:00:00",
38660,2,22401,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf","2016-01-25 00:00:00",
52260,2,22401,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022401s019lbl.pdf","2018-02-02 00:00:00",
52300,1,22401,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022401Orig1s019ltr.pdf","2018-02-02 00:00:00",
24296,21,22402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402s000_SumR.pdf","2009-12-30 00:00:00",
29683,1,22402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022402s000ltr.pdf","2009-07-22 00:00:00",
38661,2,22402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf","2009-07-24 00:00:00",
42508,3,22402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402_codeine_sulfate_toc.cfm","2009-12-30 00:00:00",
17321,2,22402,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf","2012-04-20 00:00:00",
29684,1,22402,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022402s003ltr.pdf","2012-04-19 00:00:00",
7331,1,22402,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022402Orig1s006ltr.pdf","2013-05-14 00:00:00",
17322,2,22402,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf","2013-05-14 00:00:00",
46336,2,22402,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf","2016-12-21 00:00:00",
46377,1,22402,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022402Orig1s008ltr.pdf","2016-12-21 00:00:00",
49611,2,22402,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf","2017-08-30 00:00:00",
49612,8,22402,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf#page=26","2017-08-30 00:00:00",
49636,1,22402,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022402Orig1s009ltr.pdf","2017-08-31 00:00:00",
55593,2,22402,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf","2018-09-24 00:00:00",
55595,8,22402,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf#page=26","2018-09-24 00:00:00",
55705,1,22402,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf","2018-10-01 00:00:00",
55594,2,22402,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf","2018-09-24 00:00:00",
55596,8,22402,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf#page=26","2018-09-24 00:00:00",
55706,1,22402,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf","2018-10-01 00:00:00",
17323,2,22404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf","2010-05-03 00:00:00",
22012,3,22404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404s000_oravig_toc.cfm","2010-12-23 00:00:00",
24297,21,22404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404Orig1s000SumR.pdf","2010-12-23 00:00:00",
29685,1,22404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022404s000ltr.pdf","2010-05-03 00:00:00",
29686,1,22404,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022404s002ltr.pdf","2011-04-13 00:00:00",
38662,2,22404,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022404s002lbl.pdf","2011-04-11 00:00:00",
17324,2,22404,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf","2013-03-08 00:00:00",
29687,1,22404,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022404Orig1s003ltr.pdf","2013-03-06 00:00:00",
17325,2,22405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf","2011-04-15 00:00:00",
23393,8,22405,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250399.pdf","2011-04-07 00:00:00",
24029,14,22405,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=11","2011-07-08 00:00:00",
29688,1,22405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s000ltr.pdf","2011-04-11 00:00:00",
29689,1,22405,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s001ltr.pdf","2011-06-29 00:00:00",
38663,2,22405,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf","2011-06-29 00:00:00",
42509,3,22405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000TOC.cfm","2011-05-03 00:00:00",
44748,21,22405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000SumR.pdf","2011-05-03 00:00:00",
7332,1,22405,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022405Orig1s003ltr.pdf","2012-10-11 00:00:00",
38664,2,22405,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf","2012-10-12 00:00:00",
17326,2,22405,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf","2013-07-05 00:00:00",
29690,1,22405,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s004ltr.pdf","2013-07-08 00:00:00",
7333,1,22405,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s005ltr.pdf","2013-12-05 00:00:00",
17327,2,22405,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf","2014-04-01 00:00:00",
29691,1,22405,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf","2014-04-02 00:00:00",
48460,1,22405,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022405Orig1s009ltr.pdf","2017-05-19 00:00:00",
29692,1,22405,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf","2016-08-01 00:00:00",
38665,2,22405,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf","2016-08-02 00:00:00",
7334,1,22406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf","2011-07-07 00:00:00",
17328,2,22406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf","2011-07-07 00:00:00",
22013,3,22406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000TOC.cfm","2013-09-05 00:00:00",
29693,1,22406,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf","2012-11-06 00:00:00",
38666,2,22406,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf","2012-11-06 00:00:00",
7335,1,22406,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf","2012-11-06 00:00:00",
17329,2,22406,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf","2012-11-06 00:00:00",
17330,2,22406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf","2012-11-06 00:00:00",
29694,1,22406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf","2012-11-06 00:00:00",
7336,1,22406,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022406Orig1s004ltr.pdf","2013-03-04 00:00:00",
17331,2,22406,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022406s004lbl.pdf","2013-03-05 00:00:00",
17332,2,22406,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s007lbl.pdf","2014-01-10 00:00:00",
29695,1,22406,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s007ltr.pdf","2014-01-09 00:00:00",
7337,1,22406,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s009ltr.pdf","2014-03-07 00:00:00",
17547,2,22406,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s009lbl.pdf","2014-03-07 00:00:00",
17548,2,22406,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s010lbl.pdf","2014-02-14 00:00:00",
29696,1,22406,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s010ltr.pdf","2014-02-14 00:00:00",
38667,2,22406,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s011lbl.pdf","2014-09-19 00:00:00",
7338,1,22406,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022406Orig1s012ltr.pdf","2015-01-20 00:00:00",
17549,2,22406,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022406s012lbl.pdf","2015-01-20 00:00:00",
7339,1,22406,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s015ltr.pdf","2014-12-24 00:00:00",
17550,2,22406,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s015lbl.pdf","2015-01-09 00:00:00",
45048,1,22406,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s017ltr.pdf","2016-08-17 00:00:00",
45095,2,22406,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s017lbl.pdf","2016-08-22 00:00:00",
45059,1,22406,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf","2016-08-25 00:00:00",
45167,2,22406,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf","2016-08-25 00:00:00",
45060,1,22406,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf","2016-08-25 00:00:00",
45168,2,22406,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf","2016-08-25 00:00:00",
48870,2,22406,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s023lbl.pdf","2017-06-29 00:00:00",
48881,1,22406,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022406Orig1s023ltr.pdf","2017-06-30 00:00:00",
50233,2,22406,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s024lbl.pdf","2017-10-30 00:00:00",
50240,1,22406,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022406Orig1s024ltr.pdf","2017-10-31 00:00:00",
50245,8,22406,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s024lbl.pdf#page=45","2017-11-01 00:00:00",
55075,2,22406,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s028lbl.pdf","2018-08-02 00:00:00",
55086,1,22406,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022406Orig1s028Ltr.pdf","2018-08-03 00:00:00",
17551,2,22407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf","2013-06-25 00:00:00",
24298,21,22407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407Orig1s000SumR.pdf","2013-07-03 00:00:00",
29697,1,22407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf","2013-06-26 00:00:00",
42510,3,22407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407_vibativ_toc.cfm","2013-10-07 00:00:00",
43861,8,22407,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf","2013-06-28 00:00:00",
17552,2,22408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022408lbl.pdf","2011-01-19 00:00:00",
24299,21,22408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000SumR.pdf","2011-02-17 00:00:00",
29698,1,22408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022408s000ltr.pdf","2011-01-20 00:00:00",
42511,3,22408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408sOrig1s000TOC.cfm","2011-02-16 00:00:00",
54128,20,22408,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408 spinosad clinical PREA.pdf","1900-01-01 00:00:00",
54129,18,22408,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408 spinosad clinpharm PREA.pdf","1900-01-01 00:00:00",
54130,17,22408,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408 spinosad statistical PREA.pdf","1900-01-01 00:00:00",
54131,17,22408,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408 spinosad statistical2 PREA.pdf","1900-01-01 00:00:00",
7340,1,22408,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022408Orig1s005ltr.pdf","2015-01-07 00:00:00",
38668,2,22408,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf","2015-01-05 00:00:00",
51483,20,22408,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408s005 spinosad clinical prea.pdf","1900-01-01 00:00:00",
51488,18,22408,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22408s005 spinosad clinpharm prea.pdf","1900-01-01 00:00:00",
50046,19,22410,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=352","2017-10-12 00:00:00",
7341,1,22410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf","2010-09-02 00:00:00",
24300,21,22410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000SumR.pdf","2011-08-12 00:00:00",
38669,2,22410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf","2010-09-10 00:00:00",
42512,3,22410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000TOC.cfm","2011-08-12 00:00:00",
7342,1,22410,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf","2014-04-29 00:00:00",
38670,2,22410,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf","2014-04-29 00:00:00",
17553,2,22410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf","2012-08-15 00:00:00",
42513,3,22410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s006.pdf","2013-02-25 00:00:00",
17554,2,22410,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf","2012-08-15 00:00:00",
42514,3,22410,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s007.pdf","2013-02-25 00:00:00",
22014,3,22410,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022410Orig1s011.pdf","2014-08-05 00:00:00",
22015,3,22410,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s014.pdf","2014-08-05 00:00:00",
7343,1,22410,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022410Orig1s015ltr.pdf","2013-11-25 00:00:00",
17555,2,22410,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf","2013-11-26 00:00:00",
42515,3,22410,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s016.pdf","2014-08-05 00:00:00",
7344,1,22410,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf","2014-04-29 00:00:00",
38671,2,22410,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf","2014-04-29 00:00:00",
7345,1,22410,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf","2014-04-29 00:00:00",
17556,2,22410,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf","2014-04-29 00:00:00",
7346,1,22410,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf","2015-09-24 00:00:00",
38672,2,22410,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf","2015-10-06 00:00:00",
7347,1,22410,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf","2015-09-24 00:00:00",
38673,2,22410,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf","2015-10-06 00:00:00",
47196,1,22410,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022410Orig1s023ltr.pdf","2017-02-14 00:00:00",
47248,2,22410,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf","2017-02-16 00:00:00",
29699,1,22410,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf","2016-07-12 00:00:00",
46335,2,22410,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf","2016-12-21 00:00:00",
46379,1,22410,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf","2016-12-21 00:00:00",
46334,2,22410,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf","2016-12-21 00:00:00",
46380,1,22410,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf","2016-12-21 00:00:00",
49839,1,22410,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf","2017-09-22 00:00:00",
52245,2,22410,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s031lbl.pdf","2018-02-01 00:00:00",
52288,1,22410,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022410Orig1s031ltr.pdf","2018-02-02 00:00:00",
54593,1,22410,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s019,020733Orig1s023,022410Orig1s033ltr.pdf","2018-06-14 00:00:00",
54610,2,22410,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf","2018-06-19 00:00:00",
54621,8,22410,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32","2018-06-20 00:00:00",
7348,1,22411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022411s000ltr.pdf","2010-02-05 00:00:00",
17557,2,22411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022411lbl.pdf","2010-02-04 00:00:00",
23396,8,22411,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf","2010-02-04 00:00:00",
42516,3,22411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411_oleptro_toc.cfm","2010-07-27 00:00:00",
44749,21,22411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411s000SumR.pdf","2010-07-27 00:00:00",
29700,1,22411,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022411s004ltr.pdf","2011-05-10 00:00:00",
38674,2,22411,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022411s004lbl.pdf","2011-05-06 00:00:00",
7349,1,22411,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022411Orig1s007ltr.pdf","2012-11-14 00:00:00",
17558,2,22411,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022411s007lbl.pdf","2012-11-15 00:00:00",
7350,1,22411,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022411Orig1s008ltr.pdf","2014-07-21 00:00:00",
38675,2,22411,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022411s008lbl.pdf","2014-07-22 00:00:00",
17559,2,22416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf","2013-11-15 00:00:00",
22016,3,22416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm","2013-12-20 00:00:00",
24301,21,22416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm","2013-12-20 00:00:00",
29701,1,22416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022416Orig1s000ltr.pdf","2013-11-13 00:00:00",
29702,1,22416,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022416Orig1s001ltr.pdf","2015-09-01 00:00:00",
38676,2,22416,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf","2015-08-28 00:00:00",
47510,1,22416,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s006ltr.pdf","2017-03-08 00:00:00",
49733,2,22416,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf","2017-09-14 00:00:00",
49734,8,22416,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf#page=26","2017-09-14 00:00:00",
49814,1,22416,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s009ltr.pdf","2017-09-20 00:00:00",
52480,57,22416,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/198_22416S009 eslicarbazepine CDTL clinical prea.pdf","1900-01-01 00:00:00",
52481,20,22416,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/199_22416S009 eslicarbazepine clinical prea.pdf","1900-01-01 00:00:00",
52482,18,22416,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200_22416S009 eslicarbazepine clinpharm prea.pdf","1900-01-01 00:00:00",
7351,1,22417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022417s000ltr.pdf","2010-02-17 00:00:00",
17560,2,22417,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf","2010-05-07 00:00:00",
24302,21,22417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022417s000_SumR.pdf","2010-06-06 00:00:00",
29703,1,22417,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001ltr.pdf","2010-05-03 00:00:00",
38677,2,22417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022417lbl.pdf","2010-02-16 00:00:00",
42517,3,22417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022417s000TOC.cfm","2010-06-06 00:00:00",
7352,1,22417,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020659s055,022417s006ltr.pdf","2011-12-08 00:00:00",
17561,2,22417,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf","2011-12-14 00:00:00",
7353,1,22417,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007ltr.pdf","2012-02-27 00:00:00",
38678,2,22417,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf","2012-02-22 00:00:00",
7354,1,22417,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659Orig1s057ltr.pdf","2012-11-23 00:00:00",
38679,2,22417,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf","2012-11-28 00:00:00",
7355,1,22417,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020659Orig1s058,022417Orig1s010ltr.pdf","2013-11-08 00:00:00",
17562,2,22417,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf","2013-11-08 00:00:00",
7356,1,22417,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s012,020659Orig1s060ltr.pdf","2015-03-17 00:00:00",
38680,2,22417,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf","2015-03-19 00:00:00",
7357,1,22417,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659Orig1s061ltr.pdf","2015-04-03 00:00:00",
17563,2,22417,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf","2015-04-07 00:00:00",
17564,2,22417,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf","2015-11-12 00:00:00",
29704,1,22417,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417Orig1s14ltr.pdf","2015-11-17 00:00:00",
45949,1,22417,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s063,022417Orig1s015ltr.pdf","2016-11-23 00:00:00",
45993,2,22417,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf","2016-12-01 00:00:00",
46512,2,22417,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf","2016-12-22 00:00:00",
46531,1,22417,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s064022417Orig1s016ltr.pdf","2016-12-23 00:00:00",
45285,1,22417,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf","2016-09-19 00:00:00",
45310,2,22417,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf","2016-09-15 00:00:00",
48877,2,22417,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf","2017-06-30 00:00:00",
48885,1,22417,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf","2017-06-30 00:00:00",
48678,2,22417,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf","2017-06-08 00:00:00",
48679,1,22417,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s067,022417Orig1s019ltr.pdf","2017-06-08 00:00:00",
49918,2,22417,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf","2017-10-03 00:00:00",
49925,1,22417,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf","2017-10-03 00:00:00",
7358,1,22418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022418s000ltr.pdf","2009-08-21 00:00:00",
17565,2,22418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022418lbl.pdf","2009-10-01 00:00:00",
42518,3,22418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418_fibricor_toc.cfm","2010-01-05 00:00:00",
44750,21,22418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418s000_SumR.pdf","2010-01-05 00:00:00",
7359,1,22418,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s006ltr.pdf","2012-01-17 00:00:00",
38681,2,22418,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s006lbl.pdf","2012-01-06 00:00:00",
29705,1,22418,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s007ltr.pdf","2012-03-19 00:00:00",
38682,2,22418,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s007lbl.pdf","2012-03-16 00:00:00",
7360,1,22418,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf","2012-12-19 00:00:00",
38683,2,22418,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf","2012-12-13 00:00:00",
7361,1,22418,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf","2012-12-19 00:00:00",
17566,2,22418,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf","2012-12-13 00:00:00",
29706,1,22418,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022418Orig1s010ltr.pdf","2013-03-19 00:00:00",
38684,2,22418,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022418s010lbl.pdf","2013-03-11 00:00:00",
7362,1,22418,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022418Orig1s011ltr.pdf","2014-01-07 00:00:00",
38685,2,22418,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022418s011lbl.pdf","2014-01-07 00:00:00",
54281,2,22418,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022418s014lbl.pdf","2018-05-21 00:00:00",
54320,1,22418,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022418Orig1s014ltr.pdf","2018-05-24 00:00:00",
29707,1,22420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022420s000ltr.pdf","2010-03-10 00:00:00",
7363,1,22421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s000ltr.pdf","2010-02-26 00:00:00",
7364,1,22421,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s001ltr.pdf","2010-07-15 00:00:00",
24303,21,22421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf","2010-08-20 00:00:00",
38686,2,22421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf","2010-02-25 00:00:00",
38687,2,22421,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf","2010-07-22 00:00:00",
42519,3,22421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000TOC.cfm","2010-08-20 00:00:00",
44184,10,22421,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm","2012-09-19 00:00:00",
17567,2,22421,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf","2014-05-12 00:00:00",
29708,1,22421,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022421Orig1s003ltr.pdf","2014-05-09 00:00:00",
7365,1,22421,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022421Orig1s006ltr.pdf","2012-09-05 00:00:00",
17568,2,22421,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf","2012-09-06 00:00:00",
29709,1,22421,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022421Orig1s007ltr.pdf","2013-03-04 00:00:00",
38688,2,22421,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf","2013-03-05 00:00:00",
7366,1,22421,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022421Orig1s010ltr.pdf","2015-04-01 00:00:00",
38689,2,22421,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf","2015-04-02 00:00:00",
7367,1,22421,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s013ltr.pdf","2016-01-15 00:00:00",
17569,2,22421,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf","2016-01-15 00:00:00",
7368,1,22421,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s014ltr.pdf","2016-08-01 00:00:00",
38690,2,22421,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf","2016-08-02 00:00:00",
54141,2,22421,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022421s017lbl.pdf","2018-05-11 00:00:00",
54194,1,22421,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf","2018-05-15 00:00:00",
7369,1,22424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022424Orig1s000ltr.pdf","2015-05-21 00:00:00",
38691,2,22424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022424Orig1s00lbl.pdf","2015-05-20 00:00:00",
42520,3,22424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022424Orig1s000TOC.cfm","2016-03-02 00:00:00",
44751,21,22424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022424Orig1s000SumR.pdf","2016-03-02 00:00:00",
46863,2,22424,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022424s001lbl.pdf","2017-01-13 00:00:00",
46936,1,22424,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022279Orig1s001,022424Orig1s001ltr.pdf","2017-01-24 00:00:00",
54759,2,22424,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf","2018-07-05 00:00:00",
54798,8,22424,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf#page=26","2018-07-06 00:00:00",
54840,1,22424,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022279Orig1s002,022424Orig1s002ltr.pdf","2018-07-06 00:00:00",
22017,3,22425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000TOC.cfm","2009-08-20 00:00:00",
23398,8,22425,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM171764.pdf","2009-11-19 00:00:00",
29710,1,22425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022425s000ltr.pdf","2009-07-30 00:00:00",
29711,1,22425,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s001ltr.pdf","2011-02-15 00:00:00",
38692,2,22425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf","2009-07-06 00:00:00",
38693,2,22425,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s001lbl.pdf","2011-02-24 00:00:00",
44752,21,22425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_SumR.pdf","2009-08-20 00:00:00",
29712,1,22425,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s002ltr.pdf","2012-01-30 00:00:00",
38694,2,22425,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s002lbl.pdf","2012-01-31 00:00:00",
17570,2,22425,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s004lbl.pdf","2011-01-31 00:00:00",
29713,1,22425,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s004ltr.pdf","2011-02-04 00:00:00",
29714,1,22425,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s005ltr.pdf","2011-02-15 00:00:00",
7370,1,22425,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s006ltr.pdf","2011-08-11 00:00:00",
29715,1,22425,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s007ltr.pdf","2011-03-14 00:00:00",
38695,2,22425,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s007lbl.pdf","2011-03-11 00:00:00",
7371,1,22425,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s010ltr.pdf","2011-06-27 00:00:00",
17571,2,22425,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s010lbl.pdf","2011-06-29 00:00:00",
7372,1,22425,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s012ltr.pdf","2011-09-06 00:00:00",
38696,2,22425,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s012lbl.pdf","2011-09-07 00:00:00",
17572,2,22425,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s013lbl.pdf","2011-12-19 00:00:00",
29716,1,22425,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s013ltr.pdf","2011-12-21 00:00:00",
17573,2,22425,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s014lbl.pdf","2012-06-18 00:00:00",
29717,1,22425,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s014ltr.pdf","2012-06-15 00:00:00",
7373,1,22425,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf","2012-09-10 00:00:00",
17574,2,22425,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf","2012-09-11 00:00:00",
29718,1,22425,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf","2012-09-10 00:00:00",
38697,2,22425,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf","2012-09-11 00:00:00",
29719,1,22425,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf","2012-09-10 00:00:00",
38698,2,22425,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf","2012-09-11 00:00:00",
7374,1,22425,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022425Orig1s021ltr.pdf","2013-03-29 00:00:00",
17575,2,22425,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022425s021lbl.pdf","2013-04-01 00:00:00",
7375,1,22425,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s022ltr.pdf","2014-03-20 00:00:00",
7376,1,22425,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s023ltr.pdf","2014-02-04 00:00:00",
38699,2,22425,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s023lbl.pdf","2014-01-31 00:00:00",
7377,1,22425,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s025ltr.pdf","2014-04-03 00:00:00",
17576,2,22425,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf","2014-06-23 00:00:00",
7378,1,22425,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022425Orig1s027ltr.pdf","2016-02-16 00:00:00",
17577,2,22426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf","2013-02-12 00:00:00",
22018,3,22426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022426Orig1s000TOC.cfm","2014-04-17 00:00:00",
29720,1,22426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000Ltr_1_.pdf","2013-02-12 00:00:00",
44503,14,22426,"ORIG",1,"Original Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000ltr.pdf","2013-02-12 00:00:00",
7379,1,22426,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf","2016-04-07 00:00:00",
38700,2,22426,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf","2016-04-07 00:00:00",
17578,2,22426,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf","2015-09-21 00:00:00",
29721,1,22426,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf","2015-09-01 00:00:00",
46142,1,22426,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf","2016-12-13 00:00:00",
46145,1,22426,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf","2016-12-14 00:00:00",
46197,2,22426,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf","2016-12-19 00:00:00",
46562,8,22426,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf#page=42","2016-12-27 00:00:00",
50856,2,22426,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022426s010lbl.pdf","2017-12-26 00:00:00",
50920,1,22426,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022426Orig1s010ltr.pdf","2017-12-27 00:00:00",
7380,1,22427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022427s000ltr.pdf","2009-07-30 00:00:00",
17579,2,22427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022427s000lbl.pdf","2009-08-14 00:00:00",
22019,3,22427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022427_acuvail_toc.cfm","2010-01-21 00:00:00",
24304,21,22427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022427s000_SumR.pdf","2010-01-21 00:00:00",
29722,1,22427,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022427s001ltr.pdf","2010-07-01 00:00:00",
17580,2,22427,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s003lbl.pdf","2012-11-16 00:00:00",
29723,1,22427,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s003ltr.pdf","2012-11-16 00:00:00",
7381,1,22427,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s004ltr.pdf","2012-11-19 00:00:00",
38701,2,22427,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s004lbl.pdf","2012-11-19 00:00:00",
7382,1,22427,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022427Orig1s005ltr.pdf","2014-12-05 00:00:00",
17581,2,22427,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022427s005lbl.pdf","2014-12-10 00:00:00",
7383,1,22428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022428s000ltr.pdf","2010-11-26 00:00:00",
22020,3,22428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428_moxeza_toc.cfm","2011-06-07 00:00:00",
24305,21,22428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428Orig1s000SumR.pdf","2011-06-07 00:00:00",
29724,1,22428,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022428s001ltr.pdf","2011-10-20 00:00:00",
38702,2,22428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022428s000lbl.pdf","2010-11-26 00:00:00",
53347,20,22428,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022428s000MedRPREA.pdf","1900-01-01 00:00:00",
53348,18,22428,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022428s000ClinPharm PREA.pdf","1900-01-01 00:00:00",
53349,17,22428,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022428s000StatRPREA.pdf","1900-01-01 00:00:00",
7384,1,22428,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022428Orig1s002ltr.pdf","2012-09-18 00:00:00",
38703,2,22428,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf","2012-09-18 00:00:00",
47270,2,22428,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf","2017-02-21 00:00:00",
47294,1,22428,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022428Orig1s009ltr.pdf","2017-02-23 00:00:00",
42521,3,22429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022429_cetirizine_hydrochloride_toc.cfm","2009-12-16 00:00:00",
7385,1,22429,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022429s003ltr.pdf","2010-04-08 00:00:00",
17582,2,22429,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf","2014-01-14 00:00:00",
29725,1,22429,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022429Orig1s009ltr.pdf","2013-02-07 00:00:00",
7386,1,22430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022430s000ltr.pdf","2009-11-19 00:00:00",
24306,21,22430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf","2010-05-06 00:00:00",
38704,2,22430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf","2009-11-17 00:00:00",
42522,3,22430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm","2010-05-06 00:00:00",
51496,18,22430,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022430 tranexamic acid Lysteda clinpharm prea.pdf","1900-01-01 00:00:00",
7387,1,22430,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022430s002ltr.pdf","2011-04-11 00:00:00",
17583,2,22430,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf","2011-04-07 00:00:00",
42523,3,22430,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/022430Orig1s002.pdf","2011-10-10 00:00:00",
7388,1,22430,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s003ltr.pdf","2013-08-22 00:00:00",
17584,2,22430,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf","2013-08-22 00:00:00",
29726,1,22430,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf","2013-10-04 00:00:00",
38705,2,22430,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf","2013-10-08 00:00:00",
29727,1,22432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022432s000ltr.pdf","2010-10-20 00:00:00",
38706,2,22432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf","2010-10-19 00:00:00",
42524,3,22432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432_hp_acthar_gel_toc.cfm","2011-07-20 00:00:00",
43866,8,22432,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf","2010-11-01 00:00:00",
44753,21,22432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432Orig1s0900SumR.pdf","2011-07-20 00:00:00",
7389,1,22433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022433Orig1s000ltr.pdf","2011-07-20 00:00:00",
24307,21,22433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000SumR.pdf","2011-08-23 00:00:00",
38707,2,22433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022433s000lbl.pdf","2011-07-20 00:00:00",
42525,3,22433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000TOC.cfm","2011-08-23 00:00:00",
7390,1,22433,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s006ltr.pdf","2013-01-28 00:00:00",
17585,2,22433,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf","2013-01-30 00:00:00",
17586,2,22433,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s008lbl.pdf","2013-04-01 00:00:00",
29728,1,22433,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s008ltr.pdf","2013-04-01 00:00:00",
7391,1,22433,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s009ltr.pdf","2013-10-31 00:00:00",
7392,1,22433,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s010ltr.pdf","2013-12-17 00:00:00",
17587,2,22433,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s010lbl.pdf","2013-12-17 00:00:00",
7393,1,22433,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s013ltr.pdf","2015-03-27 00:00:00",
17588,2,22433,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s013lbl.pdf","2015-03-27 00:00:00",
7394,1,22433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s015ltr.pdf","2015-09-08 00:00:00",
38708,2,22433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s015lbl.pdf","2015-09-08 00:00:00",
42526,3,22433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022433Orig1s015TOC.cfm","2016-02-10 00:00:00",
44504,14,22433,"SUPPL",15,"Priority 3 Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022433Orig1s015(2).pdf","2016-07-28 00:00:00",
7395,1,22433,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s017ltr.pdf","2015-09-22 00:00:00",
38709,2,22433,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s017lbl.pdf","2015-09-23 00:00:00",
7396,1,22433,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s018ltr.pdf","2016-07-26 00:00:00",
38710,2,22433,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s018lbl.pdf","2016-07-25 00:00:00",
45090,2,22433,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433Orig1s019lbl.pdf","2016-08-22 00:00:00",
45395,1,22433,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s020ltr.pdf","2016-09-26 00:00:00",
45418,2,22433,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s020lbl.pdf","2016-09-29 00:00:00",
52940,2,22433,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022433s022lbl.pdf","2018-03-13 00:00:00",
52951,8,22433,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022433s022lbl.pdf#page=25","2018-03-14 00:00:00",
52992,1,22433,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022433Orig1s022ltr.pdf","2018-03-15 00:00:00",
7397,1,22434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022434s000ltr.pdf","2011-07-06 00:00:00",
24308,21,22434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434Orig1s000SumR.pdf","2011-11-22 00:00:00",
38711,2,22434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022434s000lbl.pdf","2011-06-30 00:00:00",
42527,3,22434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434_argatroban_toc.cfm","2011-11-22 00:00:00",
7398,1,22434,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022434Orig1s006ltr.pdf","2014-09-10 00:00:00",
38712,2,22434,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf","2014-09-11 00:00:00",
29729,1,22434,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022434Orig1s010ltr.pdf","2016-05-27 00:00:00",
38713,2,22434,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf","2016-06-01 00:00:00",
54641,1,22434,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022434Orig1s011ltr.pdf","2018-06-21 00:00:00",
54678,2,22434,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022434s011lbl.pdf","2018-06-22 00:00:00",
7399,1,22436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022436s000ltr.pdf","2009-08-17 00:00:00",
7400,1,22436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022436s001ltr.pdf","2010-05-17 00:00:00",
17589,2,22436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf","2010-05-17 00:00:00",
22021,3,22436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022436_acyclovir_hydrocortisone_toc.cfm","2010-01-13 00:00:00",
24309,21,22436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022436s000_SumR.pdf","2010-01-13 00:00:00",
7401,1,22436,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022436Orig1s004ltr.pdf","2014-01-23 00:00:00",
17590,2,22436,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022436s004lbl.pdf","2014-01-23 00:00:00",
51429,20,22436,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022436_acyclovir, hydrocortisone_combined clinical_PREA.pdf","1900-01-01 00:00:00",
52982,18,22436,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022436_acyclovir, hydrocortisone_clinpharm_PREA.pdf","1900-01-01 00:00:00",
52984,17,22436,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022436_acyclovir, hydrocortisone_combined clinica_stats_PREA.pdf","1900-01-01 00:00:00",
7402,1,22437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022437s000ltr.pdf","2010-03-18 00:00:00",
24310,21,22437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022437Orig1s000sumr.pdf","2011-02-17 00:00:00",
38714,2,22437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022437lbl.pdf","2010-03-17 00:00:00",
42528,3,22437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022437_trelstar_toc.cfm","2010-11-10 00:00:00",
44185,10,22437,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm","2011-12-20 00:00:00",
29730,1,22437,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf","2011-01-20 00:00:00",
38715,2,22437,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf","2011-01-20 00:00:00",
17591,2,22437,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf","2011-05-23 00:00:00",
29731,1,22437,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,022437s003ltr.pdf","2011-05-24 00:00:00",
17592,2,22437,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf","2013-03-15 00:00:00",
29732,1,22437,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf","2013-03-15 00:00:00",
7403,1,22437,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288Orig1s028,022437Orig1s008ltr.pdf","2014-07-15 00:00:00",
17593,2,22437,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf","2014-07-15 00:00:00",
29733,1,22439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022439s000ltr.pdf","2011-06-13 00:00:00",
38716,2,22439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022439s000lbl.pdf","2011-06-10 00:00:00",
42529,3,22439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022439_zutripro_toc.cfm","2012-02-03 00:00:00",
44754,21,22439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022439Orig1s000SumR.pdf","2012-01-23 00:00:00",
46866,2,22439,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022439s009lbl.pdf","2017-01-13 00:00:00",
46909,1,22439,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf","2017-01-19 00:00:00",
54760,2,22439,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022439s010lbl.pdf#page=58","2018-07-05 00:00:00",
54783,8,22439,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022439s010lbl.pdf#page=28","2018-07-06 00:00:00",
54839,1,22439,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf","2018-07-06 00:00:00",
17594,2,22442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf","2011-06-10 00:00:00",
22022,3,22442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442_rezira_toc.cfm","2012-02-03 00:00:00",
24311,21,22442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442Orig1s000SumR.pdf","2012-02-03 00:00:00",
29734,1,22442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022442s000ltr.pdf","2011-06-13 00:00:00",
46867,2,22442,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022442s009lbl.pdf","2017-01-13 00:00:00",
46911,1,22442,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf","2017-01-19 00:00:00",
54761,2,22442,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf","2018-07-05 00:00:00",
54799,8,22442,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26","2018-07-06 00:00:00",
54838,1,22442,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf","2018-07-06 00:00:00",
45015,2,22445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf","2016-08-09 00:00:00",
45017,1,22445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022445Orig1s000ltr.pdf","2016-08-09 00:00:00",
45514,8,22445,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524796.pdf","2016-10-12 00:00:00",
55494,3,22445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022445Orig1s000TOC.cfm","2018-09-18 00:00:00",
24312,21,22450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450Orig1s000SumR.pdf","2011-04-04 00:00:00",
29735,1,22450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022450s000ltr.pdf","2010-11-08 00:00:00",
38717,2,22450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf","2010-11-05 00:00:00",
42530,3,22450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450_ofirmev_toc.cfm","2011-04-04 00:00:00",
17595,2,22450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf","2013-10-22 00:00:00",
29736,1,22450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf","2013-10-21 00:00:00",
7404,1,22450,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf","2013-10-21 00:00:00",
38718,2,22450,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf","2013-10-22 00:00:00",
47028,2,22450,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022450s010lbl.pdf","2017-01-27 00:00:00",
47039,1,22450,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022450Orig1s010ltr.pdf","2017-01-31 00:00:00",
51132,23,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022450_acetaminophen_Orig_WR.pdf","2007-08-24 00:00:00",
51136,25,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022450_acetaminophen_Amend_1.pdf","2010-12-20 00:00:00",
51137,26,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022450_acetaminophen_Amend_2.pdf","2011-12-08 00:00:00",
51143,27,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022450_acetaminophen_Amend_3.pdf","2015-03-30 00:00:00",
51426,20,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/65_22450 Acetaminophen clinical prea.pdf","1900-01-01 00:00:00",
51427,18,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/66_22450 Acetaminophen clinpharm prea.pdf","1900-01-01 00:00:00",
51428,17,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/67_22450 Acetaminophen_Stat.pdf","1900-01-01 00:00:00",
54093,20,22450,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22450_Acetaminophen_Clinical_Safety_PREA.pdf","1900-01-01 00:00:00",
53659,1,22450,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022450Orig1s011ltr.pdf","2018-04-12 00:00:00",
7405,1,22453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022453Orig1s000ltr.pdf","2012-12-26 00:00:00",
22023,3,22453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453_topotecan_toc.cfm","2013-07-26 00:00:00",
38719,2,22453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022453s000lbl.pdf","2012-12-21 00:00:00",
44755,21,22453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453Orig1s000SumR.pdf","2013-07-26 00:00:00",
7406,1,22453,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022453Orig1s002ltr.pdf","2014-03-05 00:00:00",
38720,2,22453,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf","2014-03-04 00:00:00",
17596,2,22453,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf","2016-02-25 00:00:00",
29737,1,22453,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf","2016-01-29 00:00:00",
49817,2,22453,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf","2017-09-21 00:00:00",
49838,1,22453,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022453Orig1s010ltr.pdf","2017-09-22 00:00:00",
22024,3,22454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000TOC.cfm","2011-02-16 00:00:00",
29738,1,22454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022454s000ltr.pdf","2011-01-20 00:00:00",
38721,2,22454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf","2015-07-28 00:00:00",
44756,21,22454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000SumR.pdf","2011-02-17 00:00:00",
23083,7,22454,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004DHCPletter.pdf","2015-09-11 00:00:00",
29739,1,22454,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004ltr.pdf","2015-09-11 00:00:00",
38722,2,22454,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf","2015-09-11 00:00:00",
24313,21,22456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456s000sumr.pdf","2010-03-25 00:00:00",
29740,1,22456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022456s000ltr.pdf","2010-01-07 00:00:00",
38723,2,22456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022456lbl.pdf","2010-01-07 00:00:00",
42531,3,22456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456_magnsium_hydroxide_omeprazole_sodium_bicarbonate_toc.cfm","2010-03-25 00:00:00",
17597,2,22456,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf","2010-09-10 00:00:00",
29741,1,22456,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf","2010-09-08 00:00:00",
29742,1,22456,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s003ltr.pdf","2011-05-25 00:00:00",
7407,1,22456,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s004ltr.pdf","2011-12-13 00:00:00",
38724,2,22456,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022456s004lbl.pdf","2011-12-14 00:00:00",
29743,1,22456,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456Orig1s005ltr.pdf","2012-12-13 00:00:00",
38725,2,22456,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s005lbl.pdf","2012-12-13 00:00:00",
17598,2,22456,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s006lbl.pdf","2012-05-29 00:00:00",
29744,1,22456,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456s006ltr.pdf","2012-05-24 00:00:00",
7408,1,22458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf","2012-05-03 00:00:00",
22025,3,22458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022458Orig1s000TOC.cfm","2012-06-04 00:00:00",
38726,2,22458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf","2012-05-02 00:00:00",
7409,1,22458,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s002ltr.pdf","2014-05-19 00:00:00",
17599,2,22458,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s002lbl.pdf","2014-05-15 00:00:00",
7410,1,22458,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf","2014-08-29 00:00:00",
38727,2,22458,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf","2014-08-28 00:00:00",
7411,1,22458,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf","2014-08-29 00:00:00",
38728,2,22458,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf","2014-08-28 00:00:00",
29745,1,22458,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022458Orig1s007ltr.pdf","2015-11-23 00:00:00",
38729,2,22458,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022458s007lbl.pdf","2015-11-25 00:00:00",
7412,1,22458,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022458Orig1s012ltr.pdf","2016-06-21 00:00:00",
38730,2,22458,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf","2016-06-21 00:00:00",
46497,2,22458,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s013lbl.pdf","2016-12-21 00:00:00",
46519,1,22458,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/22458Orig1s013ltr.pdf","2016-12-23 00:00:00",
29746,1,22459,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022459s000TAltr.pdf","2010-03-22 00:00:00",
7413,1,22460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000ltr.pdf","2010-06-16 00:00:00",
7414,1,22460,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022460s001ltr.pdf","2011-06-13 00:00:00",
17600,2,22460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf","2010-06-15 00:00:00",
17601,2,22460,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022460s001lbl.pdf","2011-06-10 00:00:00",
22026,3,22460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460s000_jalyn_toc.cfm","2011-02-03 00:00:00",
23710,10,22460,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm","2011-12-20 00:00:00",
29747,1,22460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.pdf","2010-03-22 00:00:00",
44757,21,22460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460Orig1s000SumR.pdf","2011-02-03 00:00:00",
7415,1,22460,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022460s002ltr.pdf","2012-06-29 00:00:00",
17602,2,22460,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022460s002lbl.pdf","2012-06-28 00:00:00",
7416,1,22460,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf","2013-04-30 00:00:00",
38731,2,22460,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf","2013-04-29 00:00:00",
17603,2,22460,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf","2013-04-29 00:00:00",
29748,1,22460,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf","2013-04-30 00:00:00",
29749,1,22460,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf","2013-04-30 00:00:00",
38732,2,22460,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf","2013-04-29 00:00:00",
50289,2,22460,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf","2017-11-03 00:00:00",
50290,2,22460,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf","2017-11-03 00:00:00",
7417,1,22461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022461s000ltr.pdf","2010-01-05 00:00:00",
17604,2,22462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf","2010-11-26 00:00:00",
22027,3,22462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000TOC.cfm","2011-03-07 00:00:00",
24314,21,22462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000SumR.pdf","2011-03-07 00:00:00",
29750,1,22462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022462s000ltr.pdf","2010-11-29 00:00:00",
7418,1,22462,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022462Orig1s008ltr.pdf","2015-02-12 00:00:00",
38733,2,22462,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf","2015-02-12 00:00:00",
29751,1,22464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022464s000ltr.pdf","2010-01-05 00:00:00",
7419,1,22465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022465s000ltr.pdf","2009-11-03 00:00:00",
17605,2,22465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf","2009-10-20 00:00:00",
22028,3,22465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000TOC.cfm","2010-01-22 00:00:00",
24315,21,22465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000_SumR.pdf","2010-01-22 00:00:00",
7420,1,22465,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022465s002ltr.pdf","2010-05-03 00:00:00",
38734,2,22465,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf","2010-05-07 00:00:00",
7421,1,22465,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf","2011-10-25 00:00:00",
17606,2,22465,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf","2011-10-25 00:00:00",
7422,1,22465,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf","2011-10-25 00:00:00",
38735,2,22465,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf","2011-10-25 00:00:00",
7423,1,22465,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s006ltr.pdf","2011-04-22 00:00:00",
7424,1,22465,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s007ltr.pdf","2012-01-17 00:00:00",
38736,2,22465,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf","2012-01-23 00:00:00",
7425,1,22465,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf","2012-05-02 00:00:00",
17607,2,22465,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf","2012-04-27 00:00:00",
7426,1,22465,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s011ltr.pdf","2012-03-26 00:00:00",
17608,2,22465,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf","2012-03-23 00:00:00",
17609,2,22465,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf","2012-04-27 00:00:00",
29752,1,22465,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf","2012-05-02 00:00:00",
7427,1,22465,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465Orig1s013ltr.pdf","2012-11-16 00:00:00",
38737,2,22465,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf","2012-11-16 00:00:00",
17610,2,22465,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf","2013-08-15 00:00:00",
29753,1,22465,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf","2013-08-16 00:00:00",
7428,1,22465,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf","2013-08-16 00:00:00",
38738,2,22465,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf","2013-08-15 00:00:00",
17611,2,22465,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf","2013-08-15 00:00:00",
29754,1,22465,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf","2013-08-16 00:00:00",
7429,1,22465,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s017ltr.pdf","2013-12-18 00:00:00",
38739,2,22465,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf","2013-12-03 00:00:00",
29755,1,22465,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s018ltr.pdf","2014-06-05 00:00:00",
38740,2,22465,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf","2014-06-04 00:00:00",
7430,1,22465,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s019ltr.pdf","2014-11-20 00:00:00",
17612,2,22465,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf","2014-11-20 00:00:00",
7431,1,22465,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf","2015-04-02 00:00:00",
17613,2,22465,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf","2015-04-01 00:00:00",
38741,2,22465,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf","2015-04-02 00:00:00",
17614,2,22465,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf","2015-10-06 00:00:00",
29756,1,22465,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s021ltr.pdf","2015-09-24 00:00:00",
17615,2,22465,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf","2016-05-23 00:00:00",
29757,1,22465,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s022ltr.pdf","2016-05-24 00:00:00",
45002,1,22465,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s023ltr.pdf","2016-08-05 00:00:00",
45038,2,22465,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf","2016-08-05 00:00:00",
48620,2,22465,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf","2017-06-01 00:00:00",
48622,8,22465,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf#page=26","2017-06-01 00:00:00",
48645,1,22465,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf","2017-06-05 00:00:00",
48621,2,22465,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf","2017-06-01 00:00:00",
48623,8,22465,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf#page=26","2017-06-01 00:00:00",
48646,1,22465,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf","2017-06-05 00:00:00",
7432,1,22466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022466s000ltr.pdf","2010-03-04 00:00:00",
7433,1,22466,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022466s001ltr.pdf","2011-01-25 00:00:00",
17616,2,22466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022466lbl.pdf","2010-03-02 00:00:00",
24316,21,22466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022466Orig1s000SumR.pdf","2011-02-17 00:00:00",
38742,2,22466,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022466s001lbl.pdf","2011-01-24 00:00:00",
42532,3,22466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022466_articaine_toc.cfm","2010-12-01 00:00:00",
7434,1,22468,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022468s001ltr.pdf","2010-04-29 00:00:00",
17617,2,22468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf","2009-09-25 00:00:00",
22029,3,22468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022468s000TOC.cfm","2009-11-23 00:00:00",
29758,1,22468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022468s000ltr.pdf","2009-09-29 00:00:00",
38743,2,22468,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf","2010-04-28 00:00:00",
7435,1,22468,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf","2011-01-14 00:00:00",
17618,2,22468,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf","2011-01-10 00:00:00",
7436,1,22468,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf","2011-01-14 00:00:00",
38744,2,22468,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf","2011-01-10 00:00:00",
17619,2,22468,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf","2011-01-10 00:00:00",
29759,1,22468,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf","2011-01-14 00:00:00",
29760,1,22468,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s009ltr.pdf","2012-02-17 00:00:00",
38745,2,22468,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf","2012-02-17 00:00:00",
29761,1,22468,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf","2012-06-04 00:00:00",
38746,2,22468,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf","2012-06-06 00:00:00",
7437,1,22468,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf","2012-06-04 00:00:00",
17620,2,22468,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf","2012-06-06 00:00:00",
17621,2,22468,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf","2016-05-17 00:00:00",
29762,1,22468,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022468Orig1s012ltr.pdf","2016-05-16 00:00:00",
29763,1,22470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022470s000ltr.pdf","2009-12-02 00:00:00",
42533,3,22470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022470_nexcede_toc.cfm","2010-04-21 00:00:00",
44758,21,22470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022470s000sumr.pdf","2010-04-21 00:00:00",
22030,3,22472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm","2015-05-29 00:00:00",
29764,1,22472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf","2014-07-01 00:00:00",
38747,2,22472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf","2014-07-01 00:00:00",
44505,14,22472,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=319","2014-07-02 00:00:00",
44759,21,22472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000SumR.pdf","2015-05-29 00:00:00",
7438,1,22472,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s002ltr.pdf","2015-04-21 00:00:00",
17622,2,22472,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf","2015-04-21 00:00:00",
17623,2,22472,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf","2015-04-22 00:00:00",
17624,2,22472,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf","2015-09-23 00:00:00",
7439,1,22472,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s005ltr.pdf","2015-03-13 00:00:00",
17625,2,22472,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf","2015-04-14 00:00:00",
7440,1,22472,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf","2015-07-14 00:00:00",
17626,2,22472,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf","2015-06-25 00:00:00",
17627,2,22472,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf","2015-06-25 00:00:00",
29765,1,22472,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf","2015-07-14 00:00:00",
38748,2,22472,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf","2016-02-18 00:00:00",
49904,2,22472,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf","2017-10-02 00:00:00",
49905,8,22472,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf#page=12","2017-10-02 00:00:00",
49923,1,22472,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdf","2017-10-03 00:00:00",
53810,1,22472,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s017ltr.pdf","2018-04-24 00:00:00",
7441,1,22473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022473s000ltr.pdf","2009-11-20 00:00:00",
17628,2,22473,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf","2010-11-26 00:00:00",
24317,21,22473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473s000_SumR.pdf","2010-02-18 00:00:00",
29766,1,22473,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf","2010-11-22 00:00:00",
38749,2,22473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022473lbl.pdf","2009-11-20 00:00:00",
42534,3,22473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473_revatio_toc.cfm","2010-02-18 00:00:00",
7442,1,22473,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022473Orig1s003ltr.pdf","2012-09-05 00:00:00",
17629,2,22473,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022473s003lbl.pdf","2012-09-06 00:00:00",
7443,1,22473,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf","2014-03-13 00:00:00",
38750,2,22473,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf","2014-03-13 00:00:00",
7444,1,22473,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
17630,2,22473,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
7445,1,22473,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
38751,2,22473,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
7446,1,22473,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf","2014-03-07 00:00:00",
38752,2,22473,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf","2014-03-07 00:00:00",
17631,2,22473,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf","2015-05-12 00:00:00",
29767,1,22473,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf","2015-04-29 00:00:00",
50674,2,22473,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203109s011,022473s011,021845s020lbl.pdf","2017-12-13 00:00:00",
7447,1,22474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022474s000ltr.pdf","2010-08-13 00:00:00",
22031,3,22474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000TOC.cfm","2010-09-17 00:00:00",
24318,21,22474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000SumR.pdf","2010-09-17 00:00:00",
38753,2,22474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf","2010-08-13 00:00:00",
54132,20,22474,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22474 ella clinical prea.pdf","1900-01-01 00:00:00",
54133,18,22474,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22474 ella clinpharm prea.pdf","1900-01-01 00:00:00",
54134,62,22474,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22474 ella clinpharm addendum prea.pdf","1900-01-01 00:00:00",
54135,17,22474,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22474 ella statistical prea.pdf","1900-01-01 00:00:00",
7448,1,22474,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022474s002ltr.pdf","2012-05-04 00:00:00",
38754,2,22474,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022474s002lbl.pdf","2012-05-07 00:00:00",
7449,1,22474,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s004ltr.pdf","2014-06-17 00:00:00",
17632,2,22474,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s004lbl.pdf","2014-06-17 00:00:00",
29768,1,22474,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s005ltr.pdf","2014-09-03 00:00:00",
38755,2,22474,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s005lbledt.pdf","2014-08-28 00:00:00",
7450,1,22474,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022474Orig1s007ltr.pdf","2015-03-11 00:00:00",
17633,2,22474,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022474s007lbl.pdf","2015-03-12 00:00:00",
22032,3,22474,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022474Orig1s007TOC.cfm","2015-03-31 00:00:00",
54000,1,22474,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022474Orig1s010ltr.pdf","2018-05-03 00:00:00",
54013,2,22474,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022474s010lbl.pdf","2018-05-04 00:00:00",
29769,1,22479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022479s000TAltr.pdf","2010-05-21 00:00:00",
7451,1,22483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf","2010-03-29 00:00:00",
7452,1,22483,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf","2011-03-25 00:00:00",
17634,2,22483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf","2011-02-18 00:00:00",
17635,2,22483,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf","2011-03-28 00:00:00",
22033,3,22483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483_zyclara_toc.cfm","2010-12-01 00:00:00",
24319,21,22483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf","2011-02-17 00:00:00",
7453,1,22483,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf","2011-10-03 00:00:00",
38756,2,22483,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf","2011-09-30 00:00:00",
7454,1,22483,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf","2011-07-19 00:00:00",
17636,2,22483,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf","2011-07-18 00:00:00",
17637,2,22483,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf","2012-02-17 00:00:00",
29770,1,22483,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf","2012-02-17 00:00:00",
7455,1,22484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022484s000ltr.pdf","2010-05-05 00:00:00",
24320,21,22484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022484Orig1s000SumR.pdf","2011-02-17 00:00:00",
38757,2,22484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022484S000lbl.pdf","2010-05-07 00:00:00",
42535,3,22484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022484s000_itraconazole__toc.cfm","2011-01-11 00:00:00",
7456,1,22485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf","2011-05-12 00:00:00",
17638,2,22485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf","2011-05-09 00:00:00",
29771,1,22485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf","2011-01-19 00:00:00",
42536,3,22485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm","2012-01-05 00:00:00",
44760,21,22485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf","2012-01-05 00:00:00",
29772,1,22485,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf","2016-05-27 00:00:00",
38758,2,22485,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf","2016-06-01 00:00:00",
54784,1,22485,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022485Orig1s011ltr.pdf","2018-07-06 00:00:00",
55862,2,22485,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022485s011lbl.pdf","2018-10-10 00:00:00",
17639,2,22488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf","2010-01-08 00:00:00",
17640,2,22488,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf","2011-04-29 00:00:00",
22034,3,22488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488_lyrica_toc.cfm","2010-06-22 00:00:00",
24321,21,22488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488s000sumr.pdf","2010-06-22 00:00:00",
29773,1,22488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf","2010-01-06 00:00:00",
29774,1,22488,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf","2011-04-29 00:00:00",
7457,1,22488,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf","2011-04-29 00:00:00",
17641,2,22488,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf","2011-04-29 00:00:00",
29775,1,22488,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf","2011-04-29 00:00:00",
38759,2,22488,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf","2011-04-29 00:00:00",
29776,1,22488,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf","2011-08-26 00:00:00",
38760,2,22488,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf","2011-08-30 00:00:00",
29777,1,22488,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf","2011-06-29 00:00:00",
38761,2,22488,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf","2011-07-07 00:00:00",
7458,1,22488,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022488s006ltr.pdf","2012-04-18 00:00:00",
7459,1,22488,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s007ltr.pdf","2013-03-01 00:00:00",
38762,2,22488,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022488s007lbl.pdf","2013-03-15 00:00:00",
17642,2,22488,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf","2013-12-24 00:00:00",
29778,1,22488,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf","2013-12-26 00:00:00",
17643,2,22488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf","2016-03-15 00:00:00",
29779,1,22488,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf","2016-03-11 00:00:00",
46516,2,22488,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf","2016-12-22 00:00:00",
46529,1,22488,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s032, 022488Orig1s011ltr.pdf","2016-12-23 00:00:00",
54024,2,22488,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf","2018-05-04 00:00:00",
54025,8,22488,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54","2018-05-04 00:00:00",
54040,1,22488,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021446Orig1s035,022488Orig1s013ltr.pdf","2018-05-08 00:00:00",
22035,3,22494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000TOC.cfm","2011-05-04 00:00:00",
24322,21,22494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000SumR.pdf","2011-05-04 00:00:00",
29780,1,22494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022494s000ltr.pdf","2011-02-03 00:00:00",
7460,1,22496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf","2011-10-31 00:00:00",
22036,3,22496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022496Orig1s000TOC.cfm","2012-06-04 00:00:00",
38763,2,22496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf","2011-11-01 00:00:00",
7461,1,22496,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022496Orig1s005ltr.pdf","2014-12-09 00:00:00",
17644,2,22496,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf","2014-12-16 00:00:00",
53635,2,22496,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf","2018-04-06 00:00:00",
7462,1,22496,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022496Orig1s019ltr.pdf","2015-12-14 00:00:00",
38764,2,22496,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022496s019lbl.pdf","2015-12-14 00:00:00",
24323,21,22497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497Orig1s000SumR.pdf","2012-07-06 00:00:00",
29781,1,22497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022497s000ltr.pdf","2011-11-17 00:00:00",
38765,2,22497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf","2011-11-16 00:00:00",
42537,3,22497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497_forfivo_xl_toc.cfm","2012-07-06 00:00:00",
17645,2,22497,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf","2014-07-22 00:00:00",
29782,1,22497,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022497Orig1s002ltr.pdf","2014-07-21 00:00:00",
45218,2,22497,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf","2016-08-30 00:00:00",
48261,2,22497,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf","2017-05-08 00:00:00",
48262,8,22497,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf#page=32","2017-05-08 00:00:00",
48302,1,22497,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022497Orig1s004ltr.pdf","2017-05-09 00:00:00",
17646,2,22499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022499lbl.pdf","2009-12-10 00:00:00",
24324,21,22499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022499s000sumr.pdf","2010-05-12 00:00:00",
29783,1,22499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000ltr.pdf","2009-12-11 00:00:00",
29784,1,22499,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001ltr.pdf","2010-09-29 00:00:00",
38766,2,22499,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022499s001lbl.pdf","2010-09-29 00:00:00",
42538,3,22499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022499_clonidine_toc.cfm","2010-05-12 00:00:00",
7463,1,22500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000ltr.pdf","2009-12-11 00:00:00",
17647,2,22500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022500lbl.pdf","2009-12-10 00:00:00",
29785,1,22500,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001ltr.pdf","2010-09-29 00:00:00",
38767,2,22500,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022500s001lbl.pdf","2010-09-29 00:00:00",
42539,3,22500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500_clonidine_toc.cfm","2010-05-12 00:00:00",
44761,21,22500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500s000sumr.pdf","2010-05-12 00:00:00",
17648,2,22501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf","2010-10-25 00:00:00",
29786,1,22501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf","2010-10-26 00:00:00",
42540,3,22501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501_lo_loestrin_fe_toc.cfm","2011-05-13 00:00:00",
44762,21,22501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501Orig1s000SumR.pdf","2011-05-13 00:00:00",
54120,20,22501,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne clinical prea.pdf","1900-01-01 00:00:00",
54121,18,22501,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne clinpharm prea.pdf","1900-01-01 00:00:00",
54122,17,22501,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne statistical prea.pdf","1900-01-01 00:00:00",
49306,2,22501,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf","2017-08-10 00:00:00",
49387,1,22501,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s008ltr.pdf","2017-08-15 00:00:00",
50011,2,22501,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf","2017-10-11 00:00:00",
50025,1,22501,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s009ltr.pdf","2017-10-12 00:00:00",
7464,1,22502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022502s000ltr.pdf","2010-03-22 00:00:00",
22037,3,22502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502_differin_toc.cfm","2010-08-30 00:00:00",
24325,21,22502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502s000SumR.pdf","2010-08-30 00:00:00",
38768,2,22502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022502lbl.pdf","2010-03-18 00:00:00",
53154,17,22502,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022502 (adapalene)_Biostat Review PREA.pdf","1900-01-01 00:00:00",
53155,18,22502,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022502 (adapalene)_Clinpharm Review PREA.pdf","1900-01-01 00:00:00",
53156,20,22502,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022502 (adapalene)_Clinical Review 1_PREA_CORRECTED.pdf","1900-01-01 00:00:00",
17649,2,22502,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022502s003lbl.pdf","2013-04-23 00:00:00",
29787,1,22502,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022502Orig1s003ltr.pdf","2013-04-23 00:00:00",
17650,2,22503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022503s000lbl.pdf","2015-06-04 00:00:00",
24326,21,22503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000SumR.pdf","2015-12-09 00:00:00",
29788,1,22503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022503Orig1s000ltr.pdf","2015-06-09 00:00:00",
42541,3,22503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000TOC.cfm","2015-12-09 00:00:00",
22038,3,22504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504_axiron_toc.cfm","2011-09-16 00:00:00",
29789,1,22504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022504s000ltr.pdf","2010-11-29 00:00:00",
38769,2,22504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022504s000lbl.pdf","2010-11-23 00:00:00",
44506,14,22504,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=7","2011-04-04 00:00:00",
44763,21,22504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504Orig1s000SumR.pdf","2011-09-16 00:00:00",
17651,2,22504,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf","2011-04-01 00:00:00",
29790,1,22504,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s002ltr.pdf","2011-04-04 00:00:00",
17652,2,22504,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf","2011-12-23 00:00:00",
29791,1,22504,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s005ltr.pdf","2011-12-28 00:00:00",
42542,3,22504,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022504Orig1s005.pdf","2014-07-07 00:00:00",
7465,1,22504,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022504Orig1s011ltr.pdf","2014-06-23 00:00:00",
38770,2,22504,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022504s011lbl.pdf","2014-06-23 00:00:00",
17653,2,22504,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf","2015-05-13 00:00:00",
29792,1,22504,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022504Orig1s012ltr.pdf","2015-05-13 00:00:00",
47100,2,22504,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf","2017-02-06 00:00:00",
47127,1,22504,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504rig1s013ltr.pdf","2017-02-07 00:00:00",
45678,1,22504,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022504Orig1s014ltr.pdf","2016-10-27 00:00:00",
45744,2,22504,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022504s014lbl.pdf","2016-11-01 00:00:00",
46988,1,22504,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s015ltr.pdf","2017-01-27 00:00:00",
48981,2,22504,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf","2017-07-14 00:00:00",
48982,8,22504,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf#page=15","2017-07-14 00:00:00",
48988,1,22504,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s016ltr.pdf","2017-07-14 00:00:00",
22039,3,22505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.cfm","2010-12-14 00:00:00",
24327,21,22505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf","2010-12-14 00:00:00",
29793,1,22505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022505s000ltr.pdf","2010-11-15 00:00:00",
38771,2,22505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf","2010-11-12 00:00:00",
38772,2,22505,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf","2011-12-02 00:00:00",
17654,2,22505,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf","2011-12-02 00:00:00",
38773,2,22505,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf","2013-01-11 00:00:00",
7466,1,22505,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022505Orig1s007ltr.pdf","2015-06-10 00:00:00",
38774,2,22505,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf","2015-06-10 00:00:00",
22040,3,22509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509_lamictal_xr_toc.cfm","2010-12-01 00:00:00",
29794,1,22509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022509s000ltr.pdf","2010-02-17 00:00:00",
38775,2,22509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf","2010-02-16 00:00:00",
43872,8,22509,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm254322.pdf","2011-05-06 00:00:00",
44764,21,22509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509Orig1s000SumR.pdf","2011-02-17 00:00:00",
53308,20,22509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022509_lamotrigine_clinical_PREA(2).pdf","1900-01-01 00:00:00",
53309,17,22509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022509_lamotrigine_statistical_PREA (2).pdf","1900-01-01 00:00:00",
17655,2,22510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf","2011-01-10 00:00:00",
24032,14,22510,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2011-01-14 00:00:00",
29795,1,22510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s000ltr.pdf","2011-01-14 00:00:00",
42543,3,22510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510_abstral_toc.cfm","2011-11-02 00:00:00",
44765,21,22510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510Orig1s000SumR.pdf","2011-11-02 00:00:00",
7467,1,22510,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf","2012-01-03 00:00:00",
17656,2,22510,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf","2012-01-06 00:00:00",
17657,2,22510,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf","2012-06-11 00:00:00",
29796,1,22510,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf","2012-06-07 00:00:00",
7468,1,22510,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf","2013-11-12 00:00:00",
7469,1,22510,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf","2013-07-30 00:00:00",
38776,2,22510,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf","2013-07-30 00:00:00",
7470,1,22510,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf","2014-12-24 00:00:00",
17658,2,22510,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf","2014-11-07 00:00:00",
7471,1,22510,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf","2014-12-30 00:00:00",
46333,2,22510,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf","2016-12-21 00:00:00",
46381,1,22510,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022510Orig1s015ltr.pdf","2016-12-21 00:00:00",
46602,8,22510,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf#page=29","2016-12-30 00:00:00",
49714,1,22510,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022510Orig1s017ltr.pdf","2017-09-11 00:00:00",
7472,1,22511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022511s000ltr.pdf","2010-05-07 00:00:00",
22041,3,22511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000TOC.cfm","2011-02-28 00:00:00",
23711,10,22511,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm","2011-12-20 00:00:00",
29797,1,22511,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s001ltr.pdf","2011-11-22 00:00:00",
38777,2,22511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf","2010-05-07 00:00:00",
38778,2,22511,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf","2011-11-29 00:00:00",
44766,21,22511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000SumR.pdf","2011-02-28 00:00:00",
51397,20,22511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/152_22511 S19 naproxen-esomeprazole clinical prea.pdf","1900-01-01 00:00:00",
51398,18,22511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/153_22511 S19 naproxen-esomeprazole clinpharm prea.pdf","1900-01-01 00:00:00",
29798,1,22511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf","2011-06-29 00:00:00",
38779,2,22511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf","2011-06-29 00:00:00",
7473,1,22511,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf","2011-06-29 00:00:00",
17659,2,22511,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf","2011-06-29 00:00:00",
29799,1,22511,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s004ltr.pdf","2011-05-25 00:00:00",
38780,2,22511,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf","2011-05-26 00:00:00",
7474,1,22511,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511s006ltr.pdf","2012-01-23 00:00:00",
38781,2,22511,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf","2012-01-24 00:00:00",
17660,2,22511,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf","2012-10-04 00:00:00",
29800,1,22511,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s007ltr.pdf","2012-10-03 00:00:00",
17661,2,22511,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf","2012-10-12 00:00:00",
29801,1,22511,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s008ltr.pdf","2012-10-11 00:00:00",
7475,1,22511,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s010ltr.pdf","2014-03-28 00:00:00",
38782,2,22511,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf","2014-04-01 00:00:00",
17662,2,22511,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf","2014-02-27 00:00:00",
29802,1,22511,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s012ltr.pdf","2014-02-27 00:00:00",
29803,1,22511,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s015ltr.pdf","2015-03-26 00:00:00",
38783,2,22511,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf","2015-05-08 00:00:00",
7476,1,22511,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s016ltr.pdf","2015-06-23 00:00:00",
38784,2,22511,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf","2015-06-23 00:00:00",
29804,1,22511,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s017ltr.pdf","2014-12-23 00:00:00",
38785,2,22511,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf","2014-12-29 00:00:00",
7477,1,22511,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s018ltr.pdf","2016-05-10 00:00:00",
17663,2,22511,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf","2016-05-11 00:00:00",
48928,2,22511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022511s019lbl.pdf","2017-07-07 00:00:00",
48937,1,22511,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022511Orig1s019ltr.pdf","2017-07-10 00:00:00",
45651,1,22511,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s020ltr.pdf","2016-11-10 00:00:00",
45727,2,22511,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf","2016-11-10 00:00:00",
54527,2,22511,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf","2018-06-12 00:00:00",
54528,8,22511,"SUPPL",23,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf#page=38","2018-06-12 00:00:00",
54582,1,22511,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022511Orig1s023ltr.pdf","2018-06-14 00:00:00",
17664,2,22512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf","2010-10-20 00:00:00",
22042,3,22512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000TOC.cfm","2010-11-30 00:00:00",
23407,8,22512,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf","2013-01-03 00:00:00",
24328,21,22512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000SumR.pdf","2011-02-17 00:00:00",
29805,1,22512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf","2010-10-20 00:00:00",
44186,10,22512,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm248694.htm","2011-03-29 00:00:00",
22043,3,22512,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022512Orig1s004.pdf","2013-06-04 00:00:00",
29806,1,22512,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s004ltr.pdf","2011-03-08 00:00:00",
38786,2,22512,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s004lbl.pdf","2011-03-07 00:00:00",
7478,1,22512,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s005ltr.pdf","2011-04-07 00:00:00",
7479,1,22512,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s007ltr.pdf","2011-11-14 00:00:00",
38787,2,22512,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf","2011-11-10 00:00:00",
29807,1,22512,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s009ltr.pdf","2012-01-19 00:00:00",
38788,2,22512,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s009lbl.pdf","2012-01-23 00:00:00",
17665,2,22512,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010lbl.pdf","2012-05-01 00:00:00",
29808,1,22512,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s010ltr.pdf","2012-05-02 00:00:00",
17666,2,22512,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf","2012-06-11 00:00:00",
29809,1,22512,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s011ltr.pdf","2012-06-05 00:00:00",
42544,3,22512,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022512Orig1s011_replace.pdf","2013-04-10 00:00:00",
7480,1,22512,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s014ltr.pdf","2012-11-06 00:00:00",
38789,2,22512,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014lbl.pdf","2012-11-06 00:00:00",
29810,1,22512,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s016ltr.pdf","2012-12-26 00:00:00",
38790,2,22512,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s016lbl.pdf","2012-12-21 00:00:00",
29811,1,22512,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s017ltr.pdf","2013-04-30 00:00:00",
38791,2,22512,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s017lbl.pdf","2013-04-29 00:00:00",
29812,1,22512,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s018ltr.pdf","2014-04-09 00:00:00",
38792,2,22512,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s018lbl.pdf","2014-04-08 00:00:00",
7481,1,22512,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s021ltr.pdf","2013-12-13 00:00:00",
38793,2,22512,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s021lbl.pdf","2013-12-11 00:00:00",
7482,1,22512,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s023ltr.pdf","2014-08-15 00:00:00",
38794,2,22512,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s023lbl.pdf","2014-08-15 00:00:00",
7483,1,22512,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s024ltr.pdf","2015-01-20 00:00:00",
38795,2,22512,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s024lbl.pdf","2015-01-20 00:00:00",
7484,1,22512,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s025ltr.pdf","2014-09-08 00:00:00",
38796,2,22512,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s025.pdf","2014-09-26 00:00:00",
7485,1,22512,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s027ltr.pdf","2015-09-14 00:00:00",
38797,2,22512,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s027lbl.pdf","2015-09-11 00:00:00",
7486,1,22512,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s028ltr.pdf","2015-11-23 00:00:00",
38798,2,22512,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf","2015-11-25 00:00:00",
17667,2,22512,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512Orig1s031lbl.pdf","2015-09-21 00:00:00",
29813,1,22512,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s031ltr.pdf","2015-08-28 00:00:00",
7487,1,22512,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s032ltr.pdf","2015-10-26 00:00:00",
38799,2,22512,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s032lbl.pdf","2015-10-27 00:00:00",
52977,2,22512,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022512s035lbl.pdf","2018-03-15 00:00:00",
52983,1,22512,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022512Orig1s035ltr.pdf","2018-03-15 00:00:00",
7488,1,22514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022514s000ltr.pdf","2010-03-24 00:00:00",
38800,2,22514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022514lbl.pdf","2010-03-26 00:00:00",
42545,3,22514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514_mirapex_er_toc.cfm","2010-09-03 00:00:00",
44187,10,22514,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm","2012-09-19 00:00:00",
44767,21,22514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514s000SumR.pdf","2010-09-03 00:00:00",
17668,2,22516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516lbl.pdf","2010-11-05 00:00:00",
22044,3,22516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022516_cymbalta_tocEDT.cfm","2011-09-16 00:00:00",
29814,1,22516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022516s000ltr.pdf","2010-11-09 00:00:00",
44768,21,22516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516Orig1s000SumR.pdf","2010-12-01 00:00:00",
54658,2,22517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf","2018-06-21 00:00:00",
54659,8,22517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf#page=14","2018-06-21 00:00:00",
54660,1,22517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022517Orig1s000Ltr.pdf","2018-06-21 00:00:00",
54661,3,22517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022517Orig1s000TOC.cfm","2018-06-21 00:00:00",
7489,1,22518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022518s000ltr.pdf","2010-06-29 00:00:00",
24329,21,22518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518Orig1s000SumR.pdf","2011-05-25 00:00:00",
38801,2,22518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022518s000lbl.pdf","2010-06-24 00:00:00",
42546,3,22518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518_dulera_toc.cfm","2011-05-25 00:00:00",
52903,17,22518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22518s000_mometasone_statistical_PREA.pdf","1900-01-01 00:00:00",
54117,18,22518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22518s000_mometasone_clinpharm_PREA.pdf","1900-01-01 00:00:00",
54118,20,22518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22518s000_mometasone_clinical_PREA.pdf","1900-01-01 00:00:00",
54119,17,22518,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22518s000_mometasone_statistical_PREA.pdf","1900-01-01 00:00:00",
29815,1,22518,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf","2011-08-22 00:00:00",
38802,2,22518,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf","2011-08-24 00:00:00",
7490,1,22518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf","2011-08-22 00:00:00",
38803,2,22518,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf","2011-08-24 00:00:00",
17669,2,22518,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf","2012-08-22 00:00:00",
29816,1,22518,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s005ltr.pdf","2012-08-23 00:00:00",
7491,1,22518,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s006ltr.pdf","2012-11-26 00:00:00",
17670,2,22518,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf","2012-11-28 00:00:00",
29817,1,22518,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf","2012-11-29 00:00:00",
7492,1,22518,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s008ltr.pdf","2013-01-17 00:00:00",
38804,2,22518,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf","2013-01-22 00:00:00",
29818,1,22518,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf","2012-11-29 00:00:00",
7493,1,22518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s011ltr.pdf","2013-08-01 00:00:00",
17671,2,22518,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf","2013-08-09 00:00:00",
17672,2,22518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf","2013-08-22 00:00:00",
29819,1,22518,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s013ltr.pdf","2013-08-22 00:00:00",
29820,1,22518,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022518Orig1s014ltr.pdf","2014-04-18 00:00:00",
38805,2,22518,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022518s015lbl.pdf","2015-04-24 00:00:00",
7494,1,22518,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022518Orig1s018ltr.pdf","2015-12-29 00:00:00",
17673,2,22518,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf","2016-07-13 00:00:00",
29821,1,22518,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf","2016-07-13 00:00:00",
51384,20,22518,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22518 mometasone clinical prea.pdf","1900-01-01 00:00:00",
48848,2,22518,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s021lbl.pdf","2017-06-28 00:00:00",
48867,1,22518,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s021ltr.pdf","2017-06-29 00:00:00",
50837,2,22518,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s022lbl.pdf","2017-12-22 00:00:00",
50927,1,22518,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022518Orig1s022ltr.pdf","2017-12-27 00:00:00",
53467,2,22518,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf","2018-03-27 00:00:00",
53513,1,22518,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf","2018-03-29 00:00:00",
53468,2,22518,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf","2018-03-27 00:00:00",
53514,1,22518,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022518Orig1s023s024ltr.pdf","2018-03-29 00:00:00",
17674,2,22519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf","2011-04-26 00:00:00",
24330,21,22519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519Orig1s000SumR.pdf","2011-11-02 00:00:00",
29822,1,22519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022519s000ltr.pdf","2011-04-28 00:00:00",
42547,3,22519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519_duexis_toc.cfm","2011-11-02 00:00:00",
7495,1,22519,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022519Orig1s009ltr.pdf","2016-05-10 00:00:00",
38806,2,22519,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf","2016-05-11 00:00:00",
48673,2,22519,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf","2017-06-07 00:00:00",
48674,1,22519,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022519Orig1s011ltr.pdf","2017-06-07 00:00:00",
48675,8,22519,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf#page=22","2017-06-08 00:00:00",
7496,1,22522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022522s000ltr.pdf","2011-03-07 00:00:00",
38807,2,22522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022522s000lbl.pdf","2011-03-10 00:00:00",
42548,3,22522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm","2011-04-14 00:00:00",
44769,21,22522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000SumR.pdf","2011-04-14 00:00:00",
29823,1,22522,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022522Orig1s003ltr.pdf","2013-08-27 00:00:00",
38808,2,22522,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf","2013-08-27 00:00:00",
17675,2,22522,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf","2015-11-25 00:00:00",
29824,1,22522,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022522Orig1s006ltr.pdf","2015-11-25 00:00:00",
49647,2,22522,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022522s008lbl.pdf","2017-09-01 00:00:00",
49657,1,22522,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022522Orig1s008ltr.pdf","2017-09-01 00:00:00",
51709,2,22522,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf","2018-01-25 00:00:00",
51710,8,22522,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf#page=17","2018-01-25 00:00:00",
51720,1,22522,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022522Orig1s009ltr.pdf","2018-01-25 00:00:00",
17676,2,22523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf","2010-04-12 00:00:00",
23411,8,22523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523MedGuide.pdf","2010-04-12 00:00:00",
24331,21,22523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523Orig1s000SumR.pdf","2011-02-17 00:00:00",
29825,1,22523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022523s000ltr.pdf","2010-04-14 00:00:00",
42549,3,22523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523_pancreaze_toc.cfm","2011-01-03 00:00:00",
51454,20,22523,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22523 pancrelipase clinical prea.pdf","1900-01-01 00:00:00",
53366,18,22523,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_pancreaze_clinpharm_PREA.pdf","1900-01-01 00:00:00",
53367,17,22523,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_pancreaze_statistical_PREA.pdf","1900-01-01 00:00:00",
29826,1,22523,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022523s002ltr.pdf","2011-06-29 00:00:00",
7497,1,22523,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022523Orig1s004ltr.pdf","2014-03-11 00:00:00",
17677,2,22523,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf","2014-03-10 00:00:00",
17678,2,22523,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf","2014-05-28 00:00:00",
29827,1,22524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022524s000ltr.pdf","2010-07-27 00:00:00",
38809,2,22524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022524s000lbl.pdf","2010-07-12 00:00:00",
42550,3,22524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524_zuplenz_toc.cfm","2011-05-13 00:00:00",
44770,21,22524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524Orig1s000SumR.pdf","2011-05-13 00:00:00",
17679,2,22524,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf","2013-10-31 00:00:00",
29828,1,22524,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022524Orig1s002ltr.pdf","2013-10-31 00:00:00",
7498,1,22524,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022524Orig1s003ltr.pdf","2014-09-23 00:00:00",
38810,2,22524,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf","2014-09-22 00:00:00",
17680,2,22525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf","2010-06-02 00:00:00",
22045,3,22525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525s000_namenda_xr_toc.cfm","2010-12-23 00:00:00",
24332,21,22525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdf","2010-12-23 00:00:00",
29829,1,22525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022525s000ltr.pdf","2010-06-24 00:00:00",
51325,20,22525,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022525Orig1s000_Memantine_Clinical.pdf","1900-01-01 00:00:00",
51326,18,22525,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022525Orig1s000_Memantine_Clinpharm.pdf","1900-01-01 00:00:00",
51327,17,22525,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022525Orig1s000_Memantine_Statistical.pdf","1900-01-01 00:00:00",
29830,1,22525,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s005ltr.pdf","2014-07-07 00:00:00",
38811,2,22525,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf","2014-07-09 00:00:00",
7499,1,22525,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s006ltr.pdf","2014-10-01 00:00:00",
38812,2,22525,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf","2014-09-30 00:00:00",
7500,1,22526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022526ltr.pdf","2015-08-18 00:00:00",
24333,21,22526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf","2015-08-24 00:00:00",
38813,2,22526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf","2015-08-18 00:00:00",
42551,3,22526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000TOC.cfm","2015-10-01 00:00:00",
43877,8,22526,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM459254.pdf","2015-08-20 00:00:00",
44508,14,22526,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=350","2015-08-18 00:00:00",
29831,1,22526,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022526Orig1s002ltr.pdf","2016-04-11 00:00:00",
48778,1,22526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022526Orig1s004ltr.pdf","2017-06-20 00:00:00",
7501,1,22527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000ltr.pdf","2010-09-27 00:00:00",
17681,2,22527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf","2010-09-23 00:00:00",
22046,3,22527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000TOC.cfm","2010-11-12 00:00:00",
44188,10,22527,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm284282.htm","2011-12-21 00:00:00",
44771,21,22527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000sumr.pdf","2011-02-17 00:00:00",
7502,1,22527,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf","2011-07-25 00:00:00",
38814,2,22527,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf","2011-07-25 00:00:00",
38815,2,22527,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf","2011-07-06 00:00:00",
7503,1,22527,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s005ltr.pdf","2012-03-05 00:00:00",
29832,1,22527,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s006ltr.pdf","2012-03-20 00:00:00",
38816,2,22527,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf","2012-03-20 00:00:00",
7504,1,22527,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s008ltr.pdf","2012-05-11 00:00:00",
38817,2,22527,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf","2012-05-10 00:00:00",
17682,2,22527,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf","2014-05-02 00:00:00",
29833,1,22527,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022527Orig1s009ltr.pdf","2014-05-01 00:00:00",
29834,1,22527,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022527Orig1s010ltr.pdf","2013-05-29 00:00:00",
7505,1,22527,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s013ltr.pdf","2015-05-04 00:00:00",
38818,2,22527,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf","2015-05-04 00:00:00",
7506,1,22527,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s015ltr.pdf","2015-05-19 00:00:00",
7507,1,22527,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s016ltr.pdf","2015-07-10 00:00:00",
17683,2,22527,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf","2015-07-06 00:00:00",
7508,1,22527,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s018ltr.pdf","2016-02-23 00:00:00",
17684,2,22527,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf","2016-02-23 00:00:00",
17685,2,22527,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf","2015-08-06 00:00:00",
29835,1,22527,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s019ltr.pdf","2015-08-06 00:00:00",
45973,1,22527,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s021ltr.pdf","2016-12-01 00:00:00",
50783,1,22527,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/22527Orig1s022ltr.pdf","2017-12-20 00:00:00",
50834,2,22527,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022527s022lbl.pdf","2017-12-22 00:00:00",
54171,2,22527,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf","2018-05-11 00:00:00",
54197,1,22527,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022527Orig1s024ltr.pdf","2018-05-15 00:00:00",
55622,8,22527,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf#page=25","2018-09-27 00:00:00",
29836,1,22529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022529Orig1s000ltr.pdf","2012-06-27 00:00:00",
38819,2,22529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf","2012-06-27 00:00:00",
42552,3,22529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022529Orig1s000TOC.cfm","2012-08-07 00:00:00",
29837,1,22529,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022529Orig1s003ltr.pdf","2014-12-11 00:00:00",
38820,2,22529,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022529s003lbl.pdf","2016-04-04 00:00:00",
48532,1,22529,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022529Orig1s005,022529Orig1s007,208524Orig1s001ltr.pdf","2017-05-25 00:00:00",
48543,2,22529,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf","2017-05-26 00:00:00",
48531,1,22529,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022529Orig1s005,022529Orig1s007,208524Orig1s001ltr.pdf","2017-05-25 00:00:00",
48544,2,22529,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf","2017-05-26 00:00:00",
7509,1,22532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022532s000ltr.pdf","2010-09-29 00:00:00",
7510,1,22532,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022532s001ltr.pdf","2012-02-21 00:00:00",
17686,2,22532,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf","2012-02-14 00:00:00",
22047,3,22532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532_beyaz_toc.cfm","2011-04-04 00:00:00",
23712,10,22532,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm","2011-11-16 00:00:00",
38821,2,22532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf","2010-09-29 00:00:00",
42553,3,22532,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s001.pdf","2016-02-03 00:00:00",
44772,21,22532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532Orig1s000SumR.pdf","2011-04-04 00:00:00",
53238,20,22532,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22532 beyaz clinical prea.pdf","1900-01-01 00:00:00",
53239,18,22532,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22532 beyaz clinpharm prea.pdf","1900-01-01 00:00:00",
53240,17,22532,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22532 beyaz statistical prea.pdf","1900-01-01 00:00:00",
53241,61,22532,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22532 beyaz statistical addendum prea.pdf","1900-01-01 00:00:00",
17687,2,22532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf","2012-04-10 00:00:00",
22048,3,22532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s004.pdf","2016-02-03 00:00:00",
29838,1,22532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf","2012-04-12 00:00:00",
17688,2,22532,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf","2015-06-04 00:00:00",
29839,1,22532,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf","2015-06-03 00:00:00",
49295,2,22532,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf","2017-08-09 00:00:00",
49386,1,22532,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022532Orig1s009ltr.pdf","2017-08-15 00:00:00",
7511,1,22534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf","2010-03-22 00:00:00",
17689,2,22534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf","2011-05-24 00:00:00",
22049,3,22534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.cfm","2012-02-10 00:00:00",
24334,21,22534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf","2012-02-10 00:00:00",
29840,1,22534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf","2011-05-05 00:00:00",
7512,1,22534,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf","2012-07-20 00:00:00",
38822,2,22534,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf","2012-07-25 00:00:00",
29841,1,22534,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf","2014-10-31 00:00:00",
38823,2,22534,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf","2014-11-04 00:00:00",
7513,1,22535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022535Orig1s000ltr.pdf","2014-10-22 00:00:00",
17690,2,22535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf","2014-10-16 00:00:00",
38824,2,22535,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022535s001lbl.pdf","2015-10-07 00:00:00",
42554,3,22535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000toc.cfm","2014-12-05 00:00:00",
44773,21,22535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000SumR.pdf","2014-12-05 00:00:00",
46801,2,22535,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022535s005lbl.pdf","2017-01-11 00:00:00",
46875,1,22535,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022535Orig1s005ltr.pdf","2017-01-18 00:00:00",
17691,2,22536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf","2010-03-18 00:00:00",
22050,3,22536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536_indomethacin_toc.cfm","2010-08-02 00:00:00",
29842,1,22536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022536s000ltr.pdf","2010-03-22 00:00:00",
44774,21,22536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536s000SumR.pdf","2010-08-02 00:00:00",
7514,1,22537,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022537s000ltr.pdf","2010-09-01 00:00:00",
29843,1,22541,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022541s000ltr.pdf","2010-08-11 00:00:00",
7515,1,22542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022542s000ltr.pdf","2012-03-01 00:00:00",
23412,8,22542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000MG.pdf","2012-03-01 00:00:00",
24335,21,22542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542Orig1s000SumR.pdf","2013-08-09 00:00:00",
38825,2,22542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf","2012-03-01 00:00:00",
42555,3,22542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542_viokace_toc.cfm","2013-08-09 00:00:00",
7516,1,22544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf","2011-02-03 00:00:00",
22051,3,22544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544_gralise_toc.cfm","2011-10-18 00:00:00",
23413,8,22544,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM245196.pdf","2011-03-01 00:00:00",
38826,2,22544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf","2011-02-04 00:00:00",
44775,21,22544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544Orig1s000SumR.pdf","2011-10-18 00:00:00",
7517,1,22544,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf","2011-07-05 00:00:00",
38827,2,22544,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf","2011-06-30 00:00:00",
29844,1,22544,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf","2011-05-03 00:00:00",
17692,2,22544,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf","2012-02-01 00:00:00",
29845,1,22544,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf","2012-02-03 00:00:00",
7518,1,22544,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf","2012-08-10 00:00:00",
38828,2,22544,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf","2012-08-09 00:00:00",
17693,2,22544,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf","2013-04-01 00:00:00",
7519,1,22545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf","2010-08-31 00:00:00",
17694,2,22545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf","2010-08-27 00:00:00",
22052,3,22545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545_tekamlo_toc.cfm","2011-05-25 00:00:00",
29846,1,22545,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s001ltr.pdf","2011-04-01 00:00:00",
38829,2,22545,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf","2011-04-01 00:00:00",
44776,21,22545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545Origs000SumR.pdf","2011-05-25 00:00:00",
17695,2,22545,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf","2011-10-20 00:00:00",
29847,1,22545,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s005ltr.pdf","2011-10-14 00:00:00",
29848,1,22545,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s007ltr.pdf","2012-02-07 00:00:00",
38830,2,22545,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf","2012-01-31 00:00:00",
17696,2,22545,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf","2011-11-14 00:00:00",
29849,1,22545,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s008ltr.pdf","2011-11-16 00:00:00",
29850,1,22545,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s010ltr.pdf","2012-02-06 00:00:00",
38831,2,22545,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf","2012-02-06 00:00:00",
7520,1,22545,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf","2012-10-02 00:00:00",
38832,2,22545,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf","2012-10-01 00:00:00",
7521,1,22545,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s012ltr.pdf","2012-04-18 00:00:00",
17697,2,22545,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf","2012-04-16 00:00:00",
7522,1,22545,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf","2012-10-02 00:00:00",
17698,2,22545,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf","2012-10-01 00:00:00",
7523,1,22545,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022545Orig1s014ltr.pdf","2013-11-06 00:00:00",
17699,2,22545,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf","2013-11-04 00:00:00",
17700,2,22545,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf","2014-03-19 00:00:00",
29851,1,22545,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s016ltr.pdf","2015-04-01 00:00:00",
38833,2,22545,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf","2015-04-02 00:00:00",
7524,1,22545,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s017ltr.pdf","2015-12-23 00:00:00",
17701,2,22545,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf","2015-12-28 00:00:00",
45829,1,22545,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022545Orig1s020ltr.pdf","2016-11-08 00:00:00",
45850,2,22545,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf","2016-11-08 00:00:00",
29852,1,22547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022547s000TAltr.pdf","2011-03-08 00:00:00",
7525,1,22548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022548s000ltr.pdf","2010-05-21 00:00:00",
24336,21,22548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm","2011-02-17 00:00:00",
38834,2,22548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022548s000lbl.pdf","2010-05-28 00:00:00",
42556,3,22548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm","2010-12-08 00:00:00",
53282,20,22548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022548_Gatifloxacin_Clinical_PREA.pdf","1900-01-01 00:00:00",
53283,18,22548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022548_Gatifloxacin_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53284,17,22548,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22548_Gatifloxacin_Statistical_PREA.pdf","1900-01-01 00:00:00",
45267,2,22548,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022548s002lbl.pdf","2016-09-08 00:00:00",
45279,1,22548,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022548Orig1s002ltr.pdf","2016-09-12 00:00:00",
53673,2,22549,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf","2013-01-11 00:00:00",
53674,1,22549,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022549Orig1s000ltr.pdf","2012-12-27 00:00:00",
53675,3,22549,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549_adasuve_toc.cfm","2013-08-09 00:00:00",
53676,21,22549,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549Orig1s000SumR.pdf","2013-08-09 00:00:00",
53677,21,22549,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549Orig1s000SumR.pdf","2013-08-09 00:00:00",
7526,1,22549,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022549Orig1s002ltr.pdf","2013-12-13 00:00:00",
45491,1,22549,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022549Orig1s005ltr.pdf","2016-09-30 00:00:00",
47286,2,22549,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf","2017-02-22 00:00:00",
47291,8,22549,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf#page=26","2017-02-23 00:00:00",
47350,2,22549,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf","2017-02-27 00:00:00",
47372,1,22549,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022549Orig1s006ltr.pdf","2017-03-02 00:00:00",
7527,1,22554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022554s000ltr.pdf","2010-03-29 00:00:00",
22053,3,22554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554_xifaxan_toc_.cfm","2011-07-26 00:00:00",
38836,2,22554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf","2010-03-26 00:00:00",
44510,14,22554,"ORIG",1,"Latest label for Xifaxan (original NDA 021361)","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf","2015-11-05 00:00:00",
44777,21,22554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554Orig1s000SumR.pdf","2011-07-26 00:00:00",
17702,2,22555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf","2010-06-03 00:00:00",
22054,3,22555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022555_cysview_toc.cfm","2011-07-20 00:00:00",
24338,21,22555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022555Orig1s000SumR.pdf","2011-07-20 00:00:00",
29854,1,22555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022555s000ltr.pdf","2010-06-08 00:00:00",
17703,2,22555,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf","2016-08-02 00:00:00",
52659,2,22555,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf","2018-02-16 00:00:00",
52706,1,22555,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022555Orig1s005ltr.pdf","2018-02-23 00:00:00",
7528,1,22556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022556Orig1s000ltr.pdf","2013-04-01 00:00:00",
17704,2,22556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf","2013-04-01 00:00:00",
22055,3,22556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000TOC.cfm","2014-06-24 00:00:00",
24339,21,22556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000SumR.pdf","2014-06-24 00:00:00",
52407,20,22556,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022556 carbinoxamine clinical prea.pdf","1900-01-01 00:00:00",
52408,18,22556,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022556 carbinoxamine clinpharm prea.pdf","1900-01-01 00:00:00",
7529,1,22560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022560s000ltr.pdf","2010-10-19 00:00:00",
7530,1,22560,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf","2011-02-15 00:00:00",
17705,2,22560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf","2010-10-18 00:00:00",
17706,2,22560,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf","2012-03-22 00:00:00",
22056,3,22560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000TOC.cfm","2011-03-21 00:00:00",
24340,21,22560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000SumR.pdf","2011-03-21 00:00:00",
44189,10,22560,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2011-12-20 00:00:00",
17707,2,22560,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf","2012-03-22 00:00:00",
29855,1,22560,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf","2011-02-15 00:00:00",
29856,1,22560,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s003ltr.pdf","2011-08-24 00:00:00",
29857,1,22560,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022560Orig1s004ltr.pdf","2012-08-15 00:00:00",
38837,2,22560,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf","2012-08-15 00:00:00",
7531,1,22560,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022560Orig1s005ltr.pdf","2013-04-24 00:00:00",
17708,2,22560,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf","2013-04-23 00:00:00",
29858,1,22560,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s006ltr.pdf","2015-03-27 00:00:00",
38838,2,22560,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf","2015-03-27 00:00:00",
7532,1,22560,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s007ltr.pdf","2015-04-13 00:00:00",
17709,2,22560,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf","2015-04-10 00:00:00",
46101,8,22560,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf#page=23","2016-12-08 00:00:00",
22057,3,22562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022562s000TOC.cfm","2010-04-20 00:00:00",
29859,1,22562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022562s000ltr.pdf","2010-03-22 00:00:00",
38839,2,22562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf","2010-03-18 00:00:00",
29860,1,22562,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022562Orig1s002ltr.pdf","2013-08-06 00:00:00",
38840,2,22562,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf","2013-08-05 00:00:00",
50437,2,22562,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022562s005lbl.pdf","2017-11-17 00:00:00",
50449,1,22562,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022562Orig1s005ltr.pdf","2017-11-17 00:00:00",
7533,1,22563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf","2010-10-13 00:00:00",
7534,1,22563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf","2011-04-25 00:00:00",
17710,2,22563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf","2011-04-22 00:00:00",
24341,21,22563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf","2011-05-03 00:00:00",
38841,2,22563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf","2010-10-12 00:00:00",
42558,3,22563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563_sorilux_toc.cfm","2011-05-03 00:00:00",
17711,2,22563,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf","2012-09-28 00:00:00",
29861,1,22563,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf","2012-10-02 00:00:00",
22058,3,22565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000TOC.cfm","2010-09-23 00:00:00",
29862,1,22565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022565s000ltr.pdf","2010-06-03 00:00:00",
44778,21,22565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000SumR.pdf","2010-09-23 00:00:00",
17712,2,22565,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf","2015-04-14 00:00:00",
29863,1,22565,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf","2015-04-02 00:00:00",
48047,2,22565,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf","2017-04-17 00:00:00",
48054,1,22565,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022565Orig1s003ltr.pdf","2017-04-18 00:00:00",
7535,1,22567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s000ltr.pdf","2011-01-26 00:00:00",
7536,1,22567,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s001ltr.pdf","2011-09-23 00:00:00",
17713,2,22567,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001lbl.pdf","2011-09-23 00:00:00",
22059,3,22567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000TOC.cfm","2011-03-01 00:00:00",
23713,10,22567,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283587.htm","2012-02-13 00:00:00",
24342,21,22567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000SumR.pdf","2011-03-01 00:00:00",
38842,2,22567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s000lbl.pdf","2011-01-24 00:00:00",
7537,1,22567,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s002ltr.pdf","2011-07-06 00:00:00",
17714,2,22567,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005lbl.pdf","2013-01-11 00:00:00",
29864,1,22567,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022567Orig1s005ltr.pdf","2012-12-26 00:00:00",
7538,1,22567,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022567Orig1s009ltr.pdf","2013-12-19 00:00:00",
17715,2,22567,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022567s009lbl.pdf","2013-12-19 00:00:00",
17716,2,22567,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s011lbl.pdf","2014-04-08 00:00:00",
29865,1,22567,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s011ltr.pdf","2014-04-09 00:00:00",
7539,1,22567,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022567Orig1s012ltr.pdf","2015-04-02 00:00:00",
17717,2,22567,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022567s012lbl.pdf","2015-03-19 00:00:00",
7540,1,22567,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s013ltr.pdf","2014-07-17 00:00:00",
17718,2,22567,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s013lbl.pdf","2014-07-17 00:00:00",
45244,2,22567,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022567s019lbl.pdf","2016-09-06 00:00:00",
45275,1,22567,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022567Orig1s019ltr.pdf","2016-09-08 00:00:00",
46680,2,22567,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022567s020lbl.pdf","2017-01-06 00:00:00",
46785,8,22567,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022567s020lbl.pdf#page=17","2017-01-11 00:00:00",
46786,1,22567,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf","2017-01-11 00:00:00",
7541,1,22568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s000ltr.pdf","2010-07-28 00:00:00",
24343,21,22568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022568Orig1s000SumR.pdf","2011-02-17 00:00:00",
38843,2,22568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s000lbl.pdf","2010-07-30 00:00:00",
42559,3,22568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022568_aricept_toc.cfm","2010-12-01 00:00:00",
29866,1,22568,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf","2010-11-30 00:00:00",
38844,2,22568,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf","2010-12-01 00:00:00",
7542,1,22568,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pd","2012-03-05 00:00:00",
38845,2,22568,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf","2012-03-09 00:00:00",
17719,2,22568,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf","2012-09-26 00:00:00",
29867,1,22568,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf","2012-09-06 00:00:00",
7543,1,22568,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf","2013-09-10 00:00:00",
38846,2,22568,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf","2013-09-09 00:00:00",
7544,1,22568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf","2015-07-22 00:00:00",
38847,2,22568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf","2015-07-22 00:00:00",
7545,1,22569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s000ltr.pdf","2011-07-06 00:00:00",
17720,2,22569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s000lbl.pdf","2011-07-06 00:00:00",
42560,3,22569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000TOC.cfm","2012-04-16 00:00:00",
44511,14,22569,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2011-07-08 00:00:00",
44779,21,22569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000SumR.pdf","2012-04-16 00:00:00",
7546,1,22569,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s002ltr.pdf","2011-11-14 00:00:00",
7547,1,22569,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s005ltr.pdf","2012-01-03 00:00:00",
38848,2,22569,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s005lbl.pdf","2011-12-28 00:00:00",
7548,1,22569,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022569s007ltr.pdf","2012-06-07 00:00:00",
38849,2,22569,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022569s007lbl.pdf","2012-06-11 00:00:00",
7549,1,22569,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf","2013-11-13 00:00:00",
17721,2,22569,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf","2013-11-19 00:00:00",
29868,1,22569,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf","2014-12-31 00:00:00",
38850,2,22569,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf","2015-01-08 00:00:00",
7550,1,22569,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf","2013-11-13 00:00:00",
17722,2,22569,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf","2013-11-19 00:00:00",
7551,1,22569,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf","2013-11-13 00:00:00",
17723,2,22569,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf","2013-11-19 00:00:00",
29869,1,22569,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf","2014-12-31 00:00:00",
38851,2,22569,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf","2015-01-08 00:00:00",
7552,1,22569,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf","2014-12-31 00:00:00",
38852,2,22569,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf","2015-01-09 00:00:00",
29870,1,22569,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022569Orig1s022ltr.pdf","2015-12-22 00:00:00",
46330,2,22569,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022569s023lbl.pdf","2016-12-21 00:00:00",
46382,1,22569,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022569Orig1s023ltr.pdf","2016-12-21 00:00:00",
47633,2,22569,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf","2017-03-22 00:00:00",
47634,8,22569,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf#page=35","2017-03-22 00:00:00",
47684,1,22569,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022569Orig1s024ltr.pdf","2017-03-24 00:00:00",
49715,1,22569,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022569Orig1s026ltr.pdf","2017-09-11 00:00:00",
17724,2,22571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf","2010-07-31 00:00:00",
22060,3,22571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571s000_cuvposa_toc.cfm","2011-02-23 00:00:00",
29871,1,22571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022571s000ltr.pdf","2010-08-02 00:00:00",
44780,21,22571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000SumR.pdf","2011-02-23 00:00:00",
7553,1,22571,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022571Orig1s003ltr.pdf","2013-05-23 00:00:00",
38853,2,22571,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf","2013-05-23 00:00:00",
7554,1,22571,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022571Orig1s004ltr.pdf","2015-11-13 00:00:00",
17725,2,22571,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf","2015-11-12 00:00:00",
7555,1,22571,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022571Orig1s006ltr.pdf","2016-05-20 00:00:00",
38854,2,22571,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf","2016-05-20 00:00:00",
52715,2,22571,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022571s008lbl.pdf","2018-02-26 00:00:00",
52718,1,22571,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022571Orig1s008ltr.pdf","2018-02-26 00:00:00",
17726,2,22572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022572s000lbl.pdf","2012-02-09 00:00:00",
22061,3,22572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572_mitosol_toc.cfm","2013-01-02 00:00:00",
24344,21,22572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572Orig1s000SumR.pdf","2013-01-02 00:00:00",
29872,1,22572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022572s000ltr.pdf","2012-02-14 00:00:00",
7556,1,22572,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022572Orig1s003ltr.pdf","2014-09-29 00:00:00",
38855,2,22572,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022572s003lbl.pdf","2014-09-30 00:00:00",
29873,1,22572,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022572Orig1s004ltr.pdf","2016-01-21 00:00:00",
38856,2,22572,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022572s004lbl.pdf","2016-01-26 00:00:00",
50911,1,22572,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022572Orig1s005ltr.pdf","2017-12-27 00:00:00",
50932,2,22572,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022572s005lbl.pdf","2017-12-27 00:00:00",
17727,2,22573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf","2010-12-26 00:00:00",
29874,1,22573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022573s000ltr.pdf","2010-12-28 00:00:00",
42561,3,22573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573_norethindrone_ethinyl_toc.cfm","2011-07-26 00:00:00",
44781,21,22573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573Orig1s000SumR.pdf","2011-07-26 00:00:00",
49304,2,22573,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf","2017-08-09 00:00:00",
49385,1,22573,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022573Orig1s008ltr.pdf","2017-08-15 00:00:00",
7557,1,22574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022574s000ltr.pdf","2010-12-21 00:00:00",
7558,1,22574,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022574s001ltr.pdf","2012-02-21 00:00:00",
17728,2,22574,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf","2012-02-14 00:00:00",
22062,3,22574,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s001.pdf","2016-02-03 00:00:00",
23714,10,22574,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm","2011-11-16 00:00:00",
38857,2,22574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf","2010-12-22 00:00:00",
42562,3,22574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574_safyral_toc.cfm","2011-07-15 00:00:00",
44782,21,22574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574Orig1s000SumR.pdf","2011-07-15 00:00:00",
53243,20,22574,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022574 safyral clinical _PREA.pdf","1900-01-01 00:00:00",
53244,18,22574,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022574 safyral clinpharm_ PREA.pdf","1900-01-01 00:00:00",
53245,17,22574,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022574 safyral statistical _PREA_CORRECTED.pdf","1900-01-01 00:00:00",
17729,2,22574,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf","2012-04-10 00:00:00",
29875,1,22574,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf","2012-04-12 00:00:00",
42563,3,22574,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s004.pdf","2016-02-03 00:00:00",
7559,1,22574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf","2015-06-03 00:00:00",
17730,2,22574,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf","2015-06-04 00:00:00",
49297,2,22574,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022574s009lbl.pdf","2017-08-09 00:00:00",
49384,1,22574,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022574Orig1s009ltr.pdf","2017-08-15 00:00:00",
17731,2,22575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022575lbl.pdf","2010-03-02 00:00:00",
22063,3,22575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022575s000TOC.cfm","2010-08-04 00:00:00",
29876,1,22575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022575s000ltr.pdf","2010-03-04 00:00:00",
17732,2,22575,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf","2013-04-01 00:00:00",
29877,1,22575,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s007,s009ltr.pdf","2013-03-28 00:00:00",
38858,2,22575,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf","2013-04-01 00:00:00",
17733,2,22575,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s012lbl.pdf","2013-11-22 00:00:00",
29878,1,22575,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s012ltr.pdf","2013-11-25 00:00:00",
7560,1,22575,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s013ltr.pdf","2013-10-04 00:00:00",
17734,2,22575,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s013lbl.pdf","2013-10-08 00:00:00",
29879,1,22575,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022575Orig1s017ltr.pdf","2015-05-11 00:00:00",
38859,2,22575,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022575s017lbl.pdf","2015-05-06 00:00:00",
7561,1,22577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022577s000ltr.pdf","2012-01-31 00:00:00",
7562,1,22577,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577Orig1s001ltr.pdf","2012-08-09 00:00:00",
17735,2,22577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022577lbl.pdf","2012-01-31 00:00:00",
17736,2,22577,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf","2012-08-08 00:00:00",
22064,3,22577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022577_viread_toc.cfm","2012-11-13 00:00:00",
44783,21,22577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022577Orig1s000SumR.pdf","2012-11-13 00:00:00",
17737,2,22577,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf","2012-08-17 00:00:00",
29880,1,22577,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577Orig1s002ltr.pdf","2012-08-20 00:00:00",
17738,2,22577,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf","2013-07-30 00:00:00",
29881,1,22577,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577Orig1s003ltr.pdf","2013-07-26 00:00:00",
7563,1,22577,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577Orig1s004ltr.pdf","2013-04-03 00:00:00",
38860,2,22577,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf","2013-04-09 00:00:00",
17739,2,22577,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf","2013-10-25 00:00:00",
29882,1,22577,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577Orig1s006ltr.pdf","2013-10-25 00:00:00",
7564,1,22577,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577Orig1s007ltr.pdf","2015-06-02 00:00:00",
38861,2,22577,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf","2015-06-04 00:00:00",
7565,1,22577,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577Orig1s009ltr.pdf","2016-02-18 00:00:00",
17740,2,22577,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf","2016-02-18 00:00:00",
47912,2,22577,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf","2017-04-10 00:00:00",
47981,1,22577,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021356Orig1s055,022577Orig1s011ltr.pdf","2017-04-12 00:00:00",
55070,2,22577,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf","2018-07-31 00:00:00",
7566,1,22578,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022578s001ltr.pdf","2011-12-05 00:00:00",
22065,3,22578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578s000_zyrtec_allergy_toc.cfm","2011-01-25 00:00:00",
29883,1,22578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022578s000ltr.pdf","2010-09-08 00:00:00",
44784,21,22578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578Orig1s000SumR.pdf","2011-02-17 00:00:00",
45176,2,22578,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf","2016-08-23 00:00:00",
45229,1,22578,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022578Orig1s007ltr.pdf","2016-08-23 00:00:00",
7567,1,22580,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Orig1s001ltr.pdf","2012-11-06 00:00:00",
17741,2,22580,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf","2012-11-02 00:00:00",
22066,3,22580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000_qsymia_toc.cfm","2013-04-08 00:00:00",
24037,14,22580,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=45","2012-07-18 00:00:00",
24345,21,22580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000SumR.pdf","2013-04-08 00:00:00",
29884,1,22580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Origs000ltr.pdf","2012-07-18 00:00:00",
38862,2,22580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf","2012-07-18 00:00:00",
17742,2,22580,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf","2013-04-17 00:00:00",
29885,1,22580,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022580Orig1s004ltr.pdf","2013-04-18 00:00:00",
38863,2,22580,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf","2013-03-26 00:00:00",
17743,2,22580,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf","2014-09-30 00:00:00",
29886,1,22580,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf","2014-09-30 00:00:00",
29887,1,22580,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf","2014-09-30 00:00:00",
38864,2,22580,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf","2014-09-30 00:00:00",
7568,1,22580,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf","2014-09-30 00:00:00",
17744,2,22580,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf","2014-09-30 00:00:00",
53463,2,22580,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf","2018-03-27 00:00:00",
53464,8,22580,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf#page=37","2018-03-27 00:00:00",
53506,1,22580,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022580rig1s016ltr.pdf","2018-03-29 00:00:00",
7569,1,22581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022581s000ltr.pdf","2011-04-20 00:00:00",
17745,2,22581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf","2011-04-21 00:00:00",
22067,3,22581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581_phoslyra_toc.cfm","2011-10-20 00:00:00",
44785,21,22581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581Orig1s000SumR.pdf","2011-10-20 00:00:00",
29888,1,22581,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022581Orig1s006ltr.pdf","2015-05-04 00:00:00",
38865,2,22581,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581s006lbl.pdf","2015-05-04 00:00:00",
29889,1,40009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide%20Dinitrate_Approv.pdf","2004-06-07 00:00:00",
42564,3,40009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide.cfm","1998-12-30 00:00:00",
7570,1,40010,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040010Orig1s008ltr.pdf","2014-06-11 00:00:00",
38866,2,40010,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040010Orig1s008lbl.pdf","2014-06-24 00:00:00",
17746,2,40024,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf","2009-09-22 00:00:00",
29890,1,40026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40026ltr.pdf","1998-09-25 00:00:00",
42565,3,40027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40027.pdf","2003-07-30 00:00:00",
22068,3,40028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/040028Orig1s000.pdf","2012-06-29 00:00:00",
7571,1,40032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40032ltr.pdf","1999-08-17 00:00:00",
22069,3,40032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040032_cyclophosphamide_toc.cfm","2003-07-30 00:00:00",
23715,10,40050,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm","2006-11-27 00:00:00",
44512,14,40050,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
17747,2,40056,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf","2012-08-30 00:00:00",
42566,3,40084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/040084.PDF","2004-12-08 00:00:00",
42567,3,40084,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22070,3,40084,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22071,3,40084,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42568,3,40084,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22072,3,40084,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42569,3,40084,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42570,3,40084,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22073,3,40084,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42571,3,40084,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22074,3,40084,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22075,3,40084,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42572,3,40084,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22076,3,40084,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42573,3,40084,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42574,3,40084,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22077,3,40084,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42575,3,40084,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22078,3,40084,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22079,3,40084,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42576,3,40084,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22080,3,40084,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42577,3,40084,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42578,3,40084,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22081,3,40084,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42579,3,40084,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
22082,3,40084,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
42580,3,40084,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf","2005-07-22 00:00:00",
17748,2,40098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen%20And%20Codeine%20Phosphate_Prntlbl.pdf","2003-12-23 00:00:00",
29891,1,40098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen%20And%20Codeine%20Phosphate_Approv.pdf","2003-12-23 00:00:00",
42581,3,40098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040098_acetaminophen_TOC.cfm","2003-12-23 00:00:00",
22083,3,40099,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/040099_S.PDF","2004-12-08 00:00:00",
7572,1,40099,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040099Orig1s018ltr.pdf","2014-12-09 00:00:00",
38867,2,40099,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040099Orig1s018lbl.pdf","2014-12-12 00:00:00",
22084,3,40105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040105ap.pdf","2003-12-23 00:00:00",
29892,1,40124,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040124s014ltr.pdf","2008-01-09 00:00:00",
42582,3,40126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040126ap.pdf","2011-05-06 00:00:00",
22085,3,40131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40131ap.pdf","1998-02-24 00:00:00",
42583,3,40136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040136_hydralazine_toc.cfm","2003-07-30 00:00:00",
17749,2,40136,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040136s005lbl.pdf","2014-02-28 00:00:00",
29893,1,40136,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040136s005ltr.pdf","2014-02-28 00:00:00",
42584,3,40138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040138ap.pdf","1998-01-30 00:00:00",
29894,1,40140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40140ltr.pdf","1998-11-20 00:00:00",
42585,3,40140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/040140.PDF","2004-12-08 00:00:00",
42586,3,40148,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf","2005-07-22 00:00:00",
22086,3,40148,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf","2005-07-22 00:00:00",
42587,3,40148,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf","2005-07-22 00:00:00",
42588,3,40148,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf","2005-07-22 00:00:00",
22087,3,40148,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf","2005-07-22 00:00:00",
7573,1,40148,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040148s053ltr.pdf","2015-10-22 00:00:00",
17750,2,40148,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf","2015-11-04 00:00:00",
29895,1,40162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf","1998-01-20 00:00:00",
38868,2,40162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf","1998-01-20 00:00:00",
42589,3,40162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf","1998-01-20 00:00:00",
22088,3,40166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040166_acetic-acid_toc.cfm","2003-07-30 00:00:00",
7574,1,40168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone%20and%20Acetic%20Acid%20Otic_Approv.pdf","2003-08-01 00:00:00",
17751,2,40168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone%20and%20Acetic%20Acid%20Otic_Prntlbl.pdf","2003-08-01 00:00:00",
22089,3,40168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040168_hydrocortisone-aceticacid_toc.cfm","2003-07-30 00:00:00",
7575,1,40180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40180ltr.pdf","1998-04-30 00:00:00",
42590,3,40182,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40182ap.pdf","1998-03-13 00:00:00",
7576,1,40183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40183ltr.pdf","1998-12-22 00:00:00",
17752,2,40183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40183_Methylprednisolone_Prntlbl.pdf","2004-06-09 00:00:00",
22090,3,40183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040183_methylprednisolone_toc.cfm","2003-07-30 00:00:00",
22091,3,40184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40184ap.pdf","1998-02-06 00:00:00",
42591,3,40187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040187ap.pdf","2011-05-06 00:00:00",
7577,1,40191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40191ltr.pdf","1998-12-17 00:00:00",
17753,2,40191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine%20Hydrochloride_Prntlbl.pdf","2004-06-09 00:00:00",
22092,3,40191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040191_meperidine_toc.cfm","2003-07-30 00:00:00",
7578,1,40192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40192ltr.pdf","1998-05-28 00:00:00",
42592,3,40192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40192ap.pdf","1998-05-28 00:00:00",
22093,3,40194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040194ap.pdf","2011-05-06 00:00:00",
42593,3,40197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/40197ap.pdf","2011-03-10 00:00:00",
7579,1,40199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and%20Acetaminophen_Approv.pdf","2004-06-10 00:00:00",
22094,3,40199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040199_oxycodone_toc.cfm","2003-07-30 00:00:00",
38869,2,40199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40199_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf","2004-06-10 00:00:00",
22095,3,40201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40201ap.pdf","1998-02-27 00:00:00",
7580,1,40203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40203ltr.pdf","1999-03-15 00:00:00",
42594,3,40203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40203_Oxycodone%20and%20Acetaminophen.pdf","1999-03-15 00:00:00",
7581,1,40206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40206ltr.pdf","1998-08-28 00:00:00",
42595,3,40207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/40207ap.pdf","2011-05-06 00:00:00",
29896,1,40213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40213ltr.pdf","1998-05-29 00:00:00",
7582,1,40215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40215ltr.pdf","1999-05-25 00:00:00",
42596,3,40215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40216_Sulfacetamide%20Sodium%20Ophthalmic.pdf","2002-09-24 00:00:00",
7583,1,40216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40215ltr.pdf","1999-05-25 00:00:00",
22096,3,40216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40216_Sulfacetamide%20Sodium%20Ophthalmic.pdf","2002-09-24 00:00:00",
53876,14,40223,"SUPPL",27,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040223_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7584,1,40224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40224ltr.pdf","1999-01-26 00:00:00",
22097,3,40224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40224_Chlorpromazine%20Hydrochloride.pdf","1999-01-26 00:00:00",
17754,2,40226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Prntlbl.pdf","2004-06-14 00:00:00",
29897,1,40226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Approv.pdf","2004-06-14 00:00:00",
42597,3,40226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040226_perphenazine_toc.cfm","2003-07-30 00:00:00",
22098,3,40227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040227ap.pdf","2011-02-18 00:00:00",
22099,3,40230,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040230_dicyclomine_toc.cfm","2003-07-30 00:00:00",
29898,1,40230,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40230ltr.pdf","1999-02-26 00:00:00",
38870,2,40230,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40230_Dicyclomine%20Hydrochloride_Prntlbl.pdf","2004-06-02 00:00:00",
7585,1,40231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40231ltr.pdf","1999-12-30 00:00:00",
22100,3,40231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040231_chlorpromazine_toc.cfm","2003-07-30 00:00:00",
7586,1,40233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40233ltr.pdf","1999-06-17 00:00:00",
22101,3,40233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40233_Methotrexate.pdf","2001-07-11 00:00:00",
42598,3,40235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40235ap.pdf","1998-03-11 00:00:00",
22102,3,40241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40241ap.pdf","2004-06-09 00:00:00",
29899,1,40241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40241ltr.pdf","2004-06-09 00:00:00",
44513,14,40241,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
7587,1,40246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40246ltr.pdf","2000-06-28 00:00:00",
42599,3,40246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40246_Compro.pdf","2000-06-28 00:00:00",
7588,1,40247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40247ltr.pdf","1999-07-23 00:00:00",
7589,1,40248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40248ltr.pdf","2000-04-28 00:00:00",
22103,3,40248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040248.pdf","2004-12-08 00:00:00",
7590,1,40249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40249ltr.pdf","1999-01-29 00:00:00",
22104,3,40249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040249_orphenadrine_toc.cfm","2003-07-30 00:00:00",
38871,2,40249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf","2004-06-10 00:00:00",
22105,3,40251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040251_trihexyphenidyl_toc.cfm","2003-07-30 00:00:00",
29900,1,40251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40251ltr.pdf","1999-09-27 00:00:00",
38872,2,40251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40251_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf","2004-06-28 00:00:00",
7591,1,40253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40253ltr.pdf","2000-11-22 00:00:00",
38873,2,40253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40253_Ethosuximide_Prntlbl.pdf","2004-06-03 00:00:00",
42600,3,40253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040253_ethosuximide_toc.cfm","2003-07-31 00:00:00",
17755,2,40254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf","2004-06-28 00:00:00",
29901,1,40254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40254ltr.pdf","1998-12-24 00:00:00",
42601,3,40254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040254_trihexyphenidyl_toc.cfm","2003-07-31 00:00:00",
22106,3,40255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40255ap.pdf","1998-02-27 00:00:00",
29902,1,40256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40256ltr.pdf","2003-04-08 00:00:00",
17756,2,40257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40257_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf","2004-06-10 00:00:00",
22107,3,40257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040257_oxycodone_toc.cfm","2003-07-31 00:00:00",
29903,1,40257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40257ltr.pdf","1998-08-04 00:00:00",
7592,1,40258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40258ltr.pdf","1999-02-26 00:00:00",
7593,1,40259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40259ltr.pdf","1999-07-29 00:00:00",
42602,3,40259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40259_Hydrocortisone%20Acetate.pdf","1999-07-29 00:00:00",
29904,1,40260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40260ltr.pdf","1998-07-17 00:00:00",
7594,1,40261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40261ltr.pdf","1998-10-28 00:00:00",
17757,2,40261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf","1998-10-28 00:00:00",
42603,3,40261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf","2002-09-26 00:00:00",
53877,14,40261,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040261_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7595,1,40262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40262ltr.pdf","1999-12-15 00:00:00",
17758,2,40262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40262_Leucovorin%20Calcium_Prntlbl.pdf","2004-06-08 00:00:00",
22108,3,40262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040262_leucovorin_toc.cfm","2003-07-31 00:00:00",
17759,2,40263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40263_Methotrexate_Prntlbl.pdf","2004-06-09 00:00:00",
22109,3,40263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040263_methotrexate_toc.cfm","2003-07-31 00:00:00",
29905,1,40263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40263ltr.pdf","1999-02-26 00:00:00",
7596,1,40265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40265ltr.pdf","1999-02-26 00:00:00",
22110,3,40265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040265_methotrexate-preservative-free_toc.cfm","2003-07-31 00:00:00",
38874,2,40265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40265_Methotrexate_Prntlbl.pdf","2004-06-09 00:00:00",
7597,1,40266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40266ltr.pdf","1999-02-26 00:00:00",
17760,2,40266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40266_Methotrexate_Prntlbl.pdf","2004-06-09 00:00:00",
22111,3,40266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040266_methotrexate-preservative-free_toc.cfm","2003-07-31 00:00:00",
7598,1,40267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40267ltr.pdf","1998-07-30 00:00:00",
42604,3,40267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40267_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf","2002-09-26 00:00:00",
42605,3,40268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40268ap.pdf","1998-02-27 00:00:00",
7599,1,40272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40272ltr.pdf","1998-06-30 00:00:00",
42606,3,40272,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40272ap.pdf","1998-06-30 00:00:00",
29906,1,40273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40273ltr.pdf","1998-09-09 00:00:00",
7600,1,40274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40274ltr.pdf","1998-05-29 00:00:00",
17761,2,40274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-274_Hydroxychloroquine%20Sulfate_Prntlbl.pdf","2004-06-07 00:00:00",
42607,3,40274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040274_hydroxychloroqine_toc.cfm","2003-07-31 00:00:00",
29907,1,40275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40275ltr.pdf","1998-12-29 00:00:00",
38875,2,40275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-275_Estradiol_Prntlbl.pdf","2004-06-03 00:00:00",
42608,3,40275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040275_estradiol_toc.cfm","2003-07-31 00:00:00",
29908,1,40276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40276ltr.pdf","1998-11-25 00:00:00",
38876,2,40276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40276_Phentermine%20Hydrochloride_Prntlbl.pdf","2004-06-14 00:00:00",
42609,3,40276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040276_phentermine_toc.cfm","2003-07-31 00:00:00",
7601,1,40277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40277ltr.pdf","2000-03-16 00:00:00",
17762,2,40277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40277_Proparacaine%20Hydrochloride%20Ophthalmic_Prntlbl.pdf","2004-06-14 00:00:00",
22112,3,40277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040277_proparacaine_toc.cfm","2003-07-31 00:00:00",
22113,3,40278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040278_fluorouracil_toc.cfm","2003-07-31 00:00:00",
29909,1,40278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40278_Fluorouracil_Approv.pdf","2004-06-04 00:00:00",
38877,2,40278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40278_Fluorouracil_Prntlbl.pdf","2004-06-04 00:00:00",
17763,2,40279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Prntlbl.pdf","2004-06-04 00:00:00",
22114,3,40279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040279_fluorouracil_toc.cfm","2003-07-31 00:00:00",
29910,1,40279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40279_Fluorouracil_Approv.pdf","2004-06-04 00:00:00",
7602,1,40280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40280ltr.pdf","1998-09-30 00:00:00",
22115,3,40281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040281_hydrocodone_toc.cfm","2003-07-31 00:00:00",
29911,1,40281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40281ltr.pdf","1998-09-30 00:00:00",
38878,2,40281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40281_Hydrocodone%20Bitarttate%20and%20Acetaminophen_Prntlbl.pd","2004-06-07 00:00:00",
22116,3,40282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40282_Digoxin.pdf","1999-12-23 00:00:00",
29912,1,40282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40282ltr.pdf","1999-12-23 00:00:00",
7603,1,40282,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040282Orig1s013ltr.pdf","2014-09-04 00:00:00",
7604,1,40283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40283ltr.pdf","1998-12-29 00:00:00",
22117,3,40283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-283_Carisoprodol%20Aspirin%20Codeine%20Phosphate.pdf","1998-12-29 00:00:00",
7605,1,40284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40284ltr.pdf","1998-06-19 00:00:00",
29913,1,40285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40285ltr.pdf","1999-07-19 00:00:00",
29914,1,40286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40286ltr.pdf","1999-02-26 00:00:00",
42610,3,40286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-286_Leucovorin.pdf","2002-01-17 00:00:00",
7606,1,40287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40287ltr.pdf","1999-05-28 00:00:00",
22118,3,40287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040287_prednisolone_toc.cfm","2003-07-31 00:00:00",
38879,2,40287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40287_Prednisolone_Prntlbl.pdf","2004-06-14 00:00:00",
29915,1,40288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40288ltr.pdf","1998-11-27 00:00:00",
7607,1,40289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40289ltr.pdf","1999-03-16 00:00:00",
7608,1,40291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40291ltr.pdf","1999-03-24 00:00:00",
29916,1,40295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40295ltr.pdf","2000-12-01 00:00:00",
7609,1,40296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40296LTR.PDF","1999-11-01 00:00:00",
29917,1,40297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40297ltr.pdf","2003-04-08 00:00:00",
7610,1,40298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40298ltr.pdf","1998-12-28 00:00:00",
17764,2,40298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf","1998-12-28 00:00:00",
22119,3,40298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040298_phenytoin-sodium_TOC.cfm","2003-12-23 00:00:00",
7611,1,40298,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf","2003-04-08 00:00:00",
29918,1,40298,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf","2003-04-08 00:00:00",
29919,1,40298,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf","2003-04-08 00:00:00",
7612,1,40299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/40299ltr.pdf","1999-05-13 00:00:00",
22120,3,40299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40299_Dextroamphetamine.pdf","1999-05-13 00:00:00",
7613,1,40300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40300ltr.pdf","1998-11-27 00:00:00",
17765,2,40300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf","2004-06-09 00:00:00",
22121,3,40300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040300_methylphenidate_toc.cfm","2003-07-31 00:00:00",
7614,1,40301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40301ltr.pdf","1999-06-15 00:00:00",
22122,3,40301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin.cfm","2003-07-23 00:00:00",
38880,2,40301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Prntlbl.pdf","2004-06-30 00:00:00",
7615,1,40302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40302ltr.pdf","1998-09-28 00:00:00",
17766,2,40303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40303_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf","2004-06-10 00:00:00",
29920,1,40303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40303ltr.pdf","1999-12-30 00:00:00",
42611,3,40303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040303_oxycodone_toc.cfm","2003-07-31 00:00:00",
7616,1,40304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40304ltr.pdf","2000-10-02 00:00:00",
17767,2,40306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf","2003-12-23 00:00:00",
29921,1,40306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40306LTR.PDF","1999-10-20 00:00:00",
42612,3,40306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/040306_metadate_toc.cfm","2003-12-23 00:00:00",
44190,10,40306,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
7617,1,40307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40307ltr.pdf","2000-07-26 00:00:00",
42613,3,40307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40-307_Hydrocodone%20Bitartrate%20and%20Acetaminophen.pdf","2000-07-26 00:00:00",
29922,1,40308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40308ltr.pdf","2000-07-26 00:00:00",
38881,2,40308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40308_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl.","2004-06-07 00:00:00",
42614,3,40308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040308_hydrocodone-bitartrate_toc.cfm","2003-07-31 00:00:00",
7618,1,40309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40309ltr.pdf","2000-07-26 00:00:00",
22123,3,40309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040309_hydrocodone-bitartrate_toc.cfm","2003-07-31 00:00:00",
38882,2,40309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40309_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl.","2004-06-07 00:00:00",
7619,1,40310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40310ltr.pdf","2000-12-29 00:00:00",
17768,2,40310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40310_Hydrocortisone_Prntlbl.pdf","2004-06-07 00:00:00",
42615,3,40310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040310_hydrocortisone_toc.cfm","2003-07-31 00:00:00",
29923,1,40311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40311ltr.pdf","1999-12-01 00:00:00",
7620,1,40312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40312ltr.pdf","1999-11-19 00:00:00",
22124,3,40312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40312_Innofem.pdf","1999-11-19 00:00:00",
7621,1,40316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40316ltr.pdf","1999-04-28 00:00:00",
7622,1,40317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40317ltr.pdf","1999-09-07 00:00:00",
7623,1,40318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40318ltr.pdf","1999-10-05 00:00:00",
29924,1,40319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40319ltr.pdf","1999-09-07 00:00:00",
7624,1,40320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40320ltr.pdf","2000-03-31 00:00:00",
17769,2,40320,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040320s005lbl.pdf","2012-07-25 00:00:00",
29925,1,40321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40321ltr.pdf","2003-04-08 00:00:00",
29926,1,40322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40322ltr.pdf","2000-01-19 00:00:00",
42616,3,40322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40-322_Prednisolone.pdf","2000-01-19 00:00:00",
17770,2,40323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf","1999-05-13 00:00:00",
22125,3,40323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40323.cfm","1999-05-13 00:00:00",
29927,1,40323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40323ltr.pdf","1999-05-13 00:00:00",
22126,3,40326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040326_estradiol_toc.cfm","2003-07-31 00:00:00",
29928,1,40326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40326ltr.pdf","1999-04-21 00:00:00",
38883,2,40326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40326_Estradiol_Prntlbl.pdf","2004-06-03 00:00:00",
29929,1,40327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40327ltr.pdf","2000-02-15 00:00:00",
7625,1,40330,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40330ltr..pdf","1999-06-25 00:00:00",
22127,3,40330,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-330_Oxycodone%20and%20Acetaminophen.pdf","1999-06-25 00:00:00",
38884,2,40330,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf","2006-11-30 00:00:00",
7626,1,40331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40331ltr.pdf","1999-05-28 00:00:00",
7627,1,40332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40322ltr.pdf","1999-06-28 00:00:00",
17771,2,40333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40333_Fluorouracil_Prntlbl.pdf","2003-12-23 00:00:00",
22128,3,40333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040333_fluorouracil_toc.cfm","2003-12-23 00:00:00",
29930,1,40333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40333ltr.pdf","2000-01-27 00:00:00",
17772,2,40334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.pdf","2004-06-04 00:00:00",
22129,3,40334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040334_fluorouracil_toc.cfm","2003-07-31 00:00:00",
29931,1,40334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Approv.pdf","2004-06-04 00:00:00",
29932,1,40335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40335ltr.pdf","2000-04-20 00:00:00",
38885,2,40335,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf","2012-08-30 00:00:00",
7628,1,40336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40036ltr.pdf","1999-08-18 00:00:00",
53878,14,40336,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040336_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7629,1,40337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40337ltr.pdf","2000-02-16 00:00:00",
29933,1,40338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40338ltr.pdf","2001-01-31 00:00:00",
7630,1,40341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40341ltr.pdf","1999-07-26 00:00:00",
22130,3,40341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-341_Oxycodone%20And%20Acetaminophen.pdf","1999-07-26 00:00:00",
17773,2,40341,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf","2006-11-30 00:00:00",
29934,1,40342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40342ltr.pdf","2001-01-31 00:00:00",
29935,1,40347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40347ltr.pdf","2000-04-25 00:00:00",
38886,2,40347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40347_Leucovorin%20Calcium_Prntlbl.pdf","2004-06-08 00:00:00",
42617,3,40347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040347_leucovorin-calcium_toc.cfm","2003-07-31 00:00:00",
38887,2,40347,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf","2012-08-30 00:00:00",
22131,3,40349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040349.pdf","2005-07-22 00:00:00",
7631,1,40350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40350ltr.pdf","2000-03-29 00:00:00",
22132,3,40350,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf","2005-07-22 00:00:00",
42618,3,40350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040350.pdf","2005-07-22 00:00:00",
42619,3,40350,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf","2005-07-22 00:00:00",
22133,3,40350,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf","2005-07-22 00:00:00",
17774,2,40350,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf","2015-08-14 00:00:00",
7632,1,40351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40351ltr.pdf","2000-07-25 00:00:00",
7633,1,40352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40352ltr.pdf","2000-06-13 00:00:00",
17775,2,40352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40352_Meperidine%20Hydrochloride_Prntlbl.pdf","2004-06-09 00:00:00",
42620,3,40352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040352_meperidine_toc.cfm","2003-07-31 00:00:00",
7634,1,40353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40353ltr.pdf","1999-07-29 00:00:00",
29936,1,40355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40355ltr.pdf","2000-05-31 00:00:00",
29937,1,40356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40356ltr.pdf","2000-05-31 00:00:00",
29938,1,40358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40358ltr.pdf","2000-05-31 00:00:00",
7635,1,40359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40359ltr.pdf","1999-08-26 00:00:00",
7636,1,40360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40360ltr.pdf","2001-05-25 00:00:00",
17776,2,40361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Prntlbl.pdf","2004-06-02 00:00:00",
22134,3,40361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040361_dextroamphetamine_toc.cfm","2003-07-31 00:00:00",
29939,1,40361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-361_Dextroamphetamine%20Sulfate_Approv.pdf","2004-06-02 00:00:00",
7637,1,40361,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040361Orig1s017ltr.pdf","2014-04-03 00:00:00",
38888,2,40361,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf","2014-08-06 00:00:00",
29940,1,40362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40362ltr.pdf","2001-08-29 00:00:00",
7638,1,40364,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40364ltr.pdf","2003-04-08 00:00:00",
7639,1,40368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40368ltr.pdf","2000-06-23 00:00:00",
29941,1,40371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40371ltr.pdf","2000-12-29 00:00:00",
42621,3,40371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40-371_Oxycodone%20And%20Acetaminophe.pdf","2000-12-29 00:00:00",
29942,1,40372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40372ltr.pdf","2000-06-08 00:00:00",
38889,2,40372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40372_Promethazine%20Hydrochloride_Prntlbl.pdf","2004-06-14 00:00:00",
42622,3,40372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040372_promethazine_toc.cfm","2003-07-31 00:00:00",
7640,1,40373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40373ltr.pdf","2000-02-23 00:00:00",
17777,2,40374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40374_Triamcinolone%20Acetonide_Prntlbl.pdf","2003-12-23 00:00:00",
22135,3,40374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040374_triamcinolone-acetonide_toc.cfm","2003-12-23 00:00:00",
29943,1,40374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40374ltr.pdf","2001-06-05 00:00:00",
29944,1,40377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40377ltr.pdf","2002-01-04 00:00:00",
7641,1,40378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40378ltr.pdf","2000-05-03 00:00:00",
17778,2,40378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40378_Niacor_Prntlbl.pdf","2004-06-10 00:00:00",
22136,3,40378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040378_niacor_toc.cfm","2003-07-31 00:00:00",
22137,3,40379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40-379_Fluorouracil.pdf","2000-11-15 00:00:00",
29945,1,40379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40379ltr.pdf","2000-11-15 00:00:00",
7642,1,40385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40385ltr.pdf","2001-03-21 00:00:00",
42623,3,40385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL TABLETS _ORIGINAL.pdf","2007-03-31 00:00:00",
22138,3,40386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040386_triamcinolone-acetonide_toc.cfm","2003-12-23 00:00:00",
29946,1,40386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40386ltr.pdf","2001-06-05 00:00:00",
38890,2,40386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40386_Triamcinolone%20Acetonide_Prntlbl.pdf","2003-12-23 00:00:00",
7643,1,40388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40388ltr.pdf","2001-03-13 00:00:00",
7644,1,40391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40391ltr.pdf","2003-04-08 00:00:00",
7645,1,40391,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040391Orig1s007ltr.pdf","2014-06-11 00:00:00",
17779,2,40391,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040391Orig1s007lbl.pdf","2014-06-24 00:00:00",
29947,1,40395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40395ltr.pdf","2000-11-27 00:00:00",
29948,1,40396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40396ltr.pdf","2001-02-27 00:00:00",
7646,1,40397,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40397ltr.pdf","2000-09-21 00:00:00",
7647,1,40398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40398ltr.pdf","2003-04-08 00:00:00",
7648,1,40400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40400ltr.pdf","2000-07-26 00:00:00",
7649,1,40402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40402ltr.pdf","2003-04-09 00:00:00",
7650,1,40403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40403ltr.pdf","2003-04-09 00:00:00",
29949,1,40404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40404ltr.pdf","2001-03-29 00:00:00",
7651,1,40405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40405ltr.pdf","2000-09-08 00:00:00",
7652,1,40409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40409ltr.pdf","2000-10-20 00:00:00",
29950,1,40410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40410Ltr.pdf","2001-02-09 00:00:00",
29951,1,40411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40411ltr.pdf","2001-03-27 00:00:00",
7653,1,40412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40412ltr.pdf","2003-04-09 00:00:00",
38891,2,40415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf","2007-01-16 00:00:00",
42624,3,40417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040417.pdf","2005-07-15 00:00:00",
7654,1,40418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf","2001-06-27 00:00:00",
38892,2,40418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf","2001-06-27 00:00:00",
42625,3,40418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf","2001-06-27 00:00:00",
29952,1,40419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40419ltr.pdf","2001-05-31 00:00:00",
7655,1,40420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40420ltr.pdf","2003-04-09 00:00:00",
42626,3,40420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040420_PhenytoinTOC.cfm","2006-04-20 00:00:00",
29953,1,40421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40421ltr.pdf","2001-06-21 00:00:00",
42627,3,40421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-421_Carisoprodol.pdf","2001-06-21 00:00:00",
42628,3,40422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040422.PDF","2004-12-08 00:00:00",
17780,2,40422,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040422Orig1s030lbl.pdf","2014-01-09 00:00:00",
29954,1,40422,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s033,s034ltr.pdf","2014-02-14 00:00:00",
38893,2,40422,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040422Orig1s033s034lbl.pdf","2014-02-14 00:00:00",
7656,1,40422,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s033,s034ltr.pdf","2014-02-14 00:00:00",
38894,2,40422,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040422Orig1s033s034lbl.pdf","2014-02-14 00:00:00",
17781,2,40422,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040422s036lbl.pdf","2014-06-20 00:00:00",
29955,1,40422,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040422Orig1s036ltr.pdf","2015-01-06 00:00:00",
7657,1,40422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040422Orig1s038ltr.pdf","2015-05-21 00:00:00",
38895,2,40422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/040422s038lbl.pdf","2015-05-21 00:00:00",
29956,1,40423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40423ltr.pdf","2003-04-10 00:00:00",
7658,1,40424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40424ltr.pdf","2003-04-10 00:00:00",
22139,3,40424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040424_spironolactone_toc.cfm","2003-07-31 00:00:00",
38896,2,40424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-424_Spironolactone_Prntlbl.pdf","2004-06-18 00:00:00",
7659,1,40427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40427ltr.pdf","2003-04-10 00:00:00",
22140,3,40428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040428.PDF","2004-12-08 00:00:00",
7660,1,40431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40431ltr.pdf","2003-04-09 00:00:00",
17782,2,40432,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf","2015-10-27 00:00:00",
29957,1,40432,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf","2015-10-22 00:00:00",
22141,3,40433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/040433Orig1s000.pdf","2013-06-03 00:00:00",
7661,1,40439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40439ltr.pdf","2003-04-09 00:00:00",
53879,14,40441,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040441_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53880,14,40443,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040443_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7662,1,40444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40444ltr.pdf","2003-04-09 00:00:00",
7663,1,40445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040445s000ltr.pdf","2010-04-05 00:00:00",
22143,3,40445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/040445Orig1s000.pdf","2013-01-28 00:00:00",
22144,3,40445,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/040445Orig1s003Approv.pdf","2013-05-14 00:00:00",
29959,1,40446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40446ltr.pdf","2003-04-09 00:00:00",
53881,14,40447,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040447,040488_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7664,1,40452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40452ltr.pdf","2003-04-09 00:00:00",
22145,3,40453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040453.pdf","2005-07-22 00:00:00",
7665,1,40454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40454ltr.pdf","2003-04-09 00:00:00",
42629,3,40454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040454_S000_APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
22146,3,40454,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/040454_s006_promethazine_hydrochloride_injection.pdf","2011-02-15 00:00:00",
22147,3,40458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040458_CarbinoxamineTOC.cfm","2006-04-20 00:00:00",
7666,1,40459,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40459ltr.pdf","2003-04-09 00:00:00",
7667,1,40461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40461ltr.pdf","2004-02-27 00:00:00",
7668,1,40466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40466ltr.pdf","2003-04-09 00:00:00",
42630,3,40475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040475.pdf","2005-07-22 00:00:00",
29960,1,40486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040486Orig1s000ltr.pdf","2015-03-04 00:00:00",
53882,14,40488,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040447,040488_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7669,1,40491,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf","2015-07-28 00:00:00",
38897,2,40491,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040491s008lbl.pdf","2015-07-27 00:00:00",
22148,3,40503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040503_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
42631,3,40512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040512.pdf","2007-04-02 00:00:00",
44514,14,40517,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
7670,1,40541,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40541ltr.pdf","2004-11-16 00:00:00",
7671,1,40572,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf","2015-07-28 00:00:00",
17785,2,40572,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/40572s002lbledt.pdf","2015-08-17 00:00:00",
22149,3,40575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040575Orig1s000BioeqR.pdf","2012-09-12 00:00:00",
7672,1,40578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040578ltr.pdf","2006-04-20 00:00:00",
7673,1,40583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40583ltr.pdf","2004-08-02 00:00:00",
42632,3,40583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040583_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
44191,10,40603,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-11-02 00:00:00",
53937,14,40604,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040600,040602,040604_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7674,1,40612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40612ltr.pdf","2004-08-25 00:00:00",
22150,3,40612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040612_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
42633,3,40620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040620Orig1s000BioeqR.pdf","2012-06-26 00:00:00",
44515,14,40620,"ORIG",1,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040620Orig1s000.pdf","2013-06-03 00:00:00",
42634,3,40621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/040621_original_approval_pkg.pdf","2006-12-11 00:00:00",
44192,10,40622,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-07-31 00:00:00",
29962,1,40640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040640s000LTR.pdf","2006-07-13 00:00:00",
44193,10,40643,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-05-03 00:00:00",
42635,3,40647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/040647Orig1s000BioeqR.pdf","2012-09-12 00:00:00",
23716,10,40654,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-12-18 00:00:00",
7675,1,40658,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf","2015-10-22 00:00:00",
38898,2,40658,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf","2015-10-27 00:00:00",
23717,10,40660,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2006-12-18 00:00:00",
7676,1,40668,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040668s000LTR.pdf","2006-07-13 00:00:00",
44194,10,40673,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2008-03-10 00:00:00",
53883,14,40688,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040688_SLCOrderLtr.pdf","2018-05-01 00:00:00",
22151,3,40692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040692Orig1s000Approv.pdf","2016-02-02 00:00:00",
53884,14,40701,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040701_SLCOrderLtr.pdf","2018-05-01 00:00:00",
29963,1,40712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040712s000LTR.pdf","2006-08-11 00:00:00",
44195,10,40718,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2007-04-10 00:00:00",
22152,3,40719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/040719Orig1s000.pdf","2013-05-10 00:00:00",
7677,1,40735,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/040735s004,040770s003ltr.pdf","2011-08-29 00:00:00",
38899,2,40735,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/040735s004,040770s003lbl.pdf","2011-08-26 00:00:00",
44196,10,40737,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2008-05-02 00:00:00",
42636,3,40745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/040745Orig1s000ChemR.pdf","2012-03-27 00:00:00",
17786,2,40745,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf","2014-10-27 00:00:00",
7678,1,40749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040749s000LTR.pdf","2007-07-30 00:00:00",
53938,14,40751,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040751,040752, 040753_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7679,1,40759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040759s000ltr.pdf","2008-01-09 00:00:00",
38900,2,40759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040759lbl.pdf","2007-12-21 00:00:00",
17787,2,40770,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/040735s004,040770s003lbl.pdf","2011-08-26 00:00:00",
29965,1,40770,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/040735s004,040770s003ltr.pdf","2011-08-29 00:00:00",
23420,8,40776,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088583.pdf","2008-02-28 00:00:00",
42637,3,40776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/040776Orig1s000.pdf","2013-01-24 00:00:00",
44197,10,40785,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2008-11-13 00:00:00",
23719,10,40791,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109364.htm","2008-05-30 00:00:00",
22153,3,40794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/040794Orig1s000.pdf","2013-05-10 00:00:00",
53885,14,40805,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040805_SLCOrderLtr.pdf","2018-05-01 00:00:00",
7680,1,40811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040811s000ltr.pdf","2007-11-26 00:00:00",
44198,10,40834,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm","2008-04-25 00:00:00",
42638,3,40837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/040837Orig1s000.pdf","2013-10-23 00:00:00",
29966,1,40846,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf","2015-10-22 00:00:00",
38901,2,40846,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf","2015-10-27 00:00:00",
29967,1,40861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040861s000ltr.pdf","2010-06-08 00:00:00",
53886,14,40864,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040864_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53887,14,40883,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/040883_SLCOrderLtr.pdf","2018-05-01 00:00:00",
38902,2,40903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040903lbl.pdf","2013-10-04 00:00:00",
7681,1,40904,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/040904s000ltr.pdf","2008-12-19 00:00:00",
29968,1,50006,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf","2002-06-18 00:00:00",
29969,1,50006,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf","2004-03-16 00:00:00",
17788,2,50006,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf","2008-02-14 00:00:00",
29970,1,50006,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050006s079ltr.pdf","2008-02-13 00:00:00",
38903,2,50006,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf","2011-05-16 00:00:00",
7682,1,50006,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf","2013-04-30 00:00:00",
17789,2,50006,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf","2013-05-01 00:00:00",
7683,1,50006,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf","2013-09-09 00:00:00",
17790,2,50006,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf","2013-09-09 00:00:00",
7684,1,50006,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf","2014-09-16 00:00:00",
38904,2,50006,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf","2014-10-02 00:00:00",
29971,1,50006,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf","2016-04-05 00:00:00",
38905,2,50006,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf","2016-04-07 00:00:00",
46504,2,50006,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf","2016-12-21 00:00:00",
46588,1,50006,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf","2016-12-29 00:00:00",
49091,2,50006,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf","2017-07-27 00:00:00",
49110,1,50006,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf","2017-07-28 00:00:00",
29972,1,50007,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf","2002-06-18 00:00:00",
29973,1,50007,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf","2004-03-16 00:00:00",
7685,1,50007,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050007s020ltr.pdf","2008-02-13 00:00:00",
17791,2,50007,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf","2008-02-14 00:00:00",
17792,2,50007,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf","2011-05-16 00:00:00",
7686,1,50007,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf","2013-05-01 00:00:00",
17793,2,50007,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf","2013-05-01 00:00:00",
7687,1,50007,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf","2013-09-09 00:00:00",
17794,2,50007,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf","2013-09-09 00:00:00",
29974,1,50007,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf","2014-09-16 00:00:00",
38906,2,50007,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf","2014-10-02 00:00:00",
38907,2,50007,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050007s029lbl.pdf","2015-05-07 00:00:00",
29975,1,50007,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf","2016-04-05 00:00:00",
38908,2,50007,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf","2016-04-07 00:00:00",
46503,2,50007,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf","2016-12-21 00:00:00",
46589,1,50007,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf","2016-12-29 00:00:00",
49092,2,50007,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf","2017-07-27 00:00:00",
49111,1,50007,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf","2017-07-28 00:00:00",
7688,1,50023,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050023s025ltr.pdf","2008-04-28 00:00:00",
38909,2,50023,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050023s025lbl.pdf","2008-06-12 00:00:00",
48004,2,50023,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s032lbl.pdf","2017-04-13 00:00:00",
48026,1,50023,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050023Orig1s032ltr.pdf","2017-04-14 00:00:00",
50770,2,50023,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s036lbl.pdf","2017-12-19 00:00:00",
50790,1,50023,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050023Orig1s036ltr.pdf","2017-12-20 00:00:00",
29976,1,50065,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf","2003-07-28 00:00:00",
38910,2,50065,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf","2003-07-28 00:00:00",
7689,1,50065,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf","2003-07-28 00:00:00",
17795,2,50065,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf","2003-07-28 00:00:00",
7690,1,50065,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf","2004-07-21 00:00:00",
17796,2,50065,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf","2004-07-21 00:00:00",
29977,1,50065,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf","2004-07-21 00:00:00",
38911,2,50065,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf","2004-07-21 00:00:00",
48002,2,50065,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s061lbl.pdf","2017-04-13 00:00:00",
48038,1,50065,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s061ltr.pdf","2017-04-14 00:00:00",
50761,2,50065,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s064lbl.pdf","2017-12-19 00:00:00",
50870,1,50065,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s064ltr.pdf","2017-12-27 00:00:00",
17797,2,50091,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf","2003-05-02 00:00:00",
7691,1,50095,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50095slr044ltr.pdf","2003-06-22 00:00:00",
38912,2,50095,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf","2003-06-22 00:00:00",
17798,2,50095,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf","2008-07-29 00:00:00",
29978,1,50095,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050095s062ltr.pdf","2008-07-25 00:00:00",
44199,10,50108,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118080.htm","2007-06-29 00:00:00",
29979,1,50108,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50108slr023ltr.pdf","2004-06-01 00:00:00",
7692,1,50108,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050108s024ltr.pdf","2006-01-20 00:00:00",
38913,2,50108,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050108s024lbl.pdf","2006-01-13 00:00:00",
7693,1,50108,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050108s026ltr.pdf","2009-05-19 00:00:00",
17799,2,50108,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050108s026lbl.pdf","2009-06-07 00:00:00",
17800,2,50108,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050108s030lbl.pdf","2013-03-08 00:00:00",
29980,1,50108,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050108Orig1s030ltr.pdf","2013-03-08 00:00:00",
48051,2,50108,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050108s033lbl.pdf","2017-04-18 00:00:00",
48057,1,50108,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050108Orig1s033ltr.pdf","2017-04-18 00:00:00",
29981,1,50114,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050114s008ltr.pdf","2009-11-09 00:00:00",
29982,1,50138,"SUPPL",219,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s219ltr.pdf","2004-05-28 00:00:00",
29983,1,50138,"SUPPL",222,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf","2002-04-29 00:00:00",
7694,1,50138,"SUPPL",223,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf","2002-04-29 00:00:00",
29984,1,50138,"SUPPL",228,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50138s228ltr.pdf","2004-12-29 00:00:00",
7695,1,50138,"SUPPL",229,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf","2005-11-18 00:00:00",
17801,2,50138,"SUPPL",231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf","2009-12-22 00:00:00",
29985,1,50138,"SUPPL",231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf","2009-12-31 00:00:00",
17802,2,50138,"SUPPL",234,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf","2012-09-11 00:00:00",
29986,1,50138,"SUPPL",234,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf","2012-09-07 00:00:00",
29987,1,50138,"SUPPL",235,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050138Orig1s235,050141Orig1s232ltr.pdf","2014-04-29 00:00:00",
38914,2,50138,"SUPPL",235,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf","2014-05-12 00:00:00",
29988,1,50138,"SUPPL",236,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050138Orig1s236ltr.pdf","2015-10-14 00:00:00",
38915,2,50138,"SUPPL",236,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050138s236lbl.pdf","2015-10-15 00:00:00",
50657,1,50138,"SUPPL",238,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050138Orig1s238, 050141Orig1s235ltr.pdf","2017-12-12 00:00:00",
7696,1,50141,"SUPPL",215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50141s215ltr.pdf","2002-03-01 00:00:00",
7697,1,50141,"SUPPL",218,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf","2002-04-29 00:00:00",
7698,1,50141,"SUPPL",219,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf","2002-04-29 00:00:00",
7699,1,50141,"SUPPL",224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf","2005-11-18 00:00:00",
7700,1,50141,"SUPPL",226,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf","2009-12-31 00:00:00",
38916,2,50141,"SUPPL",226,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050141s226lbl.pdf","2009-12-22 00:00:00",
7701,1,50141,"SUPPL",231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf","2012-09-07 00:00:00",
38917,2,50141,"SUPPL",231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050141s231lbl.pdf","2012-09-11 00:00:00",
29989,1,50141,"SUPPL",232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050138Orig1s235,050141Orig1s232ltr.pdf","2014-04-29 00:00:00",
38918,2,50141,"SUPPL",232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf","2014-05-12 00:00:00",
17803,2,50141,"SUPPL",233,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050141s233lbl.pdf","2015-10-15 00:00:00",
29990,1,50141,"SUPPL",233,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050141Orig1s233ltr.pdf","2015-10-14 00:00:00",
50658,1,50141,"SUPPL",235,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050138Orig1s238, 050141Orig1s235ltr.pdf","2017-12-12 00:00:00",
7702,1,50155,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050155s039ltr.pdf","2005-08-11 00:00:00",
38919,2,50155,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050155s039lbl.pdf","2016-05-31 00:00:00",
17804,2,50162,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf","2004-10-04 00:00:00",
29991,1,50162,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf","2004-10-04 00:00:00",
7703,1,50162,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf","2004-02-02 00:00:00",
7704,1,50162,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050162s085ltr.pdf","2010-01-21 00:00:00",
17805,2,50162,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf","2009-11-23 00:00:00",
7705,1,50162,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf","2011-06-10 00:00:00",
29992,1,50162,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf","2014-06-27 00:00:00",
38920,2,50162,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf","2014-06-30 00:00:00",
7706,1,50162,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf","2014-06-27 00:00:00",
38921,2,50162,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf","2014-06-30 00:00:00",
7707,1,50162,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf","2016-03-25 00:00:00",
17806,2,50162,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf","2016-03-29 00:00:00",
17807,2,50162,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf","2016-03-29 00:00:00",
29993,1,50162,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf","2016-03-25 00:00:00",
48237,2,50162,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf","2017-05-04 00:00:00",
48278,1,50162,"SUPPL",98,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050162Orig1s098,s099ltr.pdf","2017-05-08 00:00:00",
48238,2,50162,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf","2017-05-04 00:00:00",
48277,1,50162,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050162Orig1s098,s099ltr.pdf","2017-05-08 00:00:00",
53043,2,50162,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050162s100lbl.pdf","2018-03-16 00:00:00",
53065,1,50162,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050162Orig1s100ltr.pdf","2018-03-20 00:00:00",
7708,1,50168,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50168slr078ltr.pdf","2003-11-28 00:00:00",
17808,2,50168,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf","2003-12-02 00:00:00",
7709,1,50169,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50169slr046ltr.pdf","2003-12-02 00:00:00",
38922,2,50169,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50169slr046_cortisporin_lbl.pdf","2003-12-02 00:00:00",
29994,1,50182,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf","2002-05-23 00:00:00",
7710,1,50182,"SUPPL",125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50609s019,50182s125ltr.pdf","2004-09-17 00:00:00",
42639,3,50207,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s055_Erythromycin.cfm","2004-09-21 00:00:00",
22154,3,50207,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s055_Erythromycin.cfm","2004-09-21 00:00:00",
7711,1,50207,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf","2002-04-25 00:00:00",
7712,1,50207,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050207s058, 050297s021LTR.pdf","2006-08-14 00:00:00",
17809,2,50207,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf","2006-08-11 00:00:00",
7713,1,50207,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf","2004-03-16 00:00:00",
7714,1,50207,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050207s064ltr.pdf","2011-02-07 00:00:00",
17810,2,50207,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050207s064lbl.pdf","2011-01-31 00:00:00",
29995,1,50207,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s065ltr.pdf","2008-01-09 00:00:00",
38923,2,50207,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050207s065lbl.pdf","2008-01-08 00:00:00",
7715,1,50207,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s066ltr.pdf","2008-05-28 00:00:00",
29996,1,50207,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050207s067,050297s029ltr.pdf","2010-11-08 00:00:00",
7716,1,50207,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s068, 050297s030ltr.pdf","2008-12-19 00:00:00",
17811,2,50207,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf","2009-01-02 00:00:00",
7717,1,50207,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050207s071,050611s035ltr.pdf","2012-02-06 00:00:00",
17812,2,50207,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050207s071lbl.pdf","2012-02-06 00:00:00",
49494,1,50207,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050207Orig1s073ltr.pdf","2017-08-21 00:00:00",
49497,2,50207,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050207s073lbl.pdf","2017-08-22 00:00:00",
53802,2,50207,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf","2018-04-24 00:00:00",
53809,1,50207,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050207Orig1s074,050611Orig1s036ltr.pdf","2018-04-24 00:00:00",
29997,1,50218,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50218slr051ltr.pdf","2004-06-02 00:00:00",
7718,1,50261,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf","2003-12-22 00:00:00",
7719,1,50261,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr095ltr.pdf","2003-05-30 00:00:00",
7720,1,50261,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf","2003-12-22 00:00:00",
17813,2,50261,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050261s100lbl.pdf","2008-06-05 00:00:00",
29998,1,50261,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050261s100ltr.pdf","2008-04-25 00:00:00",
7721,1,50261,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050261Orig1s101ltr.pdf","2012-09-07 00:00:00",
17814,2,50261,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050261s101lbl.pdf","2012-09-06 00:00:00",
7722,1,50278,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050278Orig1s037ltr.pdf","2015-04-29 00:00:00",
17815,2,50278,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050278s037lbl.pdf","2015-05-12 00:00:00",
42640,3,50297,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm","2004-09-21 00:00:00",
7723,1,50297,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf","2002-04-25 00:00:00",
17816,2,50297,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf","2006-08-11 00:00:00",
29999,1,50297,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050207s058, 050297s021LTR.pdf","2006-08-14 00:00:00",
7724,1,50297,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf","2004-03-16 00:00:00",
30000,1,50297,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s027ltr.pdf","2008-01-09 00:00:00",
38924,2,50297,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s027lbl.pdf","2008-01-08 00:00:00",
30001,1,50297,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s028ltr.pdf","2008-05-28 00:00:00",
7725,1,50297,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050207s067,050297s029ltr.pdf","2010-11-08 00:00:00",
17817,2,50297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf","2009-01-02 00:00:00",
30002,1,50297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s068, 050297s030ltr.pdf","2008-12-19 00:00:00",
30003,1,50297,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050297Orig1s031ltr.pdf","2012-08-17 00:00:00",
38925,2,50297,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050297s031lbl.pdf","2012-08-16 00:00:00",
7726,1,50316,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50317slr167,50316slr099ltr.pdf","2004-06-07 00:00:00",
53613,1,50317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205580Orig1s000TAltr.pdf","2018-04-05 00:00:00",
7727,1,50317,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50317slr167,50316slr099ltr.pdf","2004-06-07 00:00:00",
30004,1,50317,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050317s172ltr.pdf","2008-02-29 00:00:00",
38926,2,50317,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050317s172lbl.pdf","2008-02-28 00:00:00",
7728,1,50317,"SUPPL",177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050317Orig1s177ltr.pdf","2014-10-21 00:00:00",
17818,2,50317,"SUPPL",177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050317s177lbl.pdf","2014-10-16 00:00:00",
45867,1,50317,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050317Orig1s179,050317Orig1s180ltr.pdf","2016-11-10 00:00:00",
45874,2,50317,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050317s179s180lbl.pdf","2016-11-10 00:00:00",
45868,1,50317,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050317Orig1s179,050317Orig1s180ltr.pdf","2016-11-10 00:00:00",
45873,2,50317,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050317s179s180lbl.pdf","2016-11-10 00:00:00",
53589,1,50317,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050317s184ltr.pdf","2018-04-02 00:00:00",
53590,2,50317,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050317s184lbl.pdf","2018-04-02 00:00:00",
30005,1,50347,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50347s052ltr.pdf","2004-08-25 00:00:00",
7729,1,50347,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050347s058ltr.pdf","2011-11-21 00:00:00",
38927,2,50347,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050347s058lbl.pdf","2011-11-16 00:00:00",
30006,1,50347,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050347Orig1s060ltr.pdf","2012-08-17 00:00:00",
38928,2,50347,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050347s060lbl.pdf","2012-08-16 00:00:00",
30007,1,50356,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50356s45ltr.pdf","2002-03-01 00:00:00",
17819,2,50356,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf","2009-06-04 00:00:00",
30008,1,50356,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050356s050ltr.pdf","2009-06-08 00:00:00",
7730,1,50405,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405s092ltr.pdf","2004-12-02 00:00:00",
30009,1,50405,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr094ltr.pdf","2004-01-22 00:00:00",
38929,2,50405,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf","2004-01-22 00:00:00",
30010,1,50405,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr095ltr.pdf","2004-07-01 00:00:00",
7731,1,50405,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050405s097ltr.pdf","2006-05-16 00:00:00",
17820,2,50405,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf","2006-05-16 00:00:00",
30011,1,50405,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s099ltr.pdf","2008-05-21 00:00:00",
30012,1,50405,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s101ltr.pdf","2008-09-17 00:00:00",
7732,1,50405,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf","2015-11-04 00:00:00",
38930,2,50405,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050405s106lbl.pdf","2015-11-04 00:00:00",
7733,1,50416,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50416slr015ltr.pdf","2004-03-24 00:00:00",
38931,2,50416,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50416slr015_cortisporin_lbl.pdf","2004-04-05 00:00:00",
30013,1,50417,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50417slr011ltr.pdf","2004-05-04 00:00:00",
38932,2,50417,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50417slr011_neosporin_lbl.pdf","2004-05-04 00:00:00",
30014,1,50420,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf","2004-08-25 00:00:00",
38933,2,50420,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf","2004-08-25 00:00:00",
17821,2,50420,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf","2010-11-12 00:00:00",
30015,1,50420,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf","2010-11-22 00:00:00",
7734,1,50420,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf","2013-03-01 00:00:00",
38934,2,50420,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf","2013-03-01 00:00:00",
48101,2,50420,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050420s076,050627s017lbl.pdf","2017-04-25 00:00:00",
48140,1,50420,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050627Orig1S017,050420Orig1S076ltr.pdf","2017-04-27 00:00:00",
51003,2,50420,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf","2018-01-09 00:00:00",
51010,1,50420,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050420Orig1s077, 050627Orig1s020ltr.pdf","2018-01-10 00:00:00",
7735,1,50429,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50429s083ltr.pdf","2004-12-02 00:00:00",
17822,2,50429,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50429s083lbl.pdf","2004-12-03 00:00:00",
7736,1,50435,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50435s008ltr.pdf","2004-12-29 00:00:00",
7737,1,50435,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050435s009ltr.pdf","2008-02-29 00:00:00",
17823,2,50435,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050435s009lbl.pdf","2008-02-28 00:00:00",
30016,1,50441,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf","2004-10-04 00:00:00",
38935,2,50441,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf","2004-10-04 00:00:00",
30017,1,50441,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50441s47ltr.pdf","2001-11-21 00:00:00",
38936,2,50441,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf","2003-05-02 00:00:00",
30018,1,50441,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf","2004-02-02 00:00:00",
7738,1,50441,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s053ltr.pdf","2008-02-25 00:00:00",
17824,2,50441,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf","2008-02-25 00:00:00",
7739,1,50441,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf","2008-04-16 00:00:00",
38937,2,50441,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf","2008-04-23 00:00:00",
30019,1,50441,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050441s059ltr.pdf","2010-10-20 00:00:00",
30020,1,50441,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf","2011-06-10 00:00:00",
17825,2,50441,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf","2014-06-25 00:00:00",
30021,1,50441,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf","2014-06-12 00:00:00",
7740,1,50441,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf","2014-06-12 00:00:00",
17826,2,50441,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf","2014-06-25 00:00:00",
30022,1,50441,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf","2014-06-12 00:00:00",
38938,2,50441,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf","2014-06-25 00:00:00",
7741,1,50441,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf","2016-03-28 00:00:00",
17827,2,50441,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf","2016-03-29 00:00:00",
45004,1,50441,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf","2016-08-05 00:00:00",
45027,2,50441,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf","2016-08-05 00:00:00",
45003,1,50441,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf","2016-08-05 00:00:00",
45028,2,50441,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2016/050441s073,050639s034lbl.pdf","2016-08-05 00:00:00",
48239,2,50441,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-04 00:00:00",
48280,1,50441,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf","2017-05-08 00:00:00",
48240,2,50441,"SUPPL",78,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-04 00:00:00",
48279,1,50441,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf","2017-05-08 00:00:00",
53701,2,50441,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf","2018-04-17 00:00:00",
53715,1,50441,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050441Orig1s079,050639Orig1s038ltr.pdf","2018-04-17 00:00:00",
7742,1,50442,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf","2002-06-18 00:00:00",
7743,1,50442,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050442Orig1s016ltr.pdf","2013-09-13 00:00:00",
17828,2,50442,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050442s016lbl.pdf","2013-09-17 00:00:00",
30023,1,50442,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050442Orig1s017ltr.pdf","2014-09-25 00:00:00",
38939,2,50442,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050442s017lbl.pdf","2014-09-26 00:00:00",
7744,1,50442,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf","2016-04-05 00:00:00",
17829,2,50442,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf","2016-04-07 00:00:00",
46502,2,50442,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf","2016-12-21 00:00:00",
46590,1,50442,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf","2016-12-29 00:00:00",
49093,2,50442,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf","2017-07-27 00:00:00",
49112,1,50442,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf","2017-07-28 00:00:00",
42641,3,50443,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050443s026_blenoxane.pdf","1999-08-02 00:00:00",
7745,1,50443,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50443slr027ltr.pdf","2004-07-01 00:00:00",
17830,2,50443,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.pdf","2003-03-26 00:00:00",
30024,1,50443,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50443slr035ltr.pdf","2003-03-26 00:00:00",
7746,1,50443,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050443s036ltr.pdf","2010-05-17 00:00:00",
17831,2,50443,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf","2010-05-11 00:00:00",
30025,1,50444,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf","2002-01-30 00:00:00",
7747,1,50444,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf","2002-01-30 00:00:00",
30026,1,50444,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf","2002-01-30 00:00:00",
7748,1,50444,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf","2002-05-31 00:00:00",
42642,3,50444,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm","2004-06-29 00:00:00",
7749,1,50444,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf","2005-02-17 00:00:00",
30027,1,50444,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf","2004-06-01 00:00:00",
7750,1,50444,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf","2004-06-01 00:00:00",
7751,1,50444,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf","2005-10-20 00:00:00",
38940,2,50444,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf","2005-09-30 00:00:00",
7752,1,50444,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf","2007-01-18 00:00:00",
17832,2,50444,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf","2007-01-18 00:00:00",
7753,1,50444,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050444s047ltr.pdf","2010-09-17 00:00:00",
38941,2,50444,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050444s047lbl.pdf","2010-09-20 00:00:00",
17833,2,50444,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050444s048lbl.pdf","2014-11-18 00:00:00",
30028,1,50444,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050444Orig1s048ltr.pdf","2014-10-27 00:00:00",
17834,2,50444,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050444s049lbl.pdf","2015-04-22 00:00:00",
7754,1,50445,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf","2002-02-01 00:00:00",
7755,1,50445,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf","2002-02-01 00:00:00",
30029,1,50445,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf","2002-02-01 00:00:00",
30030,1,50445,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf","2002-02-01 00:00:00",
7756,1,50445,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf","2002-05-31 00:00:00",
42643,3,50445,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm","2004-06-29 00:00:00",
30031,1,50445,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf","2005-02-17 00:00:00",
7757,1,50445,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf","2004-06-01 00:00:00",
30032,1,50445,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf","2004-06-01 00:00:00",
17835,2,50445,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf","2005-09-30 00:00:00",
30033,1,50445,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf","2005-10-20 00:00:00",
30034,1,50445,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf","2007-01-18 00:00:00",
38942,2,50445,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf","2007-01-18 00:00:00",
7758,1,50445,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050445s028ltr.pdf","2010-09-16 00:00:00",
17836,2,50445,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf","2010-09-20 00:00:00",
30035,1,50445,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050445Orig1s029ltr.pdf","2015-02-27 00:00:00",
38943,2,50445,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050445s029lbl.pdf","2015-03-02 00:00:00",
22155,3,50456,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-456S020.pdf","2003-09-11 00:00:00",
17837,2,50461,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr135_ancef_lbl.pdf","2004-01-22 00:00:00",
30036,1,50461,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr135ltr.pdf","2004-01-22 00:00:00",
7759,1,50461,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50461s138ltr.pdf","2005-01-11 00:00:00",
30037,1,50461,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr139ltr.pdf","2004-06-07 00:00:00",
38944,2,50461,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf","2004-06-07 00:00:00",
30038,1,50467,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf","2002-09-25 00:00:00",
38945,2,50467,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf","2002-09-25 00:00:00",
17838,2,50467,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf","2002-09-25 00:00:00",
30039,1,50467,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf","2002-09-25 00:00:00",
7760,1,50467,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf","2003-05-30 00:00:00",
38946,2,50467,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf","2003-05-13 00:00:00",
17839,2,50467,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf","2003-05-29 00:00:00",
30040,1,50467,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf","2003-05-30 00:00:00",
7761,1,50467,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017ltr.pdf","2010-08-09 00:00:00",
38947,2,50467,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050467s070lbl.pdf","2010-07-30 00:00:00",
30041,1,50467,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019ltr.pdf","2011-09-29 00:00:00",
38948,2,50467,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050467s071lbl.pdf","2011-09-26 00:00:00",
7762,1,50467,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050467Orig1s073ltr.pdf","2013-11-06 00:00:00",
17840,2,50467,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050467s073lbl.pdf","2013-11-01 00:00:00",
17841,2,50475,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf","2003-03-28 00:00:00",
30042,1,50475,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf","2003-04-14 00:00:00",
7763,1,50475,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050475s053ltr.pdf","2007-02-02 00:00:00",
38949,2,50475,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf","2007-02-02 00:00:00",
17842,2,50475,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf","2010-10-19 00:00:00",
30043,1,50475,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050475s054ltr.pdf","2010-10-25 00:00:00",
7764,1,50475,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050475Orig1s057ltr.pdf","2016-04-22 00:00:00",
17843,2,50475,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf","2016-04-20 00:00:00",
30044,1,50477,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50477slr024,50519slr024ltr.pdf","2003-04-18 00:00:00",
22156,3,50479,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50479S015_Cortisporin.pdf","1999-08-26 00:00:00",
7765,1,50480,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf","2002-06-18 00:00:00",
30045,1,50480,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf","2004-03-16 00:00:00",
7766,1,50480,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050480s042ltr.pdf","2008-02-13 00:00:00",
38950,2,50480,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf","2008-02-14 00:00:00",
38951,2,50480,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf","2011-05-16 00:00:00",
7767,1,50480,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf","2013-04-30 00:00:00",
17844,2,50480,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf","2013-05-01 00:00:00",
7768,1,50480,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf","2013-09-09 00:00:00",
17845,2,50480,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf","2013-09-09 00:00:00",
7769,1,50480,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf","2014-09-16 00:00:00",
38952,2,50480,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf","2014-10-02 00:00:00",
17846,2,50480,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf","2016-04-07 00:00:00",
30046,1,50480,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf","2016-04-05 00:00:00",
46501,2,50480,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf","2016-12-21 00:00:00",
46591,1,50480,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf","2016-12-29 00:00:00",
49094,2,50480,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf","2017-07-27 00:00:00",
49113,1,50480,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf","2017-07-28 00:00:00",
7770,1,50504,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50504s059ltr.pdf","2002-07-18 00:00:00",
7771,1,50504,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50504slr062ltr.pdf","2003-03-10 00:00:00",
7772,1,50512,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf","2004-06-02 00:00:00",
17847,2,50512,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf","2004-06-02 00:00:00",
7773,1,50512,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf","2003-12-19 00:00:00",
38953,2,50512,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf","2003-12-29 00:00:00",
7774,1,50512,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf","2007-06-07 00:00:00",
17848,2,50512,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf","2007-06-07 00:00:00",
7775,1,50514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050514s009ltr.pdf","2008-07-23 00:00:00",
17849,2,50514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf","2008-07-22 00:00:00",
42644,3,50517,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517s031_50-581s020_Mefoxin.cfm","2004-08-10 00:00:00",
42645,3,50517,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-517s038_Mefoxin.cfm","2004-11-22 00:00:00",
22157,3,50517,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517S039_Mefoxin.pdf","2004-08-10 00:00:00",
7776,1,50517,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf","2004-07-01 00:00:00",
7777,1,50517,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf","2004-07-01 00:00:00",
17850,2,50517,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf","2004-06-07 00:00:00",
30047,1,50517,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr046ltr.pdf","2004-06-07 00:00:00",
30048,1,50517,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050517s047ltr.pdf","2007-09-25 00:00:00",
38954,2,50517,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf","2007-09-19 00:00:00",
7778,1,50517,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050517s050ltr.pdf","2011-02-10 00:00:00",
7779,1,50517,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050517Orig1s051ltr.pdf","2013-05-14 00:00:00",
17851,2,50517,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf","2013-05-14 00:00:00",
47519,2,50517,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050517s053lbl.pdf","2017-03-10 00:00:00",
47551,1,50517,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050517Orig1s053ltr.pdf","2017-03-14 00:00:00",
7780,1,50519,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50477slr024,50519slr024ltr.pdf","2003-04-18 00:00:00",
42646,3,50521,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf","1998-02-02 00:00:00",
7781,1,50521,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf","2003-03-10 00:00:00",
7782,1,50521,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf","2004-03-24 00:00:00",
38955,2,50521,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf","2004-04-05 00:00:00",
42647,3,50522,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf","1998-02-02 00:00:00",
7783,1,50522,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf","2003-03-10 00:00:00",
7784,1,50522,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf","2004-03-24 00:00:00",
38956,2,50522,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf","2004-04-05 00:00:00",
7785,1,50526,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50526slr010ltr.pdf","2002-12-15 00:00:00",
17852,2,50526,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.pdf","2002-12-15 00:00:00",
30049,1,50527,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf","2004-06-02 00:00:00",
38957,2,50527,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf","2004-06-02 00:00:00",
7786,1,50527,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf","2003-12-19 00:00:00",
17853,2,50527,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf","2003-12-29 00:00:00",
30050,1,50527,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf","2007-06-07 00:00:00",
38958,2,50527,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf","2007-06-07 00:00:00",
7787,1,50528,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf","2004-06-02 00:00:00",
38959,2,50528,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf","2004-06-02 00:00:00",
7788,1,50528,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf","2003-12-19 00:00:00",
38960,2,50528,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf","2003-12-29 00:00:00",
30051,1,50528,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf","2007-06-07 00:00:00",
38961,2,50528,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf","2007-06-07 00:00:00",
7789,1,50529,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50529slr033ltr.pdf","2004-02-27 00:00:00",
7790,1,50533,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf","2002-06-18 00:00:00",
7791,1,50533,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf","2004-03-16 00:00:00",
30052,1,50533,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050533s036ltr.pdf","2008-02-13 00:00:00",
38962,2,50533,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf","2008-02-14 00:00:00",
38963,2,50533,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf","2011-05-16 00:00:00",
17854,2,50533,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf","2013-05-01 00:00:00",
30053,1,50533,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf","2013-04-30 00:00:00",
7792,1,50533,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf","2013-09-09 00:00:00",
17855,2,50533,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf","2013-09-09 00:00:00",
30054,1,50533,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf","2014-09-16 00:00:00",
38964,2,50533,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf","2014-10-02 00:00:00",
30055,1,50533,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf","2016-04-05 00:00:00",
38965,2,50533,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf","2016-04-07 00:00:00",
46500,2,50533,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf","2016-12-21 00:00:00",
46592,1,50533,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf","2016-12-29 00:00:00",
49095,2,50533,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf","2017-07-27 00:00:00",
49114,1,50533,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf","2017-07-28 00:00:00",
30056,1,50536,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50536slr016ltr.pdf","2004-02-27 00:00:00",
30057,1,50536,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50536slr018ltr.pdf","2003-12-22 00:00:00",
30058,1,50536,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050536s019ltr.pdf","2006-01-20 00:00:00",
38966,2,50536,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050536s019lbl.pdf","2006-01-13 00:00:00",
7793,1,50536,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050536s020ltr.pdf","2008-02-25 00:00:00",
17856,2,50536,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf","2008-02-25 00:00:00",
7794,1,50536,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050536Orig1s021ltr_corrected.pdf","2013-03-22 00:00:00",
38967,2,50536,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050536s021lbl.pdf","2013-03-26 00:00:00",
30059,1,50536,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050536s022ltr.pdf","2012-02-21 00:00:00",
38968,2,50536,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050536s022lbl.pdf","2012-02-17 00:00:00",
53799,2,50536,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050536s026lbl.pdf","2018-04-24 00:00:00",
53811,1,50536,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050536Orig1s026ltr.pdf","2018-04-24 00:00:00",
17857,2,50537,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf","2002-07-14 00:00:00",
30060,1,50537,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf","2002-07-14 00:00:00",
7795,1,50537,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf","2003-06-08 00:00:00",
17858,2,50537,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf","2003-06-08 00:00:00",
7796,1,50537,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf","2014-04-07 00:00:00",
17859,2,50537,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf","2014-04-08 00:00:00",
17860,2,50537,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf","2016-01-26 00:00:00",
30061,1,50537,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf","2016-01-20 00:00:00",
50439,2,50537,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf","2017-11-17 00:00:00",
50451,1,50537,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf","2017-11-17 00:00:00",
7797,1,50541,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50541slr017ltr.pdf","2003-07-28 00:00:00",
38969,2,50541,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50541slr017_tobrex_lbl.pdf","2003-07-28 00:00:00",
17861,2,50541,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf","2013-01-02 00:00:00",
30062,1,50541,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050541Orig1s024ltr.pdf","2012-12-19 00:00:00",
42648,3,50542,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm","1998-02-27 00:00:00",
42649,3,50542,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm","1998-02-27 00:00:00",
22158,3,50542,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm","1998-02-27 00:00:00",
22159,3,50542,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-542s016_50-754s001_Amoxil.cfm","2004-09-09 00:00:00",
30063,1,50542,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf","2004-05-27 00:00:00",
22160,3,50542,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm","2004-09-09 00:00:00",
30064,1,50542,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf","2003-06-08 00:00:00",
7798,1,50542,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf","2003-12-22 00:00:00",
30065,1,50542,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf","2004-07-21 00:00:00",
7799,1,50542,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf","2008-06-13 00:00:00",
17862,2,50542,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf","2008-06-12 00:00:00",
7800,1,50542,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf","2008-04-02 00:00:00",
38970,2,50542,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf","2008-04-01 00:00:00",
30066,1,50542,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
38971,2,50542,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
7801,1,50542,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
17863,2,50542,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
17864,2,50542,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
30067,1,50542,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
30068,1,50542,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf","2015-09-28 00:00:00",
38972,2,50542,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf","2015-09-29 00:00:00",
17865,2,50542,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf","2015-12-08 00:00:00",
30069,1,50542,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf","2015-12-08 00:00:00",
30070,1,50545,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf","2003-06-08 00:00:00",
30071,1,50545,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf","2003-06-08 00:00:00",
7802,1,50545,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf","2003-06-08 00:00:00",
30072,1,50545,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50545slr050ltr.pdf","2004-04-07 00:00:00",
7803,1,50545,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf","2005-07-29 00:00:00",
30073,1,50545,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf","2005-07-29 00:00:00",
7804,1,50545,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050545s053ltr.pdf","2008-04-22 00:00:00",
38973,2,50545,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050545s053lbl.pdf","2008-06-05 00:00:00",
30074,1,50547,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf","2002-01-18 00:00:00",
7805,1,50547,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf","2004-06-24 00:00:00",
7806,1,50547,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547s061ltr.pdf","2004-09-03 00:00:00",
7807,1,50547,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050547s066ltr.pdf","2008-02-25 00:00:00",
17866,2,50547,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf","2008-02-25 00:00:00",
30075,1,50547,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf","2009-06-02 00:00:00",
7808,1,50547,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf","2011-09-13 00:00:00",
17867,2,50547,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf","2011-09-16 00:00:00",
17868,2,50547,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf","2014-02-25 00:00:00",
30076,1,50547,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf","2014-02-25 00:00:00",
7809,1,50547,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf","2015-03-24 00:00:00",
38974,2,50547,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf","2015-04-14 00:00:00",
7810,1,50551,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50551slr042ltr.pdf","2004-05-28 00:00:00",
17869,2,50551,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf","2003-04-09 00:00:00",
7811,1,50551,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050551Orig1s043ltr.pdf","2015-03-19 00:00:00",
38975,2,50551,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf","2015-03-19 00:00:00",
54636,1,50551,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050551Orig1s044ltr.pdf","2018-06-21 00:00:00",
54675,2,50551,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050551s044lbl.pdf","2018-06-21 00:00:00",
49882,2,50551,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050551s045lbl.pdf","2017-09-29 00:00:00",
49896,1,50551,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050551Orig1s045ltr.pdf","2017-09-29 00:00:00",
30077,1,50555,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf","2003-03-26 00:00:00",
38976,2,50555,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf","2003-03-26 00:00:00",
7812,1,50555,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf","2003-03-26 00:00:00",
17870,2,50555,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf","2003-03-26 00:00:00",
7813,1,50555,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf","2003-03-26 00:00:00",
38977,2,50555,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf","2003-03-26 00:00:00",
30078,1,50555,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf","2004-07-21 00:00:00",
38978,2,50555,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf","2004-07-21 00:00:00",
7814,1,50555,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf","2004-07-21 00:00:00",
38979,2,50555,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf","2004-07-21 00:00:00",
17871,2,50557,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050557s025lbl.pdf","2003-03-06 00:00:00",
38980,2,50558,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf","2003-05-02 00:00:00",
17872,2,50558,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf","2004-05-27 00:00:00",
30079,1,50558,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf","2004-05-26 00:00:00",
30080,1,50558,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf","2007-07-31 00:00:00",
38981,2,50558,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf","2007-07-31 00:00:00",
7815,1,50558,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf","2014-09-29 00:00:00",
17873,2,50558,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf","2014-09-30 00:00:00",
30081,1,50560,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf","2005-01-21 00:00:00",
22161,3,50564,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050564s022_augmentin.pdf","1999-08-02 00:00:00",
30082,1,50564,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
7816,1,50564,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf","2003-08-15 00:00:00",
30083,1,50564,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr018ltr.pdf","2004-06-01 00:00:00",
7817,1,50564,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr.pdf","2004-09-03 00:00:00",
7818,1,50564,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021ltr.pdf","2005-08-11 00:00:00",
7819,1,50564,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049, 050720s022ltr.pdf","2008-06-13 00:00:00",
17874,2,50564,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf","2008-06-12 00:00:00",
30084,1,50564,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050, 050720s023ltr.pdf","2008-12-11 00:00:00",
38982,2,50564,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf","2008-12-08 00:00:00",
30085,1,50564,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s051ltr.pdf","2008-04-02 00:00:00",
38983,2,50564,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s051lbl.pdf","2008-03-27 00:00:00",
17875,2,50564,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf","2011-09-30 00:00:00",
30086,1,50564,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050564s052,050720s025ltr.pdf","2011-10-03 00:00:00",
7820,1,50564,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
17876,2,50564,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
17877,2,50564,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
30087,1,50564,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
7821,1,50573,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
17878,2,50573,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
7822,1,50573,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
38984,2,50573,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
7823,1,50573,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-02-27 00:00:00",
17879,2,50573,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
30088,1,50573,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-02-27 00:00:00",
38985,2,50573,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
7824,1,50573,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf","2005-07-26 00:00:00",
17880,2,50573,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf","2005-07-26 00:00:00",
7825,1,50573,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf","2006-03-23 00:00:00",
17881,2,50573,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf","2006-03-10 00:00:00",
7826,1,50573,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf","2009-11-10 00:00:00",
17882,2,50573,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf","2009-10-14 00:00:00",
7827,1,50573,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf","2010-05-06 00:00:00",
17883,2,50573,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf","2010-05-07 00:00:00",
7828,1,50573,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf","2012-09-05 00:00:00",
17884,2,50573,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf","2012-08-31 00:00:00",
30089,1,50573,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf","2013-05-07 00:00:00",
38986,2,50573,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf","2013-05-09 00:00:00",
17885,2,50573,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf","2015-04-01 00:00:00",
30090,1,50573,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf","2015-04-02 00:00:00",
30091,1,50574,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
38987,2,50574,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
30092,1,50574,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
38988,2,50574,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
30093,1,50574,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-02-27 00:00:00",
38989,2,50574,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
30094,1,50574,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-02-27 00:00:00",
38990,2,50574,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
7829,1,50574,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf","2005-07-26 00:00:00",
17886,2,50574,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf","2005-07-26 00:00:00",
30095,1,50574,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf","2006-03-23 00:00:00",
38991,2,50574,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf","2006-03-10 00:00:00",
30096,1,50574,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf","2009-11-10 00:00:00",
38992,2,50574,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf","2009-10-14 00:00:00",
30097,1,50574,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf","2010-05-06 00:00:00",
38993,2,50574,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf","2010-05-07 00:00:00",
30098,1,50574,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf","2012-09-05 00:00:00",
38994,2,50574,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf","2012-08-31 00:00:00",
30099,1,50574,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf","2013-05-07 00:00:00",
38995,2,50574,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf","2013-05-09 00:00:00",
17887,2,50574,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf","2015-04-01 00:00:00",
30100,1,50574,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf","2015-04-02 00:00:00",
22162,3,50575,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050564s022_augmentin.pdf","1999-08-02 00:00:00",
30101,1,50575,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
30102,1,50575,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf","2003-06-08 00:00:00",
30103,1,50575,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf","2004-06-07 00:00:00",
7830,1,50575,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf","2004-08-12 00:00:00",
17888,2,50575,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf","2008-12-08 00:00:00",
30104,1,50575,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf","2008-12-11 00:00:00",
7831,1,50575,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf","2008-04-02 00:00:00",
17889,2,50575,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf","2008-03-27 00:00:00",
17890,2,50575,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf","2011-09-30 00:00:00",
30105,1,50575,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf","2011-10-04 00:00:00",
7832,1,50575,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
17891,2,50575,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
7833,1,50575,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
38996,2,50575,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
7834,1,50577,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf","2003-07-30 00:00:00",
7835,1,50577,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf","2003-01-22 00:00:00",
7836,1,50578,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf","2002-03-29 00:00:00",
17892,2,50578,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf","2002-03-29 00:00:00",
30106,1,50578,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf","2002-03-22 00:00:00",
30107,1,50578,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf","2004-05-26 00:00:00",
38997,2,50578,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf","2004-05-27 00:00:00",
38998,2,50578,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf","2007-03-15 00:00:00",
7837,1,50578,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf","2007-07-16 00:00:00",
17893,2,50578,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf","2007-07-10 00:00:00",
17894,2,50578,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf","2014-09-26 00:00:00",
30108,1,50578,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf","2014-09-26 00:00:00",
49161,2,50578,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050578s061,050634s028lbl.pdf","2017-07-31 00:00:00",
49190,1,50578,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050578Orig1s061,050634Orig1s028ltr.pdf","2017-08-02 00:00:00",
7838,1,50580,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf","2002-03-25 00:00:00",
7839,1,50580,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf","2004-12-30 00:00:00",
7840,1,50580,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050580s040ltr.pdf","2008-01-24 00:00:00",
17895,2,50580,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf","2008-01-24 00:00:00",
7841,1,50580,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050580Orig1s042ltr.pdf","2013-06-18 00:00:00",
38999,2,50580,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050580s042lbl.pdf","2013-06-17 00:00:00",
54638,1,50580,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050580Orig1s044,050632Orig1s019ltr.pdf","2018-06-21 00:00:00",
54677,2,50580,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050580s044lbl.pdf","2018-06-21 00:00:00",
42650,3,50581,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517s031_50-581s020_Mefoxin.cfm","2004-08-10 00:00:00",
7842,1,50582,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50582s016ltr.pdf","2002-06-18 00:00:00",
30109,1,50582,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50582slr021ltr.pdf","2003-06-08 00:00:00",
30110,1,50582,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50582slr022ltr.pdf","2004-02-27 00:00:00",
7843,1,50582,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050582s024ltr.pdf","2005-05-17 00:00:00",
39000,2,50582,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050582s024lbl.pdf","2005-05-17 00:00:00",
7844,1,50582,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050582s027ltr.pdf","2008-02-13 00:00:00",
39001,2,50582,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050582s027lbl.pdf","2008-02-14 00:00:00",
30111,1,50582,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf","2011-03-24 00:00:00",
30112,1,50582,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050582Orig1s029ltr.pdf","2015-09-04 00:00:00",
39002,2,50582,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050582s029lbl.pdf","2015-09-04 00:00:00",
52506,2,50582,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050582s030lbl.pdf","2018-02-08 00:00:00",
52511,1,50582,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050582Orig1s030ltr.pdf","2018-02-08 00:00:00",
44200,10,50585,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm10Providers/ucm109103.htm","2007-09-11 00:00:00",
39003,2,50585,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf","2008-08-26 00:00:00",
7845,1,50585,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585slr054ltr.pdf","2004-04-07 00:00:00",
17896,2,50585,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585slr054_rocephin_lbl.pdf","2004-04-05 00:00:00",
30113,1,50585,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s056,50624s026ltr.pdf","2004-09-03 00:00:00",
39004,2,50585,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf","2004-09-03 00:00:00",
30114,1,50585,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf","2004-09-15 00:00:00",
39005,2,50585,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf","2004-09-15 00:00:00",
7846,1,50585,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s058ltr.pdf","2007-07-24 00:00:00",
17897,2,50585,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s058lbl.pdf","2007-07-24 00:00:00",
30115,1,50585,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s059ltr.pdf","2007-05-16 00:00:00",
39006,2,50585,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s059lbl.pdf","2007-05-16 00:00:00",
17898,2,50585,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf","2008-08-26 00:00:00",
30116,1,50585,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050585s050,050585s060ltr.pdf","2008-08-20 00:00:00",
17899,2,50585,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050585s061lbl.pdf","2009-04-03 00:00:00",
30117,1,50585,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s061ltr.pdf","2009-03-13 00:00:00",
17900,2,50585,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s062lbl.pdf","2010-11-17 00:00:00",
30118,1,50585,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s062ltr.pdf","2010-11-18 00:00:00",
30119,1,50585,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s063ltr.pdf","2009-06-16 00:00:00",
39007,2,50585,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/0550585s063lbl.pdf","2009-06-10 00:00:00",
17901,2,50585,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s064lbl.pdf","2010-03-03 00:00:00",
30120,1,50585,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s064ltr.pdf","2010-03-04 00:00:00",
17902,2,50585,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050585s065lbl.pdf","2013-04-16 00:00:00",
30121,1,50585,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050585Orig1s065ltr.pdf","2013-04-16 00:00:00",
7847,1,50585,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s066ltr.pdf","2015-03-24 00:00:00",
17903,2,50585,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s066lbl.pdf","2015-03-23 00:00:00",
7848,1,50585,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s067ltr.pdf","2015-07-08 00:00:00",
39008,2,50585,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s067lbl.pdf","2015-07-01 00:00:00",
54879,2,50585,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf","2018-07-13 00:00:00",
54905,1,50585,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050585Orig1s068ltr.pdf","2018-07-16 00:00:00",
17904,2,50586,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf","2006-01-05 00:00:00",
30122,1,50586,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf","2006-01-19 00:00:00",
7849,1,50586,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf","2006-01-19 00:00:00",
39009,2,50586,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf","2006-01-05 00:00:00",
47624,2,50586,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050586s031lbl.pdf","2017-03-21 00:00:00",
47690,1,50586,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050586Orig1s031ltr.pdf","2017-03-24 00:00:00",
54494,2,50586,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050586s032lbl.pdf","2018-06-11 00:00:00",
54559,1,50586,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050586Orig1s032ltr.pdf","2018-06-14 00:00:00",
42651,3,50587,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S039_PRIMAXIN.pdf","2008-02-19 00:00:00",
22163,3,50587,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S041_PRIMAXIN.pdf","2008-02-19 00:00:00",
42652,3,50587,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050587_S045_PRIMAXIN.pdf","2008-08-11 00:00:00",
42653,3,50587,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S046_PRIMAXIN.pdf","2008-02-19 00:00:00",
7850,1,50587,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50587sltr.pdf","1998-04-08 00:00:00",
39010,2,50587,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50587s5-lbl.pdf","1998-04-08 00:00:00",
42654,3,50587,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050587_S052_PRIMAXIN I.V..pdf","2007-11-19 00:00:00",
7851,1,50587,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf","2001-11-30 00:00:00",
42655,3,50587,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S054_PRIMAXIN I.V..pdf","2007-11-19 00:00:00",
42656,3,50587,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S055_PRIMAXIN I.V.pdf","2007-11-19 00:00:00",
30123,1,50587,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf","2003-03-10 00:00:00",
42657,3,50587,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050587_S058_PRIMAXIN.pdf","2008-02-19 00:00:00",
22164,3,50587,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050587_S059_PRIMAXIN.pdf","2008-08-01 00:00:00",
7852,1,50587,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf","2004-05-26 00:00:00",
42658,3,50587,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050587_S061_PRIMAXIN.pdf","2008-02-19 00:00:00",
30124,1,50587,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf","2006-08-07 00:00:00",
30125,1,50587,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf","2008-04-02 00:00:00",
39011,2,50587,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf","2008-04-01 00:00:00",
7853,1,50587,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf","2008-12-19 00:00:00",
30126,1,50587,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf","2009-11-20 00:00:00",
39012,2,50587,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf","2009-09-22 00:00:00",
7854,1,50587,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050587s073ltr.pdf","2012-04-18 00:00:00",
39013,2,50587,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050587s073lbl.pdf","2012-04-16 00:00:00",
46270,2,50587,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050587s074lbl.pdf","2016-12-20 00:00:00",
46448,1,50587,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050587Orig1s074ltr.pdf","2016-12-21 00:00:00",
7855,1,50587,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050587Orig1s076ltr.pdf","2014-12-17 00:00:00",
17905,2,50587,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050587s076lbl.pdf","2014-12-17 00:00:00",
17906,2,50588,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf","2004-05-28 00:00:00",
30127,1,50588,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr027ltr.pdf","2003-03-10 00:00:00",
7856,1,50588,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf","2003-07-06 00:00:00",
17907,2,50588,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf","2003-07-08 00:00:00",
30128,1,50588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50588slr030ltr.pdf","2004-07-01 00:00:00",
39014,2,50588,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf","2004-07-01 00:00:00",
47520,2,50588,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050588s032lbl.pdf","2017-03-10 00:00:00",
47552,1,50588,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050588Orig1s032ltr.pdf","2017-03-14 00:00:00",
7857,1,50589,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf","2005-01-21 00:00:00",
30129,1,50590,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590S027ltr.pdf","2002-05-17 00:00:00",
30130,1,50590,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf","2002-03-18 00:00:00",
30131,1,50590,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf","2004-12-02 00:00:00",
30132,1,50590,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf","2007-03-23 00:00:00",
39015,2,50590,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf","2007-03-16 00:00:00",
30133,1,50590,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf","2008-12-19 00:00:00",
7858,1,50590,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s057ltr.pdf","2008-04-22 00:00:00",
39016,2,50590,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050590s057lbl.pdf","2008-06-05 00:00:00",
7859,1,50590,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf","2010-12-28 00:00:00",
17908,2,50590,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf","2010-12-26 00:00:00",
30134,1,50590,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf","2010-12-28 00:00:00",
39017,2,50590,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf","2010-12-26 00:00:00",
17909,2,50590,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf","2011-06-14 00:00:00",
30135,1,50590,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf","2011-06-13 00:00:00",
17910,2,50590,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf","2011-06-14 00:00:00",
30136,1,50590,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf","2011-06-13 00:00:00",
30137,1,50590,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf","2012-10-09 00:00:00",
39018,2,50590,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf","2012-10-05 00:00:00",
7860,1,50590,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf","2013-10-01 00:00:00",
17911,2,50590,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf","2013-10-01 00:00:00",
7861,1,50590,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf","2014-06-17 00:00:00",
17912,2,50590,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf","2014-06-17 00:00:00",
22165,3,50591,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50591S022_Bactroban.pdf","2002-07-12 00:00:00",
30138,1,50591,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50591s22ltr.pdf","1999-04-22 00:00:00",
30139,1,50591,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050591Orig1s030ltr.pdf","2015-03-20 00:00:00",
39019,2,50591,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf","2015-03-20 00:00:00",
7862,1,50591,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf","2014-05-27 00:00:00",
39020,2,50591,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf","2014-05-28 00:00:00",
39021,2,50591,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf","2015-12-15 00:00:00",
48318,2,50591,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050591s034lbl.pdf","2017-05-09 00:00:00",
48344,1,50591,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050591Orig1s034ltr.pdf","2017-05-10 00:00:00",
7863,1,50592,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50592slr032ltr.pdf","2003-07-06 00:00:00",
17913,2,50592,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50592slr032_tobradex_lbl.pdf","2003-07-08 00:00:00",
7864,1,50596,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf","2002-01-18 00:00:00",
30140,1,50596,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf","2004-06-24 00:00:00",
7865,1,50596,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf","2008-02-25 00:00:00",
39022,2,50596,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf","2008-02-25 00:00:00",
7866,1,50596,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf","2009-06-02 00:00:00",
7867,1,50596,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf","2011-09-13 00:00:00",
39023,2,50596,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf","2011-09-16 00:00:00",
17914,2,50596,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf","2014-02-25 00:00:00",
30141,1,50596,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf","2014-02-25 00:00:00",
17915,2,50596,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf","2015-04-14 00:00:00",
30142,1,50596,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf","2015-03-24 00:00:00",
30143,1,50597,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
30144,1,50597,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf","2003-06-08 00:00:00",
30145,1,50597,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf","2004-06-07 00:00:00",
7868,1,50597,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf","2004-08-12 00:00:00",
17916,2,50597,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf","2008-12-08 00:00:00",
30146,1,50597,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf","2008-12-11 00:00:00",
7869,1,50597,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf","2008-04-02 00:00:00",
39024,2,50597,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf","2008-03-27 00:00:00",
30147,1,50597,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf","2011-10-04 00:00:00",
39025,2,50597,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf","2011-10-18 00:00:00",
30148,1,50597,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
39026,2,50597,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
7870,1,50597,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
39027,2,50597,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
17917,2,50600,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf","2002-07-14 00:00:00",
30149,1,50600,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf","2002-07-14 00:00:00",
7871,1,50600,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf","2003-06-08 00:00:00",
39028,2,50600,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf","2003-06-08 00:00:00",
7872,1,50600,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf","2014-04-07 00:00:00",
39029,2,50600,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf","2014-04-08 00:00:00",
7873,1,50600,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf","2016-01-20 00:00:00",
39030,2,50600,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf","2016-01-26 00:00:00",
50440,2,50600,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf","2017-11-17 00:00:00",
50452,1,50600,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf","2017-11-17 00:00:00",
7874,1,50605,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf","2002-03-29 00:00:00",
17918,2,50605,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf","2002-03-29 00:00:00",
22166,3,50605,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf","1999-08-24 00:00:00",
30150,1,50605,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf","1999-08-24 00:00:00",
7875,1,50605,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf","2002-04-11 00:00:00",
17919,2,50605,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf","2002-04-11 00:00:00",
7876,1,50605,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf","2002-07-24 00:00:00",
17920,2,50605,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf","2004-06-07 00:00:00",
30151,1,50605,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf","2004-06-07 00:00:00",
17921,2,50605,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf","2007-07-24 00:00:00",
30152,1,50605,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050605s042ltr.pdf","2007-07-27 00:00:00",
30153,1,50605,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf","2014-09-23 00:00:00",
39031,2,50605,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf","2014-09-22 00:00:00",
30154,1,50605,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf","2014-09-23 00:00:00",
39032,2,50605,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf","2014-09-22 00:00:00",
30155,1,50605,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf","2015-07-07 00:00:00",
39033,2,50605,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf","2015-07-01 00:00:00",
17922,2,50605,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf","2015-08-27 00:00:00",
30156,1,50605,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf","2015-08-28 00:00:00",
45950,1,50605,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050605Orig1s049,050672Orig1s035ltr.pdf","2016-11-23 00:00:00",
45977,2,50605,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf","2016-12-01 00:00:00",
50071,2,50605,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf","2017-10-17 00:00:00",
50086,1,50605,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050605Orig1s050,050672Orig1s36ltr.pdf","2017-10-18 00:00:00",
7877,1,50606,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50606s015ltr.pdf","2002-05-24 00:00:00",
30157,1,50606,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr019ltr.pdf","2004-03-24 00:00:00",
30158,1,50606,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr020ltr.pdf","2004-06-01 00:00:00",
39034,2,50606,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50606slr020_vancocin_lbl.pdf","2004-06-01 00:00:00",
30159,1,50606,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050606s026ltr.pdf","2010-01-14 00:00:00",
7878,1,50606,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050606s028ltr.pdf","2011-12-15 00:00:00",
39035,2,50606,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050606s028lbl.pdf","2011-12-14 00:00:00",
22167,3,50608,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050608ap.pdf","1997-02-12 00:00:00",
30160,1,50608,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50608s026ltr.pdf","2004-08-25 00:00:00",
17923,2,50608,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf","2008-04-23 00:00:00",
30161,1,50608,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050608s029ltr.pdf","2008-04-16 00:00:00",
7879,1,50608,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050608s040ltr.pdf","2012-03-13 00:00:00",
39036,2,50608,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf","2012-03-07 00:00:00",
7880,1,50608,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf","2014-11-19 00:00:00",
17924,2,50608,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf","2014-11-20 00:00:00",
17925,2,50608,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf","2014-11-20 00:00:00",
30162,1,50608,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf","2014-11-19 00:00:00",
47197,1,50608,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050608Orig1s044ltr.pdf","2017-02-14 00:00:00",
47247,2,50608,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050608s044lbl.pdf","2017-02-16 00:00:00",
53752,2,50608,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050608s046lbl.pdf","2018-04-20 00:00:00",
53779,1,50608,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050608Orig1s046ltr.pdf","2018-04-23 00:00:00",
30163,1,50609,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf","2002-05-23 00:00:00",
30164,1,50609,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50609s019,50182s125ltr.pdf","2004-09-17 00:00:00",
7881,1,50609,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050609s025ltr.pdf","2008-02-29 00:00:00",
17926,2,50609,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050609s025lbl.pdf","2008-02-28 00:00:00",
7882,1,50609,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050609s032ltr.pdf","2011-06-13 00:00:00",
17927,2,50609,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050609s032lbl.pdf","2011-06-16 00:00:00",
30165,1,50609,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050609s033ltr.pdf","2012-02-06 00:00:00",
39037,2,50609,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050609s033lbl.pdf","2012-02-06 00:00:00",
7883,1,50609,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050609Orig1s034ltr.pdf","2013-08-22 00:00:00",
17928,2,50609,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050609s034lbl.pdf","2013-08-21 00:00:00",
53800,2,50609,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050609s039lbl.pdf","2018-04-24 00:00:00",
53812,1,50609,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050609Orig1s039ltr.pdf","2018-04-24 00:00:00",
42659,3,50611,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm","2004-09-21 00:00:00",
30166,1,50611,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf","2002-04-25 00:00:00",
30167,1,50611,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050611s022LTR.pdf","2006-08-14 00:00:00",
39038,2,50611,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050611s022lbl.pdf","2006-08-11 00:00:00",
30168,1,50611,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf","2004-03-16 00:00:00",
30169,1,50611,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050611s027ltr.pdf","2011-02-07 00:00:00",
39039,2,50611,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050611s027lbl.pdf","2011-01-31 00:00:00",
7884,1,50611,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s029ltr.pdf","2008-01-09 00:00:00",
39040,2,50611,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s029lbl.pdf","2008-01-08 00:00:00",
7885,1,50611,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s030ltr.pdf","2008-05-28 00:00:00",
7886,1,50611,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050611s031ltr.pdf","2010-11-08 00:00:00",
7887,1,50611,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s032ltr.pdf","2008-12-19 00:00:00",
17929,2,50611,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf","2009-01-02 00:00:00",
17930,2,50611,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050611s035lbl.pdf","2012-02-06 00:00:00",
30170,1,50611,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050207s071,050611s035ltr.pdf","2012-02-06 00:00:00",
53801,2,50611,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf","2018-04-24 00:00:00",
53808,1,50611,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050207Orig1s074,050611Orig1s036ltr.pdf","2018-04-24 00:00:00",
30171,1,50612,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50612SCM014ltr.pdf","2003-10-28 00:00:00",
47623,2,50612,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050612s020lbl.pdf","2017-03-21 00:00:00",
47691,1,50612,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050612Orig1s020ltr.pdf","2017-03-24 00:00:00",
54495,2,50612,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050612s021lbl.pdf","2018-06-11 00:00:00",
54560,1,50612,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050612Orig1s021ltr.pdf","2018-06-14 00:00:00",
7888,1,50615,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf","2002-07-14 00:00:00",
39041,2,50615,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf","2002-07-14 00:00:00",
17931,2,50615,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf","2003-06-08 00:00:00",
30172,1,50615,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf","2003-06-08 00:00:00",
17932,2,50615,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf","2014-04-08 00:00:00",
30173,1,50615,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf","2014-04-07 00:00:00",
7889,1,50615,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf","2016-01-20 00:00:00",
39042,2,50615,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf","2016-01-26 00:00:00",
50441,2,50615,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf","2017-11-17 00:00:00",
50453,1,50615,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf","2017-11-17 00:00:00",
22168,3,50616,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/50-616S009.pdf","2003-09-11 00:00:00",
7890,1,50616,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf","2004-06-28 00:00:00",
39043,2,50616,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf","2004-06-28 00:00:00",
30174,1,50616,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf","2004-06-28 00:00:00",
39044,2,50616,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf","2004-06-28 00:00:00",
17933,2,50616,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf","2003-03-26 00:00:00",
30175,1,50616,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf","2003-03-26 00:00:00",
30176,1,50616,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf","2004-07-21 00:00:00",
39045,2,50616,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf","2004-07-21 00:00:00",
7891,1,50616,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf","2004-07-21 00:00:00",
17934,2,50616,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf","2004-07-21 00:00:00",
7892,1,50619,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_50619slr004ltr.pdf","2003-05-29 00:00:00",
7893,1,50621,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf","2004-04-07 00:00:00",
17935,2,50621,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf","2004-04-05 00:00:00",
17936,2,50621,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf","2003-08-28 00:00:00",
30177,1,50621,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf","2003-08-28 00:00:00",
17937,2,50622,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf","2004-04-05 00:00:00",
30178,1,50622,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf","2004-04-07 00:00:00",
17938,2,50622,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf","2003-08-28 00:00:00",
30179,1,50622,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf","2003-08-28 00:00:00",
7894,1,50624,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s056,50624s026ltr.pdf","2004-09-03 00:00:00",
39046,2,50624,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf","2004-09-03 00:00:00",
17939,2,50624,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf","2004-09-15 00:00:00",
30180,1,50624,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf","2004-09-15 00:00:00",
7895,1,50625,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
17940,2,50625,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
7896,1,50625,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf","2004-06-17 00:00:00",
39047,2,50625,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf","2003-03-05 00:00:00",
30181,1,50625,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-02-27 00:00:00",
39048,2,50625,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
17941,2,50625,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf","2004-03-03 00:00:00",
30182,1,50625,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf","2004-06-17 00:00:00",
7897,1,50625,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf","2005-07-26 00:00:00",
17942,2,50625,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf","2005-07-26 00:00:00",
17943,2,50625,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf","2006-03-10 00:00:00",
30183,1,50625,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf","2006-03-23 00:00:00",
17944,2,50625,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf","2009-10-14 00:00:00",
30184,1,50625,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf","2009-11-10 00:00:00",
17945,2,50625,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf","2010-05-07 00:00:00",
30185,1,50625,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf","2010-05-06 00:00:00",
7898,1,50625,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf","2012-09-05 00:00:00",
17946,2,50625,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf","2012-08-31 00:00:00",
30186,1,50625,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf","2013-05-07 00:00:00",
39049,2,50625,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf","2013-05-09 00:00:00",
17947,2,50625,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf","2015-04-01 00:00:00",
30187,1,50625,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf","2015-04-02 00:00:00",
7899,1,50627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf","2004-08-25 00:00:00",
39050,2,50627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf","2004-08-25 00:00:00",
7900,1,50627,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf","2010-11-22 00:00:00",
39051,2,50627,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf","2010-11-12 00:00:00",
17948,2,50627,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf","2013-03-01 00:00:00",
30188,1,50627,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf","2013-03-01 00:00:00",
48100,2,50627,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050420s076,050627s017lbl.pdf","2017-04-25 00:00:00",
48141,1,50627,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050627Orig1S017,050420Orig1S076ltr.pdf","2017-04-27 00:00:00",
51004,2,50627,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf","2018-01-09 00:00:00",
51011,1,50627,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050420Orig1s077, 050627Orig1s020ltr.pdf","2018-01-10 00:00:00",
39052,2,50628,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf","2003-04-23 00:00:00",
7901,1,50629,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf","2002-09-25 00:00:00",
17949,2,50629,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf","2002-09-25 00:00:00",
7902,1,50629,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf","2002-09-25 00:00:00",
39053,2,50629,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf","2002-09-25 00:00:00",
7903,1,50629,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf","2003-05-30 00:00:00",
17950,2,50629,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf","2003-05-13 00:00:00",
17951,2,50629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf","2003-05-29 00:00:00",
30189,1,50629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf","2003-05-30 00:00:00",
7904,1,50629,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017ltr.pdf","2010-08-09 00:00:00",
17952,2,50629,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050629s017lbl.pdf","2010-07-30 00:00:00",
7905,1,50629,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019ltr.pdf","2011-09-29 00:00:00",
17953,2,50629,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050629s019lbl.pdf","2011-09-26 00:00:00",
7906,1,50629,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050629Orig1s022ltr.pdf","2013-11-06 00:00:00",
17954,2,50629,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf","2013-11-01 00:00:00",
22169,3,50630,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050630_S009_PRIMAXIN.pdf","2008-08-11 00:00:00",
42660,3,50630,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S011_PRIMAXIN.pdf","2008-08-11 00:00:00",
22170,3,50630,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S014_PRIMAXIN.pdf","2008-08-11 00:00:00",
42661,3,50630,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50638S15_Primaxin.pdf","1999-02-04 00:00:00",
30190,1,50630,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf","2001-11-30 00:00:00",
42662,3,50630,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050630_S019_PRIMAXIN.pdf","2008-02-19 00:00:00",
22171,3,50630,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050630_S021_PRIMAXIN.pdf","2008-02-19 00:00:00",
30191,1,50630,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf","2003-03-10 00:00:00",
7907,1,50630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf","2004-05-26 00:00:00",
42663,3,50630,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050630_S023_PRIMAXIN.pdf","2008-02-19 00:00:00",
7908,1,50630,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf","2006-08-07 00:00:00",
17955,2,50630,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf","2007-03-31 00:00:00",
30192,1,50630,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050630s027LTR.pdf","2007-03-31 00:00:00",
7909,1,50630,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf","2008-04-02 00:00:00",
39054,2,50630,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf","2008-04-01 00:00:00",
30193,1,50630,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf","2008-12-19 00:00:00",
30194,1,50630,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf","2009-11-25 00:00:00",
39055,2,50630,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf","2009-09-22 00:00:00",
7910,1,50632,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50632s10ltr.pdf","1998-12-24 00:00:00",
22172,3,50632,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50632s010.cfm","1998-12-24 00:00:00",
39056,2,50632,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50623s10lbl.pdf","1998-12-24 00:00:00",
30195,1,50632,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf","2002-03-25 00:00:00",
30196,1,50632,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf","2004-12-30 00:00:00",
7911,1,50632,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050632s013ltr.pdf","2008-01-24 00:00:00",
39057,2,50632,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf","2008-01-24 00:00:00",
7912,1,50632,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050632Orig1s015ltr.pdf","2013-06-18 00:00:00",
17956,2,50632,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050632s015lbl.pdf","2013-06-17 00:00:00",
54637,1,50632,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050580Orig1s044,050632Orig1s019ltr.pdf","2018-06-21 00:00:00",
54676,2,50632,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050632s019lbl.pdf","2018-06-21 00:00:00",
17957,2,50634,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf","2002-03-29 00:00:00",
30197,1,50634,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf","2002-03-29 00:00:00",
30198,1,50634,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf","2002-03-22 00:00:00",
7913,1,50634,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf","2004-05-26 00:00:00",
39058,2,50634,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf","2004-05-27 00:00:00",
30199,1,50634,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s051,050634s018lbl.pdf","2007-03-15 00:00:00",
39059,2,50634,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf","2007-03-15 00:00:00",
30200,1,50634,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf","2007-07-16 00:00:00",
39060,2,50634,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf","2007-07-10 00:00:00",
30201,1,50634,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf","2014-09-26 00:00:00",
39061,2,50634,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf","2014-09-26 00:00:00",
49160,2,50634,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050578s061,050634s028lbl.pdf","2017-07-31 00:00:00",
49191,1,50634,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050578Orig1s061,050634Orig1s028ltr.pdf","2017-08-02 00:00:00",
30202,1,50638,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50638slr007ltr.pdf","2002-08-23 00:00:00",
30203,1,50638,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50638slr010ltr.pdf","2004-06-15 00:00:00",
30204,1,50638,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50638s011ltr.pdf","2005-02-08 00:00:00",
30205,1,50638,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050638s012ltr.pdf","2008-03-05 00:00:00",
39062,2,50638,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf","2008-03-05 00:00:00",
7914,1,50638,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050638s016ltr.pdf","2012-04-18 00:00:00",
17958,2,50638,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf","2012-04-16 00:00:00",
17959,2,50638,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf","2016-07-21 00:00:00",
30206,1,50638,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050638Orig1s019ltr.pdf","2016-07-20 00:00:00",
50514,2,50638,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050638s020lbl.pdf","2017-11-28 00:00:00",
50557,1,50638,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050638Orig1s020ltr.pdf","2017-12-01 00:00:00",
7915,1,50639,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf","2004-10-04 00:00:00",
39063,2,50639,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf","2004-10-04 00:00:00",
30207,1,50639,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf","2004-02-02 00:00:00",
17960,2,50639,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf","2008-02-25 00:00:00",
30208,1,50639,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050639s015ltr.pdf","2008-02-25 00:00:00",
7916,1,50639,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf","2008-04-16 00:00:00",
17961,2,50639,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf","2008-04-23 00:00:00",
7917,1,50639,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf","2011-06-10 00:00:00",
7918,1,50639,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf","2014-06-27 00:00:00",
17962,2,50639,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf","2014-07-03 00:00:00",
7919,1,50639,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf","2014-06-27 00:00:00",
39064,2,50639,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf","2014-07-03 00:00:00",
17963,2,50639,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf","2014-07-03 00:00:00",
30209,1,50639,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf","2014-06-27 00:00:00",
30210,1,50639,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf","2016-03-28 00:00:00",
39065,2,50639,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf","2016-03-29 00:00:00",
45005,1,50639,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf","2016-08-05 00:00:00",
45030,2,50639,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf","2016-08-05 00:00:00",
45006,1,50639,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf","2016-08-05 00:00:00",
45029,2,50639,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf","2016-08-05 00:00:00",
48255,2,50639,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-05 00:00:00",
48282,1,50639,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-08 00:00:00",
48254,2,50639,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-05 00:00:00",
48281,1,50639,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf","2017-05-08 00:00:00",
53702,2,50639,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf","2018-04-17 00:00:00",
53714,1,50639,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050441Orig1s079,050639Orig1s038ltr.pdf","2018-04-17 00:00:00",
7920,1,50640,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50640slr006ltr.pdf","2002-08-23 00:00:00",
30211,1,50640,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50640slr007ltr.pdf","2004-03-24 00:00:00",
7921,1,50640,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050640s010ltr.pdf","2008-04-22 00:00:00",
17964,2,50640,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf","2008-06-05 00:00:00",
7922,1,50640,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050640s011ltr.pdf","2011-10-17 00:00:00",
17965,2,50640,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf","2011-10-20 00:00:00",
7923,1,50640,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050640Orig1s015ltr.pdf","2012-11-23 00:00:00",
17966,2,50640,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf","2012-11-28 00:00:00",
30212,1,50640,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050640Orig1s017ltr.pdf","2015-01-08 00:00:00",
39066,2,50640,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf","2015-01-07 00:00:00",
47339,2,50640,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050640s020lbl.pdf","2017-02-27 00:00:00",
47442,1,50640,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050640Orig1s020ltr.pdf","2017-03-03 00:00:00",
30213,1,50641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s8ltr.pdf","2002-03-21 00:00:00",
30214,1,50641,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s010ltr.pdf","2002-06-18 00:00:00",
7924,1,50641,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s013ltr.pdf","2007-02-12 00:00:00",
17967,2,50641,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf","2008-01-08 00:00:00",
30215,1,50641,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s014ltr.pdf","2008-01-09 00:00:00",
30216,1,50641,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050641s018ltr.pdf","2012-01-17 00:00:00",
39067,2,50641,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf","2012-01-23 00:00:00",
7925,1,50641,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050641s026ltr.pdf","2011-03-10 00:00:00",
17968,2,50641,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf","2011-03-11 00:00:00",
7926,1,50641,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050641Orig1s027ltr.pdf","2013-10-15 00:00:00",
17969,2,50641,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf","2013-10-17 00:00:00",
47852,2,50641,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050641s029lbl.pdf","2017-04-04 00:00:00",
47870,1,50641,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050641Orig1s029ltr.pdf","2017-04-05 00:00:00",
17970,2,50643,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf","2003-05-02 00:00:00",
7927,1,50643,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf","2004-05-26 00:00:00",
39068,2,50643,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf","2004-05-27 00:00:00",
30217,1,50643,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf","2007-07-31 00:00:00",
39069,2,50643,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf","2007-07-31 00:00:00",
30218,1,50643,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf","2014-09-29 00:00:00",
39070,2,50643,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf","2014-09-30 00:00:00",
17971,2,50646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf","2002-03-29 00:00:00",
30219,1,50646,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf","2002-03-29 00:00:00",
7928,1,50649,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50649s7ltr.pdf","2002-02-01 00:00:00",
7929,1,50649,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50649s7ltr.pdf","2002-02-01 00:00:00",
7930,1,50649,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf","2002-05-31 00:00:00",
42664,3,50649,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm","2004-06-29 00:00:00",
30220,1,50649,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf","2005-02-17 00:00:00",
7931,1,50649,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50649slr016,017ltr.pdf","2004-06-01 00:00:00",
30221,1,50649,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50649slr016,017ltr.pdf","2004-06-01 00:00:00",
7932,1,50649,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf","2005-10-20 00:00:00",
7933,1,50649,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649s019ltr.pdf","2007-04-09 00:00:00",
17972,2,50649,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649s019lbl.pdf","2007-04-06 00:00:00",
7934,1,50649,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649S020_LTR.pdf","2007-02-02 00:00:00",
39071,2,50649,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649S020_LBL.pdf","2007-01-25 00:00:00",
30222,1,50649,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649s021ltr.pdf","2007-06-04 00:00:00",
7935,1,50649,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050649s022ltr.pdf","2008-07-01 00:00:00",
39072,2,50649,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050649s022lbl.pdf","2008-06-30 00:00:00",
17973,2,50649,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050649023lbl.pdf","2010-09-20 00:00:00",
30223,1,50649,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050649s023ltr.pdf","2010-09-17 00:00:00",
30224,1,50649,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050649Orig1s025ltr.pdf","2015-03-11 00:00:00",
39073,2,50649,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050649s025lbl.pdf","2015-03-26 00:00:00",
46175,1,50649,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050649Orig1s026ltr.pdf","2016-12-15 00:00:00",
46189,2,50649,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050649s026lbl.pdf","2016-12-14 00:00:00",
49025,2,50649,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050649s027lbl.pdf","2017-07-20 00:00:00",
49037,1,50649,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050649Orig1s027ltr.pdf","2017-07-21 00:00:00",
7936,1,50655,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf","2002-08-23 00:00:00",
30225,1,50655,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50655slr013ltr.pdf","2003-08-15 00:00:00",
30226,1,50655,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050655s016LTR.pdf","2006-08-14 00:00:00",
30227,1,50655,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050655s017ltr.pdf","2008-04-16 00:00:00",
39074,2,50655,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050655s017lbl.pdf","2008-04-23 00:00:00",
7937,1,50655,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050655s018ltr.pdf","2011-11-14 00:00:00",
39075,2,50655,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050655s018lbl.pdf","2011-11-10 00:00:00",
17974,2,50655,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf","2015-04-07 00:00:00",
30228,1,50655,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050655Orig1s023ltr.pdf","2015-04-06 00:00:00",
49002,1,50655,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050655Orig1s025ltr.pdf","2017-07-17 00:00:00",
49030,2,50655,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050655s025lbl.pdf","2017-07-21 00:00:00",
53628,1,50655,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050655Orig1s026ltr.pdf","2018-04-06 00:00:00",
53637,2,50655,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050655s026lbl.pdf","2018-04-09 00:00:00",
7938,1,50658,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf","2002-03-18 00:00:00",
7939,1,50658,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf","2004-12-02 00:00:00",
17975,2,50658,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf","2007-03-16 00:00:00",
30229,1,50658,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf","2007-03-23 00:00:00",
7940,1,50658,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf","2008-12-19 00:00:00",
17976,2,50658,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf","2008-06-05 00:00:00",
30230,1,50658,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050658s022ltr.pdf","2008-04-22 00:00:00",
7941,1,50658,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf","2010-12-28 00:00:00",
17977,2,50658,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf","2010-12-26 00:00:00",
7942,1,50658,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf","2011-06-13 00:00:00",
17978,2,50658,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf","2011-06-14 00:00:00",
17979,2,50658,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf","2012-10-05 00:00:00",
30231,1,50658,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf","2012-10-09 00:00:00",
17980,2,50658,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf","2013-10-01 00:00:00",
30232,1,50658,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf","2013-10-01 00:00:00",
7943,1,50658,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf","2014-06-17 00:00:00",
17981,2,50658,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf","2014-06-17 00:00:00",
7944,1,50661,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr007ltr.pdf","2002-09-30 00:00:00",
7945,1,50661,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr008ltr.pdf","2002-10-11 00:00:00",
17982,2,50661,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf","2014-12-10 00:00:00",
30233,1,50661,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050661Orig1s014ltr.pdf","2014-12-05 00:00:00",
44201,10,50662,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
42665,3,50662,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050662s013_biaxin.pdf","1999-08-02 00:00:00",
42666,3,50662,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S028_Biaxin.cfm","2004-06-29 00:00:00",
17983,2,50662,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50662S29lbl.pdf","2000-10-20 00:00:00",
30234,1,50662,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50662S29ltr.pdf","2000-10-20 00:00:00",
42667,3,50662,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S029_Biaxin.cfm","2001-11-23 00:00:00",
7946,1,50662,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf","2002-06-06 00:00:00",
22173,3,50662,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm","2004-06-29 00:00:00",
22174,3,50662,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm","2004-06-29 00:00:00",
30235,1,50662,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf","2002-06-06 00:00:00",
30236,1,50662,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf","2004-07-21 00:00:00",
30237,1,50662,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf","2005-10-20 00:00:00",
39076,2,50662,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf","2005-10-10 00:00:00",
30238,1,50662,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf","2006-07-13 00:00:00",
17984,2,50662,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf","2007-12-27 00:00:00",
30239,1,50662,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf","2008-01-09 00:00:00",
30240,1,50662,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf","2008-05-29 00:00:00",
17985,2,50662,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf","2009-09-22 00:00:00",
30241,1,50662,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf","2009-11-20 00:00:00",
30242,1,50662,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
39077,2,50662,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
7947,1,50662,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
17986,2,50662,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
7948,1,50662,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
17987,2,50662,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
7949,1,50662,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf","2012-06-05 00:00:00",
17988,2,50662,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf","2012-07-10 00:00:00",
30243,1,50662,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf","2012-07-10 00:00:00",
7950,1,50662,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
39078,2,50662,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
17989,2,50662,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s052lbl.pdf","2013-09-09 00:00:00",
30244,1,50662,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
7951,1,50662,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
17990,2,50662,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s053lbl.pdf","2013-09-09 00:00:00",
7952,1,50662,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf","2016-05-31 00:00:00",
39079,2,50662,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf","2016-06-01 00:00:00",
7953,1,50662,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf","2014-07-28 00:00:00",
39080,2,50662,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf","2014-08-07 00:00:00",
7954,1,50662,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf","2015-01-09 00:00:00",
17991,2,50662,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf","2015-01-12 00:00:00",
17992,2,50662,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf","2015-10-29 00:00:00",
30245,1,50662,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf","2015-10-28 00:00:00",
48691,2,50662,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf","2017-06-12 00:00:00",
48703,1,50662,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050662Orig1s058,050698Orig1s038,050775Orig1s026ltr.pdf","2017-06-12 00:00:00",
7955,1,50664,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf","2004-06-25 00:00:00",
17993,2,50664,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf","2004-06-25 00:00:00",
30246,1,50664,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf","2007-09-25 00:00:00",
39081,2,50664,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf","2007-09-19 00:00:00",
45952,1,50664,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050664Orig1s026,050665Orig1s026ltr.pdf","2016-11-23 00:00:00",
45974,2,50664,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf","2016-12-01 00:00:00",
7956,1,50665,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf","2004-06-09 00:00:00",
30247,1,50665,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf","2004-06-25 00:00:00",
39082,2,50665,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf","2004-06-25 00:00:00",
7957,1,50665,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf","2007-09-25 00:00:00",
17994,2,50665,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf","2007-09-19 00:00:00",
45953,1,50665,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050664Orig1s026,050665Orig1s026ltr.pdf","2016-11-23 00:00:00",
45975,2,50665,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf","2016-12-01 00:00:00",
42668,3,50667,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050667ap.pdf","1997-11-04 00:00:00",
42669,3,50668,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050667ap.pdf","1997-11-04 00:00:00",
23720,10,50670,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-15 00:00:00",
22175,3,50670,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050670ap.pdf","1997-11-04 00:00:00",
7958,1,50670,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf","2000-11-13 00:00:00",
39083,2,50670,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf","2000-11-13 00:00:00",
42670,3,50670,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm","2000-11-13 00:00:00",
7959,1,50670,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf","2002-10-16 00:00:00",
7960,1,50670,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
7961,1,50670,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf","2004-03-28 00:00:00",
17995,2,50670,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf","2004-04-05 00:00:00",
7962,1,50670,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf","2004-01-22 00:00:00",
17996,2,50670,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf","2007-11-07 00:00:00",
30248,1,50670,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf","2007-11-08 00:00:00",
47799,2,50670,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf","2017-03-31 00:00:00",
47836,1,50670,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf","2017-04-03 00:00:00",
42671,3,50671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf","1998-01-08 00:00:00",
42672,3,50671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf","1998-01-08 00:00:00",
7963,1,50671,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50671slr006ltr.pdf","2004-04-07 00:00:00",
17997,2,50671,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf","2004-04-05 00:00:00",
30249,1,50671,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050671s010ltr.pdf","2007-09-25 00:00:00",
39084,2,50671,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf","2007-09-19 00:00:00",
7964,1,50671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050671s012ltr.pdf","2008-05-07 00:00:00",
39085,2,50671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf","2008-05-08 00:00:00",
30250,1,50671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050671s014ltr.pdf","2009-03-13 00:00:00",
39086,2,50671,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf","2009-04-03 00:00:00",
7965,1,50671,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050671s018ltr.pdf","2012-01-19 00:00:00",
17998,2,50671,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf","2012-01-23 00:00:00",
7966,1,50671,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050671Orig1s022ltr.pdf","2015-12-22 00:00:00",
17999,2,50671,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf","2015-12-28 00:00:00",
46767,2,50671,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s023lbl.pdf","2017-01-06 00:00:00",
46852,1,50671,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s023ltr.pdf","2017-01-17 00:00:00",
49879,2,50671,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050671s024lbl.pdf","2017-09-29 00:00:00",
49893,1,50671,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050671Orig1s024ltr.pdf","2017-09-29 00:00:00",
7967,1,50672,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf","2002-03-29 00:00:00",
18000,2,50672,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf","2002-03-29 00:00:00",
22176,3,50672,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf","1999-08-24 00:00:00",
30251,1,50672,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf","1999-08-24 00:00:00",
18001,2,50672,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf","2002-04-11 00:00:00",
30252,1,50672,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf","2002-04-11 00:00:00",
30253,1,50672,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf","2004-06-07 00:00:00",
39087,2,50672,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf","2004-06-07 00:00:00",
7968,1,50672,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050672s028ltr.pdf","2007-08-02 00:00:00",
39088,2,50672,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf","2007-08-02 00:00:00",
30254,1,50672,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf","2014-09-23 00:00:00",
39089,2,50672,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf","2014-09-22 00:00:00",
30255,1,50672,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf","2014-09-23 00:00:00",
39090,2,50672,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf","2014-09-22 00:00:00",
30256,1,50672,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf","2015-07-07 00:00:00",
39091,2,50672,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf","2015-07-01 00:00:00",
18002,2,50672,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf","2015-08-27 00:00:00",
30257,1,50672,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf","2015-08-28 00:00:00",
45951,1,50672,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050605Orig1s049,050672Orig1s035ltr.pdf","2016-11-23 00:00:00",
45976,2,50672,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf","2016-12-01 00:00:00",
50072,2,50672,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf","2017-10-17 00:00:00",
50085,1,50672,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050605Orig1s050,050672Orig1s36ltr.pdf","2017-10-18 00:00:00",
7969,1,50674,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50674s12ltr.pdf","1998-11-20 00:00:00",
22177,3,50674,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm","1998-11-20 00:00:00",
7970,1,50674,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf","2004-06-07 00:00:00",
39092,2,50674,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf","2004-06-07 00:00:00",
18003,2,50674,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf","2007-06-07 00:00:00",
30258,1,50674,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014, 050675s017ltr.pdf","2007-06-07 00:00:00",
30259,1,50674,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675Orig1s018ltr.pdf","2013-06-24 00:00:00",
39093,2,50674,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050674s015,050675s018lbl.pdf","2013-06-25 00:00:00",
22178,3,50675,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675S14_Vantin.cfm","1998-11-20 00:00:00",
30260,1,50675,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf","1998-11-20 00:00:00",
7971,1,50675,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf","1998-11-20 00:00:00",
22179,3,50675,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm","1999-07-27 00:00:00",
7972,1,50675,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf","2004-06-07 00:00:00",
39094,2,50675,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf","2004-06-07 00:00:00",
7973,1,50675,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014, 050675s017ltr.pdf","2007-06-07 00:00:00",
18004,2,50675,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf","2007-06-07 00:00:00",
7974,1,50675,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675Orig1s018ltr.pdf","2013-06-24 00:00:00",
39095,2,50675,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050674s015,050675s018lbl.pdf","2013-06-25 00:00:00",
22180,3,50678,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050678s003_dynabac_toc.cfm","2010-05-25 00:00:00",
7975,1,50678,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50678s010ltr.pdf","2004-06-02 00:00:00",
44202,10,50679,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198675.htm","2007-12-17 00:00:00",
22181,3,50679,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050679s002.cfm","1997-05-16 00:00:00",
7976,1,50679,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf","1999-01-27 00:00:00",
39096,2,50679,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf","1999-01-27 00:00:00",
42673,3,50679,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine.cfm","2001-07-18 00:00:00",
7977,1,50679,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf","2002-08-21 00:00:00",
7978,1,50679,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf","2002-08-21 00:00:00",
30261,1,50679,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf","2002-08-21 00:00:00",
7979,1,50679,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-021ltr.pdf","2003-03-26 00:00:00",
39097,2,50679,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf","2003-03-26 00:00:00",
7980,1,50679,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf","2004-06-10 00:00:00",
18005,2,50679,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf","2004-06-10 00:00:00",
30262,1,50679,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf","2007-11-26 00:00:00",
39098,2,50679,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf","2007-09-19 00:00:00",
30263,1,50679,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf","2014-05-06 00:00:00",
39099,2,50679,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf","2014-05-02 00:00:00",
7981,1,50679,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf","2009-11-20 00:00:00",
39100,2,50679,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf","2009-09-30 00:00:00",
30264,1,50679,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf","2013-03-18 00:00:00",
39101,2,50679,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf","2013-03-19 00:00:00",
7982,1,50679,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf","2012-09-10 00:00:00",
18006,2,50679,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf","2012-09-11 00:00:00",
7983,1,50679,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf","2016-03-03 00:00:00",
39102,2,50679,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf","2016-03-03 00:00:00",
48243,2,50679,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050679s042lbl.pdf","2017-05-05 00:00:00",
48290,1,50679,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050679Orig1s042ltr.pdf","2017-05-09 00:00:00",
7984,1,50680,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680s002_appltr.pdf","1998-03-02 00:00:00",
22182,3,50680,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680S002.cfm","1998-03-02 00:00:00",
7985,1,50680,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50680slr004ltr.pdf","2003-08-29 00:00:00",
18007,2,50680,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf","2003-08-29 00:00:00",
30265,1,50680,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf","2014-05-12 00:00:00",
39103,2,50680,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf","2014-05-12 00:00:00",
7986,1,50680,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf","2015-07-15 00:00:00",
18008,2,50680,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf","2015-07-16 00:00:00",
49706,2,50680,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf","2017-09-11 00:00:00",
49747,1,50680,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050680Orig1s013,050767Orig1s014ltr.pdf","2017-09-15 00:00:00",
30266,1,50682,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50682slr019ltr.pdf","2002-10-28 00:00:00",
7987,1,50682,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50682slr020ltr.pdf","2003-03-26 00:00:00",
7988,1,50682,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50682s021ltr.pdf","2004-12-06 00:00:00",
7989,1,50682,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050682s022ltr.pdf","2005-08-19 00:00:00",
7990,1,50682,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050682s025ltr.pdf","2009-03-17 00:00:00",
18009,2,50682,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf","2009-04-03 00:00:00",
18010,2,50682,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf","2012-02-06 00:00:00",
30267,1,50682,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf","2012-02-07 00:00:00",
7991,1,50682,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf","2012-02-07 00:00:00",
39104,2,50682,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf","2012-02-06 00:00:00",
55204,2,50682,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf","2018-08-17 00:00:00",
55207,1,50682,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s033Ltr.pdf","2018-08-20 00:00:00",
55187,2,50682,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf","2018-08-16 00:00:00",
55206,1,50682,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s034Ltr.pdf","2018-08-20 00:00:00",
7992,1,50684,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf","2002-03-27 00:00:00",
7993,1,50684,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684se2-033ltr.pdf","2003-05-29 00:00:00",
39105,2,50684,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s033lbl.pdf","2003-04-30 00:00:00",
7994,1,50684,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684slr035ltr.pdf","2003-05-30 00:00:00",
39106,2,50684,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s035lbl.pdf","2003-05-06 00:00:00",
30268,1,50684,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50684slr038ltr.pdf","2004-02-03 00:00:00",
7995,1,50684,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf","2005-03-18 00:00:00",
7996,1,50684,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011ltr.pdf","2005-06-29 00:00:00",
18011,2,50684,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf","2005-10-10 00:00:00",
22183,3,50684,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050684_S045_050750_s012_ZosynTOC.cfm","2007-06-11 00:00:00",
30269,1,50684,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012ltr.pdf","2005-10-20 00:00:00",
7997,1,50684,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050684s046LTR.pdf","2006-08-04 00:00:00",
18012,2,50684,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050684s046lbl.pdf","2006-07-27 00:00:00",
7998,1,50684,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf","2008-04-22 00:00:00",
39107,2,50684,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf","2008-06-05 00:00:00",
18013,2,50684,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf","2008-06-05 00:00:00",
30270,1,50684,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf","2008-04-22 00:00:00",
18014,2,50684,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf","2012-05-15 00:00:00",
18015,2,50684,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf","2012-05-15 00:00:00",
30271,1,50684,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016ltr.pdf","2012-05-15 00:00:00",
18016,2,50684,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
30272,1,50684,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
7999,1,50684,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024ltr.pdf","2011-10-03 00:00:00",
39108,2,50684,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf","2011-09-30 00:00:00",
18017,2,50684,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
30273,1,50684,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
8000,1,50684,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
39109,2,50684,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
8001,1,50684,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083; 050750Orig1s033ltr.pdf","2015-12-22 00:00:00",
18018,2,50684,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf","2015-12-29 00:00:00",
30274,1,50684,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf","2016-06-13 00:00:00",
39110,2,50684,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf","2016-06-13 00:00:00",
8002,1,50684,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf","2016-06-13 00:00:00",
39111,2,50684,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf","2016-06-13 00:00:00",
48272,2,50684,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48309,1,50684,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
48271,2,50684,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48308,1,50684,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
48270,2,50684,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48307,1,50684,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
18019,2,50685,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf","2009-02-12 00:00:00",
30275,1,50685,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf","2009-02-12 00:00:00",
30276,1,50685,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf","2010-11-08 00:00:00",
8003,1,50686,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf","2009-02-12 00:00:00",
39112,2,50686,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf","2009-02-12 00:00:00",
8004,1,50686,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf","2010-11-08 00:00:00",
30277,1,50686,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf","2011-03-16 00:00:00",
39113,2,50686,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf","2011-03-14 00:00:00",
8005,1,50687,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
18020,2,50687,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
22184,3,50687,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
8006,1,50687,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
22185,3,50687,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
39114,2,50687,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
30278,1,50687,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
39115,2,50687,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
42674,3,50687,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
8007,1,50687,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
18021,2,50687,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
42675,3,50687,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
8008,1,50687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
22186,3,50687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
39116,2,50687,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
18022,2,50687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
30279,1,50687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
42676,3,50687,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
8009,1,50687,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
18023,2,50687,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
22187,3,50687,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
22188,3,50688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
30280,1,50688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
39117,2,50688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
18024,2,50688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
30281,1,50688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
42677,3,50688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
22189,3,50688,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
30282,1,50688,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
39118,2,50688,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
8010,1,50688,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
18025,2,50688,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
42678,3,50688,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
18026,2,50688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
22190,3,50688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
30283,1,50688,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
8011,1,50688,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
39119,2,50688,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
42679,3,50688,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
8012,1,50688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF","2000-02-10 00:00:00",
18027,2,50688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf","2000-02-10 00:00:00",
42680,3,50688,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.cfm","2000-02-10 00:00:00",
30284,1,50689,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf","2001-11-09 00:00:00",
39120,2,50689,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50689s11s13lbl.pdf","2003-05-07 00:00:00",
8013,1,50689,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf","2001-11-09 00:00:00",
18028,2,50689,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050689s016lbl.pdf","2008-06-05 00:00:00",
30285,1,50689,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050689s016ltr.pdf","2008-05-14 00:00:00",
30286,1,50689,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050689Orig1s018ltr.pdf","2014-11-14 00:00:00",
39121,2,50689,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050689Orig1s018lbl.pdf","2014-12-02 00:00:00",
8014,1,50689,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050689Orig1s022ltr.pdf","2015-07-09 00:00:00",
39122,2,50689,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050689s022lbl.pdf","2015-07-06 00:00:00",
44203,10,50693,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
8015,1,50693,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf","2000-11-13 00:00:00",
39123,2,50693,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf","2000-11-13 00:00:00",
42681,3,50693,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm","2000-11-13 00:00:00",
8016,1,50693,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf","2002-10-16 00:00:00",
8017,1,50693,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
18029,2,50693,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf","2004-04-05 00:00:00",
30287,1,50693,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf","2004-03-28 00:00:00",
8018,1,50693,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf","2004-01-22 00:00:00",
30288,1,50693,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf","2007-11-08 00:00:00",
39124,2,50693,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf","2007-11-07 00:00:00",
18030,2,50693,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.pdf","2009-04-03 00:00:00",
30289,1,50693,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf","2009-03-10 00:00:00",
8019,1,50693,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf","2010-08-17 00:00:00",
39125,2,50693,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf","2010-08-19 00:00:00",
18031,2,50693,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf","2011-02-04 00:00:00",
30290,1,50693,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
8020,1,50693,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf","2012-11-06 00:00:00",
39126,2,50693,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf","2012-11-06 00:00:00",
30291,1,50693,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf","2014-06-11 00:00:00",
39127,2,50693,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf","2014-06-10 00:00:00",
8021,1,50693,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
18032,2,50693,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
18033,2,50693,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf","2013-02-21 00:00:00",
30292,1,50693,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf","2013-02-21 00:00:00",
30293,1,50693,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf","2016-05-25 00:00:00",
39128,2,50693,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf","2016-05-25 00:00:00",
47181,1,50693,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s027,050730Orig1s035ltr.pdf","2017-02-13 00:00:00",
47182,2,50693,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf","2017-02-10 00:00:00",
47785,2,50693,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf","2017-03-30 00:00:00",
47838,1,50693,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s029,050730Orig1s037ltr.pdf","2017-04-03 00:00:00",
22191,3,50694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/50694.pdf","1999-03-04 00:00:00",
8022,1,50697,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf","2004-07-21 00:00:00",
44204,10,50698,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-09-25 00:00:00",
8023,1,50698,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50697s002ltr.pdf","2002-05-24 00:00:00",
8024,1,50698,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf","2004-07-21 00:00:00",
8025,1,50698,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf","2005-10-20 00:00:00",
18034,2,50698,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf","2005-10-10 00:00:00",
8026,1,50698,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf","2006-07-13 00:00:00",
18035,2,50698,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf","2007-12-27 00:00:00",
30294,1,50698,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf","2008-01-09 00:00:00",
8027,1,50698,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf","2008-05-29 00:00:00",
8028,1,50698,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf","2009-11-20 00:00:00",
39129,2,50698,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf","2009-09-22 00:00:00",
30295,1,50698,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
39130,2,50698,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
18036,2,50698,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
30296,1,50698,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
8029,1,50698,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
39131,2,50698,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
30297,1,50698,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf","2012-06-05 00:00:00",
8030,1,50698,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf","2012-07-10 00:00:00",
18037,2,50698,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf","2012-07-10 00:00:00",
8031,1,50698,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
39132,2,50698,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
8032,1,50698,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
18038,2,50698,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s031lbl.pdf","2013-09-09 00:00:00",
18039,2,50698,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s032lbl.pdf","2013-09-09 00:00:00",
30298,1,50698,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
18040,2,50698,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf","2016-06-01 00:00:00",
30299,1,50698,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf","2016-05-31 00:00:00",
30300,1,50698,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf","2014-07-28 00:00:00",
39133,2,50698,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf","2014-08-07 00:00:00",
8033,1,50698,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf","2015-01-09 00:00:00",
39134,2,50698,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf","2015-01-12 00:00:00",
18041,2,50698,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf","2015-10-29 00:00:00",
30301,1,50698,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf","2015-10-28 00:00:00",
48692,2,50698,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf","2017-06-12 00:00:00",
48704,1,50698,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050662Orig1s058,050698Orig1s038,050775Orig1s026ltr.pdf","2017-06-12 00:00:00",
8034,1,50703,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf","2014-05-27 00:00:00",
39135,2,50703,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf","2014-05-28 00:00:00",
8035,1,50703,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050703Orig1s016ltr.pdf","2015-05-19 00:00:00",
18042,2,50703,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf","2015-05-21 00:00:00",
48317,2,50703,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050703s017lbl.pdf","2017-05-09 00:00:00",
48345,1,50703,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050703ORig1s017ltr.pdf","2017-05-10 00:00:00",
30302,1,50704,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50704s8ltr.pdf","2002-02-21 00:00:00",
8036,1,50705,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050705s005ltr.pdf","2005-05-02 00:00:00",
18043,2,50705,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf","2005-05-02 00:00:00",
18044,2,50705,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf","2009-01-02 00:00:00",
30303,1,50705,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf","2008-12-29 00:00:00",
8037,1,50705,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050705s007ltr.pdf","2010-11-22 00:00:00",
39136,2,50705,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf","2010-11-17 00:00:00",
8038,1,50705,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050705Orig1s010ltr.pdf","2013-03-01 00:00:00",
39137,2,50705,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf","2013-03-01 00:00:00",
48098,2,50705,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050705s011lbl.pdf","2017-04-25 00:00:00",
48139,1,50705,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050705Orig1s011ltr.pdf","2017-04-27 00:00:00",
51002,2,50705,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf","2018-01-09 00:00:00",
51012,1,50705,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050705Orig1s012ltr.pdf","2018-01-10 00:00:00",
8039,1,50706,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50706slr016ltr.pdf","2004-06-07 00:00:00",
18045,2,50706,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050706s018lbl.pdf","2005-05-26 00:00:00",
30304,1,50706,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s018ltr.pdf","2005-05-26 00:00:00",
42682,3,50706,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050706_S018_MERREM.pdf","2007-07-20 00:00:00",
8040,1,50706,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s020ltr.pdf","2005-08-19 00:00:00",
8041,1,50706,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s022ltr.pdf","2008-04-02 00:00:00",
18046,2,50706,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf","2008-03-27 00:00:00",
8042,1,50706,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s023ltr.pdf","2008-03-17 00:00:00",
18047,2,50706,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s023lbl.pdf","2008-03-17 00:00:00",
8043,1,50706,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050706s025ltr.pdf","2009-11-20 00:00:00",
18048,2,50706,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050706s025lbl.pdf","2009-11-06 00:00:00",
18049,2,50706,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050706s028lbl.pdf","2010-12-26 00:00:00",
30305,1,50706,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050706s028ltr.pdf","2010-12-28 00:00:00",
30306,1,50706,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s031ltr.pdf","2013-04-01 00:00:00",
39138,2,50706,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s031lbl.pdf","2013-04-01 00:00:00",
18050,2,50706,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf","2013-12-17 00:00:00",
30307,1,50706,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf","2013-12-17 00:00:00",
8044,1,50706,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf","2013-12-17 00:00:00",
22192,3,50706,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/050706Orig1s034.pdf","2014-07-07 00:00:00",
39139,2,50706,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf","2013-12-17 00:00:00",
30308,1,50706,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050706Orig1s035ltr.pdf","2014-12-24 00:00:00",
39140,2,50706,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050706s035lbl.pdf","2015-01-09 00:00:00",
8045,1,50706,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050706Orig1s036ltr.pdf","2016-07-28 00:00:00",
39141,2,50706,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050706s036lbl.pdf","2016-07-28 00:00:00",
46652,2,50706,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050706s037lbl.pdf","2017-01-03 00:00:00",
46669,1,50706,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050706Orig1s037ltr.pdf","2017-01-05 00:00:00",
51090,2,50706,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s039lbl.pdf","2018-01-18 00:00:00",
51865,1,50706,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050706Orig1s039ltr.pdf","2018-01-26 00:00:00",
54460,1,50706,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050706Orig1s040ltr.pdf","2018-06-05 00:00:00",
54468,2,50706,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s040lbl.pdf","2018-06-06 00:00:00",
42683,3,50708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050708_prograf_toc.cfm","2003-09-10 00:00:00",
39142,2,50708,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf","2004-06-14 00:00:00",
39143,2,50708,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf","2003-05-02 00:00:00",
18051,2,50708,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf","2003-05-02 00:00:00",
39144,2,50708,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf","2003-05-02 00:00:00",
8046,1,50708,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf","2004-06-23 00:00:00",
39145,2,50708,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf","2004-06-23 00:00:00",
8047,1,50708,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf","2006-04-05 00:00:00",
8048,1,50708,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf","2005-12-16 00:00:00",
8049,1,50708,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf","2006-05-01 00:00:00",
18052,2,50708,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf","2006-05-01 00:00:00",
8050,1,50708,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf","2009-05-27 00:00:00",
18053,2,50708,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf","2009-05-21 00:00:00",
42684,3,50708,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050708Orig1s027_StatR.pdf","2012-10-11 00:00:00",
44516,14,50708,"SUPPL",27,"Medical Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050708Orig1s027_MedR.pdf","2012-10-11 00:00:00",
18054,2,50708,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf","2009-02-20 00:00:00",
30309,1,50708,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf","2009-02-18 00:00:00",
8051,1,50708,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf","2011-07-19 00:00:00",
18055,2,50708,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf","2011-07-18 00:00:00",
18056,2,50708,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf","2011-07-18 00:00:00",
30310,1,50708,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf","2011-07-19 00:00:00",
8052,1,50708,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf","2012-02-08 00:00:00",
39146,2,50708,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf","2012-02-06 00:00:00",
18057,2,50708,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf","2012-07-10 00:00:00",
30311,1,50708,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf","2012-07-09 00:00:00",
8053,1,50708,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf","2012-08-15 00:00:00",
18058,2,50708,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf","2012-08-15 00:00:00",
18059,2,50708,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf","2013-09-09 00:00:00",
30312,1,50708,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf","2013-09-09 00:00:00",
18060,2,50708,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf","2015-05-21 00:00:00",
30313,1,50708,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf","2015-05-21 00:00:00",
54347,2,50708,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf","2018-05-29 00:00:00",
54353,1,50708,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf","2018-05-29 00:00:00",
42685,3,50709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050709_prograf_toc.cfm","2003-09-10 00:00:00",
39147,2,50709,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf","2003-05-02 00:00:00",
18061,2,50709,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s12lbl.pdf","2003-05-02 00:00:00",
18062,2,50709,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf","2004-06-23 00:00:00",
30314,1,50709,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf","2004-06-23 00:00:00",
8054,1,50709,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf","2005-12-16 00:00:00",
30315,1,50709,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf","2006-04-05 00:00:00",
30316,1,50709,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf","2006-05-01 00:00:00",
39148,2,50709,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf","2006-05-01 00:00:00",
8055,1,50709,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf","2009-05-27 00:00:00",
18063,2,50709,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf","2009-05-21 00:00:00",
42686,3,50709,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050709Orig1s021_StatR.pdf","2012-10-11 00:00:00",
44517,14,50709,"SUPPL",21,"Medical Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050709Orig1s021_MedR.pdf","2012-10-11 00:00:00",
8056,1,50709,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf","2009-02-18 00:00:00",
39149,2,50709,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf","2009-02-20 00:00:00",
18064,2,50709,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf","2011-07-18 00:00:00",
30317,1,50709,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf","2011-07-19 00:00:00",
8057,1,50709,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf","2011-07-19 00:00:00",
18065,2,50709,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf","2011-07-18 00:00:00",
8058,1,50709,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf","2012-02-08 00:00:00",
39150,2,50709,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf","2012-02-06 00:00:00",
8059,1,50709,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf","2012-07-09 00:00:00",
39151,2,50709,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf","2012-07-10 00:00:00",
8060,1,50709,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf","2012-08-15 00:00:00",
18066,2,50709,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf","2012-08-15 00:00:00",
8061,1,50709,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf","2013-09-09 00:00:00",
18067,2,50709,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf","2013-09-09 00:00:00",
8062,1,50709,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf","2015-05-21 00:00:00",
39152,2,50709,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf","2015-05-21 00:00:00",
54348,2,50709,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf","2018-05-29 00:00:00",
54354,1,50709,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf","2018-05-29 00:00:00",
23722,10,50710,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
8063,1,50710,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710slr007,50711slr008ltr.pdf","2002-10-16 00:00:00",
8064,1,50710,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf","2001-12-14 00:00:00",
39153,2,50710,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s8lbl.pdf","2001-12-14 00:00:00",
30318,1,50710,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf","2001-12-14 00:00:00",
39154,2,50710,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s9lbl.pdf","2001-12-14 00:00:00",
22193,3,50710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-710S011_50-711S009_Zithromax.cfm","2004-06-04 00:00:00",
30319,1,50710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf","2002-05-24 00:00:00",
39155,2,50710,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf","2002-05-24 00:00:00",
8065,1,50710,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
30320,1,50710,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50710slr016ltr.pdf","2003-07-06 00:00:00",
8066,1,50710,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf","2004-01-22 00:00:00",
18068,2,50710,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf","2004-01-22 00:00:00",
30321,1,50710,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr019ltr.pdf","2004-04-29 00:00:00",
8067,1,50710,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf","2003-12-22 00:00:00",
30322,1,50710,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf","2004-01-22 00:00:00",
39156,2,50710,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf","2004-01-22 00:00:00",
18069,2,50710,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf","2007-11-07 00:00:00",
30323,1,50710,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf","2007-11-08 00:00:00",
30324,1,50710,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf","2009-03-03 00:00:00",
39157,2,50710,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf","2009-04-03 00:00:00",
18070,2,50710,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf","2010-08-19 00:00:00",
30325,1,50710,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf","2010-08-17 00:00:00",
8068,1,50710,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
18071,2,50710,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf","2011-02-04 00:00:00",
30326,1,50710,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf","2012-11-06 00:00:00",
39158,2,50710,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf","2012-11-06 00:00:00",
18072,2,50710,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf","2014-06-10 00:00:00",
30327,1,50710,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf","2014-06-11 00:00:00",
18073,2,50710,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
30328,1,50710,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
18074,2,50710,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf","2013-02-21 00:00:00",
30329,1,50710,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf","2013-02-21 00:00:00",
8069,1,50710,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf","2016-05-25 00:00:00",
18075,2,50710,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf","2016-05-25 00:00:00",
47172,2,50710,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf","2017-02-13 00:00:00",
47188,1,50710,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050710Orig1s044,050711Orig1s041,050784Orig1s028ltr.pdf","2017-02-13 00:00:00",
47798,2,50710,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf","2017-03-31 00:00:00",
47835,1,50710,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf","2017-04-03 00:00:00",
22194,3,50711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050711_Original_ap_pkg.PDF","2005-08-04 00:00:00",
23723,10,50711,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
30330,1,50711,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710slr007,50711slr008ltr.pdf","2002-10-16 00:00:00",
18076,2,50711,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf","2002-05-24 00:00:00",
30331,1,50711,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf","2002-05-24 00:00:00",
42687,3,50711,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-710S011_50-711S009_Zithromax.cfm","2004-06-04 00:00:00",
8070,1,50711,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
30332,1,50711,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf","2004-01-22 00:00:00",
39159,2,50711,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf","2004-01-22 00:00:00",
30333,1,50711,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf","2003-12-22 00:00:00",
8071,1,50711,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf","2004-01-22 00:00:00",
39160,2,50711,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf","2004-01-22 00:00:00",
8072,1,50711,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf","2007-11-08 00:00:00",
39161,2,50711,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf","2007-11-07 00:00:00",
8073,1,50711,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf","2009-03-03 00:00:00",
18077,2,50711,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf","2009-04-03 00:00:00",
30334,1,50711,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf","2010-08-17 00:00:00",
39162,2,50711,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf","2010-08-19 00:00:00",
8074,1,50711,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
18078,2,50711,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf","2011-02-04 00:00:00",
18079,2,50711,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf","2012-11-06 00:00:00",
30335,1,50711,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf","2012-11-06 00:00:00",
18080,2,50711,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf","2014-06-10 00:00:00",
30336,1,50711,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf","2014-06-11 00:00:00",
18081,2,50711,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
30337,1,50711,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
18082,2,50711,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf","2013-02-21 00:00:00",
30338,1,50711,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf","2013-02-21 00:00:00",
8075,1,50711,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf","2016-05-25 00:00:00",
18083,2,50711,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf","2016-05-25 00:00:00",
47173,2,50711,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf","2017-02-13 00:00:00",
47189,1,50711,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050710Orig1s044,050711Orig1s041,050784Orig1s028ltr.pdf","2017-02-13 00:00:00",
47797,2,50711,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf","2017-03-31 00:00:00",
47834,1,50711,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf","2017-04-03 00:00:00",
30339,1,50715,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf","2002-06-12 00:00:00",
39163,2,50715,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf","2002-06-12 00:00:00",
8076,1,50715,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf","2002-06-12 00:00:00",
18084,2,50715,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf","2002-06-12 00:00:00",
8077,1,50715,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf","2004-06-09 00:00:00",
39164,2,50715,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf","2004-03-03 00:00:00",
18085,2,50715,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf","2004-06-09 00:00:00",
30340,1,50715,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf","2004-06-09 00:00:00",
18086,2,50715,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf","2005-07-26 00:00:00",
30341,1,50715,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024ltr.pdf","2005-07-26 00:00:00",
18087,2,50715,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf","2006-03-10 00:00:00",
30342,1,50715,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025ltr.pdf","2006-03-23 00:00:00",
8078,1,50715,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050715s028, 050716s026ltr.pdf","2007-08-02 00:00:00",
18088,2,50715,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf","2007-08-02 00:00:00",
8079,1,50715,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s027,050716s028ltr.pdf","2009-11-12 00:00:00",
18089,2,50715,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf","2009-10-01 00:00:00",
8080,1,50715,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s028ltr.pdf","2009-11-09 00:00:00",
39165,2,50715,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf","2009-10-14 00:00:00",
8081,1,50715,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050715Orig1s029,050716Orig1s030ltr.pdf","2012-09-05 00:00:00",
18090,2,50715,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf","2012-08-31 00:00:00",
18091,2,50715,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf","2013-05-09 00:00:00",
30343,1,50715,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716Orig1s034ltr.pdf","2013-05-07 00:00:00",
8082,1,50715,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050715Orig1s035,050716Orig1s038ltr.pdf","2015-04-02 00:00:00",
39166,2,50715,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050715s035,050716s038lbl.pdf","2015-04-01 00:00:00",
30344,1,50716,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf","2002-06-12 00:00:00",
39167,2,50716,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf","2002-06-12 00:00:00",
8083,1,50716,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf","2002-06-12 00:00:00",
18092,2,50716,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf","2002-06-12 00:00:00",
8084,1,50716,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf","2004-02-27 00:00:00",
39168,2,50716,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf","2004-03-03 00:00:00",
18093,2,50716,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf","2004-03-03 00:00:00",
30345,1,50716,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf","2004-02-27 00:00:00",
8085,1,50716,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024ltr.pdf","2005-07-26 00:00:00",
18094,2,50716,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf","2005-07-26 00:00:00",
18095,2,50716,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf","2006-03-10 00:00:00",
30346,1,50716,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025ltr.pdf","2006-03-23 00:00:00",
8086,1,50716,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050715s028, 050716s026ltr.pdf","2007-08-02 00:00:00",
18096,2,50716,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf","2007-08-02 00:00:00",
8087,1,50716,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s027,050716s028ltr.pdf","2009-11-12 00:00:00",
18097,2,50716,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf","2009-10-01 00:00:00",
8088,1,50716,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050716s029ltr.pdf","2009-11-09 00:00:00",
39169,2,50716,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf","2009-10-14 00:00:00",
8089,1,50716,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050715Orig1s029,050716Orig1s030ltr.pdf","2012-09-05 00:00:00",
18098,2,50716,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf","2012-08-31 00:00:00",
18099,2,50716,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf","2013-05-09 00:00:00",
30347,1,50716,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716Orig1s034ltr.pdf","2013-05-07 00:00:00",
8090,1,50716,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050715Orig1s035,050716Orig1s038ltr.pdf","2015-04-02 00:00:00",
18100,2,50716,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050715s035,050716s038lbl.pdf","2015-04-01 00:00:00",
30348,1,50717,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50717slr004ltr.pdf","2002-12-18 00:00:00",
39170,2,50717,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50717SLR004_Monurol_lbl.pdf","2003-04-07 00:00:00",
18101,2,50717,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050717s005lbl.pdf","2008-03-13 00:00:00",
30349,1,50717,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050717s005ltr.pdf","2008-03-13 00:00:00",
8091,1,50717,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050717s007ltr.pdf","2011-04-13 00:00:00",
18102,2,50717,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050717s007lbl.pdf","2011-04-11 00:00:00",
54397,2,50717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s009lbl.pdf","2018-05-31 00:00:00",
54408,1,50717,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050717Orig1s009ltr.pdf","2018-06-01 00:00:00",
30350,1,50718,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50718s06ltr.pdf","1999-06-28 00:00:00",
39171,2,50718,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf","1999-06-28 00:00:00",
8092,1,50718,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50718s10ltr.pdf","2004-06-02 00:00:00",
18103,2,50718,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50718s019lbl.pdf","2004-11-01 00:00:00",
30351,1,50718,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50718s019ltr.pdf","2004-10-29 00:00:00",
42688,3,50718,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050718Orig1s019.pdf","2011-10-10 00:00:00",
18104,2,50718,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50718s019,020lbl.pdf","2005-02-03 00:00:00",
30352,1,50718,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50718s019,020ltr.pdf","2005-02-03 00:00:00",
30353,1,50718,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf","2007-05-29 00:00:00",
39172,2,50718,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s028s029lbl.pdf","2007-05-29 00:00:00",
8093,1,50718,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf","2007-05-29 00:00:00",
39173,2,50718,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf","2007-05-18 00:00:00",
30354,1,50718,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050718s033ltr.pdf","2008-06-13 00:00:00",
39174,2,50718,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050718s033lbl.pdf","2008-06-19 00:00:00",
44786,21,50718,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/050718se7-033_SUMR.pdf","2008-07-17 00:00:00",
18105,2,50718,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050718s043lbl.pdf","2012-09-20 00:00:00",
30355,1,50718,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050718Orig1s043ltr.pdf","2012-09-24 00:00:00",
30356,1,50718,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050718Orig1s045ltr.pdf","2013-09-04 00:00:00",
39175,2,50718,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050718s045lbl.pdf","2013-09-09 00:00:00",
39176,2,50718,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s046lbl.pdf","2015-01-29 00:00:00",
50611,3,50718,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/050718Orig1s046.pdf","2017-12-06 00:00:00",
8094,1,50718,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s048ltr.pdf","2015-04-17 00:00:00",
18106,2,50718,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s048lbl.pdf","2015-04-17 00:00:00",
8095,1,50718,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s050ltr.pdf","2015-12-29 00:00:00",
48428,3,50718,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/050718Orig1s050.pdf","2017-05-17 00:00:00",
49020,2,50718,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050718s051lbl.pdf","2017-07-20 00:00:00",
8096,1,50719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf","2004-06-07 00:00:00",
48682,2,50719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/050719lbl.pdf","2017-06-09 00:00:00",
8097,1,50719,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50719slr06ltr.pdf","2004-06-07 00:00:00",
39177,2,50719,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50719slr006_Helidac_lbl.pdf","2002-12-12 00:00:00",
30357,1,50719,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50719slr007ltr.pdf","2003-05-29 00:00:00",
39178,2,50719,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050719s007lbl.pdf","2003-05-06 00:00:00",
30358,1,50719,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50719s008ltr.pdf","2004-09-15 00:00:00",
39179,2,50719,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50719s008lbl.pdf","2004-09-15 00:00:00",
8098,1,50719,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050719s009ltr.pdf","2007-07-27 00:00:00",
18107,2,50719,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050719s013lbl.pdf","2008-06-30 00:00:00",
30359,1,50719,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050719s013ltr.pdf","2008-07-01 00:00:00",
30360,1,50719,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050719s015ltr.pdf","2010-01-21 00:00:00",
39180,2,50719,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050719s015lbl.pdf","2009-11-16 00:00:00",
18108,2,50719,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf","2012-06-26 00:00:00",
18109,2,50719,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050719s017s020lbl.pdf","2012-06-20 00:00:00",
18110,2,50719,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050719s021lbl.pdf","2015-08-12 00:00:00",
30361,1,50719,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050719Orig1s021ltr.pdf","2015-09-10 00:00:00",
22195,3,50720,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050720s001_Augmentin.cfm","2004-11-22 00:00:00",
42689,3,50720,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050720s004_Augmentin.cfm","2004-11-22 00:00:00",
42690,3,50720,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050720s005_Augmentin.cfm","2004-11-22 00:00:00",
8099,1,50720,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
22196,3,50720,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s006_Augmentin.cfm","2004-11-22 00:00:00",
22197,3,50720,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s007_Augmentin.cfm","2004-11-22 00:00:00",
42691,3,50720,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s008_Augmentin.cfm","2004-11-22 00:00:00",
42692,3,50720,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s009_Augmentin.cfm","2004-11-22 00:00:00",
42693,3,50720,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s011_Augmentin.cfm","2004-11-22 00:00:00",
22198,3,50720,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s012_Augmentin.cfm","2004-11-22 00:00:00",
42694,3,50720,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s013_Augmentin.cfm","2004-11-22 00:00:00",
8100,1,50720,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf","2003-08-15 00:00:00",
42695,3,50720,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050720s015_Augmentin.cfm","2004-11-22 00:00:00",
42696,3,50720,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s016_Augmentin.cfm","2004-11-22 00:00:00",
22199,3,50720,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s017_Augmentin.cfm","2004-11-22 00:00:00",
30362,1,50720,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr018ltr.pdf","2004-06-01 00:00:00",
8101,1,50720,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr.pdf","2004-09-03 00:00:00",
30363,1,50720,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021ltr.pdf","2005-08-11 00:00:00",
8102,1,50720,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049, 050720s022ltr.pdf","2008-06-13 00:00:00",
39181,2,50720,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf","2008-06-12 00:00:00",
18111,2,50720,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf","2008-12-08 00:00:00",
30364,1,50720,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050, 050720s023ltr.pdf","2008-12-11 00:00:00",
8103,1,50720,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050720s024ltr.pdf","2008-04-10 00:00:00",
39182,2,50720,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf","2008-04-16 00:00:00",
8104,1,50720,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050564s052,050720s025ltr.pdf","2011-10-03 00:00:00",
18112,2,50720,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf","2011-09-30 00:00:00",
8105,1,50720,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
39183,2,50720,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
8106,1,50720,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
18113,2,50720,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
23724,10,50722,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44518,14,50722,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2012-09-27 00:00:00",
22200,3,50722,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm","2004-10-08 00:00:00",
30365,1,50722,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF","2000-07-28 00:00:00",
39184,2,50722,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF","2000-07-28 00:00:00",
42697,3,50722,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm","2000-07-28 00:00:00",
22201,3,50722,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s006_CellCept.cfm","2004-10-08 00:00:00",
8107,1,50722,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf","2000-12-20 00:00:00",
22202,3,50722,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm","2000-12-22 00:00:00",
39185,2,50722,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf","2000-12-20 00:00:00",
18114,2,50722,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf","2003-02-28 00:00:00",
30366,1,50722,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf","2003-03-10 00:00:00",
42698,3,50722,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-722s009_CellCept.cfm","2004-10-08 00:00:00",
8108,1,50722,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf","2005-10-19 00:00:00",
39186,2,50722,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf","2005-10-19 00:00:00",
8109,1,50722,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf","2008-01-09 00:00:00",
18115,2,50722,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf","2007-12-27 00:00:00",
30367,1,50722,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf","2007-09-25 00:00:00",
39187,2,50722,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf","2007-09-26 00:00:00",
8110,1,50722,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf","2008-05-15 00:00:00",
18116,2,50722,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s018lbl.pdf","2008-05-16 00:00:00",
8111,1,50722,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf","2008-12-24 00:00:00",
39188,2,50722,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf","2009-01-02 00:00:00",
18117,2,50722,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf","2009-03-19 00:00:00",
30368,1,50722,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf","2009-03-05 00:00:00",
30369,1,50722,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf","2009-06-23 00:00:00",
39189,2,50722,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf","2009-06-24 00:00:00",
8112,1,50722,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf","2012-09-27 00:00:00",
18118,2,50722,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf","2009-10-14 00:00:00",
30370,1,50722,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf","2009-11-09 00:00:00",
18119,2,50722,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf","2012-06-18 00:00:00",
30371,1,50722,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf","2012-06-12 00:00:00",
8113,1,50722,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf","2012-06-26 00:00:00",
18120,2,50722,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf","2012-06-26 00:00:00",
8114,1,50722,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
18121,2,50722,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
30372,1,50722,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
39190,2,50722,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
8115,1,50722,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf","2015-07-14 00:00:00",
39191,2,50722,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf","2015-07-13 00:00:00",
30373,1,50722,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf","2015-11-19 00:00:00",
55285,2,50722,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf","2018-08-24 00:00:00",
55292,8,50722,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39","2018-08-24 00:00:00",
55305,1,50722,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050722Orig1s035,050723Orig1s035,050758Orig1s033,050759Orig1s041Ltr.pdf","2018-08-24 00:00:00",
50762,2,50722,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf","2017-12-19 00:00:00",
50871,1,50722,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050722Orig1s037, 050723Orig1s037, 050758Orig1s034, 050759Orig1s042ltr.pdf","2017-12-27 00:00:00",
44205,10,50723,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44519,14,50723,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2012-09-27 00:00:00",
22203,3,50723,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm","2004-10-08 00:00:00",
30374,1,50723,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf","2000-12-22 00:00:00",
39192,2,50723,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf","2000-12-22 00:00:00",
42699,3,50723,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm","2000-12-22 00:00:00",
8116,1,50723,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF","2000-07-28 00:00:00",
22204,3,50723,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm","2000-07-28 00:00:00",
39193,2,50723,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF","2000-07-28 00:00:00",
8117,1,50723,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf","2003-03-10 00:00:00",
39194,2,50723,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf","2003-02-28 00:00:00",
8118,1,50723,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf","2005-10-19 00:00:00",
39195,2,50723,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf","2005-10-19 00:00:00",
18122,2,50723,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf","2007-12-27 00:00:00",
30375,1,50723,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf","2008-01-09 00:00:00",
8119,1,50723,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf","2007-09-25 00:00:00",
39196,2,50723,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf","2007-09-26 00:00:00",
30376,1,50723,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf","2008-05-15 00:00:00",
39197,2,50723,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050723s015lbl.pdf","2008-05-16 00:00:00",
18123,2,50723,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf","2009-01-02 00:00:00",
30377,1,50723,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf","2008-12-24 00:00:00",
8120,1,50723,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf","2009-03-05 00:00:00",
18124,2,50723,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf","2009-03-19 00:00:00",
8121,1,50723,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf","2009-06-23 00:00:00",
39198,2,50723,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf","2009-06-24 00:00:00",
30378,1,50723,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf","2012-09-27 00:00:00",
30379,1,50723,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050723s021ltr.pdf","2009-11-20 00:00:00",
18125,2,50723,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf","2009-10-14 00:00:00",
30380,1,50723,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf","2009-11-09 00:00:00",
18126,2,50723,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf","2012-06-18 00:00:00",
30381,1,50723,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf","2012-06-12 00:00:00",
8122,1,50723,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf","2012-06-26 00:00:00",
18127,2,50723,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf","2012-06-26 00:00:00",
8123,1,50723,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
18128,2,50723,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
30382,1,50723,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
39199,2,50723,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
8124,1,50723,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf","2015-07-14 00:00:00",
39200,2,50723,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf","2015-07-13 00:00:00",
30383,1,50723,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf","2015-11-19 00:00:00",
55286,2,50723,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf","2018-08-24 00:00:00",
55291,8,50723,"SUPPL",35,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39","2018-08-24 00:00:00",
55306,1,50723,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050722Orig1s035,050723Orig1s035,050758Orig1s033,050759Orig1s041Ltr.pdf","2018-08-24 00:00:00",
50763,2,50723,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf","2017-12-19 00:00:00",
50872,1,50723,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050722Orig1s037, 050723Orig1s037, 050758Orig1s034, 050759Orig1s042ltr.pdf","2017-12-27 00:00:00",
22205,3,50725,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050725_S003_Augmentin_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
22206,3,50725,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050725_S004_Augmentin_APPROVAL PACKAGE.pdf","2006-10-25 00:00:00",
30384,1,50725,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
42700,3,50725,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S005_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42701,3,50725,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S006_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42702,3,50725,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S007_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42703,3,50725,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S008_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42704,3,50725,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S010_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42705,3,50725,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S011_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42706,3,50725,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S013_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
42707,3,50725,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S014_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
22207,3,50725,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S017_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
30385,1,50725,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf","2003-06-08 00:00:00",
22208,3,50725,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S021_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
22209,3,50725,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S023_Augmentin_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
8125,1,50725,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf","2004-06-07 00:00:00",
8126,1,50725,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf","2004-08-12 00:00:00",
18129,2,50725,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf","2008-12-08 00:00:00",
30386,1,50725,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf","2008-12-11 00:00:00",
30387,1,50725,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf","2008-04-02 00:00:00",
39201,2,50725,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf","2008-03-27 00:00:00",
8127,1,50725,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf","2011-10-04 00:00:00",
18130,2,50725,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf","2011-09-30 00:00:00",
18131,2,50725,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
30388,1,50725,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
18132,2,50725,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
30389,1,50725,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
30390,1,50726,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf","2004-05-27 00:00:00",
30391,1,50726,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf","2003-06-08 00:00:00",
8128,1,50726,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf","2004-06-07 00:00:00",
8129,1,50726,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf","2004-08-12 00:00:00",
8130,1,50726,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf","2008-12-11 00:00:00",
18133,2,50726,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf","2008-12-08 00:00:00",
18134,2,50726,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf","2008-03-27 00:00:00",
30392,1,50726,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf","2008-04-02 00:00:00",
8131,1,50726,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf","2011-10-04 00:00:00",
18135,2,50726,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050726s021lbl.pdf","2011-10-18 00:00:00",
8132,1,50726,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
18136,2,50726,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
18137,2,50726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf","2013-01-23 00:00:00",
30393,1,50726,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf","2013-01-24 00:00:00",
23725,10,50730,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
22210,3,50730,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm","2000-11-13 00:00:00",
30394,1,50730,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf","2000-11-13 00:00:00",
39202,2,50730,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf","2000-11-13 00:00:00",
30395,1,50730,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf","2002-10-16 00:00:00",
8133,1,50730,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
30396,1,50730,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf","2004-03-28 00:00:00",
39203,2,50730,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf","2004-04-05 00:00:00",
30397,1,50730,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf","2004-01-22 00:00:00",
8134,1,50730,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf","2007-11-08 00:00:00",
39204,2,50730,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf","2007-11-07 00:00:00",
8135,1,50730,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf","2009-03-10 00:00:00",
39205,2,50730,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050730s021,050693s014lbl.pdf","2009-04-23 00:00:00",
8136,1,50730,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf","2010-08-17 00:00:00",
39206,2,50730,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf","2010-08-19 00:00:00",
18138,2,50730,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf","2011-02-04 00:00:00",
30398,1,50730,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
30399,1,50730,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf","2012-11-06 00:00:00",
39207,2,50730,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf","2012-11-06 00:00:00",
8137,1,50730,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf","2014-06-11 00:00:00",
39208,2,50730,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf","2014-06-10 00:00:00",
8138,1,50730,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
39209,2,50730,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
8139,1,50730,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf","2013-02-21 00:00:00",
39210,2,50730,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf","2013-02-21 00:00:00",
18139,2,50730,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf","2016-05-25 00:00:00",
30400,1,50730,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf","2016-05-25 00:00:00",
47183,2,50730,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf","2017-02-10 00:00:00",
47184,1,50730,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s027,050730Orig1s035ltr.pdf","2017-02-13 00:00:00",
47784,2,50730,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf","2017-03-30 00:00:00",
47837,1,50730,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s029,050730Orig1s037ltr.pdf","2017-04-03 00:00:00",
22211,3,50731,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50731.pdf","1998-01-30 00:00:00",
55762,1,50731,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050731Orig1s008Rplacementltr.pdf","2018-10-01 00:00:00",
23726,10,50733,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
42708,3,50733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050733ap.pdf","1997-01-30 00:00:00",
39211,2,50733,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf","2003-05-02 00:00:00",
30401,1,50733,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733slr006ltr.pdf","2002-10-16 00:00:00",
30402,1,50733,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50733slr007ltr.pdf","2003-06-22 00:00:00",
8140,1,50733,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733s9ltr.pdf","2002-03-13 00:00:00",
8141,1,50733,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf","2002-07-22 00:00:00",
30403,1,50733,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr012ltr.pdf","2004-01-22 00:00:00",
8142,1,50733,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr013ltr.pdf","2004-01-22 00:00:00",
18140,2,50733,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf","2007-11-07 00:00:00",
30404,1,50733,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050733s018ltr.pdf","2007-11-08 00:00:00",
30405,1,50733,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050733s023ltr.pdf","2009-03-03 00:00:00",
39212,2,50733,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf","2009-04-03 00:00:00",
30406,1,50733,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050733s029ltr.pdf","2010-08-17 00:00:00",
39213,2,50733,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf","2010-08-19 00:00:00",
8143,1,50733,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
18141,2,50733,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf","2011-02-04 00:00:00",
30407,1,50733,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050733Orig1s031ltr.pdf","2014-06-10 00:00:00",
39214,2,50733,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf","2014-06-10 00:00:00",
30408,1,50733,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050733s033ltr.pdf","2011-11-21 00:00:00",
39215,2,50733,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf","2011-11-21 00:00:00",
18142,2,50733,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
30409,1,50733,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
8144,1,50733,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050733Orig1s035ltr.pdf","2013-02-21 00:00:00",
18143,2,50733,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf","2013-02-21 00:00:00",
30410,1,50733,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050733Orig1s040ltr.pdf","2016-05-26 00:00:00",
39216,2,50733,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf","2016-05-25 00:00:00",
47171,2,50733,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s043lbl.pdf","2017-02-13 00:00:00",
47187,1,50733,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s043ltr.pdf","2017-02-13 00:00:00",
47788,2,50733,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s046lbl.pdf","2017-03-30 00:00:00",
47839,1,50733,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s046ltr.pdf","2017-04-03 00:00:00",
8145,1,50734,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50734slr005ltr.pdf","2003-05-30 00:00:00",
18144,2,50734,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf","2003-05-06 00:00:00",
8146,1,50734,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050734Orig1s022ltr.pdf","2014-12-05 00:00:00",
39217,2,50734,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf","2015-01-09 00:00:00",
42709,3,50739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm","2006-01-03 00:00:00",
30411,1,50739,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50739S2LTR.PDF","1999-11-24 00:00:00",
39218,2,50739,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50739S2LBL.PDF","1999-11-24 00:00:00",
8147,1,50739,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50739slr006ltr.pdf","2002-07-24 00:00:00",
30412,1,50739,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf","2004-09-03 00:00:00",
18145,2,50739,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf","2005-07-21 00:00:00",
30413,1,50739,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf","2005-07-21 00:00:00",
18146,2,50739,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf","2007-06-27 00:00:00",
30414,1,50739,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf","2007-07-05 00:00:00",
8148,1,50739,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf","2007-09-25 00:00:00",
39219,2,50739,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf","2007-09-19 00:00:00",
8149,1,50739,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf","2008-12-19 00:00:00",
39220,2,50739,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf","2009-01-02 00:00:00",
18147,2,50739,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf","2015-11-19 00:00:00",
30415,1,50739,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf","2015-11-20 00:00:00",
8150,1,50740,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_Approv.pdf","2000-01-28 00:00:00",
18148,2,50740,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf","2000-01-28 00:00:00",
22212,3,50740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050740_ambisome_toc.cfm","2009-06-19 00:00:00",
42710,3,50740,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/050740s001_ambisome_toc.cfm","2003-07-31 00:00:00",
8151,1,50740,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50740S2LTR.PDF","2000-07-18 00:00:00",
18149,2,50740,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF","2000-07-18 00:00:00",
42711,3,50740,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S2_AmBisome.cfm","2004-05-27 00:00:00",
18150,2,50740,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf","2003-09-26 00:00:00",
30416,1,50740,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50740slr014ltr.pdf","2003-09-25 00:00:00",
30417,1,50740,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050740s016ltr.pdf","2008-10-14 00:00:00",
39221,2,50740,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf","2008-11-07 00:00:00",
8152,1,50740,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf","2012-03-13 00:00:00",
18151,2,50740,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf","2012-03-09 00:00:00",
8153,1,50741,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50741ltr.pdf","2003-04-28 00:00:00",
18152,2,50741,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50741lbl.pdf","2003-04-28 00:00:00",
42712,3,50741,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050741_duac.cfm","2003-04-28 00:00:00",
8154,1,50741,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741slr003ltr.pdf","2003-10-24 00:00:00",
39222,2,50741,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741slr003_duac_lbl.pdf","2003-10-27 00:00:00",
30418,1,50741,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741scs004ltr.pdf","2003-11-25 00:00:00",
39223,2,50741,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741scs004_duac_lbl.pdf","2003-12-02 00:00:00",
30419,1,50741,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050741s011ltr.pdf","2008-07-24 00:00:00",
39224,2,50741,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050741s011lbl.pdf","2008-07-23 00:00:00",
8155,1,50741,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050741s015ltr.pdf","2010-11-10 00:00:00",
18153,2,50741,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050741s015lbl.pdf","2010-11-08 00:00:00",
8156,1,50741,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050741s019ltr.pdf","2011-12-28 00:00:00",
39225,2,50741,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf","2011-12-23 00:00:00",
8157,1,50741,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s020ltr.pdf","2013-06-11 00:00:00",
30420,1,50741,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s021ltr.pdf","2013-12-31 00:00:00",
39226,2,50741,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050741s021lbl.pdf","2013-12-30 00:00:00",
30421,1,50741,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050741Orig1s024ltr.pdf","2015-04-17 00:00:00",
39227,2,50741,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050741s024lbl.pdf","2015-04-16 00:00:00",
22213,3,50742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050742ap.pdf","1997-11-26 00:00:00",
42713,3,50742,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50-742s001_Stromectol.cfm","2005-03-08 00:00:00",
30422,1,50742,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50742slr011ltr.pdf","2003-01-15 00:00:00",
39228,2,50742,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50742slr011_stromectol_lbl.pdf","2003-01-15 00:00:00",
8158,1,50742,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf","2004-02-27 00:00:00",
39229,2,50742,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf","2004-03-03 00:00:00",
18154,2,50742,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf","2004-03-03 00:00:00",
30423,1,50742,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf","2004-02-27 00:00:00",
18155,2,50742,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742s015lbl.pdf","2004-12-02 00:00:00",
8159,1,50742,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf","2006-01-30 00:00:00",
39230,2,50742,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf","2006-01-27 00:00:00",
18156,2,50742,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf","2006-01-27 00:00:00",
30424,1,50742,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf","2006-01-30 00:00:00",
18157,2,50742,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf","2007-09-26 00:00:00",
30425,1,50742,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf","2007-10-04 00:00:00",
8160,1,50742,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s020ltr.pdf","2008-02-27 00:00:00",
8161,1,50742,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf","2007-10-04 00:00:00",
39231,2,50742,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf","2007-09-26 00:00:00",
18158,2,50742,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050742s022lbl.pdf","2008-09-16 00:00:00",
30426,1,50742,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s022ltr.pdf","2008-09-16 00:00:00",
39232,2,50742,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s023lbl.pdf","2009-05-11 00:00:00",
8162,1,50742,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf","2009-06-17 00:00:00",
39233,2,50742,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf","2009-06-22 00:00:00",
8163,1,50742,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf","2009-06-17 00:00:00",
18159,2,50742,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf","2009-06-22 00:00:00",
30427,1,50742,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s026ltr.pdf","2009-12-24 00:00:00",
39234,2,50742,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s026lbl.pdf","2009-12-16 00:00:00",
8164,1,50744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50744ltr.pdf","1998-09-30 00:00:00",
18160,2,50744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50744lbl.pdf","1998-09-30 00:00:00",
22214,3,50744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50744.cfm","1998-09-30 00:00:00",
42714,3,50746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050746_bactroban_toc.cfm","2003-08-08 00:00:00",
8165,1,50746,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s013ltr.pdf","2015-03-20 00:00:00",
39235,2,50746,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf","2015-03-20 00:00:00",
8166,1,50746,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf","2014-05-27 00:00:00",
18161,2,50746,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf","2014-05-28 00:00:00",
18162,2,50746,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf","2015-12-15 00:00:00",
30428,1,50746,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s020ltr.pdf","2015-12-15 00:00:00",
48314,2,50746,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050746s021lbl.pdf","2017-05-09 00:00:00",
48346,1,50746,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050746Orig1s021ltr.pdf","2017-05-10 00:00:00",
8167,1,50747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf","1999-09-21 00:00:00",
39236,2,50747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50747lbl.pdf","1999-09-21 00:00:00",
30429,1,50747,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008ltr.pdf","2008-06-20 00:00:00",
39237,2,50747,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf","2008-06-19 00:00:00",
18163,2,50747,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf","2010-11-17 00:00:00",
30430,1,50747,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf","2010-11-22 00:00:00",
30431,1,50747,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013ltr.pdf","2012-01-18 00:00:00",
39238,2,50747,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf","2012-01-25 00:00:00",
48755,2,50747,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050747s015,050748s014lbl.pdf","2017-06-19 00:00:00",
48776,1,50747,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050748Orig1s014,050747Orig1s015ltr.pdf","2017-06-20 00:00:00",
18164,2,50748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50748lbl.pdf","1999-09-21 00:00:00",
22215,3,50748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50747_Synercid.cfm","2001-07-18 00:00:00",
30432,1,50748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf","1999-09-21 00:00:00",
8168,1,50748,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008ltr.pdf","2008-06-20 00:00:00",
18165,2,50748,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf","2008-06-19 00:00:00",
8169,1,50748,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf","2010-11-22 00:00:00",
39239,2,50748,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf","2010-11-17 00:00:00",
18166,2,50748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf","2010-11-17 00:00:00",
30433,1,50748,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf","2010-11-22 00:00:00",
30434,1,50748,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013ltr.pdf","2012-01-18 00:00:00",
39240,2,50748,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf","2012-01-25 00:00:00",
48754,2,50748,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050747s015,050748s014lbl.pdf","2017-06-19 00:00:00",
48777,1,50748,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050748Orig1s014,050747Orig1s015ltr.pdf","2017-06-20 00:00:00",
22216,3,50749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm","2006-01-03 00:00:00",
18167,2,50749,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50749s02lbl.pdf","1999-07-14 00:00:00",
30435,1,50749,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50749s02ltr.pdf","1999-07-14 00:00:00",
30436,1,50749,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf","2004-09-03 00:00:00",
8170,1,50749,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s010ltr.pdf","2004-07-30 00:00:00",
8171,1,50749,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf","2005-07-21 00:00:00",
39241,2,50749,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf","2005-07-21 00:00:00",
8172,1,50749,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf","2007-07-05 00:00:00",
18168,2,50749,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf","2007-06-27 00:00:00",
30437,1,50749,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf","2007-09-25 00:00:00",
39242,2,50749,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf","2007-09-19 00:00:00",
18169,2,50749,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf","2009-01-02 00:00:00",
30438,1,50749,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf","2008-12-19 00:00:00",
8173,1,50749,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf","2015-11-20 00:00:00",
39243,2,50749,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf","2015-11-19 00:00:00",
22217,3,50750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50750.pdf","1998-02-24 00:00:00",
8174,1,50750,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf","2002-03-27 00:00:00",
18170,2,50750,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s007lbl.pdf","2003-05-13 00:00:00",
30439,1,50750,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750slr007ltr.pdf","2003-05-30 00:00:00",
30440,1,50750,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750se2-008ltr.pdf","2003-05-30 00:00:00",
39244,2,50750,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s008lbl.pdf","2003-05-13 00:00:00",
8175,1,50750,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf","2005-03-18 00:00:00",
8176,1,50750,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011ltr.pdf","2005-06-29 00:00:00",
18171,2,50750,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf","2005-10-10 00:00:00",
22218,3,50750,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050684_S045_050750_s012_ZosynTOC.cfm","2007-06-11 00:00:00",
30441,1,50750,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012ltr.pdf","2005-10-20 00:00:00",
30442,1,50750,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050750s014LTR.pdf","2006-08-04 00:00:00",
39245,2,50750,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050750s014lbl.pdf","2006-07-27 00:00:00",
30443,1,50750,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050750s015ltr.pdf","2008-04-22 00:00:00",
39246,2,50750,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050750s015lbl.pdf","2008-06-05 00:00:00",
8177,1,50750,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016ltr.pdf","2012-05-15 00:00:00",
39247,2,50750,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf","2012-05-15 00:00:00",
18172,2,50750,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf","2012-05-15 00:00:00",
8178,1,50750,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
39248,2,50750,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
8179,1,50750,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024ltr.pdf","2011-10-03 00:00:00",
39249,2,50750,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf","2011-09-30 00:00:00",
8180,1,50750,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
39250,2,50750,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
18173,2,50750,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf","2013-09-09 00:00:00",
30444,1,50750,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf","2013-09-11 00:00:00",
8181,1,50750,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083; 050750Orig1s033ltr.pdf","2015-12-22 00:00:00",
39251,2,50750,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf","2015-12-29 00:00:00",
18174,2,50750,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf","2016-06-13 00:00:00",
30445,1,50750,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf","2016-06-13 00:00:00",
8182,1,50750,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf","2016-06-13 00:00:00",
39252,2,50750,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf","2016-06-13 00:00:00",
48275,2,50750,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48312,1,50750,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
48274,2,50750,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48311,1,50750,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
48273,2,50750,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf","2017-05-08 00:00:00",
48310,1,50750,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf","2017-05-09 00:00:00",
8183,1,50751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50751ltr.pdf","1998-09-04 00:00:00",
18175,2,50751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50751lbl.pdf","1998-09-04 00:00:00",
42715,3,50751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50751.cfm","2004-05-27 00:00:00",
18176,2,50751,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751slr009_Atridox_lbl.pdf","2003-03-26 00:00:00",
30446,1,50751,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751slr009ltr.pdf","2003-03-26 00:00:00",
8184,1,50751,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50751scs011ltr.pdf","2003-07-06 00:00:00",
18177,2,50751,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50751scs011_atridox_lbl.pdf","2003-07-08 00:00:00",
8185,1,50751,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050751s013ltr.pdf","2009-06-10 00:00:00",
30447,1,50751,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050751s015ltr.pdf","2011-02-23 00:00:00",
39253,2,50751,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050751s015lbl.pdf","2011-02-14 00:00:00",
22219,3,50753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050753_tobi_toc.cfm","2010-05-25 00:00:00",
30448,1,50753,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf","2002-03-21 00:00:00",
8186,1,50753,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf","2008-10-22 00:00:00",
18178,2,50753,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf","2013-09-27 00:00:00",
30449,1,50753,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf","2013-10-01 00:00:00",
30450,1,50753,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf","2014-04-29 00:00:00",
39254,2,50753,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf","2014-04-29 00:00:00",
8187,1,50753,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf","2015-10-06 00:00:00",
18179,2,50753,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf","2015-10-08 00:00:00",
8188,1,50754,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf","2004-05-27 00:00:00",
22220,3,50754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50754.pdf","2004-05-27 00:00:00",
30451,1,50754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50754AP.PDF","1998-07-10 00:00:00",
42716,3,50754,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-542s016_50-754s001_Amoxil.cfm","2004-09-09 00:00:00",
42717,3,50754,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm","2004-09-09 00:00:00",
8189,1,50754,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf","2003-06-08 00:00:00",
8190,1,50754,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf","2003-12-22 00:00:00",
30452,1,50754,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf","2004-07-21 00:00:00",
8191,1,50754,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf","2008-06-13 00:00:00",
18180,2,50754,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf","2008-06-12 00:00:00",
8192,1,50754,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf","2008-04-02 00:00:00",
39255,2,50754,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf","2008-04-01 00:00:00",
30453,1,50754,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
39256,2,50754,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8193,1,50754,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18181,2,50754,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8194,1,50754,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18182,2,50754,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
30454,1,50754,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050754s019ltr.pdf050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf","2015-09-28 00:00:00",
39257,2,50754,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf","2015-09-29 00:00:00",
8195,1,50754,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf","2015-12-08 00:00:00",
39258,2,50754,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf","2015-12-08 00:00:00",
22221,3,50755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin.cfm","2004-05-27 00:00:00",
30455,1,50755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50755ltr.pdf","2001-06-26 00:00:00",
39259,2,50755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf","2001-06-26 00:00:00",
22222,3,50755,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-755s003_AugmentinTOC.cfm","2005-06-27 00:00:00",
30456,1,50755,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50755slr003ltr.pdf","2003-06-08 00:00:00",
22223,3,50755,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050755_S010.pdf","2005-02-04 00:00:00",
30457,1,50755,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755slr010ltr.pdf","2004-06-07 00:00:00",
39260,2,50755,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf","2004-07-27 00:00:00",
30458,1,50755,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s011ltr.pdf","2004-11-16 00:00:00",
8196,1,50755,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s012ltr.pdf","2004-12-30 00:00:00",
39261,2,50755,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf","2004-12-30 00:00:00",
8197,1,50755,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050755s014ltr.pdf","2009-01-26 00:00:00",
39262,2,50755,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf","2009-01-16 00:00:00",
8198,1,50755,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050755s015ltr.pdf","2008-04-22 00:00:00",
8199,1,50755,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf","2011-08-31 00:00:00",
39263,2,50755,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf","2011-08-30 00:00:00",
30459,1,50755,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf","2011-08-31 00:00:00",
39264,2,50755,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf","2011-08-30 00:00:00",
8200,1,50755,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050755Orig1s022ltr.pdf","2015-03-17 00:00:00",
39265,2,50755,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050755s022lbl.pdf","2015-03-19 00:00:00",
8201,1,50756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_Approv.pdf","2000-12-21 00:00:00",
18183,2,50756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf","2000-12-21 00:00:00",
42718,3,50756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin.cfm","2000-12-21 00:00:00",
8202,1,50756,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50756scp007ltr.pdf","2002-08-09 00:00:00",
39266,2,50756,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf","2002-08-09 00:00:00",
18184,2,50756,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf","2005-05-02 00:00:00",
30460,1,50756,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050756s016ltr.pdf","2005-05-02 00:00:00",
18185,2,50756,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf","2007-05-29 00:00:00",
30461,1,50756,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s026ltr.pdf","2007-06-04 00:00:00",
18186,2,50756,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf","2007-04-25 00:00:00",
30462,1,50756,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s027ltr.pdf","2007-05-01 00:00:00",
8203,1,50756,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050756s034ltr.pdf","2009-06-17 00:00:00",
39267,2,50756,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf","2009-06-22 00:00:00",
8204,1,50756,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050756s037ltr.pdf","2010-06-18 00:00:00",
39268,2,50756,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf","2010-06-24 00:00:00",
8205,1,50756,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050756s040ltr.pdf","2011-03-08 00:00:00",
18187,2,50756,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf","2011-03-07 00:00:00",
42719,3,50757,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050757a.pdf","1997-12-02 00:00:00",
8206,1,50757,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50757s2ltr.pdf","1999-01-22 00:00:00",
22224,3,50757,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s002_Prevpac.cfm","1999-01-22 00:00:00",
39269,2,50757,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50757s2lbl.pdf","1999-01-22 00:00:00",
22225,3,50757,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s003_Prevpac.cfm","1999-08-20 00:00:00",
30463,1,50757,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_Approv.pdf","1999-08-20 00:00:00",
39270,2,50757,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_prntlbl.pdf","1999-08-20 00:00:00",
18188,2,50757,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_prntlbl.pdf","1999-10-22 00:00:00",
30464,1,50757,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_Approv.pdf","1999-10-22 00:00:00",
42720,3,50757,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s004_Prevpac.cfm","1999-10-22 00:00:00",
30465,1,50757,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf","2002-11-22 00:00:00",
39271,2,50757,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf","2002-11-22 00:00:00",
30466,1,50757,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf","2004-06-14 00:00:00",
39272,2,50757,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf","2004-06-14 00:00:00",
30467,1,50757,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf","2004-07-30 00:00:00",
8207,1,50757,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf","2004-07-30 00:00:00",
30468,1,50757,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050757s011ltr.pdf","2005-04-28 00:00:00",
39273,2,50757,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050757s011lbl.pdf","2005-04-28 00:00:00",
30469,1,50757,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf","2006-08-14 00:00:00",
8208,1,50757,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf","2006-08-14 00:00:00",
8209,1,50757,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s014ltr.pdf","2007-06-04 00:00:00",
8210,1,50757,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s015ltr.pdf","2007-11-08 00:00:00",
18189,2,50757,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050757s015lbl.pdf","2007-11-07 00:00:00",
8211,1,50757,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050757s016ltr.pdf","2009-04-03 00:00:00",
30470,1,50757,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050757Orig1s017ltr.pdf","2013-11-08 00:00:00",
39274,2,50757,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050757s017lbl.pdf","2013-11-08 00:00:00",
47392,2,50757,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf","2017-03-02 00:00:00",
47449,1,50757,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050757Orig1s018ltr.pdf","2017-03-03 00:00:00",
8212,1,50757,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050757Orig1s019ltr.pdf","2014-12-23 00:00:00",
39275,2,50757,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050757s019lbl.pdf","2014-12-22 00:00:00",
45650,1,50757,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050757Orig1s020ltr.pdf","2016-10-26 00:00:00",
45724,2,50757,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050757s020lbl.pdf","2016-10-31 00:00:00",
50530,2,50757,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s021lbl.pdf","2017-11-30 00:00:00",
50565,1,50757,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050757Orig1s021ltr.pdf","2017-12-01 00:00:00",
54535,2,50757,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050757s022lbl.pdf","2018-06-12 00:00:00",
54586,1,50757,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050757Orig1s022ltr.pdf","2018-06-14 00:00:00",
22226,3,50758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/505758.cfm","1998-08-12 00:00:00",
23727,10,50758,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44520,14,50758,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2012-09-27 00:00:00",
22227,3,50758,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm","2004-10-08 00:00:00",
22228,3,50758,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm","2000-07-28 00:00:00",
30471,1,50758,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF","2000-07-28 00:00:00",
39276,2,50758,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF","2000-07-28 00:00:00",
30472,1,50758,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf","2003-03-10 00:00:00",
39277,2,50758,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf","2003-02-28 00:00:00",
8213,1,50758,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050758s010ltr.pdf","2005-04-19 00:00:00",
39278,2,50758,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050758s010lbl.pdf","2005-04-19 00:00:00",
30473,1,50758,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf","2005-10-19 00:00:00",
39279,2,50758,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf","2005-10-19 00:00:00",
8214,1,50758,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf","2008-01-09 00:00:00",
39280,2,50758,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf","2007-12-27 00:00:00",
8215,1,50758,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf","2007-09-25 00:00:00",
18190,2,50758,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf","2007-09-26 00:00:00",
18191,2,50758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050758s016lbl.pdf","2008-05-16 00:00:00",
30474,1,50758,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf","2008-05-15 00:00:00",
8216,1,50758,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf","2008-12-24 00:00:00",
39281,2,50758,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf","2009-01-02 00:00:00",
30475,1,50758,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf","2009-03-05 00:00:00",
39282,2,50758,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf","2009-03-19 00:00:00",
18192,2,50758,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf","2009-06-24 00:00:00",
30476,1,50758,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf","2009-06-23 00:00:00",
30477,1,50758,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf","2012-09-27 00:00:00",
30478,1,50758,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf","2009-11-09 00:00:00",
39283,2,50758,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf","2009-10-14 00:00:00",
30479,1,50758,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf","2012-06-12 00:00:00",
39284,2,50758,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf","2012-06-18 00:00:00",
8217,1,50758,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf","2012-06-26 00:00:00",
39285,2,50758,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf","2012-06-26 00:00:00",
18193,2,50758,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
30480,1,50758,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
8218,1,50758,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
18194,2,50758,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf","2013-10-01 00:00:00",
18195,2,50758,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf","2015-07-13 00:00:00",
30481,1,50758,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf","2015-07-14 00:00:00",
30482,1,50758,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf","2015-11-19 00:00:00",
55287,2,50758,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf","2018-08-24 00:00:00",
55290,8,50758,"SUPPL",33,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39","2018-08-24 00:00:00",
55307,1,50758,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050722Orig1s035,050723Orig1s035,050758Orig1s033,050759Orig1s041Ltr.pdf","2018-08-24 00:00:00",
50764,2,50758,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf","2017-12-19 00:00:00",
50873,1,50758,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050722Orig1s037, 050723Orig1s037, 050758Orig1s034, 050759Orig1s042ltr.pdf","2017-12-27 00:00:00",
8219,1,50759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50759ltr.pdf","1998-10-01 00:00:00",
24039,14,50759,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2012-09-27 00:00:00",
42721,3,50759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050759_s000_CellCeptTOC.cfm","2005-07-11 00:00:00",
44206,10,50759,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
22229,3,50759,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm","2004-10-08 00:00:00",
18196,2,50759,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf","2000-12-22 00:00:00",
30483,1,50759,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf","2000-12-22 00:00:00",
42722,3,50759,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm","2000-12-22 00:00:00",
8220,1,50759,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF","2000-07-28 00:00:00",
18197,2,50759,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF","2000-07-28 00:00:00",
42723,3,50759,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm","2000-07-28 00:00:00",
8221,1,50759,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf","2003-03-10 00:00:00",
39286,2,50759,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf","2003-02-28 00:00:00",
30484,1,50759,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf","2005-10-19 00:00:00",
39287,2,50759,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf","2005-10-19 00:00:00",
18198,2,50759,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf","2007-12-27 00:00:00",
30485,1,50759,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf","2008-01-09 00:00:00",
30486,1,50759,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf","2007-09-25 00:00:00",
39288,2,50759,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf","2007-09-26 00:00:00",
8222,1,50759,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf","2008-05-15 00:00:00",
39289,2,50759,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050759s021lbl.pdf","2008-05-16 00:00:00",
30487,1,50759,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf","2008-12-24 00:00:00",
39290,2,50759,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf","2009-01-02 00:00:00",
8223,1,50759,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf","2009-03-05 00:00:00",
18199,2,50759,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf","2009-03-19 00:00:00",
8224,1,50759,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf","2009-06-23 00:00:00",
39291,2,50759,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf","2009-06-24 00:00:00",
8225,1,50759,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf","2012-09-27 00:00:00",
30488,1,50759,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf","2009-11-09 00:00:00",
39292,2,50759,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf","2009-10-14 00:00:00",
8226,1,50759,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf","2012-06-12 00:00:00",
18200,2,50759,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf","2012-06-18 00:00:00",
18201,2,50759,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf","2012-06-26 00:00:00",
30489,1,50759,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf","2012-06-26 00:00:00",
8227,1,50759,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
30490,1,50759,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf","2013-10-01 00:00:00",
8228,1,50759,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf","2015-07-14 00:00:00",
39293,2,50759,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf","2015-07-13 00:00:00",
30491,1,50759,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf","2015-11-19 00:00:00",
55288,2,50759,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf","2018-08-24 00:00:00",
55289,8,50759,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39","2018-08-24 00:00:00",
55308,1,50759,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050722Orig1s035,050723Orig1s035,050758Orig1s033,050759Orig1s041Ltr.pdf","2018-08-24 00:00:00",
50765,2,50759,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf","2017-12-19 00:00:00",
50874,1,50759,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050722Orig1s037, 050723Orig1s037, 050758Orig1s034, 050759Orig1s042ltr.pdf","2017-12-27 00:00:00",
18202,2,50760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50760lbl.pdf","1999-04-15 00:00:00",
30492,1,50760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50760ltr.pdf","1999-04-15 00:00:00",
42724,3,50760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050760_s000_AmoxilTOC.cfm","2005-07-11 00:00:00",
42725,3,50760,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm","2004-09-09 00:00:00",
30493,1,50760,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf","2003-06-08 00:00:00",
30494,1,50760,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf","2003-12-22 00:00:00",
30495,1,50760,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf","2004-07-21 00:00:00",
30496,1,50760,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009ltr.pdf","2006-01-30 00:00:00",
39294,2,50760,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050761s009_050760s009lbl.pdf","2006-01-27 00:00:00",
8229,1,50760,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf","2008-06-13 00:00:00",
18203,2,50760,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf","2008-06-12 00:00:00",
8230,1,50760,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf","2008-04-02 00:00:00",
39295,2,50760,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf","2008-04-01 00:00:00",
30497,1,50760,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
39296,2,50760,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8231,1,50760,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18204,2,50760,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
30498,1,50760,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
39297,2,50760,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8232,1,50760,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf","2015-09-28 00:00:00",
18205,2,50760,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf","2015-09-29 00:00:00",
8233,1,50760,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf","2015-12-08 00:00:00",
39298,2,50760,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf","2015-12-08 00:00:00",
8234,1,50761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50761ltr.pdf","2004-05-27 00:00:00",
39299,2,50761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50761lbl.pdf","2004-05-27 00:00:00",
42726,3,50761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050761_s000_AmoxilTOC.cfm","2005-08-02 00:00:00",
42727,3,50761,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm","2004-09-09 00:00:00",
8235,1,50761,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf","2003-06-08 00:00:00",
8236,1,50761,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf","2003-12-22 00:00:00",
8237,1,50761,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf","2004-07-21 00:00:00",
8238,1,50761,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009ltr.pdf","2006-01-30 00:00:00",
18206,2,50761,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050761s009_050760s009lbl.pdf","2006-01-27 00:00:00",
30499,1,50761,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf","2008-06-13 00:00:00",
39300,2,50761,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf","2008-06-12 00:00:00",
18207,2,50761,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf","2008-04-01 00:00:00",
30500,1,50761,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf","2008-04-02 00:00:00",
8239,1,50761,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18208,2,50761,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8240,1,50761,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18209,2,50761,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8241,1,50761,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf","2011-11-21 00:00:00",
18210,2,50761,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf","2011-11-21 00:00:00",
8242,1,50761,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf","2015-09-28 00:00:00",
18211,2,50761,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf","2015-09-29 00:00:00",
18212,2,50761,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf","2015-12-08 00:00:00",
30501,1,50761,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf","2015-12-08 00:00:00",
8243,1,50762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050762a_appltr_prntlbl.pdf","1998-12-28 00:00:00",
39301,2,50762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50-762.pdf","1998-12-18 00:00:00",
42728,3,50762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050762.cfm","1999-07-04 00:00:00",
30502,1,50763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050763s000ltr.pdf","2007-01-08 00:00:00",
39302,2,50763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50763_Mitozytrex_lbl.pdf","2002-11-14 00:00:00",
42729,3,50763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050763_mytozytrex.cfm","2003-06-26 00:00:00",
18213,2,50767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50767lbl.pdf","1999-08-13 00:00:00",
30503,1,50767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50767ltr.pdf","1999-08-13 00:00:00",
42730,3,50767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50767_Cleocin.cfm","1999-08-13 00:00:00",
18214,2,50767,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050767s010lbl.pdf","2013-06-26 00:00:00",
30504,1,50767,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050767Orig1s010ltr.pdf","2013-06-20 00:00:00",
8244,1,50767,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf","2014-05-12 00:00:00",
18215,2,50767,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf","2014-05-12 00:00:00",
8245,1,50767,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf","2015-07-15 00:00:00",
39303,2,50767,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf","2015-07-16 00:00:00",
49707,2,50767,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf","2017-09-11 00:00:00",
49748,1,50767,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050680Orig1s013,050767Orig1s014ltr.pdf","2017-09-15 00:00:00",
22230,3,50769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-769_Benamycin.cfm","2004-02-04 00:00:00",
45468,1,50769,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050769Orig1s017ltr.pdf","2016-10-04 00:00:00",
47282,2,50769,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf","2017-02-22 00:00:00",
8246,1,50775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50775ltr.pdf","2000-03-03 00:00:00",
8247,1,50775,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50775s1ltr.pdf","2001-08-03 00:00:00",
22231,3,50775,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50775S1_Biaxin.cfm","2001-11-23 00:00:00",
39304,2,50775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50775lbl.pdf","2000-03-03 00:00:00",
39305,2,50775,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50775s1lbl.pdf","2001-08-03 00:00:00",
42731,3,50775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50755_BiaxinXL.cfm","2001-10-11 00:00:00",
44207,10,50775,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
8248,1,50775,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50775slr004ltr.pdf","2003-04-18 00:00:00",
22232,3,50775,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-775s004_BiaxinXL.cfm","2004-06-29 00:00:00",
8249,1,50775,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf","2004-07-21 00:00:00",
30505,1,50775,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf","2005-10-20 00:00:00",
39306,2,50775,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf","2005-10-10 00:00:00",
30506,1,50775,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf","2006-07-13 00:00:00",
8250,1,50775,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf","2008-01-09 00:00:00",
39307,2,50775,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf","2007-12-27 00:00:00",
30507,1,50775,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf","2008-05-29 00:00:00",
8251,1,50775,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf","2009-11-20 00:00:00",
18216,2,50775,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf","2009-09-22 00:00:00",
8252,1,50775,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
18217,2,50775,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
8253,1,50775,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
39308,2,50775,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
8254,1,50775,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf","2011-05-31 00:00:00",
39309,2,50775,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf","2011-05-31 00:00:00",
8255,1,50775,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf","2012-06-05 00:00:00",
18218,2,50775,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf","2012-07-10 00:00:00",
30508,1,50775,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf","2012-07-10 00:00:00",
18219,2,50775,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf","2012-05-07 00:00:00",
30509,1,50775,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf","2012-05-09 00:00:00",
8256,1,50775,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
18220,2,50775,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf","2013-09-09 00:00:00",
8257,1,50775,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf","2013-09-11 00:00:00",
18221,2,50775,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf","2013-09-24 00:00:00",
18222,2,50775,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf","2016-06-01 00:00:00",
30510,1,50775,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf","2016-05-31 00:00:00",
8258,1,50775,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf","2014-07-28 00:00:00",
18223,2,50775,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf","2014-08-07 00:00:00",
18224,2,50775,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf","2015-01-12 00:00:00",
30511,1,50775,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf","2015-01-09 00:00:00",
18225,2,50775,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf","2015-10-29 00:00:00",
30512,1,50775,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf","2015-10-28 00:00:00",
48693,2,50775,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf","2017-06-12 00:00:00",
48705,1,50775,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050662Orig1s058,050698Orig1s038,050775Orig1s026ltr.pdf","2017-06-12 00:00:00",
18226,2,50777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50777lbl.pdf","2003-04-07 00:00:00",
22233,3,50777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50777_protopic.cfm","2003-04-22 00:00:00",
23728,10,50777,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107845.htm","2005-04-15 00:00:00",
30513,1,50777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50777ltr.pdf","2003-04-09 00:00:00",
8259,1,50777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scp004ltr.pdf","2003-05-29 00:00:00",
18227,2,50777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scp004_protopic_lbl.pdf","2003-05-29 00:00:00",
8260,1,50777,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scs006ltr.pdf","2003-12-24 00:00:00",
39310,2,50777,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scs006_protopic_lbl.pdf","2003-12-29 00:00:00",
30514,1,50777,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050777s010ltr.pdf","2005-07-15 00:00:00",
30515,1,50777,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05077s012ltr.pdf","2006-01-30 00:00:00",
39311,2,50777,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050777s012lbl.pdf","2006-01-19 00:00:00",
43890,8,50777,"SUPPL",12,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf","2006-01-19 00:00:00",
8261,1,50777,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050777s014ltr.pdf","2009-01-06 00:00:00",
30516,1,50777,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050777s018ltr.pdf","2011-11-08 00:00:00",
39312,2,50777,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf","2011-11-17 00:00:00",
22234,3,50778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-778_Ellence.cfm","2004-06-03 00:00:00",
30517,1,50778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50778ltr.pdf","1999-09-15 00:00:00",
39313,2,50778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf","1999-09-15 00:00:00",
8262,1,50778,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf","2003-04-18 00:00:00",
30518,1,50778,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf","2003-04-18 00:00:00",
8263,1,50778,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50778s008ltr.pdf","2005-03-10 00:00:00",
39314,2,50778,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf","2005-03-10 00:00:00",
30519,1,50778,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf","2011-09-19 00:00:00",
39315,2,50778,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf","2011-09-16 00:00:00",
8264,1,50778,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf","2011-09-19 00:00:00",
39316,2,50778,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf","2011-09-16 00:00:00",
30520,1,50778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf","2011-09-19 00:00:00",
39317,2,50778,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf","2011-09-16 00:00:00",
8265,1,50778,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050778Orig1s019ltr.pdf","2013-02-21 00:00:00",
18228,2,50778,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf","2013-02-21 00:00:00",
8266,1,50778,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050778Orig1s021ltr.pdf","2014-12-16 00:00:00",
18229,2,50778,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf","2014-12-16 00:00:00",
8267,1,50779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50779ltr.pdf","2000-08-04 00:00:00",
18230,2,50779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf","2000-08-04 00:00:00",
22235,3,50779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50779_Cefazolin.cfm","2000-08-04 00:00:00",
8268,1,50779,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50779slr005ltr.pdf","2004-07-01 00:00:00",
39318,2,50779,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50779slr005_cefazolin_lbl.pdf","2004-07-01 00:00:00",
30521,1,50779,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050779s006ltr.pdf","2005-05-17 00:00:00",
8269,1,50779,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050779s011ltr.pdf","2008-11-07 00:00:00",
8270,1,50779,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050779s013ltr.pdf","2007-09-11 00:00:00",
39319,2,50779,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050779s013lbl.pdf","2007-09-11 00:00:00",
42732,3,50779,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050779s013ltr.pdf","2007-09-24 00:00:00",
18231,2,50779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf","2012-01-26 00:00:00",
30522,1,50779,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s018ltr.pdf","2012-01-18 00:00:00",
30523,1,50779,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s019ltr.pdf","2012-04-25 00:00:00",
39320,2,50779,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s019lbl.pdf","2012-04-23 00:00:00",
30524,1,50779,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050779Orig1s023ltr.pdf","2014-09-23 00:00:00",
30525,1,50779,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050779Orig1s025ltr.pdf","2015-10-13 00:00:00",
39321,2,50779,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050779s025lbl.pdf","2015-10-15 00:00:00",
8271,1,50780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_approv.pdf","2001-02-21 00:00:00",
18232,2,50780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf","2001-02-21 00:00:00",
42733,3,50780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime.cfm","2001-02-21 00:00:00",
8272,1,50780,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf","2003-08-29 00:00:00",
30526,1,50780,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf","2004-07-01 00:00:00",
30527,1,50780,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf","2005-05-17 00:00:00",
8273,1,50780,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf","2007-09-11 00:00:00",
18233,2,50780,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf","2007-09-11 00:00:00",
30528,1,50780,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf","2015-05-04 00:00:00",
39322,2,50780,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050780s019lbl.pdf","2015-05-04 00:00:00",
18234,2,50781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf","2003-05-02 00:00:00",
22236,3,50781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50781_Arestin.cfm","2003-03-07 00:00:00",
8274,1,50781,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050781s012ltr.pdf","2008-02-20 00:00:00",
39323,2,50781,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050781s012lbl.pdf","2008-02-25 00:00:00",
8275,1,50781,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050781Orig1s019ltr.pdf","2012-07-31 00:00:00",
39324,2,50781,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050781s019lbl.pdf","2012-07-31 00:00:00",
48327,2,50781,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050781s020lbl.pdf","2017-05-09 00:00:00",
48347,1,50781,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050781Orig1s020ltr.pdf","2017-05-10 00:00:00",
22237,3,50782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-782_Clindagel.cfm","2004-07-15 00:00:00",
30529,1,50782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50782LTR-LBL.PDF","2000-11-27 00:00:00",
39325,2,50782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf","2003-05-02 00:00:00",
8276,1,50783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50783ltr.pdf","2001-02-02 00:00:00",
18235,2,50783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50783LBL.pdf","2001-02-02 00:00:00",
22238,3,50783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-783_Periostat.cfm","2001-02-02 00:00:00",
8277,1,50783,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50783slr002ltr.pdf","2004-04-07 00:00:00",
39326,2,50783,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50783slr002_periostat_lbl.pdf","2004-04-05 00:00:00",
8278,1,50784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784ltr.pdf","2002-05-24 00:00:00",
39327,2,50784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax_prntlbl.pdf","2002-05-24 00:00:00",
42734,3,50784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax.cfm","2002-05-24 00:00:00",
44208,10,50784,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
8279,1,50784,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784slr002ltr.pdf","2002-10-16 00:00:00",
30530,1,50784,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf","2004-01-22 00:00:00",
39328,2,50784,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf","2004-01-22 00:00:00",
42735,3,50784,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm","2007-06-11 00:00:00",
8280,1,50784,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf","2003-12-22 00:00:00",
30531,1,50784,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf","2004-01-22 00:00:00",
39329,2,50784,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf","2004-01-22 00:00:00",
42736,3,50784,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm","2007-06-11 00:00:00",
8281,1,50784,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf","2007-11-08 00:00:00",
39330,2,50784,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf","2007-11-07 00:00:00",
18236,2,50784,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf","2009-04-03 00:00:00",
30532,1,50784,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf","2009-03-03 00:00:00",
18237,2,50784,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf","2010-08-19 00:00:00",
30533,1,50784,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf","2010-08-17 00:00:00",
8282,1,50784,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf","2011-02-03 00:00:00",
18238,2,50784,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf","2011-02-04 00:00:00",
18239,2,50784,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf","2012-11-06 00:00:00",
30534,1,50784,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf","2012-11-06 00:00:00",
18240,2,50784,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf","2014-06-10 00:00:00",
30535,1,50784,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf","2014-06-11 00:00:00",
8283,1,50784,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf","2012-06-08 00:00:00",
18241,2,50784,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf","2012-06-11 00:00:00",
30536,1,50784,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf","2013-02-21 00:00:00",
39331,2,50784,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf","2013-02-21 00:00:00",
30537,1,50784,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf","2016-05-25 00:00:00",
39332,2,50784,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf","2016-05-25 00:00:00",
47174,2,50784,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf","2017-02-13 00:00:00",
47190,1,50784,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050710Orig1s044,050711Orig1s041,050784Orig1s028ltr.pdf","2017-02-13 00:00:00",
47796,2,50784,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf","2017-03-31 00:00:00",
47833,1,50784,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf","2017-04-03 00:00:00",
18242,2,50785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf","2002-09-25 00:00:00",
30538,1,50785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50785ltr.pdf","2002-09-25 00:00:00",
42737,3,50785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50785_AugmentinXR.cfm","2003-07-06 00:00:00",
53174,20,50785,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50785_amoxicillin_clinical_PREA.pdf","1900-01-01 00:00:00",
53175,18,50785,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50785_amoxicillin_clinpharm_PREA.pdf","1900-01-01 00:00:00",
8284,1,50785,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785slr002ltr.pdf","2003-06-08 00:00:00",
30539,1,50785,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785scs003ltr.pdf","2003-06-08 00:00:00",
8285,1,50785,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785slr004ltr.pdf","2004-05-26 00:00:00",
8286,1,50785,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785s005ltr.pdf","2004-09-17 00:00:00",
18243,2,50785,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf","2005-06-21 00:00:00",
30540,1,50785,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050785s006ltr.pdf","2005-06-21 00:00:00",
8287,1,50785,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s007ltr.pdf","2008-12-19 00:00:00",
18244,2,50785,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf","2009-01-02 00:00:00",
30541,1,50785,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s008ltr.pdf","2008-04-22 00:00:00",
8288,1,50785,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf","2011-08-31 00:00:00",
39333,2,50785,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf","2011-08-30 00:00:00",
39334,2,50785,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf","2010-09-10 00:00:00",
18245,2,50785,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf","2010-09-10 00:00:00",
30542,1,50785,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050785s011,s012ltr.pdf","2010-09-09 00:00:00",
8289,1,50785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050785Orig1s014ltr.pdf","2013-11-29 00:00:00",
18246,2,50785,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf","2013-12-03 00:00:00",
8290,1,50785,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050785s015ltr.pdf","2014-04-07 00:00:00",
18247,2,50785,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf","2014-04-08 00:00:00",
18248,2,50786,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf","2007-05-29 00:00:00",
30543,1,50786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050786s000LTR.pdf","2006-10-02 00:00:00",
30544,1,50786,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050786s001ltr.pdf","2007-05-29 00:00:00",
42738,3,50786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050786s000_PyleraTOC.cfm","2006-11-22 00:00:00",
8291,1,50786,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050786s003ltr.pdf","2011-01-24 00:00:00",
30545,1,50786,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050786Orig1s007ltr.pdf","2013-01-25 00:00:00",
39335,2,50786,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050786s007lbl.pdf","2013-01-24 00:00:00",
46974,2,50786,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s012lbl.pdf","2017-01-25 00:00:00",
46998,1,50786,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050786Orig1s012ltr.pdf","2017-01-27 00:00:00",
48615,2,50786,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s016lbl.pdf","2017-06-01 00:00:00",
48637,1,50786,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050786Orig1s016ltr.pdf","2017-06-02 00:00:00",
52095,1,50786,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050786Orig1s017ltr.pdf","2018-01-30 00:00:00",
52426,2,50786,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s017lbl.pdf","2018-02-06 00:00:00",
55858,2,50786,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s019lbl.pdf","2018-10-10 00:00:00",
8292,1,50788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50788ltr.pdf","2002-12-04 00:00:00",
18249,2,50788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50788_Mupirocin_lbl.pdf","2002-12-04 00:00:00",
22239,3,50788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050788_mupirocin.cfm","2003-04-30 00:00:00",
18250,2,50788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050788s005lbl.pdf","2015-06-22 00:00:00",
30546,1,50788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050788Orig1s005ltr.pdf","2015-06-22 00:00:00",
30547,1,50789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50789ltr.pdf","2004-07-21 00:00:00",
39336,2,50789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf","2004-07-21 00:00:00",
42739,3,50789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050789s000_TobramycinTOC.cfm","2006-10-25 00:00:00",
39337,2,50789,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf","2009-09-22 00:00:00",
8293,1,50789,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050789s027ltr.pdf","2009-11-27 00:00:00",
8294,1,50790,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790slr001ltr.pdf","2003-09-25 00:00:00",
18251,2,50790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf","2003-09-08 00:00:00",
18252,2,50790,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.pdf","2003-09-26 00:00:00",
30548,1,50790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf","2003-09-08 00:00:00",
42740,3,50790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-023_Restasis.cfm","2005-04-14 00:00:00",
22240,3,50790,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050790_S002_RestasisTOC.cfm","2007-06-11 00:00:00",
8295,1,50790,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf","2003-10-01 00:00:00",
30549,1,50790,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf","2003-10-01 00:00:00",
8296,1,50790,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050790Orig1s020ltr.pdf","2012-12-05 00:00:00",
39338,2,50790,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf","2012-12-04 00:00:00",
18253,2,50790,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf","2013-06-04 00:00:00",
46103,2,50790,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf","2016-12-09 00:00:00",
46102,2,50790,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf","2016-12-09 00:00:00",
49018,2,50790,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf","2017-07-19 00:00:00",
49033,1,50790,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050790Orig1s027ltr.pdf","2017-07-21 00:00:00",
22241,3,50791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-791_Myfortic.cfm","2005-04-27 00:00:00",
23425,8,50791,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf","2009-10-16 00:00:00",
24040,14,50791,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2012-09-27 00:00:00",
30550,1,50791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50791ltr.pdf","2004-03-03 00:00:00",
30551,1,50791,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050791s001ltr.pdf","2007-11-08 00:00:00",
39339,2,50791,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050791s001lbl.pdf","2007-11-07 00:00:00",
44209,10,50791,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
18254,2,50791,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s002lbl.pdf","2008-05-16 00:00:00",
30552,1,50791,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s002ltr.pdf","2008-05-14 00:00:00",
18255,2,50791,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s004lbl.pdf","2009-01-02 00:00:00",
30553,1,50791,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s004ltr.pdf","2008-12-19 00:00:00",
30554,1,50791,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791Orig1s005ltr.pdf","2012-09-27 00:00:00",
30555,1,50791,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s006ltr.pdf","2009-04-01 00:00:00",
18256,2,50791,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf","2009-07-14 00:00:00",
30556,1,50791,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s007ltr.pdf","2009-07-17 00:00:00",
18257,2,50791,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s008lbl.pdf","2009-10-14 00:00:00",
30557,1,50791,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s008ltr.pdf","2009-11-09 00:00:00",
18258,2,50791,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050791s011lbl.pdf","2010-10-28 00:00:00",
30558,1,50791,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050791s011ltr.pdf","2010-11-03 00:00:00",
30559,1,50791,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s012ltr_corrected.pdf","2013-05-07 00:00:00",
39340,2,50791,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s012lbl.pdf","2013-05-09 00:00:00",
18259,2,50791,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf","2012-06-26 00:00:00",
30560,1,50791,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791s014ltr.pdf","2012-06-26 00:00:00",
18260,2,50791,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf","2013-09-30 00:00:00",
30561,1,50791,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf","2013-10-01 00:00:00",
8297,1,50791,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf","2013-10-01 00:00:00",
18261,2,50791,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s019lbl.pdf","2013-09-30 00:00:00",
8298,1,50791,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s021ltr.pdf","2015-08-12 00:00:00",
30562,1,50791,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s022ltr.pdf","2015-11-16 00:00:00",
8299,1,50791,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s024ltr.pdf","2015-10-29 00:00:00",
39341,2,50791,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf","2015-10-29 00:00:00",
18262,2,50792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf","2004-08-02 00:00:00",
22242,3,50792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050792s000_Duplex_ContainerTOC.cfm","2006-07-28 00:00:00",
30563,1,50792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50792ltr.pdf","2004-08-02 00:00:00",
8300,1,50792,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050792s002ltr.pdf","2007-09-11 00:00:00",
18263,2,50792,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050792s002lbl.pdf","2007-09-11 00:00:00",
18264,2,50793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf","2004-12-03 00:00:00",
30564,1,50793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050793ltr.pdf","2004-12-06 00:00:00",
42741,3,50793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050793s000_ClinesseTOC.cfm","2006-09-26 00:00:00",
30565,1,50793,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf","2010-12-21 00:00:00",
39342,2,50793,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf","2010-12-16 00:00:00",
8301,1,50793,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050793s015ltr.pdf","2012-02-23 00:00:00",
39343,2,50793,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf","2012-02-17 00:00:00",
18265,2,50794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050794lbl.pdf","2004-05-19 00:00:00",
22243,3,50794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-794_Vidaza.cfm","2004-08-05 00:00:00",
30566,1,50794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50794ltr.pdf","2004-05-26 00:00:00",
30567,1,50794,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050794s001ltr.pdf","2005-07-08 00:00:00",
39344,2,50794,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050794s005lbl.pdf","2007-02-02 00:00:00",
30568,1,50794,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s010ltr.pdf","2008-02-25 00:00:00",
8302,1,50794,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s011ltr.pdf","2008-08-22 00:00:00",
39345,2,50794,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050794s011lbl.pdf","2008-08-26 00:00:00",
18266,2,50794,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf","2011-08-24 00:00:00",
30569,1,50794,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf","2011-08-22 00:00:00",
8303,1,50794,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf","2011-08-22 00:00:00",
39346,2,50794,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf","2011-08-24 00:00:00",
30570,1,50794,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050794s023ltr.pdf","2012-01-27 00:00:00",
39347,2,50794,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s023LBL.pdf","2012-01-25 00:00:00",
39348,2,50794,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s024lbl.pdf","2012-12-21 00:00:00",
8304,1,50794,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050794Orig1s026ltr.pdf","2014-01-14 00:00:00",
18267,2,50794,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050794s026lbledt.pdf","2014-01-13 00:00:00",
30571,1,50794,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050794Orig1s028ltr.pdf","2015-12-18 00:00:00",
39349,2,50794,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050794s028lbl.pdf","2015-12-24 00:00:00",
45198,2,50794,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050794s029lbl.pdf","2016-08-23 00:00:00",
45199,1,50794,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050794Orig1s029ltr.pdf","2016-08-23 00:00:00",
54973,1,50794,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050794Orig1s031ltr.pdf","2018-07-25 00:00:00",
55071,2,50794,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050794s031lbl.pdf","2018-08-02 00:00:00",
8305,1,50795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050795ltr.pdf","2005-05-17 00:00:00",
39350,2,50795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050795lbl.pdf","2005-05-17 00:00:00",
42742,3,50795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050795s000_DoryxTOC.cfm","2006-04-21 00:00:00",
30572,1,50795,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050795s002ltr.pdf","2006-12-28 00:00:00",
39351,2,50795,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050795s002lbl.pdf","2006-12-26 00:00:00",
18268,2,50795,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050795s003lbl.pdf","2007-12-27 00:00:00",
30573,1,50795,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050795s003ltr.pdf","2008-01-09 00:00:00",
18269,2,50795,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf","2008-06-26 00:00:00",
30574,1,50795,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050795s005ltr.pdf","2008-06-24 00:00:00",
18270,2,50795,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050795s010lbl.pdf","2013-04-16 00:00:00",
30575,1,50795,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050795Orig1s010ltr.pdf","2013-04-16 00:00:00",
52622,18,50795,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycyclene clinpharm prea.pdf","1900-01-01 00:00:00",
52623,17,50795,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycycline statistical prea.pdf","1900-01-01 00:00:00",
53534,20,50795,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycycline clinical prea.pdf","1900-01-01 00:00:00",
8306,1,50795,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf","2011-03-24 00:00:00",
18271,2,50795,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s013lbl.pdf","2011-03-28 00:00:00",
18272,2,50795,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s014lbl.pdf","2011-09-16 00:00:00",
8307,1,50795,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s018ltr.pdf","2015-06-10 00:00:00",
39352,2,50795,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795s018lbl.pdf","2015-06-10 00:00:00",
18273,2,50795,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf","2016-04-01 00:00:00",
22244,3,50795,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/050795Orig1s019.pdf","2015-11-18 00:00:00",
30576,1,50795,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050795Orig1s019ltr.pdf","2016-04-01 00:00:00",
18274,2,50795,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795Orig1s020lbl.pdf","2015-03-12 00:00:00",
30577,1,50795,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s020ltr.pdf","2015-03-06 00:00:00",
30578,1,50795,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s021ltr.pdf","2016-05-20 00:00:00",
39353,2,50795,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf","2016-05-20 00:00:00",
30579,1,50795,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s022ltr.pdf","2016-05-24 00:00:00",
39354,2,50795,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s022lbl.pdf","2016-05-23 00:00:00",
48619,2,50795,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050795s024lbl.pdf","2017-06-01 00:00:00",
48641,1,50795,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050795Orig1s024ltr.pdf","2017-06-05 00:00:00",
52505,2,50795,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050795s026lbl.pdf","2018-02-08 00:00:00",
52510,1,50795,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050795Orig1s026ltr.pdf","2018-02-08 00:00:00",
8308,1,50796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050796ltr.pdf","2005-04-28 00:00:00",
18275,2,50796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf","2005-04-28 00:00:00",
42743,3,50796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050796s000TOC.cfm","2007-07-02 00:00:00",
8309,1,50796,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050796s004ltr.pdf","2007-09-11 00:00:00",
39355,2,50796,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf","2007-09-11 00:00:00",
8310,1,50796,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf","2008-12-19 00:00:00",
30580,1,50796,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf","2008-12-19 00:00:00",
30581,1,50796,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050796s011ltr(2).pdf","2012-02-07 00:00:00",
39356,2,50796,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf","2012-02-07 00:00:00",
8311,1,50796,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050796s012ltr.pdf","2010-06-30 00:00:00",
39357,2,50796,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf","2010-07-01 00:00:00",
30582,1,50796,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Origs014ltr.pdf","2013-03-13 00:00:00",
39358,2,50796,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf","2013-03-11 00:00:00",
8312,1,50796,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Orig1s017ltr.pdf","2013-04-16 00:00:00",
18276,2,50796,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf","2013-04-16 00:00:00",
8313,1,50796,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050796Orig1s019ltr.pdf","2015-07-13 00:00:00",
18277,2,50796,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050796s019lbl.pdf","2015-07-10 00:00:00",
8314,1,50797,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050797s001ltr.pdf","2007-11-08 00:00:00",
18278,2,50797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf","2005-06-14 00:00:00",
30583,1,50797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050797ltr.pdf","2005-06-14 00:00:00",
39359,2,50797,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf","2007-11-07 00:00:00",
42744,3,50797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050797s000TOC.cfm","2007-09-10 00:00:00",
44210,10,50797,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm","2013-03-12 00:00:00",
8315,1,50797,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050797s008ltr.pdf","2008-10-09 00:00:00",
18279,2,50797,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf","2008-10-09 00:00:00",
53181,20,50797,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050797s008_Azithromycin_Clinical_PREA.pdf","1900-01-01 00:00:00",
53182,18,50797,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050797s008_Azithromycin_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
8316,1,50797,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf","2011-06-10 00:00:00",
18280,2,50797,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf","2011-09-20 00:00:00",
18281,2,50797,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf","2011-09-20 00:00:00",
30584,1,50797,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf","2011-06-10 00:00:00",
30585,1,50797,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s013ltr.pdf","2013-10-15 00:00:00",
39360,2,50797,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf","2013-10-17 00:00:00",
30586,1,50797,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf","2011-06-10 00:00:00",
39361,2,50797,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf","2011-09-20 00:00:00",
18282,2,50797,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf","2012-03-06 00:00:00",
30587,1,50797,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050797s016ltr.pdf","2012-03-05 00:00:00",
18283,2,50797,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf","2013-02-21 00:00:00",
30588,1,50797,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s017ltr.pdf","2013-02-21 00:00:00",
8317,1,50797,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050797Orig1s019ltr.pdf","2015-07-10 00:00:00",
39362,2,50797,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf","2015-07-06 00:00:00",
8318,1,50797,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050797Orig1s020ltr.pdf","2016-05-26 00:00:00",
39363,2,50797,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf","2016-05-25 00:00:00",
47170,2,50797,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s021lbl.pdf","2017-02-10 00:00:00",
47186,1,50797,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s021ltr.pdf","2017-02-13 00:00:00",
47795,2,50797,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s024lbl.pdf","2017-03-31 00:00:00",
47840,1,50797,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s024ltr.pdf","2017-04-03 00:00:00",
30589,1,50801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709ltr.pdf","2004-10-22 00:00:00",
39364,2,50801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf","2004-10-22 00:00:00",
42745,3,50801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050801s000_EvoclinTOC.cfm","2006-10-25 00:00:00",
44521,14,50801,"ORIG",1,"Application Number Change Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709to50801_Num_Change_ltr.pdf","2004-11-17 00:00:00",
8319,1,50801,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050801s006LTR.pdf","2006-07-13 00:00:00",
39365,2,50801,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf","2006-07-13 00:00:00",
8320,1,50801,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050801s011ltr.pdf","2010-12-22 00:00:00",
18284,2,50801,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf","2010-12-20 00:00:00",
8321,1,50801,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050801s015ltr.pdf","2012-01-25 00:00:00",
39366,2,50801,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf","2012-01-24 00:00:00",
53705,2,50801,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf","2018-04-17 00:00:00",
53755,1,50801,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050801Orig1s018ltr.pdf","2018-04-20 00:00:00",
18285,2,50802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050802lbl.pdf","2006-11-09 00:00:00",
30590,1,50802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050802s000ltr.pdf","2006-11-13 00:00:00",
42746,3,50802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050802_ziana_toc.cfm","2008-11-25 00:00:00",
8322,1,50803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050803s000ltr.pdf","2010-07-20 00:00:00",
39367,2,50803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf","2010-07-22 00:00:00",
42747,3,50803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803s000_veltin_toc.cfm","2011-01-28 00:00:00",
44787,21,50803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803Orig1s000SumR.pdf","2011-01-28 00:00:00",
8323,1,50804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050804ltr.pdf","2004-12-30 00:00:00",
18286,2,50804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf","2004-12-30 00:00:00",
42748,3,50804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50804_ZyletTOC.cfm","2005-06-23 00:00:00",
8324,1,50804,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050804s015ltr.pdf","2010-06-08 00:00:00",
39368,2,50804,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050804s015lbl.pdf","2010-06-07 00:00:00",
18287,2,50804,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf","2012-10-04 00:00:00",
30591,1,50804,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050804Orig1s017ltr.pdf","2012-10-04 00:00:00",
18288,2,50804,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf","2013-02-08 00:00:00",
30592,1,50804,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050804Orig1s018ltr.pdf","2013-02-08 00:00:00",
52314,23,50804,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50804_loteprednol_Original_WR.pdf","2010-12-28 00:00:00",
52315,25,50804,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50804_loteprednol_Amendment_1.pdf","2010-12-28 00:00:00",
53038,20,50804,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50804 lo-tob clinical Prea.pdf","1900-01-01 00:00:00",
53039,20,50804,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50804 .lo-tob clinical2 prea.pdf","1900-01-01 00:00:00",
8325,1,50805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050805s000LTR.pdf","2006-05-30 00:00:00",
39369,2,50805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf","2006-05-30 00:00:00",
42749,3,50805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000TOC.cfm","2008-02-22 00:00:00",
30593,1,50805,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050805s002ltr.pdf","2010-05-17 00:00:00",
39370,2,50805,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf","2010-05-17 00:00:00",
8326,1,50805,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050805Orig1s007ltr.pdf","2012-11-08 00:00:00",
39371,2,50805,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf","2012-11-08 00:00:00",
8327,1,50805,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050805Orig1s008ltr.pdf","2013-07-29 00:00:00",
39372,2,50805,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf","2013-07-30 00:00:00",
18289,2,50807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050807lbl.pdf","2006-09-18 00:00:00",
24346,21,50807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050807s000_SumR.pdf","2008-10-01 00:00:00",
30594,1,50807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050807ltr.pdf","2006-09-20 00:00:00",
42750,3,50807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050807s000TOC.cfm","2008-10-01 00:00:00",
22245,3,50808,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050808s000TOC.cfm","2007-06-29 00:00:00",
30595,1,50808,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050808s000ltr.pdf","2006-05-16 00:00:00",
39373,2,50808,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf","2006-05-16 00:00:00",
8328,1,50808,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s007ltr.pdf","2009-07-31 00:00:00",
18290,2,50808,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf","2009-07-30 00:00:00",
18291,2,50808,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf","2010-01-12 00:00:00",
30596,1,50808,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s011ltr.pdf","2010-01-05 00:00:00",
39374,2,50808,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf","2010-12-16 00:00:00",
8329,1,50808,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s014ltr.pdf","2011-03-25 00:00:00",
18292,2,50808,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf","2011-03-18 00:00:00",
22246,3,50808,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050808Orig1s014.pdf","2012-03-27 00:00:00",
30597,1,50808,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s015ltr.pdf","2011-04-21 00:00:00",
30598,1,50808,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050808Orig1s023ltr.pdf","2013-10-22 00:00:00",
39375,2,50808,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf","2013-10-21 00:00:00",
22247,3,50809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050809_azithromycin_toc.cfm","2008-10-03 00:00:00",
30599,1,50809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050809s000ltr.pdf","2006-12-28 00:00:00",
39376,2,50809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050809lbl.pdf","2006-12-26 00:00:00",
8330,1,50810,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf","2009-05-11 00:00:00",
22248,3,50810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050810_azasite_toc.cfm","2009-08-13 00:00:00",
30600,1,50810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050810s000ltr.pdf","2007-05-01 00:00:00",
39377,2,50810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf","2007-05-01 00:00:00",
8331,1,50810,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf","2009-05-11 00:00:00",
30601,1,50810,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf","2009-05-11 00:00:00",
30602,1,50810,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050810s007ltr.pdf","2011-04-04 00:00:00",
39378,2,50810,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf","2011-04-01 00:00:00",
18293,2,50810,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf","2012-10-17 00:00:00",
22249,3,50810,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/050810Orig1s012.pdf","2013-02-27 00:00:00",
8332,1,50810,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050810s014ltr.pdf","2012-07-09 00:00:00",
39379,2,50810,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf","2012-07-10 00:00:00",
8333,1,50813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050813s000ltr.pdf","2008-01-25 00:00:00",
24347,21,50813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813s000sumr.pdf","2010-03-26 00:00:00",
39380,2,50813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf","2008-01-24 00:00:00",
42751,3,50813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813_moxatag_toc.cfm","2010-03-26 00:00:00",
53171,20,50813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050813s000_Amoxicillin_Clinical_PREA.pdf","1900-01-01 00:00:00",
53172,18,50813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050813s000_Amoxicillin_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53173,17,50813,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050813s000_Amoxicillin_Statistics_PREA.pdf","1900-01-01 00:00:00",
8334,1,50813,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050813Orig1s003ltr.pdf","2015-06-10 00:00:00",
18294,2,50813,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf","2015-06-11 00:00:00",
8335,1,50814,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s001ltr.pdf","2010-08-25 00:00:00",
22250,3,50814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814s000_cayston_toc.cfm","2011-03-04 00:00:00",
22251,3,50814,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s001.pdf","2011-12-09 00:00:00",
30603,1,50814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s000ltr.pdf","2010-02-26 00:00:00",
39381,2,50814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf","2010-03-03 00:00:00",
44788,21,50814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s000SumR.pdf","2011-03-04 00:00:00",
30604,1,50814,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050814Orig1s007ltr.pdf","2012-09-26 00:00:00",
39382,2,50814,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf","2012-09-25 00:00:00",
8336,1,50814,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050814Orig1s016ltr.pdf","2015-12-30 00:00:00",
18295,2,50817,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf","2010-07-06 00:00:00",
23729,10,50817,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070797.htm","2008-09-19 00:00:00",
30605,1,50817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050817s000ltr.pdf","2008-08-12 00:00:00",
30606,1,50817,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050817s001ltr.pdf","2010-07-02 00:00:00",
42752,3,50817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817_cefepime_toc.cfm","2009-12-31 00:00:00",
44789,21,50817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817s000_SumR.pdf","2009-12-31 00:00:00",
8337,1,50817,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050817Orig1s003ltr.pdf","2014-06-05 00:00:00",
39383,2,50817,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf","2014-06-10 00:00:00",
8338,1,50817,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050817Orig1s004ltr.pdf","2012-09-10 00:00:00",
18296,2,50817,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf","2012-09-11 00:00:00",
30607,1,50817,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050817Orig1s007ltr.pdf","2016-05-10 00:00:00",
39384,2,50817,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050817s007lbl.pdf","2016-05-11 00:00:00",
18297,2,50818,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf","2010-08-10 00:00:00",
24348,21,50818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818s000sumr.pdf","2010-04-21 00:00:00",
30608,1,50818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050818s000ltr.pdf","2009-02-18 00:00:00",
39385,2,50818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050818lbl.pdf","2009-03-02 00:00:00",
42753,3,50818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818_tobradex_st_toc.cfm","2010-04-21 00:00:00",
24349,21,50819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_SumR_P1.pdf","2009-10-29 00:00:00",
30609,1,50819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050819s000ltr.pdf","2008-10-29 00:00:00",
39386,2,50819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf","2008-11-07 00:00:00",
42754,3,50819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819_acanya_toc.cfm","2009-10-29 00:00:00",
18298,2,50819,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf","2010-07-01 00:00:00",
30610,1,50819,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s002ltr.pdf","2010-06-29 00:00:00",
18299,2,50819,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf","2010-10-18 00:00:00",
30611,1,50819,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s003ltr.pdf","2010-10-20 00:00:00",
30612,1,50819,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s010ltr.pdf","2014-03-05 00:00:00",
39387,2,50819,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf","2014-03-04 00:00:00",
30613,1,50819,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.pdf","2014-11-26 00:00:00",
39388,2,50819,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf","2014-11-26 00:00:00",
8339,1,50821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050821s000ltr.pdf","2010-05-10 00:00:00",
8340,1,50821,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050821Orig1s001ltr.pdf","2012-09-10 00:00:00",
18300,2,50821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf","2010-05-17 00:00:00",
24350,21,50821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821s000SumR.pdf","2010-08-30 00:00:00",
39389,2,50821,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050821s001lbl.pdf","2012-09-11 00:00:00",
42755,3,50821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821_cefepime_toc.cfm","2010-08-30 00:00:00",
30614,1,50821,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050821Orig1s002ltr.pdf","2014-06-10 00:00:00",
39390,2,50821,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf","2014-06-10 00:00:00",
8341,1,50821,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050821Orig1s004ltr.pdf","2015-11-13 00:00:00",
39391,2,50821,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050821s004lbl.pdf","2015-11-13 00:00:00",
8342,1,50823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050823s000ltr.pdf","2011-06-27 00:00:00",
24351,21,50823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823Orig1s000SumR.pdf","2012-06-05 00:00:00",
42756,3,50823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823_ceftazidime_toc.cfm","2012-06-05 00:00:00",
8343,1,50823,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050823Orig1s004ltr.pdf","2015-05-19 00:00:00",
39392,2,50823,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050823s004lbl.pdf","2015-05-21 00:00:00",
52434,14,50824,"APPL",0,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/50824_SLCOrderLtr.pdf","2018-02-06 00:00:00",
8344,1,50824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050824s000ltr.pdf","2011-02-14 00:00:00",
18301,2,50824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050824s000lbl.pdf","2011-02-09 00:00:00",
22252,3,50824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824_omeprazole_clarithromycin_amoxicillin_toc.cfm","2011-12-08 00:00:00",
24352,21,50824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824Orig1s000SumR.pdf","2011-12-08 00:00:00",
53933,14,50824,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/050824_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8345,1,50824,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050824Orig1s004ltr.pdf","2014-12-31 00:00:00",
39393,2,50824,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050824s004lbl.pdf","2015-01-09 00:00:00",
45649,1,50824,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050824Orig1s006ltr.pdf","2016-10-26 00:00:00",
45725,2,50824,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050824s006lbl.pdf","2016-10-31 00:00:00",
47101,2,60180,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf","2017-02-06 00:00:00",
51065,2,60180,"SUPPL",48,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s048lbl.pdf","2018-01-17 00:00:00",
22253,3,60212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060212Orig1s000.pdf","2012-03-27 00:00:00",
18302,2,60359,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/060359s028lbl.pdf","2014-01-31 00:00:00",
42757,3,60582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060582_original_approval_package.pdf","1955-04-11 00:00:00",
50819,2,60613,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060613s013lbl.pdf","2017-12-21 00:00:00",
42758,3,60666,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060666_s000_TotacillinTOC.cfm","2006-04-20 00:00:00",
18303,2,60704,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf","2014-01-31 00:00:00",
18304,2,60716,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716s018lbl.pdf","2012-07-30 00:00:00",
18305,2,60716,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716Orig1s020Lbl.pdf","2015-03-23 00:00:00",
22254,3,61621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/061621Orig1s000.pdf","2016-07-28 00:00:00",
39394,2,61621,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061621s039lbl.pdf","2014-01-31 00:00:00",
39395,2,61639,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf","2014-01-31 00:00:00",
22255,3,61667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/061667Orig1s000.pdf","2012-10-12 00:00:00",
18306,2,61904,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061904Orig1s021lbl.pdf","2014-02-27 00:00:00",
30615,1,61904,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/061904Orig1s021ltr.pdf","2014-02-26 00:00:00",
39396,2,61905,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf","2014-01-31 00:00:00",
22256,3,62178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062178Orig1s000.pdf","2012-03-27 00:00:00",
42759,3,62279,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf","2005-07-22 00:00:00",
18307,2,62279,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf","2014-04-10 00:00:00",
39397,2,62298,"SUPPL",68,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062298s068lbl.pdf","2014-01-31 00:00:00",
39398,2,62366,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf","2014-03-21 00:00:00",
18308,2,62475,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062475s038lbl.pdf","2014-01-31 00:00:00",
22257,3,62483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/062483_grifulvin-v_toc.cfm","2003-07-31 00:00:00",
22258,3,62483,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S001.pdf","2003-08-05 00:00:00",
22259,3,62483,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S002.pdf","2003-08-05 00:00:00",
22260,3,62483,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S003.pdf","2003-08-05 00:00:00",
22261,3,62483,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S004.pdf","2003-08-05 00:00:00",
22262,3,62483,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s005.pdf","2003-08-05 00:00:00",
22263,3,62483,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s006.pdf","2003-08-05 00:00:00",
22264,3,62483,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/62483s007.pdf","2003-08-05 00:00:00",
22265,3,62483,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s008.pdf","2003-07-31 00:00:00",
42760,3,62483,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s009.pdf","2003-07-31 00:00:00",
22266,3,62483,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s010.pdf","2003-07-31 00:00:00",
42761,3,62483,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s011.pdf","2003-07-31 00:00:00",
22267,3,62483,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s012.pdf","2003-07-31 00:00:00",
42762,3,62483,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf","2005-07-22 00:00:00",
22268,3,62483,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/62483s014.pdf","2003-07-31 00:00:00",
22269,3,62483,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/62483s015.pdf","2003-07-31 00:00:00",
22270,3,62488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/62488_Neomycin.pdf","2002-07-16 00:00:00",
18309,2,62638,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062638s029lbl.pdf","2014-01-31 00:00:00",
18310,2,62644,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf","2012-11-27 00:00:00",
23730,10,62654,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2007-09-11 00:00:00",
22271,3,62756,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S003_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
42763,3,62756,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S004_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
42764,3,62756,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf","2007-08-06 00:00:00",
22272,3,62756,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S006_ADD_PRIMAXIN_VANTAGE.pdf","2007-11-19 00:00:00",
22273,3,62756,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf","2007-08-06 00:00:00",
42765,3,62756,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf","2007-08-06 00:00:00",
22274,3,62756,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S009_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
22275,3,62756,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf","2007-08-06 00:00:00",
22276,3,62756,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN","2007-09-26 00:00:00",
22277,3,62756,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S012_PRIMAXIN ADD-VANTAGE.pdf","2007-09-26 00:00:00",
22278,3,62756,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S013_PRIMAXIN ADD-VANTAGE.pdf","2007-09-26 00:00:00",
22279,3,62756,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S014_PRIMAXIN ADD-VANTAGE.pdf","2007-09-26 00:00:00",
22280,3,62756,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S015_PRIMAXIN ADD-VANTAGE.pdf","2007-09-26 00:00:00",
42766,3,62756,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN","2007-09-26 00:00:00",
42767,3,62756,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf","2007-09-26 00:00:00",
22281,3,62756,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN","2007-09-26 00:00:00",
22282,3,62756,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S020_PRIMAXIN ADD-VANTAGE.pdf","2007-09-13 00:00:00",
42768,3,62756,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S021_PRIMAXIN ADD-VANTAGE.pdf","2007-09-26 00:00:00",
22283,3,62756,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf","2007-09-26 00:00:00",
42769,3,62756,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/062756_S023_PRIMAXIN.pdf","2007-09-26 00:00:00",
22284,3,62756,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S024_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
22285,3,62756,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S025_PRIMAXIN I.V.pdf","2007-09-26 00:00:00",
42770,3,62756,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf","2007-09-26 00:00:00",
42771,3,62756,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S027_PRIMAXIN I.V.pdf","2007-09-26 00:00:00",
22286,3,62756,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/062756_S028_PRIMAXIN.pdf","2007-09-26 00:00:00",
42772,3,62756,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/062756_S029_PRIMAXIN.pdf","2007-09-26 00:00:00",
22287,3,62756,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/062756_S030_PRIMAXIN.pdf","2007-09-26 00:00:00",
22288,3,62756,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S032_PRIMAXIN_I.V._VANTAGE.pdf","2007-11-19 00:00:00",
42773,3,62756,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S033&S034_PRIMAXIN_VANTAGE.pdf","2007-11-19 00:00:00",
22289,3,62756,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S033&S034_PRIMAXIN_VANTAGE.pdf","2007-11-19 00:00:00",
42774,3,62756,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S035_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
22290,3,62756,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S037_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
42775,3,62756,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S038_PRIMAXIN_ADD_VANTAGE.pdf","2007-11-19 00:00:00",
18311,2,62774,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf","2012-07-30 00:00:00",
39399,2,62911,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062911s035lbl.pdf","2012-07-30 00:00:00",
8346,1,62912,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/062912s038,s039ltr.pdf","2009-01-09 00:00:00",
30616,1,62912,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/062912s038,s039ltr.pdf","2009-01-09 00:00:00",
18312,2,62912,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062912s040lbl.pdf","2012-07-30 00:00:00",
39400,2,62912,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062912s049lbl.pdf","2014-02-03 00:00:00",
18313,2,62921,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf","2012-12-12 00:00:00",
39401,2,62931,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062931s018lbl.pdf","2012-07-30 00:00:00",
18314,2,62933,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062933s021lbl.pdf","2012-07-30 00:00:00",
18315,2,62933,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062933s032lbl.pdf","2014-02-03 00:00:00",
39402,2,62975,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062975s021lbl.pdf","2012-12-12 00:00:00",
8347,1,63009,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/063009Orig1s034ltr.pdf","2014-02-24 00:00:00",
18316,2,63009,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf","2014-02-21 00:00:00",
42776,3,63014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063014Orig1s000.pdf","2016-07-28 00:00:00",
39403,2,63024,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf","2012-07-30 00:00:00",
22291,3,63065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/63065_Minocycline Hydrochloride.cfm","2003-07-24 00:00:00",
18317,2,63065,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf","2004-06-09 00:00:00",
22292,3,63065,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm","2003-08-27 00:00:00",
30617,1,63065,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf","1999-06-10 00:00:00",
8348,1,63065,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf","1999-06-10 00:00:00",
39404,2,63065,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf","2004-06-09 00:00:00",
42777,3,63065,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm","2003-08-27 00:00:00",
39405,2,63076,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063076s025lbl.pdf","2014-02-03 00:00:00",
39406,2,63081,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063081s030lbl.pdf","2012-07-30 00:00:00",
18318,2,63111,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063111s014lbl.pdf","2014-02-06 00:00:00",
39407,2,63112,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf","2014-04-22 00:00:00",
39408,2,63116,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf","2012-07-30 00:00:00",
42778,3,63165,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s003_adriamycin_toc.cfm","2003-07-31 00:00:00",
42779,3,63165,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s005_adriamycin_toc.cfm","2003-07-31 00:00:00",
22293,3,63165,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s006_adriamycin_toc.cfm","2003-07-31 00:00:00",
23731,10,63239,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
18319,2,64071,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf","2014-02-06 00:00:00",
8349,1,64081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_Approv.pdf","1998-09-16 00:00:00",
22294,3,64081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor.cfm","1998-09-16 00:00:00",
39409,2,64081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_prntlbl.pdf","1998-09-16 00:00:00",
22295,3,64084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/064084_bleomycin-sulfate_toc.cfm","2003-07-31 00:00:00",
39410,2,64097,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064097s016lbl.pdf","2012-12-12 00:00:00",
42780,3,64118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/064118.PDF","2005-07-22 00:00:00",
42781,3,64126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/064126ap.pdf","2011-03-10 00:00:00",
22296,3,64127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064127ap.pdf","2011-03-10 00:00:00",
8350,1,64134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64134LTR.PDF","1999-10-27 00:00:00",
39411,2,64134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-134_Tobramycin%20and%20Dexamethasone_prntlbl.pdf","2004-06-28 00:00:00",
42782,3,64134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-134_Tobramycin.cfm","2002-01-17 00:00:00",
8351,1,64142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64142ltr.pdf","1998-06-25 00:00:00",
18320,2,64142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142ap_appltr_prntlbl_chemr.pdf","1998-06-25 00:00:00",
42783,3,64142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142.cfm","1998-06-25 00:00:00",
30618,1,64144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64144ltr.pdf","1998-04-30 00:00:00",
42784,3,64146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/64146AP.PDF","1997-04-02 00:00:00",
8352,1,64150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150aplet.pdf","2011-03-10 00:00:00",
42785,3,64150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150review.pdf","2011-03-10 00:00:00",
22297,3,64155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064155_cefaclor_toc.cfm","2003-07-31 00:00:00",
42786,3,64159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/064159.pdf","2005-07-22 00:00:00",
30619,1,64160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64160ltr.pdf","2000-01-28 00:00:00",
42787,3,64160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/064160_Clindamycin_toc.cfm","2003-08-27 00:00:00",
8353,1,64163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/64163ltr.pdf","2001-10-12 00:00:00",
42788,3,64164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064164_cefaclor_toc.cfm","2003-07-31 00:00:00",
42789,3,64165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064165_cefaclor_toc.cfm","2003-07-31 00:00:00",
42790,3,64166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064166_cefaclor_toc.cfm","2003-07-31 00:00:00",
8354,1,64169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64169ltr.pdf","1998-08-14 00:00:00",
42791,3,64170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64170.cfm","1998-03-18 00:00:00",
8355,1,64180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64180ltr.pdf","1999-12-23 00:00:00",
22298,3,64184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/64184ap.pdf","2011-03-10 00:00:00",
8356,1,64191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64191apl.pdf","2003-03-14 00:00:00",
8357,1,64192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64192ltr.pdf","2002-04-13 00:00:00",
30620,1,64200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64200ltr.pdf","2000-03-24 00:00:00",
42792,3,64200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/064200.pdf","2005-07-22 00:00:00",
30621,1,64201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64201ltr.pdf","2000-03-24 00:00:00",
42793,3,64201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/064201.PDF","2005-07-22 00:00:00",
22299,3,64204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64204ap.pdf","1998-02-16 00:00:00",
42794,3,64205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64204ap.pdf","1998-02-16 00:00:00",
42795,3,64206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64204ap.pdf","1998-02-16 00:00:00",
42796,3,64207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64204ap.pdf","1998-02-16 00:00:00",
8358,1,64210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64210ltr.pdf","1998-06-30 00:00:00",
39412,2,64210,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf","2012-07-30 00:00:00",
8359,1,64212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64212ltr.pdf","1998-06-23 00:00:00",
8360,1,64216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64216ltr.pdf","1999-02-26 00:00:00",
22300,3,64216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/064216Orig1s000.pdf","2012-06-27 00:00:00",
23732,10,64216,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118080.htm","2007-06-29 00:00:00",
8361,1,64217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64217LTR.PDF","1999-10-29 00:00:00",
18321,2,64217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-217_Rifampin_prntlbl.pdf","1999-10-29 00:00:00",
42797,3,64217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-217_Rifampin.cfm","1999-10-29 00:00:00",
8362,1,65000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65000ltr.pdf","1999-05-25 00:00:00",
30622,1,65001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65001ltr.pdf","2001-05-30 00:00:00",
8363,1,65002,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/65002ltr.pdf","1998-09-28 00:00:00",
42798,3,65002,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/65002_Cefuroxime.pdf","1998-09-28 00:00:00",
8364,1,65003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65003ltr.pdf","2000-05-12 00:00:00",
42799,3,65003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065003_gengraf_toc.cfm","2003-07-31 00:00:00",
8365,1,65004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65004LTR.PDF","1999-10-29 00:00:00",
8366,1,65005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65005ltr.pdf","1999-03-23 00:00:00",
22301,3,65005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/65-005_Minocycline.cfm","2002-01-15 00:00:00",
39413,2,65005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/65-005_Minocycline%20Hydrochloride_prntlbl.pdf","2004-06-09 00:00:00",
30623,1,65006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/65006ltr.pdf","1998-12-17 00:00:00",
8367,1,65007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65007ltr.pdf","1999-09-16 00:00:00",
30624,1,65009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65009ltr.pdf","2002-03-18 00:00:00",
42800,3,65009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065009.pdf","2005-07-22 00:00:00",
8368,1,65010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65010ltr.pdf","2003-04-09 00:00:00",
42801,3,65010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065010_ORIGINAL APPROVAL_PACKAGE.pdf","2008-08-01 00:00:00",
18322,2,65010,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065010s002lbl.pdf","2012-07-30 00:00:00",
8369,1,65011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65011ltr.pdf","2000-07-03 00:00:00",
8370,1,65012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65012ltr.pdf","2000-07-03 00:00:00",
22302,3,65012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/065012_ORIGINAL APPROVAL_PACKAGE.pdf","2007-12-06 00:00:00",
18323,2,65013,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.pdf","2012-07-30 00:00:00",
30625,1,65015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65015ltr.pdf","1999-06-22 00:00:00",
30626,1,65016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65016ltr.pdf","1999-04-08 00:00:00",
8371,1,65017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65017ltr.pdf","2000-01-13 00:00:00",
39414,2,65017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine_prntlbl.pdf","2000-01-13 00:00:00",
42802,3,65017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine.cfm","2001-06-07 00:00:00",
30627,1,65018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65018ltr.pdf","1999-04-23 00:00:00",
8372,1,65021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65021ltr.pdf","1999-12-23 00:00:00",
42803,3,65024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065024_S000_Gentamicin Ophthalmic OintmentTOC.cfm","2007-04-02 00:00:00",
22303,3,65025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65025_Cyclosporine.pdf","2001-06-07 00:00:00",
30628,1,65025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65025ltr.pdf","2000-03-03 00:00:00",
8373,1,65026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65026ltr.pdf","2003-04-10 00:00:00",
22304,3,65027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/65-027_Clindamycin.cfm","2001-06-29 00:00:00",
8374,1,65028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65028ltr.pdf","2001-03-14 00:00:00",
30629,1,65031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65031ltr.pdf","2000-03-10 00:00:00",
30630,1,65032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65032ltr.pdf","2000-06-30 00:00:00",
8375,1,65033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65033ltr.pdf","2000-06-27 00:00:00",
30631,1,65034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65034ltr.pdf","2001-11-20 00:00:00",
8376,1,65035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65035ltr.pdf","2000-01-24 00:00:00",
8377,1,65036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65036ltr.pdf","2003-04-09 00:00:00",
8378,1,65037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65037ltr.pdf","2003-04-09 00:00:00",
22305,3,65040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065040.PDF","2005-07-22 00:00:00",
30632,1,65040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65040ltr.pdf","2003-04-09 00:00:00",
30633,1,65041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65041ltr.pdf","2000-04-28 00:00:00",
8379,1,65042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65042ltr.pdf","2003-04-10 00:00:00",
8380,1,65043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65043ltr.pdf","2002-02-15 00:00:00",
30634,1,65044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65044ltr.pdf","2000-12-20 00:00:00",
22306,3,65047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/065047.pdf","2004-12-08 00:00:00",
30635,1,65047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65047ltr.pdf","2003-04-10 00:00:00",
30636,1,65049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65049ltr.pdf","2000-05-25 00:00:00",
42804,3,65049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065049_clindamycin_toc.cfm","2003-08-27 00:00:00",
30637,1,65050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65050ltr.pdf","2000-09-11 00:00:00",
30638,1,65051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65051ltr.pdf","2000-09-11 00:00:00",
30639,1,65053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65053ltr.pdf","2000-11-22 00:00:00",
30640,1,65055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65055ltr.pdf","2000-12-01 00:00:00",
18324,2,65055,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf","2014-02-06 00:00:00",
18325,2,65055,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf","2014-07-30 00:00:00",
30641,1,65055,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065055Orig1s013ltr.pdf","2014-07-24 00:00:00",
8381,1,65056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65056ltr.pdf","2000-09-18 00:00:00",
22307,3,65056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065056_amoxicillin_toc.cfm","2003-07-31 00:00:00",
18326,2,65056,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf","2014-02-06 00:00:00",
18327,2,65059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-059_Amoxicillin_prntlbl.pdf","2000-11-24 00:00:00",
22308,3,65059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-059_Amoxicillin.cfm","2004-05-27 00:00:00",
30642,1,65059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65059ltr.pdf","2000-11-24 00:00:00",
30643,1,65060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65060ltr.pdf","2000-11-29 00:00:00",
30644,1,65061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65061ltr.pdf","2001-02-02 00:00:00",
30645,1,65062,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65062ltr.pdf","2000-11-30 00:00:00",
30646,1,65063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65063ltr.pdf","2002-03-14 00:00:00",
8382,1,65064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65064ltr.pdf","2002-03-15 00:00:00",
30647,1,65065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65065ltr.pdf","2003-04-09 00:00:00",
8383,1,65066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65066ltr.pdf","2003-04-09 00:00:00",
42805,3,65066,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065066.pdf","2007-04-02 00:00:00",
42806,3,65067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065067.pdf","2005-07-22 00:00:00",
8384,1,65068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65068Ltr.pdf","2001-02-26 00:00:00",
18328,2,65068,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065068s013lbl.pdf","2014-02-06 00:00:00",
30648,1,65070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65070ltr.pdf","2000-12-15 00:00:00",
22309,3,65072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065072.pdf","2005-07-22 00:00:00",
30649,1,65074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65074ltr.pdf","2002-03-19 00:00:00",
8385,1,65076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65076ltr.pdf","2002-03-19 00:00:00",
22310,3,65080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065080.pdf","2005-07-22 00:00:00",
30650,1,65082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65082ltr.pdf","2003-04-09 00:00:00",
42807,3,65085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065085.pdf","2007-04-02 00:00:00",
8386,1,65087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65087ltr.pdf","2002-10-10 00:00:00",
30651,1,65088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65010ltr.pdf","2004-06-09 00:00:00",
42808,3,65089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065089_S000_AmoxicillinTOC.cfm","2007-06-11 00:00:00",
22311,3,65093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065093.pdf","2005-07-22 00:00:00",
30652,1,65095,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065095Orig1s014ltr.pdf","2014-07-24 00:00:00",
39415,2,65095,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065095Orig1s014lbl.pdf","2014-07-30 00:00:00",
22312,3,65100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065100.pdf","2005-07-22 00:00:00",
42809,3,65112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065112_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8387,1,65115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/65115_Cefadroxil_Approv.pdf","2003-12-23 00:00:00",
22313,3,65115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/065115_cefadroxil_toc.cfm","2003-12-23 00:00:00",
39416,2,65115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/65115_Cefadroxil_Prntlbl.pdf","2003-12-23 00:00:00",
42810,3,65117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065117.pdf","2005-07-22 00:00:00",
18329,2,65119,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf","2014-02-06 00:00:00",
39417,2,65122,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065122s008lbl.pdf","2014-02-04 00:00:00",
42811,3,65123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065123.pdf","2007-04-02 00:00:00",
22314,3,65125,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065125.pdf","2005-07-22 00:00:00",
44211,10,65125,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
18330,2,65131,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf","2014-03-04 00:00:00",
44212,10,65136,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
23733,10,65137,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
30653,1,65139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/065139ltr.pdf","2004-12-29 00:00:00",
30654,1,65141,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065141Orig1s003ltr.pdf","2014-02-26 00:00:00",
39418,2,65141,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065141s003lbl.pdf","2014-02-06 00:00:00",
23734,10,65144,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
23735,10,65145,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
44213,10,65154,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm","2006-03-03 00:00:00",
23736,10,65155,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
42812,3,65156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065156_s000_MinocyclineTOC.cfm","2006-04-20 00:00:00",
22315,3,65156,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/065156Orig1s010.pdf","2013-10-23 00:00:00",
22316,3,65161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065161_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
22317,3,65162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8388,1,65162,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065162s021ltr.pdf","2010-11-10 00:00:00",
18331,2,65162,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf","2010-10-26 00:00:00",
44214,10,65168,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
18332,2,65168,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf","2014-02-04 00:00:00",
44215,10,65169,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
8389,1,65169,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065169Orig1s022ltr.pdf","2014-02-24 00:00:00",
39419,2,65169,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf","2014-02-20 00:00:00",
44216,10,65174,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
44217,10,65177,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118080.htm","2007-06-29 00:00:00",
23737,10,65178,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
44218,10,65180,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
22318,3,65184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065184_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
22319,3,65189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065189_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
44219,10,65195,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
42813,3,65200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065200_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
23738,10,65204,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
42814,3,65205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065205_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
44220,10,65210,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
18333,2,65214,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf","2010-02-16 00:00:00",
18334,2,65214,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf","2010-03-03 00:00:00",
18335,2,65214,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065214s013lbl.pdf","2013-06-11 00:00:00",
30655,1,65214,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065214Orig1s013ltr.pdf","2013-06-06 00:00:00",
23739,10,65224,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44221,10,65227,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
23740,10,65230,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44222,10,65231,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44223,10,65232,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
30656,1,65235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/065235ltr.pdf","2005-11-18 00:00:00",
8390,1,65236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/065236ltr.pdf","2005-12-15 00:00:00",
44224,10,65245,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
30657,1,65246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065246s000LTR.pdf","2006-07-13 00:00:00",
39420,2,65247,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065247s011lbl.pdf","2014-02-06 00:00:00",
44225,10,65250,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-03-03 00:00:00",
44226,10,65252,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
8391,1,65259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065259s000LTR.pdf","2006-06-02 00:00:00",
8392,1,65262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065262s000LTR.pdf","2006-07-13 00:00:00",
23741,10,65262,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44227,10,65263,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
8393,1,65264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065264s000LTR.pdf","2006-05-22 00:00:00",
23742,10,65266,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2006-06-06 00:00:00",
23743,10,65268,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44228,10,65269,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44229,10,65274,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
23744,10,65283,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2007-09-24 00:00:00",
42815,3,65286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/065286Orig1s000.pdf","2016-07-29 00:00:00",
23745,10,65294,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44230,10,65305,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-01-30 00:00:00",
44231,10,65328,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44232,10,65329,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44233,10,65342,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-01-17 00:00:00",
30658,1,65369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065369s000ltr.pdf","2007-07-23 00:00:00",
42816,3,65369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/065369_original_approval_pkg.pdf","2007-06-18 00:00:00",
8394,1,65374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065374ltr.pdf","2007-08-14 00:00:00",
30659,1,65375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065375ltr.pdf","2007-08-14 00:00:00",
44234,10,65379,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44522,14,65379,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
8395,1,65380,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/065380s000ltr.pdf","2010-10-29 00:00:00",
18336,2,65382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/065382s000lbl.pdf","2007-09-06 00:00:00",
23746,10,65382,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2007-09-24 00:00:00",
30660,1,65382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065382s000ltr.pdf","2007-09-04 00:00:00",
44235,10,65384,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm","2007-08-24 00:00:00",
8396,1,65386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065386s000ltr.pdf","2009-09-22 00:00:00",
39421,2,65386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065386lbl.pdf","2009-10-01 00:00:00",
44236,10,65391,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
8397,1,65396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065396s000ltr.pdf","2010-11-10 00:00:00",
39422,2,65396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf","2010-10-26 00:00:00",
39423,2,65396,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf","2014-04-22 00:00:00",
8398,1,65410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065410s000ltr.pdf","2008-08-01 00:00:00",
39424,2,65410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065410s000lbl.pdf","2008-11-20 00:00:00",
44237,10,65410,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2008-09-19 00:00:00",
44523,14,65410,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
8399,1,65413,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065413s000ltr.pdf","2008-08-04 00:00:00",
24041,14,65413,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
39425,2,65413,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065413s000lbl.pdf","2008-11-20 00:00:00",
44238,10,65413,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2008-09-19 00:00:00",
24042,14,65416,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
44239,10,65416,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
30661,1,65430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065430ltr.pdf","2007-08-14 00:00:00",
8400,1,65431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065431s000ltr.pdf","2008-11-28 00:00:00",
23747,10,65433,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
42817,3,65439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/065439Orig1s000.pdf","2016-07-28 00:00:00",
44240,10,65441,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070797.htm","2008-03-21 00:00:00",
22320,3,65443,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065443Orig1s000.pdf","2012-10-12 00:00:00",
8401,1,65446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065446s000ltr.pdf","2009-09-22 00:00:00",
18337,2,65446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065446s000lbl.pdf","2009-10-21 00:00:00",
30662,1,65447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/065447Orig1s000ltr.pdf","2015-08-21 00:00:00",
23748,10,65451,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
24043,14,65451,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
30663,1,65454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065454s000ltr.pdf","2008-07-17 00:00:00",
39426,2,65454,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf","2008-07-22 00:00:00",
23749,10,65457,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
24044,14,65457,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
18338,2,65461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf","2009-08-13 00:00:00",
30664,1,65461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065461s000ltr.pdf","2009-08-14 00:00:00",
42818,3,65461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065461Orig1s000.pdf","2011-12-02 00:00:00",
18339,2,65462,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf","2014-02-20 00:00:00",
30665,1,65462,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065462Orig1s005ltr.pdf","2014-02-24 00:00:00",
44241,10,65465,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44242,10,65475,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
44243,10,65477,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
30666,1,65478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065478s000ltr.pdf","2012-04-11 00:00:00",
50981,1,65485,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065485Orig1s004ltr.pdf","2018-01-08 00:00:00",
48285,1,65485,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf","2017-05-09 00:00:00",
48286,1,65485,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf","2017-05-09 00:00:00",
8402,1,65490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065490s000ltr.pdf","2012-04-11 00:00:00",
24045,14,65491,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
44244,10,65491,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
23750,10,65504,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
23751,10,65505,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109103.htm","2008-09-19 00:00:00",
8403,1,65510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065510s000ltr.pdf","2012-04-11 00:00:00",
24046,14,65520,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
44245,10,65520,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44246,10,65521,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44524,14,65521,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
53939,14,70088,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070088_SLCOrderLtr.pdf","2018-05-01 00:00:00",
42819,3,70189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/070189.pdf","2005-07-22 00:00:00",
24149,16,70231,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
18340,2,70434,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/070434s032lbl.pdf","2013-09-06 00:00:00",
53942,14,70444,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070445, 070444_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53940,14,70445,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070445, 070444_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53941,14,70445,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070445, 070444_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53945,14,70683,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070766, 070765,070683_SLCOrderLtr.pdf","2018-05-01 00:00:00",
42820,3,70704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/070704_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
53944,14,70765,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070766, 070765,070683_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53943,14,70766,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/070766, 070765,070683_SLCOrderLtr.pdf","2018-05-01 00:00:00",
18341,2,70791,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/070791s027lbl.pdf","2014-09-05 00:00:00",
22321,3,70848,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/070848.PDF","2005-07-15 00:00:00",
22322,3,70920,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s019Approv.pdf","2012-09-12 00:00:00",
22323,3,70920,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s020Approv.pdf","2012-09-12 00:00:00",
42821,3,70920,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s023Approv.pdf","2012-09-12 00:00:00",
42822,3,70920,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s024Approv.pdf","2012-09-12 00:00:00",
53956,14,71156,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071212, 071173,071172,071157,071156_SLCOrderLtr.pdf","2018-05-01 00:00:00",
18342,2,71165,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071165s020lbl.pdf","2010-02-22 00:00:00",
39427,2,71168,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf","2010-02-22 00:00:00",
53955,14,71172,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071212, 071173,071172,071157,071156_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53954,14,71173,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071212, 071173,071172,071157,071156_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53958,14,71196,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071258, 071196_SLCOrderLtr.pdf","2018-05-01 00:00:00",
47232,2,71196,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf","2017-02-16 00:00:00",
47233,8,71196,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf#page=3","2017-02-16 00:00:00",
8404,1,71196,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/071258Orig1s040,071196Orig1s063ltr.pdf","2013-11-20 00:00:00",
39428,2,71196,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf","2013-11-20 00:00:00",
53953,14,71212,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071212, 071173,071172,071157,071156_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53957,14,71258,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/071258, 071196_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8405,1,71258,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/071258Orig1s040,071196Orig1s063ltr.pdf","2013-11-20 00:00:00",
39429,2,71258,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf","2013-11-20 00:00:00",
18343,2,71259,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf","2012-07-30 00:00:00",
30667,1,71297,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/071297Orig1s025ltr.pdf","2014-07-24 00:00:00",
39430,2,71297,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf","2014-07-30 00:00:00",
8406,1,71297,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/071297Orig1s026ltr.pdf","2014-07-24 00:00:00",
18344,2,71297,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf","2014-07-30 00:00:00",
23427,8,71297,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf","2014-07-30 00:00:00",
18345,2,71297,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf","2014-09-05 00:00:00",
42823,3,71402,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s007.pdf","2011-12-02 00:00:00",
42824,3,71402,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s008.pdf","2011-12-02 00:00:00",
18346,2,71413,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071413s019lbl.pdf","2011-10-06 00:00:00",
30668,1,71413,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/071413s019ltr.pdf","2011-10-07 00:00:00",
18347,2,71443,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf","2014-09-05 00:00:00",
44612,16,71479,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
30669,1,71484,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/071484Orig1s042ltr.pdf","2014-08-06 00:00:00",
39431,2,71484,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071484s042lbl.pdf","2014-08-06 00:00:00",
18348,2,71609,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf","2014-09-05 00:00:00",
44613,16,71696,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
8407,1,71881,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/071881Orig1s005ltr.pdf","2015-10-16 00:00:00",
24150,16,71940,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
52762,3,71961,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S002LBL.pdf","2018-02-28 00:00:00",
52763,3,71961,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S003ChemR.pdf","2018-02-28 00:00:00",
52764,3,71961,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S004MicroR.pdf","2018-02-28 00:00:00",
45084,2,71961,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071961s013lbl.pdf","2014-01-27 00:00:00",
18349,2,72285,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf","2014-09-05 00:00:00",
42825,3,72354,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/072354Orig1s000.pdf","2012-01-27 00:00:00",
18350,2,72691,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072691s036lbl.pdf","2014-09-05 00:00:00",
42826,3,72744,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s010.pdf","2011-12-02 00:00:00",
42827,3,72744,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s011.pdf","2011-12-02 00:00:00",
53959,14,72854,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/072854_SLCOrderLtr.pdf","2018-05-01 00:00:00",
42828,3,73045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/073045_albuterol_toc.cfm","2003-08-01 00:00:00",
53960,14,73143,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/073143, 074436_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8408,1,73193,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073193Orig1s033ltr.pdf","2015-08-27 00:00:00",
18351,2,73193,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf","2015-08-26 00:00:00",
8409,1,73210,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073210Orig1s029ltr.pdf","2015-08-27 00:00:00",
39432,2,73210,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073210Orig1s029Lbl.pdf","2015-08-26 00:00:00",
42829,3,73249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/73249ap.pdf","1998-02-13 00:00:00",
18352,2,73303,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf","2013-04-30 00:00:00",
22324,3,73416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/073416_e-z-scrub_toc.cfm","2003-08-01 00:00:00",
30670,1,73416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/73416ltr.pdf","2000-03-14 00:00:00",
42830,3,73440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/1998/073440Orig1s000.pdf","2012-10-29 00:00:00",
42831,3,73479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073479_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
42832,3,73585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073585Orig1s000.pdf","2012-03-27 00:00:00",
23752,10,73644,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
39433,2,73644,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/073645s028,073644s023lbl.pdf","2014-09-05 00:00:00",
23753,10,73645,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
39434,2,73645,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/073645s028,073644s023lbl.pdf","2014-09-05 00:00:00",
22325,3,73680,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/073680Orig1s017.pdf","2011-12-02 00:00:00",
42833,3,73680,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/073680Orig1s018.pdf","2011-12-02 00:00:00",
42834,3,73695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073695_periogard_toc.cfm","2003-08-27 00:00:00",
30671,1,74124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/74124ltr.pdf","2004-06-15 00:00:00",
44247,10,74184,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm","2006-11-27 00:00:00",
8410,1,74253,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf","2003-04-09 00:00:00",
30672,1,74253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75253ltr&TA.pdf","2001-03-28 00:00:00",
30673,1,74253,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf","2003-04-09 00:00:00",
8411,1,74278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74278ltr.pdf","2000-03-31 00:00:00",
22326,3,74278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074278.PDF","2005-07-22 00:00:00",
54904,1,74278,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/074278Orig1s011ltredt.pdf","2018-07-16 00:00:00",
22327,3,74285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074285_diflunisal_toc.cfm","2003-08-01 00:00:00",
42835,3,74286,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1996/074286Orig1s001.pdf","2012-03-27 00:00:00",
42836,3,74286,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/074286Orig1s002.pdf","2012-03-27 00:00:00",
22328,3,74286,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074286Orig1s003.pdf","2012-03-29 00:00:00",
42837,3,74286,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074286Orig1s004.pdf","2012-03-29 00:00:00",
42838,3,74286,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/074286Orig1s006.pdf","2012-03-29 00:00:00",
42839,3,74286,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s007.pdf","2012-03-29 00:00:00",
22329,3,74286,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s008.pdf","2012-03-29 00:00:00",
22330,3,74286,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s009.pdf","2012-03-29 00:00:00",
42840,3,74286,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/074286Orig1s010.pdf","2012-03-29 00:00:00",
22331,3,74286,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s012.pdf","2012-03-29 00:00:00",
42841,3,74286,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s013.pdf","2012-03-29 00:00:00",
42842,3,74286,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/074286Orig1s016.pdf","2012-03-29 00:00:00",
18353,2,74286,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf","2015-01-06 00:00:00",
30674,1,74286,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/074286Orig1s017ltr.pdf","2015-01-07 00:00:00",
22332,3,74312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074312.pdf","2005-07-22 00:00:00",
22333,3,74314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074314.pdf","2005-07-22 00:00:00",
18354,2,74315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_prntlbl.pdf","2004-06-18 00:00:00",
22334,3,74315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin.cfm","2002-01-15 00:00:00",
30675,1,74315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_Approv.pdf","2004-06-18 00:00:00",
53962,14,74334,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074334_SLCOrderLtr.pdf","2018-05-01 00:00:00",
30676,1,74347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74347ltr.pdf","1998-05-28 00:00:00",
30677,1,74348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74348ltr.pdf","1998-05-28 00:00:00",
42843,3,74395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074395.PDF","2005-07-22 00:00:00",
30678,1,74404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74404ltr.pdf","1998-05-14 00:00:00",
42844,3,74404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74404.cfm","1998-05-14 00:00:00",
42845,3,74414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074414.PDF","2005-07-22 00:00:00",
8412,1,74415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74415ltr.pdf","1998-06-08 00:00:00",
22335,3,74415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74415ap.pdf","1998-06-08 00:00:00",
8413,1,74432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74432ltr.pdf","1999-07-29 00:00:00",
53961,14,74436,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/073143, 074436_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8414,1,74446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74446ltr.pdf","2000-05-18 00:00:00",
18355,2,74446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74446_Terazosin%20Hydrochloride_Prntlbl.pdf","2004-06-18 00:00:00",
22336,3,74446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/074446_terazosin_toc.cfm","2003-08-01 00:00:00",
8415,1,74464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74464ltr.pdf","1998-05-28 00:00:00",
22337,3,74464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74464.cfm","1998-05-28 00:00:00",
22338,3,74467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074467_ranitidine_toc.cfm","2003-08-01 00:00:00",
42846,3,74467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074467.pdf","2005-07-22 00:00:00",
42847,3,74471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74471.cfm","1998-03-19 00:00:00",
42848,3,74479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074479ap.pdf","2011-03-10 00:00:00",
18356,2,74489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone%20Valertate_prntlbl.pdf","2004-06-07 00:00:00",
22339,3,74489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone.cfm","1998-08-12 00:00:00",
30679,1,74489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74489ltr.pdf","1998-08-12 00:00:00",
18357,2,74496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74496_Lorazepam_Prntlbl.pdf","2004-06-08 00:00:00",
22340,3,74496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074496_lorazepam_toc.cfm","2003-08-01 00:00:00",
30680,1,74496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74496ltr.pdf","1998-09-28 00:00:00",
8416,1,74504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74504TA.pdf","2004-06-18 00:00:00",
8417,1,74507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74507ltr.pdf","1999-03-15 00:00:00",
18358,2,74507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-507_Nicotine_prntlbl.pdf","2004-06-10 00:00:00",
42849,3,74507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-507_Nicotine.cfm","2003-04-30 00:00:00",
42850,3,74511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074511_sulster_toc.cfm","2003-08-01 00:00:00",
8418,1,74513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75513ltr.pdf","2000-05-09 00:00:00",
30681,1,74517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74517ltr.pdf","1998-09-30 00:00:00",
39435,2,74517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74517_Guanabenz%20Acetate_Prntlbl.pdf","2004-06-04 00:00:00",
42851,3,74517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074517_guanabenz_toc.cfm","2003-08-01 00:00:00",
8419,1,74530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74530ltr.pdf","2000-04-21 00:00:00",
39436,2,74530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74530_Terazosin%20Hydrochloride_Prntlbl.pdf","2004-06-18 00:00:00",
42852,3,74530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/074530_terazosin_toc.cfm","2003-08-01 00:00:00",
42853,3,74531,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074531Orig1s001.pdf","2013-04-11 00:00:00",
53901,14,74531,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074531,089523, 89903, 089523_SLCOrderLtr.pdf","2018-05-01 00:00:00",
22341,3,74538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074538.pdf","2005-07-22 00:00:00",
18359,2,74538,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf","2014-01-24 00:00:00",
8420,1,74539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf","2004-06-18 00:00:00",
8421,1,74539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf","2003-05-02 00:00:00",
22342,3,74539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF","2005-07-22 00:00:00",
8422,1,74542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75542ltr.pdf","2000-05-10 00:00:00",
22343,3,74543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074543ap.pdf","1998-01-15 00:00:00",
30682,1,74545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74545ltr.pdf","1998-06-25 00:00:00",
8423,1,74552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74552ltr.pdf","1998-07-30 00:00:00",
8424,1,74555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74555LTR.PDF","1998-09-30 00:00:00",
22344,3,74555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74555_Cholestramine.pdf","1998-09-30 00:00:00",
8425,1,74567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74567ltr.pdf","2001-04-17 00:00:00",
42854,3,74567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/074567.pdf","2005-07-22 00:00:00",
30683,1,74574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74574ltr.pdf","2000-02-18 00:00:00",
30684,1,74575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74575ltr.pdf","2000-02-18 00:00:00",
42855,3,74579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074579_betamethasone_toc.cfm","2003-08-05 00:00:00",
42856,3,74582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074582_danazol_toc.cfm","2003-08-01 00:00:00",
22345,3,74586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074586.PDF","2005-07-22 00:00:00",
22346,3,74597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/074597.pdf","2007-04-02 00:00:00",
30685,1,74597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74597ltr.pdf","1998-07-29 00:00:00",
30686,1,74616,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74616ltr.pdf","1998-08-03 00:00:00",
22347,3,74629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/074629a.pdf","1997-11-07 00:00:00",
22348,3,74648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74648ap.pdf","2011-03-10 00:00:00",
24151,16,74649,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
42857,3,74650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074650Orig1s000ChemR.pdf","2012-04-13 00:00:00",
18360,2,74650,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.pdf","2014-02-06 00:00:00",
8426,1,74653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74653ltr.pdf","1998-07-29 00:00:00",
22349,3,74655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74655_Ranitidine.cfm","1997-10-22 00:00:00",
30687,1,74656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74656ltr.pdf","2000-05-16 00:00:00",
8427,1,74657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74657ta.pdf","2004-06-18 00:00:00",
8428,1,74657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74657ltr.pdf","2000-04-28 00:00:00",
18361,2,74657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74657_Terazosin%20Hydrochloride_Prntlbl.pdf","2004-06-18 00:00:00",
42858,3,74657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/074657_terazosin_toc.cfm","2003-08-01 00:00:00",
8429,1,74664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf","2004-05-26 00:00:00",
42859,3,74664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074664.PDF","2005-07-22 00:00:00",
8430,1,74681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/74681ltr.pdf","2004-07-30 00:00:00",
30688,1,74686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74686ltr.pdf","1999-04-20 00:00:00",
42860,3,74686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074686_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
8431,1,74688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74688ltr.pdf","1999-08-25 00:00:00",
8432,1,74699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74699ltr.pdf","2000-03-24 00:00:00",
43892,8,74703,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM244086.pdf","2011-02-18 00:00:00",
22350,3,74703,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s006.pdf","2011-12-02 00:00:00",
22351,3,74703,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s007.pdf","2011-12-02 00:00:00",
30689,1,74703,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/074703s007ltr.pdf","2011-05-17 00:00:00",
8433,1,74703,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/074703s009ltr.pdf","2011-05-17 00:00:00",
18362,2,74707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine%20Polacrilex_prntlbl.pdf","2004-06-10 00:00:00",
22352,3,74707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-707_Nicotine.cfm","1999-03-19 00:00:00",
30690,1,74707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74707ltr.pdf","1999-03-19 00:00:00",
42861,3,74712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074712Orig1s000.pdf","2011-12-14 00:00:00",
8434,1,74713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74713ltr.pdf","1999-11-14 00:00:00",
8435,1,74719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74719ta.pdf","2004-06-14 00:00:00",
30691,1,74721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74721ltr.pdf","1998-12-29 00:00:00",
8436,1,74723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74723ltr.pdf","1999-03-30 00:00:00",
22353,3,74725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074725ap.pdf","2011-05-06 00:00:00",
8437,1,74726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74726ltr.pdf","1998-11-20 00:00:00",
18363,2,74726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74726_KLOR-CON_Prntlbl.pdf","2004-06-07 00:00:00",
22354,3,74726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074726_klor-con_toc.cfm","2003-08-01 00:00:00",
22355,3,74726,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/074726Orig1s001.pdf","2016-02-03 00:00:00",
42862,3,74726,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074726Orig1s005.pdf","2016-02-03 00:00:00",
42863,3,74726,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/074726Orig1s013.pdf","2016-02-03 00:00:00",
42864,3,74726,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/074726Orig1s016.pdf","2016-02-03 00:00:00",
22356,3,74727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074727_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
30692,1,74728,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74728ltr.pdf","1998-08-04 00:00:00",
42865,3,74728,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74728.cfm","1999-03-15 00:00:00",
39437,2,74728,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf","2012-08-02 00:00:00",
8438,1,74732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74732ta3.pdf","2004-06-18 00:00:00",
30693,1,74735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74735ltr.pdf","1999-07-16 00:00:00",
8439,1,74737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74737ltr.pdf","1998-10-28 00:00:00",
8440,1,74739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74739ltr.pdf","1998-11-30 00:00:00",
18364,2,74739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone_prntlbl.pdf","1998-11-30 00:00:00",
22357,3,74739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone.cfm","2004-05-27 00:00:00",
23754,10,74739,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
42866,3,74745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74745ap.pdf","1998-02-17 00:00:00",
8441,1,74751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74751ltr.pdf","1998-09-30 00:00:00",
42867,3,74751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74751_Clomipramine%20Hydrochloride.pdf","1998-09-30 00:00:00",
18365,2,74752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/74752lbl.pdf","1998-07-09 00:00:00",
22358,3,74752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074752.pdf","2005-07-22 00:00:00",
30694,1,74752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74752ltr.pdf","1998-07-09 00:00:00",
42868,3,74752,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22359,3,74752,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42869,3,74752,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42870,3,74752,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22360,3,74752,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42871,3,74752,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22361,3,74752,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22362,3,74752,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42872,3,74752,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42873,3,74752,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42874,3,74752,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22363,3,74752,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22364,3,74752,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22365,3,74752,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42875,3,74752,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
22366,3,74752,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF","2005-07-22 00:00:00",
42876,3,74754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74754_Ketorolac.cfm","1997-05-16 00:00:00",
30695,1,74755,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074755Orig1s025ltr.pdf","2014-12-16 00:00:00",
39438,2,74755,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf","2014-12-19 00:00:00",
30696,1,74756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74756ltr.pdf","1998-11-25 00:00:00",
8442,1,74759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74759ltr.pdf","1998-09-02 00:00:00",
22367,3,74759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074759_Aminocaproic_toc.cfm","2003-08-01 00:00:00",
39439,2,74759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74759_Aminocaproic%20Acid.pdf","1998-09-02 00:00:00",
42877,3,74760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074760.PDF","2005-07-22 00:00:00",
30697,1,74764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/74764ltr.pdf","2004-12-02 00:00:00",
8443,1,74769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74769ltr.pdf","1998-07-02 00:00:00",
22368,3,74769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769.cfm","1999-03-30 00:00:00",
24048,14,74769,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
39440,2,74769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf","1998-07-02 00:00:00",
22369,3,74771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74771_Cholestyramine.cfm","1997-07-09 00:00:00",
8444,1,74782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74782ltr.pdf","1998-07-06 00:00:00",
42878,3,74782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74782apTOC.cfm","1998-07-06 00:00:00",
22370,3,74787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074787_labetalol_toc.cfm","2003-08-01 00:00:00",
30698,1,74787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74787ltr.pdf","1998-08-03 00:00:00",
39441,2,74787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74787_Labetalol%20Hydrochloride_Prntlbl.pdf","2004-06-08 00:00:00",
8445,1,74792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74792ltr.pdf","1998-06-26 00:00:00",
18366,2,74793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74-793_Lorazepam_prntlbl.pdf","2002-01-15 00:00:00",
22371,3,74793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/74-793_Lorazepam.cfm","2000-03-16 00:00:00",
30699,1,74793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74793ltr.pdf","2000-03-16 00:00:00",
42879,3,74795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074795ap.pdf","2011-05-06 00:00:00",
22372,3,74800,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74-800_Cromolyn%20Sodium.pdf","2001-07-26 00:00:00",
18367,2,74802,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf","2015-07-23 00:00:00",
18368,2,74803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf","2004-06-04 00:00:00",
23755,10,74803,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30700,1,74803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf","2004-06-04 00:00:00",
30701,1,74803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74803ta.pdf","2004-06-04 00:00:00",
42880,3,74803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074803_fluoxetine_toc.cfm","2003-08-04 00:00:00",
8446,1,74803,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
30702,1,74803,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
8447,1,74803,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
8448,1,74803,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
30703,1,74803,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
8449,1,74803,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf","2003-04-09 00:00:00",
8450,1,74805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74805ltr.pdf","2003-04-09 00:00:00",
42881,3,74806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074806ap.pdf","1998-01-23 00:00:00",
22373,3,74811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74811ap.pdf","1998-01-30 00:00:00",
8451,1,74812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74812ta.pdf","2004-06-14 00:00:00",
8452,1,74814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74814ltr.pdf","2000-05-16 00:00:00",
22374,3,74815,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074815ap.pdf","1998-01-20 00:00:00",
30704,1,74816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74816ta.pdf","2004-06-14 00:00:00",
42882,3,74817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/074817ap.pdf","1997-12-02 00:00:00",
42883,3,74818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74818ap.pdf","2011-03-10 00:00:00",
53916,14,74819,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/079093, 074819_SLCOrderLtr.pdf","2018-05-01 00:00:00",
22375,3,74823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74823ap.pdf","1998-03-30 00:00:00",
42884,3,74826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74826ap.pdf","2011-03-10 00:00:00",
8453,1,74830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74830ltr.pdf","1999-01-25 00:00:00",
42885,3,74830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-830_Desmopressin.cfm","2003-04-30 00:00:00",
42886,3,74833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/074833_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8454,1,74843,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf","2001-02-15 00:00:00",
30705,1,74843,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf","2001-02-15 00:00:00",
30706,1,74843,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf","2001-02-15 00:00:00",
30707,1,74843,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf","2001-02-15 00:00:00",
8455,1,74845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74845ltr.pdf","1999-09-15 00:00:00",
39442,2,74845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74845_Diltiazem_prntlbl.pdf","1999-09-15 00:00:00",
42887,3,74845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-845_Diltiazem.cfm","1999-09-15 00:00:00",
8456,1,74847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74847ltr.pdf","1999-04-23 00:00:00",
8457,1,74848,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/074848ltr.pdf","2005-04-28 00:00:00",
44248,10,74848,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm","2007-06-18 00:00:00",
30708,1,74859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74859ltr.pdf","1998-07-09 00:00:00",
8458,1,74862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74862ltr.pdf","1998-07-07 00:00:00",
18369,2,74862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862ap_appltr_prntlbl_chemr.pdf","1998-07-07 00:00:00",
24049,14,74862,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
42888,3,74862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862.cfm","1999-03-30 00:00:00",
8459,1,74865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf","1998-04-13 00:00:00",
18370,2,74865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf","1998-04-13 00:00:00",
42889,3,74865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865.cfm","1999-03-15 00:00:00",
42890,3,74870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074870_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
22376,3,74872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074872_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8460,1,74873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74873ltr.pdf","1998-06-19 00:00:00",
42891,3,74873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74873ap.pdf","1999-03-16 00:00:00",
30709,1,74874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74874ltr.pdf","1999-05-25 00:00:00",
42892,3,74879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74879.pdf","2003-08-04 00:00:00",
30710,1,74881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74881ltr.pdf","2000-07-28 00:00:00",
22377,3,74889,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074889_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
22378,3,74890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-890_Cimetidine.cfm","1998-12-18 00:00:00",
30711,1,74890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74890ltr.pdf","1998-12-18 00:00:00",
39443,2,74890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-890_Cimetidine_prntlbl.pdf","1998-12-18 00:00:00",
42893,3,74891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074891_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
23756,10,74895,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
30712,1,74895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74895ltr.pdf","1999-04-16 00:00:00",
22379,3,74898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074898_iopamidol_toc.cfm","2003-08-05 00:00:00",
53963,14,74900,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074900, 074901_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8461,1,74904,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74904ltr.pdf","1998-07-14 00:00:00",
42894,3,74904,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74904ap.pdf","1998-07-14 00:00:00",
18371,2,74904,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf","2015-08-26 00:00:00",
30713,1,74904,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074904Orig1s015ltr.pdf","2015-08-27 00:00:00",
22380,3,74905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74905ap.pdf","1997-08-26 00:00:00",
22381,3,74909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74909ap.pdf","1998-03-25 00:00:00",
22382,3,74910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074910_diltiazem_toc.cfm","2003-07-28 00:00:00",
30714,1,74911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74911ltr.pdf","2003-04-09 00:00:00",
8462,1,74912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.pdf","1998-04-30 00:00:00",
39444,2,74912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912ap_appltr_prntlbl_chemr.pdf","1998-04-30 00:00:00",
42895,3,74912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74912.cfm","1999-03-15 00:00:00",
30715,1,74914,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74914_Acyclovir_Approv.pdf","2003-12-23 00:00:00",
39445,2,74914,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74914_Acyclovir_Prntlbl.pdf","2003-12-23 00:00:00",
42896,3,74914,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074914_acyclovir_toc.cfm","2003-12-23 00:00:00",
8463,1,74916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74916ta.pdf","1998-01-09 00:00:00",
22383,3,74917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74917ap.pdf","1998-02-03 00:00:00",
30716,1,74918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74918ltr.pdf","1998-05-08 00:00:00",
42897,3,74918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74918.cfm","1998-05-08 00:00:00",
30717,1,74920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74920ltr.pdf","1998-08-04 00:00:00",
43893,8,74921,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf","2013-07-01 00:00:00",
30718,1,74924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74924ltr.pdf","1998-04-29 00:00:00",
42898,3,74925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074925ap.pdf","2011-03-10 00:00:00",
18372,2,74926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole%20Nitrate_Prntlbl.pdf","2004-06-09 00:00:00",
22384,3,74926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole.cfm","2002-01-14 00:00:00",
30719,1,74926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74926ltr.pdf","1999-04-16 00:00:00",
8464,1,74928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf","1998-03-19 00:00:00",
18373,2,74928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928ap_appltr_prntlbl_chemr.pdf","1998-03-19 00:00:00",
22385,3,74928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74928.cfm","1998-03-19 00:00:00",
8465,1,74929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.pdf","1998-01-30 00:00:00",
18374,2,74929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929ap_appltr_prntlbl_chemr.pdf","1998-01-30 00:00:00",
42899,3,74929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74929.cfm","1998-01-30 00:00:00",
8466,1,74930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74930ltr.pdf","1998-05-13 00:00:00",
42900,3,74930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74930ap.pdf","1998-05-13 00:00:00",
8467,1,74931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74931ltr.pdf","1998-07-20 00:00:00",
18375,2,74931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74931_Ibuprofen_Prntlbl.pdf","2004-06-07 00:00:00",
42901,3,74931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074931_ibuprofen_toc.cfm","2003-08-04 00:00:00",
8468,1,74936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.pdf","1998-02-24 00:00:00",
18376,2,74936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.pdf","1998-02-24 00:00:00",
42902,3,74936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936.cfm","1998-02-24 00:00:00",
8469,1,74937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74937ltr.pdf","1998-12-22 00:00:00",
22386,3,74937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen.cfm","1998-12-22 00:00:00",
39446,2,74937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen_prntlbl.pdf","1998-12-22 00:00:00",
22387,3,74940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074940.pdf","2011-03-10 00:00:00",
18377,2,74941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_prntlbl.pdf","2003-04-30 00:00:00",
30720,1,74941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_approv.pdf","2003-04-30 00:00:00",
42903,3,74941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem.cfm","2003-04-30 00:00:00",
8470,1,74943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74943ltr.pdf","1998-08-06 00:00:00",
18378,2,74943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74943_Diltiazem%20Hydrochloride_Prntlbl.pdf","2004-06-02 00:00:00",
42904,3,74943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074943_diltiazem_toc.cfm","2003-08-04 00:00:00",
22388,3,74944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074944_atracurium_toc.cfm","2003-08-04 00:00:00",
30721,1,74944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74944ltr.pdf","1998-07-28 00:00:00",
8471,1,74945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74945ltr.pdf","1998-07-28 00:00:00",
22389,3,74945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074945_atracurium_toc.cfm","2003-08-04 00:00:00",
53965,14,74945,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074944, 074945_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8472,1,74947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74947ltr.pdf","1998-04-30 00:00:00",
8473,1,74948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74948ltr.pdf","1998-06-19 00:00:00",
22390,3,74949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74949ap.pdf","1998-01-26 00:00:00",
24050,14,74949,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
8474,1,74951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74951ltr.pdf","1998-08-31 00:00:00",
42905,3,74951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074951_butalbital_toc.cfm","2003-08-04 00:00:00",
8475,1,74956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74956ltr.pdf","1998-09-30 00:00:00",
22391,3,74956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74956_Dipridamole.pdf","1998-09-30 00:00:00",
30722,1,74961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74961taltr.pdf","2004-06-01 00:00:00",
30723,1,74962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74962ltr.pdf","1999-03-31 00:00:00",
39447,2,74962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_Pentoxifylline_prntlbl.pdf","2004-06-14 00:00:00",
42906,3,74962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_pentoxifylline.cfm","2003-04-30 00:00:00",
30724,1,74963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74963ltr.pdf","1998-06-19 00:00:00",
8476,1,74966,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74966let.pdf","1998-04-16 00:00:00",
22392,3,74967,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74967ap.pdf","2003-06-17 00:00:00",
22393,3,74968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074968ap.pdf","1998-01-09 00:00:00",
22394,3,74970,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74970ap.pdf","1999-03-15 00:00:00",
8477,1,74971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74971ltr.pdf","1999-06-15 00:00:00",
22395,3,74971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole.cfm","1999-06-15 00:00:00",
39448,2,74971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole_prntlbl.pdf","1999-06-15 00:00:00",
8478,1,74972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74972ltr.pdf","1998-06-19 00:00:00",
8479,1,74973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74973ltr.pdf","2000-01-24 00:00:00",
42907,3,74973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/74973_Primsol.pdf","2000-01-24 00:00:00",
46499,2,74973,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/074973s008lbl.pdf","2016-12-21 00:00:00",
46520,1,74973,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/74973Orig1s008ltr.pdf","2016-12-23 00:00:00",
22396,3,74974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-974_Lorazepam.cfm","2011-03-10 00:00:00",
30725,1,74975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74975ltr.pdf","1998-09-30 00:00:00",
42908,3,74975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074975_acyclovir_toc.cfm","2003-08-04 00:00:00",
30726,1,74976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-976_Acyclovir.htm","1998-04-13 00:00:00",
39449,2,74976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-976_Acyclovir.htm","1998-04-13 00:00:00",
42909,3,74976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-976_Acyclovir.cfm","2004-05-25 00:00:00",
42910,3,74977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74977.cfm","1998-04-13 00:00:00",
22397,3,74978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74978ap.pdf","1998-03-25 00:00:00",
39450,2,74978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf","2014-12-19 00:00:00",
8480,1,74978,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/074978Orig1s030ltr.pdf","2014-11-13 00:00:00",
22398,3,74979,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74979ap.pdf","2011-03-10 00:00:00",
30727,1,74980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74980ltr.pdf","1998-09-30 00:00:00",
22399,3,74983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74983_Etoposide.pdf","1998-09-30 00:00:00",
30728,1,74983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74983LTR.PDF","1998-09-30 00:00:00",
30729,1,74984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74984ltr.pdf","1999-12-20 00:00:00",
18379,2,74986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Doclofenec%20Sodium_prntlbl.pdf","2004-06-02 00:00:00",
30730,1,74986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74986ltr.pdf","1999-02-26 00:00:00",
42911,3,74986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Diclofenac.cfm","1999-02-26 00:00:00",
8481,1,74988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74988ltr.pdf","1999-04-30 00:00:00",
8482,1,74989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74989ltr.pdf","1998-09-30 00:00:00",
42912,3,74989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74989_Labetalol%20Hydrochloride.pdf","2002-09-25 00:00:00",
42913,3,74992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74992_Nitroglycerine.pdf","1999-11-12 00:00:00",
8483,1,74993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74993ltr.pdf","1997-01-27 00:00:00",
42914,3,74995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74995ap.pdf","1998-03-31 00:00:00",
22400,3,75000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75000ap.pdf","1998-01-30 00:00:00",
8484,1,75004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75004ltr.pdf","2000-02-16 00:00:00",
22401,3,75005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75005ap.pdf","1998-02-24 00:00:00",
42915,3,75006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075006_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8485,1,75008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75008ltr.pdf","1999-06-30 00:00:00",
8486,1,75009,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf","1999-12-28 00:00:00",
30731,1,75009,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf","1999-12-28 00:00:00",
30732,1,75009,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf","1999-12-28 00:00:00",
8487,1,75009,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf","1999-12-28 00:00:00",
30733,1,75009,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf","1999-12-28 00:00:00",
8488,1,75010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75010ltr.pdf","1999-03-01 00:00:00",
42916,3,75010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075010_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-20 00:00:00",
42917,3,75010,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075010_S001_IBUPROFEN TABLETS.pdf","2007-07-20 00:00:00",
42918,3,75010,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075010_S002_IBUPROFEN_TABLETS.pdf","2007-07-20 00:00:00",
42919,3,75010,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075010_S003_IBUPROFEN_TABLETS.pdf","2007-07-20 00:00:00",
8489,1,75012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75012ltr.pdf","1998-09-30 00:00:00",
8490,1,75014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75014ltr.pdf","2000-03-28 00:00:00",
18380,2,75014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75014_Permethrin_Prntlbl.pdf","2004-06-14 00:00:00",
42920,3,75014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075014_permethrin_toc.cfm","2003-08-04 00:00:00",
8491,1,75020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75020ltr.pdf","1998-07-30 00:00:00",
42921,3,75020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75020_Hydroxyurea.pdf","1998-07-30 00:00:00",
22402,3,75021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75021.cfm","1998-03-18 00:00:00",
8492,1,75025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75025ltr.pdf","1998-07-23 00:00:00",
42922,3,75025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75025_Lorazepam.pdf","2002-09-25 00:00:00",
30734,1,75028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75028ltr.pdf","1998-07-20 00:00:00",
42923,3,75028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75028_Pentoxifyline.pdf","1998-07-20 00:00:00",
30735,1,75030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75030ltr.pdf","1999-01-29 00:00:00",
30736,1,75034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75034ltr.pdf","1998-07-20 00:00:00",
42924,3,75034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75034_Gemfibrozil.pdf","1998-07-20 00:00:00",
8493,1,75036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75036ta.pdf","2004-06-01 00:00:00",
8494,1,75036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75036ltr.pdf","2000-11-07 00:00:00",
22403,3,75036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin.cfm","2000-11-07 00:00:00",
39451,2,75036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin_prntlbl.pdf","2000-11-07 00:00:00",
30737,1,75037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75037ltr.pdf","1998-10-30 00:00:00",
8495,1,75040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75040ta.pdf","2004-06-14 00:00:00",
8496,1,75041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75041ltr.pdf","1998-09-22 00:00:00",
18381,2,75041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf","1998-09-22 00:00:00",
22404,3,75041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide.cfm","1998-09-22 00:00:00",
22405,3,75042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075042_hydrocortisone_toc.cfm","2003-08-05 00:00:00",
30738,1,75042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75042ltr.pdf","1998-08-25 00:00:00",
39452,2,75042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-042_prntlbl.PDF","2004-06-07 00:00:00",
18382,2,75043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf","2004-06-07 00:00:00",
22406,3,75043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone.cfm","1998-08-25 00:00:00",
30739,1,75043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75043ltr.pdf","1998-08-25 00:00:00",
8497,1,75045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75045ltr.pdf","1998-08-12 00:00:00",
53964,14,75045,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074944, 074945_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8498,1,75046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75046ltr.pdf","1998-08-12 00:00:00",
42925,3,75046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75046_Stadol.pdf","2002-09-25 00:00:00",
53966,14,75046,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/075045, 075046_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8499,1,75047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75047ltr.pdf","1999-12-30 00:00:00",
22407,3,75047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075047Orig1s000BioeqR.pdf","2012-02-14 00:00:00",
8500,1,75048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75048ta.pdf","2004-06-24 00:00:00",
8501,1,75048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75048ltr.pdf","2000-08-22 00:00:00",
8502,1,75049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Approv.pdf","2004-06-04 00:00:00",
8503,1,75049,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2004-06-04 00:00:00",
18383,2,75049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Prntlbl.pdf","2004-06-04 00:00:00",
22408,3,75049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075049_fluoxetine_toc.cfm","2003-08-04 00:00:00",
23757,10,75049,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8504,1,75049,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
30740,1,75049,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
8505,1,75049,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
8506,1,75049,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
8507,1,75049,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
30741,1,75049,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
30742,1,75049,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
8508,1,75049,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf","2003-04-09 00:00:00",
30743,1,75050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75050ltr.pdf","1998-06-18 00:00:00",
8509,1,75051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75051ltr.pdf","2001-01-26 00:00:00",
18384,2,75051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-051_Metoclopramide_prntlbl.pdf","2001-01-26 00:00:00",
42926,3,75051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-051_Metoclopramide.cfm","2002-01-04 00:00:00",
30744,1,75052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75052ltr.pdf","1999-06-18 00:00:00",
30745,1,75055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75055ltr.pdf","1998-06-18 00:00:00",
8510,1,75057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75057ltr.pdf","1998-08-12 00:00:00",
8511,1,75058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75058ltr.pdf","2001-04-27 00:00:00",
8512,1,75060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75060ltr.pdf","1998-12-24 00:00:00",
22409,3,75061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75061ap.pdf","1998-02-18 00:00:00",
8513,1,75062,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75062ltr.pdf","2001-04-16 00:00:00",
30746,1,75063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75063ltr.pdf","1999-02-09 00:00:00",
8514,1,75065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75065ltr.pdf","1999-02-25 00:00:00",
30747,1,75067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75067ltr.pdf","1999-07-19 00:00:00",
42927,3,75067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74706ap.pdf","1999-07-19 00:00:00",
22410,3,75069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75069.cfm","1998-04-16 00:00:00",
30748,1,75069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75069let.pdf","1998-04-16 00:00:00",
30749,1,75071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75071ltr.pdf","1998-09-30 00:00:00",
8515,1,75072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75072ltr.pdf","1999-05-25 00:00:00",
18385,2,75072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf","1999-05-25 00:00:00",
22411,3,75072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil.cfm","1999-05-25 00:00:00",
22412,3,75073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75073_Nitroglycerin.pdf","1999-11-12 00:00:00",
22413,3,75074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75074ap.pdf","1998-03-11 00:00:00",
42928,3,75075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75073_Nitroglycerin.pdf","1999-11-12 00:00:00",
42929,3,75076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75073_Nitroglycerin.pdf","1999-11-12 00:00:00",
22414,3,75077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75077_Acetaminophen.pdf","2001-06-07 00:00:00",
30750,1,75077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75077ltr.pdf","2000-02-25 00:00:00",
22415,3,75078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75078.cfm","1998-04-30 00:00:00",
42930,3,75082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75082ap.pdf","1999-03-22 00:00:00",
8516,1,75086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem%20Hydrochloride_Approv.pdf","2004-06-02 00:00:00",
18386,2,75086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem%20Hydrochloride_prntlbl.pdf","2004-06-02 00:00:00",
42931,3,75086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem.cfm","1998-04-09 00:00:00",
8517,1,75088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75088ltr.pdf","1999-04-27 00:00:00",
30751,1,75089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75089ltr.pdf","1999-07-01 00:00:00",
30752,1,75090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75090ltr.pdf","1999-01-26 00:00:00",
42932,3,75090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075090_ORIGINAL APPROVAL_PACKAGE.pdf","2007-04-09 00:00:00",
18387,2,75091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf","1999-09-30 00:00:00",
22416,3,75091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa.cfm","1999-09-30 00:00:00",
30753,1,75091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75091ta.pdf","2004-06-24 00:00:00",
8518,1,75093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75093ltr.pdf","1999-08-10 00:00:00",
30754,1,75094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75094ta.pdf","2004-06-14 00:00:00",
30755,1,75095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75095ltr.pdf","1999-11-30 00:00:00",
8519,1,75099,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75099APltr.PDF","2002-06-28 00:00:00",
8520,1,75100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75100ltr.pdf","1998-12-10 00:00:00",
42933,3,75100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75100_Bromocriptine.cfm","1998-12-10 00:00:00",
42934,3,75101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75101.cfm","1998-04-15 00:00:00",
22417,3,75102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75102_Propofol.pdf","1999-01-04 00:00:00",
44249,10,75102,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm","2007-06-18 00:00:00",
8521,1,75103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75103ltr.pdf","2000-09-29 00:00:00",
42935,3,75104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75104.cfm","1998-02-06 00:00:00",
30756,1,75105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75105ltr.pdf","1998-07-23 00:00:00",
39453,2,75105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide_prntlbl.pdf","1998-07-23 00:00:00",
42936,3,75105,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide.cfm","1998-07-23 00:00:00",
8522,1,75106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75106ltr.pdf","1999-04-29 00:00:00",
8523,1,75107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75107ltr.pdf","1998-09-04 00:00:00",
8524,1,75108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75108ltr.pdf","1999-12-17 00:00:00",
18388,2,75108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine_prntlbl.pdf","1999-12-17 00:00:00",
22418,3,75108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine.cfm","1999-12-17 00:00:00",
30757,1,75108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75108ta.pdf","2004-06-10 00:00:00",
30758,1,75110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75110ltr.pdf","1998-06-18 00:00:00",
8525,1,75111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75111ltr.pdf","1999-04-23 00:00:00",
18389,2,75111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium%20Bromide_prntlbl.pdf","1999-04-23 00:00:00",
42937,3,75111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium.cfm","1999-04-23 00:00:00",
30759,1,75113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75113ltr.pdf","1998-08-04 00:00:00",
30760,1,75114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75114ltr.pdf","1999-07-26 00:00:00",
30761,1,75116,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75116ltr.pdf","1999-12-23 00:00:00",
30762,1,75117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75117ltr.pdf","2000-12-14 00:00:00",
39454,2,75117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-117_Orapred_prntlbl.pdf","2000-12-14 00:00:00",
42938,3,75117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-117_Orapred.cfm","2000-12-14 00:00:00",
8526,1,75119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75119ta.pdf","2004-06-24 00:00:00",
8527,1,75119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75119ltr.pdf","2003-04-09 00:00:00",
30763,1,75122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75122ltr.pdf","1998-06-19 00:00:00",
8528,1,75124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf","1998-03-18 00:00:00",
22419,3,75124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124.cfm","1998-03-18 00:00:00",
39455,2,75124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf","1998-03-18 00:00:00",
8529,1,75126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75126ltr.pdf","1999-09-16 00:00:00",
8530,1,75128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75128ltr.pdf","2000-03-10 00:00:00",
22420,3,75128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075128.pdf","2005-07-22 00:00:00",
30764,1,75128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75128ta.pdf","2004-06-10 00:00:00",
30765,1,75129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75129ltr.pdf","2001-02-13 00:00:00",
30766,1,75132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75132ltr.pdf","2000-01-14 00:00:00",
8531,1,75133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75133ltr.pdf","1998-08-03 00:00:00",
42939,3,75133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75133_Labetalol%20Hydrochloride.pdf","2002-09-25 00:00:00",
22421,3,75135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135.cfm","1999-05-28 00:00:00",
22422,3,75135,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
23758,10,75135,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-08-01 00:00:00",
30767,1,75135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf","1998-04-30 00:00:00",
30768,1,75135,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s001ltr.pdf","1998-04-30 00:00:00",
39456,2,75135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf","1998-04-30 00:00:00",
43894,8,75135,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf","2009-11-20 00:00:00",
8532,1,75135,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s002ltr.pdf","1999-12-02 00:00:00",
42940,3,75135,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
30769,1,75135,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s003ltr.pdf","1999-09-24 00:00:00",
42941,3,75135,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
8533,1,75135,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s004ltr.pdf","2000-02-01 00:00:00",
22423,3,75135,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
42942,3,75135,"SUPPL",5,"10/29/02","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
22424,3,75135,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
22425,3,75135,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf","2002-10-29 00:00:00",
30770,1,75136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75136ltr.pdf","1998-10-20 00:00:00",
42943,3,75136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75136_Verapamil%20Hydrochloride.pdf","1998-10-20 00:00:00",
8534,1,75137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75137ltr.pdf","1998-12-18 00:00:00",
8535,1,75138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75138ltr.pdf","1999-04-20 00:00:00",
39457,2,75138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-138_Verapamil%20Hydrochloride_prntlbl.pdf","2004-06-29 00:00:00",
42944,3,75138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-138_Verapamil.cfm","1999-04-20 00:00:00",
22426,3,75139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/075139_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-24 00:00:00",
22427,3,75139,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075139_S001_IBUPROFEN_TABLETS.pdf","2007-07-24 00:00:00",
30771,1,75139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75139ltr.pdf","1999-03-01 00:00:00",
42945,3,75139,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf","2007-07-24 00:00:00",
42946,3,75139,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf","2007-07-24 00:00:00",
22428,3,75139,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S004_IBUPROFEN TABLETS.pdf","2007-07-24 00:00:00",
22429,3,75139,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S005_IBUPROFEN TABLETS.pdf","2007-07-27 00:00:00",
42947,3,75139,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S006_IBUPROFEN TABLETS.pdf","2007-07-27 00:00:00",
42948,3,75139,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075139_S007_IBUPROFEN TABLETS.pdf","2007-07-27 00:00:00",
42949,3,75139,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/075139_S008_IBUPROFEN TABLETS.pdf","2007-07-27 00:00:00",
8536,1,75140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75140ta.pdf","2004-06-18 00:00:00",
18390,2,75140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75140_Terazosin%20Hydrochloride_prntlbl.pdf","2004-06-18 00:00:00",
22430,3,75140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75140_Terazosin.cfm","2004-06-18 00:00:00",
30772,1,75140,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75140ltr.pdf","2000-02-11 00:00:00",
22431,3,75141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75141ap.pdf","1998-05-29 00:00:00",
8537,1,75143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75143ltr.pdf","1998-10-16 00:00:00",
22432,3,75143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75143_Hydroxyurea.pdf","1998-10-16 00:00:00",
30773,1,75147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm","1998-11-27 00:00:00",
39458,2,75147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm","1998-11-27 00:00:00",
42950,3,75147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.cfm","1998-11-27 00:00:00",
8538,1,75149,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75149ltr.pdf","1999-08-20 00:00:00",
22433,3,75150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75150_Clonazepam.pdf","1998-10-05 00:00:00",
30774,1,75150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75150LTR.PDF","1998-10-05 00:00:00",
30775,1,75151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75151ltr.pdf","2000-04-25 00:00:00",
8539,1,75152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75152ltr.pdf","1998-11-27 00:00:00",
8540,1,75153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75153ltr.pdf","1999-02-26 00:00:00",
8541,1,75154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75154ta.pdf","2004-06-09 00:00:00",
30776,1,75154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75154ltr.pdf","2000-06-20 00:00:00",
8542,1,75155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75155ltr.pdf","1998-10-30 00:00:00",
8543,1,75155,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075155Orig1s034ltr.pdf","2014-10-24 00:00:00",
39459,2,75155,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf","2014-10-24 00:00:00",
8544,1,75160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75160ltr.pdf","1998-07-06 00:00:00",
42951,3,75160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75160_Metoprolol%20Tartrate.pdf","2002-09-25 00:00:00",
22434,3,75161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075161_ticlopidine_toc.cfm","2003-08-04 00:00:00",
30777,1,75161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75161ltr.pdf","1999-09-13 00:00:00",
39460,2,75161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75161_Ticlopidine%20Hydrochloride_Prntlbl.pdf","2004-06-18 00:00:00",
8545,1,75164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75164ltr.pdf","1999-10-21 00:00:00",
42952,3,75164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75164_Vecuronium.pdf","1999-10-21 00:00:00",
8546,1,75165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75165ltr.pdf","1998-09-30 00:00:00",
30778,1,75166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75166ltr.pdf","1999-10-07 00:00:00",
30779,1,75167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75167ltr.pdf","2000-05-04 00:00:00",
30780,1,75168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75168ltr.pdf","1998-07-28 00:00:00",
8547,1,75170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75170ltr.pdf","1998-09-28 00:00:00",
42953,3,75170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75170_Butorphanol%20Tartrate.pdf","2002-09-25 00:00:00",
30781,1,75172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75172ltr.pdf","1999-12-06 00:00:00",
8548,1,75174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75174ltr.pdf","1998-06-22 00:00:00",
22435,3,75175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-175_Cromolyn.cfm","2002-01-02 00:00:00",
30782,1,75175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75175ltr.pdf","1999-09-30 00:00:00",
39461,2,75175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-175_Cromolyn%20Sodium_prntlbl.pdf","2002-01-02 00:00:00",
8549,1,75176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75176ltr.pdf","2000-02-09 00:00:00",
22436,3,75176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-176_Haloperidol.cfm","2000-02-09 00:00:00",
39462,2,75176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-176_Haloperidol%20Decanoate_prntlbl.pdf","2004-06-07 00:00:00",
8550,1,75178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75178ltr.pdf","2001-03-23 00:00:00",
30783,1,75178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75178ta.pdf","2004-06-03 00:00:00",
22437,3,75179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-179_Nabumetone.cfm","2000-06-06 00:00:00",
30784,1,75179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75179TAAP.PDF","2000-06-06 00:00:00",
39463,2,75179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-179_Nabumetone_prntlbl.pdf","2004-06-09 00:00:00",
30785,1,75180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75180ltr.pdf","1999-01-28 00:00:00",
8551,1,75181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75181taf.pdf","2003-04-09 00:00:00",
8552,1,75182,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75182ltr.pdf","2000-02-24 00:00:00",
22438,3,75182,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75182_Estradiol.pdf","2000-02-24 00:00:00",
8553,1,75182,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182 s015s016_ltr.pdf","2006-07-21 00:00:00",
30786,1,75182,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182 s015s016_ltr.pdf","2006-07-21 00:00:00",
8554,1,75184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Approv.pdf","2004-06-14 00:00:00",
18391,2,75184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Prntlbl.pdf","2004-06-14 00:00:00",
42954,3,75184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075184_paclitaxel_toc.cfm","2003-08-04 00:00:00",
8555,1,75185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75185ltr.pdf","1998-11-13 00:00:00",
42955,3,75187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75187ap.pdf","1998-03-30 00:00:00",
8556,1,75188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_Approv.pdf","1999-02-24 00:00:00",
22439,3,75188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone.cfm","2004-05-27 00:00:00",
39464,2,75188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf","1999-02-24 00:00:00",
44250,10,75188,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8557,1,75189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf","2004-06-09 00:00:00",
18392,2,75189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf","2000-05-26 00:00:00",
30787,1,75189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF","2000-05-26 00:00:00",
30788,1,75189,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf","2003-04-09 00:00:00",
42956,3,75189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone.cfm","2000-05-26 00:00:00",
30789,1,75189,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf","2003-04-09 00:00:00",
8558,1,75190,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75190ltr.pdf","2003-04-09 00:00:00",
22440,3,75190,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075190.PDF","2005-07-22 00:00:00",
30790,1,75190,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75190rescind.pdf","2003-04-10 00:00:00",
30791,1,75191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75191ltr.pdf","1999-06-09 00:00:00",
8559,1,75192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75192ta.pdf","2004-06-04 00:00:00",
30792,1,75193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75193ta.pdf","2004-06-04 00:00:00",
30793,1,75194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75194ta.pdf","2004-06-04 00:00:00",
8560,1,75199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75199ltr.pdf","1999-09-03 00:00:00",
8561,1,75201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75201ltr.pdf","1998-12-04 00:00:00",
30794,1,75203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75203ltr.pdf","2000-10-24 00:00:00",
39465,2,75203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75203_Propafenone%20Hydrochloride_Prntlbl.pdf","2003-12-23 00:00:00",
42957,3,75203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075203_propafenone-hydrochloride_toc.cfm","2003-12-23 00:00:00",
8562,1,75205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75205ltr.pdf","1998-11-13 00:00:00",
8563,1,75207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75207ta.pdf","2004-06-04 00:00:00",
23759,10,75207,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8564,1,75208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75208ltr.pdf","1998-12-17 00:00:00",
8565,1,75209,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75209altr.pdf","2003-07-24 00:00:00",
30795,1,75211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75211ltr.pdf","1998-09-28 00:00:00",
42958,3,75211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075211_acyclovir_toc.cfm","2003-08-04 00:00:00",
30796,1,75212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75212ltr.pdf","2000-01-14 00:00:00",
8566,1,75213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf","1998-12-24 00:00:00",
18393,2,75213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin_prntlbl.pdf","1998-12-24 00:00:00",
42959,3,75213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin.cfm","2001-08-24 00:00:00",
30797,1,75215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75215ltr.pdf","1999-07-29 00:00:00",
8567,1,75217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75217ltr.pdf","1998-12-16 00:00:00",
39466,2,75217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf","1998-12-16 00:00:00",
42960,3,75217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen.cfm","1998-12-16 00:00:00",
8568,1,75218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ltr.pdf","1999-08-23 00:00:00",
30798,1,75218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ta.pdf","2004-06-29 00:00:00",
53967,14,75218,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/075218_SLCOrderLtr.pdf","2018-05-01 00:00:00",
30799,1,75219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75219ltr.pdf","1998-08-06 00:00:00",
30800,1,75220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75220ltr.pdf","2000-08-28 00:00:00",
8569,1,75221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75221ltr.pdf","1999-10-28 00:00:00",
30801,1,75223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75223ltr.pdf","1998-11-23 00:00:00",
22441,3,75224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-224_Clobetasol.cfm","1998-11-16 00:00:00",
30802,1,75224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75224ltr.pdf","1998-11-16 00:00:00",
8570,1,75225,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75225ltr.pdf","1999-10-20 00:00:00",
30803,1,75226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75226ltr.pdf","1998-11-24 00:00:00",
30804,1,75227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75227ltr.pdf","1998-06-30 00:00:00",
8571,1,75229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75229ltr.pdf","1998-11-20 00:00:00",
8572,1,75230,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75230ltr.pdf","1999-11-25 00:00:00",
30805,1,75231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75231ltr.pdf","2003-04-10 00:00:00",
18394,2,75232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide_prntlbl.pdf","2000-01-06 00:00:00",
30806,1,75232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75232ltr.pdf","2000-01-06 00:00:00",
42961,3,75232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide.cfm","2001-12-28 00:00:00",
22442,3,75233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75233_Estradiol.pdf","2000-02-24 00:00:00",
30807,1,75233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75233ltr.pdf","2000-02-24 00:00:00",
8573,1,75235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75235ltr.pdf","2000-01-27 00:00:00",
8574,1,75237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75237ta.pdf","2004-06-18 00:00:00",
8575,1,75237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75237ltr.pdf","2000-05-01 00:00:00",
39467,2,75237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-237_Sotalol%20Hydrochloride_prntlbl.pdf","2004-06-18 00:00:00",
42962,3,75237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-237_Sotalol.cfm","2001-12-28 00:00:00",
8576,1,75238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75238ta.pdf","2004-06-18 00:00:00",
30808,1,75238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75238ltr.pdf","2000-07-13 00:00:00",
8577,1,75239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75239ltr.pdf","2004-06-08 00:00:00",
30809,1,75240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75240ta.pdf","2004-06-08 00:00:00",
30810,1,75240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75240ltr.pdf","2004-06-08 00:00:00",
22443,3,75241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide.cfm","1999-05-28 00:00:00",
30811,1,75241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75241ltr.pdf","1999-05-28 00:00:00",
39468,2,75241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide_prntlbl.pdf","1999-05-28 00:00:00",
8578,1,75242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75242ltr.pdf","2004-06-08 00:00:00",
30812,1,75242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75242ta.pdf","2004-06-08 00:00:00",
8579,1,75243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75243ltr.pdf","2000-06-20 00:00:00",
30813,1,75243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75243ta.pdf","2004-06-09 00:00:00",
30814,1,75245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75245ltr.pdf","2004-06-04 00:00:00",
44251,10,75245,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8580,1,75247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75247ta.pdf","2004-06-09 00:00:00",
30815,1,75247,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75247ltr.pdf","2000-06-23 00:00:00",
8581,1,75249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75249ltr.pdf","2000-06-23 00:00:00",
8582,1,75250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75250wd.pdf","2003-04-10 00:00:00",
42963,3,75250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075250_PrednisoloneTOC.cfm","2006-10-17 00:00:00",
8583,1,75252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75252ltr.pdf","1999-06-07 00:00:00",
30816,1,75253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75253ltr.pdf","1999-08-20 00:00:00",
39469,2,75253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-253_Ticlopidine_prntlbl.pdf","2004-06-18 00:00:00",
42964,3,75253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-253_Ticlopidine.cfm","2003-04-30 00:00:00",
30817,1,75254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75254ltr.pdf","2000-01-14 00:00:00",
8584,1,75256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75256ltr.pdf","1999-08-12 00:00:00",
8585,1,75256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
18395,2,75256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and%20Ethinyl%20Estradiol_Prntlbl.pdf","2004-06-02 00:00:00",
22444,3,75256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256_desogestrel_toc.cfm","2003-07-29 00:00:00",
39470,2,75256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
42965,3,75256,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256s001_desogestrel_toc.cfm","2003-07-29 00:00:00",
8586,1,75256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
22445,3,75256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s002_desogestral_toc.cfm","2003-07-29 00:00:00",
39471,2,75256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
8587,1,75256,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
18396,2,75256,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
22446,3,75256,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s003_desogestrel_toc.cfm","2003-07-29 00:00:00",
22447,3,75256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s004_desogestrel_toc.cfm","2003-07-29 00:00:00",
30818,1,75256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
39472,2,75256,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
22448,3,75256,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s005_desogestrel_toc.cfm","2003-07-29 00:00:00",
30819,1,75256,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
39473,2,75256,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
18397,2,75256,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
30820,1,75256,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
42966,3,75256,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s006_desogestrel_toc.cfm","2003-07-29 00:00:00",
30821,1,75256,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Approv.pdf","2004-06-02 00:00:00",
39474,2,75256,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Prntlbl.pdf","2004-06-02 00:00:00",
42967,3,75256,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075256s007_desogestrel_toc.cfm","2003-07-29 00:00:00",
30822,1,75259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75259ltr.pdf","1998-08-27 00:00:00",
8588,1,75260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75260ltr.pdf","1999-01-25 00:00:00",
18398,2,75260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-260_Tretinoin_prntlbl.pdf","1999-01-25 00:00:00",
22449,3,75260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-260_Tretinoin.cfm","2001-12-26 00:00:00",
30823,1,75262,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75262ltr.pdf","1999-03-31 00:00:00",
30824,1,75263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75263ltr.pdf","2000-06-26 00:00:00",
18399,2,75264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin_prntlbl.pdf","1998-12-24 00:00:00",
22450,3,75264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin.cfm","2001-08-24 00:00:00",
30825,1,75264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf","1998-12-24 00:00:00",
18400,2,75265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin_prntlbl.pdf","1998-12-24 00:00:00",
22451,3,75265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin.cfm","2001-08-24 00:00:00",
30826,1,75265,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf","1998-12-24 00:00:00",
8589,1,75269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75269ta.pdf","2004-06-10 00:00:00",
30827,1,75269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75269ltr.pdf","2000-12-04 00:00:00",
42968,3,75269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075269.PDF","2005-07-22 00:00:00",
8590,1,75270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75270ltr.pdf","1999-03-24 00:00:00",
8591,1,75271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75271ltr.pdf","2000-01-18 00:00:00",
18401,2,75271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn%20Sodium_prntlbl.pdf","2000-02-04 00:00:00",
42969,3,75271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn.cfm","2001-12-26 00:00:00",
8592,1,75273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75273ltr.pdf","1999-06-15 00:00:00",
18402,2,75273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole_prntlbl.pdf","1999-06-15 00:00:00",
42970,3,75273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole.cfm","1999-06-15 00:00:00",
8593,1,75274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75274ltr.pdf","1999-05-26 00:00:00",
22452,3,75274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75274_Naltrexone.pdf","1999-05-26 00:00:00",
8594,1,75276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone%20Dipropionate_Approv.pdf","2003-12-23 00:00:00",
39475,2,75276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/75276_Betamethasone%20Dipropionate_Prntlbl.pdf","2003-12-23 00:00:00",
42971,3,75276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/075276_betamethasone-dipropionate_toc.cfm","2003-12-23 00:00:00",
22453,3,75278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/75278_Paclitaxel.cfm","2004-08-26 00:00:00",
30831,1,75279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75279ltr.pdf","1999-05-28 00:00:00",
42972,3,75279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075279_clobetasol_toc.cfm","2003-08-04 00:00:00",
8595,1,75280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75280taltr.pdf","2004-06-09 00:00:00",
8596,1,75280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75280ltr.pdf","2003-04-10 00:00:00",
8597,1,75282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75282ltr.pdf","1999-06-16 00:00:00",
30832,1,75284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75284ltr.pdf","1999-06-23 00:00:00",
42973,3,75284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075284.PDF","2005-07-22 00:00:00",
8598,1,75285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75285ltr.pdf","1998-10-29 00:00:00",
22454,3,75285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75285_Cimetidine.pdf","1998-10-29 00:00:00",
8599,1,75286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75286ltr.pdf","1999-06-30 00:00:00",
30833,1,75287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75287ltr.pdf","2000-09-18 00:00:00",
8600,1,75288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75288ltr.pdf","1999-07-28 00:00:00",
39476,2,75288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf","2003-12-23 00:00:00",
42974,3,75288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075288_norgestrel-and-ethinyl-estradiol_toc.cfm","2003-12-23 00:00:00",
8601,1,75289,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75289S1Ltr.pdf","2001-02-06 00:00:00",
22455,3,75289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075289.PDF","2005-07-22 00:00:00",
8602,1,75290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75290ltr.pdf","2001-04-30 00:00:00",
22456,3,75290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate.cfm","2001-04-30 00:00:00",
23760,10,75290,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
39477,2,75290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate%20Disodium_prntlbl.pdf","2004-06-14 00:00:00",
30834,1,75292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75292TA.pdf","2004-06-04 00:00:00",
30835,1,75292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75292ltr.pdf","2003-04-10 00:00:00",
44252,10,75292,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8603,1,75293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75293ta.pdf","2004-06-09 00:00:00",
30836,1,75293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75293ltr.pdf","2000-06-20 00:00:00",
52645,3,75293,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/075293Orig1s014.pdf","2018-02-14 00:00:00",
30837,1,75294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75294ta.pdf","2004-06-14 00:00:00",
30838,1,75294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75294ltr.pdf","2000-03-28 00:00:00",
30839,1,75295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75295ltr.pdf","1998-10-28 00:00:00",
42975,3,75295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/075295.PDF","2005-07-22 00:00:00",
44525,14,75295,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
30840,1,75296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75296ltr.pdf","2000-01-14 00:00:00",
8604,1,75297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75297ltr.pdf","2001-03-27 00:00:00",
18403,2,75297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-297_Paclitaxel_prntlbl.pdf","2001-03-27 00:00:00",
22457,3,75297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-297_Paclitaxel.cfm","2001-03-27 00:00:00",
8605,1,75298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75298TA.pdf","2004-06-04 00:00:00",
30841,1,75298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75298ltr.pdf","2003-04-11 00:00:00",
8606,1,75299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75229ltr.pdf","1999-11-03 00:00:00",
8607,1,75300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75300ta.pdf","2004-06-28 00:00:00",
8608,1,75302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75302ltr.pdf","2001-04-16 00:00:00",
8609,1,75303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75303ltr.pdf","1999-05-28 00:00:00",
30842,1,75305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75305ltr.pdf","1998-09-28 00:00:00",
42976,3,75305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75305_Haloperidol%20Decanoate.pdf","1998-09-28 00:00:00",
8610,1,75309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75309ltr.pdf","2000-04-26 00:00:00",
44253,10,75310,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
8611,1,75311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75311ltr.pdf","2001-04-16 00:00:00",
22458,3,75311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075311_famotidine_toc.cfm","2003-08-04 00:00:00",
39478,2,75311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-311_Famotidine_Prntlbl.pdf","2004-06-04 00:00:00",
30843,1,75312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75312ta.pdf","2004-06-04 00:00:00",
30844,1,75312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75312ltr.pdf","2004-06-04 00:00:00",
18404,2,75313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75313_Ipratropium%20Bromide_Prntlbl.pdf","2004-06-07 00:00:00",
30845,1,75313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75313_Ipratropium%20Bromide_Approv.pdf","2004-06-07 00:00:00",
42977,3,75313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075313_ipratropium_toc.cfm","2003-08-04 00:00:00",
30846,1,75314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75314ltr.pdf","1999-06-15 00:00:00",
8612,1,75315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf","1998-12-23 00:00:00",
42978,3,75315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075315_amiodarone_toc.cfm","2003-08-04 00:00:00",
44254,10,75315,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8613,1,75315,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf","2000-06-30 00:00:00",
30847,1,75315,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf","2000-06-30 00:00:00",
30848,1,75315,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf","2000-04-12 00:00:00",
8614,1,75315,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf","2000-04-12 00:00:00",
8615,1,75316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75316ltr.pdf","1999-11-02 00:00:00",
8616,1,75318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75318ltr.pdf","1999-08-20 00:00:00",
18405,2,75318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-318_Ticlopidine_prntlbl.pdf","2004-06-18 00:00:00",
42979,3,75318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-318_Ticlopidine.cfm","2003-04-30 00:00:00",
8617,1,75319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75319ltr.pdf","1999-06-15 00:00:00",
8618,1,75321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75321ltr.pdf","1998-12-04 00:00:00",
8619,1,75323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75323ltr.pdf","2000-04-21 00:00:00",
30849,1,75324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75324ta.pdf","2004-06-09 00:00:00",
30850,1,75324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75324ltr.pdf","2000-06-20 00:00:00",
30851,1,75325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75325ltr.pdf","1998-12-24 00:00:00",
8620,1,75326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75326ltr.pdf","1999-08-20 00:00:00",
22459,3,75326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-326_Ticlopidine.cfm","2001-12-20 00:00:00",
39479,2,75326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-326_Ticlopidine%20Hydrochloride_prntlbl.pdf","2004-06-18 00:00:00",
8621,1,75327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75327ltr.pdf","1999-03-24 00:00:00",
30852,1,75328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75328ltr.pdf","2000-04-19 00:00:00",
8622,1,75329,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75329ltr.pdf","1999-04-20 00:00:00",
39480,2,75329,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-329_Miconazole%20Nitrate_prntlbl.pdf","2004-06-09 00:00:00",
42980,3,75329,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-329_Miconazole.cfm","2001-12-18 00:00:00",
8623,1,75337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75337ltr.pdf","1999-05-26 00:00:00",
30853,1,75338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75338ltr.pdf","2001-02-09 00:00:00",
22460,3,75339,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075339.PDF","2004-12-07 00:00:00",
8624,1,75340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75340ltr.pdf","1999-02-24 00:00:00",
8625,1,75341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75341ltr.pdf","1999-07-27 00:00:00",
30854,1,75342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75342ltr.pdf","1999-11-04 00:00:00",
8626,1,75343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75343ltr.pdf","1999-11-09 00:00:00",
22461,3,75343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75343_Albuterol.pdf","2004-05-26 00:00:00",
30855,1,75345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75345ltr.pdf","1999-06-16 00:00:00",
30856,1,75346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75346ltr.pdf","1999-10-25 00:00:00",
8627,1,75347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75347ta.pdf","2004-06-10 00:00:00",
30857,1,75347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75347ltr.PDF","2001-11-16 00:00:00",
42981,3,75347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075347.PDF","2004-12-07 00:00:00",
8628,1,75348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75348ltr.pdf","2000-11-29 00:00:00",
22462,3,75350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075350_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
24152,16,75350,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
22463,3,75351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-351_Butalbital.cfm","2003-04-30 00:00:00",
8629,1,75352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75352ltr.pdf","1998-11-30 00:00:00",
30858,1,75353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75353ltr.pdf","2001-01-12 00:00:00",
30859,1,75355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75355ta.pdf","1999-12-29 00:00:00",
23761,10,75356,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
30860,1,75356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75356ap.pdf","2003-07-31 00:00:00",
8630,1,75357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75357ltr.pdf","1999-07-30 00:00:00",
42982,3,75357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/1999/075357Orig1s000.pdf","2015-07-21 00:00:00",
18406,2,75358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol%20Sulfate_prntlbl.pdf","2004-05-26 00:00:00",
30861,1,75358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75358ltr.pdf","2000-03-29 00:00:00",
42983,3,75358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-358_Albuterol.cfm","2000-03-29 00:00:00",
42984,3,75360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/075360_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8631,1,75361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75361ltr.pdf","2000-10-05 00:00:00",
8632,1,75362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75362ltr.pdf","1999-06-15 00:00:00",
8633,1,75363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75363Ltr.pdf","2000-12-29 00:00:00",
8634,1,75366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf","2000-05-01 00:00:00",
30862,1,75366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf","2004-06-18 00:00:00",
39481,2,75366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf","2004-06-17 00:00:00",
42985,3,75366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm","2001-12-18 00:00:00",
8635,1,75368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75368ltr.pdf","2000-02-15 00:00:00",
8636,1,75369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75370ta.pdf","2004-06-28 00:00:00",
30863,1,75370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75370ltr.pdf","2000-08-22 00:00:00",
8637,1,75371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75371ltr.pdf","1999-08-27 00:00:00",
8638,1,75373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75373ltr.pdf","1999-06-22 00:00:00",
22464,3,75373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-373_Betamethasone%20Dipropionate.pdf","2002-01-17 00:00:00",
18407,2,75374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone%20Diacetate_prntlbl.pdf","2004-06-02 00:00:00",
22465,3,75374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone.cfm","1999-04-27 00:00:00",
30864,1,75374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75374ltr.pdf","1999-04-27 00:00:00",
30865,1,75375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75375ltr.pdf","1999-09-30 00:00:00",
8639,1,75379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75379ltr.pdf","2000-12-15 00:00:00",
30866,1,75382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75382ltr.pdf","1999-04-30 00:00:00",
42986,3,75382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075382_ORIGINAL APPROVAL_PACKAGE.pdf","2007-04-09 00:00:00",
8640,1,75383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75383ltr.pdf","1999-11-22 00:00:00",
22466,3,75383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075383.PDF","2005-07-22 00:00:00",
30867,1,75384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75348ltr.pdf","2000-12-01 00:00:00",
8641,1,75385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75388TA.pdf","2004-05-28 00:00:00",
30868,1,75385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75385ltr.pdf","2003-04-10 00:00:00",
8642,1,75386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75386ltr.pdf","2000-06-30 00:00:00",
30869,1,75387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75387ltr.pdf","2000-04-06 00:00:00",
8643,1,75389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75389ltr.pdf","2001-01-25 00:00:00",
23762,10,75389,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
30870,1,75390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75390ltr.pdf","2001-04-19 00:00:00",
39482,2,75390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen_prntlbl.pdf","2001-04-19 00:00:00",
42987,3,75390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen.cfm","2001-04-19 00:00:00",
30871,1,75391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75391ltr.pdf","1999-02-08 00:00:00",
42988,3,75391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075391_clobetasol_toc.cfm","2003-08-04 00:00:00",
8644,1,75392,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75392ltr.pdf","2000-09-19 00:00:00",
39483,2,75392,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75392_Propofol_Prntlbl.pdf","2004-06-14 00:00:00",
42989,3,75392,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075392_propofol_toc.cfm","2003-08-04 00:00:00",
44255,10,75392,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm","2007-06-18 00:00:00",
8645,1,75393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75393ltr.pdf","1999-05-11 00:00:00",
42990,3,75393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75393_Haloperidol.pdf","1999-05-11 00:00:00",
22467,3,75394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm","2004-05-26 00:00:00",
30872,1,75394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75394ltr.pdf","1999-11-22 00:00:00",
8646,1,75395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75395ltr.pdf","2000-03-16 00:00:00",
8647,1,75396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75396ltr.pdf","2000-06-20 00:00:00",
30873,1,75400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75400taltr.pdf","2003-04-10 00:00:00",
8648,1,75401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75401TA.pdf","2004-06-18 00:00:00",
22468,3,75401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075401.pdf","2005-07-22 00:00:00",
8649,1,75402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75402ltr.pdf","2001-02-28 00:00:00",
8650,1,75403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75403ltr.pdf","2001-02-28 00:00:00",
8651,1,75404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75404ltr.pdf","2004-06-04 00:00:00",
8652,1,75405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75405ta.pdf","2004-06-01 00:00:00",
8653,1,75405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75405ltr.pdf","2000-02-28 00:00:00",
42991,3,75405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075405_cladribine_toc.cfm","2003-08-04 00:00:00",
30874,1,75406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/75406ltr.pdf","1999-12-15 00:00:00",
8654,1,75406,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075406Orig1s016ltr.pdf","2013-04-24 00:00:00",
39484,2,75406,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/075406s016lbl.pdf","2013-04-23 00:00:00",
8655,1,75407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75407ltr.pdf","2000-01-28 00:00:00",
8656,1,75409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75409ta.pdf","2004-06-09 00:00:00",
30875,1,75409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75409ltr.pdf","2000-06-20 00:00:00",
8657,1,75410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75410TA.pdf","2004-06-28 00:00:00",
42992,3,75410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075410.PDF","2005-07-22 00:00:00",
18408,2,75411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75411_Timolol%20Maleate%20Ophthalmic_Prntlbl.pdf","2004-06-28 00:00:00",
22469,3,75411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075411_timolol_toc.cfm","2003-08-04 00:00:00",
30876,1,75411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75411ltr.pdf","2000-09-08 00:00:00",
8658,1,75412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75412ltr.pdf","2000-09-08 00:00:00",
18409,2,75412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-412_Timolol%20Maleate_prntlbl.pdf","2000-09-08 00:00:00",
22470,3,75412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-412_Timolol.cfm","2001-12-17 00:00:00",
8659,1,75413,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75413ltr.pdf","2003-04-10 00:00:00",
8660,1,75414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/075414s000_ltr.pdf","2007-02-12 00:00:00",
22471,3,75416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075416Orig1s000.pdf","2014-08-01 00:00:00",
30877,1,75417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75417ltr.pdf","1999-05-27 00:00:00",
42993,3,75417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075417_clozapine_toc.cfm","2003-08-04 00:00:00",
44526,14,75417,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
8661,1,75417,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf","2010-04-28 00:00:00",
8662,1,75417,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf","2010-04-28 00:00:00",
30878,1,75417,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/75417s021s024s025ltr.pdf","2010-04-28 00:00:00",
8663,1,75419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75419ltr.pdf","2000-07-28 00:00:00",
8664,1,75421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75421ta.pdf","2004-06-09 00:00:00",
8665,1,75421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75421ltr.pdf","2000-06-20 00:00:00",
30879,1,75423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75423ltr.pdf","2001-04-27 00:00:00",
8666,1,75424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75424ltr.pdf","2001-03-30 00:00:00",
44256,10,75424,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8667,1,75425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75425ltr.pdf","1999-07-29 00:00:00",
8668,1,75426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75426ltr.pdf","2000-10-18 00:00:00",
42994,3,75427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075427_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-24 00:00:00",
18410,2,75429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol%20Hydrochloride_prntlbl.pdf","2004-06-17 00:00:00",
30880,1,75429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75429ta.pdf","2004-06-17 00:00:00",
30881,1,75429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75429ltr.pdf","2000-05-01 00:00:00",
42995,3,75429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol.cfm","2001-12-17 00:00:00",
22472,3,75430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-430_clobetasol.cfm","2003-04-30 00:00:00",
30882,1,75430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75430ltr.pdf","1999-05-26 00:00:00",
30883,1,75431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75431ltr.pdf","1999-12-29 00:00:00",
30884,1,75432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75432ltr.pdf","2000-10-18 00:00:00",
18411,2,75434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-434_Naltrexone%20Hydrochloride_prntlbl.pdf","2004-06-09 00:00:00",
30885,1,75434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75434ltr.pdf","2000-03-08 00:00:00",
42996,3,75434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-434_Naltrexone.cfm","2000-03-08 00:00:00",
8669,1,75435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75435ltr.pdf","2004-10-08 00:00:00",
8670,1,75439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75439ltr.pdf","2000-04-19 00:00:00",
8671,1,75440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75440ltr.pdf","2000-02-28 00:00:00",
22473,3,75440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075440_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-09 00:00:00",
8672,1,75440,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/075440s023ltr.pdf","2008-01-09 00:00:00",
8673,1,75441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75441ltr.pdf","2001-03-28 00:00:00",
42997,3,75441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-441_Ipratropium%20Bromide.pdf","2001-03-28 00:00:00",
30886,1,75446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75446ltr.pdf","2000-09-28 00:00:00",
30887,1,75448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75448ltr.pdf","2000-06-19 00:00:00",
23763,10,75452,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30888,1,75452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75452ta.pdf","2004-06-04 00:00:00",
30889,1,75453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453ltr.pdf","2000-10-18 00:00:00",
30890,1,75453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75453TA.pdf","2004-06-02 00:00:00",
8674,1,75455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75455ltr.pdf","2000-06-20 00:00:00",
8675,1,75456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75456ta.pdf","2004-06-28 00:00:00",
8676,1,75457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75457ta.pdf","2004-06-04 00:00:00",
30891,1,75457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75457ltr.pdf","2001-04-18 00:00:00",
8677,1,75458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75456ta.pdf","2004-06-28 00:00:00",
39485,2,75458,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075458s007lbl.pdf","2010-05-07 00:00:00",
30892,1,75459,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf","2000-08-22 00:00:00",
30893,1,75463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75463ltr.pdf","1999-07-26 00:00:00",
8678,1,75464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75464TA.pdf","2004-06-04 00:00:00",
44257,10,75464,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8679,1,75465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Approv.pdf","2004-06-04 00:00:00",
30894,1,75465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75465ltr.pdf","2004-06-04 00:00:00",
39486,2,75465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Prntlbl.pdf","2004-06-04 00:00:00",
42998,3,75465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075465_fluoxetine_toc.cfm","2003-08-04 00:00:00",
44258,10,75465,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8680,1,75466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75466ltr.pdf","2000-10-18 00:00:00",
22474,3,75467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-467_Buspirone.pdf","2002-07-17 00:00:00",
30895,1,75467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75467ltr&TA.pdf","2001-03-28 00:00:00",
8681,1,75467,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf","2003-04-10 00:00:00",
30896,1,75467,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf","2003-04-10 00:00:00",
30897,1,75468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75468ltr.pdf","2000-10-06 00:00:00",
8682,1,75469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75469ta.pdf","2004-05-28 00:00:00",
30898,1,75469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75469ltr.pdf","2000-09-25 00:00:00",
30899,1,75471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf","2000-10-25 00:00:00",
30900,1,75472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75472ltr.pdf","2000-08-22 00:00:00",
30901,1,75472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75472ta.pdf","2004-06-03 00:00:00",
30902,1,75473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75473ltr.pdf","2000-08-03 00:00:00",
8683,1,75475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75475ltr.pdf","2000-08-03 00:00:00",
30903,1,75476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75476ta.pdf","2004-05-28 00:00:00",
30904,1,75476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75476ltr.pdf","2000-01-03 00:00:00",
30905,1,75478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75478TA.pdf","2004-06-10 00:00:00",
30906,1,75479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ltr.pdf","2000-08-22 00:00:00",
30907,1,75479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ta.pdf","2004-06-03 00:00:00",
8684,1,75480,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75480ltr.pdf","2000-08-22 00:00:00",
8685,1,75480,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75480ta.pdf","2004-06-03 00:00:00",
30908,1,75481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75481ltr.pdf","2000-06-30 00:00:00",
8686,1,75482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ltr.pdf","2000-08-22 00:00:00",
8687,1,75482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ta.pdf","2004-06-03 00:00:00",
30909,1,75483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75483ltr.pdf","2000-08-22 00:00:00",
30910,1,75484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75484ltr.pdf","2000-06-20 00:00:00",
8688,1,75486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75486ltr.pdf","2001-04-16 00:00:00",
30911,1,75486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75486TA.pdf","2004-06-04 00:00:00",
8689,1,75488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75488ltr.pdf","2001-04-16 00:00:00",
30912,1,75488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75488TA.pdf","2004-06-04 00:00:00",
8690,1,75491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75491ltr.pdf","2000-04-17 00:00:00",
22475,3,75491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075491_bupropion_toc.cfm","2003-07-30 00:00:00",
44259,10,75491,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
8691,1,75492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75492ltr.pdf","2000-02-11 00:00:00",
22476,3,75492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75492_Doclofenac.pdf","2000-02-11 00:00:00",
22477,3,75493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-493_Vincristine%20Sulfate.pdf","1999-09-14 00:00:00",
30913,1,75493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75493ltr.pdf","1999-09-01 00:00:00",
8692,1,75494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75494ltr.pdf","2000-06-30 00:00:00",
8693,1,75496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf","2004-06-03 00:00:00",
8694,1,75497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75497ltr.pdf","2000-01-14 00:00:00",
8695,1,75498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75498ltr.pdf","2001-04-12 00:00:00",
22478,3,75499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075499_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-27 00:00:00",
30914,1,75500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75500ltr.pdf","2001-04-27 00:00:00",
8696,1,75501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75501ta.pdf","2004-06-03 00:00:00",
30915,1,75501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75501ltr.pdf","2000-08-22 00:00:00",
22479,3,75502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-502_Clotrimazole.cfm","2001-06-05 00:00:00",
30916,1,75502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf","2001-06-05 00:00:00",
8697,1,75503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/075503s000ltr.pdf","2006-10-02 00:00:00",
8698,1,75504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75504ltr.pdf","2003-04-10 00:00:00",
44260,10,75504,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-09-24 00:00:00",
8699,1,75505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75505apltr.pdf","2003-12-12 00:00:00",
22480,3,75506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75506_Prozac.pdf","2001-08-02 00:00:00",
23764,10,75506,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30917,1,75506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75506ltr.pdf","2001-08-02 00:00:00",
8700,1,75507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75507ltr.pdf","2001-01-19 00:00:00",
8701,1,75508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75508ltr.pdf","2000-04-24 00:00:00",
30918,1,75509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75509ltr.pdf","2000-10-19 00:00:00",
8702,1,75510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75510TAPF2.pdf","2004-06-28 00:00:00",
30919,1,75511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75511ltr.pdf","2001-04-16 00:00:00",
23765,10,75514,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8703,1,75515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75515ltr.pdf","2003-04-14 00:00:00",
30920,1,75517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75517ltr.pdf","2000-03-14 00:00:00",
42999,3,75517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75517_Ursodiol.pdf","2000-03-14 00:00:00",
8704,1,75518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75518ta.pdf","2004-06-09 00:00:00",
8705,1,75518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75518ltr.pdf","2000-11-17 00:00:00",
30921,1,75520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75520ltr.pdf","2000-05-08 00:00:00",
8706,1,75521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75521TA.pdf","2004-05-28 00:00:00",
8707,1,75521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75521.ap.pdf","2003-04-10 00:00:00",
30922,1,75522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75522ltr.pdf","2000-04-17 00:00:00",
43000,3,75522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-522_Isosorbide%20Mononitrate.pdf","2000-04-17 00:00:00",
22481,3,75523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75523_Pentazocine_Naloxone.pdf","2000-03-17 00:00:00",
30923,1,75523,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523ltr.pdf","2000-03-17 00:00:00",
53968,14,75523,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/075523_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8708,1,75524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75524ltr.pdf","1999-11-29 00:00:00",
44261,10,75525,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
53969,14,75525,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/075525_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8709,1,75527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ta.pdf","2004-05-28 00:00:00",
30924,1,75527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75527ltr.pdf","2000-09-25 00:00:00",
30925,1,75528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75528ltr.pdf","1999-08-30 00:00:00",
8710,1,75529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75529ltr.pdf","2000-02-22 00:00:00",
43001,3,75529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75529_Tretinoin.pdf","2001-06-07 00:00:00",
8711,1,75530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75530ta.pdf","2004-06-09 00:00:00",
8712,1,75536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ltr.pdf","2000-10-18 00:00:00",
30926,1,75536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ta.pdf","2004-06-02 00:00:00",
44614,16,75539,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
30927,1,75541,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75441ltr.pdf","1999-10-22 00:00:00",
8713,1,75541,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075541Orig1s010ltr.pdf","2014-12-31 00:00:00",
18412,2,75541,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf","2014-12-31 00:00:00",
30928,1,75546,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75546ltr.pdf","2000-01-20 00:00:00",
8714,1,75547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75547ltr.pdf","2001-04-02 00:00:00",
22482,3,75547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa.cfm","2001-12-17 00:00:00",
39487,2,75547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa_prntlbl.pdf","2001-04-02 00:00:00",
30929,1,75547,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/075547Orig1s006ltr.pdf","2015-07-30 00:00:00",
39488,2,75547,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/075547Orig1s006lbl.pdf","2015-07-30 00:00:00",
22483,3,75548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075548Orig1s000.pdf","2013-05-02 00:00:00",
30930,1,75548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75548ltr.pdf","2001-02-05 00:00:00",
30931,1,75549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75549ltr.pdf","2000-06-13 00:00:00",
18413,2,75549,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075549s009lbl.pdf","2010-12-04 00:00:00",
43002,3,75551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075551.PDF","2005-07-22 00:00:00",
43003,3,75552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075552_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-26 00:00:00",
22484,3,75553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075553_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-26 00:00:00",
30932,1,75555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75555ltr.pdf","2000-02-18 00:00:00",
30933,1,75556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75556ltr.pdf","2000-08-22 00:00:00",
30934,1,75556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75556ta.pdf","2004-06-03 00:00:00",
8715,1,75558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75558.ap.pdf","2003-04-14 00:00:00",
8716,1,75559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75559ltr.pdf","2000-03-20 00:00:00",
30935,1,75561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75561ltr.pdf","2000-11-14 00:00:00",
30936,1,75562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75562.ap.pdf","2003-04-14 00:00:00",
43004,3,75562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075562.pdf","2005-07-22 00:00:00",
30937,1,75564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75564ltr.pdf","2000-10-27 00:00:00",
44262,10,75566,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
22485,3,75567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine.cfm","2001-12-17 00:00:00",
30938,1,75567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75567ltr.pdf","2001-03-29 00:00:00",
39489,2,75567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine_prntlbl.pdf","2001-03-29 00:00:00",
30939,1,75568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75568ltr.pdf","1999-12-13 00:00:00",
8717,1,75569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75569ltr.pdf","2003-04-14 00:00:00",
22486,3,75570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075570_s000_AmmoniumTOC.cfm","2006-04-20 00:00:00",
8718,1,75571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75571ltr.pdf","2000-08-22 00:00:00",
8719,1,75571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75571ta.pdf","2004-06-03 00:00:00",
8720,1,75572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75572ap.pdf","2003-04-10 00:00:00",
30940,1,75572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75572ta.pdf","2004-05-28 00:00:00",
30941,1,75574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75574ta.pdf","2004-06-02 00:00:00",
30942,1,75574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75574ltr.pdf","2000-10-18 00:00:00",
30943,1,75577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75577TA.pdf","2004-06-04 00:00:00",
44263,10,75577,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8721,1,75578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ta.pdf","2004-06-03 00:00:00",
30944,1,75578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ltr.pdf","2000-08-22 00:00:00",
8722,1,75579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75579ltr.pdf","2000-09-25 00:00:00",
8723,1,75579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75579ta.pdf","2004-05-28 00:00:00",
8724,1,75580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ltr.pdf","2000-10-18 00:00:00",
8725,1,75580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ta.pdf","2004-06-02 00:00:00",
18414,2,75581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf","2000-04-25 00:00:00",
30945,1,75581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75581ltr.pdf","2000-04-25 00:00:00",
43005,3,75581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole.cfm","2000-04-25 00:00:00",
8726,1,75582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75582ltr.pdf","2001-02-23 00:00:00",
8727,1,75583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75583ta.pdf","2004-06-03 00:00:00",
30946,1,75583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523LTR.PDF","2000-08-22 00:00:00",
23766,10,75584,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
30947,1,75584,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75584ltr.pdf","2000-02-07 00:00:00",
43006,3,75584,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75584_Bupropion.pdf","2001-06-07 00:00:00",
30948,1,75585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75585ltr.pdf","2000-12-21 00:00:00",
8728,1,75588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75588TA.pdf","2004-06-07 00:00:00",
30949,1,75588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75588.ap.pdf","2003-04-10 00:00:00",
39490,2,75588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75588_Prntlbl.pdf","2003-12-24 00:00:00",
43007,3,75588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075588_ibuprofen-pseudoephedrine_toc.cfm","2003-12-24 00:00:00",
8729,1,75590,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75590TA.pdf","2004-06-09 00:00:00",
8730,1,75591,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75591ltr.pdf","2001-05-10 00:00:00",
30950,1,75592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75592ltr.pdf","2000-05-25 00:00:00",
43008,3,75592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-592_Ursodiol.pdf","2001-03-08 00:00:00",
8731,1,75593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75593ltr.pdf","2004-06-15 00:00:00",
30951,1,75594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75594.ta.pdf","2003-04-14 00:00:00",
43009,3,75594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075594.pdf","2005-07-22 00:00:00",
44264,10,75594,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
30952,1,75595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75595ltr.pdf","2000-02-28 00:00:00",
8732,1,75597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75597ltr.pdf","1999-12-23 00:00:00",
8733,1,75598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75598ta.pdf","2004-06-09 00:00:00",
8734,1,75598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75598ltr.pdf","2001-06-13 00:00:00",
22487,3,75598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075598Orig1s000.pdf","2015-07-22 00:00:00",
22488,3,75602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075602_aminocaproic_toc.cfm","2003-08-04 00:00:00",
30953,1,75602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75602ltr.pdf","2001-05-24 00:00:00",
30954,1,75604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75604.ap.pdf","2003-04-10 00:00:00",
8735,1,75606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75606ltr.pdf","2000-08-23 00:00:00",
8736,1,75607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75607ltr.pdf","2001-05-10 00:00:00",
8737,1,75609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75609ltr.pdf","2000-10-18 00:00:00",
18415,2,75609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75609_Doxazosin%20Mesylate_Prntlbl.pdf","2004-06-02 00:00:00",
43010,3,75609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075609_doxazosin_toc.cfm","2003-07-30 00:00:00",
30955,1,75610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75610.apf.pdf","2003-04-10 00:00:00",
8738,1,75611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75611_Famotidine_Approv.pdf","2003-12-24 00:00:00",
18416,2,75611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pdf","2003-12-24 00:00:00",
22489,3,75611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075611_famotidine_toc.cfm","2003-12-24 00:00:00",
8739,1,75613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75613ltr.pdf","2000-10-10 00:00:00",
22490,3,75613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-613_Bupropiion%20Hydrochloride.pdf","2001-12-05 00:00:00",
44265,10,75613,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
30956,1,75614,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75614ltr.pdf","2001-01-30 00:00:00",
30957,1,75615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75615ltr.pdf","2001-01-26 00:00:00",
30958,1,75616,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75616ta.pdf","2004-06-10 00:00:00",
30959,1,75618,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75618ltr.pdf","2001-03-23 00:00:00",
8740,1,75619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75619ta.pdf","2004-06-09 00:00:00",
30960,1,75619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75619ltr.pdf","2000-11-17 00:00:00",
30961,1,75620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75620ltr.pdf","2000-11-01 00:00:00",
30962,1,75621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75621ltr.pdf","2000-08-22 00:00:00",
30963,1,75621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75621ta.pdf","2004-06-03 00:00:00",
8741,1,75622,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75622ltr.pdf","2001-04-16 00:00:00",
30964,1,75622,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75622TA.pdf","2004-06-04 00:00:00",
8742,1,75624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75624ta.pdf","2004-06-03 00:00:00",
8743,1,75624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75624.ap.pdf","2001-09-18 00:00:00",
30965,1,75627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75627ltr.pdf","2001-03-28 00:00:00",
8744,1,75629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75629ltr.pdf","2000-05-09 00:00:00",
23767,10,75629,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
43011,3,75629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-629_Mythylphenidate%20Hydrochloride.pdf","2001-12-05 00:00:00",
8745,1,75630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75630ltr.pdf","2001-04-12 00:00:00",
30966,1,75630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75630ta.pdf","2005-04-08 00:00:00",
30967,1,75632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75632ltr.pdf","2000-09-27 00:00:00",
22491,3,75633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075633_approval_package.pdf","2003-08-04 00:00:00",
30968,1,75634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75634ltr.pdf","2000-08-22 00:00:00",
30969,1,75634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75634ta.pdf","2004-06-03 00:00:00",
8746,1,75635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75635.ap..pdf","2003-04-14 00:00:00",
43012,3,75635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/75-635_Etoposide.pdf","2001-09-19 00:00:00",
22492,3,75636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075636.PDF","2005-07-22 00:00:00",
8747,1,75637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75637ltr.pdf","2000-10-31 00:00:00",
8748,1,75640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75640ltr.pdf","2000-01-28 00:00:00",
43013,3,75640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075640.pdf","2005-07-22 00:00:00",
30970,1,75641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75641ltr.pdf","2000-10-19 00:00:00",
30971,1,75642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75642ltr.pdf","2000-12-27 00:00:00",
30972,1,75643,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75643ltr.pdf","2000-11-16 00:00:00",
30973,1,75646,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75646ltr.pdf","2000-10-18 00:00:00",
8749,1,75647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75647ltr.pdf","2001-02-05 00:00:00",
8750,1,75650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75650ta.pdf","2004-06-04 00:00:00",
8751,1,75650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75650d2.apf.pdf","2003-04-14 00:00:00",
43014,3,75650,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/75650ap.pdf","2003-09-25 00:00:00",
8752,1,75651,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75651ltr.pdf","2001-04-16 00:00:00",
30974,1,75656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75656ltr.pdf","2001-01-30 00:00:00",
43015,3,75656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075656.PDF","2005-07-22 00:00:00",
30975,1,75657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75657ltr.pdf","2001-01-23 00:00:00",
23768,10,75658,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30976,1,75658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75658ta.pdf","2004-06-04 00:00:00",
8753,1,75659,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75659TA.pdf","2003-04-14 00:00:00",
18417,2,75660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75660_Milrinone%20Lactate_Prntlbl.pdf","2003-12-24 00:00:00",
22493,3,75660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075660_milrinone-lactate_toc.cfm","2003-12-24 00:00:00",
30977,1,75660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75660_Milrinone%20Lactate_Approv.pdf","2003-12-24 00:00:00",
18418,2,75661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75661_Ibuprofen_Prntlbl.pdf","2003-12-24 00:00:00",
30978,1,75661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75661_Ibuprofen_Approv.pdf","2003-12-24 00:00:00",
43016,3,75661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075661_ibuprofen_toc.cfm","2003-12-24 00:00:00",
23769,10,75662,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30979,1,75663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75663ltr.pdf","2000-11-07 00:00:00",
43017,3,75663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075663.PDF","2005-07-22 00:00:00",
8754,1,75664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf","2003-04-14 00:00:00",
43018,3,75664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075664.pdf","2005-07-22 00:00:00",
30980,1,75665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75665ltrTA.pdf","2000-07-31 00:00:00",
30981,1,75665,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf","2001-02-05 00:00:00",
30982,1,75665,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf","2001-02-05 00:00:00",
8755,1,75665,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf","2001-02-05 00:00:00",
30983,1,75666,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75666ltr.pdf","2000-05-24 00:00:00",
8756,1,75667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75667ltr.pdf","2000-07-28 00:00:00",
8757,1,75669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75669TA.pdf","2004-06-04 00:00:00",
8758,1,75669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75669ltr.pdf","2001-04-16 00:00:00",
8759,1,75671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf","2001-07-25 00:00:00",
22494,3,75671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf","2002-01-17 00:00:00",
30984,1,75671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75671ta.pdf","2004-06-09 00:00:00",
8760,1,75672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ltr.pdf","2000-09-25 00:00:00",
30985,1,75672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75672ta.pdf","2004-05-28 00:00:00",
30986,1,75673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75673ltr.pdf","2001-05-29 00:00:00",
8761,1,75678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75678ltr.pdf","2000-07-26 00:00:00",
8762,1,75679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75679.ap.pdf","2003-04-10 00:00:00",
8763,1,75682,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75682ltr.pdf","2003-04-14 00:00:00",
22495,3,75682,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075682.PDF","2005-07-22 00:00:00",
30987,1,75684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75684ltr.pdf","2001-04-16 00:00:00",
43019,3,75684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075684_famotidine_toc.cfm","2003-07-30 00:00:00",
8764,1,75685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75685ta.pdf","2004-06-24 00:00:00",
30988,1,75686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75686ltr.pdf","2001-01-19 00:00:00",
8765,1,75687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75687ltr.pdf","2000-10-24 00:00:00",
24153,16,75687,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
30989,1,75689,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75689ltr.pdf","2001-03-09 00:00:00",
8766,1,75690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75690TA.pdf","2004-06-04 00:00:00",
23770,10,75690,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
30990,1,75693,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75693ltr.pdf","2001-01-26 00:00:00",
24154,16,75694,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
8767,1,75696,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75696ltr.pdf","2000-07-31 00:00:00",
8768,1,75698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75698.ap.pdf","2003-04-14 00:00:00",
18419,2,75702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn%20Sodium_prntlbl.pdf","2001-07-03 00:00:00",
22496,3,75702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn.cfm","2001-07-03 00:00:00",
30991,1,75702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn%20Sodium_Approv.pdf","2001-07-03 00:00:00",
8769,1,75703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75703ltr.pdf","2000-11-27 00:00:00",
30992,1,75704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704ltr.pdf","2001-04-16 00:00:00",
30993,1,75704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704TA.pdf","2004-06-04 00:00:00",
8770,1,75705,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75705TA.pdf","2004-06-04 00:00:00",
30994,1,75705,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75705ltr.pdf","2001-04-16 00:00:00",
8771,1,75706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75706_Loratadine And Pseudoephedrine Sulfate_Approv.pdf","2003-12-24 00:00:00",
18420,2,75706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/75706_Loratadine And Pseudoephedrine Sulfate_Prntlbl.pdf","2003-12-24 00:00:00",
43020,3,75706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/075706_loratadine-pseudoephedrine_toc.cfm","2003-12-24 00:00:00",
8772,1,75707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75707TA.pdf","2004-06-04 00:00:00",
30995,1,75708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75708TA.pdf","2004-06-04 00:00:00",
30996,1,75709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75709ltr.pdf","2001-04-16 00:00:00",
30997,1,75709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75709TA.pdf","2004-06-04 00:00:00",
8773,1,75710,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf","2008-02-07 00:00:00",
23771,10,75710,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-02-28 00:00:00",
43021,3,75710,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/075710Orig1s000.pdf","2012-03-30 00:00:00",
24155,16,75712,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
44527,14,75713,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
24156,16,75714,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
44266,10,75716,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2005-08-01 00:00:00",
30998,1,75718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75718ltr.pdf","2001-04-16 00:00:00",
23772,10,75719,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2006-07-05 00:00:00",
30999,1,75719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75719 APltr.pdf","2006-07-03 00:00:00",
44267,10,75719,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/sertraline/default.htm","2005-08-01 00:00:00",
8774,1,75721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75721ap.pdf","2003-04-14 00:00:00",
8775,1,75725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75725ltr.pdf","2000-12-19 00:00:00",
43022,3,75725,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-725_Sotalol%20Hydrochloride.pdf","2001-12-05 00:00:00",
8776,1,75726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75726ltr.pdf","2001-03-30 00:00:00",
8777,1,75727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727TA.pdf","2004-06-03 00:00:00",
31000,1,75727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75727ltr.pdf","2004-06-24 00:00:00",
8778,1,75730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75730ltr.pdf","2001-04-20 00:00:00",
31001,1,75731,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75731ltr.pdf","2000-04-27 00:00:00",
8779,1,75733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75733_Clobetasol Propionate_Approv.pdf","2003-12-24 00:00:00",
18421,2,75733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75733_Clobetasol Propionate_Prntlbl.pdf","2003-12-24 00:00:00",
22497,3,75733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075733_clobetasol_propionate_toc.cfm","2003-12-24 00:00:00",
8780,1,75734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75734ltr.pdf","2000-08-29 00:00:00",
8781,1,75737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75737.AP.pdf","2003-04-10 00:00:00",
22498,3,75737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075737Orig1s000.pdf","2015-07-22 00:00:00",
31002,1,75738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75738ltr.pdf","2001-02-02 00:00:00",
8782,1,75742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75742ltr.pdf","2000-11-29 00:00:00",
8783,1,75743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75743TA.pdf","2004-06-24 00:00:00",
31003,1,75747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75747TA.pdf","2004-06-01 00:00:00",
31004,1,75747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75747ltr.pdf","2004-06-15 00:00:00",
8784,1,75749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75749.apd.pdf","2003-04-15 00:00:00",
31005,1,75750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75750ltr.pdf","2004-06-02 00:00:00",
8785,1,75751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75751ltr.pdf","2001-03-12 00:00:00",
22499,3,75751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-751_Desonide.pdf","2001-03-12 00:00:00",
31006,1,75752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75752ltr.pdf","2003-04-15 00:00:00",
31007,1,75753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75753.ta.pdf","2003-04-10 00:00:00",
18422,2,75753,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/075753s005lbl.pdf","2013-02-20 00:00:00",
18423,2,75755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf","2004-06-04 00:00:00",
23773,10,75755,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
31008,1,75755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf","2001-08-02 00:00:00",
43023,3,75755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075755_fluoxetine_toc.cfm","2003-08-04 00:00:00",
18424,2,75755,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf","2015-08-31 00:00:00",
31009,1,75758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75758TA.pdf","2004-06-04 00:00:00",
23774,10,75761,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31010,1,75761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf","2003-04-15 00:00:00",
43024,3,75761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075761_s000_AmiodaroneTOC.cfm","2006-04-20 00:00:00",
31011,1,75762,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75762TA.pdf","2004-06-10 00:00:00",
23775,10,75763,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8786,1,75764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75764ltr.pdf","2001-06-05 00:00:00",
43025,3,75764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075764.PDF","2005-07-22 00:00:00",
31012,1,75765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75765.ap.pdf","2003-04-15 00:00:00",
31013,1,75768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75768ltr.pdf","2000-09-25 00:00:00",
22500,3,75773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075773.PDF","2005-07-22 00:00:00",
23776,10,75773,"SUPPL",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
31014,1,75773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75773.TA.pdf","2003-04-15 00:00:00",
44268,10,75773,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
22501,3,75774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075774.PDF","2005-07-22 00:00:00",
31015,1,75780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75780.ap.pdf","2003-04-15 00:00:00",
8787,1,75782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75782ltr.pdf","2000-12-22 00:00:00",
31016,1,75783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75783TA2.pdf","2004-06-24 00:00:00",
8788,1,75786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75786ltr.pdf","2001-04-16 00:00:00",
31017,1,75786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75786TA.pdf","2004-06-04 00:00:00",
44269,10,75787,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8789,1,75788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788ltr.pdf","2004-06-24 00:00:00",
8790,1,75788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788TA.pdf","2004-06-03 00:00:00",
31018,1,75790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75790TA.pdf","2004-06-08 00:00:00",
31019,1,75792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75792ltr.pdf","2000-08-29 00:00:00",
8791,1,75793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75793ltr.pdf","2001-04-16 00:00:00",
8792,1,75794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf","2003-04-15 00:00:00",
31020,1,75795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75795ltr.pdf","2001-06-13 00:00:00",
8793,1,75796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75796ltr.pdf","2004-05-27 00:00:00",
22502,3,75796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21.cfm","2004-05-27 00:00:00",
39491,2,75796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-796_Aviane-21%20and%20Aviane-28_prntlbl.pdf","2004-05-27 00:00:00",
8794,1,75797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75797TA.pdf","2004-06-18 00:00:00",
44270,10,75800,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
8795,1,75803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75803.ap.pdf","2003-04-10 00:00:00",
22503,3,75803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075803_levonorgestrel-ethinyl_toc.cfm","2003-12-24 00:00:00",
39492,2,75803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75803_Levonorgestrel And Ethinyl Estradiol_Prntlbl.pdf","2003-12-24 00:00:00",
43026,3,75804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075804_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
31021,1,75805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75805ltr.pdf","2001-04-16 00:00:00",
31022,1,75806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75806ta.pdf","2004-06-10 00:00:00",
23777,10,75807,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
22504,3,75808,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075808_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
31023,1,75810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75810ta.pdf","2003-04-15 00:00:00",
44271,10,75810,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
18425,2,75811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna_prntlbl.pdf","2001-04-26 00:00:00",
22505,3,75811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna.cfm","2001-12-14 00:00:00",
31024,1,75811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75811ltr.pdf","2001-04-26 00:00:00",
31025,1,75812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75812ltr.pdf","2001-06-15 00:00:00",
31026,1,75813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75813TA.pdf","2001-04-16 00:00:00",
8796,1,75817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75817.ta.pdf","2004-06-24 00:00:00",
31027,1,75818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75818.ap.pdf","2003-04-15 00:00:00",
31028,1,75818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75818TA.pdf","2004-06-04 00:00:00",
31029,1,75820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75820.ap.pdf","2003-04-15 00:00:00",
22506,3,75822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075822_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
31030,1,75822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75822Altr.pdf","2003-02-10 00:00:00",
8797,1,75824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75824AP.pdf","2003-04-10 00:00:00",
22507,3,75824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075824.PDF","2005-07-22 00:00:00",
8798,1,75825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75825ltr.pdf","2001-04-17 00:00:00",
8799,1,75825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75825TA.pdf","2004-06-04 00:00:00",
31031,1,75826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75826Approval.pdf","2003-04-15 00:00:00",
22508,3,75828,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075828.PDF","2005-07-22 00:00:00",
8800,1,75829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75829.ap.pdf","2003-04-15 00:00:00",
18426,2,75830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75830_Milrinone%20Lactate_Prntlbl.pdf","2003-12-24 00:00:00",
22509,3,75830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075830_milrinone-lactate_toc.cfm","2003-12-24 00:00:00",
31032,1,75830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75830tadf.pdf","2003-04-15 00:00:00",
31033,1,75830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75830_Milrinone%20Lactate_Approv.pdf","2003-12-24 00:00:00",
8801,1,75834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75834_Milrinone%20Lactate_Approv.pdf","2003-12-24 00:00:00",
22510,3,75834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075834_milrinone-lactate_toc.cfm","2003-12-24 00:00:00",
39493,2,75834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75834_Milrinone%20Lactate_Prntlbl.pdf","2003-12-24 00:00:00",
8802,1,75835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75835.ap..pdf","2003-04-15 00:00:00",
8803,1,75837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75837ltr.pdf","2001-02-22 00:00:00",
43027,3,75837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075837.PDF","2005-07-22 00:00:00",
31034,1,75839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf","2002-01-17 00:00:00",
43028,3,75839,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf","2002-01-17 00:00:00",
8804,1,75840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75840.ap.pdf","2003-04-15 00:00:00",
43029,3,75841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075841_s000_PamidronateTOC.cfm","2006-04-20 00:00:00",
44272,10,75841,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
8805,1,75842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75842ltr.pdf","2001-04-12 00:00:00",
8806,1,75843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75843.apdF.pdf","2003-04-15 00:00:00",
8807,1,75845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75845ltr.pdf","2001-01-31 00:00:00",
8808,1,75847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75847ltr.pdf","2001-02-28 00:00:00",
31035,1,75848,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75848ltr.pdf","2001-02-09 00:00:00",
31036,1,75850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75850ltr.pdf","2001-04-27 00:00:00",
8809,1,75851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75851ltr.pdf","2003-04-15 00:00:00",
39494,2,75851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf","2003-12-24 00:00:00",
43030,3,75851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin.pdf","2001-08-17 00:00:00",
8810,1,75852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75852_Milrinone%20Lactate_Approv.pdf","2003-12-24 00:00:00",
22511,3,75852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075852_milrinone-lactate_toc.cfm","2003-12-24 00:00:00",
39495,2,75852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75852_Milrinone%20Lactate_Prntlbl.pdf","2003-12-24 00:00:00",
8811,1,75855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75855ltr.pdf","2001-01-31 00:00:00",
8812,1,75858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75858ltr.pdf","2001-06-18 00:00:00",
8813,1,75860,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75860.ap.pdf","2003-04-10 00:00:00",
31037,1,75861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75861ltr.pdf","2001-06-22 00:00:00",
31038,1,75863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75863.ta.pdf","2003-04-15 00:00:00",
31039,1,75863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75863.ap.pdf","2003-04-10 00:00:00",
23778,10,75865,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8814,1,75868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75868.ta.pdf","2003-04-10 00:00:00",
8815,1,75869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75869TA.pdf","2004-06-08 00:00:00",
8816,1,75870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75870d.apF.pdf","2003-04-17 00:00:00",
31040,1,75872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75872TA.pdf","2004-06-04 00:00:00",
44273,10,75872,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8817,1,75873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75873.TA.pdf","2003-04-10 00:00:00",
8818,1,75875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75875ltr.pdf","2000-12-21 00:00:00",
24157,16,75875,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
23779,10,75877,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
31041,1,75881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75881ltr.pdf","2001-03-29 00:00:00",
39496,2,75881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-881_Levocarnitine_prntlbl.pdf","2001-03-29 00:00:00",
43031,3,75881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-881_Levocarnitine.cfm","2001-12-14 00:00:00",
22512,3,75883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075883.pdf","2007-04-02 00:00:00",
23780,10,75887,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
31042,1,75887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75887ltr.pdf","2001-01-05 00:00:00",
8819,1,75888,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75888ltr.pdf","2000-11-29 00:00:00",
44274,10,75888,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
23781,10,75889,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
31043,1,75889,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75889ltr.pdf","2000-11-29 00:00:00",
31044,1,75890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75890.ta.pdf","2003-04-10 00:00:00",
44275,10,75893,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8820,1,75894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75894ltr.pdf","2001-04-18 00:00:00",
23782,10,75894,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
22513,3,75895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075895.pdf","2005-07-22 00:00:00",
22514,3,75896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075896_ORIGINAL APPROVAL_PACKAGE.pdf","2007-11-19 00:00:00",
31045,1,75896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75896ltr.pdf","2004-11-08 00:00:00",
8821,1,75897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75897ltr.pdf","2001-01-25 00:00:00",
23783,10,75897,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8822,1,75898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75898ltr.pdf","2001-03-12 00:00:00",
44276,10,75898,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8823,1,75899,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75899ltr.pdf","2001-01-17 00:00:00",
44277,10,75899,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
44278,10,75900,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm","2006-03-02 00:00:00",
8824,1,75901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75901ltr.pdf","2000-12-28 00:00:00",
18427,2,75901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75901_Fluvoxamine Maleate_Prntlbl.pdf","2003-12-24 00:00:00",
22515,3,75901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075901_fluvoxamine-maleate_toc.cfm","2003-12-24 00:00:00",
23784,10,75901,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8825,1,75902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75902ltr.pdf","2001-05-07 00:00:00",
44279,10,75902,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8826,1,75905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75905d.apF.pdf","2003-04-17 00:00:00",
8827,1,75906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75906ltr.pdf","2001-04-25 00:00:00",
18428,2,75906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf","2001-04-25 00:00:00",
22516,3,75906,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone.cfm","2001-04-25 00:00:00",
22517,3,75907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075907.pdf","2005-07-22 00:00:00",
8828,1,75909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75909ltr.pdf","2003-04-17 00:00:00",
39497,2,75909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-909_Enalapril%20Maleate%20and%20Hydrochlorothiazide_Prntlb","2004-06-03 00:00:00",
43032,3,75909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075909_enalapril_toc.cfm","2003-08-04 00:00:00",
8829,1,75911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75911APD.pdf","2003-04-10 00:00:00",
8830,1,75913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75913ltr.pdf","2004-03-24 00:00:00",
22518,3,75913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-24 00:00:00",
22519,3,75913,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S001_AP.pdf","2007-07-06 00:00:00",
23785,10,75913,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
43033,3,75913,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S002_AP.pdf","2007-07-06 00:00:00",
43034,3,75913,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075913_S003_AP.pdf","2007-07-06 00:00:00",
23786,10,75914,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
8831,1,75915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75915.ap.pdf","2003-04-16 00:00:00",
43035,3,75915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075915.pdf","2005-07-22 00:00:00",
31046,1,75916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75916.apdF.pdf","2003-04-16 00:00:00",
22520,3,75918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075918_ORIGINAL_APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
23787,10,75920,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8833,1,75926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75926ltr.pdf","2004-06-24 00:00:00",
8834,1,75928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75928ltr.pdf","2004-06-10 00:00:00",
31047,1,75928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75928.ta.pdf","2003-04-10 00:00:00",
8835,1,75932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75932TAF.pdf","2003-04-10 00:00:00",
8836,1,75932,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf","2004-03-24 00:00:00",
22521,3,75932,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S001_AP.pdf","2007-07-06 00:00:00",
23788,10,75932,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
43036,3,75932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075932_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-24 00:00:00",
31048,1,75932,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf","2004-03-24 00:00:00",
43037,3,75932,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S002_AP.pdf","2007-07-06 00:00:00",
8837,1,75934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75934d.taF.pdf","2004-06-24 00:00:00",
8838,1,75936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75936taf.pdf","2003-04-16 00:00:00",
8839,1,75939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75939ltr.pdf","2004-06-15 00:00:00",
8840,1,75940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75940.ap.pdf","2003-04-16 00:00:00",
8841,1,75944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75944ta2.pdf","2004-06-24 00:00:00",
24051,14,75945,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
31049,1,75945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75945ltr.pdf","2002-11-08 00:00:00",
44280,10,75945,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2003-12-17 00:00:00",
43038,3,75945,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/075945Orig1s011.pdf","2012-03-28 00:00:00",
22522,3,75945,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/075945Orig1s014.pdf","2012-03-28 00:00:00",
44615,16,75948,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
8842,1,75950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75950.ap.pdf","2003-04-16 00:00:00",
44281,10,75950,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
18429,2,75951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75951_Norethindrone Acetate_Prntlbl.pdf","2003-12-24 00:00:00",
31050,1,75951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75951ltr.pdf","2001-05-25 00:00:00",
43039,3,75951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075951_norethindrone_acetate_toc.cfm","2003-12-24 00:00:00",
43040,3,75953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075953_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
23789,10,75955,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
39498,2,75955,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/075955s015lbl.pdf","2013-08-23 00:00:00",
31051,1,75960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75960ltr.pdf","2002-06-19 00:00:00",
39499,2,75960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75960lbl.pdf","2002-06-19 00:00:00",
18430,2,75962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75962lbl.pdf","2002-06-24 00:00:00",
31052,1,75962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75962ltr.pdf","2002-06-24 00:00:00",
43041,3,75962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075962_ORIGINAL APPROVAL_PACKAGE.pdf","2008-02-19 00:00:00",
18431,2,75964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75964lbl.pdf","2002-06-19 00:00:00",
31053,1,75964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75964ltr.pdf","2002-06-19 00:00:00",
8843,1,75968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75968ltr.pdf","2002-06-25 00:00:00",
18432,2,75968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75968lbl.pdf","2002-06-25 00:00:00",
18433,2,75974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-974_Lorazepam_prntlbl.pdf","1998-07-23 00:00:00",
22523,3,75974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-974_Lorazepam.cfm","2002-01-10 00:00:00",
31054,1,75974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74974ltr.pdf","1998-07-23 00:00:00",
18434,2,75977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75977lbl.pdf","2002-06-19 00:00:00",
22524,3,75977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075977_ORIGINAL APPROVAL_PACKAGE.pdf","2008-08-01 00:00:00",
31055,1,75977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75977ltr.pdf","2002-06-19 00:00:00",
8844,1,75983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75983ltr.pdf","2002-06-25 00:00:00",
18435,2,75983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75983lbl.pdf","2002-06-25 00:00:00",
18436,2,75986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75986lbl.pdf","2002-06-21 00:00:00",
31056,1,75986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75986ltr.pdf","2002-06-21 00:00:00",
43042,3,75986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075986_ORIGINAL APPROVAL_PACKAGE.pdf","2008-08-01 00:00:00",
22525,3,75988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075988_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
43043,3,75989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075989_original_approval_pkg.pdf","2004-03-04 00:00:00",
31057,1,75994,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75994TA.pdf","2004-06-08 00:00:00",
31058,1,75995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75995AP.pdf","2003-04-10 00:00:00",
43044,3,75997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075997.pdf","2005-07-22 00:00:00",
8845,1,75998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75998APltrF.pdf","2003-04-10 00:00:00",
8846,1,75999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75999ltr.pdf","2003-04-16 00:00:00",
23790,10,76001,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8847,1,76003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76003ltr.pdf","2002-06-20 00:00:00",
18437,2,76003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76003lbl.pdf","2002-06-20 00:00:00",
18438,2,76005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole Nirate_Prntlbl.pdf","2003-12-24 00:00:00",
31059,1,76005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76005_Econazole Nirate_Approv.pdf","2003-12-24 00:00:00",
43045,3,76005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076005_econazole-nirate_toc.cfm","2003-12-24 00:00:00",
23791,10,76006,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8848,1,76007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf","2003-04-10 00:00:00",
31060,1,76007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf","2004-06-08 00:00:00",
23792,10,76015,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
53970,14,76015,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/076015_SLCOrderLtr.pdf","2018-05-01 00:00:00",
8849,1,76017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76017ltr.pdf","2004-04-29 00:00:00",
22526,3,76018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076018_amiodarone-hydrochloride_toc.cfm","2003-12-24 00:00:00",
23793,10,76018,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31061,1,76018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76018_Amiodarone%20Hydrochloride_Approv.pdf","2003-12-24 00:00:00",
39500,2,76018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76018_Amiodarone%20Hydrochloride_Prntlbl.pdf","2003-12-24 00:00:00",
22527,3,76019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076019_s000_DeferoxamineTOC.cfm","2006-04-20 00:00:00",
31062,1,76019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76019ltr.pdf","2004-03-19 00:00:00",
23794,10,76022,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
44282,10,76024,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
22528,3,76025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076025_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-26 00:00:00",
22529,3,76028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076028.pdf","2005-07-22 00:00:00",
8850,1,76030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76030ta.pdf","2003-04-16 00:00:00",
8851,1,76032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76032ltr.pdf","2001-05-09 00:00:00",
8852,1,76035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76035.ap.pdf","2003-04-16 00:00:00",
44283,10,76037,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
39501,2,76037,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076037s011lbl.pdf","2014-09-05 00:00:00",
31063,1,76038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76038.APF.pdf","2003-04-10 00:00:00",
22530,3,76041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076041.pdf","2005-07-22 00:00:00",
23795,10,76041,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2003-12-17 00:00:00",
44528,14,76041,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
52753,8,76041,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf","2018-02-28 00:00:00",
8853,1,76042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76042ltr.pdf","2004-07-30 00:00:00",
8854,1,76044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76044.ap.pdf","2003-04-10 00:00:00",
8855,1,76045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76045.ap.pdf","2003-04-15 00:00:00",
18439,2,76047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076047lbl.pdf","2008-01-08 00:00:00",
31064,1,76047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076047ltr.pdf","2008-01-09 00:00:00",
22531,3,76050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076050Orig1Approv.pdf","2012-03-28 00:00:00",
31065,1,76050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76050APltr.pdf","2004-06-08 00:00:00",
23796,10,76052,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
31066,1,76052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076052s000LTR.pdf","2006-06-27 00:00:00",
8856,1,76057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76057.apdf.pdf","2003-04-16 00:00:00",
8857,1,76058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76058.TA.pdf","2003-04-16 00:00:00",
31067,1,76058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76058.apd.pdf","2003-04-10 00:00:00",
8858,1,76059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76059ltr.pdf","2003-04-10 00:00:00",
22532,3,76061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076061.PDF","2005-07-22 00:00:00",
44284,10,76061,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143341.htm","2007-03-29 00:00:00",
31068,1,76062,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076062s000ltr.pdf","2007-05-01 00:00:00",
43046,3,76062,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076062_ORIGINAL APPROVAL_PACKAGE.pdf","2007-11-19 00:00:00",
52751,8,76062,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Zolpidem.pdf","2018-02-28 00:00:00",
8859,1,76067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ap.pdf","2003-04-10 00:00:00",
8860,1,76067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ta.pdf","2003-04-10 00:00:00",
39502,2,76067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76067_Mometasone Furoate_Approv.pdf","2003-12-24 00:00:00",
43047,3,76067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076067_mometasone-furoate_toc.cfm","2003-12-24 00:00:00",
31069,1,76068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76068ltr.pdf","2004-10-04 00:00:00",
43048,3,76070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076070.pdf","2005-07-22 00:00:00",
8861,1,76071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76071ta2.pdf","2004-06-24 00:00:00",
23797,10,76072,"ORIG",1,"0","http://www.fda.gov/cder/drug/antidepressants/default.htm","2007-05-09 00:00:00",
44285,10,76072,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
23798,10,76073,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
18440,2,76075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76075_Econazole%20Nitrate_Prntlbl.pdf","2004-04-13 00:00:00",
31070,1,76075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76075_Econazole%20Nitrate_Approv.pdf","2004-04-13 00:00:00",
43049,3,76075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075075_econazole.cfm","2004-04-13 00:00:00",
31071,1,76077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76077ltr.pdf","2004-07-30 00:00:00",
22533,3,76078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076078.pdf","2005-07-22 00:00:00",
31072,1,76086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76086ltr.pdf","2004-07-30 00:00:00",
8862,1,76087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76087ltr.pdf","2004-07-30 00:00:00",
43050,3,76087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076087_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
23799,10,76088,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31073,1,76089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76089ltr.pdf","2004-06-15 00:00:00",
22534,3,76090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076090.PDF","2005-07-22 00:00:00",
8863,1,76092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76092.apdf.pdf","2003-04-16 00:00:00",
43051,3,76092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076092_s000_KetamineTOC.cfm","2006-04-20 00:00:00",
31074,1,76093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76093.ta.pdf","2003-04-16 00:00:00",
23800,10,76094,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143341.htm","2007-03-29 00:00:00",
22535,3,76095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076095.pdf","2005-07-22 00:00:00",
23801,10,76095,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111315.htm","2005-07-29 00:00:00",
31075,1,76095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76095ltr.pdf","2002-07-10 00:00:00",
8864,1,76100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76100ltr.pdf","2002-06-20 00:00:00",
39503,2,76100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76100lbl.pdf","2002-06-20 00:00:00",
31076,1,76101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76101d.taF.pdf","2003-04-16 00:00:00",
22536,3,76103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076103_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-26 00:00:00",
8865,1,76104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76104ltr.pdf","2004-06-01 00:00:00",
44286,10,76108,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8866,1,76109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076109s000ltr.pdf","2009-11-09 00:00:00",
22537,3,76110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076110.pdf","2005-07-22 00:00:00",
43052,3,76112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/76-112_Ibuprofen.pdf","2001-10-31 00:00:00",
31077,1,76113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76113tadF.pdf","2003-04-10 00:00:00",
8867,1,76114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76114ltr.pdf","2003-04-10 00:00:00",
8868,1,76117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76117ltr.pdf","2003-04-16 00:00:00",
22538,3,76117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076117.PDF","2005-07-22 00:00:00",
31078,1,76118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76118ltr.pdf","2004-02-12 00:00:00",
23802,10,76119,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
31079,1,76119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76119tapd.pdf","2004-06-24 00:00:00",
43053,3,76119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076119.pdf","2005-07-22 00:00:00",
22539,3,76121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076121.PDF","2005-07-22 00:00:00",
31080,1,76121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76121d.apf.pdf","2003-04-16 00:00:00",
31081,1,76122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf","2003-04-10 00:00:00",
43054,3,76122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076122.pdf","2005-07-22 00:00:00",
44287,10,76122,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
31082,1,76124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76124s000ltr.pdf","2007-03-05 00:00:00",
44288,10,76125,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
31083,1,76126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76126ltr.pdf","2004-06-15 00:00:00",
23803,10,76129,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
43055,3,76130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076130_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
39504,2,76131,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076131s022lbl.pdf","2013-03-12 00:00:00",
31084,1,76134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76134.ta.pdf","2003-04-16 00:00:00",
43056,3,76134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076134Orig1Approv.pdf","2012-03-28 00:00:00",
24052,14,76135,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
44289,10,76135,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2005-07-28 00:00:00",
31085,1,76136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76136.ta.pdf","2003-04-16 00:00:00",
31086,1,76136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76136ltr.pdf","2004-06-15 00:00:00",
31087,1,76138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76138ltr.pdf","2004-06-15 00:00:00",
8869,1,76141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76141.ap.pdf","2003-04-10 00:00:00",
44290,10,76143,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2006-02-15 00:00:00",
8870,1,76145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76145ltr.pdf","2004-07-30 00:00:00",
43057,3,76145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076145_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
43058,3,76151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076151_s000_DiltTOC.cfm","2006-04-20 00:00:00",
23804,10,76153,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
31088,1,76153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.AP.pdf","2003-04-10 00:00:00",
31089,1,76153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.TA.pdf","2003-04-11 00:00:00",
8871,1,76154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76154.ta.pdf","2003-04-11 00:00:00",
22540,3,76156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076156.pdf","2005-07-22 00:00:00",
31090,1,76162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76162ltr.pdf","2004-10-18 00:00:00",
23805,10,76163,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31091,1,76164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76164ltr.pdf","2003-04-11 00:00:00",
23806,10,76165,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
31092,1,76165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76165apf.pdf","2003-04-11 00:00:00",
22541,3,76168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm","2006-04-20 00:00:00",
31093,1,76168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf","2004-03-26 00:00:00",
39505,2,76168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf","2004-03-30 00:00:00",
43572,6,76168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf","2004-03-30 00:00:00",
31094,1,76170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium%20Carbonate_Approv.pdf","2004-06-08 00:00:00",
39506,2,76170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium%20Carbonate_Prntlbl.pdf","2004-06-08 00:00:00",
43059,3,76170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076170_lithium_toc.cfm","2003-07-30 00:00:00",
18441,2,76175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76175_Mefloquine Hydrochloride_Prntlbl.pdf","2003-12-24 00:00:00",
22542,3,76175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076175_mefloquine_toc.cfm","2003-08-04 00:00:00",
31095,1,76175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76175.ap.pdf","2003-04-11 00:00:00",
39507,2,76175,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/076175s026lbl.pdf","2012-05-16 00:00:00",
39508,2,76175,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076175s030lbl.pdf","2013-07-29 00:00:00",
44291,10,76176,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
8872,1,76178,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76178f.ta.pdf","2003-04-11 00:00:00",
8873,1,76180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76180ltr.pdf","2003-04-11 00:00:00",
18442,2,76182,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf","2014-08-06 00:00:00",
18443,2,76182,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf","2014-05-02 00:00:00",
8874,1,76183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076183s000ltr.pdf","2007-01-08 00:00:00",
23807,10,76184,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-02-28 00:00:00",
31096,1,76184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076184s000ltr.pdf","2008-02-07 00:00:00",
43060,3,76184,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf","2011-02-15 00:00:00",
8875,1,76187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/076187ltr.pdf","2004-02-18 00:00:00",
22543,3,76187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076187.cfm","2004-02-18 00:00:00",
39509,2,76187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/076187lbl.pdf","2004-02-18 00:00:00",
43061,3,76187,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/76187ABrating.pdf","2005-05-10 00:00:00",
22544,3,76187,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/76187-S003Levothyroxine.pdf","2005-05-10 00:00:00",
44292,10,76189,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
18444,2,76192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76192lbl_Ribavarin_Sandoz.pdf","2004-04-09 00:00:00",
31097,1,76192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76192ltr.pdf","2004-04-07 00:00:00",
44434,12,76192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76192exclusivity_letter.pdf","2004-04-09 00:00:00",
44293,10,76196,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8876,1,76200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76200.apd.pdf","2002-03-19 00:00:00",
22545,3,76200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s000_AcetaminophenTOC.cfm","2006-04-20 00:00:00",
43062,3,76200,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001_AcetaminophenTOC.cfm","2006-04-20 00:00:00",
43063,3,76200,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm","2007-06-11 00:00:00",
22546,3,76200,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm","2007-06-11 00:00:00",
43064,3,76200,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm","2007-06-11 00:00:00",
22547,3,76200,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076200_S005_AcetaminophenTOC.cfm","2007-06-11 00:00:00",
8877,1,76203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76203ltr.pdf","2004-04-07 00:00:00",
18445,2,76203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf","2004-04-09 00:00:00",
43895,8,76203,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf","2009-11-20 00:00:00",
44435,12,76203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76203exclusivity_letter.pdf","2004-04-09 00:00:00",
22548,3,76204,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076204.pdf","2005-07-22 00:00:00",
44294,10,76207,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-01-07 00:00:00",
31098,1,76208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76208ltr.pdf","2004-01-29 00:00:00",
8878,1,76211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76211ltr.pdf","2004-02-12 00:00:00",
31099,1,76213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76213ltr.pdf","2004-07-30 00:00:00",
23808,10,76217,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
44295,10,76219,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
31100,1,76221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076221s000ltr.pdf","2009-11-09 00:00:00",
18446,2,76228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf","2008-07-14 00:00:00",
31101,1,76228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076228s000ltr.pdf","2008-07-02 00:00:00",
44296,10,76228,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/antipsychotics/default.htm","2008-09-19 00:00:00",
8879,1,76231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76231ltr.pdf","2004-05-26 00:00:00",
23809,10,76232,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2006-07-17 00:00:00",
43065,3,76233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076233.PDF","2005-07-22 00:00:00",
31102,1,76235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76235ltr.pdf","2004-10-15 00:00:00",
8880,1,76236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076236ltr.pdf","2005-04-19 00:00:00",
23810,10,76241,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
43066,3,76241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076241.pdf","2005-07-22 00:00:00",
22549,3,76243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076243_S000_LithiumTOC.cfm","2007-06-11 00:00:00",
44297,10,76244,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
8881,1,76246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76246ltr.pdf","2004-07-30 00:00:00",
22550,3,76250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076250_ORIGINAL APPROVAL_PACKAGE.pdf","2007-11-19 00:00:00",
31103,1,76250,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076250ltr.pdf","2005-04-28 00:00:00",
23811,10,76251,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
22551,3,76258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf","2005-07-22 00:00:00",
24053,14,76258,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
31104,1,76258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf","2004-06-24 00:00:00",
31105,1,76258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf","2005-02-01 00:00:00",
8882,1,76264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76264.APD.pdf","2003-04-11 00:00:00",
22552,3,76264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076264_S000_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
8883,1,76267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76267ltr.pdf","2004-02-12 00:00:00",
18447,2,76268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf","2003-12-24 00:00:00",
31106,1,76268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76268_Digoxin_Approv.pdf","2003-12-24 00:00:00",
43067,3,76268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076268_digoxin_toc.cfm","2003-12-24 00:00:00",
8884,1,76269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76269ltr.pdf","2004-06-21 00:00:00",
44298,10,76270,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
8885,1,76274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076274Orig1s000ltr.pdf","2012-05-18 00:00:00",
31107,1,76276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76276ltr.pdf","2004-10-18 00:00:00",
8886,1,76285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076285s000LTR.pdf","2006-06-27 00:00:00",
44299,10,76285,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
8887,1,76287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076287s000ltr.pdf","2008-05-28 00:00:00",
23812,10,76287,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2008-05-30 00:00:00",
44300,10,76288,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-09-19 00:00:00",
44301,10,76295,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-02-01 00:00:00",
22553,3,76298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/076298Orig1s000Approv.pdf","2013-01-24 00:00:00",
44302,10,76299,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8888,1,76300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76300ltr.pdf","2004-05-26 00:00:00",
43068,3,76300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076300_S000_FLUTICASONE PROPIONATETOC.cfm","2006-07-28 00:00:00",
23813,10,76302,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
31108,1,76303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76303ltr.pdf","2004-07-30 00:00:00",
8889,1,76304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76304ltr.pdf","2004-07-30 00:00:00",
43069,3,76304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076304_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
23814,10,76306,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
23815,10,76307,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
23816,10,76308,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
23817,10,76309,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
8890,1,76310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076310.pdf","2006-01-06 00:00:00",
44303,10,76312,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
31109,1,76313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076313ltr.pdf","2005-03-30 00:00:00",
8891,1,76314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf","2006-09-15 00:00:00",
8892,1,76314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf","2007-07-30 00:00:00",
23818,10,76314,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm","2009-04-14 00:00:00",
23819,10,76314,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-02-01 00:00:00",
44304,10,76315,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
44305,10,76317,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
8893,1,76323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76323ltr.pdf","2004-08-11 00:00:00",
44306,10,76327,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
8894,1,76332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76332ltr.pdf","2004-07-30 00:00:00",
31110,1,76333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76333ltr.pdf","2004-02-12 00:00:00",
43070,3,76334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076334_ORIGINAL APPROVAL_PACKAGE.pdf","2007-04-09 00:00:00",
22554,3,76335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076335_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
44307,10,76336,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-12-13 00:00:00",
31111,1,76340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076340s000LTR.pdf","2006-06-20 00:00:00",
8895,1,76342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76342ltr.pdf","2004-02-12 00:00:00",
44308,10,76343,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
8896,1,76344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76344ltr.pdf","2004-02-12 00:00:00",
8897,1,76345,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76345ltr.pdf","2004-02-27 00:00:00",
8898,1,76348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76348ltr.pdf","2004-02-12 00:00:00",
22555,3,76349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076349.pdf","2007-04-02 00:00:00",
8899,1,76351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76351ltr.pdf","2004-07-30 00:00:00",
23820,10,76356,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2005-07-28 00:00:00",
24054,14,76356,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
8900,1,76359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76359ltr.pdf","2004-01-22 00:00:00",
23821,10,76362,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
8901,1,76364,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76364ltr.pdf","2004-01-15 00:00:00",
8902,1,76373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076373s000_ltr.pdf","2007-09-07 00:00:00",
31112,1,76374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76374.ltr.pdf","2004-04-07 00:00:00",
31113,1,76377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076377s000_ltr.pdf","2007-07-05 00:00:00",
31114,1,76378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076378ltr.pdf","2005-04-28 00:00:00",
8903,1,76386,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76386ltr.pdf","2004-07-30 00:00:00",
8904,1,76387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76387ltr.pdf","2004-07-30 00:00:00",
43071,3,76387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076387_Clotrimazole LozengesTOC.cfm","2006-10-26 00:00:00",
22556,3,76388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076388Orig1s000Approv.pdf","2012-02-14 00:00:00",
31115,1,76388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076388s000ltr.pdf","2006-09-18 00:00:00",
44616,16,76388,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31116,1,76390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076390s000_ltr.pdf","2007-07-05 00:00:00",
18448,2,76392,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076392s008lbl.pdf","2013-07-29 00:00:00",
23822,10,76394,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31117,1,76394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76394_Amiodarone Hydrochloride_Approv.pdf","2003-12-24 00:00:00",
39510,2,76394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/76394_Amiodarone Hydrochloride_Prntlbl.pdf","2003-12-24 00:00:00",
43072,3,76394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm","2003-12-24 00:00:00",
43073,3,76396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076396Orig1s000.pdf","2012-01-27 00:00:00",
31118,1,76402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76402ltr.pdf","2004-02-27 00:00:00",
8905,1,76404,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76404ltr.pdf","2004-06-16 00:00:00",
8906,1,76408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76408ltr.pdf","2004-06-01 00:00:00",
43074,3,76408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076408_ORIGINAL APPROVAL_PACKAGE.pdf","2007-11-19 00:00:00",
44309,10,76409,"ORIG",1,"0","http://www.fda.gov/cder/drug/antidepressants/default.htm","2007-05-09 00:00:00",
8907,1,76410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076410s000ltr.pdf","2007-05-01 00:00:00",
24055,14,76412,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
8908,1,76413,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76413ltr.pdf","2004-06-21 00:00:00",
8909,1,76417,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076417ltr.pdf","2005-04-28 00:00:00",
43075,3,76419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076419.pdf","2007-04-02 00:00:00",
31119,1,76420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076420s000LTR.pdf","2008-06-28 00:00:00",
8910,1,76422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76422ltr.pdf","2004-08-06 00:00:00",
22557,3,76422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076422_CiclopiroxTOC.cfm","2007-04-02 00:00:00",
8911,1,76424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76424ltr.pdf","2004-07-30 00:00:00",
8912,1,76430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76430ltr.pdf","2004-02-27 00:00:00",
31120,1,76432,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76432ltr.pdf","2004-07-30 00:00:00",
31121,1,76435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076435ltr.pdf","2005-01-11 00:00:00",
31122,1,76436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076436s000LTR.pdf","2006-08-04 00:00:00",
44529,14,76438,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
23823,10,76440,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2009-02-04 00:00:00",
23824,10,76442,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2007-05-08 00:00:00",
31123,1,76445,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076445s000ltr.pdf","2007-05-01 00:00:00",
31124,1,76446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76446 AP_ltr.pdf","2006-03-23 00:00:00",
22558,3,76447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076447_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
8913,1,76447,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076447s007ltr.pdf","2008-01-09 00:00:00",
8914,1,76448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076448s000ltr.pdf","2009-04-21 00:00:00",
23825,10,76448,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-02-01 00:00:00",
8915,1,76451,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76451ltr.pdf","2004-05-26 00:00:00",
22559,3,76453,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf","2005-07-22 00:00:00",
43076,3,76453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076453.pdf","2005-07-22 00:00:00",
22560,3,76453,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf","2005-07-22 00:00:00",
43077,3,76453,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf","2005-07-22 00:00:00",
22561,3,76453,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf","2005-07-22 00:00:00",
43078,3,76453,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf","2005-07-22 00:00:00",
22562,3,76458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076458_S000_FLUOXETINETOC.cfm","2007-04-02 00:00:00",
23826,10,76458,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
22563,3,76460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076460Orig1Approv.pdf","2012-03-28 00:00:00",
23827,10,76465,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2006-09-12 00:00:00",
43079,3,76466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076466Orig1s000BioeqR.pdf","2012-10-12 00:00:00",
31125,1,76468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076468ltr.pdf","2005-04-28 00:00:00",
8916,1,76470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076470ltr.pdf","2005-07-08 00:00:00",
31126,1,76475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/07647ltr.pdf","2005-04-28 00:00:00",
8917,1,76476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76476ltr.pdf","2004-02-12 00:00:00",
31127,1,76477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076477Orig1s000ltr.pdf","2011-12-01 00:00:00",
43080,3,76477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076477Orig1s000.pdf","2014-07-07 00:00:00",
8918,1,76484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076484s000ltr.pdf","2006-09-18 00:00:00",
24056,14,76485,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
43081,3,76485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/076485Orig1s003.pdf","2013-05-10 00:00:00",
31128,1,76489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076489ltr.pdf","2005-04-28 00:00:00",
31129,1,76491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76491ltr.pdf","2004-06-24 00:00:00",
31130,1,76493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76493ltr.pdf","2004-07-30 00:00:00",
22564,3,76500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076500.pdf","2005-07-22 00:00:00",
31131,1,76500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76500ltr.pdf","2004-06-16 00:00:00",
31132,1,76501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76501ltr.pdf","2004-06-16 00:00:00",
43082,3,76501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076501.pdf","2005-07-22 00:00:00",
22565,3,76503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076503.pdf","2005-07-22 00:00:00",
23828,10,76503,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm","2003-12-17 00:00:00",
44530,14,76503,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
8919,1,76504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76504ltr.pdf","2006-03-01 00:00:00",
22566,3,76504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076504_original approval_package.pdf","2011-01-04 00:00:00",
22567,3,76505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076505_S000_Metronidazole Capsules_ORIGINAL AP.pdf","2007-07-09 00:00:00",
8920,1,76507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76507ltr.pdf","2004-07-30 00:00:00",
31134,1,76513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76513ltr.pdf","2004-05-26 00:00:00",
22568,3,76514,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf","2005-07-22 00:00:00",
43083,3,76514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076514.pdf","2005-07-22 00:00:00",
43084,3,76514,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf","2005-07-22 00:00:00",
43085,3,76514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf","2005-07-22 00:00:00",
8921,1,76517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76517ltr.pdf","2004-10-18 00:00:00",
31135,1,76518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76518ltrpdf.pdf","2004-03-19 00:00:00",
39511,2,76523,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf","2013-07-29 00:00:00",
43086,3,76527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076527.pdf","2011-09-16 00:00:00",
31136,1,76530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076530ltr.pdf","2005-04-28 00:00:00",
44310,10,76532,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
8922,1,76534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076534s000ltr.pdf","2011-10-31 00:00:00",
44311,10,76539,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-02-01 00:00:00",
23829,10,76540,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/sertraline/default.htm","2005-08-01 00:00:00",
23830,10,76540,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2007-03-29 00:00:00",
23831,10,76541,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
22569,3,76545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076545_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
23832,10,76549,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
31137,1,76549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076549ltr.pdf","2005-10-27 00:00:00",
8923,1,76553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76553ltr.pdf","2004-07-30 00:00:00",
43087,3,76553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076553_S000_MedroxyprogesteroneTOC.cfm","2007-04-02 00:00:00",
8924,1,76554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076554s000ltr.pdf","2009-08-14 00:00:00",
22570,3,76557,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076557_original_approval_pkg.pdf","2011-02-15 00:00:00",
8925,1,76558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76558ltr.pdf","2004-06-15 00:00:00",
8926,1,76563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76563ltr.pdf","2006-09-15 00:00:00",
31138,1,76564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76564ltr.pdf","2004-06-16 00:00:00",
22571,3,76565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/076565Orig1s000.pdf","2015-03-09 00:00:00",
31139,1,76565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076565s000ltr.pdf","2010-07-02 00:00:00",
31140,1,76568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76568,76569ltr.pdf","2004-07-30 00:00:00",
31141,1,76569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76568,76569ltr.pdf","2004-07-30 00:00:00",
31142,1,76572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076572s000ltr.pdf","2009-02-13 00:00:00",
43088,3,76574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076574_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
43089,3,76577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076577.pdf","2005-07-22 00:00:00",
8927,1,76578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076578s000ltr.pdf","2007-05-01 00:00:00",
44312,10,76578,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-04-26 00:00:00",
8928,1,76583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076583s000ltr.pdf","2009-11-10 00:00:00",
44313,10,76584,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
8929,1,76593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76593ltr.pdf","2004-06-15 00:00:00",
22572,3,76598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076598_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-24 00:00:00",
8930,1,76607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076607ltr.pdf","2004-12-30 00:00:00",
31143,1,76608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76608ltr.pdf","2004-12-08 00:00:00",
8931,1,76610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76610 AP_ltr.pdf","2006-03-23 00:00:00",
8932,1,76611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076611ltr.pdf","2006-04-13 00:00:00",
22573,3,76611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076611_ORIGINAL APPROVAL_PACKAGE.pdf","2007-04-09 00:00:00",
31144,1,76612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76612ltr.pdf","2004-02-12 00:00:00",
8933,1,76615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76615ltr.pdf","2004-05-26 00:00:00",
8934,1,76617,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76617ltr.pdf","2004-07-30 00:00:00",
43090,3,76617,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076617_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
44314,10,76618,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2005-08-16 00:00:00",
8935,1,76622,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76622ltr.pdf","2004-05-26 00:00:00",
43091,3,76622,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076622Orig1Approv.pdf","2012-03-28 00:00:00",
39512,2,76625,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/076625Orig1s10Lbl.pdf","2012-10-22 00:00:00",
22574,3,76626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076626_S000_ORIGINAL_APPROVAL_PACKAGE.pdf","2007-04-02 00:00:00",
31145,1,76629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076629s000ltr.pdf","2010-03-22 00:00:00",
8936,1,76631,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf","2004-02-12 00:00:00",
8937,1,76633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76633ltr.pdf","2004-05-26 00:00:00",
22575,3,76633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076633_ORIGINAL APPROVAL_PACKAGE.pdf","2007-04-09 00:00:00",
31146,1,76635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076635ltr.pdf","2005-11-01 00:00:00",
8938,1,76636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76636ltr.pdf","2004-02-12 00:00:00",
22576,3,76640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076640Orig1s000BioeqR.pdf","2012-04-13 00:00:00",
31147,1,76640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076640s000ltr.pdf","2007-05-29 00:00:00",
43092,3,76642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076642_original_approval_pkg.pdf","2011-01-07 00:00:00",
8939,1,76642,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf","2007-10-22 00:00:00",
31148,1,76642,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf","2007-10-22 00:00:00",
8940,1,76642,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf","2007-10-22 00:00:00",
31149,1,76642,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf","2007-10-22 00:00:00",
8941,1,76643,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076643ltr.pdf","2005-06-14 00:00:00",
31150,1,76644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076644s000LTR.pdf","2006-11-14 00:00:00",
43093,3,76644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2005/076644Orig1s000.pdf","2013-08-09 00:00:00",
8942,1,76648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76648ltr.pdf","2004-03-24 00:00:00",
43094,3,76648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076648_ORIGINAL_APPROVAL_PACKAGE.pdf","2016-03-09 00:00:00",
31151,1,76649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076649s000_ltr.pdf","2007-09-07 00:00:00",
43095,3,76652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076652_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-20 00:00:00",
8943,1,76653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76653ltr.pdf","2004-07-30 00:00:00",
22577,3,76653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076653_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
31152,1,76654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076654lt.pdf","2005-08-08 00:00:00",
39513,2,76657,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf","2015-07-17 00:00:00",
18449,2,76657,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf","2015-07-17 00:00:00",
39514,2,76657,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/076657s017s021s025lbl.pdf","2015-07-17 00:00:00",
8944,1,76658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76658ltr.pdf","2004-07-30 00:00:00",
43096,3,76664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076664_ORIGINAL APPROVAL_PACKAGE.pdf","2007-09-24 00:00:00",
31153,1,76665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76665ltr.pdf","2004-07-30 00:00:00",
8945,1,76668,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76668ltr.pdf","2004-05-26 00:00:00",
43989,9,76671,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2005-08-01 00:00:00",
8946,1,76677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076677ltr.pdf","2008-01-09 00:00:00",
18450,2,76677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076677lbl.pdf","2008-01-08 00:00:00",
8947,1,76679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076679ltr.pdf","2004-12-30 00:00:00",
31154,1,76683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076683ltr.pdf","2005-04-28 00:00:00",
22578,3,76684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076684Orig1s000ChemR.pdf","2012-02-14 00:00:00",
23833,10,76685,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
8948,1,76688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76688ltr.pdf","2004-02-12 00:00:00",
44315,10,76689,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-09-06 00:00:00",
8949,1,76690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076690s000LTR.pdf","2006-08-07 00:00:00",
44316,10,76690,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm","2006-08-10 00:00:00",
39515,2,76690,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076690s020lbl.pdf","2014-09-05 00:00:00",
8950,1,76697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076697Orig1s000ltr.pdf","2011-05-24 00:00:00",
22579,3,76697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076697Orig1s000.pdf","2013-10-23 00:00:00",
43097,3,76698,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076698_bioeq_rev-metolazone tabs.pdf","2011-02-15 00:00:00",
8951,1,76699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76699ltr.pdf","2004-08-31 00:00:00",
22580,3,76699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076699_S000_PARCOPATOC.cfm","2007-04-02 00:00:00",
43098,3,76701,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076701Orig1s000Approv.pdf","2012-02-14 00:00:00",
22581,3,76702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076702Orig1s000.pdf","2013-08-07 00:00:00",
31155,1,76702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076702s000LTR.pdf","2006-11-14 00:00:00",
8952,1,76703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076703ltr.pdf","2005-01-27 00:00:00",
22582,3,76703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076703_ORIGINAL APPROVAL_PACKAGE.pdf","2007-10-11 00:00:00",
43099,3,76708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076708Orig1s000Approv.pdf","2012-02-14 00:00:00",
24057,14,76709,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
44317,10,76709,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114961.htm","2012-07-27 00:00:00",
44318,10,76711,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
44531,14,76720,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
43100,3,76722,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076722_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
44319,10,76723,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129288.htm","2005-10-27 00:00:00",
8953,1,76730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76730ltr.pdf","2004-07-30 00:00:00",
24058,14,76733,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
50048,19,76737,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=355","2017-10-12 00:00:00",
31156,1,76737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076737ltr.pdf","2006-02-02 00:00:00",
43101,3,76740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076740Orig1s000BioeqR.pdf","2012-01-27 00:00:00",
43102,3,76744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/076744Orig1s000.pdf","2012-06-28 00:00:00",
8954,1,76745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076745s000LTR.pdf","2006-11-14 00:00:00",
22583,3,76745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076745Orig1s000.pdf","2013-08-09 00:00:00",
31157,1,76746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76746ltr.pdf","2004-11-19 00:00:00",
8955,1,76747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076747Orig1s000ltr.pdf","2013-01-30 00:00:00",
23834,10,76747,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2009-11-12 00:00:00",
39516,2,76747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076747Orig1s000lbl.pdf","2014-01-14 00:00:00",
22584,3,76751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076751_MesalamineTOC.cfm","2007-04-02 00:00:00",
31158,1,76751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76751ltr.pdf","2004-09-17 00:00:00",
31159,1,76754,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76754ltr.pdf","2004-06-10 00:00:00",
31160,1,76759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076759s000ltr.pdf","2006-12-04 00:00:00",
18451,2,76761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076761lbl.pdf","2006-12-04 00:00:00",
22585,3,76761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076761_XANDROLONE_TABS_ORIGINAL_AP.pdf","2007-07-06 00:00:00",
31161,1,76761,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076761ltr.pdf","2006-12-06 00:00:00",
8956,1,76764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76764ltr.pdf","2004-06-24 00:00:00",
43103,3,76764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/76187ABrating.pdf","2005-05-10 00:00:00",
8957,1,76765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf","2006-05-25 00:00:00",
8958,1,76765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf","2012-03-16 00:00:00",
23835,10,76765,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm","2006-06-06 00:00:00",
31162,1,76765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf","2011-05-10 00:00:00",
31163,1,76766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76766ltr.pdf","2004-07-30 00:00:00",
44320,10,76768,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
8959,1,76770,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76770ltr.pdf","2004-04-29 00:00:00",
23836,10,76770,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
31164,1,76773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076773ltr.pdf","2005-03-03 00:00:00",
22586,3,76775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076775_NICOTINE_POLACRILEX_ORIGINAL_AP.pdf","2007-07-06 00:00:00",
22587,3,76775,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076775Orig1s018.pdf","2014-08-05 00:00:00",
22588,3,76776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076776_NICOTINE_POLACRILEX_ORIGINAL_AP.pdf","2007-07-06 00:00:00",
22589,3,76777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076777_ORIGINAL APPROVAL_PACKAGE.pdf","2007-07-06 00:00:00",
22590,3,76777,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076777Orig1s025BioeqR.pdf","2014-08-06 00:00:00",
43104,3,76778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076778_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
43105,3,76779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076779_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
31165,1,76784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076784s000ltr.pdf","2009-07-08 00:00:00",
8960,1,76786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076786s000ltr.pdf","2010-12-01 00:00:00",
43106,3,76789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076789_ORIGINAL APPROVAL_PACKAGE.pdf","2007-05-09 00:00:00",
22591,3,76790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076790_ORIGINAL APPROVAL_PACKAGE.pdf","2007-12-06 00:00:00",
8961,1,76791,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076791s004,076828s003ltr.pdf","2008-01-09 00:00:00",
8962,1,76792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76792ltr.pdf","2004-08-25 00:00:00",
8963,1,76793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76793ltr.pdf","2004-05-26 00:00:00",
8964,1,76794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76794ltr.pdf","2004-06-15 00:00:00",
8965,1,76798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076798Orig1s000TAltr.pdf","2012-08-23 00:00:00",
44321,10,76798,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
23837,10,76799,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
8966,1,76801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076801Orig1s000ltr.pdf","2012-08-21 00:00:00",
44322,10,76801,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
8967,1,76802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076802ltr.pdf","2005-10-11 00:00:00",
43107,3,76802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076802Orig1s000.pdf","2012-01-27 00:00:00",
24059,14,76809,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-16 00:00:00",
31166,1,76811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076811ltr.pdf","2005-04-28 00:00:00",
31167,1,76815,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76815ltr.pdf","2004-04-20 00:00:00",
31168,1,76822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076822Orig1s000ltr.pdf","2013-11-13 00:00:00",
39517,2,76822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076822Orig1s000lbl.pdf","2013-11-19 00:00:00",
8968,1,76828,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076791s004,076828s003ltr.pdf","2008-01-09 00:00:00",
22592,3,76832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076832Orig1s000.pdf","2011-12-16 00:00:00",
44323,10,76834,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
43108,3,76837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076837_ORIGINAL APPROVAL_PACKAGE.pdf","2007-10-11 00:00:00",
8969,1,76840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076840s000ltr.pdf","2009-02-13 00:00:00",
43109,3,76841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076841_Mesalamine Rectal Suspension_APPROVAL_PACKAGE.pdf","2006-10-25 00:00:00",
8970,1,76844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076844ltr.pdf","2005-09-22 00:00:00",
23838,10,76845,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2005-07-28 00:00:00",
44617,16,76848,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm","2008-12-22 00:00:00",
31169,1,76851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76851ltr.pdf","2004-08-11 00:00:00",
23839,10,76853,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
31170,1,76858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76858ltr.pdf","2004-09-24 00:00:00",
8971,1,76863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76863ltr.pdf","2004-10-18 00:00:00",
18452,2,76867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076867lbl.pdf","2007-02-23 00:00:00",
31171,1,76867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076867s000ltr.pdf","2007-02-23 00:00:00",
8972,1,76870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76870ltr.pdf","2004-08-31 00:00:00",
8973,1,76871,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076871revltr.pdf","2006-04-13 00:00:00",
8974,1,76872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076872ltr.pdf","2004-12-30 00:00:00",
8975,1,76875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076875ltr.pdf","2005-10-11 00:00:00",
8976,1,76876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076876s000ltr.pdf","2006-12-01 00:00:00",
22593,3,76876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076876s000LTR.pdf","2007-05-09 00:00:00",
43110,3,76880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076880Orig1s000.pdf","2014-08-01 00:00:00",
44324,10,76881,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2005-08-01 00:00:00",
31172,1,76885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf","2006-01-20 00:00:00",
31173,1,76885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf","2013-11-13 00:00:00",
39518,2,76885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf","2013-11-19 00:00:00",
18453,2,76886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076886s000lbl.pdf","2007-08-07 00:00:00",
31174,1,76886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076886s000ltr.pdf","2007-08-07 00:00:00",
23840,10,76887,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
43111,3,76894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076894_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
43112,3,76894,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S001_TORSEMIDE TABS.pdf","2008-07-30 00:00:00",
43113,3,76894,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S002_TORSEMIDE TABS.pdf","2008-07-30 00:00:00",
22594,3,76894,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S003_TORSEMIDE TABS.pdf","2008-07-18 00:00:00",
22595,3,76894,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S004_TORSEMIDE TABS.pdf","2008-07-18 00:00:00",
22596,3,76897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076897_OXANDROLONE_TABS_ORIGINAL_AP.pdf","2007-07-06 00:00:00",
31175,1,76897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076897ltr.pdf","2006-12-06 00:00:00",
39519,2,76897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076897lbl.pdf","2006-12-04 00:00:00",
8977,1,76898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/076898Orig1s000ltr.pdf","2014-06-02 00:00:00",
44325,10,76901,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
8978,1,76903,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076903ltr.pdf","2004-12-30 00:00:00",
8979,1,76910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076910ltr.pdf","2005-04-28 00:00:00",
23841,10,76919,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-11-25 00:00:00",
44326,10,76921,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2005-08-01 00:00:00",
44327,10,76922,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
23842,10,76928,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110460.htm","2009-02-04 00:00:00",
8980,1,76932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076932s000ltr.pdf","2009-07-09 00:00:00",
18454,2,76932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/076932s000lbl.pdf","2009-07-24 00:00:00",
8981,1,76933,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076933TA_ltr.pdf","2005-08-03 00:00:00",
23843,10,76934,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2006-07-05 00:00:00",
31176,1,76934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76934APltr.pdf","2006-07-03 00:00:00",
8982,1,76938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/076938Orig1s000ltr.pdf","2014-03-06 00:00:00",
31177,1,76941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076941s000ltr.pdf","2008-08-01 00:00:00",
39520,2,76941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076941s000lbl.pdf","2008-11-20 00:00:00",
43114,3,76942,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076942_ORIGINAL APPROVAL_PACKAGE.pdf","2007-12-06 00:00:00",
22597,3,76943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076943_ORIGINAL APPROVAL_PACKAGE.pdf","2008-07-31 00:00:00",
44328,10,76945,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-07-17 00:00:00",
8983,1,76953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076953s000ltr.pdf","2010-10-04 00:00:00",
31178,1,76958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076958s001ltr.pdf","2010-04-16 00:00:00",
31179,1,76962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76962ltr.pdf","2004-09-29 00:00:00",
8984,1,76969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076969s000LTR.pdf","2006-08-04 00:00:00",
31180,1,76969,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076969s002, s003ltr.pdf","2007-05-29 00:00:00",
8985,1,76969,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076969s002, s003ltr.pdf","2007-05-29 00:00:00",
8986,1,76973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076973ltr.pdf","2005-07-15 00:00:00",
8987,1,76976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076976s000ltr.pdf","2009-08-14 00:00:00",
22598,3,76979,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076979Orig1s000BioeqR.pdf","2012-05-09 00:00:00",
8988,1,76981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076981s000TAltr.pdf","2006-06-06 00:00:00",
23844,10,76984,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
31181,1,76989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076989s000_ltr.pdf","2007-09-07 00:00:00",
23845,10,76990,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2005-08-01 00:00:00",
8989,1,76992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076992s000ltr.pdf","2006-09-18 00:00:00",
31182,1,76993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076993s000ltr.pdf","2006-09-18 00:00:00",
31183,1,76994,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076994ltr.pdf","2004-12-30 00:00:00",
31184,1,76999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076999Orig1s000ltr.pdf","2012-05-18 00:00:00",
8990,1,77001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077001ltr.pdf","2004-12-30 00:00:00",
44329,10,77004,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-09-19 00:00:00",
31185,1,77007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077007ltr.pdf","2006-02-02 00:00:00",
31186,1,77015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077015s000ltr.pdf","2006-12-04 00:00:00",
8991,1,77018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077018s000LTR.pdf","2006-06-14 00:00:00",
31187,1,77019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77019LTR.pdf","2004-12-02 00:00:00",
8992,1,77021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77021ltr.pdf","2004-12-02 00:00:00",
8993,1,77022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77022ltr.pdf","2004-12-02 00:00:00",
8994,1,77031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77031ltr.pdf","2004-10-29 00:00:00",
23846,10,77031,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23847,10,77032,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
8995,1,77033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77033ltr.pdf","2004-10-29 00:00:00",
44330,10,77033,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23848,10,77034,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
8996,1,77035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77035ltr.pdf","2004-10-29 00:00:00",
23849,10,77035,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
31188,1,77036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77036ltr.pdf","2004-10-29 00:00:00",
44331,10,77036,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23850,10,77037,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
8997,1,77038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77038ltr.pdf","2004-10-29 00:00:00",
44332,10,77038,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
31189,1,77039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077039ltr.pdf","2005-02-08 00:00:00",
44333,10,77039,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23851,10,77041,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23852,10,77042,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
23853,10,77043,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
31190,1,77043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf","2004-12-13 00:00:00",
18455,2,77043,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf","2014-09-05 00:00:00",
23854,10,77044,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
44334,10,77045,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
44335,10,77046,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
44336,10,77048,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-07-29 00:00:00",
44337,10,77051,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114961.htm","2006-08-10 00:00:00",
44338,10,77052,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2006-07-17 00:00:00",
31191,1,77053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077053ltr.pdf","2005-12-13 00:00:00",
8998,1,77056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf","2006-04-25 00:00:00",
31192,1,77059,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077059ltr.pdf","2008-05-06 00:00:00",
44532,14,77062,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-16 00:00:00",
8999,1,77065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077065s000_ltr.pdf","2007-07-05 00:00:00",
9000,1,77067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077067s000_LTR.pdf","2007-04-25 00:00:00",
23855,10,77069,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
23856,10,77082,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2007-07-05 00:00:00",
9001,1,77083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077083ltr.pdf","2005-09-15 00:00:00",
44339,10,77083,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
23857,10,77084,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
31193,1,77084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077084ltr.pdf","2005-09-15 00:00:00",
31194,1,77085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077085ltr.pdf","2005-09-15 00:00:00",
44340,10,77085,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
23858,10,77086,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
31195,1,77086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077086ltr.pdf","2005-09-15 00:00:00",
9002,1,77087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077087ltr.pdf","2005-09-15 00:00:00",
23859,10,77087,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
9003,1,77090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077090ltr.pdf","2005-09-15 00:00:00",
44341,10,77090,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218691.htm","2010-08-09 00:00:00",
9004,1,77091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077091ltr.pdf","2005-10-11 00:00:00",
31196,1,77094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077094TA_ltr.pdf","2005-10-20 00:00:00",
31197,1,77107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077107s000ltr.pdf","2007-02-12 00:00:00",
31198,1,77111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077111s000ltr.pdf","2007-05-29 00:00:00",
9005,1,77123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077123ltr.pdf","2004-12-23 00:00:00",
31199,1,77130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077130s000ltr.pdf","2007-11-08 00:00:00",
31200,1,77131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077131s000ltr.pdf","2007-10-25 00:00:00",
9006,1,77132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077132s000ltr.pdf","2007-10-10 00:00:00",
18456,2,77132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf","2007-10-10 00:00:00",
44342,10,77132,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2007-10-23 00:00:00",
9007,1,77136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077136s000_ltr.pdf","2007-07-05 00:00:00",
9008,1,77137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077137s000_ltr.pdf","2007-07-05 00:00:00",
9009,1,77138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077138s000ltr.pdf","2008-03-19 00:00:00",
9010,1,77139,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077139Orig1s016ltr.pdf","2014-11-04 00:00:00",
18457,2,77139,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf","2014-11-07 00:00:00",
9011,1,77149,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077149ltr.pdf","2006-04-05 00:00:00",
23860,10,77152,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
24060,14,77154,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
9012,1,77157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077157s000ltr.pdf","2010-04-09 00:00:00",
9013,1,77159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077159s000ltr.pdf","2012-04-02 00:00:00",
44343,10,77161,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2005-07-28 00:00:00",
31201,1,77165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077165TA_ltr.pdf","2005-08-19 00:00:00",
23861,10,77166,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm","2006-09-12 00:00:00",
9014,1,77167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77167ltr.pdf","2004-12-06 00:00:00",
31202,1,77170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077170_s000ltr.pdf","2008-02-27 00:00:00",
39521,2,77170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077170_s000lbl.pdf","2008-02-28 00:00:00",
43115,3,77170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077170Orig1s000.pdf","2015-11-27 00:00:00",
31203,1,77171,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077171ltr.pdf","2005-08-08 00:00:00",
31204,1,77171,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077171s006ltr.pdf","2009-12-24 00:00:00",
9015,1,77174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077174ltr.pdf","2005-06-07 00:00:00",
43116,3,77176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077176Orig1s000BioeqR.pdf","2012-04-13 00:00:00",
9016,1,77179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077179s000ltr.pdf","2007-05-29 00:00:00",
31205,1,77195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077195s000_ltr.pdf","2007-07-05 00:00:00",
9017,1,77197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077197LTR.pdf","2006-05-25 00:00:00",
43117,3,77200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077200Orig1s000.pdf","2012-01-27 00:00:00",
22599,3,77203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2005/077203Orig1s000.pdf","2012-11-14 00:00:00",
31206,1,77206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077206TA_ltr.pdf","2005-09-22 00:00:00",
53971,14,77209,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/077291, 077209_SLCOrderLtr.pdf","2018-05-01 00:00:00",
44344,10,77210,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm","2009-11-12 00:00:00",
23862,10,77213,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2006-04-10 00:00:00",
9018,1,77214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077214s000ltr.pdf","2007-05-01 00:00:00",
9019,1,77218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077218ltr.pdf","2005-01-13 00:00:00",
31207,1,77219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077219s000ltr.pdf","2008-02-22 00:00:00",
9020,1,77223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077223s000_ltr.pdf","2007-07-05 00:00:00",
44345,10,77232,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-11-14 00:00:00",
9021,1,77233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077233s000ltr.pdf","2006-09-25 00:00:00",
44346,10,77234,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2008-02-28 00:00:00",
9022,1,77236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077236s000ltr.pdf","2007-03-15 00:00:00",
31208,1,77237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077237TA_ltr.pdf","2005-11-18 00:00:00",
44347,10,77237,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
9023,1,77238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/77238s000ltr.pdf","2008-06-09 00:00:00",
23863,10,77238,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
18458,2,77239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077239s000lbl.pdf","2008-07-14 00:00:00",
23864,10,77239,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
31209,1,77239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077239s000ltr.pdf","2008-06-10 00:00:00",
9024,1,77243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077243s000TAltr.pdf","2006-11-14 00:00:00",
31210,1,77244,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77244ltr.pdf","2004-10-22 00:00:00",
9025,1,77245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077245s000ltr.pdf","2006-09-18 00:00:00",
31211,1,77255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077255s000ltr.pdf","2009-11-13 00:00:00",
23865,10,77256,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
9026,1,77264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077264s000ltr.pdf","2006-11-06 00:00:00",
31212,1,77267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077267ltr.pdf","2005-09-22 00:00:00",
9027,1,77268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268ltr.pdf","2005-09-22 00:00:00",
31213,1,77268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268TA_ltr.pdf","2005-09-14 00:00:00",
9028,1,77269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77269ltr.pdf","2004-10-18 00:00:00",
31214,1,77270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077270ltr.pdf","2005-11-01 00:00:00",
44618,16,77272,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31215,1,77273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077273s000ltr.pdf","2007-09-26 00:00:00",
39522,2,77273,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077273s000lbl.pdf","2007-10-04 00:00:00",
9029,1,77274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077274ltr.pdf","2005-10-10 00:00:00",
9030,1,77277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077277LTR.pdf","2006-05-03 00:00:00",
44348,10,77278,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2006-03-28 00:00:00",
31216,1,77284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077284s000ltr.pdf","2006-12-28 00:00:00",
39523,2,77284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077284lbl.pdf","2007-01-19 00:00:00",
43118,3,77284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077284Orig1Approv.pdf","2012-03-28 00:00:00",
22600,3,77285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077285_000.pdf","2011-08-09 00:00:00",
9031,1,77287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077287s000ltr.pdf","2006-09-20 00:00:00",
43119,3,77287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077287Orig1s000.pdf","2012-03-02 00:00:00",
31217,1,77288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077288s000ltr.pdf","2007-05-01 00:00:00",
31218,1,77295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077295ltr.pdf","2005-10-10 00:00:00",
9032,1,77297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf","2005-08-19 00:00:00",
18459,2,77297,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf","2012-04-30 00:00:00",
44995,3,77297,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077297Orig1s010.pdf","2012-04-13 00:00:00",
9033,1,77297,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf","2014-09-24 00:00:00",
39524,2,77297,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf","2014-09-25 00:00:00",
31219,1,77302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077302s000ltr.pdf","2012-06-26 00:00:00",
31220,1,77304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077304s000ltr.pdf","2006-09-25 00:00:00",
44349,10,77307,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
9034,1,77308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077308s000ltr.pdf","2009-11-10 00:00:00",
9035,1,77309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077309ltr.pdf","2005-10-20 00:00:00",
23866,10,77311,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129288.htm","2005-11-21 00:00:00",
24061,14,77312,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2012-02-03 00:00:00",
31221,1,77312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077312s000ltr.pdf","2009-11-05 00:00:00",
39525,2,77312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312lbl.pdf","2009-11-04 00:00:00",
43896,8,77312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf","2009-11-04 00:00:00",
31222,1,77316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077316s000_ltr.pdf","2007-09-07 00:00:00",
23867,10,77319,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
31223,1,77322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077322s000ltr.pdf","2007-05-01 00:00:00",
39526,2,77322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077322s000lbl.pdf","2007-05-01 00:00:00",
9036,1,77327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077327ltr.pdf","2005-09-22 00:00:00",
18460,2,77328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077328ls000lb.pdf","2009-03-19 00:00:00",
31224,1,77332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077332s000TAltr.pdf","2006-10-23 00:00:00",
9037,1,77337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077337Orig1s000ltr.pdf","2014-05-09 00:00:00",
39527,2,77337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077337Orig1s000lbl.pdf","2014-08-05 00:00:00",
48644,1,77337,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/077337Orig1s000ltr.pdf","2017-06-05 00:00:00",
48537,2,77337,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/077337Orig1s000lbl.pdf","2017-05-25 00:00:00",
50339,1,77342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/077342Orig1s000ltr.pdf","2017-11-08 00:00:00",
31225,1,77346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077346s000ltr.pdf","2007-09-07 00:00:00",
39528,2,77346,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf","2007-09-07 00:00:00",
31226,1,77351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077351s000LTR.pdf","2006-09-27 00:00:00",
31227,1,77355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077355ltr.pdf","2008-03-20 00:00:00",
9038,1,77356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77356ltr.pdf","2006-04-12 00:00:00",
31228,1,77359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077359s000ltr.pdf","2007-05-01 00:00:00",
31229,1,77361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077361s000LTR.pdf","2006-08-07 00:00:00",
31230,1,77363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077363TA_rev2.pdf","2006-01-18 00:00:00",
31231,1,77366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077366ltr.pdf","2005-10-14 00:00:00",
9039,1,77369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077369s000ltr.pdf","2012-04-02 00:00:00",
44350,10,77376,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm","2006-03-09 00:00:00",
31232,1,77380,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077380s000ltr.pdf","2012-03-29 00:00:00",
23868,10,77381,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2006-10-10 00:00:00",
24158,16,77381,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124311.pdf","2006-10-10 00:00:00",
31233,1,77391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077391ltr.pdf","2006-01-30 00:00:00",
31234,1,77394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077394ltr.pdf","2005-11-18 00:00:00",
39529,2,77394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/077394lbl.pdf","2012-11-26 00:00:00",
22601,3,77395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077395.pdf","2011-09-19 00:00:00",
44351,10,77395,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2006-12-18 00:00:00",
9040,1,77406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077406s000ltr.pdf","2007-01-08 00:00:00",
43120,3,77407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/077407Orig1s000.pdf","2011-12-14 00:00:00",
22602,3,77410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077410_original_approval_pkg.pdf","2011-01-07 00:00:00",
9041,1,77411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77411TAltr.pdf","2006-09-15 00:00:00",
9042,1,77412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077412s000TAltr.pdf","2011-05-10 00:00:00",
52730,3,77414,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/077414Orig1S008LABL.pdf","2018-02-27 00:00:00",
31235,1,77415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf","2007-02-23 00:00:00",
43121,3,77415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf","2011-08-09 00:00:00",
22603,3,77415,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf","2013-05-14 00:00:00",
43122,3,77415,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf","2013-05-14 00:00:00",
31236,1,77416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077416s000TAltr .pdf","2006-08-11 00:00:00",
53908,14,77417,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/077417, 077809_SLCOrderLtr.pdf","2018-05-01 00:00:00",
18461,2,77419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf","2012-11-27 00:00:00",
22604,3,77419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077419Orig1Approv.pdf","2012-03-28 00:00:00",
9043,1,77421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077421s000LTR.pdf","2006-07-13 00:00:00",
18462,2,77425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf","2013-09-19 00:00:00",
31237,1,77425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077425Orig1s000ltr.pdf","2013-09-03 00:00:00",
9044,1,77428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077428s000TAltr.pdf","2006-06-28 00:00:00",
31238,1,77429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077429","2005-06-21 00:00:00",
31239,1,77431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf","2011-04-04 00:00:00",
9045,1,77437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077437Orig1s000ltr.pdf","2014-02-20 00:00:00",
22605,3,77449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077449Orig1s000.pdf","2014-01-17 00:00:00",
24062,14,77449,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
9046,1,77453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077453s000ltr.pdf","2008-01-25 00:00:00",
39530,2,77453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077453s000lbl.pdf","2008-01-30 00:00:00",
44352,10,77455,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2008-03-21 00:00:00",
31240,1,77458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77458ltr.pdf","2006-03-01 00:00:00",
18463,2,77460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077460s000lbl.pdf","2008-07-14 00:00:00",
31241,1,77460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077460s000ltr.pdf","2008-05-07 00:00:00",
9047,1,77461,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077461s000ltr.pdf","2009-09-16 00:00:00",
31242,1,77463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf","2006-08-14 00:00:00",
31243,1,77463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf","2009-09-16 00:00:00",
39531,2,77463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf","2009-10-21 00:00:00",
9048,1,77464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077464TA_ltr.pdf","2005-06-15 00:00:00",
9049,1,77464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077464s000ltr.pdf","2007-10-04 00:00:00",
9050,1,77467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077467s000ltr.pdf","2009-09-16 00:00:00",
18464,2,77467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077467s000lbl.pdf","2009-10-21 00:00:00",
23869,10,77469,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/fluoxetine/default.htm","2006-07-31 00:00:00",
23870,10,77469,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2008-11-25 00:00:00",
44533,14,77469,"ORIG",1,"Other Important Information from FDA","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2006-08-04 00:00:00",
23871,10,77470,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
31244,1,77472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077472s000TAltr.pdf","2006-11-06 00:00:00",
9051,1,77474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077474s000_ltr.pdf","2007-09-07 00:00:00",
31245,1,77477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077477s000ltr.pdf","2007-05-29 00:00:00",
31246,1,77481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077481ltr.pdf","2007-08-07 00:00:00",
39532,2,77481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077481s000lbl.pdf","2007-08-07 00:00:00",
9052,1,77487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000TAltr.pdf","2007-07-05 00:00:00",
31247,1,77487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000ltr.pdf","2007-08-27 00:00:00",
31248,1,77489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077489s000ltr.pdf","2006-12-28 00:00:00",
44353,10,77489,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-12-18 00:00:00",
9053,1,77492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077492Orig1s000ltr.pdf","2012-09-21 00:00:00",
18465,2,77492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf","2014-07-31 00:00:00",
31249,1,77492,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077492Orig1s000ltr.pdf","2014-06-27 00:00:00",
31250,1,77496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77496ltr.pdf","2006-04-13 00:00:00",
31251,1,77498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077498ltr.pdf","2008-01-09 00:00:00",
39533,2,77498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077498lbl.pdf","2008-01-08 00:00:00",
31252,1,77499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077499ltr.pdf","2008-01-09 00:00:00",
39534,2,77499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077499lbl_rc.pdf","2008-01-08 00:00:00",
9054,1,77500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077500s000_ltr.pdf","2006-09-15 00:00:00",
23872,10,77505,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
9055,1,77507,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077507ltr.pdf","2005-11-01 00:00:00",
31253,1,77510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077510s000ltr.pdf","2006-10-26 00:00:00",
43123,3,77511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077511_toc.cfm","2012-03-28 00:00:00",
31254,1,77512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077512s000TAltr.pdf","2011-05-10 00:00:00",
23873,10,77513,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
23874,10,77514,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
31255,1,77519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077519s000ltr.pdf","2008-11-21 00:00:00",
31256,1,77521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077521ta_ltr.pdf","2005-06-21 00:00:00",
44354,10,77522,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
9056,1,77524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077524s000ltr.pdf","2008-04-15 00:00:00",
43124,3,77524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077524_original_approval_pkg.pdf","2011-02-15 00:00:00",
31257,1,77527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077527s000ltr.pdf","2008-08-14 00:00:00",
31258,1,77528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077528s000ltr.pdf","2012-06-22 00:00:00",
31259,1,77532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077532s000ltr.pdf","2008-05-09 00:00:00",
31260,1,77533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077533s000_ltr.pdf","2007-07-05 00:00:00",
44355,10,77536,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-12-18 00:00:00",
43125,3,77538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077538_fluticasone_toc.cfm","2011-12-14 00:00:00",
31261,1,77540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077540s000ltr.pdf","2007-05-01 00:00:00",
9057,1,77550,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077550s000TAltr.pdf","2011-05-10 00:00:00",
43126,3,77553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077553Orig1s000LBL.pdf","2013-05-02 00:00:00",
9058,1,77555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077555s000ltr.pdf","2011-11-10 00:00:00",
9059,1,77558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077558TA.pdf","2005-07-15 00:00:00",
31262,1,77560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077560_TA_ltr.pdf","2007-05-29 00:00:00",
9060,1,77561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077561s000ltr.pdf","2012-03-06 00:00:00",
9061,1,77562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077562s000TAltr.pdf","2011-04-21 00:00:00",
44356,10,77562,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-11-13 00:00:00",
9062,1,77565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077565s000TAltr.pdf","2011-04-21 00:00:00",
18466,2,77567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077567s000lbl.pdf","2009-02-24 00:00:00",
31263,1,77567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077567s000ltr.pdf","2009-02-03 00:00:00",
43127,3,77570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077570Orig1s000BioeqR.pdf","2012-05-09 00:00:00",
44357,10,77570,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm","2008-01-30 00:00:00",
9063,1,77571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077571taltr.pdf","2007-08-14 00:00:00",
9064,1,77571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077571Orig1s000ltr.pdf","2013-07-12 00:00:00",
18467,2,77571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf","2013-07-12 00:00:00",
44534,14,77571,"ORIG",1,"Package Label","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571Orig1s000lbl.pdf","2013-09-24 00:00:00",
22606,3,77575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/077575Orig1s000.pdf","2015-03-09 00:00:00",
44619,16,77580,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085203.htm","2007-12-03 00:00:00",
44358,10,77593,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2008-09-19 00:00:00",
44359,10,77601,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2005-11-21 00:00:00",
9065,1,77603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077603s000ltr.pdf","2008-08-29 00:00:00",
23875,10,77603,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2008-09-19 00:00:00",
23876,10,77605,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2008-09-19 00:00:00",
31264,1,77605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf","2008-08-29 00:00:00",
39535,2,77605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf","2008-11-20 00:00:00",
23877,10,77610,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2008-11-25 00:00:00",
39536,2,77612,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077612s005lbl.pdf","2014-02-06 00:00:00",
31265,1,77614,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077614s000_ltr.pdf","2007-09-07 00:00:00",
9066,1,77615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077615s000ltr.pdf","2008-08-05 00:00:00",
31266,1,77623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077623s000ltr.pdf","2007-09-25 00:00:00",
44620,16,77625,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31267,1,77626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077626s000ltr.pdf","2008-06-10 00:00:00",
44360,10,77626,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
23878,10,77627,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
44361,10,77629,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2006-06-19 00:00:00",
9067,1,77631,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077631ltr.pdf","2008-01-18 00:00:00",
39537,2,77631,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077631s000lbl_CKD.pdf","2008-01-23 00:00:00",
22607,3,77633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/077633Orig1s000Approv.pdf","2012-02-14 00:00:00",
24159,16,77634,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
9068,1,77635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077635rev2.pdf","2006-01-18 00:00:00",
44621,16,77635,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
24160,16,77636,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31268,1,77636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077636rev2.pdf","2005-12-28 00:00:00",
9069,1,77637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077637rev2.pdf","2005-12-28 00:00:00",
44622,16,77637,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
24161,16,77639,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31269,1,77639,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077639ltr.pdf","2005-12-28 00:00:00",
9070,1,77641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077641ltr.pdf","2005-12-28 00:00:00",
24162,16,77641,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
9071,1,77642,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077642ltr.pdf","2005-12-28 00:00:00",
44623,16,77642,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
23879,10,77643,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
24163,16,77644,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31270,1,77644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077644ltr.pdf","2005-12-28 00:00:00",
9072,1,77645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077645ltr.pdf","2005-12-28 00:00:00",
24164,16,77645,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
9073,1,77647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077647ltr.pdf","2005-12-28 00:00:00",
44624,16,77647,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31271,1,77648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077648ltr.pdf","2005-12-28 00:00:00",
44625,16,77648,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
44626,16,77650,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
44627,16,77651,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
23880,10,77654,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2009-03-19 00:00:00",
23881,10,77660,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm","2007-08-16 00:00:00",
31272,1,77660,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077660s000ltr.pdf","2007-08-02 00:00:00",
9074,1,77665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077665Orig1s000ltr.pdf","2012-05-18 00:00:00",
39538,2,77668,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077668s006lbl.pdf","2014-09-05 00:00:00",
18468,2,77672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077672s000lbl.pdf","2009-02-04 00:00:00",
31273,1,77672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77672TA_ltr.pdf","2005-07-08 00:00:00",
31274,1,77672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077672s000TAltr.pdf","2006-07-03 00:00:00",
31275,1,77672,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077672s000ltr.pdf","2008-12-30 00:00:00",
9075,1,77673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077673TA_ltr.pdf","2005-06-29 00:00:00",
31276,1,77677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077677s001ltr.pdf","2010-01-05 00:00:00",
39539,2,77681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf","2014-03-20 00:00:00",
44535,14,77681,"ORIG",1,"Label 2","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl2.pdf","2014-03-20 00:00:00",
9076,1,77684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf","2007-07-05 00:00:00",
31277,1,77687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077687s000ltr.pdf","2007-09-25 00:00:00",
23882,10,77690,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2006-07-05 00:00:00",
23883,10,77691,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
31278,1,77693,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077693s000ltr.pdf","2008-01-31 00:00:00",
31279,1,77695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77695TA_ltr.pdf","2005-11-18 00:00:00",
31280,1,77702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077702TA.pdf","2006-01-06 00:00:00",
22608,3,77707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077707Orig1s000Approv.pdf","2012-09-17 00:00:00",
22609,3,77712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077712Orig1s000Approv.pdf","2012-09-12 00:00:00",
22610,3,77715,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077715Orig1s000.pdf","2011-12-16 00:00:00",
44362,10,77715,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm","2007-06-18 00:00:00",
31281,1,77724,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077724s000ltr.pdf","2008-02-29 00:00:00",
31282,1,77728,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf","2008-01-09 00:00:00",
31283,1,77728,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077728s000ltr.pdf","2008-02-27 00:00:00",
31284,1,77732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077732s000ltr.pdf","2010-04-09 00:00:00",
23884,10,77733,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
9077,1,77734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077734s000TAltr.pdf","2011-05-10 00:00:00",
22611,3,77742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077742Orig1s000Approv.pdf","2013-01-22 00:00:00",
31285,1,77742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077742Orig1s000ltr.pdf","2012-12-18 00:00:00",
31286,1,77744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077744s000ltr.pdf","2009-08-14 00:00:00",
31287,1,77745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077745s000ltr.pdf","2012-03-29 00:00:00",
22612,3,77747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077747_bioeq_rev.pdf","2011-02-15 00:00:00",
23885,10,77747,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-04-25 00:00:00",
44536,14,77747,"ORIG",1,"Bioequivalence Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077747_bioeq_rev.pdf","2011-02-15 00:00:00",
23886,10,77752,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
9078,1,77753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077753s000ltr.pdf","2008-03-19 00:00:00",
9079,1,77763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077763s000ltr.pdf","2008-03-11 00:00:00",
9080,1,77764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077764s000ltr.pdf","2009-03-17 00:00:00",
23887,10,77766,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
9081,1,77773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077773s000ltr.pdf","2007-05-01 00:00:00",
9082,1,77774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077774ta-ltr.pdf","2005-12-22 00:00:00",
9083,1,77774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077774s000ltr.pdf","2008-12-31 00:00:00",
44537,14,77775,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-03-24 00:00:00",
43128,3,77779,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077779Orig1s000BioeqR.pdf","2012-04-13 00:00:00",
31288,1,77780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077780s000_ltr.pdf","2007-09-07 00:00:00",
31289,1,77782,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077782s000ltr.pdf","2006-09-18 00:00:00",
22613,3,77793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077393Orig1s000.pdf","2011-12-14 00:00:00",
24165,16,77794,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-10-23 00:00:00",
31290,1,77794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077794s000ltr.pdf","2007-10-10 00:00:00",
39540,2,77794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077794s000lbl.pdf","2007-10-10 00:00:00",
9084,1,77795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077795s000ltr.pdf","2007-10-10 00:00:00",
24166,16,77795,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-10-23 00:00:00",
39541,2,77795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf","2007-10-10 00:00:00",
9085,1,77798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077798s000TAltr.pdf","2011-05-10 00:00:00",
22614,3,77801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077801_bioeq_rev.pdf","2011-02-15 00:00:00",
24167,16,77801,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-12-03 00:00:00",
9086,1,77802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077802s000ltr.pdf","2007-10-10 00:00:00",
24168,16,77802,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-10-23 00:00:00",
39542,2,77802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf","2007-10-10 00:00:00",
44363,10,77805,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
43129,3,77807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077807_original_approval_pkg.pdf","2007-12-28 00:00:00",
53910,14,77809,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/077417, 077809_SLCOrderLtr.pdf","2018-05-01 00:00:00",
44364,10,77812,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2006-09-12 00:00:00",
24169,16,77813,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31291,1,77827,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077827s001ltr.pdf","2008-01-09 00:00:00",
9087,1,77833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077833s000ltr.pdf","2007-04-09 00:00:00",
23888,10,77837,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
9088,1,77841,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077841s000ltr.pdf","2007-08-14 00:00:00",
9089,1,77844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077844s000TAltr.pdf","2006-05-21 00:00:00",
31292,1,77846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077846s000ltr.pdf","2008-10-29 00:00:00",
31293,1,77847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077847s000ltr.pdf","2008-11-03 00:00:00",
43130,3,77850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/077850Orig1s000.pdf","2014-08-01 00:00:00",
9090,1,77857,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077857s000ltr.pdf","2010-07-23 00:00:00",
43131,3,77857,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/077857Orig1s000.pdf","2013-02-25 00:00:00",
9091,1,77858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077858s000ltr.pdf","2008-10-01 00:00:00",
23889,10,77860,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-12-18 00:00:00",
31294,1,77868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077868s000ltr.pdf","2009-04-21 00:00:00",
44628,16,77869,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
22615,3,77873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077873Orig1s000.pdf","2013-01-28 00:00:00",
31295,1,77873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077873s000_ltr.pdf","2007-07-05 00:00:00",
44365,10,77873,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2007-07-05 00:00:00",
24170,16,77876,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-02-01 00:00:00",
31296,1,77882,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077882s000ltr.pdf","2009-05-18 00:00:00",
31297,1,77884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077884s000ltr.pdf","2007-05-01 00:00:00",
31298,1,77887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077887s000ltr.pdf","2007-09-11 00:00:00",
31299,1,77888,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077888s000ltr.pdf","2008-03-19 00:00:00",
23890,10,77900,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
23891,10,77903,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-08-24 00:00:00",
44366,10,77905,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
39543,2,77907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077907Orig1s000LBL.pdf","2009-02-06 00:00:00",
43132,3,77908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/077908Orig1s000BioeqR.pdf","2012-06-22 00:00:00",
44367,10,77908,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm","2007-06-18 00:00:00",
43990,9,77912,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2009-05-30 00:00:00",
44629,16,77912,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm123918.htm","2006-10-10 00:00:00",
9092,1,77916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077916TA-LTR.pdf","2006-05-26 00:00:00",
9093,1,77919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077919s000_ltr.pdf","2007-07-05 00:00:00",
31300,1,77920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77920ltr.pdf","2006-07-21 00:00:00",
31301,1,77921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077921s000ltr.pdf","2009-05-18 00:00:00",
31302,1,77923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077923s000ltr.pdf","2009-05-18 00:00:00",
9094,1,77925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77925ltr.pdf","2006-07-21 00:00:00",
9095,1,77929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77929ltr.pdf","2006-07-21 00:00:00",
31303,1,77930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77930ltr.pdf","2006-07-21 00:00:00",
31304,1,77932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77932ltr.pdf","2006-07-21 00:00:00",
9096,1,77933,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77933ltr.pdf","2006-07-21 00:00:00",
31305,1,77934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77934ltr.pdf","2006-07-21 00:00:00",
31306,1,77935,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77935ltr.pdf","2006-07-21 00:00:00",
31307,1,77936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077936s000ltr.pdf","2006-07-21 00:00:00",
31308,1,77937,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77937ltr.pdf","2006-07-21 00:00:00",
9097,1,77938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077938ltr.pdf","2006-07-21 00:00:00",
31309,1,77944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77944ltr.pdf","2006-07-21 00:00:00",
9098,1,77946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077946ltr.pdf","2008-01-09 00:00:00",
39544,2,77946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077946lbl_rc.pdf","2008-01-08 00:00:00",
31310,1,77950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077950s000TAltr.pdf","2006-07-03 00:00:00",
44368,10,77953,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-09-19 00:00:00",
31311,1,77954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077954s000ltr.pdf","2008-05-05 00:00:00",
31312,1,77954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077954s000ltr.pdf","2009-05-06 00:00:00",
9099,1,77956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077956s000TAltr.pdf","2006-05-21 00:00:00",
9100,1,77960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077960s000LTR.pdf","2006-10-18 00:00:00",
39545,2,77963,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077963s010lbl.pdf","2012-04-30 00:00:00",
9101,1,77963,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf","2014-09-24 00:00:00",
18469,2,77963,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf","2014-09-25 00:00:00",
18470,2,77973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077973s000lbl.pdf","2009-07-24 00:00:00",
31313,1,77973,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077973s000ltr.pdf","2009-07-09 00:00:00",
18471,2,77975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077975s000lbl.pdf","2011-04-19 00:00:00",
31314,1,77975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077975s000ltr.pdf","2009-12-24 00:00:00",
31315,1,77980,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077980s000TAltr.pdf","2006-06-28 00:00:00",
9102,1,77981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077981s000ltr.pdf","2008-07-01 00:00:00",
44369,10,77982,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
9103,1,77983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077983s000ltr.pdf","2008-12-29 00:00:00",
31316,1,77983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077983s000ltr.pdf","2011-02-02 00:00:00",
9104,1,77985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077985s000ltr.pdf","2007-05-01 00:00:00",
18472,2,77989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077989s000lbl.pdf","2007-08-07 00:00:00",
31317,1,77989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077989s000ltr.pdf","2007-08-07 00:00:00",
9105,1,77990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077990s000ltr.pdf","2007-05-01 00:00:00",
43133,3,77991,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077991Orig1s000.pdf","2015-11-17 00:00:00",
9106,1,77995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077995s000ltr.pdf","2009-07-09 00:00:00",
39546,2,77995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077995s000lbl.pdf","2009-07-23 00:00:00",
9107,1,78003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078003Orig1s000ltr.pdf","2015-01-28 00:00:00",
39547,2,78003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078003Orig1s000lbl.pdf","2015-02-17 00:00:00",
31318,1,78004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078004Orig1s000ltr.pdf","2012-05-18 00:00:00",
22616,3,78005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/078005_bioeq_rev-oxcarbazepine tabs.pdf","2011-02-15 00:00:00",
24171,16,78005,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2007-12-21 00:00:00",
22617,3,78009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078009Orig1s000Approv.pdf","2012-02-14 00:00:00",
31319,1,78016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078016s000ltr.pdf","2007-05-01 00:00:00",
9108,1,78020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078020Orig1s000ltr.pdf","2012-09-24 00:00:00",
31320,1,78022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078022s000ltr.pdf","2007-02-23 00:00:00",
31321,1,78024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078024s000ltr.pdf","2008-03-19 00:00:00",
23892,10,78026,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2007-07-05 00:00:00",
31322,1,78027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078027Orig1s000ltr.pdf","2015-07-10 00:00:00",
9109,1,78030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078030s000ltr.pdf","2009-03-24 00:00:00",
31323,1,78032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078032s000TAltr.pdf","2011-05-10 00:00:00",
44370,10,78032,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm","2007-01-18 00:00:00",
44371,10,78034,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
22618,3,78035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/078035Orig1s000.pdf","2013-10-23 00:00:00",
44372,10,78045,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2008-11-25 00:00:00",
9110,1,78046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078046ltr.pdf","2007-09-25 00:00:00",
31324,1,78052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078052s000ltr.pdf","2007-08-07 00:00:00",
39548,2,78052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078052s000lbl.pdf","2007-08-07 00:00:00",
31325,1,78055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078055s000ltr.pdf","2007-05-01 00:00:00",
31326,1,78058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078058s000ltr.pdf","2010-06-30 00:00:00",
9111,1,78061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078061Orig1s000ltr.pdf","2015-05-20 00:00:00",
9112,1,78064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/078064Orig1s000ltr.pdf","2006-12-28 00:00:00",
9113,1,78065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078065s000ltr.pdf","2007-01-31 00:00:00",
39549,2,78065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078065lbl.pdf","2007-01-31 00:00:00",
39550,2,78067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078067Orig1s000LBL.pdf","2009-02-06 00:00:00",
22619,3,78069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/078069_bioeq_rev-oxcarbazepine tabs.pdf","2011-02-15 00:00:00",
44630,16,78069,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm","2008-01-17 00:00:00",
9114,1,78079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078079s000ltr.pdf","2007-09-25 00:00:00",
39551,2,78080,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078080s004lbl.pdf","2012-04-30 00:00:00",
18473,2,78080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078080Orig1s005lbl.pdf","2014-09-23 00:00:00",
31327,1,78080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078080Orig1s005ltr.pdf","2014-09-24 00:00:00",
9115,1,78088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf","2009-01-12 00:00:00",
31328,1,78088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf","2007-09-25 00:00:00",
31329,1,78090,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005ltr.pdf","2014-09-24 00:00:00",
39552,2,78090,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf","2014-09-23 00:00:00",
9116,1,78095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078095s000ltr.pdf","2008-06-10 00:00:00",
44631,16,78095,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
18474,2,78096,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf","2014-09-23 00:00:00",
31330,1,78096,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005ltr.pdf","2014-09-24 00:00:00",
22620,3,78098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/078098Orig1Approv.pdf","2012-03-28 00:00:00",
31331,1,78098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078098s000ltr.pdf","2008-09-23 00:00:00",
9117,1,78104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078104s000ltr.pdf","2009-08-06 00:00:00",
18475,2,78104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078104lbl.pdf","2009-07-30 00:00:00",
31332,1,78109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078109s000ltr.pdf","2011-10-26 00:00:00",
9118,1,78112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078112ltr.pdf","2007-03-15 00:00:00",
9119,1,78114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078114s000ltr.pdf","2008-03-19 00:00:00",
9120,1,78115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf","2009-04-03 00:00:00",
23893,10,78115,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
43134,3,78115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078115Orig1s000BioeqR.pdf","2012-01-27 00:00:00",
44538,14,78115,"ORIG",1,"Approval Package","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078115Orig1s000Approv.pdf","2013-01-22 00:00:00",
31333,1,78119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078119s000TAltr.pdf","2006-11-07 00:00:00",
31334,1,78124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078124s000ltr.pdf","2007-09-25 00:00:00",
31335,1,78126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf","2007-08-07 00:00:00",
39553,2,78126,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf","2007-08-07 00:00:00",
9121,1,78128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078128ltr.pdf","2006-04-05 00:00:00",
23894,10,78129,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2008-05-14 00:00:00",
31336,1,78131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078131s000ltr.pdf","2007-09-06 00:00:00",
9122,1,78134,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078134Orig1s000Approv.pdf","2012-02-14 00:00:00",
9123,1,78137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078137s000ltr.pdf","2007-08-07 00:00:00",
39554,2,78137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078137s0000lbl.pdf","2007-08-07 00:00:00",
31337,1,78138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078138s000ltr.pdf","2009-11-13 00:00:00",
23895,10,78143,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2008-01-30 00:00:00",
9124,1,78144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078144s000ltr.pdf","2007-09-25 00:00:00",
23896,10,78147,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2009-01-06 00:00:00",
31338,1,78148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078148s000ltr.pdf","2010-12-07 00:00:00",
44373,10,78151,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
23897,10,78155,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2008-02-28 00:00:00",
23898,10,78156,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
31339,1,78157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078157s000_ltr.pdf","2007-07-05 00:00:00",
9125,1,78158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078158s000ltr.pdf","2007-08-07 00:00:00",
18476,2,78158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078158s000lbl.pdf","2007-08-07 00:00:00",
9126,1,78163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078163s000_ltr.pdf","2007-07-05 00:00:00",
9127,1,78165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078165s000_ltr.pdf","2007-09-07 00:00:00",
9128,1,78172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078172ltr.pdf","2007-09-25 00:00:00",
31340,1,78179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078179s000ltr.pdf","2010-10-20 00:00:00",
31341,1,78182,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078182s000ltr.pdf","2008-08-05 00:00:00",
31342,1,78183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078183s000LTR.pdf","2007-03-31 00:00:00",
44374,10,78184,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-09-24 00:00:00",
18477,2,78185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf","2009-02-24 00:00:00",
31343,1,78185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf","2009-02-03 00:00:00",
31344,1,78189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078189ltr.pdf","2008-10-03 00:00:00",
44375,10,78189,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm","2008-09-19 00:00:00",
44376,10,78191,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
9129,1,78193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078193Orig1s000ltr.pdf","2014-03-06 00:00:00",
52769,3,78193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/078193Orig1s000.pdf","2018-02-28 00:00:00",
44377,10,78194,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2007-07-05 00:00:00",
31345,1,78195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078195s000TAltr.pdf","2006-08-18 00:00:00",
9130,1,78199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078199s000_ltr.pdf","2007-07-05 00:00:00",
43135,3,78202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078202Orig1s000.pdf","2011-12-02 00:00:00",
43136,3,78208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078208Orig1s000.pdf","2013-01-30 00:00:00",
44378,10,78212,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-05-30 00:00:00",
31346,1,78215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078215s000ltr.pdf","2011-04-04 00:00:00",
23899,10,78216,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm","2007-04-10 00:00:00",
9131,1,78217,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078217s000_ltr.pdf","2007-09-07 00:00:00",
9132,1,78219,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078219s000TAltr.pdf","2011-05-10 00:00:00",
9133,1,78223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078223s000ltr.pdf","2008-12-11 00:00:00",
43137,3,78223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/078223Orig1s000.pdf","2013-04-18 00:00:00",
31347,1,78227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078227s000_ltr.pdf","2007-09-07 00:00:00",
31348,1,78229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078229s000_ltr.pdf","2007-07-05 00:00:00",
9134,1,78233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078233s000ltr.pdf","2007-09-25 00:00:00",
44379,10,78235,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
31349,1,78241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078241s000ltr.pdf","2009-08-14 00:00:00",
9135,1,78242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078242ltr.pdf","2008-01-30 00:00:00",
31350,1,78251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078251s000_ltr.pdf","2007-09-07 00:00:00",
31351,1,78252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078252s000ltr.pdf","2008-03-19 00:00:00",
43138,3,78267,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078267Orig1s000Approv.pdf","2013-04-10 00:00:00",
23900,10,78269,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-11-25 00:00:00",
9136,1,78270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078270s000ltr.pdf","2007-09-25 00:00:00",
45728,1,78276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078276Orig1s000ltr.pdf","2016-10-31 00:00:00",
18478,2,78277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078277s000lbl.pdf","2007-08-07 00:00:00",
31352,1,78277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078277s000ltr.pdf","2007-08-07 00:00:00",
9137,1,78279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078279Orig1s000ltr.pdf","2015-10-02 00:00:00",
39555,2,78279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078279Orig1s000lbl.pdf","2015-11-25 00:00:00",
31353,1,78284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078284s000ltr.pdf","2009-08-14 00:00:00",
31354,1,78290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078290s000ltr.pdf","2008-08-05 00:00:00",
9138,1,78292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078292s000ltr.pdf","2008-07-01 00:00:00",
43139,3,78293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/078293Orig1s000.pdf","2013-08-09 00:00:00",
9139,1,78295,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078295s000ltr.pdf","2009-08-14 00:00:00",
9140,1,78305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078305s000ltr.pdf","2008-05-08 00:00:00",
9141,1,78306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078306ltr.pdf","2007-08-14 00:00:00",
9142,1,78313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078313s000TAltr.pdf","2011-05-10 00:00:00",
23901,10,78314,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2007-05-08 00:00:00",
18479,2,78317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078317lbl_rc.pdf","2008-01-08 00:00:00",
31355,1,78317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078317ltr.pdf","2008-01-09 00:00:00",
39556,2,78318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078318Orig1s000LBL.pdf","2009-02-06 00:00:00",
23902,10,78320,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
31356,1,78322,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078322s000ltr.pdf","2010-06-30 00:00:00",
9143,1,78327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078327s000ltr.pdf","2009-08-14 00:00:00",
23903,10,78329,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110510.htm","2009-03-03 00:00:00",
9144,1,78332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078332s000_ltr.pdf","2007-09-07 00:00:00",
9145,1,78336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078336ltr.pdf","2008-01-09 00:00:00",
18480,2,78336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078336lbl.pdf","2008-01-08 00:00:00",
9146,1,78337,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078337Orig1s000ltr.pdf","2012-11-28 00:00:00",
31357,1,78340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078340Orig1s000ltr.pdf","2015-12-08 00:00:00",
31358,1,78343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078343s000ltr.pdf","2008-01-17 00:00:00",
39557,2,78343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078343s000lbl.pdf","2008-01-23 00:00:00",
23904,10,78346,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-05-02 00:00:00",
9147,1,78348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078348s000ltr.pdf","2011-02-18 00:00:00",
9148,1,78349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078349s000ltr.pdf","2007-05-29 00:00:00",
31359,1,78350,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078350Orig1s000ltr.pdf","2015-12-09 00:00:00",
31360,1,78357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/78357Ltr.pdf","2010-03-30 00:00:00",
9149,1,78366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078366s000ltr.pdf","2011-04-28 00:00:00",
31361,1,78367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078367s000ltr.pdf","2010-07-14 00:00:00",
9150,1,78368,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078368s000ltr.pdf","2008-01-09 00:00:00",
43140,3,78374,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078374Orig1s003.pdf","2013-02-27 00:00:00",
22621,3,78374,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s004.pdf","2013-02-27 00:00:00",
43141,3,78374,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s005.pdf","2013-02-27 00:00:00",
9151,1,78378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078378s000LTR.pdf","2007-07-27 00:00:00",
9152,1,78380,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/78380TA_ltr.pdf","2007-08-14 00:00:00",
9153,1,78384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078384s000_ltr.pdf","2007-09-07 00:00:00",
31362,1,78388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078388s000ltr.pdf","2011-05-13 00:00:00",
39558,2,78392,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf","2012-04-30 00:00:00",
31363,1,78392,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf","2014-09-24 00:00:00",
39559,2,78392,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf","2014-09-25 00:00:00",
31364,1,78395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078395s000ltr.pdf","2008-11-03 00:00:00",
9154,1,78396,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078396s000ltr.pdf","2008-04-28 00:00:00",
31365,1,78399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078399s000ltr.pdf","2009-11-10 00:00:00",
44380,10,78402,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-04-26 00:00:00",
24141,15,78403,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2008-01-17 00:00:00",
23905,10,78406,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2007-08-16 00:00:00",
44381,10,78413,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-05-15 00:00:00",
44382,10,78426,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-05-31 00:00:00",
18481,2,78427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078427lbl.pdf","2008-01-08 00:00:00",
31366,1,78427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078427ltr.pdf.pdf","2008-01-09 00:00:00",
23906,10,78432,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2007-05-08 00:00:00",
31367,1,78434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078434s000ltr.pdf","2009-11-12 00:00:00",
44383,10,78438,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-06-18 00:00:00",
44384,10,78443,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110460.htm","2009-03-03 00:00:00",
23907,10,78450,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-09-24 00:00:00",
44385,10,78454,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
23908,10,78457,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2007-09-24 00:00:00",
43142,3,78458,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078458Orig1s000LBL.pdf","2012-03-02 00:00:00",
9155,1,78458,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078458Orig1s010ltr.pdf","2016-06-24 00:00:00",
18482,2,78458,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/078458Orig1s010lbl.pdf","2016-06-27 00:00:00",
9156,1,78462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078462s000ltr.pdf","2009-04-01 00:00:00",
23909,10,78462,"ORIG",1,"0","http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm","2008-02-01 00:00:00",
44386,10,78462,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
9157,1,78467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078467s000TAltr.pdf","2011-05-10 00:00:00",
9158,1,78470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078470s000ltr.pdf","2008-05-09 00:00:00",
9159,1,78482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078482s000ltr.pdf","2008-08-05 00:00:00",
9160,1,78485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078485s000ltr.pdf","2010-06-30 00:00:00",
23910,10,78486,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2007-08-16 00:00:00",
23911,10,78493,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-09-19 00:00:00",
43143,3,78502,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/078502Orig1Approv.pdf","2012-03-28 00:00:00",
22622,3,78503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078503Orig1s000.pdf","2013-08-09 00:00:00",
31368,1,78509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078509s000TAltr.pdf","2007-03-31 00:00:00",
9161,1,78515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078515s000ltr.pdf","2009-04-03 00:00:00",
18483,2,78515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf","2009-04-03 00:00:00",
31369,1,78519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078519s000ltr.pdf","2008-12-02 00:00:00",
23912,10,78520,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-11-25 00:00:00",
9162,1,78522,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005ltr.pdf","2014-09-24 00:00:00",
39560,2,78522,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf","2014-09-23 00:00:00",
9163,1,78540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078540s000ltr.pdf","2010-10-20 00:00:00",
22623,3,78540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078540Orig1s000.pdf","2013-10-23 00:00:00",
9164,1,78545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078545s000TAltr.pdf","2007-03-23 00:00:00",
31370,1,78545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078545s000ltr.pdf","2009-06-24 00:00:00",
22624,3,78548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078548Orig1s000.pdf","2012-11-16 00:00:00",
31371,1,78548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078548s000ltr.pdf","2010-03-03 00:00:00",
44632,16,78559,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm","2009-03-03 00:00:00",
31372,1,78560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078560Orig1s000ltr.pdf","2015-06-29 00:00:00",
9165,1,78562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078562s000ltr.pdf","2009-05-06 00:00:00",
39561,2,78562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078562s000lbl.pdf","2009-05-07 00:00:00",
53912,14,78562,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/078562_SLCOrderLtr.pdf","2018-05-01 00:00:00",
31373,1,78567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078567s000ltr.pdf","2007-09-25 00:00:00",
31374,1,78572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078572s000ltr.pdf","2010-03-25 00:00:00",
9166,1,78575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078575s000ltr.pdf","2009-07-09 00:00:00",
18484,2,78575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078575s000lbl.pdf","2009-07-24 00:00:00",
31375,1,78576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078576Orig1s000ltr.pdf","2013-03-04 00:00:00",
9167,1,78577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078577Orig1s000ltr.pdf","2015-08-13 00:00:00",
44387,10,78578,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2008-11-25 00:00:00",
9168,1,78580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078580Orig1s000ltr.pdf","2013-03-04 00:00:00",
9169,1,78582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078582s000ltr.pdf","2009-01-21 00:00:00",
44388,10,78582,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-02-04 00:00:00",
9170,1,78584,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078584taltr.pdf","2007-08-14 00:00:00",
31376,1,78587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078587s000TA_ltr.pdf","2008-01-09 00:00:00",
39562,2,78593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078593Orig1s000LBL.pdf","2009-02-06 00:00:00",
9171,1,78597,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078597s000ltr.pdf","2008-08-05 00:00:00",
9172,1,78604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078604s000TAltr.pdf","2011-05-10 00:00:00",
9173,1,78605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078605Orig1s000ltr.pdf","2012-08-06 00:00:00",
18485,2,78615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078615lbl.pdf","2008-01-08 00:00:00",
31377,1,78615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078615ltr.pdf","2008-01-09 00:00:00",
44389,10,78616,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2009-01-06 00:00:00",
23913,10,78619,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2008-02-28 00:00:00",
9174,1,78625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078625Orig1s000Approv.pdf","2012-02-14 00:00:00",
44390,10,78626,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2008-02-28 00:00:00",
23914,10,78630,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm","2011-02-17 00:00:00",
31378,1,78633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078633s000ltr.pdf","2009-10-14 00:00:00",
44539,14,78633,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
23915,10,78638,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
31379,1,78644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078644s000TAltr.pdf","2007-07-16 00:00:00",
31380,1,78648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078648Orig1s000ltr.pdf","2013-03-01 00:00:00",
39563,2,78648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078648Orig1s000lbl.pdf","2014-01-14 00:00:00",
9175,1,78669,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078669Orig1s000Approv.pdf","2012-02-14 00:00:00",
44391,10,78674,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2009-11-12 00:00:00",
23916,10,78682,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110510.htm","2009-04-14 00:00:00",
43144,3,78682,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078682.pdf","2011-09-19 00:00:00",
44392,10,78695,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2009-11-12 00:00:00",
31381,1,78702,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078702Orig1s000ltr.pdf","2013-05-07 00:00:00",
22625,3,78705,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078705Orig1s000.pdf","2011-12-09 00:00:00",
9176,1,78706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078706s000ltr.pdf","2008-06-10 00:00:00",
44393,10,78706,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
44394,10,78707,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2009-01-06 00:00:00",
18486,2,78709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/078709Orig1s000lbl.pdf","2016-04-11 00:00:00",
31382,1,78709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078709Orig1s000ltr.pdf","2016-04-05 00:00:00",
53932,14,78712,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/078712_SLCOrderLtr.pdf","2018-05-01 00:00:00",
9177,1,78713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078713s000ltr.pdf","2008-07-18 00:00:00",
31383,1,78717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078717s000ltr.pdf","2008-12-02 00:00:00",
39564,2,78717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078717s000lbl.pdf","2009-01-16 00:00:00",
9178,1,78721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078721s000ltr.pdf","2009-11-10 00:00:00",
31384,1,78723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078723Orig1s000ltr.pdf","2012-08-06 00:00:00",
43145,3,78730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078730Orig1s000.pdf","2013-02-01 00:00:00",
9179,1,78734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078734s000ltr.pdf","2009-06-30 00:00:00",
22626,3,78734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078734Orig1s000.pdf","2011-12-16 00:00:00",
23917,10,78735,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
9180,1,78742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078742s000TAltr.pdf","2007-04-20 00:00:00",
31385,1,78743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078743s000ltr.pdf","2009-03-10 00:00:00",
43146,3,78743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078743Orig1s000.pdf","2012-06-27 00:00:00",
44395,10,78745,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
31386,1,78751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078751s000ltr.pdf","2010-07-09 00:00:00",
24063,14,78761,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-03-24 00:00:00",
22627,3,78773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078773Orig1s000.pdf","2015-03-09 00:00:00",
31387,1,78773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078773s000ltr.pdf","2011-12-01 00:00:00",
23918,10,78774,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-03-03 00:00:00",
9181,1,78775,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078775s000TAltr.pdf","2007-05-01 00:00:00",
31388,1,78777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078777s000TAltr.pdf","2011-05-10 00:00:00",
9182,1,78780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078780s000ltr.pdf","2010-01-26 00:00:00",
9183,1,78783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf","2009-11-19 00:00:00",
9184,1,78783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000ltr.pdf","2009-07-15 00:00:00",
9185,1,78785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078785s_TAltr.pdf","2008-02-07 00:00:00",
23919,10,78787,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2008-02-28 00:00:00",
22628,3,78789,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078789Orig1s000.pdf","2015-03-09 00:00:00",
9186,1,78790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078790s000ltr.pdf","2008-08-05 00:00:00",
9187,1,78800,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078800s000TAltr.pdf","2009-05-06 00:00:00",
31389,1,78804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078804s000ltr.pdf","2009-08-21 00:00:00",
18487,2,78810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078810s000lbl.pdf","2009-08-11 00:00:00",
22629,3,78813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078813Orig1s000Approv.pdf","2013-04-10 00:00:00",
43147,3,78815,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078815Orig1s000.pdf","2013-04-23 00:00:00",
43148,3,78817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078817Orig1s000Approv.pdf","2013-04-10 00:00:00",
31390,1,78818,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078818Orig1s002ltr.pdf","2013-03-22 00:00:00",
39565,2,78818,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078818Orig1s002lbl.pdf","2013-03-22 00:00:00",
23920,10,78825,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm","2009-11-12 00:00:00",
45729,1,78827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078827Orig1s000ltr.pdf","2016-10-31 00:00:00",
23921,10,78828,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2009-04-14 00:00:00",
9188,1,78829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078829s000ltr.pdf","2008-06-10 00:00:00",
23922,10,78829,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
9189,1,78830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078830Orig1s000ltr.pdf","2015-02-26 00:00:00",
18488,2,78830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078830Orig1s000lbl.pdf","2015-02-26 00:00:00",
54774,3,78830,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/078830Orig1s000.pdf","2018-07-05 00:00:00",
23923,10,78832,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-09-19 00:00:00",
9190,1,78834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078834s000ltr.pdf","2011-06-02 00:00:00",
23924,10,78848,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-05-30 00:00:00",
9191,1,78850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078850TAltr.pdf","2008-01-30 00:00:00",
31391,1,78854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078854s000ltr.pdf","2011-06-09 00:00:00",
31392,1,78857,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf","2014-06-02 00:00:00",
44396,10,78861,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053351.htm","2008-11-25 00:00:00",
31393,1,78864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078864s000ltr.pdf","2008-05-21 00:00:00",
9192,1,78868,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078868s000ltr.pdf","2012-02-10 00:00:00",
23925,10,78871,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-11-25 00:00:00",
31394,1,78872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078872s000ltr.pdf","2009-09-23 00:00:00",
43149,3,78873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078873Orig1s000Approv.pdf","2012-09-26 00:00:00",
43150,3,78878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078878Orig1s000.pdf","2013-05-10 00:00:00",
43151,3,78879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078879Orig1s000.pdf","2013-05-15 00:00:00",
31395,1,78883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078883s000ltr.pdf","2008-04-28 00:00:00",
31396,1,78886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078886_TA_PEPFAR_LTR.pdf","2008-03-04 00:00:00",
9193,1,78887,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078887s000TAltr.pdf","2007-10-04 00:00:00",
9194,1,78901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078901Orig1s000ltr.pdf","2012-12-18 00:00:00",
44397,10,78902,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053346.htm","2008-03-21 00:00:00",
31397,1,78907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078907s000ltr.pdf","2009-11-05 00:00:00",
43897,8,78907,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf","2009-11-04 00:00:00",
44540,14,78907,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2012-02-03 00:00:00",
31398,1,78908,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078908Orig1s000ltr.pdf","2013-12-05 00:00:00",
9195,1,78915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078915s000ltr.pdf","2009-10-14 00:00:00",
9196,1,78917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078917s000ltr.pdf","2009-07-09 00:00:00",
39566,2,78917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078917s000lbl.pdf","2009-07-23 00:00:00",
9197,1,78921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078921s000ltr.pdf","2010-06-30 00:00:00",
9198,1,78922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078922s000ltr.pdf","2008-02-19 00:00:00",
9199,1,78929,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/78929TA_ltr.pdf","2007-08-14 00:00:00",
9200,1,78936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000ltr.pdf","2015-08-06 00:00:00",
9201,1,78936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000TAltr.pdf","2015-02-06 00:00:00",
18489,2,78936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078936Orig1s000lbl.pdf","2015-08-04 00:00:00",
23926,10,78942,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
9202,1,78944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078944s000ltr.pdf","2010-06-30 00:00:00",
9203,1,78957,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000_TA_PEPFAR_Ltr.pdf","2008-03-04 00:00:00",
9204,1,78957,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000ltr.pdf","2008-12-31 00:00:00",
31399,1,78958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078958TAltr_rc.pdf","2008-01-09 00:00:00",
9205,1,78964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078964Orig1s000ltr.pdf","2013-11-12 00:00:00",
18490,2,78964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078964Orig1s000lbl.pdf","2013-11-19 00:00:00",
9206,1,78965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078965s000ltr.pdf","2010-08-10 00:00:00",
9207,1,78966,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078966s000ltr.pdf","2010-05-27 00:00:00",
53914,14,78969,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/078969_SLCOrderLtr.pdf","2018-05-01 00:00:00",
9208,1,78974,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078974s000ltr.pdf","2011-02-24 00:00:00",
9209,1,78976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078976s000ltr.pdf","2009-01-21 00:00:00",
31400,1,78979,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078979s000ltr.pdf","2009-01-27 00:00:00",
48629,1,78983,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/078983Orig1s000ltr.pdf","2017-06-02 00:00:00",
31401,1,78984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078984s000ltr.pdf","2010-06-30 00:00:00",
9210,1,78989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078989s000ltr.pdf","2008-06-10 00:00:00",
44398,10,78989,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm","2008-07-01 00:00:00",
9211,1,78992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078992Orig1s000ltr.pdf","2013-12-05 00:00:00",
22630,3,78995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078995Orig1s000Approv.pdf","2012-05-09 00:00:00",
43152,3,78995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078995Orig1s000OtherActionLtrs.pdf","2012-04-13 00:00:00",
22631,3,78997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078997Orig1s000Approv.pdf","2012-06-22 00:00:00",
43153,3,78998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078998Orig1s000Approv.pdf","2012-05-09 00:00:00",
43154,3,78998,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078998Orig1s000OtherActionLtrs.pdf","2012-04-13 00:00:00",
22632,3,79003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/079003Orig1s000Approv.pdf","2012-05-09 00:00:00",
43155,3,79003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/079003Orig1s000OtherActionLtrs.pdf","2012-04-13 00:00:00",
31402,1,79007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079007s000ltr.pdf","2010-06-30 00:00:00",
31403,1,79013,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079013s000ltr.pdf","2011-07-20 00:00:00",
31404,1,79014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079014s000ltr.pdf","2011-07-20 00:00:00",
48632,1,79016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/079016Orig1s000ltr.pdf","2017-06-02 00:00:00",
48640,2,79016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/079016Orig1s000lbl.pdf","2017-06-05 00:00:00",
48631,1,79019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/079019Orig1s000ltr.pdf","2017-06-02 00:00:00",
48627,1,79022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/079022Orig1s000ltr.pdf","2017-06-02 00:00:00",
23927,10,79029,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm","2008-11-13 00:00:00",
22633,3,79038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079038Orig1s000.pdf","2013-02-25 00:00:00",
24064,14,79040,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
43156,3,79040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/079040Orig1s000Approv.pdf","2013-02-27 00:00:00",
9212,1,79043,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079043s003ltr.pdf","2011-06-29 00:00:00",
23428,8,79046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf","2013-07-12 00:00:00",
31405,1,79046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf","2010-12-22 00:00:00",
44541,14,79046,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
18491,2,79046,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/079046Orig1s013lbl.pdf","2014-05-06 00:00:00",
44399,10,79049,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
31406,1,79051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079051s000ltr.pdf","2008-07-31 00:00:00",
9213,1,79054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079054s000ltr.pdf","2015-11-06 00:00:00",
31407,1,79056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079056s000ltr.pdf","2011-07-20 00:00:00",
9214,1,79057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079057s000ltr.pdf","2011-07-20 00:00:00",
9215,1,79063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079063s000ltr.pdf","2009-01-21 00:00:00",
9216,1,79070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079070s000ltr.pdf","2009-11-13 00:00:00",
9217,1,79071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/079071s000TAltr.pdf","2008-01-09 00:00:00",
9218,1,79074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079074s000ltr.pdf","2009-03-13 00:00:00",
9219,1,79075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf","2011-01-14 00:00:00",
24065,14,79075,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2016-01-11 00:00:00",
31408,1,79075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf","2010-06-24 00:00:00",
43157,3,79075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/079075Orig1s000.pdf","2013-05-15 00:00:00",
31409,1,79079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/079079TAs000ltr.pdf","2008-01-09 00:00:00",
9220,1,79086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079086s000ltr.pdf","2011-03-02 00:00:00",
44542,14,79087,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
23928,10,79088,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2008-11-25 00:00:00",
9221,1,79089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079089s000ltr.pdf","2009-07-09 00:00:00",
18492,2,79089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079089s000lbl.pdf","2009-07-23 00:00:00",
53915,14,79093,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/079093, 074819_SLCOrderLtr.pdf","2018-05-01 00:00:00",
23929,10,79096,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm","2009-01-06 00:00:00",
9222,1,79099,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079099Orig1s000Approv.pdf","2012-02-14 00:00:00",
44400,10,79099,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110460.htm","2009-03-03 00:00:00",
9223,1,79103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/079103Orig1s000ltr.pdf","2012-08-06 00:00:00",
31410,1,79107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079107s000ltr.pdf","2009-01-21 00:00:00",
31411,1,79108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf","2013-12-05 00:00:00",
18493,2,79110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079110s000lbl.pdf","2009-07-24 00:00:00",
31412,1,79110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079110s000ltr.pdf","2009-07-09 00:00:00",
22634,3,79113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/079113Orig1Approv.pdf","2012-03-28 00:00:00",
23930,10,79116,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-07-01 00:00:00",
31413,1,79120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079120s000ltr.pdf","2009-01-21 00:00:00",
31414,1,79124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079124s000ltr.pdf","2008-04-28 00:00:00",
31415,1,79132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079132Orig1s000Approv.pdf","2012-02-14 00:00:00",
9224,1,79135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079135s003ltr.pdf","2010-10-29 00:00:00",
9225,1,79138,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079138s000ltr.pdf","2010-06-24 00:00:00",
31416,1,79142,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/079142Orig1s000ltr.pdf","2012-08-06 00:00:00",
9226,1,79145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079145Orig1s000ltr.pdf","2016-07-20 00:00:00",
9227,1,79153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079153s000ltr.pdf","2009-04-01 00:00:00",
44402,10,79153,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
9228,1,79161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf","2010-05-17 00:00:00",
31417,1,79161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf","2016-07-20 00:00:00",
9229,1,79162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079162s000ltr.pdf","2009-04-03 00:00:00",
44403,10,79162,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
9230,1,79166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079166s000ltr.pdf","2010-05-17 00:00:00",
31418,1,79166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079166Orig1s000ltr.pdf","2016-07-20 00:00:00",
31419,1,79167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079167Orig1s000ltr.pdf","2016-05-03 00:00:00",
39567,2,79167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079167Orig1s000lbl.pdf","2016-05-03 00:00:00",
31420,1,79168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079168Orig1s000ltr.pdf","2016-07-20 00:00:00",
9231,1,79169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079169Orig1s000ltr.pdf","2016-07-20 00:00:00",
9232,1,79170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079170Orig1s000ltr.pdf","2016-07-20 00:00:00",
31421,1,79170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079170s000ltr.pdf","2010-05-17 00:00:00",
9233,1,79171,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf","2016-07-20 00:00:00",
31422,1,79172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079172Orig1s000ltr.pdf","2016-07-20 00:00:00",
31423,1,79183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079183s000ltr.pdf","2009-02-24 00:00:00",
18494,2,79185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079185s000lbl.pdf","2009-07-23 00:00:00",
31424,1,79185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079185s000ltr.pdf","2009-07-09 00:00:00",
31425,1,79188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079188s000ltr.pdf","2008-12-19 00:00:00",
54170,1,79188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/079188Orig1s000TAltr.pdf","2018-05-11 00:00:00",
9234,1,79191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079191s000ltr.pdf","2010-04-19 00:00:00",
9235,1,79194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079194s000ltr.pdf","2009-04-09 00:00:00",
43158,3,79197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/079197Orig1s000Approv.pdf","2013-01-22 00:00:00",
9236,1,79199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079199s000ltr.pdf","2008-12-02 00:00:00",
23931,10,79204,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110460.htm","2009-03-03 00:00:00",
22635,3,79205,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/079205.pdf","2011-09-19 00:00:00",
9237,1,79220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079220s000ltr.pdf","2010-06-30 00:00:00",
9238,1,79235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079235s000ltr.pdf","2010-10-04 00:00:00",
18495,2,79242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079242Orig1s000LBL.pdf","2009-03-02 00:00:00",
18496,2,79244,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079244lbl.pdf","2009-05-07 00:00:00",
31426,1,79244,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079244s000ltr.pdf","2009-05-05 00:00:00",
45469,1,79246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079246Orig1s000ltr.pdf","2016-10-04 00:00:00",
45595,2,79246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079246s000lbl.pdf","2016-10-06 00:00:00",
43159,3,80198,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/080198Orig1s018.pdf","2015-03-11 00:00:00",
39568,2,80258,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/080258s025lbl.pdf","2009-10-19 00:00:00",
39569,2,80258,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf","2014-01-22 00:00:00",
39570,2,80258,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf","2014-01-22 00:00:00",
22636,3,80515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/080515_cyanocobalamin_toc.cfm","2003-08-04 00:00:00",
43160,3,80600,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080600.pdf","2007-04-02 00:00:00",
43161,3,80680,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080680.pdf","2005-07-22 00:00:00",
43162,3,80686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080686.pdf","2007-04-02 00:00:00",
43163,3,80691,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080691.pdf","2007-04-02 00:00:00",
22637,3,80755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080755.pdf","2007-04-02 00:00:00",
22638,3,80784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080784.pdf","2007-07-09 00:00:00",
43164,3,80784,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080784_S001.pdf","2007-04-02 00:00:00",
43165,3,80816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080816.pdf","2007-07-09 00:00:00",
22639,3,80911,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080911.pdf","2007-07-09 00:00:00",
53917,14,81002,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/081002_SLCOrderLtr.pdf","2018-05-01 00:00:00",
43166,3,81051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051sup.pdf","2005-07-15 00:00:00",
43167,3,81051,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-001.pdf","2005-07-22 00:00:00",
22640,3,81051,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-002.pdf","2005-07-22 00:00:00",
22641,3,81051,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-003.pdf","2005-07-22 00:00:00",
43168,3,81051,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-004.pdf","2005-07-22 00:00:00",
22642,3,81051,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-005.pdf","2005-07-22 00:00:00",
22643,3,81051,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-006.pdf","2005-07-22 00:00:00",
22644,3,81051,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-007.pdf","2005-07-22 00:00:00",
22645,3,81051,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/081051_S-008.pdf","2005-07-22 00:00:00",
43169,3,81051,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf","2005-07-22 00:00:00",
22646,3,81051,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf","2005-07-22 00:00:00",
43170,3,81051,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf","2005-07-22 00:00:00",
22647,3,81051,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf","2005-07-22 00:00:00",
43171,3,81051,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-014.pdf","2005-07-22 00:00:00",
43172,3,81051,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/081051_S-015.pdf","2005-07-22 00:00:00",
43173,3,81051,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/081051_S-016;S-017.pdf","2005-07-22 00:00:00",
43174,3,81051,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/081051_S-016;S-017.pdf","2005-07-22 00:00:00",
43175,3,81051,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/081051_S-018.pdf","2005-07-22 00:00:00",
22648,3,81051,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/081051_S-020.pdf","2005-07-22 00:00:00",
43176,3,81051,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/081051_S-021.pdf","2005-07-22 00:00:00",
18497,2,81295,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf","2009-08-14 00:00:00",
22649,3,83003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083003.pdf","2007-07-09 00:00:00",
22650,3,83009,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083009_orasone_toc.cfm","2003-08-05 00:00:00",
39571,2,83082,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf","2009-11-16 00:00:00",
43177,3,83133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083133.pdf","2007-07-09 00:00:00",
22651,3,83141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083141.pdf","2005-07-22 00:00:00",
18498,2,83220,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/083220s041lbl.pdf","2009-09-30 00:00:00",
43178,3,83221,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083221_probenecid_toc.cfm","2003-07-30 00:00:00",
22652,3,83232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083232_hydrochlorothiazide_toc.cfm","2003-08-05 00:00:00",
43179,3,83526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083526.pdf","2007-07-09 00:00:00",
22653,3,83547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083547.pdf","2005-07-22 00:00:00",
22654,3,83564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083564_delcobese_toc.cfm","2003-08-04 00:00:00",
43180,3,83607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083607_hydrochlorothiazide_toc.cfm","2003-08-05 00:00:00",
22655,3,83714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083714.pdf","2005-07-22 00:00:00",
53918,14,83827,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/086502, 086503, 086501, 086500, 086499, 086498,083827_SLCOrderLtr.pdf","2018-05-01 00:00:00",
43181,3,83900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083900_amphetamine-sulfate_toc.cfm","2004-01-06 00:00:00",
43182,3,83900,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S1.pdf","2004-01-06 00:00:00",
43183,3,83900,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S2.pdf","2004-01-06 00:00:00",
22656,3,83900,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S3.pdf","2004-01-06 00:00:00",
43184,3,83900,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S4.pdf","2004-01-06 00:00:00",
22657,3,83900,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S5.pdf","2004-01-06 00:00:00",
43185,3,83900,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S6.pdf","2004-01-06 00:00:00",
22658,3,83900,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S7.pdf","2004-01-06 00:00:00",
43186,3,83900,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S8.pdf","2004-01-06 00:00:00",
43187,3,83900,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S9.pdf","2004-01-06 00:00:00",
44404,10,83902,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
43188,3,83965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083965_hydrochlorothiazide_toc.cfm","2003-08-05 00:00:00",
22659,3,83972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083972_hydrochlorothiazide_toc.cfm","2003-08-05 00:00:00",
39572,2,83976,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/083976s031lbl.pdf","2014-07-16 00:00:00",
39573,2,83976,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/083976s032lbl.pdf","2015-09-08 00:00:00",
44405,10,84051,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2011-12-20 00:00:00",
22660,3,84158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/084158.pdf","2007-07-09 00:00:00",
22661,3,84264,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084264Orig1s000.pdf","2015-11-19 00:00:00",
43189,3,84279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084279_col-probenecid_toc.cfm","2003-07-30 00:00:00",
22662,3,84321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084321_probenecid-colchicine_toc.cfm","2003-07-30 00:00:00",
43190,3,84349,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf","2012-03-28 00:00:00",
39574,2,84349,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf","2009-10-19 00:00:00",
9239,1,84349,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf","2014-03-06 00:00:00",
39575,2,84349,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf","2014-03-06 00:00:00",
39576,2,84349,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf","2011-05-06 00:00:00",
31427,1,84349,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084349Orig1s067ltr.pdf","2012-12-06 00:00:00",
39577,2,84349,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf","2012-11-30 00:00:00",
9240,1,84349,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084349Orig1s070ltr.pdf","2013-08-08 00:00:00",
39578,2,84349,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf","2013-09-19 00:00:00",
9241,1,84349,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf","2014-03-06 00:00:00",
39579,2,84349,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf","2014-03-06 00:00:00",
39580,2,84349,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf","2014-07-29 00:00:00",
31428,1,84349,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084349Orig1s074ltr.pdf","2015-04-23 00:00:00",
39581,2,84349,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf","2015-04-23 00:00:00",
48070,2,84349,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf","2017-04-19 00:00:00",
48071,8,84349,"SUPPL",80,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf#page=21","2017-04-19 00:00:00",
51835,2,84349,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf","2018-01-26 00:00:00",
51837,2,84349,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf","2018-01-26 00:00:00",
51839,2,84349,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf","2018-01-26 00:00:00",
22663,3,84427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/084427.pdf","2005-07-22 00:00:00",
39582,2,84427,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf","2014-03-11 00:00:00",
18499,2,84427,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf","2009-10-19 00:00:00",
39583,2,84427,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf","2014-03-11 00:00:00",
18500,2,84427,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf","2011-05-06 00:00:00",
39584,2,84427,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf","2014-03-11 00:00:00",
18501,2,84427,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084427s026lbl.pdf","2012-11-30 00:00:00",
31429,1,84427,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084427Orig1s026ltr.pdf","2012-12-06 00:00:00",
18502,2,84427,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084427Orig1s028lbl.pdf","2013-09-19 00:00:00",
31430,1,84427,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084427Orig1s028ltr.pdf","2013-08-08 00:00:00",
39585,2,84427,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf","2014-03-11 00:00:00",
18503,2,84427,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427Orig1s031lbl.pdf","2014-07-29 00:00:00",
9242,1,84427,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084427Orig1s032ltr.pdf","2015-04-23 00:00:00",
39586,2,84427,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084427Orig1s032lbl.pdf","2015-04-23 00:00:00",
48068,2,84427,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf","2017-04-19 00:00:00",
48069,8,84427,"SUPPL",37,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf#page=20","2017-04-19 00:00:00",
50998,2,84427,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf","2018-01-08 00:00:00",
50996,2,84427,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf","2018-01-08 00:00:00",
50997,2,84427,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf","2018-01-08 00:00:00",
43191,3,84472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084472Orig1s000.pdf","2012-06-27 00:00:00",
18504,2,84499,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf","2009-08-14 00:00:00",
18505,2,84500,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf","2009-08-14 00:00:00",
22664,3,84655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084655_prednicen-m_toc.cfm","2003-08-05 00:00:00",
22665,3,84902,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084902_promethacon_toc.cfm","2003-07-30 00:00:00",
43192,3,84915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/084915.pdf","2007-07-09 00:00:00",
9243,1,84916,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf","2015-07-28 00:00:00",
18506,2,84916,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf","2015-07-27 00:00:00",
44406,10,84935,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
43193,3,85035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085239_diphenoxylate_toc.cfm","2003-08-04 00:00:00",
43194,3,85061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085061.pdf","2007-07-09 00:00:00",
39587,2,85128,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf","2012-04-16 00:00:00",
43195,3,85141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085141.pdf","2007-07-09 00:00:00",
22666,3,85239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085239_estrone_toc.cfm","2003-08-04 00:00:00",
44407,10,85380,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
39588,2,85470,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf","2009-09-30 00:00:00",
22667,3,85552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085552_proben-c_toc.cfm","2003-07-30 00:00:00",
22668,3,85635,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085635Orig1s011.pdf","2014-08-06 00:00:00",
43196,3,85635,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/96/085635Orig1s012.pdf","2014-08-06 00:00:00",
43197,3,85635,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/97/085635Orig1s013.pdf","2014-08-06 00:00:00",
18507,2,85635,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf","2014-07-16 00:00:00",
18508,2,85635,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/085635s030lbl.pdf","2015-05-12 00:00:00",
22669,3,85753,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085753.pdf","2005-07-22 00:00:00",
43198,3,85755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085755.pdf","2005-07-22 00:00:00",
22670,3,85825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085825_original_approval_pkg.pdf","1981-11-05 00:00:00",
43199,3,85865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/85865ap.pdf","1999-04-13 00:00:00",
22671,3,85888,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085888_brompheniramine_toc.cfm","2003-07-30 00:00:00",
18509,2,85966,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
18510,2,85967,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
18511,2,85968,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
39589,2,85969,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
39590,2,85970,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
39591,2,85971,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf","2014-09-05 00:00:00",
22672,3,86069,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/086069Orig1s017.pdf","2015-05-27 00:00:00",
39592,2,86069,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf","2015-05-27 00:00:00",
23932,10,86101,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm","2007-03-16 00:00:00",
22673,3,86130,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086130_probenecid_toc.cfm","2003-07-30 00:00:00",
43200,3,86681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086681_acetaminophen_toc.cfm","2003-07-30 00:00:00",
43201,3,86683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086683_acetaminophen-codeine-phosphate_toc.cfm","2003-07-30 00:00:00",
22674,3,86766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/086766_S000_NitrofurazoneTOC.cfm","2007-06-11 00:00:00",
43202,3,86945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/86945ap.pdf","1999-04-13 00:00:00",
22675,3,86954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086954_probenecid_toc.cfm","2003-07-30 00:00:00",
53920,14,87006,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/087006_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53922,14,87014,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/087014_SLCOrderLtr.pdf","2018-05-01 00:00:00",
18512,2,87056,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf","2013-12-30 00:00:00",
22676,3,87092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087092.pdf","2005-07-22 00:00:00",
43203,3,87159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087159.PDF","2005-07-22 00:00:00",
43204,3,87165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/087165ap.pdf","2011-05-06 00:00:00",
23933,10,87266,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110452.htm","2003-12-17 00:00:00",
52760,8,87266,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf","2018-02-28 00:00:00",
31431,1,87294,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087294Orig1s026ltr.pdf","2014-06-11 00:00:00",
39593,2,87294,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087294Orig1s026lbl.pdf","2014-06-24 00:00:00",
22677,3,87301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/87301ap.pdf","1999-04-13 00:00:00",
44408,10,87313,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110452.htm","2003-12-17 00:00:00",
52761,8,87313,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneShampooMedGuide.pdf","2018-02-28 00:00:00",
9244,1,87329,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s019ltr.pdf","2014-06-11 00:00:00",
18513,2,87329,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf","2014-06-24 00:00:00",
9245,1,87329,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s020ltr.pdf","2014-10-21 00:00:00",
18514,2,87329,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf","2014-10-30 00:00:00",
44543,14,87393,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
39594,2,87393,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087393Orig1s033lbl.pdf","2014-05-06 00:00:00",
22678,3,87438,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087438.pdf","2005-07-22 00:00:00",
43205,3,87805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/87805ap.pdf","1999-04-13 00:00:00",
53923,14,87811,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/087811_SLCOrderLtr.pdf","2018-05-01 00:00:00",
22679,3,87828,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087828.pdf","2005-07-22 00:00:00",
44410,10,87846,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273","2007-05-09 00:00:00",
9247,1,87846,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/087844Orig1s025,087845Orig1s025,087846Orig1s026ltr.pdf","2013-03-13 00:00:00",
18517,2,87846,"SUPPL",26,"Prescribing Information","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026pi.pdf","2013-03-12 00:00:00",
43899,8,87846,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026medg.pdf","2013-03-12 00:00:00",
18518,2,87846,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf","2014-09-05 00:00:00",
43206,3,87955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087955.PDF","2005-07-22 00:00:00",
24066,14,87997,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
39597,2,87997,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087997Orig1s024lbl.pdf","2014-08-05 00:00:00",
39598,2,88023,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/088023s037lbl.pdf","2012-04-16 00:00:00",
43207,3,88058,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22680,3,88058,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22681,3,88058,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22682,3,88058,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43208,3,88058,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43209,3,88058,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22683,3,88058,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43210,3,88058,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22684,3,88058,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43211,3,88058,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22685,3,88058,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43212,3,88058,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43213,3,88058,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22686,3,88058,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22687,3,88058,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43214,3,88058,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22688,3,88058,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43215,3,88058,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
43216,3,88058,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
22689,3,88058,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf","2005-07-22 00:00:00",
18519,2,88058,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/088058s027lbl.pdf","2006-12-27 00:00:00",
53924,14,88184,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/088184, 088185_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53925,14,88185,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/088184, 088185_SLCOrderLtr.pdf","2018-05-01 00:00:00",
23935,10,88190,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110452.htm","2003-12-17 00:00:00",
44411,10,88191,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110452.htm","2003-12-17 00:00:00",
43217,3,88199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088199.pdf","2005-07-22 00:00:00",
22690,3,88441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088441.pdf","2007-07-09 00:00:00",
22691,3,88482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88482ap.pdf","1999-04-13 00:00:00",
22692,3,88483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88483ap.pdf","1999-04-13 00:00:00",
22693,3,88596,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88596ap.pdf","1999-04-13 00:00:00",
22694,3,88602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088602Orig1s000.pdf","2012-01-27 00:00:00",
18520,2,88617,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf","2014-04-18 00:00:00",
18521,2,88617,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf","2014-06-24 00:00:00",
31433,1,88617,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf","2014-06-11 00:00:00",
18522,2,88618,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf","2014-04-18 00:00:00",
18523,2,88618,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf","2014-06-24 00:00:00",
31434,1,88618,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf","2014-06-11 00:00:00",
18524,2,88619,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf","2014-04-18 00:00:00",
18525,2,88619,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf","2014-06-24 00:00:00",
31435,1,88619,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf","2014-06-11 00:00:00",
53926,14,88704,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/088704_SLCOrderLtr.pdf","2018-05-01 00:00:00",
22695,3,88730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088730.pdf","2005-07-22 00:00:00",
18526,2,88764,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf","2013-09-04 00:00:00",
31436,1,88764,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/088764Orig1s084ltr.pdf","2013-09-04 00:00:00",
53927,14,88831,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/088831_SLCOrderLtr.pdf","2018-05-01 00:00:00",
43218,3,89081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/089081_prelone_toc.cfm","2003-08-05 00:00:00",
43219,3,89095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089095.pdf","2007-04-09 00:00:00",
22696,3,89096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089096.pdf","2005-07-22 00:00:00",
43220,3,89202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089202.pdf","2007-04-09 00:00:00",
39599,2,89338,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089338s036lbl.pdf","2010-03-17 00:00:00",
39600,2,89384,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf","2012-08-30 00:00:00",
53903,14,89523,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074531,089523, 89903, 089523_SLCOrderLtr.pdf","2018-05-01 00:00:00",
43221,3,89557,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089557.pdf","2005-07-22 00:00:00",
43222,3,89557,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089557S-001.pdf","2005-07-22 00:00:00",
43223,3,89557,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/089557S-002.pdf","2005-07-22 00:00:00",
43224,3,89557,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/089557S-003.pdf","2005-07-22 00:00:00",
22697,3,89557,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/089557S-004.pdf","2005-07-22 00:00:00",
43225,3,89557,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/089557S-007.pdf","2005-07-22 00:00:00",
22698,3,89557,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/089557S-009.pdf","2005-07-22 00:00:00",
44412,10,89601,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2007-05-18 00:00:00",
18527,2,89683,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf","2013-12-11 00:00:00",
39601,2,89684,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf","2013-12-11 00:00:00",
18528,2,89685,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf","2013-12-11 00:00:00",
18529,2,89686,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf","2013-12-11 00:00:00",
9248,1,89699,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf","2015-10-22 00:00:00",
39602,2,89699,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf","2015-10-27 00:00:00",
39603,2,89717,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf","2012-08-30 00:00:00",
43226,3,89736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089736.PDF","2005-07-22 00:00:00",
39604,2,89736,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf","2006-12-27 00:00:00",
22699,3,89822,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089822s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
22700,3,89822,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089822s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
22701,3,89822,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089822s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
43227,3,89822,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089822s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
43228,3,89822,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089822s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
22702,3,89823,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089823s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
43229,3,89823,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089823s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
22703,3,89823,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089823s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
43230,3,89823,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089823s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
43231,3,89823,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089823s001;s002;s004;s005;s008_027.pdf","2005-07-22 00:00:00",
31437,1,89884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf","1998-10-30 00:00:00",
39605,2,89884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89884_Nitroglycerin%20Transdermal_Prntlbl.pdf","2004-06-10 00:00:00",
43232,3,89884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089884_nitroglycerin_toc.cfm","2003-07-30 00:00:00",
9249,1,89885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf","1998-10-30 00:00:00",
18530,2,89885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89885_Nitroglycerin%20Transdermal_Prntlbl.pdf","2004-06-10 00:00:00",
22704,3,89885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089885_nitroglycerin_toc.cfm","2003-07-30 00:00:00",
18531,2,89886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89886_Nitroglycerin%20Transdermal_Prntlbl.pdf","2004-06-10 00:00:00",
22705,3,89886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089886_nitroglycerin_toc.cfm","2003-07-30 00:00:00",
31438,1,89886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf","1998-10-30 00:00:00",
44413,10,89897,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm","2006-11-27 00:00:00",
44544,14,89897,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
18532,2,89897,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/089897Orig1s028lbl.pdf","2014-05-06 00:00:00",
53905,14,89903,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/074531,089523, 89903, 089523_SLCOrderLtr.pdf","2018-05-01 00:00:00",
39606,2,89903,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089903s018lbl.pdf","2013-01-09 00:00:00",
53930,14,89997,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/089998, 089997, 089999_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53928,14,89998,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/089998, 089997, 089999_SLCOrderLtr.pdf","2018-05-01 00:00:00",
53931,14,89999,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/089998, 089997, 089999_SLCOrderLtr.pdf","2018-05-01 00:00:00",
31439,1,90011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090011Orig1s000ltr.pdf","2013-04-02 00:00:00",
31440,1,90017,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090017s000ltr.pdf","2009-11-23 00:00:00",
44414,10,90022,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
9250,1,90024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090024s000ltr.pdf","2009-02-04 00:00:00",
31441,1,90031,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090031Orig1s005ltr.pdf","2014-07-24 00:00:00",
39607,2,90031,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090031Orig1s005lbl.pdf","2014-07-30 00:00:00",
9251,1,90033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090033Orig1s000ltr.pdf","2014-02-26 00:00:00",
31442,1,90040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090040TAltr.pdf","2011-03-18 00:00:00",
31443,1,90041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090041Orig1s000Ltr.pdf","2016-02-18 00:00:00",
31444,1,90043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090043Orig1s000Ltr.pdf","2016-02-18 00:00:00",
9252,1,90044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090044Orig1s000ltr.pdf","2016-02-18 00:00:00",
31445,1,90044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090044s000ltr.pdf","2010-01-15 00:00:00",
31446,1,90048,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090048s000ltr.pdf","2010-04-19 00:00:00",
9253,1,90049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090049s000ltr.pdf","2009-04-03 00:00:00",
31447,1,90051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090051Orig1s000ltr.pdf","2016-02-18 00:00:00",
44545,14,90055,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9254,1,90072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090072s000ltr.pdf","2009-11-13 00:00:00",
31448,1,90073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090073Orig1s000ltr.pdf","2016-02-18 00:00:00",
31449,1,90081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090081s000ltr.pdf","2010-03-22 00:00:00",
9255,1,90088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090088s000ltr.pdf","2010-07-02 00:00:00",
9256,1,90092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090092s000ltr.pdf","2008-04-28 00:00:00",
23936,10,90094,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070263.htm","2008-11-13 00:00:00",
31450,1,90094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090094_PEPFAR_APLetter.pdf","2008-09-26 00:00:00",
31451,1,90095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090095s000ltr.pdf","2010-12-28 00:00:00",
43233,3,90095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090095Orig1s000Approv.pdf","2013-04-10 00:00:00",
44546,14,90095,"ORIG",1,"Labeling","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/090095Orig1s000LBL.pdf","2013-04-11 00:00:00",
23937,10,90096,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm","2008-11-13 00:00:00",
22706,3,90097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/090097Orig1s000.pdf","2011-12-09 00:00:00",
44547,14,90111,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9257,1,90120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf","2012-03-28 00:00:00",
9258,1,90120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf","2012-03-30 00:00:00",
31452,1,90120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf","2015-11-06 00:00:00",
44415,10,90124,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm","2008-09-19 00:00:00",
50342,1,90132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090132Orig1s000ltr.pdf","2017-11-08 00:00:00",
54007,1,90134,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090134Orig1s018ltr.pdf","2018-05-03 00:00:00",
50724,1,90141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090141Orig1s000TAltr.pdf","2017-12-18 00:00:00",
54440,1,90141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090141Orig1s000ltr.pdf","2018-06-05 00:00:00",
9259,1,90155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090155s000ltr.pdf","2009-08-06 00:00:00",
31453,1,90159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/90159_PEPFAR_TA_LTR.pdf","2008-09-04 00:00:00",
23938,10,90162,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
9260,1,90164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090164s000ltr.pdf","2009-06-02 00:00:00",
43234,3,90164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/090164Orig1s000.pdf","2012-11-16 00:00:00",
55411,1,90165,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090165Orig1s000ltr.pdf","2018-09-07 00:00:00",
31454,1,90166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090166s000ltr.pdf","2009-06-02 00:00:00",
18533,2,90170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/090170Orig1s000LBL.pdf","2011-12-16 00:00:00",
43235,3,90170,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090170Orig1s000Approv.pdf","2011-12-16 00:00:00",
9261,1,90180,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090180s000ltr.pdf","2010-03-22 00:00:00",
45777,1,90189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090189Orig1s000ltr.pdf","2016-11-02 00:00:00",
9262,1,90193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090193s000ltr.pdf","2008-11-28 00:00:00",
39608,2,90193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/090193s000lbl.pdf","2009-01-16 00:00:00",
31455,1,90198,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090198CR1b_PEPFAR_TALtr.pdf","2008-10-09 00:00:00",
18534,2,90218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090218Orig1s000lbl.pdf","2015-04-16 00:00:00",
31456,1,90218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090218Orig1s000ltr.pdf","2015-04-17 00:00:00",
52655,3,90218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf","2018-02-15 00:00:00",
52656,3,90218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf","2018-02-15 00:00:00",
44416,10,90223,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm","2009-04-14 00:00:00",
9263,1,90227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090227s000ltr.pdf","2010-04-23 00:00:00",
31457,1,90229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090229s000ltr.pdf","2010-12-03 00:00:00",
22707,3,90233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/090233Orig1s000.pdf","2012-04-25 00:00:00",
31458,1,90240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090240s000ltr.pdf","2010-01-20 00:00:00",
53972,14,90243,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/090243_SLCOrderLtr.pdf","2018-05-01 00:00:00",
44417,10,90253,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44548,14,90253,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
31459,1,90254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090254s000ltr.pdf","2008-04-11 00:00:00",
23939,10,90263,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
31460,1,90270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090270s000ltr.pdf","2009-06-16 00:00:00",
23940,10,90278,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm","2009-04-14 00:00:00",
24067,14,90279,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
9264,1,90288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090288s000ltr.pdf","2010-07-09 00:00:00",
31461,1,90300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090300s000ltr.pdf","2008-10-22 00:00:00",
43236,3,90304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090304Orig1s000BioeqR.pdf","2012-06-22 00:00:00",
9265,1,90308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090308Orig1s000TAltr.pdf","2015-11-30 00:00:00",
44549,14,90308,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-11-30 00:00:00",
54157,1,90308,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090308Orig1s000ltr.pdf","2018-05-11 00:00:00",
9266,1,90309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090309s000ltr.pdf","2009-07-20 00:00:00",
31462,1,90323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090323s000ltr.pdf","2012-03-29 00:00:00",
43237,3,90358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090358Orig1s000.pdf","2013-09-09 00:00:00",
44550,14,90360,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
9267,1,90371,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090371s000ltr.pdf","2009-11-24 00:00:00",
31463,1,90372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090372s000ltr.pdf","2010-11-22 00:00:00",
31464,1,90377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090377s000ltr.pdf","2010-03-04 00:00:00",
52657,3,90379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/090379Orig1s000.pdf","2018-02-15 00:00:00",
31465,1,90381,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090381s000ltr.pdf","2010-07-09 00:00:00",
53973,14,90387,"ORIG",1,"Safety Labeling Change Order Letter","0https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/90387_SLCOrderLtr.pdf","2018-05-01 00:00:00",
43238,3,90406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090406Orig1s000Approv.pdf","2012-02-12 00:00:00",
22708,3,90410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090410Orig1s000BioeqR.pdf","2012-10-12 00:00:00",
43239,3,90410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090410Orig1s000Approv.pdf","2012-09-26 00:00:00",
24068,14,90419,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
44418,10,90419,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
31466,1,90431,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s004ltr.pdf","2016-05-27 00:00:00",
9268,1,90431,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s005ltr.pdf","2016-05-04 00:00:00",
18535,2,90431,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf","2016-05-03 00:00:00",
31467,1,90431,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s010ltr.pdf","2016-05-25 00:00:00",
39609,2,90431,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf","2016-05-26 00:00:00",
31468,1,90433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090433s000ltr.pdf","2009-03-19 00:00:00",
31469,1,90437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090437s000ltr.pdf","2009-08-17 00:00:00",
18536,2,90449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf","2015-07-23 00:00:00",
31470,1,90449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090449Orig1s000ltr.pdf","2015-07-22 00:00:00",
44551,14,90456,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
31471,1,90457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090457s000ltr.pdf","2009-08-07 00:00:00",
31472,1,90466,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090466Orig1s000ltr.pdf","2015-06-18 00:00:00",
31473,1,90468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090468Orig1s000ltr.pdf","2016-04-19 00:00:00",
31474,1,90471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090471s000ltr.pdf","2009-03-13 00:00:00",
22709,3,90473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090473Orig1s000LBL.pdf","2012-06-22 00:00:00",
31475,1,90482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090482Orig1s000ltr.pdf","2017-06-21 00:00:00",
48372,2,90482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/090482Orig1s000lbl.pdf","2017-05-15 00:00:00",
31476,1,90488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090488s000ltr.pdf","2009-01-02 00:00:00",
31477,1,90490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090490s000ltr.pdf","2009-12-03 00:00:00",
9269,1,90494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090494Orig1s000ltr.pdf","2012-05-18 00:00:00",
22710,3,90495,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2014/090495Orig1s000.pdf","2016-07-29 00:00:00",
44419,10,90499,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm","2009-07-15 00:00:00",
44552,14,90499,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9270,1,90505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090505s000ltr.pdf","2011-04-11 00:00:00",
9271,1,90513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090513s000ltr.pdf","2009-04-03 00:00:00",
52553,1,90513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090513Orig1s000ltr.pdf","2018-02-09 00:00:00",
31478,1,90519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090519s000ltr.pdf","2009-04-03 00:00:00",
9272,1,90526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090526Orig1s000ltr.pdf","2014-03-06 00:00:00",
9273,1,90528,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090528s000ltr.pdf","2010-04-09 00:00:00",
31479,1,90539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090539s000ltr.pdf","2010-04-28 00:00:00",
9274,1,90540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090540Orig1s000ltr.pdf","2012-05-18 00:00:00",
9275,1,90547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090547s000ltr.pdf","2010-04-28 00:00:00",
22711,3,90548,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090548Orig1s000.pdf","2015-03-09 00:00:00",
9276,1,90561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090561s000ltr.pdf","2010-11-03 00:00:00",
9277,1,90568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090568s000ltr.pdf","2010-06-30 00:00:00",
9278,1,90574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090574s000ltr.pdf","2009-12-24 00:00:00",
9279,1,90576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090576s000ltr.pdf","2009-11-20 00:00:00",
18537,2,90576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090576s000lbl.pdf","2010-08-27 00:00:00",
55393,1,90589,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090589Orig1s000ltr.pdf","2018-09-06 00:00:00",
18538,2,90600,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090600s000lbl.pdf","2009-10-21 00:00:00",
31480,1,90600,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090600s000ltr.pdf","2009-10-14 00:00:00",
24069,14,90606,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9280,1,90607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090607Orig1s000Approv.pdf","2012-02-14 00:00:00",
43240,3,90615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090615Orig1s000BioeqR.pdf","2012-02-14 00:00:00",
22712,3,90619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/090619Orig1s000.pdf","2012-01-27 00:00:00",
24070,14,90622,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
9281,1,90625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090625Orig1s000ltr.pdf","2012-05-18 00:00:00",
31481,1,90633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090633ltr.pdf","2010-03-29 00:00:00",
43241,3,90633,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090633Orig1s000.pdf","2012-11-16 00:00:00",
44553,14,90635,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
9282,1,90636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090636s000ltr.pdf","2010-04-05 00:00:00",
31482,1,90638,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090638Orig1s000ltr.pdf","2012-08-24 00:00:00",
31483,1,90643,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090643s000ltr.pdf","2010-01-15 00:00:00",
9283,1,90647,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090647s000ltr.pdf","2009-02-23 00:00:00",
52552,1,90647,"ORIG",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090647Orig1s000ltr.pdf","2018-02-09 00:00:00",
22713,3,90648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090648Orig1s000Approv.pdf","2013-01-22 00:00:00",
31484,1,90655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090655Orig1s000ltr.pdf","2012-08-06 00:00:00",
9284,1,90659,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090659s000ltr.pdf","2009-04-20 00:00:00",
24071,14,90661,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9285,1,90678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090678Orig1s000ltr.pdf","2013-11-12 00:00:00",
18539,2,90678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/090678Orig1s000lbl.pdf","2013-11-19 00:00:00",
45795,1,90681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf","2016-11-02 00:00:00",
48362,1,90681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000ltr.pdf","2017-05-12 00:00:00",
48373,2,90681,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090681Orig1s000lbl.pdf","2017-05-15 00:00:00",
45926,1,90681,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090681Orig1s000TAltr.pdf","2016-11-08 00:00:00",
31486,1,90685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090685s000ltr.pdf","2009-10-14 00:00:00",
31487,1,90688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090688s000ltr.pdf","2009-04-03 00:00:00",
31488,1,90694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090694Orig1s000ltr.pdf","2013-12-13 00:00:00",
31489,1,90704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090704Orig1s000ltr.pdf","2012-12-06 00:00:00",
24072,14,90707,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
39610,2,90707,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf","2014-05-06 00:00:00",
9286,1,90713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090713Orig1s000ltr.pdf","2018-04-05 00:00:00",
9287,1,90723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090723Orig1s000ltr.pdf","2013-12-13 00:00:00",
9288,1,90728,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090728Orig1s000ltr.pdf","2014-01-10 00:00:00",
31490,1,90732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090732s000ltr.pdf","2010-06-30 00:00:00",
9289,1,90739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090739Orig1s000ltr.pdf","2014-01-10 00:00:00",
9290,1,90745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090745Orig1s000ltr.pdf","2013-12-13 00:00:00",
9291,1,90749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090749s000ltr.pdf","2012-03-29 00:00:00",
24073,14,90762,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
31492,1,90763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090763s000ltr.pdf","2009-11-19 00:00:00",
9292,1,90774,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090774Orig1s000ltr.pdf","2013-12-13 00:00:00",
31493,1,90776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090776Orig1s000ltr.pdf","2013-12-20 00:00:00",
9293,1,90778,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090778Orig1s000ltr.pdf","2013-12-13 00:00:00",
9294,1,90780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090780Orig1s000ltr.pdf","2015-10-30 00:00:00",
39611,2,90780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090780s000lbl.pdf","2015-11-04 00:00:00",
31494,1,90783,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090783Orig1s000ltr.pdf","2013-12-13 00:00:00",
9295,1,90785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090785s000ltr.pdf","2010-04-05 00:00:00",
22714,3,90785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090785Orig1s000.pdf","2012-11-14 00:00:00",
31495,1,90786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090786Orig1s000ltr.pdf","2012-12-18 00:00:00",
9296,1,90788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090788s000ltr.pdf","2010-04-13 00:00:00",
43242,3,90790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090790Orig1s000.pdf","2013-02-01 00:00:00",
31496,1,90798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090798Orig1s000ltr.pdf","2012-04-25 00:00:00",
18540,2,90811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090811s000lbl.pdf","2015-07-16 00:00:00",
31497,1,90811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090811Orig1s000ltr.pdf","2015-07-15 00:00:00",
9297,1,90813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090813s000ltr.pdf","2010-06-02 00:00:00",
31498,1,90816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090816Orig1s000ltr.pdf","2015-07-15 00:00:00",
39612,2,90816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090816s000lbl.pdf","2015-07-16 00:00:00",
31499,1,90819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090819Orig1s000ltr.pdf","2015-02-24 00:00:00",
44554,14,90819,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
31500,1,90824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090824s000ltr.pdf","2010-07-02 00:00:00",
31501,1,90825,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090825s000ltr.pdf","2011-11-21 00:00:00",
9298,1,90829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090829s000ltr.pdf","2010-08-26 00:00:00",
9299,1,90833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090833Orig1s000ltr.pdf","2012-12-18 00:00:00",
54299,3,90842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/090842Orig1s000.pdf","2018-05-22 00:00:00",
31502,1,90844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090844Orig1s000ltr.pdf","2012-05-18 00:00:00",
31503,1,90848,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090848Orig1s000ltr.pdf","2015-07-15 00:00:00",
39613,2,90848,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090848Orig1s000lbl.pdf","2015-07-22 00:00:00",
22715,3,90849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090849Orig1s000Approv.pdf","2013-04-10 00:00:00",
22716,3,90850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090850Orig1s000Approv.pdf","2013-01-22 00:00:00",
9300,1,90853,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090853Orig1s000ltr.pdf","2014-02-19 00:00:00",
18541,2,90853,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090853Orig1s000lbl.pdf","2014-02-27 00:00:00",
9301,1,90856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090856s000ltr.pdf","2011-12-29 00:00:00",
22717,3,90862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090862Orig1s000Approv.pdf","2012-09-12 00:00:00",
44420,10,90868,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm","2011-05-26 00:00:00",
43243,3,90869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090869Orig1s000Approv.pdf","2012-06-22 00:00:00",
9302,1,90870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090870s000ltr.pdf","2011-11-21 00:00:00",
9303,1,90874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090874s000ltr.pdf","2010-07-27 00:00:00",
48706,19,90894,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=365","2017-06-13 00:00:00",
48698,1,90894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090894Orig1s000ltr.pdf","2017-06-12 00:00:00",
55001,1,90894,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090894Orig1s000Ltr.pdf","2018-07-26 00:00:00",
9304,1,90895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090895s000ltr.pdf","2009-09-01 00:00:00",
31504,1,90896,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090896s000ltr.pdf","2009-10-26 00:00:00",
22718,3,90898,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090898Orig1s000Approv.pdf","2012-09-12 00:00:00",
9305,1,90910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090910s000ltr.pdf","2011-11-28 00:00:00",
18542,2,90911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/090911s000lbl.pdf","2010-07-22 00:00:00",
50990,1,90918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090918Orig1s000ltr.pdf","2018-01-08 00:00:00",
22719,3,90922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090922Orig1s000.pdf","2015-11-17 00:00:00",
31505,1,90924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090924s000ltr.pdf","2010-01-15 00:00:00",
9306,1,90926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090926Orig1s000ltr.pdf","2012-08-06 00:00:00",
31506,1,90954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090954s000ltr.pdf","2009-12-24 00:00:00",
39614,2,90954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090954s000lbl.pdf","2011-04-19 00:00:00",
43244,3,90954,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/090954Orig1s000.pdf","2011-12-16 00:00:00",
9307,1,90955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090955Orig1s000ltr.pdf","2012-08-06 00:00:00",
31507,1,90958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090958Orig1s000TAltr.pdf","2014-02-27 00:00:00",
31508,1,90960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090960s000ltr.pdf","2012-03-29 00:00:00",
9308,1,90962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090962s000ltr.pdf","2010-06-08 00:00:00",
31509,1,90982,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090982Orig1s000ltr.pdf","2016-04-27 00:00:00",
31510,1,90984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090984Orig1s000ltr.pdf","2012-08-07 00:00:00",
22720,3,90999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090999Orig1s000Approv.pdf","2013-04-10 00:00:00",
9309,1,91001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091001s000ltr.pdf","2011-02-03 00:00:00",
9310,1,91007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091007s000ltr.pdf","2011-11-21 00:00:00",
9311,1,91011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091011Orig1s000ltr.pdf","2015-06-12 00:00:00",
50612,3,91018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/091018Orig1s000.pdf","2017-12-06 00:00:00",
9312,1,91020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091020s000ltr.pdf","2010-06-02 00:00:00",
31511,1,91023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091023Orig1s000ltr.pdf","2012-05-18 00:00:00",
31512,1,91024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091024Orig1s000ltr.pdf","2014-04-16 00:00:00",
50613,3,91028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/091028Orig1s000.pdf","2017-12-06 00:00:00",
31513,1,91050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091050s000ltr.pdf","2010-05-17 00:00:00",
9313,1,91051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091051s000ltr.pdf","2010-07-02 00:00:00",
9314,1,91052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf","2011-09-28 00:00:00",
22721,3,91052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091052Orig1s000Approv.pdf","2012-05-09 00:00:00",
9315,1,91055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091055Orig1s000ltr.pdf","2013-08-05 00:00:00",
9316,1,91070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091070Orig1s000ltr.pdf","2015-09-04 00:00:00",
31514,1,91071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091071Orig1s000ltr.pdf","2015-06-02 00:00:00",
50052,19,91073,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=373","2017-10-12 00:00:00",
49842,1,91073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091073Orig1s000ltr.pdf","2017-09-22 00:00:00",
9317,1,91077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/091077s000ltr.pdf","2009-10-14 00:00:00",
39615,2,91077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/091077s000lbl.pdf","2009-10-21 00:00:00",
31515,1,91089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091089s000ltr.pdf","2010-12-03 00:00:00",
22722,3,91093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091093Orig1s000OtherActionLtrs.pdf","2012-06-22 00:00:00",
31516,1,91093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091093Orig1s000Approv.pdf","2011-09-12 00:00:00",
31517,1,91101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091101Orig1s000ltr.pdf","2013-09-04 00:00:00",
9318,1,91108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091108s000ltr.pdf","2011-07-29 00:00:00",
9319,1,91128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091128Orig1s000ltr.pdf","2012-08-06 00:00:00",
9320,1,91135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091135Orig1s000ltr.pdf","2012-05-30 00:00:00",
48434,3,91135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/091135Orig1s000.pdf","2017-05-17 00:00:00",
9321,1,91144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091144s000ltr.pdf","2012-02-02 00:00:00",
24074,14,91149,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
43245,3,91151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091151Orig1s000Approv.pdf","2013-04-10 00:00:00",
9322,1,91154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091154Orig1s000TAltr.pdf","2015-10-21 00:00:00",
45700,1,91154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091154Orig1s000ltr.pdf","2016-10-28 00:00:00",
31518,1,91161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091161Orig1s000ltr.pdf","2016-03-24 00:00:00",
31519,1,91168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091168s000ltr.pdf","2011-04-01 00:00:00",
55184,1,91168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/091168Orig1s000ltr.pdf","2018-08-16 00:00:00",
9323,1,91169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091169s000ltr.pdf","2011-05-25 00:00:00",
31520,1,91203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091203s000TAltr.pdf","2012-07-05 00:00:00",
9324,1,91210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091210Orig1s000ltr.pdf","2016-02-09 00:00:00",
9325,1,91216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091216Orig1s000ltr.pdf","2012-05-18 00:00:00",
22723,3,91226,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091226Orig1s000.pdf","2015-03-09 00:00:00",
43246,3,91244,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091244Orig1s000Approv.pdf","2013-01-22 00:00:00",
53974,14,91244,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/091244_SLCOrdetLtr.pdf","2018-05-01 00:00:00",
43247,3,91245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091245Orig1s000Approv.pdf","2012-09-12 00:00:00",
22724,3,91246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091246Orig1s000Approv.pdf","2012-09-12 00:00:00",
9326,1,91248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091248Orig1s000ltr.pdf","2014-01-14 00:00:00",
24075,14,91248,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
44555,14,91249,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
9327,1,91260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091260s000ltr.pdf","2011-08-26 00:00:00",
9328,1,91261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091261s000ltr.pdf","2011-09-28 00:00:00",
9329,1,91263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091263s000ltr.pdf","2011-11-08 00:00:00",
31521,1,91282,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091282Orig1s000ltr.pdf","2014-07-15 00:00:00",
9330,1,91285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091285Orig1s000Approv.pdf","2011-09-12 00:00:00",
9331,1,91289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091289Orig1s000ltr.pdf","2012-10-15 00:00:00",
31522,1,91291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091291s000ltr.pdf","2011-10-03 00:00:00",
31523,1,91294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091294s000ltr.pdf","2012-06-20 00:00:00",
43248,3,91306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091306Orig1s000.pdf","2011-12-02 00:00:00",
31524,1,91316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091316s000ltr.pdf","2011-07-28 00:00:00",
9332,1,91326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091326s000ltr.pdf","2010-07-12 00:00:00",
43249,3,91328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091328Orig1s000.pdf","2015-11-17 00:00:00",
22725,3,91338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091338Orig1s000OtherActionLtrs.pdf","2012-06-22 00:00:00",
9333,1,91344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091344s000ltr.pdf","2011-05-03 00:00:00",
24076,14,91357,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-06-28 00:00:00",
22726,3,91358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091358Orig1s000Approv.pdf","2013-04-10 00:00:00",
43250,3,91363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091363Orig1s000Approv.pdf","2013-05-02 00:00:00",
45550,1,91370,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091370Orig1s000ltr.pdf","2016-10-14 00:00:00",
31525,1,91376,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091376s000ltr.pdf","2010-12-03 00:00:00",
9334,1,91379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091379Orig1s000ltr.pdf","2012-11-07 00:00:00",
31526,1,91382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091382Orig1s000ltr.pdf","2016-04-22 00:00:00",
9335,1,91387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091387s000ltr.pdf","2010-02-17 00:00:00",
9336,1,91388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091388s000ltr.pdf","2012-03-30 00:00:00",
49579,1,91390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091390Orig1s000ltr.pdf","2017-08-29 00:00:00",
31527,1,91399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091399Orig1s000Approv.pdf","2011-09-21 00:00:00",
43251,3,91399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091399Orig1s000OtherActionLtrs.pdf","2012-06-22 00:00:00",
31528,1,91414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091414Orig1s000ltr.pdf","2012-08-06 00:00:00",
9337,1,91422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091422Orig1s000ltr.pdf","2013-02-26 00:00:00",
44556,14,91422,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
9338,1,91422,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091422Orig1s006ltr.pdf","2014-05-29 00:00:00",
50982,1,91424,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091424Orig1s000TAltr.pdf","2018-01-08 00:00:00",
31529,1,91430,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091430Orig1s000Approv.pdf","2011-09-12 00:00:00",
9339,1,91433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091433s000ltr.pdf","2011-11-07 00:00:00",
31530,1,91455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091455Orig1s000ltr.pdf","2013-04-09 00:00:00",
31531,1,91464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091464Orig1s000ltr.pdf","2014-04-03 00:00:00",
31532,1,91471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091471Orig1s000ltr.pdf","2016-02-19 00:00:00",
39616,2,91471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/091471Orig1s000lbl.pdf","2016-02-23 00:00:00",
31533,1,91475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091475s000ltr.pdf","2012-05-31 00:00:00",
9340,1,91476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091476Orig1s000ltr.pdf","2013-03-15 00:00:00",
31534,1,91479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091479Orig1s000ltr.pdf","2012-11-07 00:00:00",
22727,3,91488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091488Orig1s000Approv.pdf","2012-09-12 00:00:00",
22728,3,91489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091489Orig1s000Approv.pdf","2012-09-26 00:00:00",
43252,3,91490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091490Orig1s000Approv.pdf","2012-10-09 00:00:00",
31535,1,91496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091496Orig1s000ltr.pdf","2013-09-24 00:00:00",
31536,1,91514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091514Orig1s000ltr.pdf","2015-06-29 00:00:00",
9341,1,91516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091516Orig1s000ltr.pdf","2015-04-27 00:00:00",
18543,2,91517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/091517Orig1lbl.pdf","2015-04-27 00:00:00",
31537,1,91517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091517Orig1s000ltr.pdf","2015-04-27 00:00:00",
39617,2,91526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091526lbl.pdf","2013-03-26 00:00:00",
44557,14,91558,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
22729,3,91559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/091559Orig1s000Approv.pdf","2012-06-22 00:00:00",
9342,1,91560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091560s000ltr.pdf","2010-10-04 00:00:00",
9343,1,91575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091575s000ltr.pdf","2010-08-31 00:00:00",
31538,1,91576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091576Orig1s000ltr.pdf","2012-08-06 00:00:00",
31539,1,91577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091577s000ltr.pdf","2011-05-05 00:00:00",
31540,1,91579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091579s000ltr.pdf","2011-08-31 00:00:00",
9344,1,91588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091588Orig1s000ltr.pdf","2012-08-06 00:00:00",
31541,1,91589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091589Orig1s000ltr.pdf","2013-10-11 00:00:00",
39618,2,91589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf","2013-11-20 00:00:00",
31542,1,91593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091593s000ltr.pdf","2012-02-29 00:00:00",
54441,1,91600,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/091600Orig1s000ltr.pdf","2018-06-05 00:00:00",
9345,1,91601,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091601s000ltr.pdf","2010-07-28 00:00:00",
31543,1,91607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091607Orig1s000Approv.pdf","2012-02-14 00:00:00",
43253,3,91607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091607Orig1s000Approv.pdf","2012-02-14 00:00:00",
9346,1,91611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091611s000ltr.pdf","2010-09-20 00:00:00",
9347,1,91612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091612Orig1s000ltr.pdf","2015-03-20 00:00:00",
22730,3,91619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091619Orig1s000BioeqR.pdf","2013-08-07 00:00:00",
22731,3,91623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091623Orig1s000Approv.pdf","2013-02-27 00:00:00",
43254,3,91624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091624Orig1s000.pdf","2015-03-09 00:00:00",
43255,3,91632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091632Orig1s000.pdf","2013-02-01 00:00:00",
48667,1,91640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091640Orig1s000ltr.pdf","2017-06-07 00:00:00",
48668,2,91640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/091640Orig1s000lbl.pdf","2017-06-07 00:00:00",
49959,1,91646,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091646Orig1s000ltr.pdf","2017-10-05 00:00:00",
9348,1,91648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091648Orig1s000ltr.pdf","2014-02-27 00:00:00",
9349,1,91649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091649Orig1s000ltr.pdf","2013-09-19 00:00:00",
18544,2,91649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091649Orig1s000lbl.pdf","2013-09-19 00:00:00",
9350,1,91652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091652s000ltr.pdf","2010-04-09 00:00:00",
9351,1,91664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091664Orig1s000ltr.pdf","2013-07-22 00:00:00",
39619,2,91664,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091664Orig1s000lbl.pdf","2013-09-19 00:00:00",
31544,1,91673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091673Orig1s000ltr.pdf","2014-04-23 00:00:00",
31545,1,91677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091677s000ltr.pdf","2012-05-24 00:00:00",
9352,1,101063,"SUPPL",5012,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/aspamer080102L.pdf","2004-03-12 00:00:00",
18545,2,101063,"SUPPL",5012,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf","2004-03-12 00:00:00",
9353,1,101063,"SUPPL",5036,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/101063_5036ltr.pdf","2004-07-07 00:00:00",
9354,1,101063,"SUPPL",5071,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/101063 5071 Ltr.pdf","2006-07-25 00:00:00",
18546,2,101063,"SUPPL",5071,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf","2006-07-21 00:00:00",
31546,1,101063,"SUPPL",5081,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/101063s5081LTR.pdf","2007-04-20 00:00:00",
39620,2,101063,"SUPPL",5081,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf","2007-04-20 00:00:00",
31547,1,101063,"SUPPL",5169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/101063Orig1s5169ltr.pdf","2013-07-18 00:00:00",
39621,2,101063,"SUPPL",5169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf","2013-07-17 00:00:00",
44421,10,103000,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm","2008-08-12 00:00:00",
31548,1,103000,"SUPPL",1004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botaller122100L.htm","2004-03-11 00:00:00",
43256,3,103000,"SUPPL",1004,"0","https://web.archive.org/web/20090119110807/http://www.fda.gov/cder/biologics/products/botaller122100.htm","2004-03-11 00:00:00",
9355,1,103000,"SUPPL",5000,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/botuall041202L.htm","2004-03-11 00:00:00",
18547,2,103000,"SUPPL",5000,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/botuall041202LB.pdf","2004-03-11 00:00:00",
43257,3,103000,"SUPPL",5000,"0","https://web.archive.org/web/20170113111252/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080509.htm","2004-03-11 00:00:00",
9356,1,103000,"SUPPL",5050,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103000_5050ltr.pdf","2004-07-21 00:00:00",
39622,2,103000,"SUPPL",5050,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103000s5050lbl.pdf","2004-09-15 00:00:00",
48422,3,103000,"SUPPL",5050,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103000Orig1s5050.pdf","2017-05-17 00:00:00",
18548,2,103000,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5189lbl.pdf","2010-03-17 00:00:00",
31549,1,103000,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5189ltr.pdf","2010-03-18 00:00:00",
43258,3,103000,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5189.pdf","2013-10-23 00:00:00",
9357,1,103000,"SUPPL",5209,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf","2009-08-07 00:00:00",
39623,2,103000,"SUPPL",5209,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf","2009-08-07 00:00:00",
18549,2,103000,"SUPPL",5210,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf","2009-08-07 00:00:00",
31550,1,103000,"SUPPL",5210,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf","2009-08-07 00:00:00",
9358,1,103000,"SUPPL",5215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5215ltr.pdf","2010-10-20 00:00:00",
18550,2,103000,"SUPPL",5215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5215lbl.pdf","2010-10-19 00:00:00",
43259,3,103000,"SUPPL",5215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5215.pdf","2013-08-09 00:00:00",
31551,1,103000,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103000s5232ltr.pdf","2011-08-30 00:00:00",
39624,2,103000,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf","2011-08-30 00:00:00",
43260,3,103000,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103000Orig1s5232.pdf","2015-09-23 00:00:00",
39625,2,103000,"SUPPL",5236,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5236lbl.pdf","2011-07-08 00:00:00",
18551,2,103000,"SUPPL",5244,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5244lbl.pdf","2015-08-07 00:00:00",
31552,1,103000,"SUPPL",5244,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5244ltr.pdf","2015-08-10 00:00:00",
9359,1,103000,"SUPPL",5251,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5251ltr.pdf","2013-01-23 00:00:00",
39626,2,103000,"SUPPL",5251,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5251lbl.pdf","2013-01-23 00:00:00",
18552,2,103000,"SUPPL",5252,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf","2016-01-26 00:00:00",
31553,1,103000,"SUPPL",5252,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5252ltr.pdf","2016-01-22 00:00:00",
9360,1,103000,"SUPPL",5253,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5253ltr.pdf","2012-11-14 00:00:00",
18553,2,103000,"SUPPL",5253,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103000Orig1s5253lbl.pdf","2012-11-14 00:00:00",
9361,1,103000,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5256ltr.pdf","2012-07-18 00:00:00",
18554,2,103000,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5260lbl.pdf","2013-09-17 00:00:00",
31554,1,103000,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5260ltr.pdf","2013-09-13 00:00:00",
31555,1,103000,"SUPPL",5280,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103000Orig1s5280ltr.pdf","2014-05-08 00:00:00",
31556,1,103000,"SUPPL",5282,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5282ltr.pdf","2015-04-21 00:00:00",
39627,2,103000,"SUPPL",5282,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5282lbl.pdf","2015-04-21 00:00:00",
9362,1,103000,"SUPPL",5292,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5292ltr.pdf","2015-08-12 00:00:00",
39628,2,103000,"SUPPL",5292,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5292lbl.pdf","2015-08-12 00:00:00",
9363,1,103000,"SUPPL",5294,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5294ltr.pdf","2016-02-05 00:00:00",
47856,2,103000,"SUPPL",5296,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf","2017-04-05 00:00:00",
47940,1,103000,"SUPPL",5296,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5296,s5297s5298ltr.pdf","2017-04-12 00:00:00",
47857,2,103000,"SUPPL",5297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf","2017-04-05 00:00:00",
47941,1,103000,"SUPPL",5297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5296,s5297s5298ltr.pdf","2017-04-12 00:00:00",
47858,2,103000,"SUPPL",5298,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf","2017-04-05 00:00:00",
47942,1,103000,"SUPPL",5298,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000s5298ltr.pdf","2017-04-12 00:00:00",
48073,2,103000,"SUPPL",5302,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5302lbl.pdf","2017-04-21 00:00:00",
48078,1,103000,"SUPPL",5302,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5302ltr.pdf","2017-04-21 00:00:00",
49934,2,103000,"SUPPL",5303,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5303lbl.pdf","2017-10-03 00:00:00",
49958,1,103000,"SUPPL",5303,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5303ltr.pdf","2017-10-05 00:00:00",
54224,2,103000,"SUPPL",5306,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5306lbl.pdf","2018-05-17 00:00:00",
54265,1,103000,"SUPPL",5306,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103000Orig1s5306ltr.pdf","2018-05-21 00:00:00",
54227,2,103000,"SUPPL",5307,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf","2018-05-17 00:00:00",
54228,8,103000,"SUPPL",5307,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf#page=38","2018-05-17 00:00:00",
55481,1,103000,"SUPPL",5308,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103000Orig1s5308ltr.pdf","2018-09-14 00:00:00",
9364,1,103132,"SUPPL",1116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ifnasch110697L.htm","2004-03-17 00:00:00",
18555,2,103132,"SUPPL",1116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf","2004-03-17 00:00:00",
43261,3,103132,"SUPPL",1116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/1997/ifnasch110697r.pdf","2004-03-17 00:00:00",
9365,1,103132,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf","2007-05-29 00:00:00",
9366,1,103132,"SUPPL",5064,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103132_5064ltr.pdf","2005-01-26 00:00:00",
18556,2,103132,"SUPPL",5064,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf","2005-01-26 00:00:00",
9367,1,103132,"SUPPL",5086,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103132s5086ltr.pdf","2006-10-13 00:00:00",
39629,2,103132,"SUPPL",5086,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf","2006-10-18 00:00:00",
18557,2,103132,"SUPPL",5095,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf","2007-05-29 00:00:00",
31557,1,103132,"SUPPL",5095,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf","2007-05-29 00:00:00",
9368,1,103132,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5096ltr.pdf","2007-07-24 00:00:00",
18558,2,103132,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf","2007-07-24 00:00:00",
9369,1,103132,"SUPPL",5108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103132s5108ltr.pdf","2008-05-30 00:00:00",
9370,1,103132,"SUPPL",5143,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5143ltr.pdf","2011-02-15 00:00:00",
9371,1,103132,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5161ltr.pdf","2011-12-28 00:00:00",
39630,2,103132,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf","2011-12-23 00:00:00",
31558,1,103132,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103132s5163ltr.pdf","2012-06-07 00:00:00",
18559,2,103132,"SUPPL",5178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf","2013-11-22 00:00:00",
31559,1,103132,"SUPPL",5178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103132Orig1s5178ltr.pdf","2013-11-18 00:00:00",
39631,2,103132,"SUPPL",5183,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf","2014-04-03 00:00:00",
18560,2,103132,"SUPPL",5190,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf","2014-08-12 00:00:00",
31560,1,103132,"SUPPL",5190,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103132Origs5190ltr.pdf","2014-08-12 00:00:00",
31561,1,103132,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103132Orig1s5191ltr.pdf","2015-05-26 00:00:00",
39632,2,103132,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf","2015-05-27 00:00:00",
48709,2,103132,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5195lbl.pdf","2017-06-13 00:00:00",
48711,1,103132,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5195ltr.pdf","2017-06-13 00:00:00",
49940,1,103132,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5196ltr.pdf","2017-10-04 00:00:00",
49944,2,103132,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf","2017-10-04 00:00:00",
49945,8,103132,"SUPPL",5196,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40","2017-10-04 00:00:00",
53997,1,103132,"SUPPL",5199,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103132Orig1s5199ltr.pdf","2018-05-03 00:00:00",
54011,2,103132,"SUPPL",5199,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf","2018-05-04 00:00:00",
48910,3,103172,"SUPPL",1055,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/alteplase_toc.cfm","2017-07-05 00:00:00",
48913,1,103172,"SUPPL",1055,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/altegen061896L.pdf","2017-07-06 00:00:00",
31563,1,103172,"SUPPL",5003,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/altegen090401L.htm","2004-03-12 00:00:00",
39633,2,103172,"SUPPL",5003,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/altegen090401LB.pdf","2004-03-12 00:00:00",
9372,1,103172,"SUPPL",5009,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/altegen051502L.htm","2004-03-10 00:00:00",
39634,2,103172,"SUPPL",5009,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/altegen051502LB.pdf","2004-03-10 00:00:00",
18561,2,103172,"SUPPL",5071,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103172s5071lbl.pdf","2005-07-27 00:00:00",
9373,1,103172,"SUPPL",5203,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103172Orig1s5203ltr.pdf","2015-02-17 00:00:00",
18562,2,103172,"SUPPL",5203,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf","2015-03-02 00:00:00",
43263,3,103172,"SUPPL",5203,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2015/103172Orig1s5203.pdf","2015-08-25 00:00:00",
48888,2,103172,"SUPPL",5253,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103172s5253lbl.pdf","2017-07-03 00:00:00",
48903,1,103172,"SUPPL",5253,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103172Orig1s5253ltr.pdf","2017-07-05 00:00:00",
52801,1,103172,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103172Orig1s5259ltr.pdf","2018-03-02 00:00:00",
52976,2,103172,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5259lbl.pdf","2018-03-15 00:00:00",
52804,1,103172,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103172Orig1s5260ltr.pdf","2018-03-02 00:00:00",
52969,2,103172,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5260lbl.pdf","2018-03-15 00:00:00",
24077,14,103234,"ORIG",1,"Medication Guide (Epogen)","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf","2010-02-05 00:00:00",
24078,14,103234,"ORIG",1,"Medication Guide (Procrit)","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088988.pdf","2010-02-05 00:00:00",
18563,2,103234,"SUPPL",1015,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/103234s1015_LBL.pdf","2007-06-04 00:00:00",
18564,2,103234,"SUPPL",1046,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/epoamg072699lb.pdf","2007-03-23 00:00:00",
22732,3,103234,"SUPPL",1046,"0","https://web.archive.org/web/20170113111355/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080580.htm","2007-03-23 00:00:00",
31564,1,103234,"SUPPL",1046,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/epoamg072699L.pdf","2007-03-23 00:00:00",
31565,1,103234,"SUPPL",5033,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234-5033ltr.pdf","2004-05-21 00:00:00",
43264,3,103234,"SUPPL",5033,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5033.pdf","2007-09-26 00:00:00",
31566,1,103234,"SUPPL",5053,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234_5053ltr.pdf","2004-07-07 00:00:00",
39635,2,103234,"SUPPL",5053,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5053_Epogen_lbl.pdf","2004-07-14 00:00:00",
43265,3,103234,"SUPPL",5053,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5053.pdf","2007-09-26 00:00:00",
18565,2,103234,"SUPPL",5076,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5076lbl.pdf","2005-01-26 00:00:00",
31567,1,103234,"SUPPL",5076,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103234_5076ltr.pdf","2005-01-26 00:00:00",
43266,3,103234,"SUPPL",5076,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5076_AP_PKG.pdf","2007-09-26 00:00:00",
22733,3,103234,"SUPPL",5093,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103234s5093_AP_PKG.pdf","2007-09-26 00:00:00",
31568,1,103234,"SUPPL",5093,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103234s5093ltr.pdf","2005-12-16 00:00:00",
39636,2,103234,"SUPPL",5093,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103234s5093lbl.pdf","2005-12-16 00:00:00",
18566,2,103234,"SUPPL",5104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103234s5104_LBL.pdf","2006-05-18 00:00:00",
31569,1,103234,"SUPPL",5104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103234s5104_LTR.pdf","2006-05-18 00:00:00",
9374,1,103234,"SUPPL",5122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5122ltr.pdf","2007-03-15 00:00:00",
18567,2,103234,"SUPPL",5122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5122lbl.pdf","2007-03-09 00:00:00",
18568,2,103234,"SUPPL",5158,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158lbl.pdf","2007-11-08 00:00:00",
23078,6,103234,"SUPPL",5158,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158ppi.pdf","2007-11-08 00:00:00",
31570,1,103234,"SUPPL",5158,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5158ltr.pdf","2007-11-08 00:00:00",
31571,1,103234,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5163ltr.pdf","2008-01-31 00:00:00",
39637,2,103234,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5163lbl.pdf","2008-01-30 00:00:00",
18569,2,103234,"SUPPL",5164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164lbl.pdf","2008-03-11 00:00:00",
23079,6,103234,"SUPPL",5164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164ppi.pdf","2008-03-12 00:00:00",
24353,21,103234,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166SumR.pdf","2012-05-25 00:00:00",
31572,1,103234,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,103234s5266ltr.pdf","2011-06-24 00:00:00",
39638,2,103234,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf","2011-06-24 00:00:00",
43267,3,103234,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103234_epogen_procrit_toc.cfm","2012-07-16 00:00:00",
9375,1,103234,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf","2011-04-28 00:00:00",
39639,2,103234,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5195sPI.pdf","2008-11-25 00:00:00",
9376,1,103234,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf","2011-04-28 00:00:00",
39640,2,103234,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5196PI.pdf","2008-11-25 00:00:00",
9377,1,103234,"SUPPL",5199,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103234s5199ltr.pdf","2010-02-16 00:00:00",
39641,2,103234,"SUPPL",5199,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf","2010-02-16 00:00:00",
9378,1,103234,"SUPPL",5221,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103234s5221ltr.pdf","2010-02-05 00:00:00",
18570,2,103234,"SUPPL",5221,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103234s5221Lbl.pdf","2010-02-04 00:00:00",
39642,2,103234,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5232LBL.pdf","2010-02-04 00:00:00",
31573,1,103234,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf","2011-06-24 00:00:00",
31574,1,103234,"SUPPL",5266,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,s5266ltr.pdf","2011-06-24 00:00:00",
39643,2,103234,"SUPPL",5266,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf","2011-06-24 00:00:00",
18571,2,103234,"SUPPL",5281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103234s5281lbl.pdf","2012-06-06 00:00:00",
31575,1,103234,"SUPPL",5281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103234s5281ltr.pdf","2012-06-07 00:00:00",
31576,1,103234,"SUPPL",5323,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5323ltr.pdf","2014-01-02 00:00:00",
39644,2,103234,"SUPPL",5323,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf","2014-01-07 00:00:00",
31577,1,103234,"SUPPL",5329,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5329ltr.pdf","2013-03-29 00:00:00",
48016,2,103234,"SUPPL",5360,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf","2017-04-14 00:00:00",
48041,1,103234,"SUPPL",5360,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5360s5364ltr.pdf","2017-04-14 00:00:00",
49909,2,103234,"SUPPL",5363,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf","2017-10-02 00:00:00",
49921,1,103234,"SUPPL",5363,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5363s5366ltr.pdf","2017-10-03 00:00:00",
48017,2,103234,"SUPPL",5364,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf","2017-04-14 00:00:00",
48042,1,103234,"SUPPL",5364,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5360s5364ltr.pdf","2017-04-14 00:00:00",
49910,2,103234,"SUPPL",5366,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf","2017-10-02 00:00:00",
49922,1,103234,"SUPPL",5366,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5363s5366ltr.pdf","2017-10-03 00:00:00",
49942,8,103234,"SUPPL",5366,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27","2017-10-04 00:00:00",
55002,1,103234,"SUPPL",5369,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103234Orig1s5369Ltr.pdf","2018-07-26 00:00:00",
9379,1,103293,"SUPPL",1021,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/aldechi010998L.htm","2004-03-26 00:00:00",
43268,3,103293,"SUPPL",1021,"0","https://web.archive.org/web/20170113111500/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080733.htm","2004-03-26 00:00:00",
9380,1,103293,"SUPPL",5114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5114ltr.pdf","2011-08-02 00:00:00",
9381,1,103293,"SUPPL",5123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5123ltr.pdf","2012-01-05 00:00:00",
31578,1,103293,"SUPPL",5130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103293Orig1s5130ltr.pdf","2012-08-01 00:00:00",
39645,2,103293,"SUPPL",5130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf","2012-07-30 00:00:00",
22734,3,103353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/pre96/103353Orig1s000.pdf","2011-12-02 00:00:00",
9382,1,103353,"SUPPL",1036,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/filgamg040298L.htm","2004-03-25 00:00:00",
39646,2,103353,"SUPPL",1036,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/filgamg040298lb.pdf","2004-03-25 00:00:00",
9383,1,103353,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/filgamg052902L.pdf","2004-03-25 00:00:00",
39647,2,103353,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902LB.pdf","2004-03-25 00:00:00",
18572,2,103353,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103353_5059lbl.pdf","2005-01-26 00:00:00",
31579,1,103353,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103353_5059ltr.pdf","2005-01-26 00:00:00",
18573,2,103353,"SUPPL",5086,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103353s5086LBL.pdf","2006-11-09 00:00:00",
31580,1,103353,"SUPPL",5086,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103353s5086LTR.pdf","2006-11-09 00:00:00",
18574,2,103353,"SUPPL",5127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103353_5127lbl.pdf","2010-03-11 00:00:00",
31581,1,103353,"SUPPL",5127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103353s5127ltr.pdf","2010-03-08 00:00:00",
9384,1,103353,"SUPPL",5147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103353s5147ltr.pdf","2012-05-29 00:00:00",
39648,2,103353,"SUPPL",5147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103353s5147lbl.pdf","2012-05-29 00:00:00",
9385,1,103353,"SUPPL",5157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103353Orig1s5157ltr.pdf","2013-09-17 00:00:00",
18575,2,103353,"SUPPL",5157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103353s5157lbl.pdf","2013-09-17 00:00:00",
31582,1,103353,"SUPPL",5183,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5183ltr.pdf","2015-04-03 00:00:00",
48095,2,103353,"SUPPL",5183,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5183lbl.pdf","2017-04-25 00:00:00",
9386,1,103353,"SUPPL",5184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5184ltr.pdf","2015-02-06 00:00:00",
18576,2,103353,"SUPPL",5184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf","2015-02-06 00:00:00",
18577,2,103353,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf","2015-08-04 00:00:00",
31583,1,103353,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5186ltr.pdf","2015-07-31 00:00:00",
31584,1,103353,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103353Orig1s5188ltr.pdf","2016-06-30 00:00:00",
39649,2,103353,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf","2016-07-22 00:00:00",
54642,1,103353,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103353Orig1s5194ltr.pdf","2018-06-21 00:00:00",
54686,2,103353,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103353s5194lbl.pdf","2018-06-26 00:00:00",
47178,1,103362,"SUPPL",5237,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103362Orig1s5237ltr.pdf","2017-02-10 00:00:00",
47179,2,103362,"SUPPL",5237,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf","2017-02-13 00:00:00",
53549,2,103362,"SUPPL",5240,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf","2018-03-29 00:00:00",
53577,1,103362,"SUPPL",5240,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103362Orig1s5240ltr.pdf","2018-04-01 00:00:00",
18578,2,103411,"SUPPL",5052,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103411s5052lbl.pdf","2006-07-24 00:00:00",
31585,1,103411,"SUPPL",5052,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103411s5052ltr.pdf","2006-08-04 00:00:00",
18579,2,103411,"SUPPL",5126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103411s5126lbl.pdf","2011-12-12 00:00:00",
9387,1,103411,"SUPPL",5180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103411Orig1s5180ltr.pdf","2014-04-23 00:00:00",
18580,2,103411,"SUPPL",5180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103411s5180lbl.pdf","2014-04-23 00:00:00",
45527,1,103411,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103411Orig1s5188ltr.pdf","2016-10-12 00:00:00",
45606,2,103411,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103411s5188lbl.pdf","2016-10-12 00:00:00",
22735,3,103471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/103471s0000TOC.cfm","2007-06-11 00:00:00",
9388,1,103471,"SUPPL",1039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbchi031403L.htm","2004-03-11 00:00:00",
18581,2,103471,"SUPPL",1039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbchi031403LB.pdf","2004-03-11 00:00:00",
22736,3,103471,"SUPPL",1039,"0","https://web.archive.org/web/20170118085127/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080486.htm","2004-03-11 00:00:00",
9389,1,103471,"SUPPL",5032,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103471-5032ltr.pdf","2003-10-31 00:00:00",
39650,2,103471,"SUPPL",5032,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/103471s5032lbl.pdf","2008-04-21 00:00:00",
18582,2,103471,"SUPPL",5063,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
31586,1,103471,"SUPPL",5063,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
9390,1,103471,"SUPPL",5067,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
39651,2,103471,"SUPPL",5067,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
18583,2,103471,"SUPPL",5079,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
31587,1,103471,"SUPPL",5079,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
31588,1,103471,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
39652,2,103471,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
9391,1,103471,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
39653,2,103471,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
18584,2,103471,"SUPPL",5124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
31589,1,103471,"SUPPL",5124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
18585,2,103471,"SUPPL",5125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103471s5125lbl.pdf","2013-07-11 00:00:00",
31590,1,103471,"SUPPL",5125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103471Orig1s5125ltr.pdf","2013-07-02 00:00:00",
9392,1,103471,"SUPPL",5136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
39654,2,103471,"SUPPL",5136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
31591,1,103471,"SUPPL",5138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf","2012-12-13 00:00:00",
39655,2,103471,"SUPPL",5138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf","2012-12-13 00:00:00",
18586,2,103471,"SUPPL",5185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103471s5185lbl.pdf","2014-01-31 00:00:00",
31592,1,103471,"SUPPL",5185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103471Orig1s5185ltr.pdf","2014-01-29 00:00:00",
9393,1,103471,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5186ltr.pdf","2015-09-28 00:00:00",
39656,2,103471,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5186lbl.pdf","2015-10-07 00:00:00",
31593,1,103471,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103471Orig1s5187ltr.pdf","2016-04-22 00:00:00",
39657,2,103471,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103471s5157lbl.pdf","2016-04-27 00:00:00",
9394,1,103471,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5188ltr.pdf","2015-12-23 00:00:00",
39658,2,103471,"SUPPL",5188,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5188lbl.pdf","2015-12-28 00:00:00",
48605,1,103471,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103471Orig1s5189ltr.pdf","2017-05-31 00:00:00",
54592,1,103471,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103471Orig1s5191ltr.pdf","2018-06-14 00:00:00",
55378,2,103471,"SUPPL",5193,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf","2018-09-04 00:00:00",
55379,8,103471,"SUPPL",5193,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf#page=18","2018-09-04 00:00:00",
55466,1,103471,"SUPPL",5193,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103471Orig1s5193ltr.pdf","2018-09-13 00:00:00",
9395,1,103532,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103532Orig1s5175ltr.pdf","2014-12-15 00:00:00",
18587,2,103532,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103532s5175lbl.pdf","2014-12-15 00:00:00",
9396,1,103575,"SUPPL",1008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf","2004-03-29 00:00:00",
18588,2,103575,"SUPPL",1008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf","2004-03-29 00:00:00",
43270,3,103575,"SUPPL",1008,"0","https://web.archive.org/web/20170113111532/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm","2004-03-29 00:00:00",
18589,2,103575,"SUPPL",1010,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf","2004-03-29 00:00:00",
22737,3,103575,"SUPPL",1010,"0","https://web.archive.org/web/20170113111532/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm","2004-03-29 00:00:00",
31594,1,103575,"SUPPL",1010,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf","2004-03-29 00:00:00",
31595,1,103575,"SUPPL",5022,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5022ltr.pdf","2003-12-04 00:00:00",
9397,1,103575,"SUPPL",5025,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5025ltr.pdf","2003-12-04 00:00:00",
9398,1,103575,"SUPPL",5126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103575Orig1s5126ltr.pdf","2013-11-27 00:00:00",
39659,2,103575,"SUPPL",5126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103575s5126lbl.pdf","2013-11-26 00:00:00",
18590,2,103608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/capcyt102896lab.pdf","2004-03-26 00:00:00",
31596,1,103608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/capcyt102896L.htm","2004-03-26 00:00:00",
43271,3,103608,"ORIG",1,"0","https://web.archive.org/web/20170118085129/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080734.htm","2004-03-26 00:00:00",
31597,1,103608,"SUPPL",5043,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103608s5043ltr.pdf","2012-06-27 00:00:00",
39660,2,103608,"SUPPL",5043,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103608s5043lbl.pdf","2012-06-27 00:00:00",
9399,1,103628,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/ifnbbio051796l.pdf","2004-03-11 00:00:00",
18591,2,103628,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf","2004-03-11 00:00:00",
31598,1,103628,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio013103L.htm","2004-03-11 00:00:00",
39661,2,103628,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm","2004-03-11 00:00:00",
9400,1,103628,"SUPPL",5008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbbio111202L.htm","2004-03-11 00:00:00",
39662,2,103628,"SUPPL",5008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf","2004-03-11 00:00:00",
9401,1,103628,"SUPPL",5021,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio052803L.htm","2004-03-11 00:00:00",
43272,3,103628,"SUPPL",5021,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103628s5021TOC.cfm","2004-03-11 00:00:00",
18592,2,103628,"SUPPL",5115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf","2007-02-23 00:00:00",
31599,1,103628,"SUPPL",5115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103628s5115 ltr.pdf","2007-02-12 00:00:00",
31600,1,103628,"SUPPL",5129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf","2014-09-03 00:00:00",
39663,2,103628,"SUPPL",5129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf","2014-09-03 00:00:00",
31601,1,103628,"SUPPL",5177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf","2014-09-03 00:00:00",
39664,2,103628,"SUPPL",5177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf","2014-09-03 00:00:00",
31602,1,103628,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf","2012-02-29 00:00:00",
39665,2,103628,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf","2012-02-27 00:00:00",
18593,2,103628,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf","2012-02-27 00:00:00",
31603,1,103628,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf","2012-02-29 00:00:00",
9402,1,103628,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf","2014-09-03 00:00:00",
18594,2,103628,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf","2014-09-03 00:00:00",
18595,2,103628,"SUPPL",5206,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf","2013-03-15 00:00:00",
31604,1,103628,"SUPPL",5206,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103628Orig1s5206ltr.pdf","2013-03-15 00:00:00",
31605,1,103628,"SUPPL",5224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf","2014-09-03 00:00:00",
39666,2,103628,"SUPPL",5224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf","2014-09-03 00:00:00",
9403,1,103628,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pdf","2015-12-23 00:00:00",
18596,2,103628,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf","2015-12-28 00:00:00",
46111,8,103628,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf#page=21","2016-12-09 00:00:00",
9404,1,103634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/imcicen070396L.htm","2004-03-17 00:00:00",
18597,2,103634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/imcicen070396-lab.pdf","2004-03-17 00:00:00",
22738,3,103634,"ORIG",1,"0","https://web.archive.org/web/20120303004254/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080665.htm","2004-03-17 00:00:00",
18600,2,103691,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf","2004-03-11 00:00:00",
23941,10,103691,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm072148.htm","2004-03-11 00:00:00",
31606,1,103691,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/becaomj121697L.htm","2004-03-11 00:00:00",
43273,3,103691,"ORIG",1,"0","https://web.archive.org/web/20170113111514/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080740.htm","2004-03-11 00:00:00",
9409,1,103691,"SUPPL",5015,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103691s5015ltr.pdf","2005-05-20 00:00:00",
39668,2,103691,"SUPPL",5015,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf","2005-05-20 00:00:00",
43274,3,103691,"SUPPL",5015,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103691Orig1s5015Approv.pdf","2012-02-14 00:00:00",
18601,2,103691,"SUPPL",5074,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf","2009-10-02 00:00:00",
31607,1,103691,"SUPPL",5074,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103691s5074ltr.pdf","2008-10-23 00:00:00",
39669,2,103691,"SUPPL",5095,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf","2011-03-21 00:00:00",
9410,1,103691,"SUPPL",5109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103691s5109ltr.pdf","2012-05-03 00:00:00",
23942,10,103705,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109106.htm","2004-09-22 00:00:00",
31614,1,103705,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697L.htm","2004-09-22 00:00:00",
39672,2,103705,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ritugen112697-lab.pdf","2004-09-22 00:00:00",
43275,3,103705,"ORIG",1,"0","https://web.archive.org/web/20170210011738/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093345.htm","2004-09-22 00:00:00",
18605,2,103705,"SUPPL",5209,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5209lbl.pdf","2006-02-14 00:00:00",
9412,1,103705,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5211_ltr.pdf","2006-03-14 00:00:00",
18606,2,103705,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5211_lbl.pdf","2006-03-14 00:00:00",
9413,1,103705,"SUPPL",5230,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5230LTR.pdf","2006-10-05 00:00:00",
39673,2,103705,"SUPPL",5230,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf","2006-10-02 00:00:00",
18607,2,103705,"SUPPL",5231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf","2006-10-02 00:00:00",
18608,2,103705,"SUPPL",5247,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5247Lbl.pdf","2007-03-07 00:00:00",
31615,1,103705,"SUPPL",5247,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5247Ltr.pdf","2007-03-06 00:00:00",
9414,1,103705,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5256ltr.pdf","2008-01-30 00:00:00",
39674,2,103705,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5256lbl.pdf","2008-01-30 00:00:00",
9415,1,103705,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5259ltr.pdf","2007-08-30 00:00:00",
18609,2,103705,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5259lbl.pdf","2007-08-30 00:00:00",
9416,1,103705,"SUPPL",5262,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5262ltr.pdf","2007-10-04 00:00:00",
18610,2,103705,"SUPPL",5262,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5262lbl.pdf","2007-10-10 00:00:00",
39675,2,103705,"SUPPL",5263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5263lbl.pdf","2008-01-31 00:00:00",
31616,1,103705,"SUPPL",5285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5285ltr.pdf","2008-09-16 00:00:00",
9417,1,103705,"SUPPL",5291,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5291ltr.pdf","2008-09-16 00:00:00",
18611,2,103705,"SUPPL",5299,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103705s5299lbl.pdf","2009-10-22 00:00:00",
31617,1,103705,"SUPPL",5299,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103705s5299ltr.pdf","2009-10-26 00:00:00",
18612,2,103705,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf","2010-02-19 00:00:00",
31618,1,103705,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5311ltr.pdf","2010-02-25 00:00:00",
18613,2,103705,"SUPPL",5312,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5312lbl.pdf","2010-02-19 00:00:00",
31619,1,103705,"SUPPL",5312,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5312ltr.pdf","2010-02-25 00:00:00",
9418,1,103705,"SUPPL",5332,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5332ltr.pdf","2011-02-04 00:00:00",
18614,2,103705,"SUPPL",5332,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5332lbl.pdf","2011-01-31 00:00:00",
18615,2,103705,"SUPPL",5343,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5343lbl.pdf","2011-01-10 00:00:00",
31620,1,103705,"SUPPL",5343,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5343ltr.pdf","2011-01-14 00:00:00",
9419,1,103705,"SUPPL",5344,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5344ltr.pdf","2011-04-22 00:00:00",
18616,2,103705,"SUPPL",5344,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5344lbl.pdf","2011-04-21 00:00:00",
43276,3,103705,"SUPPL",5344,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103705Orig1s5344.pdf","2014-08-01 00:00:00",
31621,1,103705,"SUPPL",5362,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705s5362ltr.pdf","2012-02-23 00:00:00",
39676,2,103705,"SUPPL",5362,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5362lbl.pdf","2012-02-22 00:00:00",
9420,1,103705,"SUPPL",5367,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf","2012-10-22 00:00:00",
39677,2,103705,"SUPPL",5367,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf","2012-10-19 00:00:00",
18617,2,103705,"SUPPL",5370,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5370lbl.pdf","2012-04-24 00:00:00",
31622,1,103705,"SUPPL",5370,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5370ltr.pdf","2012-04-19 00:00:00",
9421,1,103705,"SUPPL",5373,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5373ltr.pdf","2012-07-17 00:00:00",
39678,2,103705,"SUPPL",5373,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5373lbl.pdf","2012-07-30 00:00:00",
9422,1,103705,"SUPPL",5388,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf","2012-10-22 00:00:00",
39679,2,103705,"SUPPL",5388,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf","2012-10-19 00:00:00",
9423,1,103705,"SUPPL",5409,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5409ltr.pdf","2013-05-13 00:00:00",
18618,2,103705,"SUPPL",5409,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5409lbl.pdf","2013-05-14 00:00:00",
9424,1,103705,"SUPPL",5414,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5414ltr.pdf","2013-09-26 00:00:00",
18619,2,103705,"SUPPL",5414,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5414lbl.pdf","2013-09-27 00:00:00",
31623,1,103705,"SUPPL",5432,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103705Orig1s5432ltr.pdf","2014-08-14 00:00:00",
39680,2,103705,"SUPPL",5432,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.pdf","2014-08-13 00:00:00",
54536,2,103705,"SUPPL",5450,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf","2018-06-12 00:00:00",
54537,8,103705,"SUPPL",5450,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf#page=42","2018-06-12 00:00:00",
54562,1,103705,"SUPPL",5450,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103705Orig1s5450ltr.pdf","2018-06-14 00:00:00",
53607,2,103705,"SUPPL",5453,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf","2018-04-04 00:00:00",
53615,1,103705,"SUPPL",5453,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103705Orig1s5453ltr.pdf","2018-04-05 00:00:00",
18623,2,103764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/basnov051298lb.pdf","2004-03-29 00:00:00",
31629,1,103764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/basnov051298L.htm","2004-03-29 00:00:00",
43278,3,103764,"ORIG",1,"0","https://web.archive.org/web/20170113111552/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm","2004-03-29 00:00:00",
9428,1,103764,"SUPPL",5003,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/basnova032301L.htm","2004-03-29 00:00:00",
39684,2,103764,"SUPPL",5003,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf","2004-03-29 00:00:00",
9429,1,103764,"SUPPL",5037,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/basnov010203L.htm","2004-03-29 00:00:00",
39685,2,103764,"SUPPL",5037,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/basnov010203LB.htm","2004-03-29 00:00:00",
31630,1,103764,"SUPPL",5040,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103764-5040ltr.pdf","2003-12-04 00:00:00",
18624,2,103767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/denser020599lb.pdf","2004-03-25 00:00:00",
22742,3,103767,"ORIG",1,"0","https://web.archive.org/web/20120303004301/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080717.htm","2004-03-25 00:00:00",
31631,1,103767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/denser020599L.htm","2004-03-25 00:00:00",
31632,1,103767,"SUPPL",5094,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103767s5094ltr.pdf","2008-10-23 00:00:00",
39686,2,103767,"SUPPL",5094,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf","2008-10-28 00:00:00",
18625,2,103767,"SUPPL",5119,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103767s5119lbl.pdf","2011-09-02 00:00:00",
22743,3,103770,"ORIG",1,"0","https://web.archive.org/web/20160723194308/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093366.htm","2004-03-29 00:00:00",
31634,1,103770,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/palimed061998L.htm","2004-03-29 00:00:00",
31635,1,103770,"SUPPL",5022,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/palimed102302L.pdf","2004-03-29 00:00:00",
39688,2,103770,"SUPPL",5022,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf","2004-03-29 00:00:00",
43280,3,103770,"SUPPL",5033,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2003/103770Orig1s5033.pdf","2013-08-09 00:00:00",
9430,1,103770,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103770_s5059_ltr.pdf","2005-03-03 00:00:00",
22744,3,103770,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/103770Orig1s5059.pdf","2013-08-09 00:00:00",
39689,2,103770,"SUPPL",5059,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103770_s5059_lbl.pdf","2004-12-22 00:00:00",
31636,1,103770,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103770_5096LTR.pdf","2007-03-06 00:00:00",
39690,2,103770,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103770_5096lbl.pdf","2007-03-07 00:00:00",
9431,1,103770,"SUPPL",5113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103770s5113ltr.pdf","2008-08-05 00:00:00",
18626,2,103770,"SUPPL",5113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103770s5113lbl.pdf","2008-11-20 00:00:00",
9432,1,103770,"SUPPL",5116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103770s5116ltr.pdf","2009-03-24 00:00:00",
18627,2,103770,"SUPPL",5116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf","2009-03-24 00:00:00",
9433,1,103770,"SUPPL",5153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103770s5153ltr.pdf","2011-05-17 00:00:00",
9434,1,103770,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103770s5161ltr.pdf","2012-04-06 00:00:00",
18628,2,103770,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf","2012-04-06 00:00:00",
18629,2,103770,"SUPPL",5185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf","2014-03-25 00:00:00",
31637,1,103770,"SUPPL",5185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103770Orig1s5185ltr.pdf","2014-03-24 00:00:00",
48384,2,103770,"SUPPL",5200,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf","2017-05-16 00:00:00",
48408,1,103770,"SUPPL",5200,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103770Orig1s5200ltr.pdf","2017-05-17 00:00:00",
9435,1,103772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htm","2004-09-22 00:00:00",
39691,2,103772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf","2004-09-22 00:00:00",
43281,3,103772,"ORIG",1,"0","https://web.archive.org/web/20170118085130/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093327.htm","2004-09-22 00:00:00",
44422,10,103772,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2006-05-19 00:00:00",
18630,2,103772,"SUPPL",1004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf","2004-03-26 00:00:00",
31638,1,103772,"SUPPL",1004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm","2004-03-26 00:00:00",
43282,3,103772,"SUPPL",1004,"0","https://web.archive.org/web/20170118085130/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093335.htm","2004-03-26 00:00:00",
9436,1,103772,"SUPPL",1007,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inflcen122900L.htm","2004-03-26 00:00:00",
18631,2,103772,"SUPPL",1007,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf","2004-03-26 00:00:00",
22745,3,103772,"SUPPL",1007,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103772_S1007_REMICADE.pdf","2007-08-06 00:00:00",
9437,1,103772,"SUPPL",5004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen022702L.pdf","2004-03-26 00:00:00",
39692,2,103772,"SUPPL",5004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf","2004-03-26 00:00:00",
31639,1,103772,"SUPPL",5012,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen062802L.pdf","2004-03-26 00:00:00",
39693,2,103772,"SUPPL",5012,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf","2004-03-26 00:00:00",
9438,1,103772,"SUPPL",5020,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5020ltr.pdf","2003-11-03 00:00:00",
9439,1,103772,"SUPPL",5032,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/inflcen040103L.htm","2004-03-26 00:00:00",
31640,1,103772,"SUPPL",5056,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5056ltr.pdf","2003-11-03 00:00:00",
43283,3,103772,"SUPPL",5056,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103772_S5056_REMIICADE.pdf","2008-04-02 00:00:00",
9440,1,103772,"SUPPL",5058,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5058ltr.pdf","2004-08-10 00:00:00",
18632,2,103772,"SUPPL",5058,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf","2004-08-10 00:00:00",
18633,2,103772,"SUPPL",5073,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf","2004-09-29 00:00:00",
23080,6,103772,"SUPPL",5073,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073ppi.pdf","2004-09-29 00:00:00",
31641,1,103772,"SUPPL",5073,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5073ltr.pdf","2004-10-05 00:00:00",
31642,1,103772,"SUPPL",5077,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5077_ltr.pdf","2004-12-29 00:00:00",
39694,2,103772,"SUPPL",5077,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf","2004-12-29 00:00:00",
31643,1,103772,"SUPPL",5089,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772s5089ltr.pdf","2005-05-20 00:00:00",
39695,2,103772,"SUPPL",5089,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf","2005-05-20 00:00:00",
31644,1,103772,"SUPPL",5090,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5090_ltr.pdf","2005-03-03 00:00:00",
9441,1,103772,"SUPPL",5092,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5092ltr.pdf","2005-04-12 00:00:00",
39696,2,103772,"SUPPL",5092,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf","2005-04-12 00:00:00",
9442,1,103772,"SUPPL",5113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5113ltr.pdf","2005-10-20 00:00:00",
18634,2,103772,"SUPPL",5113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf","2005-09-20 00:00:00",
22746,3,103772,"SUPPL",5113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103772Orig1s5113.pdf","2016-01-19 00:00:00",
18635,2,103772,"SUPPL",5129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf","2007-02-23 00:00:00",
31645,1,103772,"SUPPL",5129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5129ltr.pdf","2007-02-12 00:00:00",
18636,2,103772,"SUPPL",5138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf","2006-05-19 00:00:00",
31646,1,103772,"SUPPL",5138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5138ltr.pdf","2006-05-19 00:00:00",
9443,1,103772,"SUPPL",5145,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5145LTR.pdf","2006-10-23 00:00:00",
18637,2,103772,"SUPPL",5145,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf","2006-10-23 00:00:00",
31647,1,103772,"SUPPL",5160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5160_LTR.pdf","2007-04-25 00:00:00",
39697,2,103772,"SUPPL",5160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf","2007-04-25 00:00:00",
9444,1,103772,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5163ltr.pdf","2007-01-08 00:00:00",
18638,2,103772,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf","2007-01-08 00:00:00",
9445,1,103772,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf","2006-08-14 00:00:00",
18639,2,103772,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf","2006-08-18 00:00:00",
31648,1,103772,"SUPPL",5167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf","2006-08-14 00:00:00",
39698,2,103772,"SUPPL",5167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf","2006-08-18 00:00:00",
18640,2,103772,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf","2007-07-05 00:00:00",
22747,3,103772,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/103772Orig1s5189Approv.pdf","2012-02-14 00:00:00",
31649,1,103772,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5189ltr.pdf","2007-07-05 00:00:00",
9446,1,103772,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103772s5232ltr.pdf","2009-04-20 00:00:00",
39699,2,103772,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf","2009-04-20 00:00:00",
18641,2,103772,"SUPPL",5234,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf","2009-05-07 00:00:00",
31650,1,103772,"SUPPL",5234,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5234ltr.pdf","2009-05-08 00:00:00",
9447,1,103772,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5258ltr.pdf","2009-11-25 00:00:00",
18642,2,103772,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf","2010-08-28 00:00:00",
31651,1,103772,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5259ltr.pdf","2011-01-06 00:00:00",
39700,2,103772,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf","2011-01-06 00:00:00",
31652,1,103772,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5260ltr.pdf","2010-05-10 00:00:00",
39701,2,103772,"SUPPL",5260,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf","2010-05-07 00:00:00",
31653,1,103772,"SUPPL",5278,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5278ltr.pdf","2010-08-03 00:00:00",
9448,1,103772,"SUPPL",5281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5281ltr.pdf","2011-02-28 00:00:00",
18643,2,103772,"SUPPL",5281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf","2011-03-04 00:00:00",
18644,2,103772,"SUPPL",5295,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf","2012-03-15 00:00:00",
9449,1,103772,"SUPPL",5301,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5301ltr.pdf","2011-09-29 00:00:00",
39702,2,103772,"SUPPL",5301,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf","2011-09-30 00:00:00",
9450,1,103772,"SUPPL",5317,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5317ltr.pdf","2011-08-11 00:00:00",
9451,1,103772,"SUPPL",5328,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103772s5328ltr.pdf","2012-06-29 00:00:00",
31654,1,103772,"SUPPL",5345,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5345ltr.pdf","2013-03-29 00:00:00",
39703,2,103772,"SUPPL",5345,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf","2013-04-01 00:00:00",
9452,1,103772,"SUPPL",5359,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pdf","2013-11-08 00:00:00",
18645,2,103772,"SUPPL",5359,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf","2013-11-08 00:00:00",
31655,1,103772,"SUPPL",5370,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5370ltr.pdf","2015-01-07 00:00:00",
39704,2,103772,"SUPPL",5370,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf","2015-01-05 00:00:00",
18646,2,103772,"SUPPL",5373,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf","2015-10-08 00:00:00",
31656,1,103772,"SUPPL",5373,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5373ltr.pdf","2015-10-06 00:00:00",
9453,1,103772,"SUPPL",5374,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5374ltr.pdf","2015-09-01 00:00:00",
18647,2,103772,"SUPPL",5374,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf","2015-08-28 00:00:00",
50189,2,103772,"SUPPL",5377,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf","2017-10-26 00:00:00",
50223,1,103772,"SUPPL",5377,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103772Orig1s05377ltr.pdf","2017-10-30 00:00:00",
54644,1,103772,"SUPPL",5385,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103772Orig1s5385ltr.pdf","2018-06-21 00:00:00",
54687,2,103772,"SUPPL",5385,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf","2018-06-26 00:00:00",
54688,8,103772,"SUPPL",5385,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf#page=48","2018-06-26 00:00:00",
9454,1,103780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbser030702L.htm","2003-12-17 00:00:00",
18648,2,103780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf","2003-12-17 00:00:00",
43284,3,103780,"ORIG",1,"0","https://web.archive.org/web/20170118085129/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080737.htm","2003-12-17 00:00:00",
43913,8,103780,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089019.pdf","2003-12-17 00:00:00",
22748,3,103780,"SUPPL",5010,"0","https://web.archive.org/web/20120303004314/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080739.htm","2004-03-26 00:00:00",
31657,1,103780,"SUPPL",5010,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbser050203L.htm","2004-03-26 00:00:00",
39705,2,103780,"SUPPL",5010,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf","2004-03-26 00:00:00",
18649,2,103780,"SUPPL",5030,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf","2005-01-26 00:00:00",
31658,1,103780,"SUPPL",5030,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5030ltr.pdf","2005-01-26 00:00:00",
18650,2,103780,"SUPPL",5052,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf","2005-01-26 00:00:00",
31659,1,103780,"SUPPL",5052,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5052ltr.pdf","2005-01-26 00:00:00",
18651,2,103780,"SUPPL",5062,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf","2005-07-21 00:00:00",
31660,1,103780,"SUPPL",5062,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103780s5062ltr.pdf","2005-07-21 00:00:00",
31661,1,103780,"SUPPL",5121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121ltr.pdf","2012-12-28 00:00:00",
39706,2,103780,"SUPPL",5121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf","2012-12-28 00:00:00",
9455,1,103780,"SUPPL",5140,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103780Orig1s5140ltr.pdf","2013-04-24 00:00:00",
39707,2,103780,"SUPPL",5140,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf","2013-04-23 00:00:00",
18652,2,103780,"SUPPL",5172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf","2015-03-12 00:00:00",
31662,1,103780,"SUPPL",5172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5172ltr.pdf","2015-03-11 00:00:00",
9456,1,103780,"SUPPL",5178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf","2014-04-25 00:00:00",
39708,2,103780,"SUPPL",5178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf","2014-04-28 00:00:00",
31663,1,103780,"SUPPL",5179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf","2014-04-25 00:00:00",
39709,2,103780,"SUPPL",5179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf","2014-04-28 00:00:00",
9457,1,103780,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5194ltr.pdf","2015-12-23 00:00:00",
39710,2,103780,"SUPPL",5194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf","2015-12-28 00:00:00",
45436,2,103780,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf","2016-09-30 00:00:00",
45437,1,103780,"SUPPL",5196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103780Orig1s5196ltr.pdf","2016-09-30 00:00:00",
9458,1,103786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/retboe103096L.htm","2004-03-29 00:00:00",
22749,3,103786,"ORIG",1,"0","https://web.archive.org/web/20130523120940/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093343.htm","2004-03-29 00:00:00",
22750,3,103792,"ORIG",1,"0","https://web.archive.org/web/20170128163102/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080591.htm","2004-03-15 00:00:00",
31664,1,103792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf","2004-03-15 00:00:00",
39711,2,103792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf","2004-03-15 00:00:00",
31665,1,103792,"SUPPL",1005,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/trasgen020900L.htm","2004-03-15 00:00:00",
39712,2,103792,"SUPPL",1005,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900LB.htm","2004-03-15 00:00:00",
31666,1,103792,"SUPPL",5004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/trasgen121101L.htm","2004-03-15 00:00:00",
39713,2,103792,"SUPPL",5004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/trasgen121101LB.pdf","2004-03-15 00:00:00",
9459,1,103792,"SUPPL",5008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/trasgen082802L.htm","2004-03-15 00:00:00",
39714,2,103792,"SUPPL",5008,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/trasgen082802LB.pdf","2004-03-15 00:00:00",
31667,1,103792,"SUPPL",5046,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103792-5046ltr.pdf","2003-11-06 00:00:00",
18653,2,103792,"SUPPL",5150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103792s5150lbl.pdf","2006-11-17 00:00:00",
31668,1,103792,"SUPPL",5150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103792 5150ltr.pdf","2006-12-04 00:00:00",
9460,1,103792,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5175ltr.pdf","2008-01-23 00:00:00",
39715,2,103792,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf","2008-01-23 00:00:00",
9461,1,103792,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf","2014-01-02 00:00:00",
31669,1,103792,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf","2008-05-29 00:00:00",
43285,3,103792,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm","2012-05-10 00:00:00",
9462,1,103792,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf","2014-01-02 00:00:00",
31670,1,103792,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf","2008-05-29 00:00:00",
43286,3,103792,"SUPPL",5189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm","2012-05-23 00:00:00",
31671,1,103792,"SUPPL",5250,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5250ltr.pdf","2010-10-26 00:00:00",
39716,2,103792,"SUPPL",5250,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf","2010-10-19 00:00:00",
18654,2,103792,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf","2010-11-01 00:00:00",
31672,1,103792,"SUPPL",5256,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5256ltr.pdf","2010-12-03 00:00:00",
22751,3,103792,"SUPPL",5275,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/103792Orig1s5275.pdf","2015-11-18 00:00:00",
18655,2,103792,"SUPPL",5305,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103792s5300s5305lbl.pdf","2013-11-22 00:00:00",
9463,1,103792,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5311ltr.pdf","2014-03-11 00:00:00",
22752,3,103792,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103792Orig1s5311TOC.cfm","2014-03-18 00:00:00",
39717,2,103792,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103792s5311lbl.pdf","2014-03-07 00:00:00",
44559,14,103792,"SUPPL",5311,"Medical Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103792Orig1s5311MedR.pdf","2014-03-10 00:00:00",
31673,1,103792,"SUPPL",5313,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf","2014-07-01 00:00:00",
9464,1,103792,"SUPPL",5318,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf","2014-07-01 00:00:00",
9465,1,103792,"SUPPL",5327,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103792Orig1s5327ltr.pdf","2015-04-24 00:00:00",
39718,2,103792,"SUPPL",5327,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103792s5327lbl.pdf","2015-04-24 00:00:00",
9466,1,103792,"SUPPL",5330,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103792Orig1s5330ltr.pdf","2016-03-18 00:00:00",
18656,2,103792,"SUPPL",5330,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103792s5330lbl.pdf","2016-03-22 00:00:00",
48168,2,103792,"SUPPL",5337,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103792s5337lbl.pdf","2017-04-28 00:00:00",
48198,1,103792,"SUPPL",5337,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103792Orig1s5337ltr.pdf","2017-05-02 00:00:00",
48857,3,103792,"SUPPL",5337,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/103792Orig1s5337.pdf","2017-06-28 00:00:00",
55730,1,103792,"SUPPL",5344,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf","2018-10-01 00:00:00",
22753,3,103795,"ORIG",1,"0","https://web.archive.org/web/20170118085127/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080536.htm","2004-09-22 00:00:00",
24172,16,103795,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2008-09-04 00:00:00",
31674,1,103795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/etanimm110298L.htm","2004-09-22 00:00:00",
39719,2,103795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/etanimm110298lb.pdf","2004-09-22 00:00:00",
44423,10,103795,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2011-12-20 00:00:00",
52485,20,103795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/108_103795 etanercept clinical prea.pdf","1900-01-01 00:00:00",
52486,60,103795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/110_103795 etanercept DD clinical prea.pdf","1900-01-01 00:00:00",
52487,57,103795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/107_103795 etanercept CDTL clinical prea.pdf","1900-01-01 00:00:00",
52488,18,103795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/109_103795 etanercept clinpharm prea.pdf","1900-01-01 00:00:00",
52489,17,103795,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/111_103795 etanercept statistical prea.pdf","1900-01-01 00:00:00",
31675,1,103795,"SUPPL",1001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/etanimm052799L.htm","2004-09-22 00:00:00",
43287,3,103795,"SUPPL",1001,"0","https://web.archive.org/web/20160413105708/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080578.htm","2004-09-22 00:00:00",
9467,1,103795,"SUPPL",1004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/etanimm060600L.htm","2004-09-22 00:00:00",
18657,2,103795,"SUPPL",1004,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/etanimm060600lb.txt","2004-09-22 00:00:00",
22754,3,103795,"SUPPL",5034,"0","https://web.archive.org/web/20170113111347/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080570.htm","2004-09-22 00:00:00",
31676,1,103795,"SUPPL",5034,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm011502L.htm","2004-09-22 00:00:00",
39720,2,103795,"SUPPL",5034,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm011502LB.pdf","2004-09-22 00:00:00",
18658,2,103795,"SUPPL",5051,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202LB.pdf","2004-09-22 00:00:00",
31677,1,103795,"SUPPL",5051,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm091202L.pdf","2004-09-22 00:00:00",
43573,6,103795,"SUPPL",5051,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202PLB.pdf","2004-09-22 00:00:00",
31678,1,103795,"SUPPL",5055,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5055ltr.pdf","2003-11-05 00:00:00",
22755,3,103795,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5097_ENBREL.pdf","2008-07-31 00:00:00",
31679,1,103795,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5097ltr.pdf","2003-11-05 00:00:00",
9468,1,103795,"SUPPL",5099,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5099ltr.pdf","2003-11-05 00:00:00",
22756,3,103795,"SUPPL",5102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795-5102_Enbrel.cfm","2004-12-07 00:00:00",
31680,1,103795,"SUPPL",5102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5102ltr.pdf","2003-11-06 00:00:00",
9469,1,103795,"SUPPL",5109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/etanimm060503L.htm","2004-09-22 00:00:00",
18659,2,103795,"SUPPL",5109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/etanimm060503LB.pdf","2004-09-22 00:00:00",
22757,3,103795,"SUPPL",5109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5109_ENBREL.pdf","2008-07-31 00:00:00",
9470,1,103795,"SUPPL",5110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5110ltr.pdf","2003-11-06 00:00:00",
31681,1,103795,"SUPPL",5123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5123ltr.pdf","2003-11-06 00:00:00",
43288,3,103795,"SUPPL",5123,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795s5123_EnbrelTOC.cfm","2005-12-06 00:00:00",
9471,1,103795,"SUPPL",5125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5125ltr.pdf","2004-04-08 00:00:00",
9472,1,103795,"SUPPL",5149,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103795_5149ltr.pdf","2004-06-08 00:00:00",
18660,2,103795,"SUPPL",5149,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/biologics/103795_5149ppi.pdf","2004-04-30 00:00:00",
31682,1,103795,"SUPPL",5162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795_5162LTR.pdf","2004-10-26 00:00:00",
39721,2,103795,"SUPPL",5162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5162lbl.pdf","2004-10-21 00:00:00",
18661,2,103795,"SUPPL",5184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5184lbl.pdf","2004-11-08 00:00:00",
31683,1,103795,"SUPPL",5184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795s5184ltr.pdf","2004-11-08 00:00:00",
9473,1,103795,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5191ltr.pdf","2005-06-07 00:00:00",
18662,2,103795,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5191lbl.pdf","2005-06-07 00:00:00",
18663,2,103795,"SUPPL",5225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795s5225lbl.pdf","2005-07-21 00:00:00",
31684,1,103795,"SUPPL",5225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795s5225ltr.pdf","2005-07-21 00:00:00",
9474,1,103795,"SUPPL",5229,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5229ltr.pdf","2005-08-08 00:00:00",
18664,2,103795,"SUPPL",5229,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5229lbl.pdf","2005-08-08 00:00:00",
18665,2,103795,"SUPPL",5286,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103795s5286lbl.pdf","2006-08-31 00:00:00",
9475,1,103795,"SUPPL",5322,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103795s5322ltr.pdf","2007-03-15 00:00:00",
18666,2,103795,"SUPPL",5322,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103795s5322lbl.pdf","2007-03-14 00:00:00",
39722,2,103795,"SUPPL",5356,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/enbrel_pi.pdf","2008-05-29 00:00:00",
9476,1,103795,"SUPPL",5359,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103795s5359ltr.pdf","2008-09-09 00:00:00",
39723,2,103795,"SUPPL",5359,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103795s5359lbl.pdf","2008-09-08 00:00:00",
9477,1,103795,"SUPPL",5391,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf","2010-06-29 00:00:00",
9478,1,103795,"SUPPL",5397,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf","2010-06-29 00:00:00",
9479,1,103795,"SUPPL",5400,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf","2010-06-29 00:00:00",
31685,1,103795,"SUPPL",5415,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103795s5415ltr.pdf","2009-12-03 00:00:00",
39724,2,103795,"SUPPL",5415,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103795s5415lbl.pdf","2011-01-11 00:00:00",
9480,1,103795,"SUPPL",5431,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5431ltr.pdf","2011-01-27 00:00:00",
9481,1,103795,"SUPPL",5437,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5437ltr.pdf","2010-08-02 00:00:00",
31686,1,103795,"SUPPL",5443,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5443ltr.pdf","2010-10-19 00:00:00",
31687,1,103795,"SUPPL",5445,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5445ltr.pdf","2010-11-04 00:00:00",
9482,1,103795,"SUPPL",5475,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5475ltr.pdf","2011-09-13 00:00:00",
9483,1,103795,"SUPPL",5503,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5503ltr.pdf","2012-12-05 00:00:00",
39725,2,103795,"SUPPL",5503,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf","2012-12-05 00:00:00",
9484,1,103795,"SUPPL",5507,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5507ltr.pdf","2012-12-13 00:00:00",
39726,2,103795,"SUPPL",5507,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf","2012-12-14 00:00:00",
9485,1,103795,"SUPPL",5531,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103795Orig1s5531ltr.pdf","2013-11-18 00:00:00",
18667,2,103795,"SUPPL",5531,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103795s5531lbl.pdf","2013-11-22 00:00:00",
18668,2,103795,"SUPPL",5532,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5532lbl.pdf","2015-03-24 00:00:00",
18669,2,103795,"SUPPL",5548,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5548lbl.pdf","2015-03-26 00:00:00",
31688,1,103795,"SUPPL",5548,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103795Orig1s5548ltr.pdf","2015-03-26 00:00:00",
48953,2,103795,"SUPPL",5551,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5551lbl.pdf","2017-07-12 00:00:00",
48986,1,103795,"SUPPL",5551,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5551ltr.pdf","2017-07-14 00:00:00",
45839,1,103795,"SUPPL",5552,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103795Orig1s5552ltr.pdf","2016-11-15 00:00:00",
45854,2,103795,"SUPPL",5552,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103795s5552lbl.pdf","2016-11-08 00:00:00",
49737,2,103795,"SUPPL",5556,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5556lbl.pdf","2017-09-15 00:00:00",
49777,1,103795,"SUPPL",5556,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5556ltredt.pdf","2017-09-19 00:00:00",
50510,1,103795,"SUPPL",5559,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5559ltr.pdf","2017-11-27 00:00:00",
49993,2,103795,"SUPPL",5561,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5561lbl.pdf","2017-10-10 00:00:00",
54358,1,103795,"SUPPL",5563,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5563s5564ltr.pdf","2018-05-29 00:00:00",
54367,2,103795,"SUPPL",5563,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf","2018-05-29 00:00:00",
54359,1,103795,"SUPPL",5564,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5563s5564ltr.pdf","2018-05-29 00:00:00",
54368,2,103795,"SUPPL",5564,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf","2018-05-29 00:00:00",
54369,8,103795,"SUPPL",5564,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34","2018-05-29 00:00:00",
55510,1,103795,"SUPPL",5565,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5565ltr.pdf","2018-09-18 00:00:00",
55805,2,103795,"SUPPL",5569,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5569lbl.pdf","2018-10-04 00:00:00",
55806,8,103795,"SUPPL",5569,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34","2018-10-04 00:00:00",
23944,10,103836,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109130.htm","2007-03-09 00:00:00",
31689,1,103836,"SUPPL",1001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inteint021000L.htm","2004-03-10 00:00:00",
31690,1,103836,"SUPPL",5050,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103836_5050ltr.pdf","2004-12-06 00:00:00",
39727,2,103836,"SUPPL",5050,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf","2004-12-06 00:00:00",
31691,1,103836,"SUPPL",5098,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103836s5098ltr.pdf","2007-02-12 00:00:00",
39728,2,103836,"SUPPL",5098,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf","2007-02-23 00:00:00",
18670,2,103836,"SUPPL",5182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf","2015-08-28 00:00:00",
31692,1,103836,"SUPPL",5182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103836Orig1s5182ltr.pdf","2015-09-01 00:00:00",
9486,1,103846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botelan120800L.htm","2004-03-17 00:00:00",
18671,2,103846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/botelan120800lb.pdf","2004-03-17 00:00:00",
23945,10,103846,"ORIG",1,"0","http://wcms.fda.gov/FDAgov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm","2008-08-12 00:00:00",
43289,3,103846,"ORIG",1,"0","https://web.archive.org/web/20170201030814/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080661.htm","2004-03-17 00:00:00",
9487,1,103846,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103846s5120ltr.pdf","2009-08-07 00:00:00",
23442,8,103846,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120Medguide.pdf","2009-08-07 00:00:00",
39729,2,103846,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120lbl.pdf","2009-08-07 00:00:00",
9488,1,103846,"SUPPL",5156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103846s5156ltr.pdf","2012-06-15 00:00:00",
9489,1,103909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/tenegen060200L.htm","2004-03-29 00:00:00",
39730,2,103909,"ORIG",1,"0","https://web.archive.org/web/20160803130402/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093370.htm","2004-03-29 00:00:00",
43290,3,103909,"ORIG",1,"0","https://web.archive.org/web/20090119110643/http://www.fda.gov/cder/biologics/products/tenegen060200.htm","2004-03-29 00:00:00",
52803,1,103909,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103909Orig1s5187ltr.pdf","2018-03-02 00:00:00",
52968,2,103909,"SUPPL",5187,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103909s5187lbl.pdf","2018-03-15 00:00:00",
9491,1,103946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/rasbsan071202L.htm","2004-03-12 00:00:00",
39731,2,103946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/rasbsan071202LB.pdf","2004-03-12 00:00:00",
43292,3,103946,"ORIG",1,"0","https://web.archive.org/web/20120303004138/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080525.htm","2004-03-12 00:00:00",
9492,1,103946,"SUPPL",5017,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103946_5017ltr.pdf","2005-01-26 00:00:00",
39732,2,103946,"SUPPL",5017,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103946_5017lbl.pdf","2005-01-26 00:00:00",
18673,2,103946,"SUPPL",5049,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103946s5049lbl.pdf","2007-10-04 00:00:00",
31693,1,103946,"SUPPL",5049,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103946s5049ltr.pdf","2007-10-04 00:00:00",
31694,1,103946,"SUPPL",5083,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103946s5083ltr.pdf","2009-10-26 00:00:00",
39733,2,103946,"SUPPL",5083,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103946s5083lbl.pdf","2009-10-19 00:00:00",
9493,1,103946,"SUPPL",5094,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5094ltr.pdf","2015-02-12 00:00:00",
31695,1,103946,"SUPPL",5095,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5095ltr.pdf","2015-05-26 00:00:00",
39734,2,103946,"SUPPL",5095,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103946s5095lbl.pdf","2015-05-27 00:00:00",
31696,1,103946,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103946Orig1s5097ltr.pdf","2016-06-15 00:00:00",
39735,2,103946,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103946s5097lbl.pdf","2016-06-17 00:00:00",
49759,2,103946,"SUPPL",5101,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103946s5101lbl.pdf","2017-09-18 00:00:00",
49778,1,103946,"SUPPL",5101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103946Orig1s5101ltr.pdf","2017-09-19 00:00:00",
53946,1,103948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm","2004-03-12 00:00:00",
53947,2,103948,"ORIG",1,"0","https://web.archive.org/web/20170222172020/http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088606.","2004-03-12 00:00:00",
53948,3,103948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103948s000_CampathTOC.cfm","2005-09-13 00:00:00",
53949,10,103948,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm082681.htm","2005-11-30 00:00:00",
53950,19,103948,"ORIG",1,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=340","2015-07-02 00:00:00",
53976,1,103948,"SUPPL",5070,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103948s5070lt.pdf","2004-05-19 00:00:00",
53977,1,103948,"SUPPL",5151,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103948Orig1s5151ltr.pdf","2015-09-22 00:00:00",
54913,2,103948,"SUPPL",5157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5157lbl.pdf","2018-07-18 00:00:00",
53951,1,103948,"SUPPL",5159,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103948Orig1s5159ltr.pdf","2017-12-15 00:00:00",
53952,2,103948,"SUPPL",5159,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5159lbl.pdf#page23","2017-12-14 00:00:00",
9497,1,103949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm","2004-03-25 00:00:00",
22760,3,103949,"ORIG",1,"0","https://web.archive.org/web/20160402193205/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080727.htm","2004-03-25 00:00:00",
39740,2,103949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF","2004-03-25 00:00:00",
9498,1,103949,"SUPPL",5002,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche080701L.htm","2004-03-25 00:00:00",
22761,3,103949,"SUPPL",5002,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103949s5002_PEGIntronTOC.cfm","2005-12-08 00:00:00",
39741,2,103949,"SUPPL",5002,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche080701LB.htm","2004-03-25 00:00:00",
31703,1,103949,"SUPPL",5077,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949s5077ltr.pdf","2005-11-03 00:00:00",
39742,2,103949,"SUPPL",5077,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949s5077lbl.pdf","2005-11-18 00:00:00",
18676,2,103949,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103949_5088lbl.pdf","2005-01-26 00:00:00",
31704,1,103949,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103949_5088ltr.pdf","2005-01-26 00:00:00",
31705,1,103949,"SUPPL",5105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949_5105ltr.pdf","2005-08-08 00:00:00",
39743,2,103949,"SUPPL",5105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949_5105lbl.pdf","2005-08-08 00:00:00",
31706,1,103949,"SUPPL",5124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103949s5124LTR.pdf","2007-01-16 00:00:00",
39744,2,103949,"SUPPL",5124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103949s5124LBL.pdf","2007-01-16 00:00:00",
9499,1,103949,"SUPPL",5125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5125ltr.pdf","2009-03-23 00:00:00",
39745,2,103949,"SUPPL",5125,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5125lbl.pdf","2009-03-19 00:00:00",
9500,1,103949,"SUPPL",5153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5153ltr.pdf","2011-03-31 00:00:00",
39746,2,103949,"SUPPL",5153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5153lbl.pdf","2011-03-31 00:00:00",
18677,2,103949,"SUPPL",5171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf","2009-01-16 00:00:00",
31707,1,103949,"SUPPL",5171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf","2008-12-24 00:00:00",
18678,2,103949,"SUPPL",5172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5172lbl.pdf","2009-06-07 00:00:00",
31708,1,103949,"SUPPL",5172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5172ltr.pdf","2009-06-08 00:00:00",
18679,2,103949,"SUPPL",5174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf","2009-01-16 00:00:00",
31709,1,103949,"SUPPL",5174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf","2008-12-24 00:00:00",
31710,1,103949,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5175ltr.pdf","2009-06-10 00:00:00",
31711,1,103949,"SUPPL",5201,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5201ltr.pdf","2011-02-15 00:00:00",
9501,1,103949,"SUPPL",5204,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5204ltr.pdf","2011-12-13 00:00:00",
18680,2,103949,"SUPPL",5204,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5204lbl.pdf","2011-12-07 00:00:00",
18681,2,103949,"SUPPL",5217,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf","2011-12-23 00:00:00",
31712,1,103949,"SUPPL",5217,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf","2011-12-28 00:00:00",
18682,2,103949,"SUPPL",5222,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf","2011-12-23 00:00:00",
31713,1,103949,"SUPPL",5222,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf","2011-12-28 00:00:00",
9502,1,103949,"SUPPL",5231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5231ltr.pdf","2012-06-07 00:00:00",
18683,2,103949,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5232lbl.pdf","2012-07-06 00:00:00",
31714,1,103949,"SUPPL",5232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5232ltr.pdf","2012-07-09 00:00:00",
9503,1,103949,"SUPPL",5252,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949Orig1s5252ltr.pdf","2012-12-28 00:00:00",
39747,2,103949,"SUPPL",5252,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5252lbl.pdf","2012-12-28 00:00:00",
18684,2,103949,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5259lbl.pdf","2013-12-19 00:00:00",
31715,1,103949,"SUPPL",5259,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5259ltr.pdf","2013-12-20 00:00:00",
18685,2,103949,"SUPPL",5263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5263lbl.pdf","2013-05-21 00:00:00",
31716,1,103949,"SUPPL",5263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5263ltr.pdf","2013-05-16 00:00:00",
9504,1,103949,"SUPPL",5273,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5273ltr.pdf","2013-11-25 00:00:00",
18686,2,103949,"SUPPL",5273,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5273lbl.pdf","2013-11-22 00:00:00",
31717,1,103949,"SUPPL",5285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5285ltr.pdf","2014-08-15 00:00:00",
39748,2,103949,"SUPPL",5285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5285lbl.pdf","2014-08-15 00:00:00",
9505,1,103949,"SUPPL",5287,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5287ltr.pdf","2014-09-08 00:00:00",
39749,2,103949,"SUPPL",5287,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5287lbl.pdf","2014-09-03 00:00:00",
18687,2,103949,"SUPPL",5288,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5288lbl.pdf","2014-08-12 00:00:00",
31718,1,103949,"SUPPL",5288,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5288ltr.pdf","2014-08-12 00:00:00",
18688,2,103949,"SUPPL",5293,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5293lbl.pdf","2014-11-20 00:00:00",
31719,1,103949,"SUPPL",5293,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5293ltr.pdf","2014-11-19 00:00:00",
18689,2,103949,"SUPPL",5295,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5295lbl.pdf","2014-08-01 00:00:00",
31720,1,103949,"SUPPL",5295,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5295ltr.pdf","2014-08-01 00:00:00",
31721,1,103949,"SUPPL",5296,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5296ltr.pdf","2014-10-10 00:00:00",
18690,2,103949,"SUPPL",5297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5297lbl.pdf","2015-05-27 00:00:00",
31722,1,103949,"SUPPL",5297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5297ltr.pdf","2015-05-22 00:00:00",
9506,1,103949,"SUPPL",5298,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5298ltr.pdf","2015-05-19 00:00:00",
18691,2,103949,"SUPPL",5298,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5298lbl.pdf","2015-05-14 00:00:00",
18692,2,103949,"SUPPL",5299,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5299lbl.pdf","2015-09-23 00:00:00",
31723,1,103949,"SUPPL",5299,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5299ltr.pdf","2015-09-17 00:00:00",
48552,1,103949,"SUPPL",5304,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5304ltr.pdf","2017-05-26 00:00:00",
48553,2,103949,"SUPPL",5304,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5304lbl.pdf","2017-05-30 00:00:00",
49938,1,103949,"SUPPL",5305,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5305s5307ltr.pdf","2017-10-04 00:00:00",
49946,2,103949,"SUPPL",5305,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf","2017-10-04 00:00:00",
49955,2,103949,"SUPPL",5306,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5306lbl.pdf","2017-10-05 00:00:00",
49960,1,103949,"SUPPL",5306,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5306ltr.pdf","2017-10-05 00:00:00",
49939,1,103949,"SUPPL",5307,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5305s5307ltr.pdf","2017-10-04 00:00:00",
49947,2,103949,"SUPPL",5307,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf","2017-10-04 00:00:00",
53998,1,103949,"SUPPL",5310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103949Orig1s5310ltr.pdf","2018-05-03 00:00:00",
54012,2,103949,"SUPPL",5310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949Orig1s5310lbl.pdf","2018-05-04 00:00:00",
54360,1,103949,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103949Orig1s5311ltr.pdf","2018-05-29 00:00:00",
54362,2,103949,"SUPPL",5311,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf","2018-05-29 00:00:00",
54363,8,103949,"SUPPL",5311,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27","2018-05-29 00:00:00",
18693,2,103950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf","2004-03-17 00:00:00",
22762,3,103950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103950-0_Kineret.cfm","2005-04-27 00:00:00",
31724,1,103950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/anakamg111401L.htm","2004-03-17 00:00:00",
43574,6,103950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401ptLB.pdf","2004-03-17 00:00:00",
18694,2,103950,"SUPPL",5013,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf","2004-03-17 00:00:00",
31725,1,103950,"SUPPL",5013,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/anakamg062703L.htm","2004-03-17 00:00:00",
31726,1,103950,"SUPPL",5019,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103950-5019ltr.pdf","2003-11-06 00:00:00",
9507,1,103950,"SUPPL",5039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103950_5039ltr.pdf","2004-10-26 00:00:00",
23081,6,103950,"SUPPL",5039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039ppi.pdf","2004-10-21 00:00:00",
39750,2,103950,"SUPPL",5039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf","2004-10-21 00:00:00",
39751,2,103950,"SUPPL",5116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf","2011-09-30 00:00:00",
9508,1,103950,"SUPPL",5136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103950Orig1s5136ltr.pdf","2012-12-28 00:00:00",
18695,2,103950,"SUPPL",5136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf","2012-12-28 00:00:00",
9509,1,103950,"SUPPL",5150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103950Orig1s5150ltr.pdf","2013-10-25 00:00:00",
39752,2,103950,"SUPPL",5150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf","2013-10-25 00:00:00",
9510,1,103950,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103950Orig1s5175ltr.pdf","2016-05-20 00:00:00",
18696,2,103950,"SUPPL",5175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf","2016-05-23 00:00:00",
54497,2,103950,"SUPPL",5182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf","2018-06-11 00:00:00",
54565,1,103950,"SUPPL",5182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103950Orig1s5182ltr.pdf","2018-06-14 00:00:00",
18697,2,103951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/darbamg091701LB.htm","2004-01-21 00:00:00",
22763,3,103951,"ORIG",1,"0","https://web.archive.org/web/20160317023707/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080442.htm","2004-01-21 00:00:00",
31727,1,103951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/darbamg091701L.htm","2004-01-21 00:00:00",
22764,3,103951,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2002/103951Orig1s5001.pdf","2011-12-02 00:00:00",
31728,1,103951,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/darbamg071902L.htm","2004-03-11 00:00:00",
39753,2,103951,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB.pdf","2004-03-11 00:00:00",
43575,6,103951,"SUPPL",5001,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB2.pdf","2004-09-22 00:00:00",
9511,1,103951,"SUPPL",5069,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103951_5069ltr.pdf","2005-01-26 00:00:00",
18698,2,103951,"SUPPL",5069,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103951_5069lbl.pdf","2005-01-26 00:00:00",
9512,1,103951,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5088ltr.pdf","2006-02-08 00:00:00",
39754,2,103951,"SUPPL",5088,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5088lbl.pdf","2006-02-08 00:00:00",
9513,1,103951,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103951s5096ltr.pdf","2005-12-16 00:00:00",
18699,2,103951,"SUPPL",5096,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf","2005-12-16 00:00:00",
18700,2,103951,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5097LBL.pdf","2006-04-05 00:00:00",
31729,1,103951,"SUPPL",5097,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5097ltr.pdf","2006-04-05 00:00:00",
18701,2,103951,"SUPPL",5135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5135LBL.pdf","2007-04-20 00:00:00",
31730,1,103951,"SUPPL",5135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5135ltr .pdf","2007-04-20 00:00:00",
18702,2,103951,"SUPPL",5139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5139lbl.pdf","2007-03-09 00:00:00",
31731,1,103951,"SUPPL",5139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5139ltr.pdf","2007-03-15 00:00:00",
18703,2,103951,"SUPPL",5164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164lbl.pdf","2007-11-08 00:00:00",
23082,6,103951,"SUPPL",5164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164ppi.pdf","2007-11-08 00:00:00",
31732,1,103951,"SUPPL",5164,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5164ltr.pdf","2007-11-08 00:00:00",
18704,2,103951,"SUPPL",5169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5169lbl.pdf","2008-01-30 00:00:00",
31733,1,103951,"SUPPL",5169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5169ltr.pdf","2008-01-31 00:00:00",
31734,1,103951,"SUPPL",5170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5170ltr.pdf","2008-03-13 00:00:00",
39755,2,103951,"SUPPL",5170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf","2008-03-11 00:00:00",
43576,6,103951,"SUPPL",5170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170ppi.pdf","2008-03-12 00:00:00",
9514,1,103951,"SUPPL",5173,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf","2011-06-24 00:00:00",
18705,2,103951,"SUPPL",5173,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf","2011-06-24 00:00:00",
22765,3,103951,"SUPPL",5173,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103951_aranesp_toc.cfm","2012-07-16 00:00:00",
24355,21,103951,"SUPPL",5173,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173SumR.pdf","2012-05-25 00:00:00",
31735,1,103951,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5195ltr.pdf","2011-04-28 00:00:00",
39756,2,103951,"SUPPL",5195,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5195PI.pdf","2008-11-26 00:00:00",
18706,2,103951,"SUPPL",5197,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf","2010-02-16 00:00:00",
31736,1,103951,"SUPPL",5197,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103951s5197ltr.pdf","2010-02-16 00:00:00",
31737,1,103951,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103951s5211ltr.pdf","2010-02-05 00:00:00",
39757,2,103951,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103951s5211Lbl.pdf","2010-02-04 00:00:00",
39758,2,103951,"SUPPL",5223,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5223LBL.pdf","2010-02-04 00:00:00",
31738,1,103951,"SUPPL",5248,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf","2011-06-24 00:00:00",
9515,1,103951,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf","2011-06-24 00:00:00",
18707,2,103951,"SUPPL",5258,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf","2011-06-24 00:00:00",
9516,1,103951,"SUPPL",5285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103951s5285ltr.pdf","2012-06-04 00:00:00",
18708,2,103951,"SUPPL",5285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103951s5285lbl.pdf","2012-06-06 00:00:00",
18709,2,103951,"SUPPL",5325,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5325lbl.pdf","2014-01-07 00:00:00",
31739,1,103951,"SUPPL",5325,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5325ltr.pdf","2014-01-02 00:00:00",
31740,1,103951,"SUPPL",5337,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5337ltr.pdf","2013-03-29 00:00:00",
9517,1,103951,"SUPPL",5349,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5349ltr.pdf","2014-01-02 00:00:00",
18710,2,103951,"SUPPL",5349,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5349lbl.pdf","2014-01-07 00:00:00",
31741,1,103951,"SUPPL",5363,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103951Orig1s5363ltr.pdf","2015-07-24 00:00:00",
39760,2,103951,"SUPPL",5363,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf","2015-07-24 00:00:00",
52596,20,103951,"SUPPL",5363,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103951s5363 darbepoetin clinical bpca.pdf","1900-01-01 00:00:00",
52597,17,103951,"SUPPL",5363,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103951s5363 darbepoetin statistical bpca.pdf","1900-01-01 00:00:00",
31742,1,103951,"SUPPL",5370,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103951Orig1s5370ltr.pdf","2016-04-28 00:00:00",
50247,2,103951,"SUPPL",5374,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf","2017-10-31 00:00:00",
50248,8,103951,"SUPPL",5374,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf#page=25","2017-11-01 00:00:00",
50308,1,103951,"SUPPL",5374,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103951Orig1s5374ltr.pdf","2017-11-06 00:00:00",
48014,2,103951,"SUPPL",5375,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5375lbl.pdf","2017-04-14 00:00:00",
48043,1,103951,"SUPPL",5375,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103951Orig1s5375ltr.pdf","2017-04-14 00:00:00",
22766,3,103964,"ORIG",1,"0","https://web.archive.org/web/20170113111452/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080721.htm","2004-03-25 00:00:00",
31743,1,103964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof101602L.htm","2004-03-25 00:00:00",
39761,2,103964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm","2004-03-25 00:00:00",
51543,20,103964,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinical prea-Dawn.pdf","1900-01-01 00:00:00",
51544,18,103964,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/196_103964S5270 peginterferon clinpharm prea.pdf","1900-01-01 00:00:00",
51545,17,103964,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/197_103964S5270 peginterferon statistical prea.pdf","1900-01-01 00:00:00",
9518,1,103964,"SUPPL",5000,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof120302L.htm","2004-03-25 00:00:00",
18711,2,103964,"SUPPL",5000,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof120302LB.htm","2004-03-25 00:00:00",
18712,2,103964,"SUPPL",5036,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103964_5036lbl.pdf","2005-01-26 00:00:00",
31744,1,103964,"SUPPL",5036,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103964_5036ltr.pdf","2005-01-26 00:00:00",
31745,1,103964,"SUPPL",5037,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5037ltr.pdf","2005-05-20 00:00:00",
39762,2,103964,"SUPPL",5037,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964s5037lbl.pdf","2005-05-20 00:00:00",
31746,1,103964,"SUPPL",5039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964_5039ltr.pdf","2005-03-03 00:00:00",
39763,2,103964,"SUPPL",5039,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964_5039lbl.pdf","2005-02-25 00:00:00",
31747,1,103964,"SUPPL",5057,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5057ltr.pdf","2005-05-20 00:00:00",
9519,1,103964,"SUPPL",5065,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5065ltr.pdf","2005-05-20 00:00:00",
9520,1,103964,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103964s5120ltr.pdf","2007-07-05 00:00:00",
18713,2,103964,"SUPPL",5120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103964s5120lbl.pdf","2007-07-05 00:00:00",
9521,1,103964,"SUPPL",5133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5133ltr.pdf","2008-11-07 00:00:00",
18714,2,103964,"SUPPL",5133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5133lbl.pdf","2009-01-16 00:00:00",
9522,1,103964,"SUPPL",5147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf","2009-05-08 00:00:00",
39764,2,103964,"SUPPL",5147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf","2009-05-07 00:00:00",
18715,2,103964,"SUPPL",5154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5154lbl.pdf","2009-01-16 00:00:00",
31748,1,103964,"SUPPL",5154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5154ltr.pdf","2008-10-02 00:00:00",
9523,1,103964,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf","2009-05-08 00:00:00",
39765,2,103964,"SUPPL",5163,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf","2009-05-07 00:00:00",
9524,1,103964,"SUPPL",5176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5176ltr.pdf","2010-06-29 00:00:00",
9525,1,103964,"SUPPL",5177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5177ltr.pdf","2010-03-31 00:00:00",
18716,2,103964,"SUPPL",5183,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5183lbl.pdf","2011-03-04 00:00:00",
31749,1,103964,"SUPPL",5183,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5183ltr.pdf","2011-03-02 00:00:00",
18717,2,103964,"SUPPL",5184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5184lbl.pdf","2011-05-31 00:00:00",
9526,1,103964,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf","2011-08-11 00:00:00",
39766,2,103964,"SUPPL",5186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5186lbl.pdf","2011-08-11 00:00:00",
31750,1,103964,"SUPPL",5204,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5204ltr.pdf","2011-10-05 00:00:00",
39767,2,103964,"SUPPL",5204,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf","2011-10-04 00:00:00",
9527,1,103964,"SUPPL",5213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf","2011-08-26 00:00:00",
39768,2,103964,"SUPPL",5213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf","2011-08-24 00:00:00",
31751,1,103964,"SUPPL",5241,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5241ltr.pdf","2013-05-21 00:00:00",
39769,2,103964,"SUPPL",5241,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5241lbl.pdf","2013-05-21 00:00:00",
18718,2,103964,"SUPPL",5245,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5245lbl.pdf","2013-07-03 00:00:00",
31752,1,103964,"SUPPL",5245,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5245ltr.pdf","2013-07-03 00:00:00",
31753,1,103964,"SUPPL",5261,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103964Orig1s5261ltr.pdf","2014-09-08 00:00:00",
39770,2,103964,"SUPPL",5261,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103964s5261lbl.pdf","2014-09-09 00:00:00",
31754,1,103964,"SUPPL",5264,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103964Orig1s5264ltr.pdf","2015-03-19 00:00:00",
39771,2,103964,"SUPPL",5264,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103964s5264lbl.pdf","2015-03-19 00:00:00",
50066,2,103964,"SUPPL",5270,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf","2017-10-17 00:00:00",
50067,8,103964,"SUPPL",5270,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39","2017-10-17 00:00:00",
50090,1,103964,"SUPPL",5270,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103964Orig1s5270ltr.pdf","2017-10-18 00:00:00",
9528,1,103976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/omalgen062003L.htm","2004-03-30 00:00:00",
18719,2,103976,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf","2004-03-30 00:00:00",
44424,10,103976,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103291.htm","2004-03-30 00:00:00",
51619,20,103976,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab clinical prea.pdf","1900-01-01 00:00:00",
51620,18,103976,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab clinpharm prea.pdf","1900-01-01 00:00:00",
51621,17,103976,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab statistical prea.pdf","1900-01-01 00:00:00",
18720,2,103976,"SUPPL",5087,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf","2006-04-14 00:00:00",
31755,1,103976,"SUPPL",5087,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103976s5097ltr.pdf","2006-04-14 00:00:00",
18721,2,103976,"SUPPL",5102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf","2007-07-02 00:00:00",
43917,8,103976,"SUPPL",5102,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089829.pdf","2007-07-02 00:00:00",
9529,1,103976,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5161ltr.pdf","2014-10-01 00:00:00",
39772,2,103976,"SUPPL",5161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf","2014-09-30 00:00:00",
31756,1,103976,"SUPPL",5166,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5166ltr.pdf","2010-02-05 00:00:00",
31757,1,103976,"SUPPL",5180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5180ltr.pdf","2011-01-10 00:00:00",
31758,1,103976,"SUPPL",5191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103976s5191ltr.pdf","2012-01-05 00:00:00",
18722,2,103976,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf","2014-03-25 00:00:00",
31759,1,103976,"SUPPL",5211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5211ltr.pdf","2014-03-25 00:00:00",
9530,1,103976,"SUPPL",5224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103976Orig1s5224ltr.pdf","2015-12-08 00:00:00",
39773,2,103976,"SUPPL",5224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf","2015-12-08 00:00:00",
9531,1,103976,"SUPPL",5225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103976Orig1s5225ltr.pdf","2016-07-07 00:00:00",
18723,2,103976,"SUPPL",5225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf","2016-07-08 00:00:00",
51622,20,103976,"SUPPL",5225,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab clinical prea.pdf","1900-01-01 00:00:00",
51623,18,103976,"SUPPL",5225,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab clinpharm-prea.pdf","1900-01-01 00:00:00",
51624,17,103976,"SUPPL",5225,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/103976 omalizumab statistical-prea.pdf","1900-01-01 00:00:00",
55768,1,103976,"SUPPL",5231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103976Orig1s5231ltr.pdf","2018-10-01 00:00:00",
55798,2,103976,"SUPPL",5231,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf","2018-10-03 00:00:00",
55799,8,103976,"SUPPL",5231,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf#page=32","2018-10-03 00:00:00",
9532,1,103979,"ORIG",1,"0","https://web.archive.org/web/20170202073410/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm128159.htm","2004-03-15 00:00:00",
18724,2,103979,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf","2004-03-15 00:00:00",
22767,3,103979,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103979_toc.cfm","2004-03-15 00:00:00",
9533,1,103979,"SUPPL",5058,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf","2007-01-08 00:00:00",
18725,2,103979,"SUPPL",5058,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf","2007-01-08 00:00:00",
9534,1,103979,"SUPPL",5065,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf","2007-01-08 00:00:00",
39774,2,103979,"SUPPL",5065,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf","2007-01-08 00:00:00",
9535,1,103979,"SUPPL",5066,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf","2007-01-08 00:00:00",
18726,2,103979,"SUPPL",5066,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf","2007-01-08 00:00:00",
18727,2,103979,"SUPPL",5107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf","2009-01-16 00:00:00",
31760,1,103979,"SUPPL",5107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103979s5107ltr.pdf","2008-12-29 00:00:00",
39775,2,103979,"SUPPL",5135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf","2011-01-05 00:00:00",
18731,2,125019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf","2004-03-30 00:00:00",
22770,3,125019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm","2005-12-08 00:00:00",
31763,1,125019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm","2004-03-30 00:00:00",
9538,1,125019,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf","2005-01-26 00:00:00",
39777,2,125019,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf","2005-01-26 00:00:00",
31764,1,125019,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf","2005-01-26 00:00:00",
39778,2,125019,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf","2005-01-26 00:00:00",
31765,1,125019,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf","2005-08-08 00:00:00",
39779,2,125019,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf","2005-08-08 00:00:00",
31766,1,125019,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf","2005-09-15 00:00:00",
39780,2,125019,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf","2005-09-15 00:00:00",
31767,1,125019,"SUPPL",132,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf","2007-11-08 00:00:00",
39781,2,125019,"SUPPL",132,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf","2007-11-13 00:00:00",
9539,1,125019,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf","2008-03-28 00:00:00",
18732,2,125019,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf","2008-03-27 00:00:00",
9540,1,125019,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf","2009-09-10 00:00:00",
39782,2,125019,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf","2009-09-18 00:00:00",
18733,2,125019,"SUPPL",194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf","2011-11-30 00:00:00",
31768,1,125019,"SUPPL",194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf","2011-12-02 00:00:00",
9541,1,125019,"SUPPL",210,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf","2013-09-05 00:00:00",
39783,2,125019,"SUPPL",210,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf","2013-09-09 00:00:00",
31769,1,125019,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf","2013-09-05 00:00:00",
39784,2,125019,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf","2013-09-09 00:00:00",
9543,1,125031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegfamg013102L.htm","2004-03-25 00:00:00",
18736,2,125031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102LB.pdf","2004-03-25 00:00:00",
22771,3,125031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm","2004-10-25 00:00:00",
43577,6,125031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102ptLB.pdf","2004-03-25 00:00:00",
53384,20,125031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125031s105_Pegfilgrastim_Clinical_PREA.pdf","1900-01-01 00:00:00",
53385,18,125031,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125031s105_Pegfilgrastim_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
9544,1,125031,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125031_0048ltr.pdf","2005-01-26 00:00:00",
39787,2,125031,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125031_0048lbl.pdf","2005-01-26 00:00:00",
9545,1,125031,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125031_0051ltr.pdf","2005-01-26 00:00:00",
39788,2,125031,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031_0051lbl.pdf","2005-01-26 00:00:00",
18737,2,125031,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031s0052lbl.pdf","2006-02-08 00:00:00",
31773,1,125031,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125031s072LTR.pdf","2006-11-09 00:00:00",
39789,2,125031,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125031s072LBL.pdf","2006-11-09 00:00:00",
9546,1,125031,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125031s082ltr.pdf","2007-08-01 00:00:00",
18738,2,125031,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125031s082lbl.pdf","2007-08-02 00:00:00",
9547,1,125031,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf","2008-12-04 00:00:00",
9548,1,125031,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s0095ltr.pdf","2008-05-22 00:00:00",
31774,1,125031,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf","2008-12-04 00:00:00",
9549,1,125031,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125031s120ltr.pdf","2010-03-31 00:00:00",
31775,1,125031,"SUPPL",130,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125031s130ltr.pdf","2011-06-15 00:00:00",
31776,1,125031,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125031s0142ltr.pdf","2012-05-29 00:00:00",
39790,2,125031,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125031s0142lbl.pdf","2012-05-29 00:00:00",
9550,1,125031,"SUPPL",170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf","2015-09-24 00:00:00",
39791,2,125031,"SUPPL",170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf","2015-10-06 00:00:00",
9551,1,125031,"SUPPL",175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125031Orig1s175ltr.pdf","2014-12-30 00:00:00",
50614,3,125031,"SUPPL",175,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125031Orig1s175.pdf","2017-12-06 00:00:00",
18739,2,125031,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf","2015-10-06 00:00:00",
31777,1,125031,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf","2015-09-24 00:00:00",
31778,1,125031,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s180ltr.pdf","2015-12-23 00:00:00",
39792,2,125031,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf","2015-11-19 00:00:00",
9552,1,125031,"SUPPL",181,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf","2015-09-24 00:00:00",
39793,2,125031,"SUPPL",181,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf","2015-10-06 00:00:00",
48606,3,125031,"SUPPL",181,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125031Orig1s181.pdf","2017-05-31 00:00:00",
9553,1,125031,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125031Orig1s184ltr.pdf","2016-05-03 00:00:00",
39794,2,125031,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125031s184lbl.pdf","2016-04-29 00:00:00",
50672,2,125031,"SUPPL",189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf","2017-12-13 00:00:00",
50684,1,125031,"SUPPL",189,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125031Orig1s189,s191ltr.pdf","2017-12-13 00:00:00",
50671,2,125031,"SUPPL",191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf","2017-12-13 00:00:00",
50683,1,125031,"SUPPL",191,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125031Orig1s189,s191ltr.pdf","2017-12-13 00:00:00",
54643,1,125031,"SUPPL",193,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125031Orig1s193ltr.pdf","2018-06-21 00:00:00",
54685,2,125031,"SUPPL",193,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125031s193lbl.pdf","2018-06-26 00:00:00",
9558,1,125057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm","2004-03-16 00:00:00",
39797,2,125057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm","2004-03-16 00:00:00",
43296,3,125057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm","2004-03-16 00:00:00",
44425,10,125057,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2011-12-20 00:00:00",
31781,1,125057,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf","2004-08-06 00:00:00",
39798,2,125057,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf","2004-08-06 00:00:00",
43297,3,125057,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125057Orig1s016.pdf","2015-03-11 00:00:00",
9559,1,125057,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023ltr.pdf","2004-07-07 00:00:00",
43298,3,125057,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125057Orig1s023.pdf","2013-09-09 00:00:00",
44990,3,125057,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125057Orig1s280.pdf","2014-12-24 00:00:00",
9560,1,125057,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf","2005-10-20 00:00:00",
18746,2,125057,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf","2005-10-10 00:00:00",
22772,3,125057,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s045.pdf","2015-03-09 00:00:00",
22773,3,125057,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s046.pdf","2015-03-09 00:00:00",
31782,1,125057,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf","2005-10-20 00:00:00",
39799,2,125057,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf","2005-10-10 00:00:00",
31783,1,125057,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf","2007-02-23 00:00:00",
39800,2,125057,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf","2007-02-23 00:00:00",
39801,2,125057,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf","2006-08-31 00:00:00",
9561,1,125057,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf","2006-11-14 00:00:00",
18747,2,125057,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf","2006-11-14 00:00:00",
9562,1,125057,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf","2007-03-06 00:00:00",
22774,3,125057,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125057_S0089.pdf","2013-04-09 00:00:00",
39802,2,125057,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf","2007-03-07 00:00:00",
9563,1,125057,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf","2007-08-01 00:00:00",
18748,2,125057,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf","2007-07-31 00:00:00",
9564,1,125057,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf","2006-11-14 00:00:00",
18749,2,125057,"SUPPL",95,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf","2006-11-14 00:00:00",
31784,1,125057,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf","2007-09-07 00:00:00",
39803,2,125057,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf","2007-09-07 00:00:00",
24356,21,125057,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf","2009-03-24 00:00:00",
31785,1,125057,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s0110ltr.pdf","2008-01-25 00:00:00",
39804,2,125057,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf","2008-03-27 00:00:00",
43299,3,125057,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110TOC.cfm","2009-03-24 00:00:00",
18750,2,125057,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf","2008-02-26 00:00:00",
31786,1,125057,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf","2008-02-26 00:00:00",
53151,20,125057,"SUPPL",114,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Clinical_PREA.pdf","1900-01-01 00:00:00",
53152,18,125057,"SUPPL",114,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
53153,17,125057,"SUPPL",114,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Statistical_PREA.pdf","1900-01-01 00:00:00",
31787,1,125057,"SUPPL",128,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf","2011-03-25 00:00:00",
31788,1,125057,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf","2010-06-17 00:00:00",
31789,1,125057,"SUPPL",196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf","2009-12-03 00:00:00",
39805,2,125057,"SUPPL",196,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf","2010-02-23 00:00:00",
22775,3,125057,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125057Orig1s0213.pdf","2016-02-03 00:00:00",
31790,1,125057,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf","2010-08-03 00:00:00",
18751,2,125057,"SUPPL",215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf","2011-03-04 00:00:00",
9565,1,125057,"SUPPL",224,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf","2010-10-19 00:00:00",
9566,1,125057,"SUPPL",232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf","2012-10-03 00:00:00",
39806,2,125057,"SUPPL",232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf","2012-10-02 00:00:00",
48416,3,125057,"SUPPL",232,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125057Orig1s232.pdf","2017-05-17 00:00:00",
9567,1,125057,"SUPPL",254,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf","2012-01-05 00:00:00",
31791,1,125057,"SUPPL",255,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s255ltr.pdf","2011-09-13 00:00:00",
9568,1,125057,"SUPPL",271,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf","2012-01-05 00:00:00",
9569,1,125057,"SUPPL",276,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf","2012-01-05 00:00:00",
39807,2,125057,"SUPPL",276,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf","2012-03-15 00:00:00",
9570,1,125057,"SUPPL",278,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf","2012-05-30 00:00:00",
18752,2,125057,"SUPPL",278,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf","2012-05-29 00:00:00",
9571,1,125057,"SUPPL",280,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf","2015-01-08 00:00:00",
9572,1,125057,"SUPPL",310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf","2013-05-15 00:00:00",
18753,2,125057,"SUPPL",310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf","2013-05-13 00:00:00",
18754,2,125057,"SUPPL",322,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf","2013-04-29 00:00:00",
48417,3,125057,"SUPPL",322,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125057Orig1s322.pdf","2017-05-17 00:00:00",
18755,2,125057,"SUPPL",327,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf","2013-09-24 00:00:00",
31792,1,125057,"SUPPL",327,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf","2013-09-20 00:00:00",
31793,1,125057,"SUPPL",355,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s355_replace_ltr.pdf","2014-02-27 00:00:00",
39808,2,125057,"SUPPL",355,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf","2014-02-27 00:00:00",
9573,1,125057,"SUPPL",356,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf","2014-09-25 00:00:00",
18756,2,125057,"SUPPL",356,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf","2014-09-26 00:00:00",
18757,2,125057,"SUPPL",366,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf","2014-06-03 00:00:00",
31794,1,125057,"SUPPL",366,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s366ltr.pdf","2014-06-03 00:00:00",
31795,1,125057,"SUPPL",367,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf","2014-10-02 00:00:00",
39809,2,125057,"SUPPL",367,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf","2014-10-02 00:00:00",
9574,1,125057,"SUPPL",368,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf","2014-05-20 00:00:00",
18758,2,125057,"SUPPL",368,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf","2014-05-15 00:00:00",
43300,3,125057,"SUPPL",381,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s381.pdf","2016-07-28 00:00:00",
31796,1,125057,"SUPPL",393,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf","2015-09-14 00:00:00",
9575,1,125057,"SUPPL",394,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf","2015-11-24 00:00:00",
39810,2,125057,"SUPPL",394,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf","2015-11-25 00:00:00",
44790,21,125057,"SUPPL",394,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf","2016-03-11 00:00:00",
9576,1,125057,"SUPPL",397,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf","2016-07-01 00:00:00",
39811,2,125057,"SUPPL",397,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf","2016-07-05 00:00:00",
47741,2,125057,"SUPPL",399,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf","2017-03-28 00:00:00",
47765,1,125057,"SUPPL",399,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s399ltr.pdf","2017-03-29 00:00:00",
50170,2,125057,"SUPPL",400,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf","2017-10-24 00:00:00",
48116,2,125057,"SUPPL",401,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf","2017-04-26 00:00:00",
48176,2,125057,"SUPPL",402,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf","2017-05-01 00:00:00",
48202,1,125057,"SUPPL",402,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s402ltr.pdf","2017-05-02 00:00:00",
50712,1,125057,"SUPPL",403,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s403ltr.pdf","2017-12-15 00:00:00",
50830,2,125057,"SUPPL",403,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf","2017-12-22 00:00:00",
50831,8,125057,"SUPPL",403,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53","2017-12-22 00:00:00",
55096,1,125057,"SUPPL",406,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s406ltr.pdf","2018-08-03 00:00:00",
55103,2,125057,"SUPPL",406,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf","2018-08-03 00:00:00",
55769,1,125057,"SUPPL",408,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s408ltr.pdf","2018-10-01 00:00:00",
55788,2,125057,"SUPPL",408,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf","2018-10-03 00:00:00",
9577,1,125058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/larobio043003L.htm","2004-03-10 00:00:00",
18759,2,125058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf","2004-03-10 00:00:00",
43301,3,125058,"ORIG",1,"0","https://web.archive.org/web/20170118085125/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080438.htm","2004-03-10 00:00:00",
9578,1,125058,"SUPPL",154,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125058s154ltr.pdf","2008-05-28 00:00:00",
31797,1,125058,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf","2009-06-10 00:00:00",
39812,2,125058,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf","2009-06-29 00:00:00",
9579,1,125058,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf","2009-06-10 00:00:00",
18760,2,125058,"SUPPL",161,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf","2009-06-29 00:00:00",
18761,2,125058,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf","2011-01-03 00:00:00",
9580,1,125058,"SUPPL",220,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125058Orig1s220ltr.pdf","2013-04-09 00:00:00",
18762,2,125058,"SUPPL",220,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf","2013-04-09 00:00:00",
9583,1,125084,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084-0001ltr.pdf","2004-06-24 00:00:00",
18763,2,125084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf","2004-02-12 00:00:00",
22778,3,125084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125084_erbitux_toc.cfm","2004-09-13 00:00:00",
31802,1,125084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084ltr.pdf","2004-04-08 00:00:00",
44426,10,125084,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113714.htm","2005-04-15 00:00:00",
44562,14,125084,"ORIG",1,"Questions and Answers","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113715.htm","2004-02-11 00:00:00",
22779,3,125084,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/0125084_s030_erbitux.pdf","2011-01-04 00:00:00",
31803,1,125084,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125084_0030ltr.pdf","2005-09-08 00:00:00",
39815,2,125084,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf","2005-09-08 00:00:00",
9584,1,125084,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf","2006-04-21 00:00:00",
18764,2,125084,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf","2006-04-21 00:00:00",
31804,1,125084,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046, 125084s076, 125084s077LTR.pdf","2006-05-25 00:00:00",
39816,2,125084,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf","2006-05-23 00:00:00",
9585,1,125084,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125084s103ltl.pdf","2007-10-10 00:00:00",
18765,2,125084,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf","2007-10-05 00:00:00",
43302,3,125084,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125084Orig1s103.pdf","2011-12-02 00:00:00",
31805,1,125084,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125084s139ltr.pdf","2008-09-16 00:00:00",
18766,2,125084,"SUPPL",153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf","2011-11-07 00:00:00",
31806,1,125084,"SUPPL",153,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125084s153ltr.pdf","2011-11-08 00:00:00",
18767,2,125084,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf","2009-08-06 00:00:00",
31807,1,125084,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125084s0167ltr.pdf","2009-08-12 00:00:00",
39817,2,125084,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf","2009-07-20 00:00:00",
31808,1,125084,"SUPPL",225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s225ltr.pdf","2012-07-09 00:00:00",
39818,2,125084,"SUPPL",225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf","2012-07-06 00:00:00",
9586,1,125084,"SUPPL",228,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s228ltr.pdf","2012-01-31 00:00:00",
39819,2,125084,"SUPPL",228,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf","2012-03-20 00:00:00",
9587,1,125084,"SUPPL",229,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s229ltr.pdf","2012-01-31 00:00:00",
18768,2,125084,"SUPPL",229,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf","2012-02-16 00:00:00",
18769,2,125084,"SUPPL",242,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf","2013-03-08 00:00:00",
31809,1,125084,"SUPPL",242,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125084Orig1s242ltr.pdf","2013-03-05 00:00:00",
9588,1,125084,"SUPPL",262,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s262ltr.pdf","2015-04-13 00:00:00",
18770,2,125084,"SUPPL",262,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf","2015-04-14 00:00:00",
31810,1,125084,"SUPPL",263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s263ltr.pdf","2015-03-12 00:00:00",
39820,2,125084,"SUPPL",263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf","2015-03-12 00:00:00",
45540,1,125084,"SUPPL",265,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125084Orig1s265ltr.pdf","2016-10-14 00:00:00",
47280,2,125084,"SUPPL",265,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125084s265lbl.pdf","2017-02-22 00:00:00",
54020,2,125084,"SUPPL",268,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084Orig1s268lbl.pdf","2018-05-04 00:00:00",
54042,1,125084,"SUPPL",268,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125084Orig1s268ltr.pdf","2018-05-08 00:00:00",
54459,1,125084,"SUPPL",269,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125084Orig1s269ltr.pdf","2018-06-05 00:00:00",
54469,2,125084,"SUPPL",269,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084s269lbl.pdf","2018-06-06 00:00:00",
18771,2,125085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125085lbl.pdf","2004-02-27 00:00:00",
22780,3,125085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/STN-125085_Avastin.cfm","2005-01-28 00:00:00",
31811,1,125085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125085ltr.pdf","2004-02-27 00:00:00",
44427,10,125085,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm193900.htm","2009-12-11 00:00:00",
9589,1,125085,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125085s0045ltr.pdf","2005-10-20 00:00:00",
39821,2,125085,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125085s45lbl.pdf","2005-09-30 00:00:00",
18772,2,125085,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s067LBL.pdf","2006-04-21 00:00:00",
31812,1,125085,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s067LTR.pdf","2006-04-21 00:00:00",
18773,2,125085,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/0125085s074lbl.pdf","2006-06-21 00:00:00",
31813,1,125085,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s074LTR.pdf","2006-06-27 00:00:00",
43303,3,125085,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0074_avastin.pdf","2006-06-20 00:00:00",
9590,1,125085,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s082LTR.pdf","2006-09-25 00:00:00",
39822,2,125085,"SUPPL",82,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s082LBL.pdf","2006-09-25 00:00:00",
22781,3,125085,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0085_avastin.pdf","2006-10-11 00:00:00",
31814,1,125085,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s085ltr.pdf","2006-10-23 00:00:00",
39823,2,125085,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s085lbl.pdf","2006-10-23 00:00:00",
9591,1,125085,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s091ltr.pdf","2008-02-27 00:00:00",
22782,3,125085,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125085_s091_avastin.pdf","2011-02-15 00:00:00",
39824,2,125085,"SUPPL",131,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125085s131lbl.pdf","2007-09-26 00:00:00",
31815,1,125085,"SUPPL",145,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s0145ltr.pdf","2008-03-28 00:00:00",
39825,2,125085,"SUPPL",145,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125085s145lbl.pdf","2008-03-27 00:00:00",
31816,1,125085,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0168ltr.pdf","2009-08-06 00:00:00",
39826,2,125085,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0168lbl.pdf","2009-08-04 00:00:00",
18774,2,125085,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf","2009-05-05 00:00:00",
31817,1,125085,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0169ltr.pdf","2009-05-13 00:00:00",
31818,1,125085,"SUPPL",204,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125085s204ltr.pdf","2011-01-10 00:00:00",
9592,1,125085,"SUPPL",208,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s208ltr.pdf","2011-02-15 00:00:00",
9593,1,125085,"SUPPL",225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s225ltr.pdf","2011-10-04 00:00:00",
18775,2,125085,"SUPPL",225,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125085s225lbl.pdf","2011-09-30 00:00:00",
9594,1,125085,"SUPPL",238,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085s0238ltr.pdf","2012-05-08 00:00:00",
18776,2,125085,"SUPPL",238,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s0238lbl.pdf","2012-05-07 00:00:00",
9595,1,125085,"SUPPL",239,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s239ltr.pdf","2012-10-29 00:00:00",
39827,2,125085,"SUPPL",239,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s239lbl.pdf","2012-10-26 00:00:00",
9596,1,125085,"SUPPL",241,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s0241ltr.pdf","2011-12-27 00:00:00",
31819,1,125085,"SUPPL",263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s263ltr.pdf","2013-01-25 00:00:00",
39828,2,125085,"SUPPL",263,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s263lbl.pdf","2013-01-24 00:00:00",
9597,1,125085,"SUPPL",265,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s265ltr.pdf","2012-11-23 00:00:00",
18777,2,125085,"SUPPL",265,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s265lbl.pdf","2012-11-28 00:00:00",
18778,2,125085,"SUPPL",267,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s267lbl.pdf","2013-04-01 00:00:00",
31820,1,125085,"SUPPL",267,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s267ltr.pdf","2013-03-28 00:00:00",
18779,2,125085,"SUPPL",285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s285lbl.pdf","2013-12-17 00:00:00",
31821,1,125085,"SUPPL",285,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s285ltr.pdf","2013-12-17 00:00:00",
31822,1,125085,"SUPPL",297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s297ltr.pdf","2014-09-03 00:00:00",
39829,2,125085,"SUPPL",297,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s297lbl.pdf","2014-09-03 00:00:00",
18780,2,125085,"SUPPL",301,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s301lbl.pdf","2014-08-14 00:00:00",
31823,1,125085,"SUPPL",301,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s301ltr.pdf","2014-08-15 00:00:00",
44791,21,125085,"SUPPL",301,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085Orig1s301SumR.pdf","2014-08-19 00:00:00",
9598,1,125085,"SUPPL",305,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s305ltr.pdf","2014-11-17 00:00:00",
18781,2,125085,"SUPPL",305,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf","2014-11-14 00:00:00",
31824,1,125085,"SUPPL",308,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s308ltr.pdf","2015-05-11 00:00:00",
39830,2,125085,"SUPPL",308,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s308lbl.pdf","2015-05-08 00:00:00",
9599,1,125085,"SUPPL",310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s310ltr.pdf","2015-10-01 00:00:00",
39831,2,125085,"SUPPL",310,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s310lbl.pdf","2015-10-07 00:00:00",
9600,1,125085,"SUPPL",312,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s312ltr.pdf","2015-12-02 00:00:00",
18782,2,125085,"SUPPL",312,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s312lbl.pdf","2015-12-02 00:00:00",
46088,2,125085,"SUPPL",317,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125085s317lbl.pdf","2016-12-08 00:00:00",
46099,1,125085,"SUPPL",317,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125085Orig1s317ltr.pdf","2016-12-08 00:00:00",
50626,1,125085,"SUPPL",319,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125085s319ltr.pdf","2017-12-07 00:00:00",
50627,2,125085,"SUPPL",319,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125085s319lbl.pdf","2017-12-07 00:00:00",
54544,2,125085,"SUPPL",323,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s323lbl.pdf","2018-06-13 00:00:00",
54603,1,125085,"SUPPL",323,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125085Orig1s323ltr.pdf","2018-06-14 00:00:00",
53984,2,125085,"SUPPL",324,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s324lbl.pdf","2018-05-02 00:00:00",
53995,1,125085,"SUPPL",324,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125085Orig1s324ltr.pdf","2018-05-03 00:00:00",
23948,10,125103,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110263.htm","2005-07-28 00:00:00",
31825,1,125103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125103_0000_ltr.pdf","2004-12-29 00:00:00",
39832,2,125103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125103lbl.pdf","2004-12-29 00:00:00",
43304,3,125103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125103s000_KepivanceTOC.cfm","2005-09-26 00:00:00",
51455,20,125103,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125103 palifermin Kepivance clinical prea.pdf","1900-01-01 00:00:00",
51456,18,125103,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125103 palifermin Kepivance_clinpharm prea.pdf","1900-01-01 00:00:00",
31826,1,125103,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125103s0010ltr.pdf","2005-12-16 00:00:00",
39833,2,125103,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125103s0010lbl.pdf","2005-12-16 00:00:00",
39834,2,125103,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0118lbl.pdf","2011-09-30 00:00:00",
18783,2,125103,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0120lbl.pdf","2011-11-21 00:00:00",
31827,1,125103,"SUPPL",120,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125103s0120ltr.pdf","2011-11-22 00:00:00",
31828,1,125103,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125103Orig1s146ltr.pdf","2013-05-31 00:00:00",
39835,2,125103,"SUPPL",146,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf","2013-06-04 00:00:00",
9601,1,125103,"SUPPL",167,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125103Orig1s167ltr.pdf","2015-03-16 00:00:00",
31829,1,125103,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125103Orig1s171,s172ltr.pdf","2016-07-05 00:00:00",
39836,2,125103,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf","2016-07-05 00:00:00",
18784,2,125103,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf","2016-07-05 00:00:00",
9602,1,125104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf","2004-11-24 00:00:00",
18785,2,125104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf","2004-11-24 00:00:00",
22783,3,125104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_Natalizumab.cfm","2005-03-08 00:00:00",
24083,14,125104,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=63","2012-01-18 00:00:00",
24357,21,125104,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104Orig1s015SumR.pdf","2014-01-16 00:00:00",
31830,1,125104,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125104s015LTR.pdf","2006-06-06 00:00:00",
39837,2,125104,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf","2006-06-06 00:00:00",
9603,1,125104,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s0033ltr.pdf","2008-01-23 00:00:00",
22784,3,125104,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/125104Orig1s0033.pdf","2013-10-23 00:00:00",
39838,2,125104,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf","2008-01-15 00:00:00",
9604,1,125104,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf","2008-11-03 00:00:00",
39839,2,125104,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf","2009-09-16 00:00:00",
9605,1,125104,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s106ltr.pdf","2008-11-03 00:00:00",
18786,2,125104,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf","2008-10-31 00:00:00",
18787,2,125104,"SUPPL",283,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf","2004-11-23 00:00:00",
18788,2,125104,"SUPPL",438,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf","2011-04-07 00:00:00",
18789,2,125104,"SUPPL",475,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf","2011-04-07 00:00:00",
9606,1,125104,"SUPPL",570,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125104s570ltr.pdf","2012-01-31 00:00:00",
18790,2,125104,"SUPPL",576,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf","2012-01-27 00:00:00",
31831,1,125104,"SUPPL",576,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125104s576ltr.pdf","2012-01-31 00:00:00",
39840,2,125104,"SUPPL",658,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf","2011-09-27 00:00:00",
9607,1,125104,"SUPPL",813,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s813ltr.pdf","2013-05-28 00:00:00",
39841,2,125104,"SUPPL",813,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf","2013-06-04 00:00:00",
18791,2,125104,"SUPPL",840,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf","2013-12-17 00:00:00",
31832,1,125104,"SUPPL",840,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf","2013-12-17 00:00:00",
9608,1,125104,"SUPPL",847,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf","2013-12-17 00:00:00",
39842,2,125104,"SUPPL",847,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf","2013-12-17 00:00:00",
9609,1,125104,"SUPPL",889,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf","2013-12-17 00:00:00",
39843,2,125104,"SUPPL",889,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf","2013-12-17 00:00:00",
31833,1,125104,"SUPPL",950,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125104Orig1s950ltr.pdf","2015-05-13 00:00:00",
39844,2,125104,"SUPPL",950,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf","2015-05-13 00:00:00",
9610,1,125104,"SUPPL",953,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf","2016-05-20 00:00:00",
39845,2,125104,"SUPPL",953,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf","2016-05-20 00:00:00",
9611,1,125104,"SUPPL",955,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf","2016-05-20 00:00:00",
18792,2,125104,"SUPPL",955,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf","2016-05-20 00:00:00",
45526,1,125104,"SUPPL",958,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s958ltr.pdf","2016-10-12 00:00:00",
49437,2,125104,"SUPPL",959,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf","2017-08-17 00:00:00",
49438,8,125104,"SUPPL",959,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf#page=30","2017-08-17 00:00:00",
49492,1,125104,"SUPPL",959,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125104Orig1s959ltr.pdf","2017-08-21 00:00:00",
53753,2,125104,"SUPPL",960,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf","2018-04-20 00:00:00",
53776,1,125104,"SUPPL",960,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf","2018-04-23 00:00:00",
53754,2,125104,"SUPPL",963,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf","2018-04-20 00:00:00",
53777,1,125104,"SUPPL",963,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf","2018-04-23 00:00:00",
9612,1,125117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf","2005-06-07 00:00:00",
18793,2,125117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf","2005-06-07 00:00:00",
22785,3,125117,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125117s000_NaglazyneTOC.cfm","2005-09-13 00:00:00",
18794,2,125117,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf","2011-04-29 00:00:00",
31834,1,125117,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf","2011-05-05 00:00:00",
31835,1,125117,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf","2011-05-05 00:00:00",
39846,2,125117,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf","2011-04-29 00:00:00",
9613,1,125117,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf","2011-05-05 00:00:00",
39847,2,125117,"SUPPL",90,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf","2011-04-29 00:00:00",
31836,1,125117,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf","2013-03-29 00:00:00",
39848,2,125117,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf","2013-04-01 00:00:00",
22786,3,125118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125118_s0000_OrenciaTOC.cfm","2006-05-16 00:00:00",
31837,1,125118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125118rev2.pdf","2006-01-06 00:00:00",
39849,2,125118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf","2005-12-30 00:00:00",
54026,18,125118,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/101_125118 abatacept clinpharm-2 bpca.pdf","1900-01-01 00:00:00",
54027,62,125118,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/98_125118 abatacept clinical addendum bpca.pdf","1900-01-01 00:00:00",
18795,2,125118,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf","2007-03-13 00:00:00",
9614,1,125118,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf","2008-06-03 00:00:00",
51936,18,125118,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125118s045_Abatacept_Clinical_PREA.pdf","1900-01-01 00:00:00",
51937,17,125118,"SUPPL",45,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/012510125118s045_Abatacept_Statistical_PREA.pdf","1900-01-01 00:00:00",
31838,1,125118,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf","2009-09-01 00:00:00",
39850,2,125118,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf","2009-08-27 00:00:00",
22787,3,125118,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125118Orig1s107.pdf","2014-01-17 00:00:00",
31839,1,125118,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125118s0122ltr.pdf","2011-08-11 00:00:00",
45792,3,125118,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125118Orig1s122.pdf","2016-11-02 00:00:00",
31840,1,125118,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf","2012-02-23 00:00:00",
39851,2,125118,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf","2012-02-22 00:00:00",
9615,1,125118,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125118Orig1s171ltr.pdf","2013-12-24 00:00:00",
39852,2,125118,"SUPPL",171,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf","2013-12-23 00:00:00",
9616,1,125118,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125118Orig1s179ltr.pdf","2015-01-07 00:00:00",
18796,2,125118,"SUPPL",179,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf","2015-01-05 00:00:00",
48889,2,125118,"SUPPL",209,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf","2017-07-03 00:00:00",
48902,1,125118,"SUPPL",209,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s209ltr.pdf","2017-07-05 00:00:00",
47808,2,125118,"SUPPL",211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s211lbl.pdf","2017-03-31 00:00:00",
47822,1,125118,"SUPPL",211,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s211ltr.pdf","2017-04-03 00:00:00",
51232,20,125118,"SUPPL",211,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/99_125118 abatacept clinical bpca.pdf","1900-01-01 00:00:00",
51234,18,125118,"SUPPL",211,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/100_125118 abatacept clinpharm bpca.pdf","1900-01-01 00:00:00",
9617,1,125141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf","2006-05-02 00:00:00",
18797,2,125141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf","2006-04-28 00:00:00",
22788,3,125141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125141s000_MyozymeTOC.cfm","2006-06-21 00:00:00",
18798,2,125141,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf","2009-01-16 00:00:00",
31841,1,125141,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf","2008-12-24 00:00:00",
31842,1,125141,"SUPPL",176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125141Orig1s0176ltr.pdf","2012-07-13 00:00:00",
39853,2,125141,"SUPPL",176,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf","2012-07-13 00:00:00",
18799,2,125141,"SUPPL",219,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf","2014-05-28 00:00:00",
31843,1,125141,"SUPPL",219,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf","2014-05-22 00:00:00",
18800,2,125147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125147s0000lbl.pdf","2006-09-28 00:00:00",
22789,3,125147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125147s0000TOC.cfm","2006-11-30 00:00:00",
31844,1,125147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125147LTR.pdf","2006-10-02 00:00:00",
31845,1,125147,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125147s018ltr.pdf","2007-11-19 00:00:00",
39854,2,125147,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125147s018lbl.pdf","2007-12-03 00:00:00",
9618,1,125147,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125147s026ltr.pdf","2008-07-08 00:00:00",
18801,2,125147,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125147s026lbl.pdf","2008-07-14 00:00:00",
9619,1,125147,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125147s0067ltr.pdf","2009-05-08 00:00:00",
39855,2,125147,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s067lbl.pdf","2009-05-07 00:00:00",
39856,2,125147,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s080lbl.pdf","2009-07-21 00:00:00",
9620,1,125147,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s108ltr.pdf","2014-05-27 00:00:00",
39857,2,125147,"SUPPL",108,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s108lbl.pdf","2014-05-28 00:00:00",
18802,2,125147,"SUPPL",148,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125147s0148lbl.pdf","2012-08-20 00:00:00",
31846,1,125147,"SUPPL",148,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s0148ltr.pdf","2012-08-21 00:00:00",
9621,1,125147,"SUPPL",152,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s152ltr.pdf","2012-08-27 00:00:00",
9622,1,125147,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125147Orig1s169ltr.pdf","2013-04-01 00:00:00",
39858,2,125147,"SUPPL",169,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125147s169lbl.pdf","2013-04-01 00:00:00",
9623,1,125147,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s186ltr.pdf","2014-05-27 00:00:00",
39859,2,125147,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s186lbl.pdf","2014-05-28 00:00:00",
31847,1,125147,"SUPPL",194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s194ltr.pdf","2014-09-03 00:00:00",
39860,2,125147,"SUPPL",194,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s194lbl.pdf","2014-09-03 00:00:00",
9624,1,125147,"SUPPL",200,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125147Orig1s200ltr.pdf","2015-03-12 00:00:00",
18803,2,125147,"SUPPL",200,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf","2015-03-12 00:00:00",
48873,2,125147,"SUPPL",207,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125147s207lbl.pdf","2017-06-30 00:00:00",
48899,1,125147,"SUPPL",207,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125147Orig1s207ltr.pdf","2017-07-05 00:00:00",
9625,1,125151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125151s0000_Ltr.pdf","2006-10-05 00:00:00",
43305,3,125151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125151s0000_ElapraseTOC.cfm","2006-09-26 00:00:00",
9626,1,125151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125151s032ltr.pdf","2007-11-08 00:00:00",
39861,2,125151,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125151s032lbl.pdf","2007-11-13 00:00:00",
9627,1,125151,"SUPPL",152,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf","2013-06-26 00:00:00",
39862,2,125151,"SUPPL",152,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0152lbl.pdf","2013-06-24 00:00:00",
18804,2,125151,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0184lbl.pdf","2013-06-24 00:00:00",
31848,1,125151,"SUPPL",184,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf","2013-06-26 00:00:00",
9628,1,125156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125156LTR.pdf","2006-07-13 00:00:00",
18805,2,125156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf","2006-07-13 00:00:00",
22790,3,125156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s0000_LucentisTOC.cfm","2006-09-26 00:00:00",
18806,2,125156,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf","2010-07-06 00:00:00",
31849,1,125156,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125156s053ltr.pdf","2010-07-02 00:00:00",
43306,3,125156,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125156Orig1s053.pdf","2014-01-17 00:00:00",
18807,2,125156,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf","2012-08-15 00:00:00",
31850,1,125156,"SUPPL",69,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125156Orig1s0069,s0076ltr.pdf","2012-08-13 00:00:00",
18808,2,125156,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf","2012-08-15 00:00:00",
31851,1,125156,"SUPPL",76,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125156Orig1s0069,s0076ltr.pdf","2012-08-13 00:00:00",
18809,2,125156,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125156s081lbl.pdf","2013-02-08 00:00:00",
31852,1,125156,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125156Orig1s081ltr.pdf","2013-02-08 00:00:00",
9629,1,125156,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125156Orig1s087ltr.pdf","2013-03-12 00:00:00",
31853,1,125156,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125156Orig1s094ltr.pdf","2014-03-04 00:00:00",
39863,2,125156,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s094lbl.pdf","2014-03-04 00:00:00",
9630,1,125156,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125156Orig1s105ltr.pdf","2014-11-28 00:00:00",
18810,2,125156,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf","2014-11-26 00:00:00",
9631,1,125156,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125156Orig1s106ltr.pdf","2015-02-10 00:00:00",
18811,2,125156,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125156s106lbl.pdf","2015-02-09 00:00:00",
54462,3,125156,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125156Orig1s106.pdf","2018-06-05 00:00:00",
45614,2,125156,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s110lbl.pdf","2016-10-17 00:00:00",
45634,1,125156,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125156Orig1s110ltr.pdf","2016-10-17 00:00:00",
46725,2,125156,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s111lbl.pdf","2017-01-06 00:00:00",
46838,1,125156,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125156Orig1s111ltr.pdf","2017-01-13 00:00:00",
45958,1,125156,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125156Orig1s112ltr.pdf","2016-11-25 00:00:00",
45980,2,125156,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s112lbl.pdf","2016-12-01 00:00:00",
48052,2,125156,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf","2017-04-18 00:00:00",
48056,1,125156,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125156Orig1s114ltr.pdf","2017-04-18 00:00:00",
53493,1,125156,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125156Orig1s117ltr.pdf","2018-03-28 00:00:00",
9632,1,125160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s000ltr.pdf","2008-04-30 00:00:00",
18812,2,125160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf","2008-05-08 00:00:00",
22791,3,125160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000TOC2.cfm","2008-07-07 00:00:00",
23949,10,125160,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2008-09-04 00:00:00",
44792,21,125160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000_SumR.pdf","2008-07-14 00:00:00",
31854,1,125160,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s038ltr.pdf","2009-01-30 00:00:00",
22792,3,125160,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2009/125160Orig1s080.pdf","2013-09-09 00:00:00",
9633,1,125160,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125160s092ltr.pdf","2009-12-02 00:00:00",
18813,2,125160,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125160s092lbl.pdf","2009-12-12 00:00:00",
18814,2,125160,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111lbl.pdf","2010-08-10 00:00:00",
31855,1,125160,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s111ltr.pdf","2010-08-02 00:00:00",
9634,1,125160,"SUPPL",126,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s126ltr.pdf","2010-11-04 00:00:00",
9635,1,125160,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s142ltr.pdf","2012-08-06 00:00:00",
39864,2,125160,"SUPPL",142,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0142lbl.pdf","2012-08-03 00:00:00",
9636,1,125160,"SUPPL",157,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125160s157ltr.pdf","2011-09-13 00:00:00",
18815,2,125160,"SUPPL",174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174lbl.pdf","2012-04-20 00:00:00",
31856,1,125160,"SUPPL",174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160s0174ltr.pdf","2012-04-23 00:00:00",
31857,1,125160,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s180ltr.pdf","2012-08-31 00:00:00",
39865,2,125160,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s180lbl.pdf","2012-08-31 00:00:00",
9637,1,125160,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf","2012-10-10 00:00:00",
39866,2,125160,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf","2012-10-09 00:00:00",
18816,2,125160,"SUPPL",189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189lbl.pdf","2012-11-16 00:00:00",
31858,1,125160,"SUPPL",189,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s189ltr.pdf","2012-11-16 00:00:00",
31859,1,125160,"SUPPL",192,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf","2012-10-10 00:00:00",
39867,2,125160,"SUPPL",192,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf","2012-10-09 00:00:00",
9638,1,125160,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s213ltr.pdf","2013-10-01 00:00:00",
18817,2,125160,"SUPPL",213,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s213lbl.pdf","2013-10-01 00:00:00",
9639,1,125160,"SUPPL",215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s215ltr_replace.pdf","2013-10-18 00:00:00",
18818,2,125160,"SUPPL",215,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf","2013-10-22 00:00:00",
9640,1,125160,"SUPPL",241,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s241ltr.pdf","2016-05-04 00:00:00",
39868,2,125160,"SUPPL",241,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s241lbl.pdf","2016-04-29 00:00:00",
31860,1,125160,"SUPPL",264,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125160Orig1s264ltr.pdf","2015-10-21 00:00:00",
39869,2,125160,"SUPPL",264,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125160s264lbl.pdf","2015-10-22 00:00:00",
9641,1,125160,"SUPPL",268,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s268ltr.pdf","2016-02-04 00:00:00",
18819,2,125160,"SUPPL",268,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s268lbl.pdf","2016-02-11 00:00:00",
46671,2,125160,"SUPPL",270,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdf","2017-01-05 00:00:00",
46677,1,125160,"SUPPL",270,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125160Orig1s270ltr.pdf","2017-01-05 00:00:00",
53481,2,125160,"SUPPL",281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s281lbl.pdf","2018-03-28 00:00:00",
53486,1,125160,"SUPPL",281,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125160Origs281ltr.pdf","2018-03-28 00:00:00",
54350,2,125160,"SUPPL",283,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf","2018-05-29 00:00:00",
54351,8,125160,"SUPPL",283,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf#page=37","2018-05-29 00:00:00",
54361,1,125160,"SUPPL",283,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125160Orig1s283ltr.pdf","2018-05-29 00:00:00",
39870,2,125164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125164lbl.pdf","2007-11-15 00:00:00",
43307,3,125164,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125164TOC.cfm","2008-03-17 00:00:00",
31861,1,125164,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125164Orig1s062ltr.pdf","2014-10-03 00:00:00",
39871,2,125164,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125164s062lbledt.pdf","2014-10-03 00:00:00",
9642,1,125164,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125164Orig1s070ltr.pdf","2015-08-24 00:00:00",
18820,2,125164,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125164s070lbl.pdf","2015-08-25 00:00:00",
18821,2,125164,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf","2016-04-29 00:00:00",
31862,1,125164,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf","2016-05-02 00:00:00",
9643,1,125164,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf","2016-05-02 00:00:00",
39872,2,125164,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf","2016-04-29 00:00:00",
18822,2,125164,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf","2016-04-29 00:00:00",
31863,1,125164,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf","2016-05-02 00:00:00",
54483,2,125164,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf","2018-06-08 00:00:00",
54484,8,125164,"SUPPL",78,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf#page=23","2018-06-08 00:00:00",
54602,1,125164,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125164Orig1s078ltr.pdf","2018-06-14 00:00:00",
24084,14,125166,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=49","2010-06-30 00:00:00",
31864,1,125166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125166s0000_LTR.pdf","2007-03-27 00:00:00",
39873,2,125166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125166lbl.pdf","2007-03-23 00:00:00",
43308,3,125166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125166s0000TOC.cfm","2007-05-17 00:00:00",
9644,1,125166,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125166s0033ltr.pdf","2009-08-07 00:00:00",
9645,1,125166,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125166s044ltr.pdf","2010-06-29 00:00:00",
18823,2,125166,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf","2011-09-23 00:00:00",
43309,3,125166,"SUPPL",172,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125166Orig1s172-2.pdf","2015-07-20 00:00:00",
31865,1,125166,"SUPPL",273,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125166Orig1s273ltr.pdf","2012-12-27 00:00:00",
9646,1,125166,"SUPPL",368,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf","2014-05-02 00:00:00",
18824,2,125166,"SUPPL",368,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf","2014-05-02 00:00:00",
9647,1,125166,"SUPPL",380,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf","2014-05-02 00:00:00",
39874,2,125166,"SUPPL",380,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf","2014-05-02 00:00:00",
9648,1,125166,"SUPPL",409,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s409ltr.pdf","2014-10-14 00:00:00",
31866,1,125166,"SUPPL",412,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf","2015-12-08 00:00:00",
9649,1,125166,"SUPPL",413,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf","2015-12-08 00:00:00",
18825,2,125166,"SUPPL",413,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf","2015-12-08 00:00:00",
31867,1,125166,"SUPPL",414,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125166Orig1s414ltr.pdf","2016-04-15 00:00:00",
46861,2,125166,"SUPPL",417,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s417lbl.pdf","2017-01-13 00:00:00",
46898,1,125166,"SUPPL",417,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125166Orig1s417ltr.pdf","2017-01-19 00:00:00",
50146,2,125166,"SUPPL",422,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s422lbl.pdf","2017-10-23 00:00:00",
50153,1,125166,"SUPPL",422,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125166Orig1s422ltr.pdf","2017-10-24 00:00:00",
52786,1,125166,"SUPPL",426,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s426ltr.pdf","2018-03-01 00:00:00",
52819,2,125166,"SUPPL",426,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s426lbl.pdf","2018-03-06 00:00:00",
54991,2,125166,"SUPPL",427,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf","2018-07-26 00:00:00",
55009,1,125166,"SUPPL",427,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s427s428Ltr.pdf","2018-07-26 00:00:00",
54992,2,125166,"SUPPL",428,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf","2018-07-26 00:00:00",
55010,1,125166,"SUPPL",428,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s427s428Ltr.pdf","2018-07-26 00:00:00",
55061,8,125166,"SUPPL",428,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166Orig1s427s428MedGuide.pdf","2018-07-31 00:00:00",
31869,1,125249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125249s000ltr.pdf","2008-04-09 00:00:00",
39876,2,125249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf","2008-03-11 00:00:00",
43311,3,125249,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125249s000TOC.cfm","2008-05-02 00:00:00",
9650,1,125261,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s0001ltr.pdf","2010-01-27 00:00:00",
24358,21,125261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf","2010-01-22 00:00:00",
31870,1,125261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s000ltr.pdf","2009-10-05 00:00:00",
39877,2,125261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf","2009-09-29 00:00:00",
39878,2,125261,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf","2010-01-29 00:00:00",
43312,3,125261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm","2010-01-22 00:00:00",
9651,1,125261,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf","2010-12-28 00:00:00",
39879,2,125261,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf","2012-04-09 00:00:00",
31871,1,125261,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0049ltr.pdf","2012-06-04 00:00:00",
39880,2,125261,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf","2012-06-06 00:00:00",
31872,1,125261,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0058ltr.pdf","2012-04-11 00:00:00",
9652,1,125261,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0059ltr.pdf","2012-06-15 00:00:00",
39881,2,125261,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf","2012-06-18 00:00:00",
31873,1,125261,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0063ltr.pdf","2012-05-04 00:00:00",
9653,1,125261,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s086ltr.pdf","2013-05-23 00:00:00",
39882,2,125261,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf","2013-05-23 00:00:00",
31874,1,125261,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s091ltr.pdf","2013-01-30 00:00:00",
39883,2,125261,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf","2013-01-30 00:00:00",
9654,1,125261,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf","2013-05-01 00:00:00",
18826,2,125261,"SUPPL",99,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf","2013-05-01 00:00:00",
9655,1,125261,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s103ltr.pdf","2013-09-23 00:00:00",
39884,2,125261,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf","2013-09-24 00:00:00",
9656,1,125261,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125261Orig1s114ltr.pdf","2014-03-06 00:00:00",
39885,2,125261,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf","2014-03-05 00:00:00",
48148,1,125261,"SUPPL",129,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s129ltr.pdf","2017-04-27 00:00:00",
50084,1,125261,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s138ltr.pdf","2017-10-18 00:00:00",
50125,2,125261,"SUPPL",138,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125261s138lbl.pdf","2017-10-20 00:00:00",
51688,57,125261,"SUPPL",138,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201_125261 ustekinumab CDTL clinical prea.pdf","1900-01-01 00:00:00",
51689,20,125261,"SUPPL",138,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202_125261 ustekinumab clinical prea.pdf","1900-01-01 00:00:00",
51690,18,125261,"SUPPL",138,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203_125261 ustekinumab clinpharm prea.pdf","1900-01-01 00:00:00",
51691,17,125261,"SUPPL",138,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204_125261 ustekinumab statistical prea.pdf","1900-01-01 00:00:00",
52685,2,125261,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf","2018-02-22 00:00:00",
52700,1,125261,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s141ltr.pdf","2018-02-23 00:00:00",
54539,2,125261,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf","2018-06-12 00:00:00",
54540,8,125261,"SUPPL",147,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf#page=30","2018-06-12 00:00:00",
54589,1,125261,"SUPPL",147,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s147ltr.pdf","2018-06-14 00:00:00",
18827,2,125268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf","2008-08-25 00:00:00",
22793,3,125268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268_romiplostim_toc.cfm","2008-10-17 00:00:00",
23456,8,125268,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088667.pdf","2009-11-20 00:00:00",
31875,1,125268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125268s000ltr.pdf","2008-08-25 00:00:00",
44563,14,125268,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=38","2008-10-22 00:00:00",
44794,21,125268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268s000_sumR.pdf","2008-10-17 00:00:00",
18828,2,125268,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125268s0026lbl.pdf","2009-09-18 00:00:00",
31876,1,125268,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125268s0026ltr.pdf","2009-09-09 00:00:00",
9657,1,125268,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf","2010-06-10 00:00:00",
9658,1,125268,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf","2010-06-10 00:00:00",
18829,2,125268,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf","2011-12-06 00:00:00",
31877,1,125268,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125268s077ltr.pdf","2011-12-14 00:00:00",
31878,1,125268,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125268Orig1s106ltr.pdf","2012-11-07 00:00:00",
39886,2,125268,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125268s106lbl.pdf","2012-11-06 00:00:00",
9659,1,125268,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125268Orig1s121ltr.pdf","2013-05-31 00:00:00",
39887,2,125268,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125268s121lbl.pdf","2013-06-04 00:00:00",
18830,2,125268,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125268s141lbl.pdf","2014-02-11 00:00:00",
31879,1,125268,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125268Orig1s141ltr.pdf","2014-02-12 00:00:00",
18831,2,125268,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf","2016-04-20 00:00:00",
31880,1,125268,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf","2016-04-20 00:00:00",
9660,1,125268,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf","2016-04-20 00:00:00",
39888,2,125268,"SUPPL",156,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf","2016-04-20 00:00:00",
45415,8,125268,"SUPPL",156,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088667.pdf","2016-09-28 00:00:00",
48657,1,125268,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125268Orig1s160ltr.pdf","2017-06-06 00:00:00",
48658,2,125268,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125268s160lbl.pdf","2017-06-06 00:00:00",
18832,2,125274,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf","2009-06-04 00:00:00",
22794,3,125274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_dysport_toc.cfm","2011-08-17 00:00:00",
24359,21,125274,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274Orig1s001SumR.pdf","2011-08-17 00:00:00",
31881,1,125274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000,125274s001ltr.pdf","2009-05-07 00:00:00",
31882,1,125274,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000s001 ltr.pdf","2009-05-07 00:00:00",
39889,2,125274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf","2009-06-04 00:00:00",
43313,3,125274,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s001_dysport_toc.cfm","2011-08-17 00:00:00",
44428,10,125274,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm","2013-04-05 00:00:00",
44795,21,125274,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_SumR.pdf","2011-08-17 00:00:00",
9661,1,125274,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125274s0052ltr.pdf","2012-05-23 00:00:00",
39890,2,125274,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125274s0052lbl.pdf","2012-05-23 00:00:00",
31883,1,125274,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125274Orig1s102ltr.pdf","2015-07-16 00:00:00",
18834,2,125274,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s105lbl.pdf","2016-08-02 00:00:00",
31884,1,125274,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125274Orig1s105ltr.pdf","2016-08-02 00:00:00",
51390,57,125274,"SUPPL",105,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125274 abobotulinumtoxin CDTL clinical prea.pdf","1900-01-01 00:00:00",
51421,20,125274,"SUPPL",105,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125274 abobotulinumtoxin clinical prea.pdf","1900-01-01 00:00:00",
51424,17,125274,"SUPPL",105,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125274 abobotulinumtoxin statistical prea.pdf","1900-01-01 00:00:00",
46127,2,125274,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf","2016-12-13 00:00:00",
46130,1,125274,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125274Orig1s107ltr.pdf","2016-12-13 00:00:00",
48718,2,125274,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf","2017-06-15 00:00:00",
48719,8,125274,"SUPPL",109,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf#page=30","2017-06-15 00:00:00",
48771,1,125274,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125274Orig1s109ltr.pdf","2017-06-19 00:00:00",
18835,2,125276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf","2010-01-12 00:00:00",
22795,3,125276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000TOC.cfm","2010-03-09 00:00:00",
24360,21,125276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000SumR.pdf","2010-03-09 00:00:00",
31885,1,125276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125276s000ltr.pdf","2010-01-26 00:00:00",
53421,20,125276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125276s022_toclizumab_ clinical_ prea.pdf","1900-01-01 00:00:00",
53423,18,125276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125276s022_ toclizumab_clinpharm_ prea.pdf","1900-01-01 00:00:00",
53424,17,125276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125276s022_ toclizumab_ statistical_ preaL.pdf","1900-01-01 00:00:00",
18836,2,125276,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf","2011-01-11 00:00:00",
18837,2,125276,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf","2011-01-11 00:00:00",
31886,1,125276,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf","2011-01-07 00:00:00",
31887,1,125276,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf","2011-01-07 00:00:00",
39891,2,125276,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf","2011-01-11 00:00:00",
18838,2,125276,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf","2011-04-18 00:00:00",
31888,1,125276,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf","2011-05-26 00:00:00",
18839,2,125276,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf","2011-04-18 00:00:00",
31889,1,125276,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf","2011-05-26 00:00:00",
18840,2,125276,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0046lbl.pdf","2012-08-15 00:00:00",
31890,1,125276,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0046ltr.pdf","2012-08-15 00:00:00",
9662,1,125276,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276s0048ltr.pdf","2012-06-22 00:00:00",
22796,3,125276,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/125276Orig1s049TOC.cfm","2012-12-28 00:00:00",
31891,1,125276,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0049ltr.pdf","2012-10-15 00:00:00",
39892,2,125276,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0049lbl.pdf","2012-10-15 00:00:00",
9663,1,125276,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s064ltr.pdf","2013-05-01 00:00:00",
18841,2,125276,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf","2013-05-01 00:00:00",
52647,3,125276,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125276Orig1s064.pdf","2018-02-14 00:00:00",
9664,1,125276,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s075ltr.pdf","2013-07-05 00:00:00",
18842,2,125276,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf","2013-10-21 00:00:00",
31892,1,125276,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s092ltr.pdf","2013-10-22 00:00:00",
9665,1,125276,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125276Orig1s105ltr.pdf","2014-11-14 00:00:00",
31893,1,125276,"SUPPL",106,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf","2015-08-21 00:00:00",
45389,2,125276,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf","2016-09-27 00:00:00",
45400,1,125276,"SUPPL",107,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf","2016-09-26 00:00:00",
47806,2,125276,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf","2017-03-31 00:00:00",
47824,1,125276,"SUPPL",111,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s111,125472Orig1s023ltr.pdf","2017-04-03 00:00:00",
48510,2,125276,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s112lbl.pdf","2017-05-24 00:00:00",
48511,1,125276,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s112ltr.pdf","2017-05-24 00:00:00",
50616,3,125276,"SUPPL",112,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125276Orig1s112.pdf","2017-12-06 00:00:00",
49591,2,125276,"SUPPL",114,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf","2017-08-30 00:00:00",
49638,1,125276,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s114ltr.pdf","2017-08-31 00:00:00",
53665,3,125276,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125276Orig1s114TOC.cfm","2018-04-13 00:00:00",
54172,2,125276,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf","2018-05-14 00:00:00",
54198,1,125276,"SUPPL",115,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s115,125472Orig1s028ltr.pdf","2018-05-16 00:00:00",
53106,2,125276,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf","2018-03-22 00:00:00",
53484,1,125276,"SUPPL",116,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s116,125472Orig1s030ltr.pdf","2018-03-28 00:00:00",
54261,2,125276,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf","2018-05-21 00:00:00",
54264,8,125276,"SUPPL",117,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf#page=43","2018-05-21 00:00:00",
54268,1,125276,"SUPPL",117,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s117,125472Orig1s032ltr.pdf","2018-05-21 00:00:00",
55463,2,125276,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf","2018-09-13 00:00:00",
55477,8,125276,"SUPPL",122,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf#page=45","2018-09-13 00:00:00",
55485,1,125276,"SUPPL",122,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s031,125276Orig1s122Ltr.pdf","2018-09-14 00:00:00",
9666,1,125277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf","2009-12-08 00:00:00",
23459,8,125277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277MedGuide.pdf","2009-12-02 00:00:00",
39893,2,125277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf","2009-12-02 00:00:00",
43314,3,125277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000TOC.cfm","2010-02-14 00:00:00",
44796,21,125277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000SumR.pdf","2010-02-14 00:00:00",
9667,1,125277,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf","2011-05-17 00:00:00",
9668,1,125277,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s037ltr.pdf","2011-09-13 00:00:00",
9669,1,125277,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125277s0050ltr.pdf","2012-04-27 00:00:00",
9670,1,125277,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf","2013-04-16 00:00:00",
9671,1,125277,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf","2014-04-02 00:00:00",
18843,2,125277,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf","2014-04-01 00:00:00",
9672,1,125277,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf","2014-09-10 00:00:00",
39894,2,125277,"SUPPL",71,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf","2014-09-09 00:00:00",
9673,1,125288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125288s000ltr.pdf","2011-06-24 00:00:00",
22797,3,125288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125288Orig1s000TOC.cfm","2011-08-08 00:00:00",
39895,2,125288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf","2011-06-16 00:00:00",
9674,1,125288,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125288Orig1s030ltr.pdf","2013-04-10 00:00:00",
18844,2,125288,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf","2013-04-09 00:00:00",
31894,1,125288,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s059ltr.pdf","2014-04-16 00:00:00",
39896,2,125288,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf","2014-04-16 00:00:00",
9675,1,125288,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s062ltr.pdf","2014-10-02 00:00:00",
18845,2,125288,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf","2014-10-02 00:00:00",
47081,1,125288,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s070ltr.pdf","2017-02-01 00:00:00",
47103,2,125288,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s070lbl.pdf","2017-02-06 00:00:00",
48363,1,125288,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s072ltr.pdf","2017-05-12 00:00:00",
50373,1,125288,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s074ltr.pdf","2017-11-13 00:00:00",
50390,2,125288,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf","2017-11-13 00:00:00",
53671,2,125288,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf","2018-04-13 00:00:00",
53672,8,125288,"SUPPL",75,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49","2018-04-13 00:00:00",
53697,1,125288,"SUPPL",75,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125288Orig1s075ltr.pdf","2018-04-16 00:00:00",
9676,1,125289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s000ltr.pdf","2009-05-06 00:00:00",
23950,10,125289,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm","2011-12-20 00:00:00",
39897,2,125289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s000lbl.pdf","2009-05-05 00:00:00",
43315,3,125289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s0000TOC.cfm","2009-06-05 00:00:00",
44797,21,125289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s000_SumR.pdf","2009-06-05 00:00:00",
9677,1,125289,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s006ltr.pdf","2009-11-25 00:00:00",
18846,2,125289,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf","2009-12-11 00:00:00",
31895,1,125289,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s0020ltr.pdf","2011-03-25 00:00:00",
9678,1,125289,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s025ltr.pdf","2010-08-03 00:00:00",
39898,2,125289,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s025lbl.pdf","2010-08-10 00:00:00",
9679,1,125289,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s0029ltr.pdf","2011-01-06 00:00:00",
18847,2,125289,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s0029lbl.pdf","2011-01-05 00:00:00",
9680,1,125289,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s033ltr.pdf","2010-10-19 00:00:00",
31896,1,125289,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s038ltr.pdf","2012-01-24 00:00:00",
39899,2,125289,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0038lbl.pdf","2012-01-11 00:00:00",
9681,1,125289,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s053ltr.pdf","2011-09-13 00:00:00",
31897,1,125289,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s064ltr.pdf","2012-01-03 00:00:00",
39900,2,125289,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf","2012-03-15 00:00:00",
9682,1,125289,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125289Orig1s070ltr.pdf","2012-11-26 00:00:00",
39901,2,125289,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125289s070lbl.pdf","2012-11-28 00:00:00",
18848,2,125289,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf","2013-05-21 00:00:00",
31898,1,125289,"SUPPL",77,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf","2013-05-16 00:00:00",
9683,1,125289,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf","2013-05-16 00:00:00",
39902,2,125289,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf","2013-05-21 00:00:00",
18849,2,125289,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf","2013-05-21 00:00:00",
31899,1,125289,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf","2013-05-16 00:00:00",
31900,1,125289,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s084ltr.pdf","2013-04-30 00:00:00",
39903,2,125289,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s084lbl.pdf","2013-04-30 00:00:00",
9684,1,125289,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s086ltr.pdf","2013-05-08 00:00:00",
18850,2,125289,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s086lbl.pdf","2013-05-06 00:00:00",
31901,1,125289,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s094ltr.pdf","2013-11-14 00:00:00",
39904,2,125289,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s094lbl.pdf","2013-11-15 00:00:00",
18851,2,125289,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s103lbl.pdf","2013-12-30 00:00:00",
22798,3,125289,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2013/125289Orig1s103.pdf","2014-08-01 00:00:00",
31902,1,125289,"SUPPL",103,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s103ltr.pdf","2013-12-31 00:00:00",
31904,1,125289,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125289Orig1s121ltr.pdf","2014-12-23 00:00:00",
31905,1,125289,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125289Orig1s124ltr.pdf","2015-06-18 00:00:00",
39906,2,125289,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125289s024lbl.pdf","2015-06-19 00:00:00",
48418,3,125289,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125289s124.pdf","2017-05-17 00:00:00",
18852,2,125289,"SUPPL",127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125289s127lbl.pdf","2016-01-12 00:00:00",
31906,1,125289,"SUPPL",127,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125289Orig1s127ltr.pdf","2016-01-11 00:00:00",
48802,2,125289,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s133lbl.pdf","2017-06-22 00:00:00",
48804,1,125289,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s133ltr.pdf","2017-06-22 00:00:00",
51151,20,125289,"SUPPL",133,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab clinical prea.pdf","1900-01-01 00:00:00",
51152,18,125289,"SUPPL",133,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab clinpharm prea.pdf","1900-01-01 00:00:00",
51153,57,125289,"SUPPL",133,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab CDTL clinical prea.pdf","1900-01-01 00:00:00",
51154,17,125289,"SUPPL",133,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab statistical prea.pdf","1900-01-01 00:00:00",
47055,1,125289,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s135ltr.pdf","2017-01-31 00:00:00",
47062,2,125289,"SUPPL",135,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s135lbl.pdf","2017-01-30 00:00:00",
50406,2,125289,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s037lbl.pdf","2017-11-14 00:00:00",
50426,1,125289,"SUPPL",137,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s137ltr.pdf","2017-11-15 00:00:00",
52877,2,125289,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf","2018-03-08 00:00:00",
52911,1,125289,"SUPPL",139,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125289Orig1s139ltr.pdf","2018-03-12 00:00:00",
52952,8,125289,"SUPPL",139,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf#page=38","2018-03-14 00:00:00",
52531,2,125289,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s141lbl.pdf","2018-02-09 00:00:00",
52549,1,125289,"SUPPL",141,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125289Orig1s141ltr.pdf","2018-02-09 00:00:00",
31907,1,125290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125290s0000ltr.pdf","2009-08-25 00:00:00",
39907,2,125290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125290s0000lbl.pdf","2009-08-20 00:00:00",
43316,3,125290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125290_extavia_toc.cfm","2010-04-22 00:00:00",
44798,21,125290,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/0125290s000sumr.pdf","2010-04-22 00:00:00",
31908,1,125290,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125290Orig1s029ltr.pdf","2014-12-30 00:00:00",
31909,1,125290,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125290s0033ltr.pdf","2012-03-20 00:00:00",
9685,1,125290,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125290Orig1s062ltr.pdf","2016-05-16 00:00:00",
39908,2,125290,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf","2016-05-17 00:00:00",
46654,8,125290,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf#page=16","2017-01-03 00:00:00",
9686,1,125290,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125290Orig1s063ltr.pdf","2015-12-23 00:00:00",
18853,2,125290,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125290s063lbl.pdf","2015-12-28 00:00:00",
9687,1,125291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125291s000ltrR.pdf","2010-05-27 00:00:00",
18854,2,125291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf","2010-05-26 00:00:00",
22799,3,125291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm","2010-07-13 00:00:00",
24361,21,125291,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000SumR.pdf","2010-07-13 00:00:00",
31910,1,125291,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Orig1s0063ltr.pdf","2012-07-13 00:00:00",
39909,2,125291,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf","2012-07-13 00:00:00",
31911,1,125291,"SUPPL",79,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Origs0079ltr.pdf","2012-07-18 00:00:00",
9688,1,125291,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s133ltr.pdf","2014-05-27 00:00:00",
18855,2,125291,"SUPPL",133,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf","2014-05-28 00:00:00",
22800,3,125291,"SUPPL",136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125291Orig1s136.pdf","2016-07-29 00:00:00",
31912,1,125291,"SUPPL",136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s136ltr.pdf","2014-08-04 00:00:00",
39910,2,125291,"SUPPL",136,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf","2014-08-04 00:00:00",
9689,1,125293,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s001ltr.pdf","2010-10-26 00:00:00",
23462,8,125293,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf","2010-09-30 00:00:00",
24362,21,125293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf","2011-02-17 00:00:00",
31913,1,125293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s000ltr.pdf","2010-09-20 00:00:00",
39911,2,125293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf","2010-09-20 00:00:00",
43317,3,125293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293s0000TOC.cfm","2010-11-12 00:00:00",
9690,1,125293,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf","2012-04-18 00:00:00",
18856,2,125293,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf","2012-04-16 00:00:00",
9691,1,125293,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf","2012-04-18 00:00:00",
39912,2,125293,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf","2012-04-16 00:00:00",
31914,1,125293,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125293Orig1s060ltr.pdf","2013-10-16 00:00:00",
9692,1,125293,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s081ltr.pdf","2015-07-20 00:00:00",
18857,2,125293,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf","2015-07-22 00:00:00",
31915,1,125293,"SUPPL",83,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s083ltr.pdf","2015-07-31 00:00:00",
9693,1,125293,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s085ltr.pdf","2016-05-16 00:00:00",
39913,2,125293,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf","2016-05-11 00:00:00",
31916,1,125293,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s086ltr.pdf","2016-04-12 00:00:00",
45298,1,125293,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s089ltr.pdf","2016-09-15 00:00:00",
46966,2,125293,"SUPPL",89,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf","2017-01-24 00:00:00",
54903,1,125293,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125293Orig1s092ltr.pdf","2018-07-16 00:00:00",
54921,2,125293,"SUPPL",92,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf","2018-07-20 00:00:00",
9694,1,125294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf","2012-09-04 00:00:00",
18858,2,125294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf","2012-08-31 00:00:00",
22801,3,125294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000TOC.cfm","2012-09-26 00:00:00",
44799,21,125294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000SumR.pdf","2012-09-26 00:00:00",
31917,1,125294,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125294Orig1s007ltr.pdf","2013-07-22 00:00:00",
39914,2,125294,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf","2013-07-23 00:00:00",
18859,2,125294,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf","2014-12-22 00:00:00",
47096,1,125294,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s040ltr.pdf","2017-02-03 00:00:00",
47099,2,125294,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf","2017-02-03 00:00:00",
48797,1,125294,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s042ltr.pdf","2017-06-22 00:00:00",
48799,2,125294,"SUPPL",42,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf","2017-06-22 00:00:00",
55074,2,125294,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf","2018-08-02 00:00:00",
55093,1,125294,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125294Orig1s045ltr.pdf","2018-08-03 00:00:00",
18860,2,125319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf","2009-06-29 00:00:00",
31918,1,125319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125319s000ltr.pdf","2009-06-30 00:00:00",
43318,3,125319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000TOC.cfm","2009-08-26 00:00:00",
43932,8,125319,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352352.pdf","2013-05-15 00:00:00",
44800,21,125319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000_SumR.pdf","2009-08-26 00:00:00",
18861,2,125319,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf","2012-04-02 00:00:00",
31919,1,125319,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319s047ltr.pdf","2012-04-02 00:00:00",
31920,1,125319,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319Orig1s054ltr.pdf","2012-10-15 00:00:00",
39915,2,125319,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf","2012-10-12 00:00:00",
9695,1,125319,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125319Orig1s062ltr_repl.pdf","2013-05-13 00:00:00",
39916,2,125319,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf","2013-05-13 00:00:00",
9696,1,125319,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125319Orig1s081ltr.pdf","2014-10-21 00:00:00",
39917,2,125319,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf","2014-10-21 00:00:00",
9697,1,125319,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s084ltr.pdf","2016-07-26 00:00:00",
39918,2,125319,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf","2016-07-22 00:00:00",
45391,2,125319,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf","2016-09-27 00:00:00",
45397,1,125319,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf","2016-09-26 00:00:00",
50939,3,125319,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm","2017-12-29 00:00:00",
45392,2,125319,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf","2016-09-27 00:00:00",
45398,1,125319,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf","2016-09-26 00:00:00",
50940,3,125319,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm","2017-12-29 00:00:00",
45393,2,125319,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf","2016-09-27 00:00:00",
45399,1,125319,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf","2016-09-26 00:00:00",
50941,3,125319,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm","2017-12-29 00:00:00",
46510,2,125319,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf","2016-12-22 00:00:00",
46525,1,125319,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s088ltr.pdf","2016-12-23 00:00:00",
18862,2,125320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf","2010-06-02 00:00:00",
24088,14,125320,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=43","2011-10-07 00:00:00",
24363,21,125320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000SumR.pdf","2010-08-18 00:00:00",
31921,1,125320,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000Approv.pdf","2010-06-04 00:00:00",
43319,3,125320,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s0000TOC.cfm","2010-08-18 00:00:00",
31922,1,125320,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf","2011-09-20 00:00:00",
39919,2,125320,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf","2011-09-20 00:00:00",
9698,1,125320,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf","2011-09-20 00:00:00",
18863,2,125320,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf","2011-09-20 00:00:00",
9699,1,125320,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf","2010-11-22 00:00:00",
18864,2,125320,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf","2010-11-19 00:00:00",
43320,3,125320,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/125320Orig1s007.pdf","2018-06-05 00:00:00",
45007,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45008,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45009,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45010,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45011,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45013,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45014,1,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-08-05 00:00:00",
45023,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
45024,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
45025,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
45026,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
45031,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
45039,2,125320,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf","2016-08-05 00:00:00",
18865,2,125320,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051lbl.pdf","2012-09-25 00:00:00",
31923,1,125320,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0051ltr.pdf","2012-09-24 00:00:00",
9700,1,125320,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0053ltr.pdf","2012-05-14 00:00:00",
39920,2,125320,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0053lbl.pdf","2012-05-16 00:00:00",
9701,1,125320,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0054ltr.pdf","2012-05-02 00:00:00",
18866,2,125320,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0054lbl.pdf","2012-05-01 00:00:00",
31924,1,125320,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0078ltr.pdf","2012-06-11 00:00:00",
39921,2,125320,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0078lbl.pdf","2012-06-11 00:00:00",
18867,2,125320,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s080lbl.pdf","2013-02-20 00:00:00",
31925,1,125320,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s080ltr.pdf","2013-02-20 00:00:00",
18868,2,125320,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0085lbl.pdf","2012-09-18 00:00:00",
31926,1,125320,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0085ltr.pdf","2012-09-18 00:00:00",
31927,1,125320,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s094ltr.pdf","2013-06-13 00:00:00",
39922,2,125320,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf","2013-06-13 00:00:00",
31928,1,125320,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s113ltr.pdf","2013-07-08 00:00:00",
39923,2,125320,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s113lbl.pdf","2013-07-05 00:00:00",
9702,1,125320,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf","2013-08-27 00:00:00",
39924,2,125320,"SUPPL",114,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf","2013-08-27 00:00:00",
9703,1,125320,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf","2013-08-27 00:00:00",
39925,2,125320,"SUPPL",124,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf","2013-08-27 00:00:00",
9704,1,125320,"SUPPL",150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s150ltr.pdf","2014-06-18 00:00:00",
39926,2,125320,"SUPPL",150,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s150lbl.pdf","2014-06-17 00:00:00",
9705,1,125320,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s155ltr.pdf","2014-06-05 00:00:00",
18869,2,125320,"SUPPL",155,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s155lbl.pdf","2014-06-04 00:00:00",
9706,1,125320,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s160ltr.pdf","2014-12-09 00:00:00",
39927,2,125320,"SUPPL",160,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s160lbl.pdf","2014-12-10 00:00:00",
9707,1,125320,"SUPPL",162,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s162ltr.pdf","2015-05-26 00:00:00",
18870,2,125320,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s168lbl.pdf","2015-06-10 00:00:00",
31929,1,125320,"SUPPL",168,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s168ltr.pdf","2015-06-10 00:00:00",
9708,1,125320,"SUPPL",170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s170ltr.pdf","2015-03-02 00:00:00",
39928,2,125320,"SUPPL",170,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s170lbl.pdf","2015-03-02 00:00:00",
9709,1,125320,"SUPPL",174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s174ltr.pdf","2015-04-13 00:00:00",
39929,2,125320,"SUPPL",174,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s174lbl.pdf","2015-04-10 00:00:00",
18871,2,125320,"SUPPL",177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf","2016-03-04 00:00:00",
31930,1,125320,"SUPPL",177,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s177ltr.pdf","2016-03-04 00:00:00",
45537,1,125320,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf","2016-10-17 00:00:00",
45538,2,125320,"SUPPL",178,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf","2016-10-17 00:00:00",
47075,1,125320,"SUPPL",180,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125320Orig1s180ltr.pdf","2017-01-31 00:00:00",
48569,1,125320,"SUPPL",181,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125320Orig1s181ltr.pdf","2017-05-30 00:00:00",
48571,2,125320,"SUPPL",181,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf","2017-05-26 00:00:00",
48572,8,125320,"SUPPL",181,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf#page=27","2017-05-30 00:00:00",
50980,1,125320,"SUPPL",182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320s182ltr.pdf","2018-01-04 00:00:00",
51006,2,125320,"SUPPL",182,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s182lbl.pdf","2018-01-09 00:00:00",
51905,1,125320,"SUPPL",185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s185ltr.pdf","2018-01-26 00:00:00",
51909,2,125320,"SUPPL",185,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s185lbl.pdf","2018-01-26 00:00:00",
54278,1,125320,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s186ltr.pdf","2018-05-21 00:00:00",
54285,2,125320,"SUPPL",186,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf","2018-05-22 00:00:00",
54496,2,125320,"SUPPL",191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf","2018-06-11 00:00:00",
54564,1,125320,"SUPPL",191,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s191ltr.pdf","2018-06-14 00:00:00",
18872,2,125326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf","2009-10-27 00:00:00",
23951,10,125326,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm379961.htm","2013-12-27 00:00:00",
31931,1,125326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125326s000ltr.pdf","2009-11-02 00:00:00",
43321,3,125326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm","2010-01-22 00:00:00",
44801,21,125326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000_SumR.pdf","2010-01-22 00:00:00",
9710,1,125326,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125326s0032ltr.pdf","2011-09-23 00:00:00",
39930,2,125326,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf","2011-09-23 00:00:00",
18873,2,125326,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf","2013-09-27 00:00:00",
31932,1,125326,"SUPPL",59,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125326Orig1s059ltr.pdf","2013-09-26 00:00:00",
18874,2,125326,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf","2014-04-17 00:00:00",
31933,1,125326,"SUPPL",60,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125326Orig1s060ltr.pdf","2014-04-18 00:00:00",
31934,1,125326,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s062ltr.pdf","2016-01-21 00:00:00",
39931,2,125326,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf","2016-01-19 00:00:00",
45186,1,125326,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s063ltr.pdf","2016-08-30 00:00:00",
45215,2,125326,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf","2016-08-30 00:00:00",
22802,3,125327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125327Orig1s000TOC.cfm","2012-03-07 00:00:00",
31935,1,125327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125327s000ltr.pdf","2012-01-20 00:00:00",
39932,2,125327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125327lbl.pdf","2012-01-17 00:00:00",
18875,2,125327,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125327s020lbl.pdf","2013-04-01 00:00:00",
31936,1,125327,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125327Orig1s020ltr.pdf","2013-04-01 00:00:00",
31937,1,125338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf","2010-02-18 00:00:00",
39933,2,125338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf","2010-02-16 00:00:00",
43322,3,125338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000TOC.cfm","2010-03-19 00:00:00",
44565,14,125338,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=71","2010-04-15 00:00:00",
44802,21,125338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000SumR.pdf","2010-03-19 00:00:00",
9711,1,125338,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125338s0040ltr.pdf","2012-02-27 00:00:00",
39934,2,125338,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf","2012-02-28 00:00:00",
43934,8,125338,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040mg.pdf","2012-02-28 00:00:00",
18876,2,125338,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf","2013-12-12 00:00:00",
31938,1,125338,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125338Orig1s0061ltr.pdf","2013-12-10 00:00:00",
9712,1,125338,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125338Orig1s084ltr.pdf","2014-10-22 00:00:00",
18877,2,125338,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf","2014-10-21 00:00:00",
9713,1,125338,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf","2015-05-20 00:00:00",
18878,2,125338,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf","2015-05-21 00:00:00",
9714,1,125338,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf","2015-05-20 00:00:00",
39935,2,125338,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf","2015-05-21 00:00:00",
18879,2,125338,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf","2015-05-21 00:00:00",
31939,1,125338,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf","2015-05-20 00:00:00",
45964,1,125338,"SUPPL",100,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf","2016-11-29 00:00:00",
45965,1,125338,"SUPPL",101,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf","2016-11-29 00:00:00",
45355,1,125338,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s102ltr.pdf","2016-09-21 00:00:00",
45370,2,125338,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf","2016-09-20 00:00:00",
54487,2,125338,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf","2018-06-08 00:00:00",
54563,1,125338,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s109ltr.pdf","2018-06-14 00:00:00",
55759,1,125338,"SUPPL",110,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s110ltr.pdf","2018-10-01 00:00:00",
9715,1,125349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125349Orig1s000ltr(r).pdf","2012-12-27 00:00:00",
18880,2,125349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf","2012-12-27 00:00:00",
22803,3,125349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000TOC.cfm","2013-01-25 00:00:00",
44803,21,125349,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000SumR.pdf","2013-01-25 00:00:00",
51073,2,125349,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125349s022lbl.pdf","2018-01-17 00:00:00",
9716,1,125359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125359s000ltr.pdf","2011-11-21 00:00:00",
18881,2,125359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf","2011-11-18 00:00:00",
43323,3,125359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125359_erwinaze_toc.cfm","2011-12-28 00:00:00",
44804,21,125359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125359Orig1s000SumR.pdf","2011-12-28 00:00:00",
9717,1,125359,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125359Orig1s070ltr.pdf","2014-03-11 00:00:00",
39936,2,125359,"SUPPL",70,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125359s070lbl.pdf","2014-03-10 00:00:00",
9718,1,125359,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125359Orig1s085ltr.pdf","2014-12-24 00:00:00",
39937,2,125359,"SUPPL",85,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125359s085lbl.pdf","2015-03-27 00:00:00",
9719,1,125359,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125359Orig1s088ltr.pdf","2016-03-31 00:00:00",
18882,2,125359,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125359s088lbl.pdf","2016-03-30 00:00:00",
9720,1,125360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf","2010-08-06 00:00:00",
18883,2,125360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf","2010-08-06 00:00:00",
18884,2,125360,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf","2010-08-06 00:00:00",
22804,3,125360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s0000TOC.cfm","2010-09-29 00:00:00",
24364,21,125360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s000SumR.pdf","2011-02-17 00:00:00",
31940,1,125360,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf","2010-08-06 00:00:00",
18885,2,125360,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf","2011-07-25 00:00:00",
9721,1,125360,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125360Orig1s040ltr.pdf","2012-07-18 00:00:00",
9722,1,125360,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125360Orig1s045ltr.pdf","2013-04-16 00:00:00",
18886,2,125360,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125360s045lbl.pdf","2013-04-16 00:00:00",
18887,2,125360,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s066lbl.pdf","2015-11-25 00:00:00",
31941,1,125360,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125360Orig1s067ltr.pdf","2015-12-29 00:00:00",
39938,2,125360,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s067lbl.pdf","2015-12-28 00:00:00",
54742,2,125360,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf","2018-07-03 00:00:00",
54743,8,125360,"SUPPL",73,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf#page=19","2018-07-03 00:00:00",
54782,1,125360,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125360Orig1s073ltr.pdf","2018-07-06 00:00:00",
18888,2,125370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf","2011-03-11 00:00:00",
31942,1,125370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125370s000ltr.pdf","2011-03-16 00:00:00",
43324,3,125370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000TOC.cfm","2011-04-22 00:00:00",
44805,21,125370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000SumR.pdf","2011-04-22 00:00:00",
9723,1,125370,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125370s016ltr.pdf","2012-04-02 00:00:00",
18889,2,125370,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf","2012-04-02 00:00:00",
31943,1,125370,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125370Orig1s047ltr.pdf","2013-12-17 00:00:00",
39939,2,125370,"SUPPL",47,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf","2013-12-17 00:00:00",
18890,2,125370,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf","2014-04-04 00:00:00",
31944,1,125370,"SUPPL",53,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125370Orig1s053ltr.pdf","2014-04-04 00:00:00",
46021,2,125370,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf","2016-12-02 00:00:00",
46046,1,125370,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125370Orig1s055ltr.pdf","2016-12-06 00:00:00",
46917,2,125370,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf","2017-01-18 00:00:00",
46934,1,125370,"SUPPL",57,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125370Orig1s057ltr.pdf","2017-01-24 00:00:00",
54706,1,125370,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf","2018-06-27 00:00:00",
54728,2,125370,"SUPPL",62,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf","2018-06-29 00:00:00",
54800,8,125370,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062lbl.pdf#page=29","2018-07-06 00:00:00",
9724,1,125377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf","2011-03-29 00:00:00",
18891,2,125377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf","2011-03-25 00:00:00",
22805,3,125377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm","2011-05-16 00:00:00",
24365,21,125377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf","2011-06-08 00:00:00",
9725,1,125377,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377s016ltr.pdf","2012-02-23 00:00:00",
18892,2,125377,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf","2012-10-30 00:00:00",
31945,1,125377,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377Orig1s033ltr.pdf","2012-10-30 00:00:00",
31946,1,125377,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s044ltr.pdf","2013-05-28 00:00:00",
39940,2,125377,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf","2013-05-23 00:00:00",
9726,1,125377,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s055ltr.pdf","2013-12-09 00:00:00",
39941,2,125377,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf","2013-12-06 00:00:00",
9727,1,125377,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s072ltr.pdf","2015-03-20 00:00:00",
18893,2,125377,"SUPPL",72,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf","2015-03-24 00:00:00",
9728,1,125377,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s073ltr.pdf","2015-10-30 00:00:00",
18894,2,125377,"SUPPL",73,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf","2016-04-19 00:00:00",
9729,1,125377,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s074ltr.pdf","2015-08-19 00:00:00",
39942,2,125377,"SUPPL",74,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf","2015-08-18 00:00:00",
47502,1,125377,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s084ltr.pdf","2017-03-08 00:00:00",
50138,1,125377,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s086ltr.pdf","2017-10-23 00:00:00",
50163,2,125377,"SUPPL",86,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf","2017-10-24 00:00:00",
49051,2,125377,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf","2017-07-25 00:00:00",
49075,1,125377,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s087ltr.pdf","2017-07-25 00:00:00",
51208,20,125377,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/164_125377S087 ipilimumab clinical bpca.pdf","1900-01-01 00:00:00",
51209,18,125377,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/165_125377S087 ipilimumab clinpharm bpca.pdf","1900-01-01 00:00:00",
51939,23,125377,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/B125377_ipilimumab_Orig_WR.pdf","2017-07-20 00:00:00",
51940,25,125377,"SUPPL",87,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/B125377_ipilimumab_Amend_1.pdf","2017-07-20 00:00:00",
50695,2,125377,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf","2017-12-14 00:00:00",
50751,1,125377,"SUPPL",91,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s091ltr.pdf","2017-12-18 00:00:00",
52525,2,125377,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf","2018-02-09 00:00:00",
52545,1,125377,"SUPPL",93,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s093ltr.pdf","2018-02-09 00:00:00",
53678,2,125377,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf","2018-04-16 00:00:00",
53713,1,125377,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s094ltr.pdf","2018-04-17 00:00:00",
54869,2,125377,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf","2018-07-11 00:00:00",
54901,1,125377,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s096ltr.pdf","2018-07-16 00:00:00",
54902,8,125377,"SUPPL",96,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf#page=50","2018-07-16 00:00:00",
9730,1,125387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125387s000ltr.pdf","2011-11-22 00:00:00",
22806,3,125387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387s0000TOC.cfm","2012-01-10 00:00:00",
24366,21,125387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000SumR.pdf","2012-01-10 00:00:00",
39943,2,125387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf","2011-11-21 00:00:00",
9731,1,125387,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125387Orig1s004ltr.pdf","2012-09-24 00:00:00",
39944,2,125387,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125387s004lbl.pdf","2012-09-25 00:00:00",
31947,1,125387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf","2013-06-11 00:00:00",
39945,2,125387,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf","2013-06-11 00:00:00",
31948,1,125387,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf","2013-06-11 00:00:00",
39946,2,125387,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf","2013-06-11 00:00:00",
9732,1,125387,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s023ltr.pdf","2014-01-28 00:00:00",
18895,2,125387,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s023lbl.pdf","2014-01-28 00:00:00",
18896,2,125387,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s036lbl.pdf","2015-08-04 00:00:00",
31949,1,125387,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s036ltr.pdf","2015-08-04 00:00:00",
9733,1,125387,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s037ltr.pdf","2014-07-31 00:00:00",
9734,1,125387,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s043ltr.pdf","2014-10-08 00:00:00",
39947,2,125387,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s043lbl.pdf","2014-10-09 00:00:00",
9735,1,125387,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s048ltr.pdf","2015-03-26 00:00:00",
18897,2,125387,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf","2015-03-26 00:00:00",
18898,2,125387,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s051lbl.pdf","2016-05-25 00:00:00",
31950,1,125387,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s051ltr.pdf","2016-05-25 00:00:00",
45648,1,125387,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s052ltr.pdf","2016-10-26 00:00:00",
45723,2,125387,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s052lbl.pdf","2016-10-31 00:00:00",
48576,2,125387,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125387s054lbl.pdf","2017-05-31 00:00:00",
48600,1,125387,"SUPPL",54,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125387Orig1s054ltr.pdf","2017-05-31 00:00:00",
55193,2,125387,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf","2018-08-17 00:00:00",
55223,1,125387,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125387Orig2s056s058Ltr.pdf","2018-08-20 00:00:00",
55194,2,125387,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf","2018-08-17 00:00:00",
55222,1,125387,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125387Orig2s056s058Ltr.pdf","2018-08-20 00:00:00",
24367,21,125388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000SumR.pdf","2011-10-03 00:00:00",
31951,1,125388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf","2011-08-19 00:00:00",
39948,2,125388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf","2011-08-19 00:00:00",
43325,3,125388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388_adcetris_toc.cfm","2011-10-03 00:00:00",
44429,10,125388,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287672.htm","2012-02-13 00:00:00",
18899,2,125388,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf","2012-01-13 00:00:00",
31952,1,125388,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125388s005ltr.pdf","2012-01-19 00:00:00",
9736,1,125388,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125388Orig1s045ltr.pdf","2013-08-22 00:00:00",
39949,2,125388,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf","2013-08-21 00:00:00",
18900,2,125388,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf","2014-11-25 00:00:00",
31953,1,125388,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf","2014-11-26 00:00:00",
9737,1,125388,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf","2014-11-26 00:00:00",
18901,2,125388,"SUPPL",78,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf","2014-11-25 00:00:00",
18902,2,125388,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf","2015-08-17 00:00:00",
31954,1,125388,"SUPPL",80,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf","2015-08-17 00:00:00",
9738,1,125388,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf","2015-08-17 00:00:00",
39950,2,125388,"SUPPL",81,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf","2015-08-17 00:00:00",
31955,1,125388,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s084ltr.pdf","2016-03-08 00:00:00",
39951,2,125388,"SUPPL",84,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf","2016-03-08 00:00:00",
45497,1,125388,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s088ltr.pdf","2016-09-30 00:00:00",
47285,2,125388,"SUPPL",88,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf","2017-02-22 00:00:00",
50348,2,125388,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf","2017-11-09 00:00:00",
50367,1,125388,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125388Orig1s094ltr.pdf","2017-11-13 00:00:00",
53068,2,125388,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf","2018-03-20 00:00:00",
53494,1,125388,"SUPPL",97,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s097ltr.pdf","2018-03-28 00:00:00",
22807,3,125390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000TOC.cfm","2014-04-11 00:00:00",
24089,14,125390,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=314","2014-03-12 00:00:00",
24368,21,125390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000SumR.pdf","2014-04-11 00:00:00",
31956,1,125390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s000ltr.pdf","2014-02-26 00:00:00",
39952,2,125390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf","2014-02-25 00:00:00",
18903,2,125390,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf","2014-07-02 00:00:00",
31957,1,125390,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s004ltr.pdf","2014-07-01 00:00:00",
18904,2,125390,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf","2015-08-28 00:00:00",
31958,1,125390,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s006ltr.pdf","2015-09-01 00:00:00",
18905,2,125390,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf","2015-10-06 00:00:00",
31959,1,125390,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s010ltr.pdf","2015-09-23 00:00:00",
47260,8,125390,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf#page=14","2017-02-17 00:00:00",
50718,1,125390,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125390Orig1s012ltr.pdf","2017-12-18 00:00:00",
9739,1,125399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf","2011-08-19 00:00:00",
18906,2,125399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf","2011-08-19 00:00:00",
23952,10,125399,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287672.htm","2012-02-13 00:00:00",
24369,21,125399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125399Orig1s000SumR.pdf","2011-10-03 00:00:00",
43326,3,125399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125399_adcetris_toc.cfm","2011-10-03 00:00:00",
9740,1,125409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125409Orig1s000ltr.pdf","2012-06-11 00:00:00",
24090,14,125409,"ORIG",1,"Summary Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000ODMemo.pdf","2012-06-13 00:00:00",
39953,2,125409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf","2012-06-11 00:00:00",
43327,3,125409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000TOC.cfm","2012-07-30 00:00:00",
18907,2,125409,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf","2013-04-16 00:00:00",
31960,1,125409,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s032ltr.pdf","2013-04-16 00:00:00",
9741,1,125409,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s051_corrected_ltr.pdf","2013-10-01 00:00:00",
18908,2,125409,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf","2013-09-30 00:00:00",
43328,3,125409,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409_perjeta_toc.cfm","2013-10-21 00:00:00",
44566,14,125409,"SUPPL",51,"Cross Discipline Team Leader Review","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051CrossR.pdf","2013-10-04 00:00:00",
44806,21,125409,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051SumR.pdf","2013-10-04 00:00:00",
9742,1,125409,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s104ltr.pdf","2015-03-18 00:00:00",
18909,2,125409,"SUPPL",104,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf","2015-03-19 00:00:00",
18910,2,125409,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf","2015-06-04 00:00:00",
31961,1,125409,"SUPPL",105,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s105ltr.pdf","2015-06-02 00:00:00",
31962,1,125409,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125409Orig1s109ltr.pdf","2016-03-24 00:00:00",
39954,2,125409,"SUPPL",109,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf","2016-03-23 00:00:00",
50794,2,125409,"SUPPL",113,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf","2017-12-20 00:00:00",
50889,1,125409,"SUPPL",113,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125409Orig1s113s118ltr.pdf","2017-12-27 00:00:00",
50795,2,125409,"SUPPL",118,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf","2017-12-20 00:00:00",
50890,1,125409,"SUPPL",118,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125409Orig1s113s118ltr.pdf","2017-12-27 00:00:00",
55731,1,125409,"SUPPL",121,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf","2018-10-01 00:00:00",
18911,2,125418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf","2012-08-03 00:00:00",
22808,3,125418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm","2012-09-06 00:00:00",
31963,1,125418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125418Orig1s000ltr.pdf","2012-08-03 00:00:00",
44807,21,125418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418Orig1s000SumR.pdf","2012-09-06 00:00:00",
31964,1,125418,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125418Orig1s020ltr.pdf","2013-10-28 00:00:00",
39955,2,125418,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf","2013-10-31 00:00:00",
9743,1,125418,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125418Orig1s033ltr.pdf","2015-09-18 00:00:00",
18912,2,125418,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf","2016-03-14 00:00:00",
31965,1,125418,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s037ltr.pdf","2016-03-11 00:00:00",
9744,1,125418,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s039ltr.pdf","2016-06-27 00:00:00",
39956,2,125418,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf","2016-06-27 00:00:00",
9745,1,125422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125422Orig1s000ltr.pdf","2012-12-05 00:00:00",
39957,2,125422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf","2012-10-18 00:00:00",
43329,3,125422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125422_jetrea_toc.cfm","2012-12-04 00:00:00",
51418,20,125422,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/6_125422 ocriplasmin clinical prea.pdf","1900-01-01 00:00:00",
51419,18,125422,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/5_125422 ocriplasmin clinpharm prea.pdf","1900-01-01 00:00:00",
51420,17,125422,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/4_125422 ocriplasmin statistical prea.pdf","1900-01-01 00:00:00",
31966,1,125422,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125422Orig1s025ltr.pdf","2014-06-18 00:00:00",
39958,2,125422,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf","2014-06-17 00:00:00",
9746,1,125422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125422Orig1s037ltr.pdf","2016-03-29 00:00:00",
39959,2,125422,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf","2016-03-29 00:00:00",
47299,1,125422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125422Orig1s038ltr.pdf","2017-02-23 00:00:00",
47302,2,125422,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf","2017-02-23 00:00:00",
18913,2,125427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf","2013-02-22 00:00:00",
22809,3,125427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000TOC.cfm","2013-02-28 00:00:00",
23953,10,125427,"ORIG",1,"0","http://www.fda.gov/drugs/drugsafety/ucm350733.htm","2014-02-07 00:00:00",
24370,21,125427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000SumR.pdf","2013-02-22 00:00:00",
31967,1,125427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000Approv.pdf","2013-02-22 00:00:00",
9747,1,125427,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s012ltr.pdf","2013-08-22 00:00:00",
39960,2,125427,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf","2013-08-21 00:00:00",
9748,1,125427,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s014ltr.pdf","2013-09-03 00:00:00",
18914,2,125427,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf","2013-08-30 00:00:00",
31968,1,125427,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125427Orig1s033ltr.pdf","2014-07-15 00:00:00",
39961,2,125427,"SUPPL",33,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf","2014-07-15 00:00:00",
9749,1,125427,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125427Orig1s087ltr.pdf","2015-06-02 00:00:00",
39962,2,125427,"SUPPL",87,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf","2015-06-04 00:00:00",
9750,1,125427,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s094ltr.pdf","2016-05-02 00:00:00",
39963,2,125427,"SUPPL",94,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf","2016-04-29 00:00:00",
31969,1,125427,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s096ltr.pdf","2016-07-26 00:00:00",
39964,2,125427,"SUPPL",96,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf","2016-07-27 00:00:00",
55732,1,125427,"SUPPL",102,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf","2018-10-01 00:00:00",
9751,1,125431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125431Orig1s000ltr.pdf","2014-04-16 00:00:00",
22810,3,125431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000TOC.cfm","2014-05-13 00:00:00",
24091,14,125431,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=316","2014-04-18 00:00:00",
24371,21,125431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf","2014-05-13 00:00:00",
39965,2,125431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf","2014-04-17 00:00:00",
9752,1,125431,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s008ltr.pdf","2015-03-11 00:00:00",
9753,1,125431,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s009ltr.pdf","2015-05-11 00:00:00",
39966,2,125431,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf","2015-05-08 00:00:00",
9754,1,125431,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s014ltr.pdf","2015-07-28 00:00:00",
45299,1,125431,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125431Orig1s018ltr.pdf","2016-09-15 00:00:00",
45406,2,125431,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf","2016-09-15 00:00:00",
49215,1,125431,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s019ltr.pdf","2017-08-02 00:00:00",
49227,2,125431,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf","2017-08-03 00:00:00",
49228,8,125431,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36","2017-08-03 00:00:00",
50844,2,125431,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf","2017-12-22 00:00:00",
50883,1,125431,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s020ltr.pdf","2017-12-27 00:00:00",
50748,1,125431,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s021ltr.pdf","2017-12-18 00:00:00",
9755,1,125433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125433Orig1s000ltr.pdf","2013-07-26 00:00:00",
18915,2,125433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125433s000lbledt.pdf","2013-07-22 00:00:00",
43330,3,125433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125433review.pdf","2013-09-30 00:00:00",
9756,1,125433,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s002ltr.pdf","2014-02-11 00:00:00",
39967,2,125433,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s002lbl.pdf","2014-02-06 00:00:00",
18916,2,125433,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s005lbl.pdf","2014-02-12 00:00:00",
31970,1,125433,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s005ltr.pdf","2014-02-13 00:00:00",
9757,1,125433,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s013ltr.pdf","2014-12-24 00:00:00",
9758,1,125433,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125433Orig1s014ltr.pdf","2015-08-10 00:00:00",
39968,2,125433,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125433s014lbl.pdf","2015-08-06 00:00:00",
53725,3,125433,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125433Orig1s14.pdf","2018-04-18 00:00:00",
31971,1,125433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s015ltr.pdf","2016-01-11 00:00:00",
39969,2,125433,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s015lbl.pdf","2016-01-12 00:00:00",
9759,1,125433,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s016ltr.pdf","2016-04-27 00:00:00",
39970,2,125433,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s016lbl.pdf","2016-05-03 00:00:00",
31972,1,125433,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s017ltr.pdf","2016-02-24 00:00:00",
39971,2,125433,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s017lbl.pdf","2016-02-23 00:00:00",
45105,2,125433,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s018lbl.pdf","2016-08-19 00:00:00",
45152,1,125433,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s018ltr.pdf","2016-08-19 00:00:00",
47059,1,125433,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s019ltr.pdf","2017-01-31 00:00:00",
47063,2,125433,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s019lbl.pdf","2017-01-30 00:00:00",
50136,1,125433,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s020s021ltr.pdf","2017-10-23 00:00:00",
50168,2,125433,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf","2017-10-24 00:00:00",
50137,1,125433,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s020s021ltr.pdf","2017-10-23 00:00:00",
50169,2,125433,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf","2017-10-24 00:00:00",
52533,2,125433,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf","2018-02-09 00:00:00",
52534,8,125433,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf#page=28","2018-02-09 00:00:00",
52550,1,125433,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125433Orig1s024ltr.pdf","2018-02-09 00:00:00",
9760,1,125460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125460Orig1s000ltr.pdf","2014-02-19 00:00:00",
22811,3,125460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000TOC.cfm","2014-03-24 00:00:00",
39972,2,125460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125460s000lbl.pdf","2014-02-19 00:00:00",
44808,21,125460,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000SumR.pdf","2014-03-24 00:00:00",
9761,1,125469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf","2014-09-19 00:00:00",
18917,2,125469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf","2015-04-01 00:00:00",
22812,3,125469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.cfm","2014-10-27 00:00:00",
31973,1,125469,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf","2015-03-11 00:00:00",
44809,21,125469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf","2014-10-27 00:00:00",
31974,1,125469,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf","2014-12-24 00:00:00",
9762,1,125469,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf","2015-07-28 00:00:00",
47029,2,125469,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf","2017-01-27 00:00:00",
47051,1,125469,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf","2017-01-31 00:00:00",
47030,2,125469,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf","2017-01-27 00:00:00",
47052,1,125469,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf","2017-01-31 00:00:00",
49213,1,125469,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf","2017-08-02 00:00:00",
49231,2,125469,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf","2017-08-04 00:00:00",
49234,8,125469,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf#page=21","2017-08-04 00:00:00",
49214,1,125469,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf","2017-08-02 00:00:00",
49232,2,125469,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf","2017-08-04 00:00:00",
49233,8,125469,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf#page=21","2017-08-04 00:00:00",
54824,1,125469,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s017ltr.pdf","2018-07-06 00:00:00",
54880,2,125469,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf","2018-07-13 00:00:00",
50749,1,125469,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s021ltr.pdf","2017-12-18 00:00:00",
55738,1,125469,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s024ltr.pdf","2018-10-01 00:00:00",
9763,1,125472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125472Orig1s000ltr.pdf","2013-10-24 00:00:00",
18918,2,125472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf","2013-10-25 00:00:00",
22813,3,125472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000TOC.cfm","2014-07-17 00:00:00",
24372,21,125472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000SumR.pdf","2014-07-17 00:00:00",
9764,1,125472,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf","2015-08-21 00:00:00",
45390,2,125472,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf","2016-09-27 00:00:00",
45401,1,125472,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf","2016-09-26 00:00:00",
47802,2,125472,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf","2017-03-31 00:00:00",
47823,1,125472,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s111,125472Orig1s023ltr.pdf","2017-04-03 00:00:00",
48509,1,125472,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125472Orig1s024ltr.pdf","2017-05-24 00:00:00",
48513,2,125472,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf","2017-05-24 00:00:00",
54173,2,125472,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf","2018-05-14 00:00:00",
54199,1,125472,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s115,125472Orig1s028ltr.pdf","2018-05-16 00:00:00",
53097,2,125472,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf","2018-03-22 00:00:00",
53483,1,125472,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s116,125472Orig1s030ltr.pdf","2018-03-28 00:00:00",
55464,2,125472,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf","2018-09-13 00:00:00",
55478,8,125472,"SUPPL",31,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf#page=45","2018-09-13 00:00:00",
55484,1,125472,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s031,125276Orig1s122Ltr.pdf","2018-09-14 00:00:00",
54262,2,125472,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf","2018-05-21 00:00:00",
54269,1,125472,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s117,125472Orig1s032ltr.pdf","2018-05-21 00:00:00",
55219,8,125472,"SUPPL",32,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf#page=43","2018-08-20 00:00:00",
9765,1,125476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125476Orig1s000ltr.pdf","2014-05-20 00:00:00",
22814,3,125476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000TOC.cfm","2014-06-19 00:00:00",
24373,21,125476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000SumR.pdf","2014-06-19 00:00:00",
39973,2,125476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf","2014-05-20 00:00:00",
52683,2,125476,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf","2018-02-22 00:00:00",
52684,8,125476,"SUPPL",22,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf#page=20","2018-02-22 00:00:00",
52701,1,125476,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125476Orig1s022ltr.pdf","2018-02-23 00:00:00",
18919,2,125477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf","2014-04-21 00:00:00",
24374,21,125477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000SumR.pdf","2014-05-16 00:00:00",
31975,1,125477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s000ltr.pdf","2014-04-22 00:00:00",
43331,3,125477,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000TOC.cfm","2014-05-16 00:00:00",
31976,1,125477,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s002ltr.pdf","2014-11-06 00:00:00",
39974,2,125477,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf","2014-11-05 00:00:00",
9766,1,125477,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s007ltr.pdf","2014-12-15 00:00:00",
39975,2,125477,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf","2014-12-12 00:00:00",
9767,1,125477,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125477Orig1s011ltr.pdf","2015-04-27 00:00:00",
18920,2,125477,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf","2015-04-24 00:00:00",
55176,2,125477,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf","2018-08-15 00:00:00",
55316,1,125477,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s030REPLACEMENT LETTER.pdf","2018-08-24 00:00:00",
18921,2,125486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf","2013-11-01 00:00:00",
22815,3,125486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000TOC.cfm","2013-11-27 00:00:00",
24375,21,125486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000SumR.pdf","2013-11-01 00:00:00",
31977,1,125486,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf","2013-11-06 00:00:00",
44567,14,125486,"ORIG",1,"Office Director Memo","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000ODMemo.pdf","2013-11-01 00:00:00",
9768,1,125486,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s008ltr.pdf","2014-07-01 00:00:00",
39976,2,125486,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf","2014-07-01 00:00:00",
31978,1,125486,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s009ltr.pdf","2014-12-31 00:00:00",
9769,1,125486,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125486Orig1s010ltr.pdf","2015-09-25 00:00:00",
18922,2,125486,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf","2015-10-06 00:00:00",
9770,1,125486,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125486Orig1s013ltr.pdf","2016-02-29 00:00:00",
39977,2,125486,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf","2016-02-26 00:00:00",
50434,2,125486,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf","2017-11-16 00:00:00",
50445,1,125486,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125486Orig1s017s018ltr.pdf","2017-11-17 00:00:00",
50433,2,125486,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf","2017-11-16 00:00:00",
50446,1,125486,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125486Orig1s017s018ltr.pdf","2017-11-17 00:00:00",
18923,2,125496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf","2014-04-23 00:00:00",
31979,1,125496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125496s000ltr.pdf","2014-04-24 00:00:00",
43332,3,125496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000TOC.cfm","2015-09-28 00:00:00",
44810,21,125496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000SumR.pdf","2014-05-27 00:00:00",
54398,2,125496,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s013lbl.pdf","2018-05-31 00:00:00",
54406,1,125496,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125496Orig1s013ltr.pdf","2018-06-01 00:00:00",
24376,21,125499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf","2014-09-17 00:00:00",
31980,1,125499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125499s000ltredt.pdf","2014-08-18 00:00:00",
39978,2,125499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf","2014-08-18 00:00:00",
43333,3,125499,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000TOC.cfm","2014-09-17 00:00:00",
43938,8,125499,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM475804.pdf","2015-12-07 00:00:00",
18924,2,125499,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf","2015-12-28 00:00:00",
31981,1,125499,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125499s009ltr.pdf","2015-12-23 00:00:00",
31982,1,125499,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125499Orig1s011ltr.pdf","2016-07-15 00:00:00",
39979,2,125499,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf","2016-07-18 00:00:00",
9771,1,125504,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf","2016-01-20 00:00:00",
18925,2,125504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf","2015-01-22 00:00:00",
18926,2,125504,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf","2016-01-26 00:00:00",
22816,3,125504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm","2015-02-19 00:00:00",
24377,21,125504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf","2015-02-19 00:00:00",
31983,1,125504,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf","2015-01-23 00:00:00",
18927,2,125504,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf","2016-01-26 00:00:00",
31984,1,125504,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf","2016-01-20 00:00:00",
54645,1,125504,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s005ltr.pdf","2018-06-21 00:00:00",
51856,2,125504,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf","2018-01-26 00:00:00",
51857,8,125504,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf#page=18","2018-01-26 00:00:00",
51903,1,125504,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s013ltr.pdf","2018-01-26 00:00:00",
49764,2,125504,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf","2017-09-18 00:00:00",
49789,1,125504,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125504Orig1s016ltr.pdf","2017-09-19 00:00:00",
31985,1,125509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125509Orig1s000ltr.pdf","2016-03-28 00:00:00",
39980,2,125509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf","2016-03-28 00:00:00",
43334,3,125509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000TOC.cfm","2016-04-26 00:00:00",
44811,21,125509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000SumR.pdf","2016-04-26 00:00:00",
50211,2,125509,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509s001lbl.pdf","2017-10-30 00:00:00",
51413,20,125509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125509_obiltoxaximab_clinical_PREA.pdf","1900-01-01 00:00:00",
51414,58,125509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125509_obiltoxaximab_Clinical_addendum_PREA.pdf","1900-01-01 00:00:00",
51415,18,125509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125509_obiltoxaximab_clinpharm_PREA.pdf","1900-01-01 00:00:00",
51416,62,125509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125509_obiltoxaximab_clinpharm_addendum_PREA.pdf","1900-01-01 00:00:00",
51417,17,125509,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125509_obiltoxaximab_StatR_PREA.pdf","1900-01-01 00:00:00",
18928,2,125511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125511s000lbl.pdf","2015-01-29 00:00:00",
22817,3,125511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000TOC.cfm","2015-02-19 00:00:00",
31986,1,125511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125511Orig1s000ltr.pdf","2015-01-26 00:00:00",
44568,14,125511,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=343","2015-01-28 00:00:00",
44812,21,125511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000SumR.pdf","2015-02-19 00:00:00",
52750,8,125511,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/natparaMedGuide.pdf","2018-02-28 00:00:00",
45457,1,125511,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s002ltr.pdf","2016-10-03 00:00:00",
31987,1,125511,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s004ltr.pdf","2016-06-21 00:00:00",
39981,2,125511,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125511s004lbl.pdf","2016-06-17 00:00:00",
55751,1,125511,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125511Orig1s014ltr.pdf","2018-10-01 00:00:00",
55812,2,125511,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf","2018-10-04 00:00:00",
55813,8,125511,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf#page=18","2018-10-04 00:00:00",
22818,3,125513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000TOC.cfm","2015-12-03 00:00:00",
31988,1,125513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125513Orig1s000ltr.pdf","2015-10-26 00:00:00",
39982,2,125513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf","2015-10-26 00:00:00",
44813,21,125513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000SumR.pdf","2015-12-03 00:00:00",
45567,1,125513,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125513Orig1s002ltr.pdf","2016-10-20 00:00:00",
47273,2,125513,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf","2017-02-22 00:00:00",
52119,2,125513,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf","2018-01-30 00:00:00",
52121,1,125513,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125513Orig1s003ltr.pdf","2018-01-30 00:00:00",
9772,1,125514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125514Orig1s000ltr.pdf","2014-09-05 00:00:00",
22819,3,125514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000TOC.cfm","2014-10-02 00:00:00",
39983,2,125514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf","2014-09-04 00:00:00",
44814,21,125514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000SumR.pdf","2014-10-02 00:00:00",
18929,2,125514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf","2015-06-23 00:00:00",
31989,1,125514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s003ltr.pdf","2015-06-22 00:00:00",
9773,1,125514,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf","2015-12-22 00:00:00",
18930,2,125514,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf","2015-12-18 00:00:00",
9774,1,125514,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s005ltr.pdf","2015-10-06 00:00:00",
18931,2,125514,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s005lbl.pdf","2015-10-02 00:00:00",
31990,1,125514,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf","2015-12-22 00:00:00",
39984,2,125514,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf","2015-12-18 00:00:00",
45722,2,125514,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s008s012lbl.pdf","2016-10-31 00:00:00",
45891,1,125514,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf","2016-11-15 00:00:00",
44996,2,125514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s009lbl.pdf","2016-08-05 00:00:00",
45012,1,125514,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s009ltr.pdf","2016-08-05 00:00:00",
45592,2,125514,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf","2016-10-25 00:00:00",
45669,1,125514,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf","2016-10-26 00:00:00",
48456,1,125514,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s013ltr.pdf","2017-05-19 00:00:00",
49043,2,125514,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s013lbl.pdf","2017-07-21 00:00:00",
48502,2,125514,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf","2017-05-23 00:00:00",
48525,1,125514,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s014ltr.pdf","2017-05-25 00:00:00",
47558,2,125514,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s015lbl.pdf","2017-03-14 00:00:00",
47602,1,125514,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s015ltr.pdf","2017-03-20 00:00:00",
48350,2,125514,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s016lbl.pdf","2017-05-11 00:00:00",
48364,1,125514,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s016ltr.pdf","2017-05-12 00:00:00",
48438,2,125514,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf","2017-05-18 00:00:00",
48463,1,125514,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s017ltr.pdf","2017-05-19 00:00:00",
48439,2,125514,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf","2017-05-18 00:00:00",
48462,1,125514,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s018ltr.pdf","2017-05-19 00:00:00",
49128,1,125514,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s019s023ltr.pdf","2017-07-28 00:00:00",
49145,2,125514,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf","2017-07-31 00:00:00",
49129,1,125514,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s019s023ltr.pdf","2017-07-28 00:00:00",
49146,2,125514,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf","2017-07-31 00:00:00",
49848,2,125514,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s024lbl.pdf","2017-09-22 00:00:00",
49853,1,125514,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s024ltr.pdf","2017-09-25 00:00:00",
52665,3,125514,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125514Orig1s024TOC.cfm","2018-02-16 00:00:00",
54545,2,125514,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s030lbl.pdf","2018-06-13 00:00:00",
54604,1,125514,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s030ltr.pdf","2018-06-14 00:00:00",
50531,2,125514,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s031lbl.pdf","2017-11-30 00:00:00",
50562,1,125514,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s031ltr.pdf","2017-12-01 00:00:00",
54543,2,125514,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s034lbl.pdf","2018-06-12 00:00:00",
54601,1,125514,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s034ltr.pdf","2018-06-14 00:00:00",
55249,2,125514,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s035lbl.pdf","2018-08-20 00:00:00",
55325,1,125514,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s035ltr.pdf","2018-08-27 00:00:00",
54613,2,125514,"SUPPL",43,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s043lbl.pdf","2018-06-20 00:00:00",
54648,1,125514,"SUPPL",43,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s043ltr.pdf","2018-06-21 00:00:00",
55190,2,125514,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s046lbl.pdf","2018-08-16 00:00:00",
55191,8,125514,"SUPPL",46,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s046lbl.pdf#page=54","2018-08-16 00:00:00",
55218,1,125514,"SUPPL",46,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s046Ltr.pdf","2018-08-20 00:00:00",
9775,1,125516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125516Orig1s000ltr.pdf","2015-03-10 00:00:00",
39985,2,125516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf","2015-03-10 00:00:00",
43335,3,125516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm","2015-04-09 00:00:00",
44815,21,125516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000SumR.pdf","2015-04-09 00:00:00",
47388,2,125516,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125516s011lbl.pdf","2017-03-02 00:00:00",
47464,1,125516,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125516Orig1s011ltr.pdf","2017-03-03 00:00:00",
9776,1,125521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125521Orig1s000ltr.pdf","2016-03-24 00:00:00",
23469,8,125521,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM493178.pdf","2016-03-30 00:00:00",
24378,21,125521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000SumR.pdf","2016-05-03 00:00:00",
39986,2,125521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf","2016-03-23 00:00:00",
43336,3,125521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000TOC.cfm","2016-05-03 00:00:00",
53783,1,125521,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s002ltr.pdf","2018-04-23 00:00:00",
53792,2,125521,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521Orig1s002lbl.pdf","2018-04-23 00:00:00",
48915,2,125521,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s003lbl.pdf","2017-07-05 00:00:00",
48921,1,125521,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125521Orig1s003ltr.pdf","2017-07-06 00:00:00",
50580,1,125521,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125521Orig1s004ltr.pdf","2017-12-01 00:00:00",
50593,2,125521,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s004lbl.pdf","2017-12-04 00:00:00",
54259,2,125521,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521s009lbl.pdf","2018-05-21 00:00:00",
54266,1,125521,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s009ltr.pdf","2018-05-21 00:00:00",
53058,1,125521,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s011ltr.pdf","2018-03-20 00:00:00",
9777,1,125522,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf","2016-07-12 00:00:00",
22820,3,125522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000TOC.cfm","2015-10-01 00:00:00",
31991,1,125522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125522Orig1s000ltr.pdf","2015-09-01 00:00:00",
39987,2,125522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf","2015-08-28 00:00:00",
44816,21,125522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000SumR.pdf","2015-10-01 00:00:00",
48431,3,125522,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125522Orig1s001.pdf","2017-05-17 00:00:00",
9778,1,125522,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf","2016-07-12 00:00:00",
48432,3,125522,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125522Orig1s004.pdf","2017-05-17 00:00:00",
45990,2,125522,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125522s008lbl.pdf","2016-12-01 00:00:00",
46036,1,125522,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s008ltr.pdf","2016-12-06 00:00:00",
46973,2,125522,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s009lbl.pdf","2017-01-25 00:00:00",
46999,1,125522,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522Orig1s009ltr.pdf","2017-01-27 00:00:00",
46662,2,125522,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s011lbl.pdf","2017-01-04 00:00:00",
46670,1,125522,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522Orig1s011ltr.pdf","2017-01-05 00:00:00",
50596,2,125522,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s013lbl.pdf","2017-12-04 00:00:00",
50597,1,125522,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522s013ltr.pdf","2017-12-04 00:00:00",
50594,1,125522,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522s014ltr.pdf","2017-12-04 00:00:00",
50595,2,125522,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s014lbl.pdf","2017-12-04 00:00:00",
9779,1,125526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125526Orig1s000Ltr.pdf","2015-11-05 00:00:00",
22821,3,125526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000TOC.cfm","2015-12-11 00:00:00",
24379,21,125526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000SumR.pdf","2015-12-11 00:00:00",
39988,2,125526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf","2015-11-05 00:00:00",
51328,20,125526,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125256 mepolizumab clinical prea.pdf","1900-01-01 00:00:00",
51329,18,125526,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125526 mepolizumab clinpharm prea.pdf","2018-01-22 00:00:00",
51330,62,125526,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125526 mepolizumab clinpharm addendum prea.pdf","1900-01-01 00:00:00",
51331,17,125526,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125526 mepolizumab statistical prea.pdf","1900-01-01 00:00:00",
47264,2,125526,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s002lbl.pdf","2017-02-17 00:00:00",
50677,2,125526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf","2017-12-13 00:00:00",
50750,1,125526,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125526Orig1s004ltr.pdf","2017-12-18 00:00:00",
9780,1,125527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125527Orig1s000ltr.pdf","2015-03-05 00:00:00",
18932,2,125527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125527s000lbl.pdf","2015-03-04 00:00:00",
46070,3,125527,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125527Orig1s000TOC.cfm","2016-09-30 00:00:00",
18933,2,125544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf","2016-04-05 00:00:00",
22822,3,125544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000TOC.cfm","2016-06-27 00:00:00",
23470,8,125544,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497384.pdf","2016-04-27 00:00:00",
31992,1,125544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125544Orig1s000ltr.pdf","2016-04-05 00:00:00",
51172,17,125544,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125544 StatReview.pdf","1900-01-01 00:00:00",
51173,20,125544,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125544 Clinical Review-05 04 2015.pdf","1900-01-01 00:00:00",
51174,61,125544,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125544 Clinical Review Addendum Memo 03.11.2016.pdf","1900-01-01 00:00:00",
55046,1,125544,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125544Orig1s008Ltr.pdf","2018-07-30 00:00:00",
54186,2,125545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf","2018-05-15 00:00:00",
54187,8,125545,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf#page=28","2018-05-15 00:00:00",
54190,1,125545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125545Orig1s000ltr.pdf","2018-05-15 00:00:00",
9781,1,125547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125547Orig1s000ltr.pdf","2015-11-24 00:00:00",
39989,2,125547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf","2015-11-24 00:00:00",
43337,3,125547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125547Orig1s000TOC.cfm","2015-12-30 00:00:00",
44817,21,125547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125547Orig1s000SumR.pdf","2015-12-30 00:00:00",
9782,1,125553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125553Orig1s000ltr.pdf","2015-03-06 00:00:00",
9783,1,125553,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125553Orig1s001ltr.pdf","2016-03-04 00:00:00",
18934,2,125553,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf","2016-03-04 00:00:00",
22823,3,125553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm","2015-04-20 00:00:00",
39990,2,125553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf","2015-03-06 00:00:00",
44818,21,125553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000SumR.pdf","2015-04-20 00:00:00",
51100,20,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinical prea.pdf","1900-01-01 00:00:00",
51102,17,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz statistical prea.pdf","1900-01-01 00:00:00",
51103,60,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinpharm DD prea.pdf","1900-01-01 00:00:00",
51104,61,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinpharm addendum prea.pdf","1900-01-01 00:00:00",
51105,57,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinical TL prea.pdf","1900-01-01 00:00:00",
54061,18,125553,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinpharm prea.pdf","1900-01-01 00:00:00",
47271,2,125553,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf","2017-02-21 00:00:00",
47295,1,125553,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125553Orig1s007ltr.pdf","2017-02-23 00:00:00",
9784,1,125554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125554Orig1s000ltr.pdf","2014-12-24 00:00:00",
9785,1,125554,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s001ltr.pdf","2015-11-24 00:00:00",
24380,21,125554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000SumR.pdf","2015-01-21 00:00:00",
39991,2,125554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf","2014-12-22 00:00:00",
39992,2,125554,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf","2015-11-25 00:00:00",
43338,3,125554,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000TOC.cfm","2015-01-21 00:00:00",
45518,2,125554,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf","2015-10-01 00:00:00",
45519,1,125554,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s002ltr.pdf","2015-10-02 00:00:00",
9786,1,125554,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s005ltr.pdf","2015-10-14 00:00:00",
39993,2,125554,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf","2015-10-09 00:00:00",
31994,1,125554,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s007ltr.pdf","2016-01-25 00:00:00",
31995,1,125554,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s012ltr.pdf","2015-11-24 00:00:00",
39994,2,125554,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf","2015-11-23 00:00:00",
45501,2,125554,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf","2016-10-06 00:00:00",
45507,1,125554,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s016ltr.pdf","2016-10-06 00:00:00",
45323,1,125554,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf","2016-09-15 00:00:00",
45404,2,125554,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf","2016-09-28 00:00:00",
45324,1,125554,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf","2016-09-15 00:00:00",
45403,2,125554,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf","2016-09-28 00:00:00",
18936,2,125554,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf","2016-05-17 00:00:00",
31996,1,125554,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s019ltr.pdf","2016-05-19 00:00:00",
45895,1,125554,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s022ltr.pdf","2016-11-15 00:00:00",
45897,2,125554,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf","2016-11-10 00:00:00",
47079,2,125554,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf","2017-02-02 00:00:00",
47095,1,125554,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s024ltr.pdf","2017-02-03 00:00:00",
48115,2,125554,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s031lbl.pdf","2017-04-26 00:00:00",
48152,1,125554,"SUPPL",31,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s031ltr.pdf","2017-04-27 00:00:00",
49172,2,125554,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf","2017-08-01 00:00:00",
49209,1,125554,"SUPPL",34,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s034ltr.pdf","2017-08-02 00:00:00",
51014,2,125554,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s035s036s037s038s039lbl.pdf","2018-01-09 00:00:00",
51036,1,125554,"SUPPL",35,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf","2018-01-11 00:00:00",
51037,1,125554,"SUPPL",36,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf","2018-01-11 00:00:00",
51038,1,125554,"SUPPL",37,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf","2018-01-11 00:00:00",
51039,1,125554,"SUPPL",38,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf","2018-01-11 00:00:00",
51040,1,125554,"SUPPL",39,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf","2018-01-11 00:00:00",
49681,2,125554,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf","2017-09-07 00:00:00",
49700,1,125554,"SUPPL",40,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s040ltr.pdf","2017-09-08 00:00:00",
49850,2,125554,"SUPPL",41,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf","2017-09-22 00:00:00",
49852,1,125554,"SUPPL",41,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s041ltr.pdf","2017-09-25 00:00:00",
52661,2,125554,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf","2018-02-16 00:00:00",
52708,1,125554,"SUPPL",44,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s044s045ltr.pdf","2018-02-23 00:00:00",
52662,2,125554,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf","2018-02-16 00:00:00",
52709,1,125554,"SUPPL",45,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s044s045ltr.pdf","2018-02-23 00:00:00",
52829,2,125554,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52897,1,125554,"SUPPL",48,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52830,2,125554,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52898,1,125554,"SUPPL",49,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52831,2,125554,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52899,1,125554,"SUPPL",50,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52832,2,125554,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52900,1,125554,"SUPPL",51,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52833,2,125554,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52901,1,125554,"SUPPL",52,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
50792,2,125554,"SUPPL",55,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s055lbl.pdf","2017-12-20 00:00:00",
50901,1,125554,"SUPPL",55,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s055ltr.pdf","2017-12-27 00:00:00",
52625,2,125554,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s056lbl.pdf","2018-02-14 00:00:00",
52642,1,125554,"SUPPL",56,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s056ltr.pdf","2018-02-14 00:00:00",
53680,2,125554,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s058lbl.pdf","2018-04-16 00:00:00",
53712,1,125554,"SUPPL",58,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s058ltr.pdf","2018-04-17 00:00:00",
52834,2,125554,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s061lbl.pdf","2018-03-06 00:00:00",
52902,1,125554,"SUPPL",61,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52835,2,125554,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52904,1,125554,"SUPPL",62,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
54870,2,125554,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf","2018-07-11 00:00:00",
54899,1,125554,"SUPPL",63,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s063ltr.pdf","2018-07-16 00:00:00",
52836,2,125554,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52905,1,125554,"SUPPL",64,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52837,2,125554,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52906,1,125554,"SUPPL",65,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
52838,2,125554,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf","2018-03-06 00:00:00",
52907,1,125554,"SUPPL",66,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf","2018-03-12 00:00:00",
55195,2,125554,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s067lbl.pdf","2018-08-17 00:00:00",
55196,8,125554,"SUPPL",67,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s067lbl.pdf#page=87","2018-08-17 00:00:00",
55221,1,125554,"SUPPL",67,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s067Ltr.pdf","2018-08-20 00:00:00",
9787,1,125557,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125557Orig1s000ltr.pdf","2014-12-04 00:00:00",
24093,14,125557,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=341","2014-12-05 00:00:00",
39995,2,125557,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf","2014-12-03 00:00:00",
43339,3,125557,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000TOC.cfm","2015-01-12 00:00:00",
45184,1,125557,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf","2016-08-30 00:00:00",
45207,2,125557,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf","2016-08-30 00:00:00",
48820,3,125557,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005TOC.cfm","2017-06-26 00:00:00",
45185,1,125557,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf","2016-08-30 00:00:00",
45208,2,125557,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf","2016-08-30 00:00:00",
48244,2,125557,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf","2017-05-05 00:00:00",
48289,1,125557,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s007ltr.pdf","2017-05-09 00:00:00",
48952,2,125557,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf","2017-07-12 00:00:00",
48987,1,125557,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s008ltr.pdf","2017-07-14 00:00:00",
50548,2,125557,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf","2017-12-01 00:00:00",
50549,8,125557,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf#page=33","2017-12-01 00:00:00",
50570,1,125557,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s012ltr.pdf","2017-12-01 00:00:00",
53544,2,125557,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf","2018-03-29 00:00:00",
53582,1,125557,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s013ltr.pdf","2018-04-01 00:00:00",
53757,1,125557,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s014ltr.pdf","2018-04-20 00:00:00",
18937,2,125559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf","2015-07-24 00:00:00",
22824,3,125559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125559Orig1s000TOC.cfm","2015-08-28 00:00:00",
31997,1,125559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125559Orig1s000ltr.pdf","2015-07-27 00:00:00",
48099,2,125559,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s001lbl.pdf","2017-04-25 00:00:00",
48138,1,125559,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s001ltr.pdf","2017-04-27 00:00:00",
49179,1,125559,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s002ltr.pdf","2017-08-02 00:00:00",
49646,2,125559,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s002lbl.pdf","2017-08-31 00:00:00",
49819,2,125559,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s006lbl.pdf","2017-09-21 00:00:00",
49837,1,125559,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s006ltr.pdf","2017-09-22 00:00:00",
55278,2,125559,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s014lbl.pdf","2018-08-23 00:00:00",
55315,1,125559,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125559Orig1s014Ltr.pdf","2018-08-24 00:00:00",
55035,2,125559,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf","2018-07-30 00:00:00",
9788,1,125561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125561Orig1s000ltr.pdf","2015-12-08 00:00:00",
18938,2,125561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf","2015-12-08 00:00:00",
22825,3,125561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125561Orig1s000TOC.cfm","2016-01-06 00:00:00",
31998,1,200043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200043s000ltr.pdf","2012-06-07 00:00:00",
9789,1,200045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200045s000ltr.pdf","2010-12-28 00:00:00",
18939,2,200045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf","2010-12-26 00:00:00",
22826,3,200045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045s000_amturnide_toc.cfm","2011-08-15 00:00:00",
24381,21,200045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf","2011-08-15 00:00:00",
9790,1,200045,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf","2011-10-14 00:00:00",
39996,2,200045,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf","2011-10-20 00:00:00",
18940,2,200045,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf","2011-10-20 00:00:00",
31999,1,200045,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf","2011-10-14 00:00:00",
32000,1,200045,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s006ltr.pdf","2012-02-17 00:00:00",
39997,2,200045,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf","2012-02-17 00:00:00",
32001,1,200045,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s007ltr.pdf","2012-01-30 00:00:00",
39998,2,200045,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf","2012-01-31 00:00:00",
9791,1,200045,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s009ltr.pdf","2011-11-07 00:00:00",
18941,2,200045,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf","2011-11-04 00:00:00",
9792,1,200045,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s010ltr.pdf","2012-02-06 00:00:00",
18942,2,200045,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf","2012-02-06 00:00:00",
9793,1,200045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf","2012-10-02 00:00:00",
39999,2,200045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf","2012-10-01 00:00:00",
32002,1,200045,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s012ltr_rev1rev2nh_Redacted.pdf","2012-04-18 00:00:00",
40000,2,200045,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf","2012-04-16 00:00:00",
9794,1,200045,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf","2012-10-02 00:00:00",
40001,2,200045,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf","2012-10-01 00:00:00",
18943,2,200045,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf","2013-11-04 00:00:00",
32003,1,200045,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200045Orig1s014ltr.pdf","2013-11-06 00:00:00",
40002,2,200045,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf","2014-03-19 00:00:00",
18944,2,200045,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf","2015-04-02 00:00:00",
32004,1,200045,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s016ltr.pdf","2015-04-01 00:00:00",
9795,1,200045,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s017ltr.pdf","2015-12-23 00:00:00",
18945,2,200045,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf","2015-12-28 00:00:00",
45827,1,200045,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200045Orig1s020ltr.pdf","2016-11-08 00:00:00",
45852,2,200045,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200045s020lbl.pdf","2016-11-08 00:00:00",
22827,3,200063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200063Orig1s000TOC.cfm","2014-11-12 00:00:00",
24382,21,200063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200063Orig1s000SumR.pdf","2014-11-12 00:00:00",
32005,1,200063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200063Orig1s000ltr.pdf","2014-09-16 00:00:00",
40003,2,200063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf","2014-09-11 00:00:00",
47531,2,200063,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s006lbl.pdf","2017-03-13 00:00:00",
47555,1,200063,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1s006ltr.pdf","2017-03-14 00:00:00",
48253,2,200063,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s009lbl.pdf","2017-05-05 00:00:00",
48291,1,200063,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1sS009ltr.pdf","2017-05-09 00:00:00",
54605,1,200063,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200063Orig1s013ltr.pdf","2018-06-14 00:00:00",
54664,2,200063,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf","2018-06-21 00:00:00",
54665,8,200063,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf#page=39","2018-06-21 00:00:00",
32006,1,200068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200068Orig1s000TAltr.pdf","2013-12-05 00:00:00",
32007,1,200068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200068Orig1s000ltr.pdf","2015-06-04 00:00:00",
43340,3,200146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200146Orig1s000Approv.pdf","2012-10-09 00:00:00",
9796,1,200153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200153Orig1s000ltr.pdf","2013-05-07 00:00:00",
18946,2,200153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf","2013-05-09 00:00:00",
43341,3,200153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153_liptruzet_toc.cfm","2013-10-03 00:00:00",
44819,21,200153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153Orig1s000SumR.pdf","2013-10-03 00:00:00",
32008,1,200153,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200153Orig1s003ltr.pdf","2014-05-20 00:00:00",
40004,2,200153,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf","2014-05-19 00:00:00",
49880,2,200153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s005lbl.pdf","2017-09-29 00:00:00",
49894,1,200153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s005ltr.pdf","2017-09-29 00:00:00",
49271,2,200153,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s006lbl.pdf","2017-08-08 00:00:00",
49280,1,200153,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s006ltr.pdf","2017-08-08 00:00:00",
22828,3,200154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200154Orig1s000Approv.pdf","2012-09-12 00:00:00",
32009,1,200156,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200156Orig1s000.pdf","2013-06-04 00:00:00",
22829,3,200159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200159Orig1s000Approv.pdf","2012-10-09 00:00:00",
9797,1,200174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200174Orig1s000ltr.pdf","2014-12-17 00:00:00",
9798,1,200175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf","2010-07-28 00:00:00",
9799,1,200175,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s001ltr.pdf","2011-04-06 00:00:00",
18947,2,200175,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf","2011-04-11 00:00:00",
24383,21,200175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000SumR.pdf","2011-07-15 00:00:00",
40005,2,200175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf","2010-07-30 00:00:00",
43342,3,200175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175_tribenzor_toc.cfm","2011-07-15 00:00:00",
9800,1,200175,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s003ltr.pdf","2011-06-27 00:00:00",
18948,2,200175,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf","2011-06-29 00:00:00",
9801,1,200175,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s007ltr.pdf","2011-11-03 00:00:00",
40006,2,200175,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf","2011-11-04 00:00:00",
9802,1,200175,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175s008ltr.pdf","2012-01-23 00:00:00",
18949,2,200175,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf","2012-01-23 00:00:00",
9803,1,200175,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s011ltr.pdf","2012-10-03 00:00:00",
18950,2,200175,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf","2012-10-02 00:00:00",
32010,1,200175,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s012ltr.pdf","2012-12-11 00:00:00",
40007,2,200175,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf","2012-12-14 00:00:00",
32011,1,200175,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200175Orig1s015ltr.pdf","2013-07-05 00:00:00",
40008,2,200175,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf","2013-07-05 00:00:00",
9804,1,200175,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s018ltr.pdf","2014-06-18 00:00:00",
40009,2,200175,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf","2014-06-17 00:00:00",
9805,1,200175,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s019ltr.pdf","2014-06-30 00:00:00",
18951,2,200175,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf","2014-07-01 00:00:00",
32012,1,200175,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s020ltr.pdf","2014-09-24 00:00:00",
40010,2,200175,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf","2014-09-26 00:00:00",
45769,2,200175,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200175s025lbl.pdf","2016-11-02 00:00:00",
45772,1,200175,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200175Orig1s025ltr.pdf","2016-11-02 00:00:00",
46724,2,200175,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200175s026lbl.pdf","2017-01-05 00:00:00",
46835,1,200175,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200175Orig1s026ltr.pdf","2017-01-13 00:00:00",
9806,1,200179,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200179Orig1s001ltr.pdf","2013-08-05 00:00:00",
32013,1,200179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200179s000ltr.pdf","2010-06-21 00:00:00",
40011,2,200179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf","2010-06-24 00:00:00",
40012,2,200179,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf","2013-08-06 00:00:00",
43343,3,200179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200179_staxyn_toc.cfm","2011-01-04 00:00:00",
9807,1,200179,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200179Orig1s002ltr.pdf","2014-04-30 00:00:00",
18952,2,200179,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf","2014-05-02 00:00:00",
32014,1,200179,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200179Orig1s003ltr.pdf","2015-09-17 00:00:00",
40013,2,200179,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf","2015-09-23 00:00:00",
49239,2,200179,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s004lbl.pdf","2017-08-04 00:00:00",
49245,1,200179,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s004ltr.pdf","2017-08-04 00:00:00",
49448,2,200179,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s005lbl.pdf","2017-08-17 00:00:00",
49573,1,200179,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s005ltr.pdf","2017-08-29 00:00:00",
9808,1,200196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200196s000ltr.pdf","2010-08-24 00:00:00",
44569,14,200197,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
9809,1,200199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200199s000ltr.pdf","2011-03-02 00:00:00",
22830,3,200199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199_topotecan_toc.cfm","2011-09-09 00:00:00",
24384,21,200199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf","2011-09-09 00:00:00",
40014,2,200199,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf","2011-03-04 00:00:00",
32015,1,200199,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf","2014-03-05 00:00:00",
40015,2,200199,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf","2014-03-04 00:00:00",
9810,1,200222,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200222s000ltr.pdf","2012-06-28 00:00:00",
9811,1,200244,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200244s000ltr.pdf","2010-09-17 00:00:00",
18953,2,200271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200271lbl.pdf","2015-10-02 00:00:00",
32016,1,200271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200271Orig1s000ltr.pdf","2015-09-16 00:00:00",
43344,3,200294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200294Orig1s000Approv.pdf","2012-06-22 00:00:00",
9812,1,200327,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s001ltr.pdf","2011-07-06 00:00:00",
18954,2,200327,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf","2011-06-30 00:00:00",
32017,1,200327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200327s000ltr.pdf","2010-11-03 00:00:00",
40016,2,200327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200327s000lbl.pdf","2010-10-29 00:00:00",
43345,3,200327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000TOC.cfm","2010-12-13 00:00:00",
44820,21,200327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000SumR.pdf","2010-12-14 00:00:00",
9813,1,200327,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s003ltr.pdf","2011-03-16 00:00:00",
18955,2,200327,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s003lbl.pdf","2011-03-14 00:00:00",
9814,1,200327,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327s005ltr.pdf","2012-05-24 00:00:00",
40017,2,200327,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s007lbl.pdf","2012-05-07 00:00:00",
9815,1,200327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327Orig1s008ltr.pdf","2012-10-24 00:00:00",
18956,2,200327,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s008lbl.pdf","2012-10-24 00:00:00",
18957,2,200327,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s009lbl.pdf","2013-06-04 00:00:00",
32018,1,200327,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s009ltr.pdf","2013-05-30 00:00:00",
9816,1,200327,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s010ltr.pdf","2015-03-23 00:00:00",
40018,2,200327,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327Orig1s010lbl.pdf","2015-03-26 00:00:00",
18958,2,200327,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s011lbl.pdf","2013-12-17 00:00:00",
32019,1,200327,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s011ltr.pdf","2013-12-17 00:00:00",
32020,1,200327,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf","2015-09-04 00:00:00",
32021,1,200327,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf","2015-09-04 00:00:00",
40019,2,200327,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s013s014s015lbl.pdf","2015-09-04 00:00:00",
9817,1,200327,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf","2015-09-04 00:00:00",
18959,2,200327,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s015lbl.pdf","2015-09-04 00:00:00",
32022,1,200327,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf","2016-05-31 00:00:00",
40020,2,200327,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf","2016-06-01 00:00:00",
52409,20,200327,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinical prea.pdf","1900-01-01 00:00:00",
52411,57,200327,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinical CDTL prea.pdf","1900-01-01 00:00:00",
52413,18,200327,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinpharm prea.pdf","1900-01-01 00:00:00",
52415,17,200327,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline statistical prea.pdf","1900-01-01 00:00:00",
9818,1,200327,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf","2016-05-31 00:00:00",
18960,2,200327,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf","2016-06-01 00:00:00",
52410,20,200327,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinical prea.pdf","1900-01-01 00:00:00",
52412,57,200327,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinical CDTL prea.pdf","1900-01-01 00:00:00",
52414,18,200327,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline clinpharm prea.pdf","1900-01-01 00:00:00",
52416,17,200327,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/200327 ceftaroline statistical prea.pdf","1900-01-01 00:00:00",
9819,1,200363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200363s000ltr.pdf","2012-03-30 00:00:00",
9820,1,200403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000ltr.pdf","2011-12-05 00:00:00",
9821,1,200403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000TAltr.pdf","2011-03-02 00:00:00",
22831,3,200403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403_hydromorphone_toc.cfm","2012-06-05 00:00:00",
40021,2,200403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200403s000lbl.pdf","2011-12-02 00:00:00",
44821,21,200403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403Orig1s000SumR.pdf","2012-06-05 00:00:00",
9822,1,200403,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200403Orig1s004ltr.pdf","2015-07-20 00:00:00",
40022,2,200403,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200403s004lbl.pdf","2015-07-17 00:00:00",
46329,2,200403,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200403s006lbl.pdf","2016-12-20 00:00:00",
46389,1,200403,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200403Orig1s006ltr.pdf","2016-12-21 00:00:00",
9823,1,200405,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200405Orig1s000ltr.pdf","2012-08-06 00:00:00",
9824,1,200407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200407s000ltr.pdf","2011-10-31 00:00:00",
24094,14,200411,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-04-18 00:00:00",
9825,1,200435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200435Orig1s000ltr.pdf","2012-09-27 00:00:00",
9826,1,200456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200456Orig1s000ltr.pdf","2012-10-02 00:00:00",
32023,1,200465,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200465Orig1s000ltr.pdf","2013-12-05 00:00:00",
52650,3,200484,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200484Orig1s000.pdf","2018-02-15 00:00:00",
18961,2,200533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf","2011-08-26 00:00:00",
24095,14,200533,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2011-08-30 00:00:00",
32024,1,200533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200533s000ltr.pdf","2011-08-29 00:00:00",
32025,1,200533,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s001ltr.pdf","2012-08-29 00:00:00",
40023,2,200533,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf","2012-08-29 00:00:00",
43346,3,200533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200533Orig1s000TOC.cfm","2012-04-12 00:00:00",
18962,2,200533,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf","2012-07-12 00:00:00",
32026,1,200533,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf","2012-07-11 00:00:00",
32027,1,200533,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200533Orig1s004ltr.pdf","2013-04-18 00:00:00",
32028,1,200533,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s010ltr.pdf","2014-04-17 00:00:00",
40024,2,200533,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf","2014-04-16 00:00:00",
32029,1,200533,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s011ltr.pdf","2014-08-20 00:00:00",
32030,1,200533,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200533Orig1s012ltr.pdf","2015-07-07 00:00:00",
9827,1,200533,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s013ltr.pdf","2016-04-22 00:00:00",
46328,2,200533,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf","2016-12-20 00:00:00",
46411,1,200533,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s014ltr.pdf","2016-12-21 00:00:00",
46607,8,200533,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf#page=32","2016-12-30 00:00:00",
45456,1,200533,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s015ltr.pdf","2016-10-03 00:00:00",
48583,1,200533,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200533Orig1s016ltr.pdf","2017-05-31 00:00:00",
55589,2,200533,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf","2018-09-24 00:00:00",
55591,8,200533,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf#page=33","2018-09-24 00:00:00",
55692,1,200533,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf","2018-10-01 00:00:00",
55590,2,200533,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf","2018-09-24 00:00:00",
55592,8,200533,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf#page=33","2018-09-24 00:00:00",
55693,1,200533,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf","2018-10-01 00:00:00",
18963,2,200534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf","2010-10-21 00:00:00",
22832,3,200534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534s000_oxycodone_toc.cfm","2011-02-24 00:00:00",
32031,1,200534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200534s000ltr.pdf","2010-10-26 00:00:00",
44822,21,200534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534Orig1s000SumR.pdf","2011-02-24 00:00:00",
46327,2,200534,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf","2016-12-20 00:00:00",
46412,1,200534,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200534Orig1s006ltr.pdf","2016-12-21 00:00:00",
46608,8,200534,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf#pg=30","2016-12-30 00:00:00",
55727,1,200534,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
55728,1,200534,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
32032,1,200535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200535s000ltr.pdf","2010-10-25 00:00:00",
40025,2,200535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000lbl.pdf","2010-10-29 00:00:00",
43347,3,200535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535s000_oxycodone_toc.cfm","2011-02-24 00:00:00",
43941,8,200535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000MedGuide.pdf","2010-10-21 00:00:00",
44823,21,200535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535Orig1s000SumR.pdf","2011-02-24 00:00:00",
9828,1,200535,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200535s004ltr.pdf","2012-01-30 00:00:00",
32033,1,200535,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf","2013-09-05 00:00:00",
40026,2,200535,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf","2013-08-27 00:00:00",
18964,2,200535,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf","2013-08-27 00:00:00",
32034,1,200535,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf","2013-09-05 00:00:00",
40027,2,200535,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf","2014-06-23 00:00:00",
46326,2,200535,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200535s011lbl.pdf","2016-12-20 00:00:00",
46414,1,200535,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200535Orig1s011ltr.pdf","2016-12-21 00:00:00",
55585,2,200535,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf","2018-09-24 00:00:00",
55587,8,200535,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf#page=29","2018-09-24 00:00:00",
55709,1,200535,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf","2018-10-01 00:00:00",
55586,2,200535,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf","2018-09-24 00:00:00",
55588,8,200535,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf#page=29","2018-09-24 00:00:00",
55710,1,200535,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf","2018-10-01 00:00:00",
9829,1,200563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200563Orig1s000ltr.pdf","2014-03-06 00:00:00",
9830,1,200582,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200582Origs001ltr.pdf","2014-03-05 00:00:00",
18965,2,200582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200582s000lbl.pdf","2011-02-04 00:00:00",
24385,21,200582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582Orig1s000SumR.pdf","2011-05-13 00:00:00",
32035,1,200582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200582s000ltr.pdf","2011-02-07 00:00:00",
40028,2,200582,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf","2014-03-04 00:00:00",
43348,3,200582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582_topotecan_toc.cfm","2011-05-13 00:00:00",
18966,2,200582,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf","2016-02-25 00:00:00",
32036,1,200582,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200582Orig1s002ltr.pdf","2016-01-29 00:00:00",
9831,1,200603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s000ltr.pdf","2010-11-03 00:00:00",
9832,1,200603,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s001ltr.pdf","2010-12-28 00:00:00",
18967,2,200603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf","2010-10-29 00:00:00",
23954,10,200603,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm","2011-12-22 00:00:00",
40029,2,200603,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf","2010-12-23 00:00:00",
43349,3,200603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm","2010-12-03 00:00:00",
44824,21,200603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000SumR.pdf","2011-02-17 00:00:00",
9833,1,200603,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf","2011-12-13 00:00:00",
40030,2,200603,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf","2011-12-13 00:00:00",
18968,2,200603,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf","2012-05-01 00:00:00",
32037,1,200603,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf","2012-04-27 00:00:00",
9834,1,200603,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf","2011-12-13 00:00:00",
40031,2,200603,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf","2011-12-13 00:00:00",
18969,2,200603,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf","2012-05-01 00:00:00",
32038,1,200603,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf","2012-04-27 00:00:00",
32039,1,200603,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf","2013-01-24 00:00:00",
40032,2,200603,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf","2013-01-23 00:00:00",
18970,2,200603,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf","2013-07-09 00:00:00",
22833,3,200603,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf","2015-11-17 00:00:00",
32040,1,200603,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf","2013-07-02 00:00:00",
9835,1,200603,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf","2013-07-02 00:00:00",
40033,2,200603,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf","2013-07-09 00:00:00",
43350,3,200603,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf","2015-11-17 00:00:00",
9836,1,200603,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf","2013-01-24 00:00:00",
40034,2,200603,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf","2013-01-23 00:00:00",
40035,2,200603,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf","2013-07-17 00:00:00",
18971,2,200603,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf","2013-09-24 00:00:00",
32041,1,200603,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Org1s016ltr.pdf","2013-09-05 00:00:00",
46802,2,200603,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s021lbl.pdf","2017-01-11 00:00:00",
46877,1,200603,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s021ltr.pdf","2017-01-18 00:00:00",
47043,1,200603,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf","2017-01-31 00:00:00",
47072,2,200603,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf","2017-02-01 00:00:00",
51321,20,200603,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/68_200603s026 lurasidone clinical prea.pdf","2018-01-22 00:00:00",
51322,17,200603,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/69_200603s026 lurasidone statistical prea.pdf","2018-01-22 00:00:00",
52324,23,200603,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N200603_lurasidone_Orig_WR.pdf","2016-12-20 00:00:00",
47044,1,200603,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf","2017-01-31 00:00:00",
47074,2,200603,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf","2017-02-01 00:00:00",
51318,20,200603,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/71_200603s027 lurasidone clinical prea.pdf","1900-01-01 00:00:00",
51319,17,200603,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/72_200603s027 lurasidone statistical prea.pdf","1900-01-01 00:00:00",
51320,18,200603,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/70_200603s026, 027 lurasidone clinpharm prea.pdf","1900-01-01 00:00:00",
52323,23,200603,"SUPPL",27,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N200603_lurasidone_Orig_WR.pdf","2016-12-20 00:00:00",
47355,2,200603,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s028lbl.pdf","2017-02-27 00:00:00",
47384,1,200603,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s028ltr.pdf","2017-03-02 00:00:00",
52854,2,200603,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf","2018-03-08 00:00:00",
52855,8,200603,"SUPPL",29,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf#page=66","2018-03-08 00:00:00",
53010,1,200603,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200603Orig1s029ltr.pdf","2018-03-15 00:00:00",
49858,2,200603,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s030lbl.pdf","2017-09-26 00:00:00",
49863,1,200603,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s030ltr.pdf","2017-09-26 00:00:00",
32042,1,200623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200623s000TAltr.pdf","2011-03-10 00:00:00",
32043,1,200624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200624Orig1s000ltr.pdf","2015-07-16 00:00:00",
55623,1,200630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200630Orig1s000ltr.pdf","2018-09-27 00:00:00",
43351,3,200644,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200644Orig1s000Approv.pdf","2013-01-22 00:00:00",
50040,19,200652,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=360","2017-10-12 00:00:00",
9837,1,200652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200652Orig1s000ltr.pdf","2015-05-05 00:00:00",
40036,2,200652,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf","2015-05-07 00:00:00",
46778,1,200652,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200652Orig1s004ltr.pdf","2017-01-10 00:00:00",
9838,1,200656,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200656Orig1s001ltr.pdf","2016-04-14 00:00:00",
18972,2,200656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200656s000lbl.pdf","2014-08-26 00:00:00",
32044,1,200656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200656Orig1s000ltr.pdf","2014-08-27 00:00:00",
40037,2,200656,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200656s001lbl.pdf","2016-04-13 00:00:00",
9839,1,200671,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s001ltr.pdf","2015-09-17 00:00:00",
18973,2,200671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s000lbl.pdf","2015-09-14 00:00:00",
32045,1,200671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s000ltr.pdf","2015-09-15 00:00:00",
40038,2,200671,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671Orig1s001lbl.pdf","2015-10-22 00:00:00",
46069,3,200671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/200671Orig1s000TOC.cfm","2016-09-30 00:00:00",
18974,2,200671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s002lbl.pdf","2015-12-10 00:00:00",
32046,1,200671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s002ltr.pdf","2015-10-02 00:00:00",
9840,1,200675,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200675Orig1s000ltr.pdf","2012-08-28 00:00:00",
22834,3,200675,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200675Orig1s000Approv.pdf","2012-10-09 00:00:00",
9841,1,200677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200677Orig1s000ltr.pdf","2012-12-21 00:00:00",
9842,1,200677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200677Orig1s001ltr.pdf","2013-02-15 00:00:00",
23473,8,200677,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM332633.pdf","2012-12-18 00:00:00",
24387,21,200677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000SumR.pdf","2013-01-22 00:00:00",
40039,2,200677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200677lbl.pdf","2012-12-17 00:00:00",
43353,3,200677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000TOC.cfm","2013-01-22 00:00:00",
32047,1,200677,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200677Orig1s002ltr.pdf","2015-03-18 00:00:00",
40040,2,200677,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200677s002lbl.pdf","2015-03-19 00:00:00",
52932,2,200677,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200677s003lbl.pdf","2018-03-13 00:00:00",
52990,1,200677,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf","2018-03-15 00:00:00",
18975,2,200678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf","2010-11-12 00:00:00",
22835,3,200678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678_kombiglyze_xr_toc.cfm","2011-09-16 00:00:00",
23474,8,200678,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf","2013-06-12 00:00:00",
32048,1,200678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf","2010-11-12 00:00:00",
44825,21,200678,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf","2011-09-16 00:00:00",
32049,1,200678,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf","2012-03-13 00:00:00",
40041,2,200678,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf","2012-03-09 00:00:00",
32050,1,200678,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf","2012-03-13 00:00:00",
40042,2,200678,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf","2012-03-09 00:00:00",
9843,1,200678,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200678s005ltr.pdf","2011-11-21 00:00:00",
40043,2,200678,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf","2011-11-16 00:00:00",
32051,1,200678,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf","2012-04-05 00:00:00",
18976,2,200678,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf","2013-06-04 00:00:00",
32052,1,200678,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf","2013-05-28 00:00:00",
9844,1,200678,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf","2016-04-07 00:00:00",
45270,2,200678,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf","2016-09-13 00:00:00",
9845,1,200678,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf","2015-09-01 00:00:00",
18977,2,200678,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf","2015-09-04 00:00:00",
47360,2,200678,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf","2017-02-28 00:00:00",
47497,1,200678,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf","2017-03-08 00:00:00",
46920,2,200678,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf","2017-01-18 00:00:00",
46931,1,200678,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf","2017-01-24 00:00:00",
46921,2,200678,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf","2017-01-18 00:00:00",
46930,1,200678,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf","2017-01-24 00:00:00",
9846,1,200732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200732s000ltr.pdf","2011-02-28 00:00:00",
22836,3,200732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200732_zidovudine_toc.cfm","2011-06-29 00:00:00",
40044,2,200732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200732s000lbl.pdf","2011-03-04 00:00:00",
32053,1,200733,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200733s000ltr.pdf","2010-12-03 00:00:00",
9847,1,200734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200734Orig1s000ltr.pdf","2014-07-15 00:00:00",
32054,1,200735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200735Orig1s000ltr.pdf","2014-07-15 00:00:00",
18978,2,200738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200738s000lbl.pdf","2011-04-18 00:00:00",
32055,1,200738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200738s000ltr.pdf","2011-04-20 00:00:00",
43354,3,200738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738_lotemax_toc.cfm","2011-09-09 00:00:00",
44826,21,200738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738Orig1s000SumR.pdf","2011-09-09 00:00:00",
9848,1,200740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200740Orig1s000ltr.pdf","2012-10-04 00:00:00",
18979,2,200740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200740s000lbl.pdf","2012-10-04 00:00:00",
43355,3,200740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200740_cystaran_toc.cfm","2013-08-26 00:00:00",
44827,21,200740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200740Orig1s000SumR.pdf","2013-08-26 00:00:00",
9849,1,200744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200744Orig1s000ltr.pdf","2014-09-10 00:00:00",
32056,1,200748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200748s000ltr.pdf","2011-01-07 00:00:00",
22837,3,200771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200771Orig1s000Approv.pdf","2013-01-22 00:00:00",
32057,1,200790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200790Orig1s000ltr.pdf","2014-11-10 00:00:00",
32058,1,200792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200792Orig1s000ltr.pdf","2014-10-28 00:00:00",
44571,14,200792,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
32059,1,200793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200793s000ltr.pdf","2010-08-06 00:00:00",
24388,21,200795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795Orig1s000SumR.pdf","2012-07-06 00:00:00",
32060,1,200795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200795s000ltr.pdf","2011-08-08 00:00:00",
40045,2,200795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200795s000lbl.pdf","2011-08-05 00:00:00",
43356,3,200795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795_gemcitabine_toc.cfm","2012-07-06 00:00:00",
32061,1,200795,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200795Orig1s004ltr.pdf","2013-09-10 00:00:00",
40046,2,200795,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200795s004lbl.pdf","2013-09-09 00:00:00",
18980,2,200795,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200795s005lbl.pdf","2014-05-12 00:00:00",
32062,1,200795,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200795Orig1s005ltr.pdf","2014-05-12 00:00:00",
52134,1,200795,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200795Orig1s008ltr.pdf","2018-01-30 00:00:00",
52621,2,200795,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200795s008lbl.pdf","2018-02-14 00:00:00",
18981,2,200796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf","2011-03-04 00:00:00",
22838,3,200796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200796sOrig1s000_Edarbi_TOC.cfm","2011-04-04 00:00:00",
32063,1,200796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s000ltr.pdf","2011-03-02 00:00:00",
32064,1,200796,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s001ltr.pdf","2011-04-15 00:00:00",
40047,2,200796,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf","2011-04-15 00:00:00",
18982,2,200796,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf","2011-12-14 00:00:00",
32065,1,200796,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s002ltr.pdf","2011-12-15 00:00:00",
9850,1,200796,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200796Orig1s003ltr_replacement.pdf","2012-10-04 00:00:00",
18983,2,200796,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf","2012-10-05 00:00:00",
32066,1,200796,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf","2014-04-21 00:00:00",
18984,2,200796,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf","2014-07-24 00:00:00",
32067,1,200796,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s006ltr.pdf","2014-08-04 00:00:00",
45647,1,200796,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200796Orig1s009ltr.pdf","2016-10-26 00:00:00",
22839,3,200812,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/200812Orig1s000.pdf","2013-10-24 00:00:00",
24096,14,200812,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
22840,3,200822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/200822Orig1s000.Approv.pdf","2015-03-11 00:00:00",
24097,14,200822,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
44572,14,200824,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
32068,1,200828,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200828Orig1s000ltr.pdf","2013-07-17 00:00:00",
43357,3,200880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200880Orig1s000Approv.pdf","2012-10-09 00:00:00",
32069,1,200881,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200881Orig1s000ltr.pdf","2013-02-26 00:00:00",
9851,1,200889,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200889Orig1s000ltr.pdf","2012-08-06 00:00:00",
9852,1,200890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s000ltr.pdf","2010-06-29 00:00:00",
18985,2,200890,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf","2010-07-12 00:00:00",
32070,1,200890,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s001ltr.pdf","2010-07-12 00:00:00",
40048,2,200890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s000lbl.pdf","2010-06-24 00:00:00",
43358,3,200890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890_carpine_toc.cfm","2010-09-14 00:00:00",
44828,21,200890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890s000SumR.pdf","2010-09-14 00:00:00",
54123,20,200890,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/53_208151 atropine sulfate clinical prea.pdf","1900-01-01 00:00:00",
54124,18,200890,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/54_208151 atropine sulfate clinpharm prea.pdf","1900-01-01 00:00:00",
54125,17,200890,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55_208151 atropine sulfate statistical prea.pdf","1900-01-01 00:00:00",
22841,3,200901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200901Orig1s000Approv.pdf","2013-02-26 00:00:00",
9853,1,200904,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200904Orig1s000ltr.pdf","2014-06-03 00:00:00",
32071,1,200904,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200904Orig1s000ltr.pdf","2015-07-20 00:00:00",
48853,3,200910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200910Orig1s000.pdf","2017-06-28 00:00:00",
32072,1,200913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200913Orig1s000ltr.pdf","2013-03-28 00:00:00",
32073,1,200926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200926Orig1s000ltr.pdf","2014-02-11 00:00:00",
9854,1,200936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200936Orig1s000ltr.pdf","2013-10-29 00:00:00",
18986,2,200936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf","2013-11-19 00:00:00",
32074,1,200938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200938Orig1s000ltr.pdf","2015-11-20 00:00:00",
32075,1,201000,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201000Orig1s000ltr.pdf","2014-10-29 00:00:00",
32076,1,201005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201005Orig1s000ltr.pdf","2014-04-25 00:00:00",
9855,1,201023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201023s000ltr.pdf","2010-06-21 00:00:00",
18987,2,201023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf","2010-06-17 00:00:00",
22842,3,201023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000TOC.cfm","2010-07-30 00:00:00",
44829,21,201023,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000SumR.pdf","2010-07-30 00:00:00",
9856,1,201023,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201023Orig1s003ltr.pdf","2012-10-09 00:00:00",
18988,2,201023,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201023s003lbl.pdf","2012-10-05 00:00:00",
32077,1,201023,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201023Orig1s007ltr.pdf","2013-04-30 00:00:00",
32078,1,201023,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201023Orig1s011ltr.pdf","2014-11-21 00:00:00",
40049,2,201023,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201023s011lbl.pdf","2014-11-20 00:00:00",
18989,2,201023,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf","2015-06-19 00:00:00",
32079,1,201023,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201023Orig1s015ltr.pdf","2015-06-22 00:00:00",
45325,1,201023,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201023Orig1s017ltr.pdf","2016-09-15 00:00:00",
45364,2,201023,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201023s017lbl.pdf","2016-09-15 00:00:00",
49736,2,201023,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s019lbl.pdf","2017-09-14 00:00:00",
49791,1,201023,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201023Orig1s019ltr.pdf","2017-09-19 00:00:00",
48447,2,201023,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s020lbl.pdf","2017-05-18 00:00:00",
48453,1,201023,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201023Orig1sS020ltr.pdf","2017-05-19 00:00:00",
51271,23,201023,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N201023_cabazitaxel_Orig_WR.pdf","2012-03-20 00:00:00",
51272,25,201023,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N201023_cabazitaxel_Amend_1.pdf","2013-05-08 00:00:00",
51273,26,201023,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N201023_cabazitaxel_Amend_2.pdf","2015-03-03 00:00:00",
52072,20,201023,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/130_201023 cabazitaxel clinical bpca.pdf","1900-01-01 00:00:00",
51020,2,201023,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201023s021lbl.pdf","2018-01-10 00:00:00",
51035,1,201023,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201023Orig1s021ltr.pdf","2018-01-11 00:00:00",
32080,1,201046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201046Orig1s000ltr.pdf","2013-07-31 00:00:00",
9857,1,201050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201050Orig1s000ltr.pdf","2012-07-18 00:00:00",
52738,3,201050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201050Orig1s000.pdf","2018-02-27 00:00:00",
44573,14,201066,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
9858,1,201089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201089Orig1s000ltr.pdf","2012-07-11 00:00:00",
22843,3,201089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201089Orig1s000BioeqR.pdf","2012-10-12 00:00:00",
32081,1,201094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201094Orig1s000ltr.pdf","2014-04-30 00:00:00",
32082,1,201107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201107s000TAltr.pdf","2012-07-09 00:00:00",
45610,2,201107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf","2016-10-12 00:00:00",
32083,1,201151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201151s000ltr.pdf","2011-09-26 00:00:00",
9859,1,201152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s000ltr.pdf","2011-03-29 00:00:00",
9860,1,201152,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf","2011-05-10 00:00:00",
18990,2,201152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf","2011-03-29 00:00:00",
22844,3,201152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000TOC.cfm","2012-06-29 00:00:00",
24098,14,201152,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089818.pdf","2011-11-17 00:00:00",
44830,21,201152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000SumR.pdf","2012-06-29 00:00:00",
51402,18,201152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201152_nevirapine clinpharm prea.pdf","1900-01-01 00:00:00",
51403,17,201152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201152_nevirapine statistical prea.pdf","1900-01-01 00:00:00",
54064,20,201152,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201152_nevirapine+clinical+prea-508-dia.pdf","1900-01-01 00:00:00",
32084,1,201152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s002ltr.pdf","2011-11-14 00:00:00",
40050,2,201152,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s002lbl.pdf","2011-11-10 00:00:00",
9861,1,201152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s004ltr.pdf","2012-11-13 00:00:00",
18991,2,201152,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf","2012-11-08 00:00:00",
9862,1,201152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s005ltr.pdf","2012-10-03 00:00:00",
18992,2,201152,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf","2012-10-04 00:00:00",
9863,1,201152,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201152Orig1s007ltr.pdf","2014-01-28 00:00:00",
18993,2,201152,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf","2014-01-28 00:00:00",
47739,2,201152,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201152s010lbl.pdf","2017-03-28 00:00:00",
47740,8,201152,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19","2017-03-28 00:00:00",
47764,1,201152,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201152Orig1s010ltr.pdf","2017-03-29 00:00:00",
55610,2,201152,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf","2018-09-25 00:00:00",
55611,8,201152,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf#page=18","2018-09-25 00:00:00",
55744,1,201152,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201152Orig1s013ltr.pdf","2018-10-01 00:00:00",
18994,2,201153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf","2011-03-28 00:00:00",
22845,3,201153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153_zyclara_toc.cfm","2011-10-03 00:00:00",
32085,1,201153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf","2011-03-25 00:00:00",
44831,21,201153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153Orig1s000SumR.pdf","2011-10-03 00:00:00",
53293,20,201153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201153Orig1s000MedR.pdf","1900-01-01 00:00:00",
53294,18,201153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201153imiquimod_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
53295,17,201153,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201153 imiquimodStatR_PREA.pdf","1900-01-01 00:00:00",
22846,3,201166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201166Orig1s000Approv.pdf","2013-02-26 00:00:00",
9864,1,201192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201192Orig1s000ltr.pdf","2014-02-27 00:00:00",
32086,1,201194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201194s000ltr.pdf","2012-01-17 00:00:00",
40051,2,201194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf","2012-01-23 00:00:00",
43359,3,201194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194_oxycodone_toc.cfm","2012-08-29 00:00:00",
44832,21,201194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194Orig1s000SumR.pdf","2012-08-29 00:00:00",
46309,2,201194,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf","2016-12-20 00:00:00",
46419,1,201194,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201194Orig1s002ltr.pdf","2016-12-21 00:00:00",
46609,8,201194,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf#page=29","2016-12-30 00:00:00",
55581,2,201194,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf","2018-09-24 00:00:00",
55583,8,201194,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf#page=29","2018-09-24 00:00:00",
55703,1,201194,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf","2018-10-01 00:00:00",
55582,2,201194,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf","2018-09-24 00:00:00",
55584,8,201194,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf#page=29","2018-09-24 00:00:00",
55704,1,201194,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf","2018-10-01 00:00:00",
9865,1,201195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201195s000ltr.pdf","2011-06-13 00:00:00",
18995,2,201195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf","2011-06-10 00:00:00",
24389,21,201195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195Orig1s000SumR.pdf","2012-02-10 00:00:00",
43360,3,201195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195_docetaxel_toc.cfm","2012-02-10 00:00:00",
18996,2,201195,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf","2013-04-09 00:00:00",
32087,1,201195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201195Orig1s006ltr.pdf","2014-07-08 00:00:00",
40052,2,201195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf","2014-07-08 00:00:00",
32088,1,201195,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201195Orig1s009ltr.pdf","2016-07-28 00:00:00",
40053,2,201195,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf","2016-07-27 00:00:00",
9866,1,201211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201211s000ltr.pdf","2011-05-16 00:00:00",
9867,1,201231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201231Orig1s000ltr.pdf","2015-09-28 00:00:00",
9868,1,201251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201251Orig1s000ltr.pdf","2015-12-29 00:00:00",
9869,1,201275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201275Orig1s000ltr.pdf","2014-02-04 00:00:00",
40054,2,201275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201275Orig1s000lbl.pdf","2014-02-14 00:00:00",
22847,3,201276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201276Orig1s000Approv.pdf","2013-02-26 00:00:00",
9870,1,201277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201277s001ltr.pdf","2012-03-26 00:00:00",
22848,3,201277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000TOC.cfm","2011-04-11 00:00:00",
32089,1,201277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201277s000ltr.pdf","2011-03-16 00:00:00",
40055,2,201277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf","2011-03-15 00:00:00",
44833,21,201277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000SumR.pdf","2011-04-11 00:00:00",
54107,20,201277,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201277_Gadavist_ gadobutrol clinical prea.pdf","1900-01-01 00:00:00",
54108,17,201277,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201277_Gadavist_ gadobutrol statistical prea.pdf","1900-01-01 00:00:00",
32090,1,201277,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201277Orig1s003ltr_replace.pdf","2013-10-18 00:00:00",
40056,2,201277,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201277s003lbl.pdf","2013-10-21 00:00:00",
9871,1,201277,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s007ltr.pdf","2014-06-12 00:00:00",
9872,1,201277,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s008ltr.pdf","2014-12-31 00:00:00",
40057,2,201277,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201277s008lbl.pdf","2015-01-05 00:00:00",
51133,20,201277,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201277s008 gadobutrol clinical prea.pdf","1900-01-01 00:00:00",
51134,18,201277,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201277s008 gadobutrol clinpharm prea.pdf","1900-01-01 00:00:00",
51135,17,201277,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201277s008 gadobutrol statistical prea.pdf","1900-01-01 00:00:00",
9873,1,201277,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201277Orig1s010ltr.pdf","2015-08-03 00:00:00",
18997,2,201277,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201277s010lbl.pdf","2015-09-21 00:00:00",
9874,1,201277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201277Orig1s011ltr.pdf","2016-04-28 00:00:00",
18998,2,201277,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201277s011lbl.pdf","2016-05-05 00:00:00",
53854,2,201277,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s013lbl.pdf","2018-04-27 00:00:00",
53909,1,201277,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201277Orig1s013Ltr.pdf","2018-05-01 00:00:00",
55022,2,201277,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf","2018-07-27 00:00:00",
55023,8,201277,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51","2018-07-27 00:00:00",
55038,1,201277,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s015,201277Orig1s015Ltr.pdf","2018-07-30 00:00:00",
32091,1,201278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201278Orig1s000ltr.pdf","2014-09-03 00:00:00",
18999,2,201280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201280lbl.pdf","2011-05-06 00:00:00",
24390,21,201280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf","2011-06-07 00:00:00",
32092,1,201280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201280s000ltr.pdf","2011-05-06 00:00:00",
43361,3,201280,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000TOC.cfm","2011-06-07 00:00:00",
19000,2,201280,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf","2012-05-23 00:00:00",
32093,1,201280,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280s002ltr.pdf","2012-05-24 00:00:00",
43362,3,201280,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201280Orig1s002.pdf","2014-07-07 00:00:00",
32094,1,201280,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf","2012-08-15 00:00:00",
40058,2,201280,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf","2012-08-15 00:00:00",
9875,1,201280,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf","2012-08-15 00:00:00",
19001,2,201280,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf","2012-08-15 00:00:00",
9876,1,201280,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s005ltr.pdf","2012-10-02 00:00:00",
19002,2,201280,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf","2012-10-01 00:00:00",
9877,1,201280,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201280Orig1s006ltr.pdf","2013-06-20 00:00:00",
19003,2,201280,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf","2013-06-25 00:00:00",
9878,1,201280,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf","2014-05-23 00:00:00",
40059,2,201280,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf","2014-05-28 00:00:00",
19004,2,201280,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf","2015-07-30 00:00:00",
32095,1,201280,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf","2015-07-29 00:00:00",
9879,1,201280,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf","2015-09-01 00:00:00",
40060,2,201280,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf","2015-09-04 00:00:00",
47603,1,201280,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf","2017-03-20 00:00:00",
47609,2,201280,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf","2017-03-21 00:00:00",
47610,8,201280,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf#page=14","2017-03-21 00:00:00",
46553,1,201280,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201280Orig1s015,208026Orig1s004ltr.pdf","2016-12-27 00:00:00",
46618,2,201280,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf","2016-12-30 00:00:00",
49347,2,201280,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s016lbl.pdf","2017-08-11 00:00:00",
49408,1,201280,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf","2017-08-15 00:00:00",
19005,2,201281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf","2012-02-01 00:00:00",
22849,3,201281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281_linagliptin_toc.cfm","2013-07-26 00:00:00",
24391,21,201281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf","2013-07-26 00:00:00",
32096,1,201281,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281s000ltr.pdf","2012-02-02 00:00:00",
9880,1,201281,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281Orig1s002ltr.pdf","2012-09-27 00:00:00",
32097,1,201281,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s003ltr.pdf","2013-06-20 00:00:00",
40061,2,201281,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf","2013-06-25 00:00:00",
19006,2,201281,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf","2013-09-09 00:00:00",
32098,1,201281,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s004ltr.pdf","2013-09-10 00:00:00",
19007,2,201281,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf","2014-07-31 00:00:00",
32099,1,201281,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201281Orig1s006ltr.pdf","2014-07-31 00:00:00",
9881,1,201281,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf","2014-05-23 00:00:00",
40062,2,201281,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf","2014-05-28 00:00:00",
19008,2,201281,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf","2015-07-30 00:00:00",
32100,1,201281,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf","2015-07-29 00:00:00",
32101,1,201281,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf","2015-09-01 00:00:00",
40063,2,201281,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf","2015-09-03 00:00:00",
46539,2,201281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf","2016-12-27 00:00:00",
46543,1,201281,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf","2016-12-27 00:00:00",
47604,1,201281,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf","2017-03-20 00:00:00",
47611,2,201281,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf","2017-03-21 00:00:00",
46538,2,201281,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf","2016-12-27 00:00:00",
46544,1,201281,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf","2016-12-27 00:00:00",
49345,2,201281,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf","2017-08-11 00:00:00",
49346,8,201281,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf#page=20","2017-08-11 00:00:00",
49409,1,201281,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf","2017-08-15 00:00:00",
9882,1,201292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s000ltr.pdf","2013-07-12 00:00:00",
19009,2,201292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf","2013-07-12 00:00:00",
32102,1,201292,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s001ltr.pdf","2013-07-26 00:00:00",
40064,2,201292,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s001lbl.pdf","2013-07-30 00:00:00",
43363,3,201292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000TOC.cfm","2013-08-15 00:00:00",
43364,3,201292,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s001.pdf","2013-10-23 00:00:00",
44834,21,201292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000SumR.pdf","2013-08-15 00:00:00",
32103,1,201292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s002ltr.pdf","2013-11-25 00:00:00",
40065,2,201292,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s002lbl.pdf","2013-11-22 00:00:00",
9883,1,201292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s006ltr.pdf","2015-11-13 00:00:00",
19010,2,201292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s006lbl.pdf","2015-11-12 00:00:00",
19011,2,201292,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s007lbl.pdf","2016-04-19 00:00:00",
32104,1,201292,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s007ltr.pdf","2016-04-18 00:00:00",
9884,1,201292,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s008ltr.pdf","2015-12-29 00:00:00",
19012,2,201292,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s008lbl.pdf","2015-12-31 00:00:00",
9885,1,201292,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s009ltr.pdf","2016-04-22 00:00:00",
19013,2,201292,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s009lbl.pdf","2016-04-27 00:00:00",
45498,2,201292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s010lbl.pdf","2016-10-06 00:00:00",
45506,1,201292,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s010ltr.pdf","2016-10-06 00:00:00",
50323,2,201292,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201292s012lbl.pdf","2017-11-07 00:00:00",
50353,1,201292,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201292Orig1s012ltr.pdf","2017-11-09 00:00:00",
51049,2,201292,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf","2018-01-12 00:00:00",
51064,1,201292,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201292Orig1s014ltr.pdf","2018-01-17 00:00:00",
32105,1,201294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201294Orig1s000ltr.pdf","2012-08-06 00:00:00",
9886,1,201311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201311Orig1s000ltr.pdf","2012-07-30 00:00:00",
9887,1,201361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201361Orig1s000ltr.pdf","2016-07-20 00:00:00",
19014,2,201361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201361Orig1s000lbl.pdf","2016-07-21 00:00:00",
9888,1,201367,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf","2011-06-03 00:00:00",
19015,2,201367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf","2011-03-07 00:00:00",
22850,3,201367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367_banzel_toc.cfm","2011-07-06 00:00:00",
32106,1,201367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf","2011-03-08 00:00:00",
43948,8,201367,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088564.pdf","2011-03-08 00:00:00",
44835,21,201367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367Orig1s000SumR.pdf","2011-07-06 00:00:00",
51473,20,201367,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201367 rufinamide clinical bpca.pdf","1900-01-01 00:00:00",
51474,18,201367,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201367 rufinamide clinpharm bpca.pdf","1900-01-01 00:00:00",
32107,1,201367,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf","2015-02-17 00:00:00",
40066,2,201367,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf","2015-03-03 00:00:00",
32108,1,201367,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf","2015-06-26 00:00:00",
40067,2,201367,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf","2015-07-01 00:00:00",
32109,1,201370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201370s000ltr.pdf","2011-07-25 00:00:00",
40068,2,201370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201370s000lbl.pdf","2011-07-25 00:00:00",
43365,3,201370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370_heparin_toc.cfm","2012-06-20 00:00:00",
44836,21,201370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370Orig1s000SumR.pdf","2012-06-20 00:00:00",
45019,2,201370,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201370s010lbl.pdf","2016-08-09 00:00:00",
45035,1,201370,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201370Orig1s010ltr.pdf","2016-08-09 00:00:00",
9889,1,201373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201373s000ltr.pdf","2011-02-02 00:00:00",
22851,3,201373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373_allegra_toc.cfm","2011-10-07 00:00:00",
24392,21,201373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373Orig1s000SumR.pdf","2011-10-07 00:00:00",
40069,2,201373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf","2013-11-26 00:00:00",
9890,1,201373,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373s002ltr.pdf","2012-02-27 00:00:00",
9891,1,201373,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373Orig1s004ltr.pdf","2012-08-27 00:00:00",
32110,1,201373,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201373Orig1s005ltr.pdf","2013-04-30 00:00:00",
40070,2,201373,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf","2013-10-02 00:00:00",
9892,1,201373,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201373Orig1s006ltr.pdf","2016-06-21 00:00:00",
19016,2,201373,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf","2016-06-17 00:00:00",
22852,3,201374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201374Orig1s000Approv.pdf","2013-02-26 00:00:00",
47447,1,201379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201379Orig1s000ltr.pdf","2017-03-03 00:00:00",
32111,1,201382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201382Orig1s000ltr.pdf","2015-06-04 00:00:00",
32112,1,201402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201402Orig1s000ltr.pdf","2012-08-17 00:00:00",
9893,1,201406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201406Orig1s000ltr.pdf","2015-12-10 00:00:00",
9894,1,201408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201408Orig1s000ltr.pdf","2015-06-04 00:00:00",
9895,1,201444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201444s000ltr.pdf","2011-01-20 00:00:00",
19017,2,201444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201444s000lbl.pdf","2011-01-20 00:00:00",
24393,21,201444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201444Orig1s000SumR.pdf","2012-02-10 00:00:00",
43366,3,201444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201444_nithiodote_toc.cfm","2012-02-10 00:00:00",
50135,1,201444,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201444Orig1s019ltr.pdf","2017-10-23 00:00:00",
50161,2,201444,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201444s019lbl.pdf","2017-10-24 00:00:00",
9896,1,201508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201508Orig1s000ltr.pdf","2012-08-06 00:00:00",
9897,1,201511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201511Orig1s000ltr.pdf","2013-02-15 00:00:00",
9898,1,201515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201515Orig1s000ltr.pdf","2012-08-07 00:00:00",
19018,2,201517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201517s000lbl.pdf","2011-06-28 00:00:00",
24394,21,201517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517Orig1s000SumR.pdf","2012-01-12 00:00:00",
32113,1,201517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201517s000ltr.pdf","2011-06-29 00:00:00",
43367,3,201517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517_morphine_toc.cfm","2012-01-12 00:00:00",
46308,2,201517,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf","2016-12-20 00:00:00",
46422,1,201517,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201517Orig1s009ltr.pdf","2016-12-21 00:00:00",
46610,8,201517,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf#page=26","2016-12-30 00:00:00",
55573,2,201517,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf","2018-09-24 00:00:00",
55575,8,201517,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf#page=26","2018-09-24 00:00:00",
55713,1,201517,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf","2018-10-01 00:00:00",
55574,2,201517,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf","2018-09-24 00:00:00",
55576,8,201517,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf#page=26","2018-09-24 00:00:00",
55714,1,201517,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf","2018-10-01 00:00:00",
32114,1,201522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201522Orig1s000ltr.pdf","2012-08-06 00:00:00",
9899,1,201525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201525s000ltr.pdf","2011-07-06 00:00:00",
19019,2,201525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf","2011-06-30 00:00:00",
24395,21,201525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000SumR.pdf","2012-01-12 00:00:00",
43368,3,201525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525_docetaxel_toc.cfm","2012-01-12 00:00:00",
9900,1,201525,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201525s002ltr.pdf","2012-03-19 00:00:00",
19020,2,201525,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf","2012-03-16 00:00:00",
9901,1,201525,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s003ltr.pdf","2014-04-24 00:00:00",
19021,2,201525,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf","2014-04-25 00:00:00",
19022,2,201525,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf","2014-11-07 00:00:00",
32115,1,201525,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf","2014-11-05 00:00:00",
9902,1,201525,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf","2014-11-05 00:00:00",
19023,2,201525,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf","2014-11-07 00:00:00",
45636,1,201525,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201525Orig1s012ltr.pdf","2016-10-25 00:00:00",
9903,1,201532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201532s000ltr.pdf","2010-11-18 00:00:00",
22853,3,201532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532s000_halaven_TOC.cfm","2011-01-03 00:00:00",
24396,21,201532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532Orig1s000SumR.pdf","2011-02-17 00:00:00",
40071,2,201532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf","2010-11-15 00:00:00",
32116,1,201532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201532s004ltr.pdf","2012-02-23 00:00:00",
40072,2,201532,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf","2012-02-22 00:00:00",
9904,1,201532,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201532Orig1s006ltr.pdf","2013-08-23 00:00:00",
40073,2,201532,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf","2013-08-27 00:00:00",
9905,1,201532,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s009ltr.pdf","2014-08-04 00:00:00",
40074,2,201532,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf","2014-08-04 00:00:00",
9906,1,201532,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s010ltr.pdf","2014-12-24 00:00:00",
40075,2,201532,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf","2015-01-09 00:00:00",
9907,1,201532,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201532s013ltr.pdf","2015-10-28 00:00:00",
19024,2,201532,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf","2015-11-04 00:00:00",
9908,1,201532,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s015ltr.pdf","2016-01-29 00:00:00",
19025,2,201532,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf","2016-01-28 00:00:00",
45573,1,201532,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s016ltr.pdf","2016-10-20 00:00:00",
45685,2,201532,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf","2016-10-27 00:00:00",
9909,1,201533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201533Orig1s000ltr.pdf","2016-04-22 00:00:00",
32117,1,201533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201533s000ltr.pdf","2011-11-21 00:00:00",
9910,1,201537,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201537Orig1s000ltr.pdf","2013-09-19 00:00:00",
32118,1,201566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201566s000ltr.pdf","2011-07-05 00:00:00",
53545,20,201567,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir clinical both.pdf","1900-01-01 00:00:00",
53547,17,201567,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir statistical both.pdf","1900-01-01 00:00:00",
53548,20,201567,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinical.pdf","1900-01-01 00:00:00",
53550,18,201567,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinpharm.pdf","1900-01-01 00:00:00",
53551,17,201567,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Statistical.pdf","1900-01-01 00:00:00",
9911,1,201573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201573Orig1s000ltr.pdf","2013-07-22 00:00:00",
19026,2,201573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf","2013-09-19 00:00:00",
48604,1,201577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201577Orig1s000ltr.pdf","2017-05-31 00:00:00",
32119,1,201586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201586Orig1s000ltr.pdf","2014-08-29 00:00:00",
9912,1,201587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201587Orig1s000ltr.pdf","2013-01-25 00:00:00",
9913,1,201588,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201588s000ltr.pdf","2011-10-26 00:00:00",
32120,1,201593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201593Orig1s000TAltr.pdf","2014-11-04 00:00:00",
32121,1,201593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201593Orig1s000ltr.pdf","2015-06-10 00:00:00",
32122,1,201615,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201615Orig1s000ltr.pdf","2013-01-17 00:00:00",
50043,19,201633,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2017-10-12 00:00:00",
9914,1,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000ltr.pdf","2013-08-20 00:00:00",
19027,2,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf","2013-08-21 00:00:00",
24397,21,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf","2014-06-24 00:00:00",
32123,1,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf","2012-06-26 00:00:00",
32124,1,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.pdf","2013-06-11 00:00:00",
43369,3,201635,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000TOC.cfm","2014-06-24 00:00:00",
32125,1,201635,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201635Orig1s007ltr.pdf","2015-05-13 00:00:00",
40076,2,201635,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201635s007lbl.pdf","2015-06-05 00:00:00",
45227,1,201635,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s011TAltr.pdf","2016-08-18 00:00:00",
47903,2,201635,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf","2017-04-07 00:00:00",
45099,2,201635,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201635s014lbl.pdf","2016-08-22 00:00:00",
45141,1,201635,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s014ltr.pdf","2016-08-18 00:00:00",
47901,2,201635,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf","2017-04-07 00:00:00",
47902,8,201635,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf#page=58","2017-04-07 00:00:00",
47955,1,201635,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201635Orig1s011s017ltr.pdf","2017-04-12 00:00:00",
50972,1,201635,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201635Orig1s018ltredt.pdf","2018-01-04 00:00:00",
50973,2,201635,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201635s018lbl.pdf","2018-01-09 00:00:00",
22854,3,201655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655_opana_er_toc.cfm","2012-08-27 00:00:00",
24398,21,201655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655Orig1s000SumR.pdf","2012-08-27 00:00:00",
32126,1,201655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201655Orig1s000Ltr.pdf","2011-12-09 00:00:00",
40077,2,201655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201655lbl.pdf","2011-12-09 00:00:00",
44574,14,201655,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2012-01-05 00:00:00",
9915,1,201655,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201655Orig1s002ltr.pdf","2012-07-11 00:00:00",
40078,2,201655,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf","2012-07-12 00:00:00",
19028,2,201655,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201655s004lbl.pdf","2013-01-14 00:00:00",
32127,1,201655,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s004ltr.pdf","2013-01-16 00:00:00",
9916,1,201655,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s005ltr.pdf","2013-04-18 00:00:00",
9917,1,201655,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s012ltr.pdf","2014-04-17 00:00:00",
40079,2,201655,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf","2014-04-16 00:00:00",
9918,1,201655,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s015ltr.pdf","2014-08-20 00:00:00",
9919,1,201655,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s016ltr.pdf","2015-01-29 00:00:00",
40080,2,201655,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201655s016lbl.pdf","2015-01-30 00:00:00",
32128,1,201655,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s017ltr.pdf","2015-07-07 00:00:00",
32129,1,201655,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s020ltr.pdf","2016-04-22 00:00:00",
46307,2,201655,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf","2016-12-20 00:00:00",
46424,1,201655,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s021ltr.pdf","2016-12-21 00:00:00",
46593,8,201655,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf#page=25","2016-12-29 00:00:00",
45455,1,201655,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s022ltr.pdf","2016-10-03 00:00:00",
48584,1,201655,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201655Orig1s023ltr.pdf","2017-05-31 00:00:00",
55577,2,201655,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf","2018-09-24 00:00:00",
55579,8,201655,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf#page26","2018-09-24 00:00:00",
55715,1,201655,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201655Orig1s024s025ltr.pdf","2018-10-01 00:00:00",
55578,2,201655,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf","2018-09-24 00:00:00",
55580,8,201655,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf#page26","2018-09-24 00:00:00",
55716,1,201655,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201655Orig1s024s025ltr.pdf","2018-10-01 00:00:00",
47448,2,201656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf","2017-03-03 00:00:00",
47450,21,201656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/201656Orig1s000SumR.pdf","2017-03-03 00:00:00",
47455,1,201656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201656Orig1s000Ltr.pdf","2017-03-03 00:00:00",
47476,8,201656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf#page=13","2017-03-07 00:00:00",
54231,3,201656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/201656Orig1s000TOC.cfm","2018-05-17 00:00:00",
9920,1,201657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201657Orig1s000ltr.pdf","2014-10-23 00:00:00",
19029,2,201657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201657s000lbl.pdf","2014-10-23 00:00:00",
22855,3,201657,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201657Orig1s000TOC.cfm","2015-01-16 00:00:00",
9921,1,201680,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201680s000ltr.pdf","2011-09-15 00:00:00",
9922,1,201688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201688Orig1s000ltr.pdf","2013-03-26 00:00:00",
24399,21,201688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000SumR.pdf","2014-03-06 00:00:00",
40081,2,201688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf","2013-03-26 00:00:00",
43370,3,201688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000TOC.cfm","2014-03-06 00:00:00",
9923,1,201688,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s002ltr.pdf","2014-04-28 00:00:00",
19030,2,201688,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf","2014-04-28 00:00:00",
9924,1,201688,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s004ltr.pdf","2014-11-20 00:00:00",
40082,2,201688,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf","2014-11-20 00:00:00",
9925,1,201688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201688Orig1s006ltr.pdf","2015-10-06 00:00:00",
19031,2,201688,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf","2015-10-08 00:00:00",
46227,2,201688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201688s008lbl.pdf","2016-12-20 00:00:00",
46873,1,201688,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201688Orig1s008ltr.pdf","2017-01-18 00:00:00",
43371,3,201692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201692Orig1s000Approv.pdf","2012-10-09 00:00:00",
9926,1,201699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201699s000ltr.pdf","2011-05-31 00:00:00",
24400,21,201699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf","2011-06-28 00:00:00",
40083,2,201699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf","2011-05-31 00:00:00",
43372,3,201699,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000TOC.cfm","2011-06-28 00:00:00",
19032,2,201699,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf","2013-04-09 00:00:00",
32130,1,201699,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_corrected.pdf","2013-04-09 00:00:00",
9927,1,201699,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201699Orig1s009ltr.pdf","2015-02-26 00:00:00",
19033,2,201739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf","2012-08-15 00:00:00",
32132,1,201739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201739Orig1s000ltr.pdf","2012-08-14 00:00:00",
43373,3,201739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739_auviQ_toc.cfm","2012-12-04 00:00:00",
52479,20,201739,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205_201739 epinephrine mulitdiciplinary prea.pdf","1900-01-01 00:00:00",
32133,1,201739,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201739Orig1s004ltr.pdf","2016-05-19 00:00:00",
40084,2,201739,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201739s004lbl.pdf","2016-05-20 00:00:00",
47091,3,201739,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/201739Orig1s004pkg.pdf","2017-02-02 00:00:00",
47296,1,201739,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s006ltr.pdf","2017-02-23 00:00:00",
50455,2,201739,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf","2017-11-17 00:00:00",
50456,1,201739,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s008,s009ltr.pdf","2017-11-17 00:00:00",
50457,2,201739,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf","2017-11-17 00:00:00",
50458,1,201739,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s008,s009ltr.pdf","2017-11-17 00:00:00",
32134,1,201742,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201742Orig1s000ltr.pdf","2014-02-13 00:00:00",
9928,1,201743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000ltr.pdf","2011-02-14 00:00:00",
9929,1,201743,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201743Orig1s001ltr.pdf","2016-05-27 00:00:00",
19034,2,201743,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201743s001lbl.pdf","2016-06-01 00:00:00",
22856,3,201743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743_argatroban_toc.cfm","2012-01-05 00:00:00",
24401,21,201743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743Orig1s000SumR.pdf","2012-01-05 00:00:00",
32135,1,201743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000(1)ltr.pdf","2011-05-12 00:00:00",
40085,2,201743,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201743lbl.pdf","2011-05-09 00:00:00",
54718,2,201743,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201743s002lbl.pdf","2018-06-28 00:00:00",
54855,1,201743,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201743Orig1s002ltr.pdf","2018-07-06 00:00:00",
32136,1,201746,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201746Orig1s000ltr.pdf","2015-06-10 00:00:00",
48951,2,201751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201751Orig1s000lbl.pdf","2017-07-11 00:00:00",
48968,1,201751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201751Orig1s000ltr.pdf","2017-07-13 00:00:00",
22857,3,201759,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/201759Orig1s000.pdf","2011-12-02 00:00:00",
32137,1,201760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201760Orig1s000ltr.pdf","2016-02-01 00:00:00",
44575,14,201760,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2016-02-03 00:00:00",
22858,3,201764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/201764Orig1s000.pdf","2011-12-02 00:00:00",
22859,3,201784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201784Orig1s000Approv.pdf","2013-02-26 00:00:00",
22860,3,201801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/201801Orig1s000Approv.pdf","2013-05-02 00:00:00",
22861,3,201803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803_advil_toc.cfm","2012-11-29 00:00:00",
32138,1,201803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201803s000ltr.pdf","2012-06-14 00:00:00",
40086,2,201803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf","2012-08-30 00:00:00",
44837,21,201803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803Orig1s000SumR.pdf","2012-11-29 00:00:00",
9930,1,201803,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201803Orig1s007ltr.pdf","2016-06-07 00:00:00",
40087,2,201803,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf","2016-06-10 00:00:00",
48710,1,201803,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s008ltr.pdf","2017-06-13 00:00:00",
48717,2,201803,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf","2017-06-14 00:00:00",
49534,2,201803,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf","2017-08-24 00:00:00",
49542,1,201803,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s009ltr.pdf","2017-08-25 00:00:00",
53691,1,201803,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s011ltr.pdf","2018-04-16 00:00:00",
53788,2,201803,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf","2018-04-23 00:00:00",
54404,1,201803,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s012ltr.pdf","2018-06-01 00:00:00",
54412,2,201803,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf","2018-06-01 00:00:00",
19035,2,201811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf","2015-04-14 00:00:00",
32139,1,201811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf","2015-03-25 00:00:00",
43374,3,201811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000TOC.cfm","2016-03-02 00:00:00",
44838,21,201811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000SumR.pdf","2016-03-02 00:00:00",
9931,1,201811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201811Orig1s003ltr.pdf","2016-05-27 00:00:00",
40088,2,201811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf","2016-06-01 00:00:00",
52278,1,201811,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201811Orig1s006ltr.pdf","2018-02-02 00:00:00",
52432,2,201811,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201811s006lbl.pdf","2018-02-06 00:00:00",
22862,3,201820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820_bethkis_toc.cfm","2013-09-03 00:00:00",
24402,21,201820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820Orig1s000SumR.pdf","2013-09-03 00:00:00",
32140,1,201820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201820Orig1s000ltr.pdf","2012-10-16 00:00:00",
40089,2,201820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf","2012-10-15 00:00:00",
51573,18,201820,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin clinpharm prea.pdf","1900-01-01 00:00:00",
51574,20,201820,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin clinical prea.pdf","1900-01-01 00:00:00",
51575,17,201820,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin statistical prea.pdf","1900-01-01 00:00:00",
48603,1,201820,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201820Orig1s003ltr.pdf","2017-05-31 00:00:00",
48611,2,201820,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201820s003lbl.pdf","2017-06-01 00:00:00",
9932,1,201824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201824Orig1s000ltr.pdf","2015-09-17 00:00:00",
44576,14,201824,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-09-18 00:00:00",
32141,1,201831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201831Orig1s000ltr.pdf","2015-05-29 00:00:00",
9933,1,201832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201832Orig1s000ltr.pdf","2015-07-28 00:00:00",
43375,3,201846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201846Orig1s000Approv.pdf","2012-10-09 00:00:00",
22863,3,201849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201849Orig1s000TOC.cfm","2016-05-25 00:00:00",
32142,1,201849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s000ltr.pdf","2015-05-13 00:00:00",
9934,1,201849,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s002ltr.pdf","2015-12-02 00:00:00",
19036,2,201849,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf","2015-12-02 00:00:00",
9935,1,201893,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201893Orig1s000ltr.pdf","2015-09-18 00:00:00",
19037,2,201917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf","2011-05-23 00:00:00",
23057,5,201917,"ORIG",1,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm","2011-05-23 00:00:00",
23481,8,201917,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf","2011-05-23 00:00:00",
23955,10,201917,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm332743.htm","2012-12-27 00:00:00",
24403,21,201917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000SumR.pdf","2011-07-08 00:00:00",
32143,1,201917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201917Orig1s000ltr.pdf","2011-05-23 00:00:00",
43376,3,201917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000TOC.cfm","2011-07-08 00:00:00",
9936,1,201917,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s003ltr.pdf","2012-03-26 00:00:00",
40090,2,201917,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003lbl.pdf","2012-03-23 00:00:00",
19038,2,201917,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf","2012-06-26 00:00:00",
32144,1,201917,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s004ltr.pdf","2012-06-25 00:00:00",
9937,1,201917,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917Orig1s007ltr.pdf","2012-12-19 00:00:00",
19039,2,201917,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf","2012-12-17 00:00:00",
19040,2,201917,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf","2013-04-29 00:00:00",
32145,1,201917,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s008ltr.pdf","2013-04-30 00:00:00",
9938,1,201917,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf","2013-10-29 00:00:00",
19041,2,201917,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s010lbl.pdf","2013-10-28 00:00:00",
32146,1,201917,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf","2013-10-29 00:00:00",
40091,2,201917,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s012lbl.pdf","2013-10-28 00:00:00",
19042,2,201922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf","2012-07-13 00:00:00",
22864,3,201922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922_ximino_toc.cfm","2013-08-13 00:00:00",
24404,21,201922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922Orig1s000SumR.pdf","2013-08-13 00:00:00",
32147,1,201922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201922Orig1s000ltr.pdf","2012-07-13 00:00:00",
40092,2,201922,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf","2015-08-14 00:00:00",
22865,3,201923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201923Orig1s000TOC.cfm","2016-03-18 00:00:00",
32148,1,201923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201923Orig1s000ltr.pdf","2014-09-29 00:00:00",
40093,2,201923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf","2014-09-30 00:00:00",
47514,2,201923,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf","2017-03-09 00:00:00",
47563,1,201923,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201923Orig1s002ltr.pdf","2017-03-14 00:00:00",
32149,1,201946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201946Orig1s000ltr.pdf","2016-07-20 00:00:00",
48394,2,201971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201971Orig1s000lbl.pdf","2017-05-17 00:00:00",
48402,1,201971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201971Orig1s000ltr.pdf","2017-05-17 00:00:00",
9939,1,202002,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202002Orig1s000ltr.pdf","2014-06-26 00:00:00",
9940,1,202007,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202007s000TAltr.pdf","2011-05-16 00:00:00",
19043,2,202008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf","2012-04-09 00:00:00",
32150,1,202008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202008Orig1s000ltr.pdf","2012-04-06 00:00:00",
43377,3,202008,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202008_Florbetapir_Orig1s000TOC.cfm","2012-05-03 00:00:00",
9941,1,202008,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202008Orig1s020ltr.pdf","2013-12-16 00:00:00",
19044,2,202008,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf","2013-12-17 00:00:00",
32151,1,202012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202012s000ltr.pdf","2011-11-21 00:00:00",
9942,1,202020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202020Orig1s000ltr.pdf","2012-07-30 00:00:00",
19045,2,202020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202020s000lbl.pdf","2012-07-30 00:00:00",
22866,3,202020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020_rayos_toc.cfm","2013-05-24 00:00:00",
44839,21,202020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf","2013-05-24 00:00:00",
32152,1,202020,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202020Orig1s003ltr.pdf","2013-06-18 00:00:00",
40094,2,202020,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202020s003lbl.pdf","2013-06-18 00:00:00",
22867,3,202022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000TOC.cfm","2011-07-05 00:00:00",
32153,1,202022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202022s000ltr.pdf","2011-05-24 00:00:00",
40095,2,202022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf","2011-05-23 00:00:00",
44840,21,202022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000SumR.pdf","2011-07-05 00:00:00",
19046,2,202022,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s002lbl.pdf","2012-12-10 00:00:00",
32154,1,202022,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s002ltr.pdf","2012-12-11 00:00:00",
32155,1,202022,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s003ltr.pdf","2012-08-15 00:00:00",
40096,2,202022,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s003lbl.pdf","2012-08-15 00:00:00",
9943,1,202022,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202022Orig1s005ltr.pdf","2013-06-21 00:00:00",
40097,2,202022,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202022s005lbl.pdf","2013-06-25 00:00:00",
9944,1,202022,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202022Orig1s007ltr.pdf","2014-05-06 00:00:00",
40098,2,202022,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202022s007lbl.pdf","2014-05-02 00:00:00",
9945,1,202022,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s008ltr.pdf","2015-08-28 00:00:00",
19047,2,202022,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s008lbledt.pdf","2015-08-27 00:00:00",
51471,20,202022,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202022 rilpivirine clinical prea.pdf","1900-01-01 00:00:00",
51472,18,202022,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202022 rilpivirine clinpharm prea.pdf","1900-01-01 00:00:00",
32156,1,202022,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s009ltr.pdf","2015-05-11 00:00:00",
40099,2,202022,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s009lbl.pdf","2015-05-07 00:00:00",
49769,2,202022,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202022s010lbl.pdf","2017-09-18 00:00:00",
49790,1,202022,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202022Orig1s010ltr.pdf","2017-09-19 00:00:00",
52240,2,202022,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202022s011lbl.pdf","2018-02-01 00:00:00",
52292,1,202022,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202022Orig1s011ltr.pdf","2018-02-02 00:00:00",
32157,1,202026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202026Orig1s000ltr.pdf","2013-07-19 00:00:00",
40100,2,202026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202026Orig1s000lbl.pdf","2013-09-24 00:00:00",
43378,3,202032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202032Orig1s000Approv.pdf","2012-01-27 00:00:00",
9946,1,202042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202042s000ltr.pdf","2012-01-23 00:00:00",
32158,1,202051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202051Orig1s000ltr.pdf","2013-09-03 00:00:00",
40101,2,202051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202051Orig1s000lbl.pdf","2013-09-19 00:00:00",
9947,1,202053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202053Orig1s000ltr.pdf","2014-09-16 00:00:00",
40102,2,202053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202053Orig1s000lbl.pdf","2014-09-23 00:00:00",
32159,1,202054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202054Orig1s000ltr.pdf","2014-09-05 00:00:00",
19048,2,202057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202057S000lbl.pdf","2012-07-30 00:00:00",
32160,1,202057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202057Orig1s000ltr.pdf","2012-07-30 00:00:00",
32161,1,202057,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s001ltr.pdf","2013-02-04 00:00:00",
43379,3,202057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057_vascepa_toc.cfm","2013-03-06 00:00:00",
44841,21,202057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000SumR.pdf","2013-03-06 00:00:00",
40103,2,202057,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf","2013-03-26 00:00:00",
32162,1,202057,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202057Orig1s006ltr.pdf","2014-02-14 00:00:00",
40104,2,202057,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202057Orig1s006lbl.pdf","2014-02-14 00:00:00",
32163,1,202057,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf","2013-11-27 00:00:00",
40105,2,202057,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf","2013-11-26 00:00:00",
40106,2,202057,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202057s012lbl.pdf","2015-06-24 00:00:00",
47263,2,202057,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202057s019lbl.pdf","2017-02-17 00:00:00",
32164,1,202058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202058s000ltr.pdf","2011-10-12 00:00:00",
43380,3,202063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202063Orig1s000Approv.pdf","2013-01-22 00:00:00",
49264,1,202065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202065Orig1s000TAltr.pdf","2017-08-07 00:00:00",
9948,1,202067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202067s000ltr.pdf","2011-10-25 00:00:00",
19049,2,202067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf","2011-10-24 00:00:00",
22868,3,202067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000TOC.cfm","2011-11-22 00:00:00",
40107,2,202067,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s001lbl.pdf","2013-03-05 00:00:00",
32165,1,202067,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993Orig1s002ltr.pdf","2013-11-26 00:00:00",
40108,2,202067,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf","2013-11-22 00:00:00",
19050,2,202067,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf","2015-05-12 00:00:00",
32166,1,202067,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993Orig1s003ltr.pdf","2014-12-11 00:00:00",
46285,2,202067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202067s004lbl.pdf","2016-12-20 00:00:00",
46472,1,202067,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202067Orig1s004,203993Orig1s005ltr.pdf","2016-12-22 00:00:00",
54631,1,202067,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202067Orig1s005,203993Orig1s007ltr.pdf","2018-06-20 00:00:00",
54654,2,202067,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf","2018-06-21 00:00:00",
54657,8,202067,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29","2018-06-21 00:00:00",
9949,1,202080,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202080Orig1s001ltr.pdf","2013-06-04 00:00:00",
19051,2,202080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf","2011-06-27 00:00:00",
32167,1,202080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202080s000ltr.pdf","2011-06-28 00:00:00",
40109,2,202080,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf","2013-06-03 00:00:00",
43381,3,202080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202080_oxecta_toc.cfm","2012-02-10 00:00:00",
19052,2,202080,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf","2014-01-17 00:00:00",
32168,1,202080,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202080Origs002ltr.pdf","2014-01-17 00:00:00",
32169,1,202080,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202080Orig1s003ltr.pdf","2015-01-27 00:00:00",
40110,2,202080,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf","2015-02-13 00:00:00",
46305,2,202080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf","2016-12-20 00:00:00",
46425,1,202080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf","2016-12-21 00:00:00",
46594,8,202080,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf#page=26","2016-12-29 00:00:00",
46306,2,202080,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf","2016-12-20 00:00:00",
46426,1,202080,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf","2016-12-21 00:00:00",
55565,2,202080,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf","2018-09-24 00:00:00",
55567,8,202080,"SUPPL",9,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf#page=27","2018-09-24 00:00:00",
55717,1,202080,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf","2018-10-01 00:00:00",
55566,2,202080,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf","2018-09-24 00:00:00",
55568,8,202080,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf#page=27","2018-09-24 00:00:00",
55718,1,202080,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf","2018-10-01 00:00:00",
9950,1,202088,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s001ltr.pdf","2011-10-17 00:00:00",
19053,2,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf","2011-06-16 00:00:00",
19054,2,202088,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s001lbl.pdf","2011-10-20 00:00:00",
22869,3,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088_suprenza_toc.cfm","2012-03-09 00:00:00",
22870,3,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088_suprenza_toc.cfm","2013-05-24 00:00:00",
24405,21,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088Orig2s000SumR.pdf","2013-05-24 00:00:00",
32170,1,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s000ltr.pdf","2011-06-16 00:00:00",
32171,1,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s000ltr.pdf","2012-03-29 00:00:00",
40111,2,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s000_2lbl.pdf","2012-03-28 00:00:00",
44842,21,202088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088Origs1s000SumR.pdf","2012-03-09 00:00:00",
32172,1,202088,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s002ltr.pdf","2012-03-30 00:00:00",
9951,1,202088,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088Orig1s004ltr.pdf","2012-12-11 00:00:00",
40112,2,202088,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s004lbl.pdf","2012-12-07 00:00:00",
9952,1,202088,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s005ltr.pdf","2013-06-12 00:00:00",
19055,2,202088,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf","2013-06-18 00:00:00",
9953,1,202088,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s006ltr.pdf","2013-10-17 00:00:00",
40113,2,202088,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088Orig1s006lbl.pdf","2013-11-20 00:00:00",
46906,1,202090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202090Orig1s000ltredt.pdf","2017-01-27 00:00:00",
46907,2,202090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf","2017-01-19 00:00:00",
46964,19,202090,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=361","2017-01-24 00:00:00",
46982,8,202090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18","2017-01-27 00:00:00",
9954,1,202091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202091Orig1s000ltr.pdf","2013-02-21 00:00:00",
19056,2,202091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202091s000lbl.pdf","2013-02-21 00:00:00",
24406,21,202091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000SumR.pdf","2014-01-08 00:00:00",
43382,3,202091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000TOC.cfm","2014-01-08 00:00:00",
9955,1,202091,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202091Orig1s002ltr.pdf","2014-06-02 00:00:00",
19057,2,202091,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202091Orig1s002lbl.pdf","2014-06-04 00:00:00",
9956,1,202091,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf","2016-01-11 00:00:00",
40114,2,202091,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf","2016-01-12 00:00:00",
47579,2,202091,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf","2017-03-17 00:00:00",
47596,1,202091,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203195Orig1s006,202091Orig1s005ltr.pdf","2017-03-20 00:00:00",
53527,1,202091,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202091Orig1s007,203195Orig1s008ltr.pdf","2018-03-29 00:00:00",
53567,2,202091,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf","2018-04-01 00:00:00",
9957,1,202093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093s000ltr.pdf","2012-05-24 00:00:00",
32173,1,202093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093Orig1s000ltr.pdf","2012-12-28 00:00:00",
45793,3,202093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202093Orig1s000.pdf","2016-11-02 00:00:00",
32174,1,202096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202096Orig1s000ltr.pdf","2012-08-06 00:00:00",
44577,14,202099,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24","2015-07-02 00:00:00",
19058,2,202100,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s001lbl.pdf","2013-05-21 00:00:00",
23956,10,202100,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm","2013-12-27 00:00:00",
24407,21,202100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100Orig1s000SumR.pdf","2013-07-08 00:00:00",
32175,1,202100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202100Orig1s000ltr.pdf","2012-10-02 00:00:00",
40115,2,202100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202100lbl.pdf","2012-09-28 00:00:00",
43383,3,202100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100_quillivantxr_toc.cfm","2013-07-08 00:00:00",
51360,20,202100,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202100 methylphenidate clinical prea.pdf","1900-01-01 00:00:00",
51361,18,202100,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202100 methylphenidate clinpharm prea.pdf","1900-01-01 00:00:00",
51362,17,202100,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202100 methylphenidate statistical prea.pdf","1900-01-01 00:00:00",
9958,1,202100,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s002ltr.pdf","2013-08-12 00:00:00",
40116,2,202100,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s002lbl.pdf","2013-08-12 00:00:00",
9959,1,202100,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s003ltr.pdf","2013-12-13 00:00:00",
40117,2,202100,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s003lbl.pdf","2013-12-17 00:00:00",
32176,1,202100,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s004ltr.pdf","2015-04-20 00:00:00",
40118,2,202100,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100s004lbl.pdf","2015-04-21 00:00:00",
19059,2,202100,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100Orig1s005lbl.pdf","2015-07-22 00:00:00",
32177,1,202100,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s005ltr.pdf","2015-07-14 00:00:00",
46978,2,202100,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s006lbl.pdf","2017-01-24 00:00:00",
47000,1,202100,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s006ltr.pdf","2017-01-27 00:00:00",
32178,1,202100,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202100Orig1s007ltr.pdf","2016-05-16 00:00:00",
40119,2,202100,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202100s007lbl.pdf","2016-05-17 00:00:00",
46710,2,202100,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf","2017-01-06 00:00:00",
46841,8,202100,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf#page=14","2017-01-17 00:00:00",
46842,1,202100,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s012,207960Orig1s004ltr.pdf","2017-01-17 00:00:00",
9960,1,202101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202101Orig1s000ltr.pdf","2015-04-29 00:00:00",
40120,2,202101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202101s000lbl.pdf","2015-04-29 00:00:00",
19060,2,202102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202102s000lbl.pdf","2015-04-29 00:00:00",
32179,1,202102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202102Orig1s000ltr.pdf","2015-04-29 00:00:00",
32180,1,202103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202103Orig1s000ltr.pdf","2016-06-14 00:00:00",
24099,14,202104,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
9961,1,202106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202106Orig1s000ltr.pdf","2015-05-05 00:00:00",
40121,2,202106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202106lbl.pdf","2015-05-06 00:00:00",
43384,3,202106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202106Orig1s000TOC.cfm","2015-12-09 00:00:00",
44843,21,202106,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202106Orig1s000SumR.pdf","2015-12-09 00:00:00",
51376,2,202106,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202106s003lbl.pdf","2018-01-22 00:00:00",
51871,1,202106,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202106Orig1s003ltr.pdf","2018-01-26 00:00:00",
9962,1,202107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202107s000ltr.pdf","2012-02-27 00:00:00",
19061,2,202107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf","2012-02-22 00:00:00",
43385,3,202107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cfm","2012-07-06 00:00:00",
44844,21,202107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107Orig1s000SumR.pdf","2012-07-06 00:00:00",
45703,1,202107,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202107Orig1s006ltr.pdf","2016-10-28 00:00:00",
45757,2,202107,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202107s006lbl.pdf","2016-11-01 00:00:00",
48440,2,202107,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf","2017-05-18 00:00:00",
48452,8,202107,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf#page=19","2017-05-19 00:00:00",
48498,1,202107,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202107Orig1s007ltr.pdf","2017-05-23 00:00:00",
50725,1,202118,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202118Orig1s000ApprovandTAltr.pdf","2017-12-18 00:00:00",
22871,3,202121,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000Approv.pdf","2012-10-09 00:00:00",
24100,14,202121,"ORIG",1,"Bioequivalencew Review","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/202121Orig1s000BioeqR.pdf","2012-10-15 00:00:00",
24101,14,202121,"SUPPL",1,"Labeling Review","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000LBL.pdf","2013-06-04 00:00:00",
43386,3,202121,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000Approv.pdf","2012-10-09 00:00:00",
44578,14,202121,"ORIG",1,"Labeling Review","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000LBL.pdf","2013-06-04 00:00:00",
44579,14,202121,"SUPPL",1,"Bioequivalencew Review","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/202121Orig1s000BioeqR.pdf","2012-10-15 00:00:00",
32181,1,202122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202122Orig1s000TAltr.pdf","2014-08-28 00:00:00",
19062,2,202123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf","2011-08-11 00:00:00",
32182,1,202123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202123s000ltr.pdf","2011-08-12 00:00:00",
43387,3,202123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123_compleratm_toc.cfm","2012-09-06 00:00:00",
44845,21,202123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123Orig1s000SumR.pdf","2012-09-06 00:00:00",
19063,2,202123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf","2013-01-30 00:00:00",
32183,1,202123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s003ltr.pdf","2013-01-30 00:00:00",
9963,1,202123,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202123Orig1s006ltr.pdf","2012-08-15 00:00:00",
40122,2,202123,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf","2012-08-15 00:00:00",
19064,2,202123,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf","2013-06-25 00:00:00",
32184,1,202123,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s011ltr.pdf","2013-06-21 00:00:00",
19065,2,202123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf","2013-12-17 00:00:00",
32185,1,202123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s012ltr.pdf","2013-12-17 00:00:00",
9964,1,202123,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s015ltr.pdf","2013-10-25 00:00:00",
40123,2,202123,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf","2013-10-25 00:00:00",
9965,1,202123,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s016ltr.pdf","2014-06-10 00:00:00",
19066,2,202123,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf","2014-06-10 00:00:00",
9966,1,202123,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s018ltr.pdf","2014-09-17 00:00:00",
40124,2,202123,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf","2014-10-02 00:00:00",
19067,2,202123,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf","2015-05-12 00:00:00",
32186,1,202123,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202123Orig1s020ltr.pdf","2015-05-11 00:00:00",
9967,1,202123,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf","2016-02-25 00:00:00",
52471,20,202123,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202123 complera clinical prea.pdf","1900-01-01 00:00:00",
52472,18,202123,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202123 Complera clinpharm prea.pdf","1900-01-01 00:00:00",
19068,2,202123,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf","2016-02-19 00:00:00",
32187,1,202123,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s023ltr.pdf","2016-02-11 00:00:00",
9968,1,202123,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf","2016-02-25 00:00:00",
40125,2,202123,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf","2016-02-25 00:00:00",
47906,2,202123,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202123s027lbl.pdf","2017-04-10 00:00:00",
47987,1,202123,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202123Orig1s027ltr.pdf","2017-04-12 00:00:00",
9969,1,202127,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202127Orig1s000ltr.pdf","2015-07-14 00:00:00",
22872,3,202129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129_zetonna_toc.cfm","2012-11-05 00:00:00",
32188,1,202129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202129s000ltr.pdf","2012-01-25 00:00:00",
40126,2,202129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf","2012-01-24 00:00:00",
44846,21,202129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129Orig1s000SumR.pdf","2012-11-05 00:00:00",
9970,1,202129,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf","2014-10-27 00:00:00",
40127,2,202129,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf","2014-11-18 00:00:00",
52421,20,202129,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide clinical prea.pdf","1900-01-01 00:00:00",
53035,18,202129,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide clinpharm prea.pdf","1900-01-01 00:00:00",
53036,17,202129,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide statistical prea.pdf","1900-01-01 00:00:00",
19069,2,202129,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf","2014-11-18 00:00:00",
32189,1,202129,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf","2014-10-27 00:00:00",
9971,1,202129,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf","2014-10-27 00:00:00",
40128,2,202129,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf","2014-11-18 00:00:00",
22873,3,202133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133_fluoxetine_toc.cfm","2012-04-24 00:00:00",
24408,21,202133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133Orig1s000SumR.pdf","2012-04-24 00:00:00",
32190,1,202133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202133s000ltr.pdf","2011-10-12 00:00:00",
40129,2,202133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202133s000lbl.pdf","2011-10-12 00:00:00",
32191,1,202133,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202133Orig1s003ltr.pdf","2014-07-23 00:00:00",
40130,2,202133,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202133s003lbl.pdf","2014-07-30 00:00:00",
46692,2,202133,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf","2017-01-06 00:00:00",
46744,8,202133,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf#page=40","2017-01-10 00:00:00",
46745,1,202133,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202133Orig1s004,s005ltr.pdf","2017-01-10 00:00:00",
46691,2,202133,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf","2017-01-06 00:00:00",
46746,1,202133,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202133Orig1s004,s005ltr.pdf","2017-01-10 00:00:00",
32192,1,202144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202144Orig1s000ltr.pdf","2014-05-13 00:00:00",
40131,2,202144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf","2014-08-05 00:00:00",
44580,14,202144,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
9972,1,202144,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202144Orig1s006ltr.pdf","2016-07-01 00:00:00",
40132,2,202144,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf","2016-07-08 00:00:00",
9973,1,202145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202145Orig1s000ltr.pdf","2013-10-01 00:00:00",
19070,2,202145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf","2013-10-02 00:00:00",
22874,3,202147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202147Orig1s000Approv.pdf","2012-10-09 00:00:00",
32193,1,202148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202148Orig1s000ltr.pdf","2015-09-15 00:00:00",
9974,1,202152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202152s000ltr.pdf","2012-03-30 00:00:00",
45553,1,202153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202153Orig1s000ltr.pdf","2016-10-05 00:00:00",
45587,2,202153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202153s000lbl.pdf","2016-10-24 00:00:00",
47130,3,202153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202153Orig1s000TOC.cfm","2017-02-08 00:00:00",
9975,1,202155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf","2013-01-02 00:00:00",
19071,2,202155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf","2012-12-31 00:00:00",
22875,3,202155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000TOC.cfm","2013-02-13 00:00:00",
19072,2,202155,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s002lbl.pdf","2014-01-31 00:00:00",
22876,3,202155,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202155Orig1s002TOC.cfm","2014-03-21 00:00:00",
32194,1,202155,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s002ltr.pdf","2014-02-04 00:00:00",
19073,2,202155,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s003lbl.pdf","2014-03-19 00:00:00",
32195,1,202155,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s003ltr.pdf","2014-03-14 00:00:00",
19074,2,202155,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202155Orig1s004lbl.pdf","2013-11-19 00:00:00",
32196,1,202155,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202155Orig1s004ltr.pdf","2013-11-06 00:00:00",
9976,1,202155,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s006ltr.pdf","2014-09-10 00:00:00",
19075,2,202155,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s006lbl.pdf","2014-09-09 00:00:00",
9977,1,202155,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s009ltr.pdf","2014-08-14 00:00:00",
40133,2,202155,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s009lbl.pdf","2014-08-13 00:00:00",
19076,2,202155,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s010lbl.pdf","2015-06-19 00:00:00",
32197,1,202155,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s010ltr.pdf","2015-06-18 00:00:00",
9978,1,202155,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s011ltr.pdf","2015-09-14 00:00:00",
19077,2,202155,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s011lbl.pdf","2015-09-11 00:00:00",
9979,1,202155,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s012ltr.pdf","2016-07-22 00:00:00",
40134,2,202155,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202155s012lbl.pdf","2016-07-21 00:00:00",
44989,3,202155,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202155Orig1s013.pdf","2016-05-03 00:00:00",
9980,1,202155,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s014ltr.pdf","2016-03-04 00:00:00",
50532,2,202155,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202155s017lbl.pdf","2017-11-30 00:00:00",
50563,1,202155,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202155Orig1s017ltr.pdf","2017-12-01 00:00:00",
52565,2,202155,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s018lbl.pdf","2018-02-12 00:00:00",
52630,1,202155,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202155Orig1s018ltr.pdf","2018-02-14 00:00:00",
54762,2,202155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf","2018-07-05 00:00:00",
54801,8,202155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf#page=40","2018-07-06 00:00:00",
54836,1,202155,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202155Orig1s020ltr.pdf","2018-07-06 00:00:00",
32198,1,202157,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202157s000ltr.pdf","2011-11-29 00:00:00",
52503,2,202158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s000lbl.pdf","2018-02-08 00:00:00",
52542,1,202158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s000ltr.pdf","2018-02-09 00:00:00",
52896,1,202158,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s002ltr.pdf","2018-03-12 00:00:00",
52926,2,202158,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s002lbl.pdf","2018-03-13 00:00:00",
54312,2,202158,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s003lbl.pdf","2018-05-23 00:00:00",
54327,1,202158,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s003ltr.pdf","2018-05-24 00:00:00",
54160,1,202159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202159Orig1s000ltr.pdf","2018-05-11 00:00:00",
9981,1,202161,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202161Orig1s000ltr.pdf","2014-11-05 00:00:00",
9982,1,202167,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202167Orig1s000ltr.pdf","2015-09-09 00:00:00",
9983,1,202171,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202171s000ltr.pdf","2011-09-13 00:00:00",
32199,1,202172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202172s000ltr.pdf","2011-08-08 00:00:00",
32200,1,202172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202172Orig1s000TAltr.pdf","2016-02-16 00:00:00",
55228,1,202190,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202190Orig1s000ltr.pdf","2018-08-20 00:00:00",
32201,1,202191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202191Orig1s000ltr.pdf","2014-08-19 00:00:00",
9984,1,202192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf","2011-11-16 00:00:00",
9985,1,202192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf","2012-06-25 00:00:00",
19078,2,202192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf","2011-11-16 00:00:00",
22877,3,202192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000TOC.cfm","2012-01-09 00:00:00",
40135,2,202192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf","2012-06-22 00:00:00",
44847,21,202192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000SumR.pdf","2012-01-09 00:00:00",
9986,1,202192,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf","2013-06-13 00:00:00",
19079,2,202192,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf","2013-06-18 00:00:00",
9987,1,202192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf","2013-11-27 00:00:00",
40136,2,202192,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf","2013-11-26 00:00:00",
19080,2,202192,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf","2014-07-28 00:00:00",
32202,1,202192,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf","2014-07-28 00:00:00",
19292,2,202192,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf","2014-12-04 00:00:00",
32203,1,202192,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf","2014-12-05 00:00:00",
32204,1,202192,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf","2014-12-16 00:00:00",
40137,2,202192,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf","2014-12-16 00:00:00",
9988,1,202192,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf","2016-03-14 00:00:00",
19293,2,202192,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf","2016-03-15 00:00:00",
50006,2,202192,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf","2017-10-11 00:00:00",
50024,1,202192,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s014ltr.pdf","2017-10-12 00:00:00",
50660,1,202192,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s015ltr.pdf","2017-12-12 00:00:00",
50665,2,202192,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf","2017-12-12 00:00:00",
9989,1,202194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202194s000ltr.pdf","2012-05-22 00:00:00",
43388,3,202194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202194Orig1s000.pdf","2014-01-17 00:00:00",
9990,1,202207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202207Orig1s000ltr.pdf","2013-03-15 00:00:00",
9991,1,202207,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s001ltr.pdf","2014-06-18 00:00:00",
19294,2,202207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202207s000lbl.pdf","2013-03-15 00:00:00",
19295,2,202207,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s001lbl.pdf","2014-06-17 00:00:00",
24409,21,202207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202207Orig1s000SumR.pdf","2013-04-22 00:00:00",
43389,3,202207,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202207Orig1s000TOC.cfm","2013-04-22 00:00:00",
9992,1,202207,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s002ltr.pdf","2014-10-16 00:00:00",
40138,2,202207,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf","2014-10-15 00:00:00",
47304,2,202207,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202207s005lbl.pdf","2017-02-24 00:00:00",
19296,2,202211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf","2013-11-12 00:00:00",
22878,3,202211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211_oxytrol_toc.cfm","2013-11-05 00:00:00",
24410,21,202211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf","2013-11-05 00:00:00",
32205,1,202211,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf","2013-01-30 00:00:00",
32206,1,202211,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf","2016-03-04 00:00:00",
40139,2,202211,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf","2016-03-04 00:00:00",
32207,1,202212,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202212Orig1s000ltr.pdf","2012-05-03 00:00:00",
32208,1,202227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202227s000ltr.pdf","2012-03-16 00:00:00",
32209,1,202229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202229Orig1s000ltr.pdf","2013-07-18 00:00:00",
19297,2,202231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202231s000lbl.pdf","2011-06-28 00:00:00",
22879,3,202231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231_levothyroxine_toc.cfm","2012-03-09 00:00:00",
32210,1,202231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202231s000ltr.pdf","2011-07-05 00:00:00",
44848,21,202231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231Orig1s000Sum.pdf","2012-03-09 00:00:00",
9993,1,202231,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202231Orig1s003ltr.pdf","2012-12-26 00:00:00",
19298,2,202231,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202231s003lbl.pdf","2012-12-21 00:00:00",
32211,1,202236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236s000ltr.pdf","2012-05-03 00:00:00",
32212,1,202236,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236Orig1s001ltr.pdf","2012-08-17 00:00:00",
40140,2,202236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s000lbl.pdf","2012-05-02 00:00:00",
40141,2,202236,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf","2012-08-22 00:00:00",
43390,3,202236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236_dymista_toc.cfm","2013-05-06 00:00:00",
44849,21,202236,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236Orig1s000SumR.pdf","2013-05-06 00:00:00",
54096,20,202236,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202236Orig1s000MedR.pdf","1900-01-01 00:00:00",
9994,1,202236,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202236Orig1s008ltr.pdf","2015-02-24 00:00:00",
40142,2,202236,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf","2015-02-23 00:00:00",
51256,23,202236,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N202236_azelastine_fluticasone_Original_WR.pdf","2013-09-06 00:00:00",
51874,20,202236,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202236 azelastine-fluticasone clinical bpca.pdf","1900-01-01 00:00:00",
51875,17,202236,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202236 azelastine-fluticasone statistical bpca.pdf","1900-01-01 00:00:00",
55409,1,202236,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202236Orig1s010ltr.pdf","2018-09-07 00:00:00",
55434,2,202236,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202236s010lbl.pdf","2018-09-12 00:00:00",
9995,1,202240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202240Orig1s000ltr.pdf","2015-06-11 00:00:00",
19299,2,202240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202240Orig1s000lbl.pdf","2015-06-19 00:00:00",
32213,1,202240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202240Orig1s000ltr.pdf","2015-04-10 00:00:00",
9996,1,202245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202245s000ltr.pdf","2011-07-06 00:00:00",
19300,2,202245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202245s000lbl.pdf","2011-07-06 00:00:00",
19301,2,202245,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202245s001lbl.pdf","2012-04-20 00:00:00",
22880,3,202245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245_codeine_toc.cfm","2012-02-13 00:00:00",
24411,21,202245,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245Orig1s000SumR.pdf","2012-02-13 00:00:00",
32214,1,202245,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202245s001ltr.pdf","2012-04-19 00:00:00",
32215,1,202245,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202245Orig1s002ltr.pdf","2013-05-13 00:00:00",
40143,2,202245,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202245s002lbl.pdf","2013-05-14 00:00:00",
46304,2,202245,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202245s004lbl.pdf","2016-12-20 00:00:00",
46427,1,202245,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202245Orig1s004ltr.pdf","2016-12-21 00:00:00",
49615,2,202245,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf","2017-08-30 00:00:00",
49616,8,202245,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf#page=26","2017-08-30 00:00:00",
49634,1,202245,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202245Orig1s005ltr.pdf","2017-08-31 00:00:00",
55569,2,202245,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf","2018-09-24 00:00:00",
55571,8,202245,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf#page=27","2018-09-24 00:00:00",
55719,1,202245,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202245Orig1s006s007ltr.pdf","2018-10-01 00:00:00",
55570,2,202245,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf","2018-09-24 00:00:00",
55572,8,202245,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf#page=27","2018-09-24 00:00:00",
55720,1,202245,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202245Orig1s006s007ltr.pdf","2018-10-01 00:00:00",
9997,1,202258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202258Orig1s000Ltr.pdf","2011-05-13 00:00:00",
9998,1,202258,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s001ltr.pdf","2012-08-01 00:00:00",
23486,8,202258,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255471.pdf","2011-05-17 00:00:00",
40144,2,202258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf","2011-05-13 00:00:00",
40145,2,202258,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf","2012-07-30 00:00:00",
43391,3,202258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000TOC.cfm","2011-06-15 00:00:00",
43557,5,202258,"ORIG",1,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm","2011-05-13 00:00:00",
44430,10,202258,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm291169.htm","2012-02-13 00:00:00",
44850,21,202258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000SumR.pdf","2011-06-15 00:00:00",
9999,1,202258,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258s002ltr.pdf","2012-04-24 00:00:00",
40146,2,202258,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf","2012-04-24 00:00:00",
10000,1,202258,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s003ltr.pdf","2013-02-15 00:00:00",
40147,2,202258,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf","2013-02-14 00:00:00",
10001,1,202258,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s004ltr.pdf","2013-03-01 00:00:00",
40148,2,202258,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf","2013-03-01 00:00:00",
32216,1,202258,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s005ltr.pdf","2012-11-06 00:00:00",
40149,2,202258,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf","2012-11-28 00:00:00",
19302,2,202258,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf","2012-12-28 00:00:00",
32217,1,202258,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s006ltr.pdf","2012-12-26 00:00:00",
10002,1,202258,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s007ltr.pdf","2013-02-20 00:00:00",
19303,2,202258,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf","2013-02-20 00:00:00",
10003,1,202258,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s009ltr.pdf","2013-09-19 00:00:00",
40150,2,202258,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf","2013-09-19 00:00:00",
10004,1,202258,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s011ltr.pdf","2014-04-10 00:00:00",
19304,2,202258,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf","2014-04-10 00:00:00",
19305,2,202258,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf","2014-01-22 00:00:00",
32218,1,202258,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s012ltr.pdf","2014-01-21 00:00:00",
10005,1,202258,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s013ltr.pdf","2014-02-11 00:00:00",
40151,2,202258,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf","2014-02-10 00:00:00",
10006,1,202258,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s014ltr.pdf","2014-02-26 00:00:00",
19306,2,202258,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf","2014-02-25 00:00:00",
32219,1,202258,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s015ltr.pdf","2014-07-29 00:00:00",
40152,2,202258,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf","2014-07-29 00:00:00",
47064,2,202258,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf","2017-01-30 00:00:00",
47070,1,202258,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202258Orig1s016ltr.pdf","2017-01-31 00:00:00",
32220,1,202259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202259Orig1s000ltr.pdf","2015-12-29 00:00:00",
22881,3,202268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202268Orig1s000Approv.pdf","2012-10-09 00:00:00",
10007,1,202270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf","2012-02-06 00:00:00",
19307,2,202270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf","2012-02-06 00:00:00",
24412,21,202270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf","2013-09-03 00:00:00",
43392,3,202270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.cfm","2013-09-03 00:00:00",
10008,1,202270,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf","2012-10-22 00:00:00",
19308,2,202270,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf","2012-10-22 00:00:00",
10009,1,202270,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf","2013-02-13 00:00:00",
40153,2,202270,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf","2013-02-11 00:00:00",
32221,1,202270,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf","2014-02-13 00:00:00",
40154,2,202270,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf","2014-02-13 00:00:00",
10010,1,202270,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf","2015-04-29 00:00:00",
40155,2,202270,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf","2015-05-04 00:00:00",
19309,2,202270,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf","2015-09-04 00:00:00",
32222,1,202270,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf","2015-09-01 00:00:00",
46924,2,202270,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf","2017-01-18 00:00:00",
46933,1,202270,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf","2017-01-24 00:00:00",
46925,2,202270,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf","2017-01-18 00:00:00",
46932,1,202270,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf","2017-01-24 00:00:00",
49352,2,202270,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf","2017-08-14 00:00:00",
49407,1,202270,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf","2017-08-15 00:00:00",
52556,2,202270,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf","2018-02-12 00:00:00",
52561,8,202270,"SUPPL",18,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf#page=32","2018-02-12 00:00:00",
52635,1,202270,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf","2018-02-14 00:00:00",
10011,1,202276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276s000ltr.pdf","2012-04-27 00:00:00",
10012,1,202276,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276Orig1s001ltr.pdf","2012-11-06 00:00:00",
19310,2,202276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf","2012-04-27 00:00:00",
22882,3,202276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202276Orig1s000TOC.cfm","2012-06-04 00:00:00",
40156,2,202276,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf","2012-11-06 00:00:00",
10013,1,202276,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s005ltr.pdf","2014-09-18 00:00:00",
40157,2,202276,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf","2014-09-19 00:00:00",
19311,2,202276,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf","2014-05-02 00:00:00",
32223,1,202276,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s006ltr.pdf","2014-04-30 00:00:00",
32224,1,202276,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s010ltr.pdf","2015-05-19 00:00:00",
40158,2,202276,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf","2015-06-05 00:00:00",
10014,1,202276,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s013ltr.pdf","2015-09-17 00:00:00",
40159,2,202276,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf","2015-09-23 00:00:00",
49441,2,202276,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s016lbl.pdf","2017-08-17 00:00:00",
49561,1,202276,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s016ltr.pdf","2017-08-29 00:00:00",
50007,2,202276,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s017lbl.pdf","2017-10-11 00:00:00",
50028,1,202276,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s017ltr.pdf","2017-10-12 00:00:00",
55121,2,202276,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202276s018lbl.pdf","2018-08-06 00:00:00",
55126,1,202276,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202276Orig1s018ltr.pdf","2018-08-07 00:00:00",
24413,21,202278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000SumR.pdf","2013-11-25 00:00:00",
32225,1,202278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf","2013-01-22 00:00:00",
32226,1,202278,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf","2014-03-25 00:00:00",
40160,2,202278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf","2013-01-22 00:00:00",
40161,2,202278,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf","2014-03-25 00:00:00",
43393,3,202278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000TOC.cfm","2013-11-25 00:00:00",
19312,2,202278,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf","2014-03-25 00:00:00",
32227,1,202278,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf","2014-03-25 00:00:00",
22883,3,202286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2014/202286Orig1s000.pdf","2016-07-29 00:00:00",
19313,2,202292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202292s000lbl.pdf","2012-12-31 00:00:00",
32228,1,202292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202292Orig1s000ltr.pdf","2013-01-02 00:00:00",
43394,3,202292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000TOC.cfm","2013-02-19 00:00:00",
44851,21,202292,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000SumR.pdf","2013-02-19 00:00:00",
52876,2,202292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf","2018-03-08 00:00:00",
52910,1,202292,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202292Orig1s006ltr.pdf","2018-03-12 00:00:00",
10015,1,202293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf","2014-01-10 00:00:00",
22884,3,202293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000TOC.cfm","2014-02-11 00:00:00",
24414,21,202293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf","2014-02-11 00:00:00",
40162,2,202293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf","2014-01-10 00:00:00",
10016,1,202293,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf","2015-03-12 00:00:00",
19314,2,202293,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf","2015-03-17 00:00:00",
10017,1,202293,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf","2014-08-11 00:00:00",
19315,2,202293,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf","2014-08-12 00:00:00",
32229,1,202293,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf","2015-12-08 00:00:00",
40163,2,202293,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf","2015-12-08 00:00:00",
10018,1,202293,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf","2016-06-16 00:00:00",
40164,2,202293,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf","2016-06-17 00:00:00",
45049,1,202293,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s010ltr.pdf","2016-08-17 00:00:00",
45091,2,202293,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf","2016-08-22 00:00:00",
47395,2,202293,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf","2017-03-02 00:00:00",
47460,1,202293,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s011ltr.pdf","2017-03-03 00:00:00",
50134,1,202293,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s012ltr.pdf","2017-10-23 00:00:00",
50159,2,202293,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf","2017-10-24 00:00:00",
50207,8,202293,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf#page=29","2017-10-27 00:00:00",
48079,1,202294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202294Orig1s000ltr.pdf","2017-04-21 00:00:00",
48170,2,202294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202294Orig1s000lbl.pdf","2017-05-01 00:00:00",
32230,1,202301,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202301Orig1s000ltr.pdf","2012-06-22 00:00:00",
47415,1,202306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202306Orig1s000ltr.pdf","2017-03-02 00:00:00",
10019,1,202308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202308Orig1s000TAltr.pdf","2014-02-26 00:00:00",
10020,1,202309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202309Orig1s000ltr.pdf","2015-11-30 00:00:00",
19316,2,202309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202309Orig1s000lbl.pdf","2015-12-11 00:00:00",
10021,1,202310,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202310Orig1s000ltr.pdf","2015-11-03 00:00:00",
22885,3,202317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000TOC.cfm","2014-03-14 00:00:00",
23491,8,202317,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366908.pdf","2013-08-30 00:00:00",
24415,21,202317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000SumR.pdf","2014-03-14 00:00:00",
32231,1,202317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202317Orig1s000ltr.pdf","2013-08-27 00:00:00",
40165,2,202317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf","2013-08-27 00:00:00",
32232,1,202317,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202317Orig1s004ltr.pdf","2015-11-03 00:00:00",
40166,2,202317,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf","2015-11-04 00:00:00",
10022,1,202319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202319s000ltr.pdf","2012-05-22 00:00:00",
10023,1,202324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202324s000ltr.pdf","2012-01-31 00:00:00",
10024,1,202324,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202324Orig1s001ltr.pdf","2013-09-17 00:00:00",
19317,2,202324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf","2012-01-27 00:00:00",
19318,2,202324,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf","2013-09-16 00:00:00",
24416,21,202324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000SumR.pdf","2012-02-27 00:00:00",
43395,3,202324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000TOC.cfm","2012-02-27 00:00:00",
10025,1,202324,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s002ltr.pdf","2014-08-04 00:00:00",
40167,2,202324,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf","2014-08-04 00:00:00",
19319,2,202324,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf","2015-12-29 00:00:00",
32233,1,202324,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s003ltr.pdf","2014-12-31 00:00:00",
55171,2,202324,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf","2018-08-13 00:00:00",
55201,1,202324,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202324Orig1s008ltr.pdf","2018-08-17 00:00:00",
19320,2,202331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202331lbl.pdf","2012-01-24 00:00:00",
22886,3,202331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331_edarbyclor_toc_.cfm","2012-08-16 00:00:00",
32234,1,202331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202331s000ltr.pdf","2011-12-27 00:00:00",
44852,21,202331,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331Orig1s000SumR.pdf","2012-08-16 00:00:00",
10026,1,202331,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202331Orig1s002ltr_replacement.pdf","2012-10-04 00:00:00",
19321,2,202331,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202331s002lbl.pdf","2012-10-05 00:00:00",
10027,1,202331,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf","2014-04-21 00:00:00",
19322,2,202331,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202331s006lbl.pdf","2014-07-24 00:00:00",
32235,1,202331,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202331Orig1s006ltr.pdf","2014-07-24 00:00:00",
32236,1,202331,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202331Orig1s007ltr.pdf","2015-04-17 00:00:00",
40168,2,202331,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202331s007lbl.pdf","2015-04-17 00:00:00",
45646,1,202331,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202331Orig1s011ltr.pdf","2016-10-26 00:00:00",
10028,1,202342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000ltr.pdf","2013-08-08 00:00:00",
10029,1,202342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.pdf","2013-05-01 00:00:00",
19323,2,202342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202342s000lbl.pdf","2013-08-09 00:00:00",
43396,3,202342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202342Orig1s000TOC.cfm","2013-11-13 00:00:00",
19324,2,202342,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf","2014-12-29 00:00:00",
32237,1,202342,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202342Orig1s002ltr.pdf","2014-12-23 00:00:00",
45645,1,202342,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202342Orig1s003ltr.pdf","2016-10-26 00:00:00",
52256,2,202342,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202342s003lbl.pdf","2018-02-01 00:00:00",
54533,2,202342,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf","2018-06-12 00:00:00",
54534,8,202342,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf#page=29","2018-06-12 00:00:00",
54585,1,202342,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202342Orig1s005ltr.pdf","2018-06-14 00:00:00",
10030,1,202343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202343s000ltr.pdf","2011-10-07 00:00:00",
23492,8,202343,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf","2011-10-07 00:00:00",
32238,1,202343,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf","2012-09-24 00:00:00",
40169,2,202343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf","2011-10-07 00:00:00",
40170,2,202343,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf","2012-09-20 00:00:00",
43397,3,202343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000TOC.cfm","2012-07-13 00:00:00",
44853,21,202343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000SumR.pdf","2012-07-13 00:00:00",
10031,1,202343,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf","2012-09-24 00:00:00",
19325,2,202343,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf","2012-09-20 00:00:00",
10032,1,202343,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf","2012-09-24 00:00:00",
19326,2,202343,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf","2012-09-20 00:00:00",
32239,1,202343,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf","2012-11-06 00:00:00",
40171,2,202343,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf","2012-11-06 00:00:00",
10033,1,202343,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s006ltr.pdf","2013-02-13 00:00:00",
40172,2,202343,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf","2013-02-11 00:00:00",
19327,2,202343,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf","2012-11-06 00:00:00",
32240,1,202343,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf","2012-11-06 00:00:00",
19328,2,202343,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf","2013-10-31 00:00:00",
32241,1,202343,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s008ltr.pdf","2013-10-28 00:00:00",
19329,2,202343,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf","2013-08-19 00:00:00",
32242,1,202343,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s010ltr.pdf","2013-08-22 00:00:00",
19330,2,202343,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf","2014-02-25 00:00:00",
32243,1,202343,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202343Orig1s011ltr.pdf","2014-02-26 00:00:00",
10034,1,202344,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202344Orig1s001ltr.pdf","2013-04-23 00:00:00",
19331,2,202344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202344s000lbl.pdf","2012-08-30 00:00:00",
24102,14,202344,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM318435.pdf","2012-08-30 00:00:00",
32244,1,202344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202344s000ltr.pdf","2012-03-26 00:00:00",
40173,2,202344,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf","2013-04-23 00:00:00",
43398,3,202344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344_binosto_toc.cfm","2013-04-29 00:00:00",
44854,21,202344,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000SumR.pdf","2013-04-29 00:00:00",
52748,8,202344,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/BinostoMedGuide.pdf","2018-02-28 00:00:00",
19332,2,202344,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s002lbl.pdf","2013-08-09 00:00:00",
19333,2,202344,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s007lbl.pdf","2015-03-03 00:00:00",
32245,1,202344,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s007ltr.pdf","2015-02-27 00:00:00",
19334,2,202344,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf","2015-04-10 00:00:00",
32246,1,202344,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s008ltr.pdf","2015-04-13 00:00:00",
32247,1,202344,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s010ltr.pdf","2016-03-24 00:00:00",
46634,1,202344,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s011ltr.pdf","2017-01-03 00:00:00",
46650,2,202344,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202344s011lbl.pdf","2017-01-03 00:00:00",
10035,1,202356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202356Orig1s000ltr.pdf","2014-03-18 00:00:00",
22887,3,202356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202356Orig1s000TOC.cfm","2015-02-06 00:00:00",
40174,2,202356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202356s000lbl.pdf","2014-03-19 00:00:00",
44855,21,202356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202356Orig1s000SumR.pdf","2015-02-06 00:00:00",
50482,2,202356,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202356s002lbl.pdf","2017-11-24 00:00:00",
50498,1,202356,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202356Orig1S002ltr.pdf","2017-11-27 00:00:00",
55621,2,202356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf","2018-09-26 00:00:00",
55749,1,202356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s011,202356Orig1s003ltr.pdf","2018-10-01 00:00:00",
43399,3,202357,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202357Orig1s000.pdf","2015-03-09 00:00:00",
19336,2,202379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf","2011-04-28 00:00:00",
32249,1,202379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202379s000ltr.pdf","2011-05-03 00:00:00",
43400,3,202379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000TOC.cfm","2011-05-27 00:00:00",
44856,21,202379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000SumR.pdf","2011-05-27 00:00:00",
10036,1,202379,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379s003ltr.pdf","2012-07-09 00:00:00",
40175,2,202379,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s003lbl.pdf","2012-07-13 00:00:00",
32250,1,202379,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s004ltr.pdf","2012-09-20 00:00:00",
40176,2,202379,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s004lbl.pdf","2012-09-17 00:00:00",
10037,1,202379,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s005ltr.pdf","2012-12-12 00:00:00",
19337,2,202379,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s005lbl.pdf","2012-12-14 00:00:00",
45794,3,202379,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202379Orig1s005.pdf","2016-11-02 00:00:00",
22888,3,202379,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202379Orig1s006.pdf","2014-01-16 00:00:00",
10038,1,202379,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202379Orig1s007ltr.pdf","2013-09-13 00:00:00",
19338,2,202379,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202379s007lbl.pdf","2013-09-17 00:00:00",
54304,3,202379,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/202379Orig1s007.pdf","2018-05-22 00:00:00",
10039,1,202379,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202379Orig1s009ltr.pdf","2014-05-19 00:00:00",
19339,2,202379,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202379s009lbl.pdf","2014-05-15 00:00:00",
10040,1,202379,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s015ltr.pdf","2015-01-26 00:00:00",
40177,2,202379,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s015lbl.pdf","2015-01-29 00:00:00",
19340,2,202379,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf","2015-03-24 00:00:00",
32251,1,202379,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s016ltr.pdf","2015-03-24 00:00:00",
10041,1,202379,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s018ltr.pdf","2015-05-22 00:00:00",
19341,2,202379,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s018lbl.pdf","2015-05-27 00:00:00",
19342,2,202379,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s021lbl.pdf","2015-12-15 00:00:00",
32252,1,202379,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s021ltr.pdf","2015-12-11 00:00:00",
32253,1,202379,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202379Orig1s023ltr.pdf","2016-05-19 00:00:00",
40178,2,202379,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202379s023lbl.pdf","2016-05-20 00:00:00",
52522,1,202379,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202379Orig1s024ltr.pdf","2018-02-08 00:00:00",
52563,2,202379,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s024lbl.pdf","2018-02-12 00:00:00",
55617,2,202379,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s025lbl.pdf","2018-09-26 00:00:00",
55746,1,202379,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202379Orig1s025ltr.pdf","2018-10-01 00:00:00",
10042,1,202381,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202381s000ltr.pdf","2012-02-03 00:00:00",
32254,1,202385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202385s000ltr.pdf","2011-12-27 00:00:00",
10043,1,202402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202402Orig1s000ltr.pdf","2016-04-01 00:00:00",
19343,2,202402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202402Orig1s000lbl.pdf","2016-04-11 00:00:00",
10044,1,202428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202428s000ltr.pdf","2012-05-16 00:00:00",
22889,3,202428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202428_fabior_toc.cfm","2012-11-05 00:00:00",
40179,2,202428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202428lbl.pdf","2012-05-15 00:00:00",
44857,21,202428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202428Orig1s000SumR.pdf","2012-11-05 00:00:00",
24417,21,202429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429Orig1s000SumR.pdf","2011-08-17 00:00:00",
32255,1,202429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202429Orig1s000ltr.pdf","2011-08-17 00:00:00",
40180,2,202429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf","2011-08-17 00:00:00",
43401,3,202429,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202429s000TOC.cfm","2011-10-21 00:00:00",
10045,1,202429,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf","2013-07-05 00:00:00",
40181,2,202429,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf","2013-07-05 00:00:00",
19344,2,202429,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf","2013-07-05 00:00:00",
32256,1,202429,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf","2013-07-05 00:00:00",
19345,2,202429,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf","2014-03-20 00:00:00",
32257,1,202429,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s004ltr.pdf","2014-03-20 00:00:00",
10046,1,202429,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s005ltr.pdf","2014-02-11 00:00:00",
19346,2,202429,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf","2014-02-07 00:00:00",
10047,1,202429,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s006ltr.pdf","2014-11-28 00:00:00",
40182,2,202429,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf","2014-12-03 00:00:00",
32258,1,202429,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202429Orig1s008ltr.pdf","2015-08-12 00:00:00",
40183,2,202429,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf","2015-08-12 00:00:00",
45161,2,202429,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf","2016-08-31 00:00:00",
45192,1,202429,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s009ltr.pdf","2016-08-31 00:00:00",
10048,1,202429,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s010ltr.pdf","2016-05-11 00:00:00",
19347,2,202429,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf","2016-05-11 00:00:00",
48055,1,202429,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s012ltr.pdf","2017-04-18 00:00:00",
48062,2,202429,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf","2017-04-18 00:00:00",
49805,1,202429,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s014ltr.pdf","2017-09-19 00:00:00",
49804,1,202429,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s015ltr.pdf","2017-09-19 00:00:00",
50292,2,202429,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf","2017-11-06 00:00:00",
50293,8,202429,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf#page=21","2017-11-06 00:00:00",
50355,1,202429,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s016ltr.pdf","2017-11-09 00:00:00",
54732,3,202429,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/202429Orig1s016TOC.cfm","2018-07-02 00:00:00",
32259,1,202435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202435Orig1s000ltr.pdf","2014-06-23 00:00:00",
19348,2,202439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf","2014-06-03 00:00:00",
32260,1,202439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf","2014-06-03 00:00:00",
43402,3,202439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439toc.cfm","2014-06-03 00:00:00",
10049,1,202439,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202439Orig1s008ltr.pdf","2013-08-08 00:00:00",
19349,2,202439,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf","2013-08-09 00:00:00",
32261,1,202439,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf","2014-02-13 00:00:00",
10050,1,202439,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202439Orig1s015ltr.pdf","2015-09-14 00:00:00",
40184,2,202439,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202439s015lbl.pdf","2015-09-11 00:00:00",
32262,1,202439,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s017ltr.pdf","2016-05-09 00:00:00",
40185,2,202439,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s017lbl.pdf","2016-05-09 00:00:00",
45273,1,202439,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s019ltr.pdf","2016-09-08 00:00:00",
45541,1,202439,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s020ltr.pdf","2016-10-14 00:00:00",
47281,2,202439,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s020lbl.pdf","2017-02-22 00:00:00",
47786,2,202439,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202439s021lbl.pdf","2017-03-30 00:00:00",
47841,1,202439,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202439Orig1s021ltr.pdf","2017-04-03 00:00:00",
55047,1,202439,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s023Ltr.pdf","2018-07-30 00:00:00",
52527,2,202439,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s024lbl.pdf","2018-02-09 00:00:00",
52546,1,202439,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s024ltr.pdf","2018-02-09 00:00:00",
55878,2,202439,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf","2018-10-11 00:00:00",
55879,8,202439,"SUPPL",25,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf#page=53","2018-10-11 00:00:00",
54763,2,202439,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf","2018-07-05 00:00:00",
54802,8,202439,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf#page=46","2018-07-06 00:00:00",
54835,1,202439,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s027ltr.pdf","2018-07-06 00:00:00",
10051,1,202440,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202440Orig1s000ltr.pdf","2015-09-23 00:00:00",
10052,1,202450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202450Orig1s000ltr.pdf","2012-07-25 00:00:00",
19350,2,202450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf","2012-07-24 00:00:00",
24418,21,202450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000SumR.pdf","2012-09-05 00:00:00",
43403,3,202450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000TOC.cfm","2012-09-05 00:00:00",
10053,1,202450,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s002ltr.pdf","2014-07-21 00:00:00",
19351,2,202450,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202450s002lbl.pdf","2014-07-22 00:00:00",
10054,1,202450,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s003ltr.pdf","2014-11-03 00:00:00",
19352,2,202450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202450s005lbl.pdf","2015-04-07 00:00:00",
32263,1,202450,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202450Orig1s005ltr.pdf","2015-04-06 00:00:00",
32264,1,202450,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202450Orig1s006ltr.pdf","2016-03-18 00:00:00",
40186,2,202450,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202450s006lbl.pdf","2016-03-17 00:00:00",
32265,1,202459,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202459Orig1s000ltr.pdf","2013-04-09 00:00:00",
10056,1,202467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202467Orig1s000ltr.pdf","2013-02-08 00:00:00",
10057,1,202468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202468Orig1s000ltr.pdf","2012-08-06 00:00:00",
48648,1,202470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202470Orig1s000TAltr.pdf","2017-06-06 00:00:00",
32266,1,202489,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202489Orig1s000ltr.pdf","2013-10-11 00:00:00",
40187,2,202489,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202489Orig1s000lbl.pdf","2013-11-20 00:00:00",
19353,2,202497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf","2012-08-09 00:00:00",
32267,1,202497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202497Orig1s000ltr.pdf","2012-08-10 00:00:00",
43404,3,202497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202497_marqibo_toc.cfm","2013-09-03 00:00:00",
44858,21,202497,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202497Orig1s000SumR.pdf","2013-09-03 00:00:00",
32268,1,202503,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202503Orig1s000ltr.pdf","2012-11-07 00:00:00",
10058,1,202509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202509Orig1s000ltr.pdf","2014-02-27 00:00:00",
47435,1,202511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202511Orig1s000ltr.pdf","2017-03-03 00:00:00",
47469,2,202511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202511Orig1s000lbl.pdf","2017-03-06 00:00:00",
10059,1,202513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202513s000ltr.pdf","2011-12-14 00:00:00",
40188,2,202513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf","2011-12-13 00:00:00",
43405,3,202513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513_anturol_toc.cfm","2012-06-26 00:00:00",
44859,21,202513,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513Orig1s000SumR.pdf","2012-06-26 00:00:00",
32269,1,202513,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202513Orig1s003ltr_replacement.pdf","2013-01-11 00:00:00",
40189,2,202513,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf","2013-01-11 00:00:00",
10060,1,202513,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202513Orig1s005ltr.pdf","2015-07-13 00:00:00",
19354,2,202513,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf","2015-07-13 00:00:00",
10061,1,202514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202514s000ltr.pdf","2012-02-14 00:00:00",
10062,1,202514,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202514Orig1s001ltr.pdf","2013-02-26 00:00:00",
19355,2,202514,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf","2013-02-26 00:00:00",
22890,3,202514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202514s000TOC.cfm","2012-03-13 00:00:00",
40190,2,202514,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf","2012-02-13 00:00:00",
10063,1,202514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf","2015-09-22 00:00:00",
40191,2,202514,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf","2015-09-08 00:00:00",
10064,1,202514,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf","2015-09-22 00:00:00",
19356,2,202514,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf","2015-09-08 00:00:00",
19357,2,202515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000Lbl.pdf","2011-11-14 00:00:00",
32270,1,202515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202515s000ltr.pdf","2011-11-28 00:00:00",
43406,3,202515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515_morphine_sulfate_toc.cfm","2012-06-26 00:00:00",
44860,21,202515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000SumR.pdf","2012-06-26 00:00:00",
46303,2,202515,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202515s006lbl.pdf","2016-12-20 00:00:00",
46428,1,202515,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202515Orig1s006ltr.pdf","2016-12-21 00:00:00",
10065,1,202517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s000ltr.pdf","2014-08-29 00:00:00",
32271,1,202517,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202517Orig1s002ltr.pdf","2014-09-04 00:00:00",
32272,1,202521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202521Orig1s000ltr.pdf","2015-10-14 00:00:00",
10066,1,202526,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202526Orig1s000TAltr.pdf","2014-08-28 00:00:00",
10067,1,202529,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202529Orig1s000ltr.pdf","2013-05-22 00:00:00",
10068,1,202535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202535Orig1s000ltr.pdf","2012-07-17 00:00:00",
19358,2,202535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf","2012-07-18 00:00:00",
22891,3,202535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535_prepopik_toc.cfm","2012-08-03 00:00:00",
24419,21,202535,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535Orig1s000SumR.pdf","2012-08-03 00:00:00",
55188,2,202535,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf","2018-08-16 00:00:00",
55189,8,202535,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf#page=15","2018-08-16 00:00:00",
55208,1,202535,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202535Orig1s005ltr.pdf","2018-08-20 00:00:00",
10069,1,202542,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202542Orig1s000ltr.pdf","2013-08-20 00:00:00",
10070,1,202543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202543s000ltr.pdf","2011-11-14 00:00:00",
40192,2,202543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202543lbl.pdf","2011-11-10 00:00:00",
43407,3,202543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543_levetiracetam_toc.cfm","2012-06-14 00:00:00",
44861,21,202543,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543Orig1s000SumR.pdf","2012-06-14 00:00:00",
45920,1,202543,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf","2016-11-22 00:00:00",
45934,2,202543,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf","2016-11-21 00:00:00",
45919,1,202543,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf","2016-11-22 00:00:00",
45935,2,202543,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf","2016-11-21 00:00:00",
48708,2,202543,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202543s010lbl.pdf","2017-06-13 00:00:00",
48712,1,202543,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202543Orig1s010ltr.pdf","2017-06-13 00:00:00",
54876,2,202543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202543s011lbl.pdf","2018-07-13 00:00:00",
54898,1,202543,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202543Orig1s011Ltr.pdf","2018-07-16 00:00:00",
32273,1,202552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202552Orig1s000ltr.pdf","2015-12-29 00:00:00",
10071,1,202564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202564Orig1s000ltr.pdf","2015-06-16 00:00:00",
32274,1,202565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202565Orig1s000ltr.pdf","2015-05-11 00:00:00",
40193,2,202565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202565Orig1s000lbl.pdf","2015-05-07 00:00:00",
32275,1,202567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202567Orig1s000ltr.pdf","2013-07-19 00:00:00",
40194,2,202567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202567Orig1s000lbl.pdf","2013-09-19 00:00:00",
10072,1,202568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202568Orig1s000ltr.pdf","2015-06-10 00:00:00",
10073,1,202570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202570s000ltr.pdf","2011-08-30 00:00:00",
19359,2,202570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf","2011-08-26 00:00:00",
22892,3,202570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000TOC.cfm","2011-09-27 00:00:00",
44862,21,202570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000SumR.pdf","2011-09-27 00:00:00",
10074,1,202570,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s002ltr.pdf","2012-02-29 00:00:00",
40195,2,202570,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf","2012-03-15 00:00:00",
32276,1,202570,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s003ltr.pdf","2012-02-29 00:00:00",
40196,2,202570,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf","2012-02-28 00:00:00",
10075,1,202570,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s004ltr.pdf","2013-03-01 00:00:00",
40197,2,202570,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf","2013-03-15 00:00:00",
32277,1,202570,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s006ltr.pdf","2013-11-25 00:00:00",
40198,2,202570,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf","2013-11-22 00:00:00",
10076,1,202570,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570s007,s009ltr.pdf","2013-10-08 00:00:00",
40199,2,202570,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf","2013-10-08 00:00:00",
10077,1,202570,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s007,s009ltr.pdf","2013-10-08 00:00:00",
40200,2,202570,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf","2013-10-07 00:00:00",
32278,1,202570,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202570Orig1s011ltr.pdf","2014-06-02 00:00:00",
40201,2,202570,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf","2014-05-30 00:00:00",
10078,1,202570,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s013ltr.pdf","2015-03-24 00:00:00",
19360,2,202570,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf","2015-03-24 00:00:00",
32279,1,202570,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s014ltr.pdf","2015-09-16 00:00:00",
40202,2,202570,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf","2015-09-23 00:00:00",
19361,2,202570,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf","2016-03-11 00:00:00",
45692,1,202570,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s016ltr.pdf","2016-10-28 00:00:00",
10079,1,202570,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s017ltr.pdf","2016-05-04 00:00:00",
40203,2,202570,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf","2016-05-03 00:00:00",
10080,1,202570,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s018ltr.pdf","2016-05-02 00:00:00",
40204,2,202570,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf","2016-04-29 00:00:00",
48175,2,202570,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s019lbl.pdf","2017-05-01 00:00:00",
48203,1,202570,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s019ltr.pdf","2017-05-02 00:00:00",
46980,2,202570,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s020lbl.pdf","2017-01-24 00:00:00",
47001,1,202570,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s020ltr.pdf","2017-01-27 00:00:00",
49045,2,202570,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf","2017-07-25 00:00:00",
49068,1,202570,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s021ltr.pdf","2017-07-25 00:00:00",
52504,2,202570,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s023lbl.pdf","2018-02-08 00:00:00",
52521,1,202570,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570Orig1s023ltr.pdf","2018-02-08 00:00:00",
52520,1,202570,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570Orig1s024ltr.pdf","2018-02-08 00:00:00",
10081,1,202573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202573Orig1s000ltr.pdf","2015-01-16 00:00:00",
19362,2,202573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202573Orig1s000lbl.pdf","2015-02-17 00:00:00",
32280,1,202577,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202577Orig1s000TA_ltr.pdf","2015-03-10 00:00:00",
10082,1,202578,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202578Orig1s000ltr.pdf","2015-06-04 00:00:00",
32281,1,202580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202580Orig1s000ltr.pdf","2013-12-05 00:00:00",
32282,1,202583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202583s000ltr.pdf","2011-12-05 00:00:00",
55229,1,202586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202586Orig1s000ltr.pdf","2018-08-20 00:00:00",
10083,1,202589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202589s000ltr.pdf","2012-02-10 00:00:00",
10084,1,202593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202593Orig1s000ltr.pdf","2015-04-27 00:00:00",
45088,2,202595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202595Orig1s000lbl.pdf","2016-08-22 00:00:00",
32283,1,202598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202598Orig1s000ltr.pdf","2012-11-07 00:00:00",
32284,1,202603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202603Orig1s000ltr.pdf","2015-06-11 00:00:00",
10085,1,202608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202608Orig1s000ltr.pdf","2013-01-03 00:00:00",
43408,3,202608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202608Orig1s000Approv.pdf","2013-01-22 00:00:00",
22893,3,202611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202611Orig1s000TOC.cfm","2012-08-10 00:00:00",
32285,1,202611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202611Orig1s000ltr.pdf","2012-06-28 00:00:00",
40205,2,202611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf","2012-06-28 00:00:00",
19363,2,202611,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s005lbl.pdf","2015-11-04 00:00:00",
32286,1,202611,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s005ltr.pdf","2015-11-04 00:00:00",
10086,1,202611,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s006ltr.pdf","2015-08-11 00:00:00",
19364,2,202611,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s006lbl.pdf","2015-08-11 00:00:00",
45082,2,202611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202611s007lbl.pdf","2016-08-17 00:00:00",
45129,1,202611,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202611Orig1s007ltr.pdf","2016-08-16 00:00:00",
53986,1,202611,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202611Orig1s011ltr.pdf","2018-05-03 00:00:00",
54035,2,202611,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202611s011lbl.pdf","2018-05-07 00:00:00",
49163,2,202611,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202611s012lbl.pdf","2017-07-31 00:00:00",
49193,1,202611,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202611Orig1s012ltr.pdf","2017-08-02 00:00:00",
10087,1,202620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202620Orig1s000ltr.pdf","2014-06-25 00:00:00",
19365,2,202620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202620Orig1lbl.pdf","2014-07-31 00:00:00",
10088,1,202632,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202632Orig1s000ltr.pdf","2014-03-06 00:00:00",
50726,1,202634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202634Orig1s000ltr.pdf","2017-12-18 00:00:00",
10089,1,202645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202645Orig1s000ltr.pdf","2015-08-06 00:00:00",
43409,3,202651,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202651Orig1s000Approv.pdf","2013-02-26 00:00:00",
10090,1,202653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202653Orig1s000ltr.pdf","2013-08-29 00:00:00",
10091,1,202662,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202662Orig1s000ltr.pdf","2015-09-24 00:00:00",
40206,2,202662,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202662Orig1s000lbl.pdf","2015-11-25 00:00:00",
10092,1,202667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202667s000ltr.pdf","2012-02-03 00:00:00",
19366,2,202667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202667s000lbl.pdf","2012-02-06 00:00:00",
22894,3,202667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202667_cosoptpf_toc.cfm","2012-11-13 00:00:00",
24420,21,202667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202667Orig1s000SumR.pdf","2012-11-13 00:00:00",
10093,1,202685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202685Orig1s000ltr.pdf","2012-09-24 00:00:00",
32287,1,202687,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202687Orig1s000ltr.pdf","2014-06-10 00:00:00",
10094,1,202688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202688Orig1s000ltr.pdf","2015-08-28 00:00:00",
19367,2,202688,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202688Orig1s000lbl.pdf","2015-10-15 00:00:00",
49885,1,202711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202711Orig1s000ltr.pdf","2017-09-29 00:00:00",
10095,1,202713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202713Orig1s000ltr.pdf","2015-04-08 00:00:00",
19368,2,202714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf","2012-07-20 00:00:00",
32288,1,202714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf","2012-07-20 00:00:00",
43410,3,202714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000TOC.cfm","2012-08-20 00:00:00",
44863,21,202714,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000SumR.pdf","2012-08-20 00:00:00",
19369,2,202714,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf","2015-04-07 00:00:00",
32289,1,202714,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s008ltr.pdf","2015-04-03 00:00:00",
32290,1,202714,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s009ltr.pdf","2015-07-27 00:00:00",
40207,2,202714,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf","2015-07-24 00:00:00",
32291,1,202714,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf","2016-01-22 00:00:00",
40208,2,202714,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf","2016-01-26 00:00:00",
10096,1,202714,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s011ltr.pdf","2016-05-25 00:00:00",
40209,2,202714,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf","2016-05-25 00:00:00",
10097,1,202714,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714s012ltr.pdf","2016-07-06 00:00:00",
19370,2,202714,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf","2016-07-06 00:00:00",
44986,1,202714,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s013ltr.pdf","2016-08-04 00:00:00",
44998,2,202714,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf","2016-08-04 00:00:00",
45908,1,202714,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s015ltr.pdf","2016-11-18 00:00:00",
45986,2,202714,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s015lbl.pdf","2016-12-01 00:00:00",
48559,2,202714,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf","2017-05-30 00:00:00",
48563,1,202714,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202714Orig1s016ltr.pdf","2017-05-30 00:00:00",
51076,1,202714,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s017ltr.pdf","2018-01-17 00:00:00",
51091,2,202714,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s017lbl.pdf","2018-01-18 00:00:00",
54493,2,202714,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf","2018-06-11 00:00:00",
54558,1,202714,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s019ltr.pdf","2018-06-14 00:00:00",
55770,1,202714,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s021ltr.pdf","2018-10-01 00:00:00",
55793,2,202714,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s021lbl.pdf","2018-10-03 00:00:00",
10098,1,202718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202718Orig1s000ltr.pdf","2015-01-06 00:00:00",
44583,14,202718,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-01-26 00:00:00",
24103,14,202720,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-06 00:00:00",
19371,2,202723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202723Orig1s000lbl.pdf","2013-09-19 00:00:00",
32292,1,202723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202723Orig1s000ltr.pdf","2013-07-26 00:00:00",
22895,3,202727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202727Orig1s000.pdf","2015-07-20 00:00:00",
32293,1,202727,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202727s000ltr.pdf","2012-05-22 00:00:00",
10099,1,202731,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202731Orig1s000TAltr.pdf","2013-12-06 00:00:00",
32294,1,202731,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202731Orig1s000ltr.pdf","2013-12-06 00:00:00",
19372,2,202736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf","2012-02-09 00:00:00",
24421,21,202736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736Orig1s000SumR.pdf","2013-01-02 00:00:00",
32295,1,202736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202736s000ltr.pdf","2012-02-10 00:00:00",
43411,3,202736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736_sklice_toc.cfm","2013-01-02 00:00:00",
53299,20,202736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202736_ ivermectin_ clinical_ prea_2.pdf","1900-01-01 00:00:00",
53300,18,202736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202736_ ivermectin_clinpharm_ prea_2.pdf","1900-01-01 00:00:00",
53301,17,202736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202736_ivermectin_ statistical_ prea_2.pdf","1900-01-01 00:00:00",
48760,2,202736,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202736s003lbl.pdf","2017-06-19 00:00:00",
48773,1,202736,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202736Orig1s003ltr.pdf","2017-06-19 00:00:00",
32296,1,202738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202738Orig1s000TAltr.pdf","2016-03-04 00:00:00",
10100,1,202755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202755Orig1s000ltr.pdf","2016-03-02 00:00:00",
10101,1,202763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202763s000ltr.pdf","2012-02-17 00:00:00",
19373,2,202763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000lbl.pdf","2012-02-17 00:00:00",
24104,14,202763,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=57","2012-03-06 00:00:00",
32297,1,202763,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s001ltr.pdf","2014-07-24 00:00:00",
40210,2,202763,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s001lbl.pdf","2014-07-24 00:00:00",
43412,3,202763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000TOC.cfm","2012-04-17 00:00:00",
43957,8,202763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000mg.pdf","2012-02-17 00:00:00",
44864,21,202763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000SumR.pdf","2012-04-17 00:00:00",
10102,1,202763,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s002ltr.pdf","2014-06-23 00:00:00",
40211,2,202763,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s002lbl.pdf","2014-06-23 00:00:00",
10103,1,202763,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202763Orig1s003ltr.pdf","2015-05-13 00:00:00",
40212,2,202763,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf","2015-05-13 00:00:00",
45679,1,202763,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202763Orig1s004ltr.pdf","2016-10-27 00:00:00",
45748,2,202763,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202763s004lbl.pdf","2016-11-01 00:00:00",
10104,1,202768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202768Orig1s000ltr.pdf","2014-10-21 00:00:00",
10105,1,202784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202784Orig1s000ltr.pdf","2015-09-23 00:00:00",
19374,2,202784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202784Orig1s000lbl.pdf","2015-11-25 00:00:00",
22896,3,202788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788_subsys_toc.cfm","2012-09-06 00:00:00",
24105,14,202788,"ORIG",1,"Medication Guide","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM287863.pdf","2012-06-15 00:00:00",
24106,14,202788,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60","2012-02-01 00:00:00",
32298,1,202788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s000ltr.pdf","2012-01-06 00:00:00",
32299,1,202788,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf","2012-06-07 00:00:00",
40213,2,202788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s000lbl.pdf","2012-01-06 00:00:00",
40214,2,202788,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf","2012-06-11 00:00:00",
44865,21,202788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Orig1s000SumR.pdf","2012-09-06 00:00:00",
19375,2,202788,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf","2012-08-31 00:00:00",
32300,1,202788,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788Orig1s002ltr.pdf","2012-09-04 00:00:00",
32301,1,202788,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf","2012-06-07 00:00:00",
40215,2,202788,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf","2012-06-11 00:00:00",
32302,1,202788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf","2013-08-05 00:00:00",
40216,2,202788,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf","2013-08-09 00:00:00",
10106,1,202788,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf","2013-08-05 00:00:00",
40217,2,202788,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf","2013-08-09 00:00:00",
10107,1,202788,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf","2014-12-31 00:00:00",
19376,2,202788,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf","2015-01-09 00:00:00",
10108,1,202788,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s010ltr.pdf","2013-11-12 00:00:00",
19377,2,202788,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf","2015-01-09 00:00:00",
32303,1,202788,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf","2014-12-31 00:00:00",
10109,1,202788,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf","2014-12-31 00:00:00",
40218,2,202788,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf","2015-01-09 00:00:00",
46302,2,202788,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf","2016-12-20 00:00:00",
46429,1,202788,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202788Orig1s016ltr.pdf","2016-12-21 00:00:00",
46597,8,202788,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf#page=38","2016-12-30 00:00:00",
49716,1,202788,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202788Orig1s018ltr.pdf","2017-09-11 00:00:00",
32304,1,202795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202795Orig1s000ltr.pdf","2013-01-25 00:00:00",
10110,1,202799,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s001ltr.pdf","2012-12-06 00:00:00",
22897,3,202799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202799_Omontys_Orig1s000TOC.cfm","2012-05-03 00:00:00",
23496,8,202799,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf","2012-03-27 00:00:00",
32305,1,202799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s000ltr.pdf","2012-03-27 00:00:00",
40219,2,202799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf","2012-03-27 00:00:00",
40220,2,202799,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf","2012-12-05 00:00:00",
44584,14,202799,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=40","2012-03-28 00:00:00",
10111,1,202801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202801Orig1s000ltr.pdf","2015-01-12 00:00:00",
32306,1,202802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202802Orig1s000TAltr.pdf","2015-11-04 00:00:00",
10112,1,202806,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s001ltr.pdf","2013-12-31 00:00:00",
24107,14,202806,"ORIG",1,"Office Director Memo","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000ODMemo.pdf","2013-06-07 00:00:00",
32307,1,202806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s000ltr.pdf","2013-05-30 00:00:00",
40221,2,202806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf","2013-05-29 00:00:00",
40222,2,202806,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf","2013-12-30 00:00:00",
43413,3,202806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202806Orig1s000TOC.cfm","2013-07-05 00:00:00",
44866,21,202806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000SumR.pdf","2013-06-07 00:00:00",
19378,2,202806,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf","2014-01-10 00:00:00",
32308,1,202806,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.pdf","2014-01-14 00:00:00",
10113,1,202806,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202806Orig1s004ltr.pdf","2015-11-23 00:00:00",
19379,2,202806,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf","2015-11-20 00:00:00",
19380,2,202806,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf","2016-06-21 00:00:00",
48808,2,202806,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf","2017-06-22 00:00:00",
48829,1,202806,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202806Orig1s006ltr.pdf","2017-06-26 00:00:00",
48758,2,202806,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s007lbl.pdf","2017-06-19 00:00:00",
53873,2,202806,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf","2018-04-30 00:00:00",
53990,1,202806,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s008ltr.pdf","2018-05-03 00:00:00",
53744,2,202806,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s009lbl.pdf","2018-04-20 00:00:00",
53786,1,202806,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s009ltr.pdf","2018-04-23 00:00:00",
54017,2,202806,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf","2018-05-04 00:00:00",
54018,8,202806,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf#page=37","2018-05-04 00:00:00",
54044,1,202806,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s010ltr.pdf","2018-05-08 00:00:00",
19381,2,202810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf","2012-10-22 00:00:00",
22898,3,202810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810_oxtellarxr_toc.cfm","2012-11-29 00:00:00",
23497,8,202810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf","2012-10-22 00:00:00",
24422,21,202810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810Orig1s000SumR.pdf","2012-11-29 00:00:00",
32309,1,202810,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202810Org1s000ltr.pdf","2012-10-23 00:00:00",
51531,20,202810,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine clinical prea.pdf","1900-01-01 00:00:00",
51532,18,202810,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine clinpharm prea.pdf","1900-01-01 00:00:00",
51533,17,202810,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine statistical prea.pdf","1900-01-01 00:00:00",
19382,2,202810,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf","2015-12-08 00:00:00",
32310,1,202810,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202810Orig1s005ltr.pdf","2015-12-08 00:00:00",
19383,2,202811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf","2012-08-31 00:00:00",
32311,1,202811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202811Orig1s000ltr.pdf","2012-08-31 00:00:00",
43414,3,202811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000TOC.cfm","2012-10-04 00:00:00",
44867,21,202811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000SumR.pdf","2012-10-04 00:00:00",
32312,1,202811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202811Orig1s003ltr.pdf","2013-08-12 00:00:00",
40223,2,202811,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202811s003lbl.pdf","2013-08-12 00:00:00",
32313,1,202811,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202811Orig1s004ltr.pdf","2014-07-10 00:00:00",
40224,2,202811,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202811s004lbl.pdf","2014-07-11 00:00:00",
10114,1,202811,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s007ltr.pdf","2016-04-08 00:00:00",
40225,2,202811,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s007lbl.pdf","2016-04-07 00:00:00",
19384,2,202811,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf","2015-11-25 00:00:00",
32314,1,202811,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202811Orig1s009ltr.pdf","2015-11-24 00:00:00",
46977,2,202811,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s010lbl.pdf","2017-01-25 00:00:00",
47004,1,202811,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s010ltr.pdf","2017-01-27 00:00:00",
45191,1,202811,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s011ltr.pdf","2016-08-31 00:00:00",
45209,2,202811,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf","2016-08-31 00:00:00",
47515,2,202811,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf","2017-03-09 00:00:00",
47526,8,202811,"SUPPL",13,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf#page=20","2017-03-13 00:00:00",
47543,1,202811,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s013ltr.pdf","2017-03-14 00:00:00",
19385,2,202813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202813s000lbl.pdf","2012-03-27 00:00:00",
22899,3,202813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813_qnasl_toc.cfm","2013-06-10 00:00:00",
32315,1,202813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202813s000ltr.pdf","2012-03-27 00:00:00",
44868,21,202813,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813Orig1s000SumR.pdf","2013-06-10 00:00:00",
32316,1,202813,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s005ltr.pdf","2014-03-20 00:00:00",
40226,2,202813,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s005lbl.pdf","2014-03-20 00:00:00",
10115,1,202813,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s006ltr.pdf","2014-07-11 00:00:00",
10116,1,202813,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf","2014-12-18 00:00:00",
40227,2,202813,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf","2014-12-19 00:00:00",
51885,20,202813,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/139_202813 beclomethasone clinical prea.pdf","1900-01-01 00:00:00",
51886,18,202813,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202813 beclomethasone clinpharm prea.pdf","1900-01-01 00:00:00",
51887,17,202813,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202813 beclomethasone statistical prea.pdf","1900-01-01 00:00:00",
19386,2,202813,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf","2014-12-19 00:00:00",
32317,1,202813,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf","2014-12-18 00:00:00",
49088,2,202813,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202813s011lbl.pdf","2017-07-27 00:00:00",
49115,1,202813,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202813Orig1s011ltr.pdf","2017-07-28 00:00:00",
32318,1,202814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202814s000ltr.pdf","2012-06-18 00:00:00",
10117,1,202832,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832Orig1s001ltr.pdf","2012-10-02 00:00:00",
32319,1,202832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832s000ltr.pdf","2012-01-10 00:00:00",
40228,2,202832,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf","2012-09-28 00:00:00",
43415,3,202832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202832_sodiumc_toc.cfm","2012-10-25 00:00:00",
50564,1,202832,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202832Orig1s002ltr.pdf","2017-12-01 00:00:00",
19387,2,202833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202833lbl.pdf","2012-01-25 00:00:00",
32320,1,202833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202833s000ltr.pdf","2012-01-30 00:00:00",
43416,3,202833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202833Orig1s000TOC.cfm","2012-03-02 00:00:00",
32321,1,202833,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202833Orig1s002ltr.pdf","2014-03-14 00:00:00",
40229,2,202833,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202833Orig1s002lbl.pdf","2014-03-26 00:00:00",
10118,1,202833,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s004ltr.pdf","2015-11-20 00:00:00",
40230,2,202833,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s004lbl.pdf","2015-11-25 00:00:00",
10119,1,202833,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s005ltr.pdf","2015-10-07 00:00:00",
19388,2,202833,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf","2015-10-08 00:00:00",
45326,1,202833,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202833Orig1s007ltr.pdf","2016-09-15 00:00:00",
45405,2,202833,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202833s007lbl.pdf","2016-09-15 00:00:00",
10120,1,202834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202834Orig1s000ltr.pdf","2012-10-26 00:00:00",
10121,1,202834,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202834Orig1s001ltr.pdf","2013-07-03 00:00:00",
19389,2,202834,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf","2013-07-11 00:00:00",
22900,3,202834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202834Orig1s000TOC.cfm","2012-11-28 00:00:00",
40231,2,202834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf","2012-10-26 00:00:00",
51559,20,202834,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel clinical prea.pdf","1900-01-01 00:00:00",
51561,18,202834,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel clinpharm_prea.pdf","1900-01-01 00:00:00",
51562,17,202834,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel statistical prea.pdf","1900-01-01 00:00:00",
32322,1,202834,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s003ltr.pdf","2014-02-26 00:00:00",
10122,1,202834,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s004ltr.pdf","2014-02-19 00:00:00",
19390,2,202834,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf","2014-02-19 00:00:00",
19391,2,202834,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf","2015-06-23 00:00:00",
32323,1,202834,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202834Orig1s005ltr.pdf","2015-06-24 00:00:00",
52947,18,202834,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel clinpharm prea (1).pdf","1900-01-01 00:00:00",
52948,17,202834,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel statistical prea (2).pdf","1900-01-01 00:00:00",
52949,20,202834,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel Clinical 2 prea (1).pdf","1900-01-01 00:00:00",
19392,2,202834,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf","2014-11-20 00:00:00",
32324,1,202834,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s006ltr.pdf","2014-11-17 00:00:00",
45824,2,202834,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202834s011lbl.pdf","2016-11-07 00:00:00",
45828,1,202834,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202834Orig1s011ltr.pdf","2016-11-08 00:00:00",
52950,17,202834,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202834 perampanel statistical prea.pdf","1900-01-01 00:00:00",
49105,1,202834,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202834Orig1s012,208277Orig1s001ltr.pdf","2017-07-28 00:00:00",
49131,2,202834,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf","2017-07-28 00:00:00",
49134,8,202834,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24","2017-07-28 00:00:00",
51464,20,202834,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/158_202834S012 perampanel clinical prea.pdf","1900-01-01 00:00:00",
51465,18,202834,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/159_202834S012 perampanel clinpharm prea.pdf","1900-01-01 00:00:00",
55763,1,202834,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202834Orig1s014,208277Orig1s002ltr.pdf","2018-10-01 00:00:00",
55800,2,202834,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf","2018-10-03 00:00:00",
55803,8,202834,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24","2018-10-03 00:00:00",
32325,1,202840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202840Orig1s000TAltr.pdf","2014-08-29 00:00:00",
46034,1,202842,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202842Orig1s000ltr.pdf","2016-12-06 00:00:00",
10123,1,202857,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202857Orig1s000ltr.pdf","2014-09-16 00:00:00",
32326,1,202864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202864Orig1s000ltr.pdf","2015-09-09 00:00:00",
32327,1,202865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202865Orig1s000ltr.pdf","2015-09-09 00:00:00",
10124,1,202867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202867Orig1s000ltr.pdf","2014-09-08 00:00:00",
22901,3,202869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202869Orig1s000Approv.pdf","2012-10-09 00:00:00",
19393,2,202872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf","2012-10-01 00:00:00",
22902,3,202872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872_lotemax_toc.cfm","2012-12-04 00:00:00",
32328,1,202872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202872Orig1s000ltr.pdf","2012-10-03 00:00:00",
44869,21,202872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872Orig1s000SumR.pdf","2012-12-04 00:00:00",
54944,1,202872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202872Orig1s002Ltr.pdf","2018-07-23 00:00:00",
55356,2,202872,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202872s002lbl.pdf","2018-08-29 00:00:00",
10125,1,202873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202873Orig1s000ltr.pdf","2015-11-30 00:00:00",
44585,14,202873,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-11-30 00:00:00",
10126,1,202880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdf","2013-10-25 00:00:00",
19394,2,202880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf","2013-10-25 00:00:00",
24108,14,202880,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2014-04-01 00:00:00",
43417,3,202880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202880Orig1s000TOC.cfm","2014-04-14 00:00:00",
44870,21,202880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880Orig1s000SumR.pdf","2013-11-15 00:00:00",
19395,2,202880,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf","2014-08-20 00:00:00",
32329,1,202880,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202880Orig1s002ltr.pdf","2014-08-20 00:00:00",
32330,1,202880,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s003ltr.pdf","2015-02-05 00:00:00",
40232,2,202880,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf","2015-02-17 00:00:00",
44871,21,202880,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003SumR.pdf","2015-02-06 00:00:00",
32331,1,202880,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s006ltr.pdf","2015-07-07 00:00:00",
10127,1,202880,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s007ltr.pdf","2016-04-22 00:00:00",
46320,2,202880,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf","2016-12-20 00:00:00",
46441,1,202880,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf","2016-12-21 00:00:00",
46579,8,202880,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf#page=28","2016-12-29 00:00:00",
46321,2,202880,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf","2016-12-20 00:00:00",
46442,1,202880,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf","2016-12-21 00:00:00",
45449,1,202880,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s011ltr.pdf","2016-10-03 00:00:00",
48585,1,202880,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202880Orig1s012ltr.pdf","2017-05-31 00:00:00",
55558,2,202880,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf","2018-09-21 00:00:00",
55560,8,202880,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf#page=29","2018-09-21 00:00:00",
55721,1,202880,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf","2018-10-01 00:00:00",
55559,2,202880,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf","2018-09-21 00:00:00",
55561,8,202880,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf#page=29","2018-09-21 00:00:00",
55722,1,202880,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf","2018-10-01 00:00:00",
32332,1,202884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202884Orig1s000ltr.pdf","2012-12-06 00:00:00",
10128,1,202895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf","2011-12-27 00:00:00",
22903,3,202895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895_prezista_toc.cfm","2012-09-06 00:00:00",
24423,21,202895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895Orig1s000SumR.pdf","2012-09-06 00:00:00",
32333,1,202895,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895s001ltr.pdf","2012-02-29 00:00:00",
40233,2,202895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf","2011-12-23 00:00:00",
40234,2,202895,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s001lbl.pdf","2012-03-15 00:00:00",
51505,23,202895,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021976_Prezista_Original_WRltr.pdf","2006-11-17 00:00:00",
51507,25,202895,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021976_Prezista_Amendment_1ltr.pdf","2007-08-16 00:00:00",
52600,18,202895,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202895 darunavir Prezista clinpharm prea.pdf","1900-01-01 00:00:00",
10129,1,202895,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf","2012-06-07 00:00:00",
40235,2,202895,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf","2012-06-05 00:00:00",
10130,1,202895,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895Orig1s003ltr.pdf","2012-11-14 00:00:00",
40236,2,202895,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf","2012-11-15 00:00:00",
19396,2,202895,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf","2013-04-29 00:00:00",
32334,1,202895,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf","2013-04-25 00:00:00",
19397,2,202895,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf","2013-02-06 00:00:00",
32335,1,202895,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf","2013-02-04 00:00:00",
10131,1,202895,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf","2013-02-04 00:00:00",
19398,2,202895,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf","2013-02-06 00:00:00",
32336,1,202895,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf","2013-02-26 00:00:00",
40237,2,202895,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf","2013-02-26 00:00:00",
10132,1,202895,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf","2013-11-08 00:00:00",
19399,2,202895,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf","2013-11-08 00:00:00",
32337,1,202895,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf","2014-04-08 00:00:00",
40238,2,202895,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf","2014-04-08 00:00:00",
19400,2,202895,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf","2015-05-29 00:00:00",
32338,1,202895,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf","2015-05-28 00:00:00",
10133,1,202895,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf","2015-04-01 00:00:00",
40239,2,202895,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf","2015-04-02 00:00:00",
10134,1,202895,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf","2016-06-21 00:00:00",
40240,2,202895,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf","2016-06-21 00:00:00",
45308,2,202895,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf","2016-09-15 00:00:00",
45336,1,202895,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf","2016-09-20 00:00:00",
48792,1,202895,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021976Orig1s045,202895Orig1s020ltr.pdf","2017-06-22 00:00:00",
48896,2,202895,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf","2017-07-05 00:00:00",
52098,1,202895,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021976Orig1s047,202895Orig1s021ltr.pdf","2018-01-30 00:00:00",
52424,2,202895,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf","2018-02-06 00:00:00",
55440,1,202895,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202895Orig1s51,021976Orig1s022Ltr.pdf","2018-09-12 00:00:00",
32339,1,202912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202912Orig1s000ltr.pdf","2013-12-09 00:00:00",
10135,1,202916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202916Orig1s000TAltr.pdf","2013-11-20 00:00:00",
50340,1,202934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202934Orig1s000ltr.pdf","2017-11-08 00:00:00",
48365,1,202939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202939Orig1s000ltr.pdf","2017-05-12 00:00:00",
48374,2,202939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202939Orig1s000lbl.pdf","2017-05-15 00:00:00",
32340,1,202941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202941Orig1s000ltr.pdf","2014-01-03 00:00:00",
40241,2,202941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202941Orig1s000_lbl.pdf","2014-01-13 00:00:00",
24109,14,202946,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
32341,1,202956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202956Orig1s000ltr.pdf","2015-10-02 00:00:00",
10136,1,202958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf","2015-03-04 00:00:00",
40242,2,202958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf","2015-03-12 00:00:00",
10137,1,202960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202960Orig1s000ltr.pdf","2014-03-20 00:00:00",
19401,2,202964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf","2016-05-05 00:00:00",
32342,1,202964,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202964Orig1s000ltr.pdf","2016-05-04 00:00:00",
32343,1,202969,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202969Orig1s000ltr.pdf","2014-09-02 00:00:00",
10138,1,202971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202971Orig1s000ltr.pdf","2013-03-01 00:00:00",
19402,2,202971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf","2013-03-15 00:00:00",
22904,3,202971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971s000TOC.cfm","2013-04-11 00:00:00",
44872,21,202971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971Orig1s000SumR.pdf","2013-04-11 00:00:00",
40243,2,202971,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s002lbl.pdf","2014-06-03 00:00:00",
10139,1,202971,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202971Orig1s003ltr.pdf","2014-12-09 00:00:00",
19403,2,202971,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s003lbl.pdf","2014-12-10 00:00:00",
43418,3,202971,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202971Orig1s003TOC.cfm","2015-07-27 00:00:00",
40244,2,202971,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s004lbl.pdf","2014-09-30 00:00:00",
32344,1,202971,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202971Orig1s006ltr.pdf","2015-07-30 00:00:00",
40245,2,202971,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202971s006lbl.pdf","2015-07-30 00:00:00",
10140,1,202971,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf","2016-01-20 00:00:00",
19404,2,202971,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s008lbl.pdf","2016-01-22 00:00:00",
45101,2,202971,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s009lbl.pdf","2016-08-23 00:00:00",
45146,1,202971,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf","2016-08-18 00:00:00",
49150,2,202971,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf","2017-07-31 00:00:00",
49180,1,202971,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202971Orig1s010ltr.pdf","2017-08-02 00:00:00",
49289,8,202971,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf#page=56","2017-08-08 00:00:00",
47323,2,202971,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s011lbl.pdf","2017-02-24 00:00:00",
47428,1,202971,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf","2017-03-02 00:00:00",
10141,1,202978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202978s000ltr.pdf","2013-01-23 00:00:00",
40246,2,202978,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202978Orig1s000lbl.pdf","2014-01-14 00:00:00",
32345,1,202984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202984Orig1s000ltr.pdf","2013-10-01 00:00:00",
32346,1,202990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202990s000ltr.pdf","2012-06-28 00:00:00",
10142,1,202992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202992Orig1s000ltr.pdf","2012-09-14 00:00:00",
19405,2,202992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf","2012-09-14 00:00:00",
19406,2,202992,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202992s001lbl.pdf","2014-10-21 00:00:00",
22905,3,202992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000TOC.cfm","2012-11-05 00:00:00",
32347,1,202992,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202992Orig1s001ltr.pdf","2014-10-22 00:00:00",
44873,21,202992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000SumR.pdf","2012-11-05 00:00:00",
45978,1,202992,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s002ltr.pdf","2016-12-01 00:00:00",
45994,2,202992,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s002lbl.pdf","2016-12-01 00:00:00",
10143,1,202992,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s003ltr.pdf","2016-06-06 00:00:00",
40247,2,202992,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf","2016-06-06 00:00:00",
46082,8,202992,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf#page=25","2016-12-06 00:00:00",
50904,1,202992,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202992Orig1s004ltr.pdf","2017-12-27 00:00:00",
24110,14,203005,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37","2015-07-02 00:00:00",
10144,1,203006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203006Orig1s000ltr.pdf","2013-08-06 00:00:00",
10145,1,203010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203010Orig1s000ltr.pdf","2014-02-27 00:00:00",
10146,1,203020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203020Orig1s000ltr.pdf","2015-12-09 00:00:00",
32348,1,203030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203030Orig1s000ltr.pdf","2015-10-21 00:00:00",
32349,1,203032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203032Orig1s000ltr.pdf","2015-05-26 00:00:00",
32350,1,203036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203036Orig1s000ltr.pdf","2016-01-22 00:00:00",
19407,2,203039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf","2015-12-01 00:00:00",
32351,1,203039,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203039Orig1s000ltr.pdf","2015-11-30 00:00:00",
44586,14,203039,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-11-30 00:00:00",
10147,1,203041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203041Orig1s000ltr.pdf","2013-04-04 00:00:00",
19408,2,203045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/203045s000lbl.pdf","2011-12-23 00:00:00",
19409,2,203045,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf","2012-03-28 00:00:00",
22906,3,203045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045_isentress_toc.cfm","2012-04-30 00:00:00",
32352,1,203045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/203045s000ltr.pdf","2011-12-27 00:00:00",
32353,1,203045,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf","2012-04-02 00:00:00",
44874,21,203045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045Orig1s000SumR.pdf","2012-04-30 00:00:00",
19410,2,203045,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf","2012-04-20 00:00:00",
32354,1,203045,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf","2012-04-23 00:00:00",
32355,1,203045,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf","2012-08-15 00:00:00",
40248,2,203045,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf","2012-08-15 00:00:00",
10148,1,203045,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf","2013-07-02 00:00:00",
40249,2,203045,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf","2013-07-03 00:00:00",
10149,1,203045,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf","2013-04-09 00:00:00",
19411,2,203045,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf","2013-04-09 00:00:00",
19412,2,203045,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s007lbl.pdf","2013-08-06 00:00:00",
32356,1,203045,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf","2013-08-06 00:00:00",
19413,2,203045,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf","2013-10-25 00:00:00",
32357,1,203045,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf","2013-10-25 00:00:00",
32358,1,203045,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf","2013-12-31 00:00:00",
40250,2,203045,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf","2013-12-23 00:00:00",
32359,1,203045,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf","2014-04-10 00:00:00",
40251,2,203045,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf","2014-04-10 00:00:00",
10150,1,203045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf","2015-02-19 00:00:00",
40252,2,203045,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf","2015-02-20 00:00:00",
32360,1,203045,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf","2015-02-24 00:00:00",
40253,2,203045,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf","2015-02-23 00:00:00",
48578,2,203045,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf","2017-05-31 00:00:00",
48598,1,203045,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022145Orig1s036,203045Orig1s013,205786Orig1s004ltr.pdf","2017-05-31 00:00:00",
50475,2,203045,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf","2017-11-24 00:00:00",
50504,1,203045,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205786Orig1s006,022145Orig1s037,203045Orig1s014ltr.pdf","2017-12-06 00:00:00",
52828,2,203045,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf","2018-03-06 00:00:00",
52912,1,203045,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s038,205786Orig1s007,203045Orig2s015ltr.pdf","2018-03-12 00:00:00",
22907,3,203049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049_argatroban_toc.cfm","2013-06-04 00:00:00",
24424,21,203049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049Orig1s000SumR.pdf","2013-06-04 00:00:00",
32361,1,203049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203049s000ltr.pdf","2012-01-09 00:00:00",
40254,2,203049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203049s000lbl.pdf","2012-01-06 00:00:00",
45448,1,203049,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s004ltr.pdf","2016-10-03 00:00:00",
45582,2,203049,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf","2016-10-06 00:00:00",
48862,3,203049,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203049Orig1s004.pdf","2017-06-29 00:00:00",
19414,2,203049,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf","2016-06-01 00:00:00",
32362,1,203049,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s005ltr.pdf","2016-05-27 00:00:00",
32363,1,203050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203050Orig1s000TAltr.pdf","2012-11-06 00:00:00",
32364,1,203050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203050Orig1s000ltr.pdf","2016-03-03 00:00:00",
40255,2,203050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203050s000lbl.pdf","2016-03-03 00:00:00",
46134,3,203050,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203050Orig1s000TOC.cfm","2016-12-13 00:00:00",
10151,1,203053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203053Orig1s000TAltr.pdf","2013-11-06 00:00:00",
19415,2,203058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203058Orig1s000lbl.pdf","2014-09-23 00:00:00",
32365,1,203058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203058Orig1s000ltr.pdf","2014-09-24 00:00:00",
32366,1,203076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203076Orig1s000ltr.pdf","2012-10-18 00:00:00",
19416,2,203085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf","2012-09-27 00:00:00",
19417,2,203085,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203085s001lbl.pdf","2013-06-04 00:00:00",
24425,21,203085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000SumR.pdf","2012-10-26 00:00:00",
32367,1,203085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203085Orig1s000ltr.pdf","2012-09-27 00:00:00",
32368,1,203085,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203085Orig1s001ltr.pdf","2013-05-31 00:00:00",
43419,3,203085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000TOC.cfm","2012-10-26 00:00:00",
10152,1,203085,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203085Orig1s004ltr.pdf","2015-04-16 00:00:00",
40256,2,203085,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203085s004lbl.pdf","2015-04-14 00:00:00",
10153,1,203085,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s005ltr.pdf","2016-06-08 00:00:00",
45058,1,203085,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s006ltr.pdf","2016-08-26 00:00:00",
45173,2,203085,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203085s006lbl.pdf","2016-08-26 00:00:00",
48129,2,203085,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203085s007lbl.pdf","2017-04-27 00:00:00",
48215,1,203085,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203085Orig1s007.pdf","2017-05-02 00:00:00",
54632,1,203085,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203085Orig1s008ltr.pdf","2018-06-20 00:00:00",
54669,2,203085,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203085s008lbl.pdf","2018-06-21 00:00:00",
54331,1,203088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203088Orig1s007ltr.pdf","2018-05-24 00:00:00",
10154,1,203093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203093Orig1s000ltr.pdf","2014-09-26 00:00:00",
19418,2,203093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203093s000lbl.pdf","2014-09-26 00:00:00",
43420,3,203093,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203093Orig1VITEKTAtoc.cfm","2016-03-28 00:00:00",
10155,1,203093,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203093Orig1s002ltr.pdf","2015-07-28 00:00:00",
40257,2,203093,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203093s002lbl.pdf","2015-07-30 00:00:00",
10156,1,203094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf","2014-09-29 00:00:00",
19419,2,203094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf","2014-10-03 00:00:00",
22908,3,203094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000TOC.cfm","2015-05-28 00:00:00",
24426,21,203094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf","2015-05-28 00:00:00",
32369,1,203094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf","2014-09-26 00:00:00",
32370,1,203094,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203094Orig1s003ltr.pdf","2015-11-27 00:00:00",
40258,2,203094,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf","2015-12-01 00:00:00",
10157,1,203094,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203094Orig1s005ltr.pdf","2016-06-21 00:00:00",
40259,2,203094,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf","2016-06-21 00:00:00",
48247,2,203094,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf","2017-05-05 00:00:00",
48295,1,203094,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s007ltr.pdf","2017-05-09 00:00:00",
49586,2,203094,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf","2017-08-30 00:00:00",
49632,1,203094,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s008ltr.pdf","2017-08-30 00:00:00",
55057,1,203094,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203094Orig1s011ltr.pdf","2018-07-30 00:00:00",
55150,2,203094,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s011lbl.pdf","2018-08-10 00:00:00",
10158,1,203098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203098Orig1s000ltr.pdf","2013-02-04 00:00:00",
19420,2,203098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf","2013-02-01 00:00:00",
22909,3,203098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000TOC.cfm","2013-06-28 00:00:00",
24111,14,203098,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=317","2015-07-07 00:00:00",
24427,21,203098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000SumR.pdf","2013-06-28 00:00:00",
19421,2,203098,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf","2014-06-23 00:00:00",
32371,1,203098,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203098Orig1s002ltr.pdf","2014-06-23 00:00:00",
10159,1,203098,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203098Orig1s006ltr.pdf","2015-05-13 00:00:00",
40260,2,203098,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf","2015-05-13 00:00:00",
45680,1,203098,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203098Orig1s009ltr.pdf","2016-10-27 00:00:00",
45742,2,203098,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf","2016-11-01 00:00:00",
19422,2,203100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf","2012-08-28 00:00:00",
22910,3,203100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000TOC.cfm","2012-10-10 00:00:00",
32372,1,203100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/0203100Orig1s000ltr.pdf","2012-08-29 00:00:00",
44875,21,203100,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000SumR.pdf","2012-10-10 00:00:00",
52456,57,203100,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/73_203100 Stribild CDTL prea.pdf","1900-01-01 00:00:00",
52457,18,203100,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/74_203100 Stribild clinpharm prea.pdf","1900-01-01 00:00:00",
10160,1,203100,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s004ltr.pdf","2013-10-08 00:00:00",
19423,2,203100,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf","2013-10-08 00:00:00",
32373,1,203100,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s009ltr.pdf","2013-10-25 00:00:00",
40261,2,203100,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf","2013-10-25 00:00:00",
32374,1,203100,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s010ltr.pdf","2014-09-02 00:00:00",
40262,2,203100,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf","2014-09-03 00:00:00",
10161,1,203100,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s011ltr.pdf","2014-12-18 00:00:00",
19424,2,203100,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf","2014-12-19 00:00:00",
32375,1,203100,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203100Orig1s016ltr.pdf","2015-07-30 00:00:00",
40263,2,203100,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf","2015-07-30 00:00:00",
19425,2,203100,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf","2016-02-23 00:00:00",
32376,1,203100,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s021ltr.pdf","2016-02-23 00:00:00",
45284,1,203100,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s024ltr.pdf","2016-09-19 00:00:00",
45305,2,203100,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf","2016-09-15 00:00:00",
47033,2,203100,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s025lbl.pdf","2017-01-27 00:00:00",
47042,1,203100,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s025ltr.pdf","2017-01-31 00:00:00",
47908,2,203100,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s028lbl.pdf","2017-04-10 00:00:00",
47985,1,203100,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s028ltr.pdf","2017-04-12 00:00:00",
48248,2,203100,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf","2017-05-05 00:00:00",
48288,1,203100,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s029ltr.pdf","2017-05-09 00:00:00",
49642,1,203100,"SUPPL",30,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s030ltr.pdf","2017-08-31 00:00:00",
49645,2,203100,"SUPPL",30,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s030lbl.pdf","2017-08-31 00:00:00",
55143,2,203100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s032lbl.pdf","2018-08-09 00:00:00",
55154,1,203100,"SUPPL",32,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203100Orig1s032ltr.pdf","2018-08-10 00:00:00",
45554,1,203102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203102Orig1s000TAltr.pdf","2016-10-07 00:00:00",
22911,3,203108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000TOC.cfm","2014-09-08 00:00:00",
24428,21,203108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000SumR.pdf","2014-09-08 00:00:00",
32377,1,203108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203108Orig1s000ltr.pdf","2014-08-01 00:00:00",
40264,2,203108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203108s000lbl.pdf","2014-08-01 00:00:00",
52754,8,203108,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/striverdi respimatMedGuide2016.pdf","2018-02-28 00:00:00",
10162,1,203108,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203108Orig1s003ltr.pdf","2016-06-10 00:00:00",
19426,2,203108,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203108s003lbl.pdf","2016-06-13 00:00:00",
53597,2,203108,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203108s006lbl.pdf","2018-04-03 00:00:00",
53621,1,203108,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203108Orig1s006ltr.pdf","2018-04-05 00:00:00",
10163,1,203109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203109Orig1s000ltr.pdf","2012-09-05 00:00:00",
19427,2,203109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203109s000lbl.pdf","2012-08-31 00:00:00",
22912,3,203109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203109_revatio_toc.cfm","2013-08-09 00:00:00",
44876,21,203109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203109Orig1s000SumR.pdf","2013-08-09 00:00:00",
51663,20,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203109 sildenafil clinical both.pdf","1900-01-01 00:00:00",
51664,18,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203109 sildenafil clinpharm both.pdf","1900-01-01 00:00:00",
51665,17,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203109 sildenafil statistical both.pdf","1900-01-01 00:00:00",
52337,23,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20895_sildenafil_Original_WR.pdf","2012-02-09 00:00:00",
52338,25,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20895_sildenafil_Amendment_1.pdf","2012-02-09 00:00:00",
52339,26,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20895_sildenafil_Amendment_2.pdf","2012-02-09 00:00:00",
52340,27,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20895_21845_sildenafil_Amendment_3.pdf","2012-02-09 00:00:00",
52341,28,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20895_21845_sildenafil_Amendment_4.pdf","2012-02-09 00:00:00",
52342,29,203109,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21845_sildenafil_Amendment_5.pdf","2012-02-09 00:00:00",
32378,1,203109,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf","2014-03-13 00:00:00",
40265,2,203109,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf","2014-03-13 00:00:00",
32379,1,203109,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
40266,2,203109,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
10164,1,203109,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf","2014-02-04 00:00:00",
19428,2,203109,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf","2014-02-03 00:00:00",
32380,1,203109,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf","2014-03-07 00:00:00",
40267,2,203109,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf","2014-03-07 00:00:00",
10165,1,203109,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf","2015-04-29 00:00:00",
19429,2,203109,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf","2015-05-12 00:00:00",
50673,2,203109,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203109s011,022473s011,021845s020lbl.pdf","2017-12-13 00:00:00",
10166,1,203110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203110Orig1s000ltr.pdf","2015-07-08 00:00:00",
32381,1,203136,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203136Orig1s000ltr.pdf","2013-02-26 00:00:00",
44587,14,203136,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
10167,1,203136,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203136Orig1s003ltr.pdf","2014-05-29 00:00:00",
19430,2,203137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf","2013-10-31 00:00:00",
32382,1,203137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203137Orig1s000ltr.pdf","2013-10-29 00:00:00",
43421,3,203137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203137_vizamyl_toc.cfm","2013-11-15 00:00:00",
10168,1,203137,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203137Orig1s002ltr.pdf","2014-12-05 00:00:00",
19431,2,203137,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf","2014-12-10 00:00:00",
10169,1,203137,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203137Orig1s005ltr.pdf","2016-04-11 00:00:00",
19432,2,203137,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf","2016-04-08 00:00:00",
47300,1,203137,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203137Orig1s008ltr.pdf","2017-02-23 00:00:00",
47303,2,203137,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203137s008lbl.pdf","2017-02-23 00:00:00",
32383,1,203146,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203146Orig1s000ltr.pdf","2014-09-23 00:00:00",
10170,1,203152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000ltr.pdf","2015-12-09 00:00:00",
10171,1,203152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000TAltr.pdf","2015-10-29 00:00:00",
19434,2,203152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203152Orig1s000lbl.pdf","2015-12-11 00:00:00",
55230,1,203153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203153Orig1s000ltr.pdf","2018-08-20 00:00:00",
10172,1,203155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203155Orig1s000ltr.pdf","2012-09-14 00:00:00",
19435,2,203155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf","2012-09-14 00:00:00",
43422,3,203155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000TOC.cfm","2012-09-17 00:00:00",
44877,21,203155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000SumR.pdf","2012-09-18 00:00:00",
10173,1,203159,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s001ltredt1.pdf","2013-08-08 00:00:00",
19436,2,203159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s000lbl.pdf","2013-01-11 00:00:00",
19437,2,203159,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s001lbledt1.pdf","2013-08-09 00:00:00",
22913,3,203159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159_skyla_toc.cfm","2013-10-04 00:00:00",
32384,1,203159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159Orig1s000ltr.pdf","2013-01-11 00:00:00",
44878,21,203159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159Orig1s000SumR.pdf","2013-10-04 00:00:00",
51306,20,203159,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350706.pdf","1900-01-01 00:00:00",
51307,18,203159,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350707.pdf","1900-01-01 00:00:00",
51308,17,203159,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350708.pdf","1900-01-01 00:00:00",
10174,1,203159,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s002ltredt1.pdf","2013-09-17 00:00:00",
19438,2,203159,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s002lbledt1.pdf","2013-09-17 00:00:00",
10175,1,203159,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s005ltr.pdf","2016-04-11 00:00:00",
40268,2,203159,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s005lbl.pdf","2016-04-12 00:00:00",
45798,1,203159,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s006ltr.pdf","2016-11-03 00:00:00",
45805,2,203159,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s006lbl.pdf","2016-11-04 00:00:00",
47474,2,203159,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203159s007lbl.pdf","2017-03-06 00:00:00",
47501,1,203159,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203159Orig1s007ltr.pdf","2017-03-08 00:00:00",
46505,2,203159,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s008lbl.pdf","2016-12-21 00:00:00",
46521,1,203159,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s008ltr.pdf","2016-12-23 00:00:00",
52793,2,203159,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203159s010lbl.pdf","2018-03-02 00:00:00",
52813,1,203159,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203159Orig1s010,208224Orig1s001ltr.pdf","2018-03-05 00:00:00",
10176,1,203168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203168Orig1s000ltr.pdf","2013-04-10 00:00:00",
19439,2,203168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf","2013-04-09 00:00:00",
22914,3,203168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168_prolensa_toc.cfm","2013-07-15 00:00:00",
24429,21,203168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168Orig1s000SumR.pdf","2013-07-15 00:00:00",
10177,1,203176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203176s000ltr.pdf","2012-05-03 00:00:00",
19440,2,203188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf","2012-01-31 00:00:00",
19441,2,203188,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf","2012-08-29 00:00:00",
23957,10,203188,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm323671.htm","2012-10-12 00:00:00",
32385,1,203188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188s000ltr.pdf","2012-01-31 00:00:00",
32386,1,203188,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188Orig1s001ltr.pdf","2012-08-29 00:00:00",
43423,3,203188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203188s000TOC.cfm","2012-03-13 00:00:00",
10178,1,203188,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s004ltr.pdf","2014-02-25 00:00:00",
40269,2,203188,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf","2014-02-25 00:00:00",
10179,1,203188,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s007ltr.pdf","2014-06-18 00:00:00",
19442,2,203188,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf","2014-06-17 00:00:00",
32387,1,203188,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s008ltr.pdf","2014-04-10 00:00:00",
40270,2,203188,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf","2014-04-10 00:00:00",
10180,1,203188,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf","2015-01-06 00:00:00",
40271,2,203188,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf","2015-01-09 00:00:00",
19443,2,203188,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf","2015-01-09 00:00:00",
32388,1,203188,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf","2015-01-06 00:00:00",
19444,2,203188,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf","2015-03-20 00:00:00",
32389,1,203188,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203188Orig1s017ltr.pdf","2015-03-06 00:00:00",
48442,2,203188,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s019lbl.pdf","2017-05-18 00:00:00",
48445,1,203188,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf","2017-05-18 00:00:00",
47155,1,203188,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s022,207925Orig1s003ltr.pdf","2017-02-09 00:00:00",
47159,2,203188,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf","2017-02-10 00:00:00",
49201,2,203188,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf","2017-08-02 00:00:00",
49206,1,203188,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s026,207925Orig1s005ltr.pdf","2017-08-02 00:00:00",
55209,1,203188,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203188Orig1s028,207925Orig1s007ltr.pdf","2018-08-20 00:00:00",
55263,2,203188,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf","2018-08-21 00:00:00",
32390,1,203189,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203189Orig1s000ltr.pdf","2014-09-05 00:00:00",
32391,1,203192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203192Orig1s000ltr.pdf","2016-01-29 00:00:00",
10181,1,203195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf","2012-06-07 00:00:00",
19445,2,203195,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf","2013-04-01 00:00:00",
40272,2,203195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf","2012-06-05 00:00:00",
43424,3,203195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195_suprax_toc.cfm","2012-11-16 00:00:00",
44879,21,203195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195Orig1s000SumR.pdf","2012-11-16 00:00:00",
10182,1,203195,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf","2016-01-11 00:00:00",
40273,2,203195,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf","2016-01-12 00:00:00",
47578,2,203195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf","2017-03-17 00:00:00",
47597,1,203195,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203195Orig1s006,202091Orig1s005ltr.pdf","2017-03-20 00:00:00",
53526,1,203195,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202091Orig1s007,203195Orig1s008ltr.pdf","2018-03-29 00:00:00",
53566,2,203195,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf","2018-04-01 00:00:00",
10183,1,203202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203202Orig1s000ltr.pdf","2014-02-19 00:00:00",
22915,3,203202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203202Orig1s000TOC.cfm","2014-03-20 00:00:00",
40274,2,203202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203202lbl.pdf","2014-02-19 00:00:00",
45477,1,203202,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203202Orig1s006ltr.pdf","2016-10-05 00:00:00",
45493,2,203202,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203202s006lbl.pdf","2016-10-06 00:00:00",
47175,2,203202,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203202s007lbl.pdf","2017-02-13 00:00:00",
47177,1,203202,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203202Orig1s007ltr.pdf","2017-02-13 00:00:00",
32392,1,203214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203214Orig1s000ltr.pdf","2012-11-07 00:00:00",
40275,2,203214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf","2012-11-28 00:00:00",
43425,3,203214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000TOC.cfm","2012-12-18 00:00:00",
44880,21,203214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000SumR.pdf","2012-12-18 00:00:00",
10184,1,203214,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s002ltr.pdf","2013-11-20 00:00:00",
22916,3,203214,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203214Orig1s002.pdf","2015-09-25 00:00:00",
40276,2,203214,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf","2013-11-22 00:00:00",
10185,1,203214,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s004ltr.pdf","2014-02-25 00:00:00",
19446,2,203214,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf","2014-02-25 00:00:00",
53726,3,203214,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203214Orig1s04.pdf","2018-04-18 00:00:00",
10186,1,203214,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s005ltr.pdf","2014-03-28 00:00:00",
19447,2,203214,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf","2014-04-01 00:00:00",
32393,1,203214,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s006ltr.pdf","2013-11-12 00:00:00",
10187,1,203214,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s007ltr.pdf","2014-05-08 00:00:00",
19448,2,203214,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf","2014-05-12 00:00:00",
10188,1,203214,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.pdf","2015-02-17 00:00:00",
32394,1,203214,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s010ltr.pdf","2015-06-24 00:00:00",
40277,2,203214,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf","2015-06-23 00:00:00",
10189,1,203214,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s011ltr.pdf","2015-12-23 00:00:00",
47468,2,203214,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s011lbl.pdf","2017-03-06 00:00:00",
32395,1,203214,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.pdf","2016-02-09 00:00:00",
49525,2,203214,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf","2017-08-24 00:00:00",
49528,2,203214,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf","2017-08-24 00:00:00",
50700,2,203214,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf","2017-12-15 00:00:00",
50708,1,203214,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203214Orig1s017,208246ORig1s003ltr.pdf","2017-12-15 00:00:00",
54373,2,203214,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf","2018-05-30 00:00:00",
54385,1,203214,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s018ltr.pdf","2018-05-31 00:00:00",
55216,1,203214,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s021,208246Orig1s007ltr.pdf","2018-08-20 00:00:00",
55259,2,203214,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf","2018-08-21 00:00:00",
55262,8,203214,"SUPPL",21,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf#page=49","2018-08-21 00:00:00",
10190,1,203231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf","2013-08-05 00:00:00",
19449,2,203231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf","2013-08-06 00:00:00",
22917,3,203231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203231Orig1s000TOC.cfm","2014-04-17 00:00:00",
32396,1,203231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.pdf","2012-11-13 00:00:00",
32397,1,203231,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s002ltr.pdf","2014-05-06 00:00:00",
40278,2,203231,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf","2014-05-06 00:00:00",
32398,1,203231,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf","2014-12-12 00:00:00",
40279,2,203231,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf","2014-12-11 00:00:00",
10191,1,203231,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf","2014-12-12 00:00:00",
19450,2,203231,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf","2014-12-11 00:00:00",
32399,1,203231,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf","2014-12-12 00:00:00",
40280,2,203231,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf","2014-12-11 00:00:00",
32400,1,203231,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203231Orig1s010ltr.pdf","2015-10-13 00:00:00",
40281,2,203231,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf","2015-10-15 00:00:00",
10192,1,203231,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203231Orig1s011ltr.pdf","2016-03-29 00:00:00",
19451,2,203231,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf","2016-03-29 00:00:00",
47093,2,203231,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203231s013lbl.pdf","2017-02-03 00:00:00",
47094,1,203231,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203231Orig1s013ltr.pdf","2017-02-03 00:00:00",
32401,1,203232,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203232Orig1s000ltr.pdf","2014-08-07 00:00:00",
10193,1,203255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203255Orig1s000ltr.pdf","2014-12-16 00:00:00",
22918,3,203255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.cfm","2016-03-02 00:00:00",
24430,21,203255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000SumR.pdf","2016-03-02 00:00:00",
40282,2,203255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf","2014-12-16 00:00:00",
52933,2,203255,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf","2018-03-13 00:00:00",
52991,1,203255,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf","2018-03-15 00:00:00",
54764,2,203255,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf","2018-07-05 00:00:00",
54803,8,203255,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27","2018-07-06 00:00:00",
54822,1,203255,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203255Orig1s004ltr.pdf","2018-07-06 00:00:00",
19452,2,203260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf","2014-01-13 00:00:00",
32402,1,203260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203260Orig1s000ltr.pdf","2014-01-03 00:00:00",
32403,1,203263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203263Orig1s000ltr.pdf","2013-02-05 00:00:00",
40283,2,203263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf","2013-02-04 00:00:00",
53718,3,203263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203263Orig1s000.pdf","2018-04-18 00:00:00",
32404,1,203283,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203283Orig1s000TAltr.pdf","2012-11-09 00:00:00",
10194,1,203284,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203284Orig1s001ltr.pdf","2014-07-08 00:00:00",
22919,3,203284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203284Orig1s000TOC.cfm","2013-03-28 00:00:00",
32405,1,203284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203284Orig1s000ltr.pdf","2013-02-04 00:00:00",
40284,2,203284,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203284s000lbl.pdf","2013-02-06 00:00:00",
40285,2,203284,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203284s001lbl.pdf","2014-07-03 00:00:00",
45266,2,203284,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s004lbl.pdf","2016-09-09 00:00:00",
45291,1,203284,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203284Orig1s004ltr.pdf","2016-09-12 00:00:00",
48174,2,203284,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf","2017-05-01 00:00:00",
48181,8,203284,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf#page=1","2017-05-02 00:00:00",
48283,1,203284,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203284Orig1s005ltr.pdf","2017-05-08 00:00:00",
49102,1,203286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203286Orig1s000ltr.pdf","2017-07-27 00:00:00",
49277,1,203293,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203293Orig1s000ltr.pdf","2017-08-08 00:00:00",
32406,1,203294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203294Orig1s000ltr.pdf","2015-06-22 00:00:00",
45351,1,203308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203308Orig1s000ltr.pdf","2016-09-21 00:00:00",
32407,1,203312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf","2015-01-08 00:00:00",
40286,2,203312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf","2015-01-08 00:00:00",
43426,3,203312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000TOC.cfm","2016-06-15 00:00:00",
44881,21,203312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000SumR.pdf","2016-06-15 00:00:00",
45733,1,203312,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203312Orig1s006ltr.pdf","2016-10-31 00:00:00",
48468,2,203312,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203312s006lbl.pdf","2017-05-19 00:00:00",
19453,2,203313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf","2015-09-29 00:00:00",
22920,3,203313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm","2015-11-25 00:00:00",
32408,1,203313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203313Orig1s000ltr.pdf","2015-09-30 00:00:00",
51187,17,203313,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203313_203314_insulin degludec and insulin degludec-insulin aspart stat prea.pdf","1900-01-01 00:00:00",
51190,20,203313,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/46_203313_203314 insulin degludec-insulin aspart clinical prea.pdf","1900-01-01 00:00:00",
51191,18,203313,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/44_203313 insulin degludec-insulin aspart clinpharm prea.pdf","1900-01-01 00:00:00",
46224,2,203313,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s002lbl.pdf","2016-12-20 00:00:00",
46474,1,203313,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203313Orig1s002ltr.pdf","2016-12-22 00:00:00",
40287,2,203313,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf","2016-08-02 00:00:00",
55148,2,203313,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203313s000lbl.pdf","2018-08-10 00:00:00",
55156,1,203313,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203313Orig1s005ltr.pdf","2018-08-10 00:00:00",
10195,1,203314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203314Orig1s000ltr.pdf","2015-09-30 00:00:00",
19454,2,203314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf","2015-09-29 00:00:00",
43427,3,203314,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm","2015-11-25 00:00:00",
51182,18,203314,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/48_203314 insulin degludec clinpharm prea.pdf","1900-01-01 00:00:00",
51183,57,203314,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/47_203314 insulin degludec CDTL clinical prea.pdf","1900-01-01 00:00:00",
51186,17,203314,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203313_203314_insulin degludec and insulin degludec-insulin aspart stat prea.pdf","1900-01-01 00:00:00",
51188,20,203314,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/46_203313_203314 insulin degludec-insulin aspart clinical prea.pdf","1900-01-01 00:00:00",
46234,2,203314,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203314s003lbl.pdf","2016-12-20 00:00:00",
46475,1,203314,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203314Orig1s003ltr.pdf","2016-12-22 00:00:00",
53462,2,203314,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf","2018-03-27 00:00:00",
53508,1,203314,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s008ltr.pdf","2018-03-29 00:00:00",
55149,2,203314,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s009lbl.pdf","2018-08-10 00:00:00",
55157,1,203314,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s009ltr.pdf","2018-08-10 00:00:00",
10196,1,203324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203324Orig1s000ltr.pdf","2016-04-19 00:00:00",
19455,2,203324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf","2016-04-19 00:00:00",
45886,21,203324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig1s000SumR.pdf","2016-11-14 00:00:00",
54467,3,203324,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig1s000TOC.cfm","2018-06-06 00:00:00",
45443,2,203324,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf","2016-07-18 00:00:00",
45444,1,203324,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203324Orig2s000ltr.pdf","2016-07-20 00:00:00",
45887,21,203324,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000SumR.pdf","2016-11-14 00:00:00",
54470,3,203324,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000TOC.cfm","2018-06-07 00:00:00",
44588,14,203326,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-07-02 00:00:00",
32410,1,203334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203334Orig1s000ltr.pdf","2015-10-21 00:00:00",
10197,1,203335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203335Orig1s000ltr.pdf","2015-11-04 00:00:00",
19457,2,203340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203340lbl.pdf","2013-05-10 00:00:00",
24431,21,203340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203340Orig1s000SumR.pdf","2014-03-06 00:00:00",
32411,1,203340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203340Orig1s000ltr.pdf","2013-05-14 00:00:00",
43428,3,203340,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203340Orig1s000TOC.cfm","2014-03-06 00:00:00",
10198,1,203341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203341Orig1s000ltr.pdf","2012-09-06 00:00:00",
19458,2,203341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf","2012-09-04 00:00:00",
22921,3,203341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341_bosulif_toc.cfm","2012-09-13 00:00:00",
24432,21,203341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022090s000_SumR.pdf","2012-09-13 00:00:00",
32412,1,203341,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf","2013-10-01 00:00:00",
40288,2,203341,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf","2013-09-30 00:00:00",
32413,1,203341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf","2014-11-28 00:00:00",
40289,2,203341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf","2015-01-05 00:00:00",
10199,1,203341,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf","2015-09-24 00:00:00",
19459,2,203341,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf","2015-10-06 00:00:00",
19460,2,203341,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf","2016-04-05 00:00:00",
32414,1,203341,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf","2016-04-06 00:00:00",
45907,1,203341,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s006ltr.pdf","2016-11-18 00:00:00",
45909,2,203341,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf","2016-11-17 00:00:00",
48039,1,203341,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf","2017-04-14 00:00:00",
48050,2,203341,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf","2017-04-18 00:00:00",
48040,1,203341,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf","2017-04-14 00:00:00",
48049,2,203341,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf","2017-04-18 00:00:00",
50777,2,203341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf","2017-12-19 00:00:00",
50884,1,203341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s009ltr.pdf","2017-12-27 00:00:00",
54001,1,203341,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s013ltr.pdf","2018-05-03 00:00:00",
10200,1,203343,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203343Orig1s000ltr.pdf","2015-06-02 00:00:00",
32415,1,203352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203352Orig1s000ltr.pdf","2016-05-24 00:00:00",
32416,1,203376,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203376Orig1s000ltr.pdf","2014-02-12 00:00:00",
10201,1,203377,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203377Orig1s000ltr.pdf","2016-04-28 00:00:00",
32417,1,203378,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203378Orig1s000ltr.pdf","2016-04-28 00:00:00",
10202,1,203380,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203380Orig1s000ltr.pdf","2016-05-06 00:00:00",
46106,1,203384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203384Orig1s000ltr.pdf","2016-12-09 00:00:00",
10203,1,203388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203388s000ltr.pdf","2012-01-31 00:00:00",
19461,2,203388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf","2012-01-30 00:00:00",
22922,3,203388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203388Orig1s000TOC.cfm","2012-03-02 00:00:00",
10204,1,203388,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf","2015-05-22 00:00:00",
19462,2,203388,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf","2015-05-27 00:00:00",
32418,1,203388,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf","2015-05-22 00:00:00",
40290,2,203388,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf","2015-05-27 00:00:00",
10205,1,203388,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf","2015-05-22 00:00:00",
19463,2,203388,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf","2015-05-27 00:00:00",
32419,1,203388,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf","2015-05-22 00:00:00",
40291,2,203388,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf","2015-05-27 00:00:00",
45797,1,203388,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203388Orig1s010ltr.pdf","2016-11-08 00:00:00",
45809,2,203388,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203388s010lbl.pdf","2016-11-04 00:00:00",
49235,2,203388,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf","2017-08-04 00:00:00",
49236,8,203388,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf#page=12","2017-08-04 00:00:00",
49242,1,203388,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203388Orig1s011ltr.pdf","2017-08-04 00:00:00",
10206,1,203389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203389Orig1s000ltr_repl.pdf","2013-05-01 00:00:00",
24433,21,203389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000SumR.pdf","2014-03-06 00:00:00",
40292,2,203389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203389s000lbl.pdf","2013-05-01 00:00:00",
43429,3,203389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000TOC.cfm","2014-03-06 00:00:00",
52582,20,203389,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203389 cysteamine clinical bpca.pdf","1900-01-01 00:00:00",
52583,18,203389,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203389 cysteamine clinpharm bpca.pdf","1900-01-01 00:00:00",
52584,62,203389,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203389 cysteamine clinpharm addendum bpca.pdf","1900-01-01 00:00:00",
10207,1,203389,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203389Orig1s010ltr.pdf","2015-08-18 00:00:00",
40293,2,203389,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203389s010lbl.pdf","2015-08-17 00:00:00",
49857,2,203389,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s017lbl.pdf","2017-09-26 00:00:00",
49862,1,203389,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203389Orig1s017ltr.pdf","2017-09-26 00:00:00",
50966,1,203389,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203389Orig1s020ltr.pdf","2017-12-29 00:00:00",
51502,23,203389,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N203389_cysteamine_Orig_WR.pdf","2013-08-19 00:00:00",
51503,25,203389,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N203389_cysteamine_Amend_1.pdf","2015-10-06 00:00:00",
54143,20,203389,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/224_203389S20 cysteamine clinical bpca.pdf","1900-01-01 00:00:00",
54145,18,203389,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/230_203389S20 cysteamine clinpharm bpca.pdf","1900-01-01 00:00:00",
54147,17,203389,"SUPPL",20,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/229_203389S20 cysteamine statistical bpca.pdf","1900-01-01 00:00:00",
55076,2,203389,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203389s020lbl.pdf","2018-08-02 00:00:00",
50967,1,203393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203393Orig1s000ltr.pdf","2017-12-29 00:00:00",
10208,1,203411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203411Orig1s000ltr.pdf","2014-04-04 00:00:00",
10209,1,203412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.pdf","2015-10-21 00:00:00",
24434,21,203414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000SumR.pdf","2014-04-18 00:00:00",
32420,1,203414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203414Orig1s000ltr.pdf","2013-01-30 00:00:00",
40294,2,203414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf","2013-01-30 00:00:00",
43430,3,203414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000TOC.cfm","2014-04-18 00:00:00",
43966,8,203414,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf","2013-02-05 00:00:00",
10210,1,203414,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf","2016-04-07 00:00:00",
40295,2,203414,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s003lbl.pdf","2016-04-07 00:00:00",
10211,1,203414,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf","2015-09-01 00:00:00",
19464,2,203414,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf","2015-09-21 00:00:00",
47253,2,203414,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf","2017-02-16 00:00:00",
46147,1,203414,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203414Orig1s008,s009ltr.pdf","2016-12-14 00:00:00",
46167,2,203414,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf","2016-12-15 00:00:00",
46148,1,203414,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203414Orig1s008,s009ltr.pdf","2016-12-14 00:00:00",
46168,2,203414,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf","2016-12-15 00:00:00",
19465,2,203415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf","2012-08-31 00:00:00",
19466,2,203415,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf","2013-03-26 00:00:00",
32421,1,203415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000ltr.pdf","2012-09-05 00:00:00",
43431,3,203415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415_xtandi_toc.cfm","2012-09-12 00:00:00",
44882,21,203415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415Orig1s000SumR.pdf","2012-09-12 00:00:00",
10212,1,203415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003ltr.pdf","2014-09-16 00:00:00",
40296,2,203415,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf","2014-09-10 00:00:00",
10213,1,203415,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s005ltr.pdf","2015-07-22 00:00:00",
40297,2,203415,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s005lbl.pdf","2015-07-22 00:00:00",
19467,2,203415,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf","2015-09-21 00:00:00",
32422,1,203415,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s006ltr.pdf","2015-08-10 00:00:00",
10214,1,203415,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s007ltr.pdf","2015-10-09 00:00:00",
19468,2,203415,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf","2015-10-08 00:00:00",
45577,2,203415,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203415s009lbl.pdf","2016-10-20 00:00:00",
45629,1,203415,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203415Orig1s009ltr.pdf","2016-10-21 00:00:00",
49082,2,203415,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203415s011lbl.pdf","2017-07-25 00:00:00",
49101,1,203415,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203415Orig1s011ltr.pdf","2017-07-27 00:00:00",
54886,2,203415,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203415s014lbl.pdf","2018-07-13 00:00:00",
54897,1,203415,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203415Orig1s014ltr.pdf","2018-07-16 00:00:00",
10215,1,203431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203431Orig1s000ltr.pdf","2015-07-15 00:00:00",
45588,1,203434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203434Orig1s000ltr.pdf","2016-10-05 00:00:00",
47725,19,203441,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=21","2017-03-28 00:00:00",
19469,2,203441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203441Orig1s000lbl.pdf","2012-12-27 00:00:00",
23500,8,203441,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf","2013-01-03 00:00:00",
32423,1,203441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203441Orig1s000ltr_replacement.pdf","2012-12-27 00:00:00",
43432,3,203441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000TOC.cfm","2013-01-25 00:00:00",
44883,21,203441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000SumR.pdf","2013-01-25 00:00:00",
19470,2,203441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf","2014-06-30 00:00:00",
32424,1,203441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203441Orig1s002ltr.pdf","2014-06-27 00:00:00",
43433,3,203441,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203441Orig1s002.pdf","2016-02-03 00:00:00",
10216,1,203441,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203441Orig1s008ltr.pdf","2016-05-31 00:00:00",
47685,1,203441,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203441Orig1s010ltr.pdf","2017-03-24 00:00:00",
32425,1,203443,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203443Orig1s000ltr.pdf","2014-08-27 00:00:00",
47769,1,203453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203453Orig1s000ltr.pdf","2017-03-29 00:00:00",
10217,1,203455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203455Orig1s000ltr.pdf","2015-12-22 00:00:00",
19471,2,203469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf","2012-12-14 00:00:00",
24114,14,203469,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=186","2013-12-20 00:00:00",
32426,1,203469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203469Orig1s000ltr.pdf","2012-12-19 00:00:00",
43434,3,203469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000TOC.cfm","2012-12-21 00:00:00",
44431,10,203469,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm383276.htm","2014-02-04 00:00:00",
44884,21,203469,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000SumR.pdf","2012-12-21 00:00:00",
19472,2,203469,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf","2013-12-20 00:00:00",
32427,1,203469,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf","2013-12-20 00:00:00",
43435,3,203469,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf","2014-07-07 00:00:00",
10218,1,203469,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf","2013-12-20 00:00:00",
22923,3,203469,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf","2014-07-07 00:00:00",
40298,2,203469,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf","2013-12-20 00:00:00",
32428,1,203469,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203469Orig1s009ltr.pdf","2014-07-28 00:00:00",
40299,2,203469,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf","2014-07-28 00:00:00",
32429,1,203469,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203469Orig1s020ltr.pdf","2015-12-03 00:00:00",
40300,2,203469,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf","2015-12-08 00:00:00",
19473,2,203469,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf","2016-06-06 00:00:00",
32430,1,203469,"SUPPL",21,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s021ltr.pdf","2016-06-06 00:00:00",
45971,1,203469,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s022ltr.pdf","2016-11-30 00:00:00",
45979,2,203469,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf","2016-12-01 00:00:00",
46089,8,203469,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf#page=24","2016-12-08 00:00:00",
45190,1,203469,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s023ltr.pdf","2016-08-31 00:00:00",
45210,2,203469,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf","2016-08-31 00:00:00",
45272,1,203469,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s024ltr.pdf","2016-09-08 00:00:00",
46960,2,203469,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf","2017-01-24 00:00:00",
50850,2,203469,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf","2017-12-26 00:00:00",
50909,1,203469,"SUPPL",27,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203469Orig1s027,s028ltr.pdf","2017-12-27 00:00:00",
50851,2,203469,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf","2017-12-26 00:00:00",
50907,1,203469,"SUPPL",28,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203469Orig1s027,s028ltr.pdf","2017-12-27 00:00:00",
54386,1,203469,"SUPPL",29,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203469Orig1s029ltr.pdf","2018-05-31 00:00:00",
10219,1,203479,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf","2013-12-09 00:00:00",
19474,2,203479,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf","2014-01-13 00:00:00",
24115,14,203479,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2013-02-08 00:00:00",
32431,1,203479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf","2013-02-08 00:00:00",
40301,2,203479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf","2013-02-08 00:00:00",
43436,3,203479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479_versacloz_toc.cfm","2013-09-20 00:00:00",
44885,21,203479,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479Orig1s000SumR.pdf","2013-09-20 00:00:00",
10220,1,203479,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf","2013-08-23 00:00:00",
19475,2,203479,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf","2013-08-27 00:00:00",
10221,1,203479,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf","2015-09-17 00:00:00",
19476,2,203479,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf","2015-09-16 00:00:00",
32432,1,203479,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf","2015-09-17 00:00:00",
40302,2,203479,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf","2015-09-16 00:00:00",
10222,1,203479,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf","2015-10-02 00:00:00",
40303,2,203479,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf","2015-12-10 00:00:00",
47352,2,203479,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf","2017-02-27 00:00:00",
47394,1,203479,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203479Orig1s010ltr.pdf","2017-03-02 00:00:00",
10223,1,203491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s000ltr.pdf","2012-10-18 00:00:00",
10224,1,203491,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s001ltr.pdf","2012-12-19 00:00:00",
19477,2,203491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s000lbl.pdf","2012-10-17 00:00:00",
24435,21,203491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491Orig1s000SumR.pdf","2013-04-08 00:00:00",
40304,2,203491,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s001lbl.pdf","2012-12-18 00:00:00",
43437,3,203491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491_nepafenac_toc.cfm","2013-04-08 00:00:00",
10225,1,203491,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203491Orig1s006ltr.pdf","2014-07-08 00:00:00",
10226,1,203496,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf","2014-10-08 00:00:00",
19478,2,203496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf","2013-12-23 00:00:00",
22924,3,203496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm","2014-12-09 00:00:00",
24436,21,203496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf","2014-12-09 00:00:00",
32433,1,203496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf","2013-12-24 00:00:00",
40305,2,203496,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf","2014-10-09 00:00:00",
10227,1,203496,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf","2016-01-28 00:00:00",
40306,2,203496,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf","2016-02-11 00:00:00",
46981,2,203496,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf","2017-01-24 00:00:00",
47005,1,203496,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s006ltr.pdf","2017-01-27 00:00:00",
48715,2,203496,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf","2017-06-14 00:00:00",
48753,1,203496,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s007ltr.pdf","2017-06-16 00:00:00",
10228,1,203505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203505Orig1s000ltr.pdf","2013-02-28 00:00:00",
40307,2,203505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf","2013-03-01 00:00:00",
43438,3,203505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203505Orig1s000TOC.cfm","2013-03-28 00:00:00",
32434,1,203505,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203505Orig1s005ltr.pdf","2015-02-27 00:00:00",
40308,2,203505,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf","2015-03-02 00:00:00",
10229,1,203506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203506Orig1s000ltr.pdf","2015-04-28 00:00:00",
44589,14,203506,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
19479,2,203510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.pdf","2013-03-26 00:00:00",
22925,3,203510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510_phenylephrine_toc.cfm","2013-09-20 00:00:00",
24437,21,203510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510Orig1s000SumR.pdf","2013-09-20 00:00:00",
32435,1,203510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203510Orig1s000ltr.pdf","2013-03-22 00:00:00",
51564,20,203510,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine clinical prea.pdf","1900-01-01 00:00:00",
51565,18,203510,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine clinpharm prea.pdf","1900-01-01 00:00:00",
51566,17,203510,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine statistical prea.pdf","1900-01-01 00:00:00",
32436,1,203511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203511Orig1s000ltr.pdf","2014-11-10 00:00:00",
32437,1,203518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203518Orig1s000ltr.pdf","2015-05-19 00:00:00",
48791,1,203547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203547Orig1s000ltr.pdf","2017-06-22 00:00:00",
10230,1,203551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000ltr.pdf","2013-04-16 00:00:00",
19480,2,203551,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s001lbl.pdf","2013-11-04 00:00:00",
22926,3,203551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551_docetaxel_toc.cfm","2013-10-21 00:00:00",
24438,21,203551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000SumR.pdf","2013-10-21 00:00:00",
32438,1,203551,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203551Orig1s001ltr.pdf","2013-11-07 00:00:00",
40309,2,203551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551Orig1s000lbledt.pdf","2013-05-07 00:00:00",
19481,2,203551,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203551s002lbl.pdf","2014-09-19 00:00:00",
32439,1,203551,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203551Orig1s002ltr.pdf","2014-09-23 00:00:00",
53661,2,203551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203551Orig1s005lbl.pdf","2018-04-12 00:00:00",
53688,1,203551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203551Orig1s005ltr.pdf","2018-04-16 00:00:00",
50727,1,203553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203553Orig1s000ApprovandTAltr.pdf","2017-12-18 00:00:00",
46522,1,203559,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203559Orig1s000ltr.pdf","2016-12-23 00:00:00",
10231,1,203560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203560Orig1s000ltr.pdf","2016-03-18 00:00:00",
40310,2,203560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203560Orig1s000lbl.pdf","2016-03-18 00:00:00",
10232,1,203563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf","2015-03-11 00:00:00",
32440,1,203563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.pdf","2015-03-11 00:00:00",
40311,2,203563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf","2015-03-12 00:00:00",
32441,1,203564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203564Orig1s000ltr.pdf","2014-11-05 00:00:00",
10233,1,203565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203565s000ltr.pdf","2013-07-29 00:00:00",
22927,3,203565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000TOC.cfm","2013-09-04 00:00:00",
40312,2,203565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf","2013-07-30 00:00:00",
44886,21,203565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000SumR.pdf","2013-09-04 00:00:00",
52118,2,203565,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s005lbl.pdf","2018-01-30 00:00:00",
52120,1,203565,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203565Orig1s005ltr.pdf","2018-01-30 00:00:00",
19482,2,203567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf","2014-06-10 00:00:00",
24439,21,203567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000SumR.pdf","2014-07-03 00:00:00",
32442,1,203567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203567Orig1s000ltr.pdf","2014-06-10 00:00:00",
43439,3,203567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm","2014-07-02 00:00:00",
19483,2,203567,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf","2015-03-20 00:00:00",
32443,1,203567,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf","2015-03-02 00:00:00",
45388,2,203567,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf","2016-09-27 00:00:00",
45525,1,203567,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203567Orig1s006ltr.pdf","2016-10-12 00:00:00",
10234,1,203568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203568Orig1s000ltr.pdf","2013-01-31 00:00:00",
19484,2,203568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203568s000lbl.pdf","2013-01-30 00:00:00",
23503,8,203568,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf","2013-02-05 00:00:00",
24116,14,203568,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=27","2013-01-30 00:00:00",
24440,21,203568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000SumR.pdf","2013-02-27 00:00:00",
43440,3,203568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000TOC.cfm","2013-02-27 00:00:00",
32444,1,203568,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203568Orig1s002ltr.pdf","2014-05-09 00:00:00",
10235,1,203568,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s004ltr.pdf","2015-02-27 00:00:00",
19485,2,203568,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203568s004lbl.pdf","2015-03-03 00:00:00",
10236,1,203568,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s005ltr.pdf","2015-07-29 00:00:00",
10237,1,203568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203568Orig1s008ltr.pdf","2016-05-25 00:00:00",
40313,2,203568,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203568s008lbl.pdf","2016-05-25 00:00:00",
50224,1,203568,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203568Orig1s009ltr.pdf","2017-10-30 00:00:00",
32445,1,203573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203573Orig1s000ltr.pdf","2014-12-23 00:00:00",
45774,1,203575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203575Orig1s000ltr.pdf","2016-11-02 00:00:00",
10238,1,203576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203576Orig1s000ltr.pdf","2015-10-22 00:00:00",
45698,1,203580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203580Orig1s000ltr.pdf","2016-10-28 00:00:00",
32446,1,203583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203583Orig1s000ltr.pdf","2015-10-02 00:00:00",
19486,2,203585,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s001lbl.pdf","2014-02-11 00:00:00",
24441,21,203585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000SumR.pdf","2012-11-28 00:00:00",
32447,1,203585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203585Orig1s000ltr.pdf","2012-10-29 00:00:00",
32448,1,203585,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s001ltr.pdf","2014-02-12 00:00:00",
40314,2,203585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203585lbl.pdf","2012-10-26 00:00:00",
43441,3,203585,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000TOC.cfm","2012-11-28 00:00:00",
23504,8,203585,"SUPPL",3,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM396919.pdf","2014-05-12 00:00:00",
32449,1,203585,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s003ltr.pdf","2014-05-06 00:00:00",
40315,2,203585,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s003lbl.pdf","2014-05-02 00:00:00",
19487,2,203585,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203585s004lbl.pdf","2016-06-17 00:00:00",
32450,1,203585,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203585Orig1s004ltr.pdf","2016-06-15 00:00:00",
48796,1,203585,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203585Orig1s005ltr.pdf","2017-06-22 00:00:00",
48805,2,203585,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203585s005lbl.pdf","2017-06-22 00:00:00",
32451,1,203586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203586Orig1s000TAltr.pdf","2015-02-17 00:00:00",
32452,1,203592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203592Orig1s000ltr.pdf","2015-08-20 00:00:00",
45542,1,203593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203593Orig1s000ltr.pdf","2016-10-14 00:00:00",
45690,2,203593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203593Orig1s000lbl.pdf","2016-10-27 00:00:00",
45544,1,203594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203594Orig1s000ltr.pdf","2016-10-14 00:00:00",
45689,2,203594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203594Orig1s000lbl.pdf","2016-10-27 00:00:00",
10239,1,203595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203595Orig1s000ltr.pdf","2013-01-23 00:00:00",
19488,2,203595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203595s000lbl.pdf","2013-01-23 00:00:00",
22928,3,203595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203595Orig1s000TOC.cfm","2014-01-24 00:00:00",
23505,8,203595,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337734.pdf","2013-02-05 00:00:00",
24442,21,203595,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203595Orig1s000SumR.pdf","2014-01-24 00:00:00",
32453,1,203602,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203602Orig1s000ltr.pdf","2015-12-18 00:00:00",
10240,1,203613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203613Orig1s000ltr.pdf","2015-06-22 00:00:00",
10241,1,203629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf","2015-01-13 00:00:00",
22929,3,203629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000TOC.cfm","2015-07-22 00:00:00",
40316,2,203629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf","2015-01-29 00:00:00",
44887,21,203629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000SumR.pdf","2015-07-22 00:00:00",
22930,3,203634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634_uceris_toc.cfm","2013-07-08 00:00:00",
24443,21,203634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634Orig1s000SumR.pdf","2013-07-08 00:00:00",
32454,1,203634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203634Orig1s000ltr.pdf","2013-01-16 00:00:00",
40317,2,203634,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203634s000lbl.pdf","2013-01-15 00:00:00",
45548,1,203634,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203634Orig1s004ltr.pdf","2016-10-17 00:00:00",
45613,2,203634,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203634s004lbl.pdf","2016-10-17 00:00:00",
32455,1,203649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203649Orig1s000ltr.pdf","2014-11-04 00:00:00",
50587,2,203649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203649Orig1s000lbl.pdf","2017-12-04 00:00:00",
50728,1,203655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203655Orig1s000ltr.pdf","2017-12-18 00:00:00",
50936,2,203655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203655Orig1s000lbl.pdf","2017-12-28 00:00:00",
10242,1,203665,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203665Orig1s000ltr.pdf","2013-02-19 00:00:00",
22931,3,203667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667_norethindrone_toc.cfm","2013-09-20 00:00:00",
24444,21,203667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667Orig1s000SumR.pdf","2013-09-20 00:00:00",
32456,1,203667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s000ltr.pdf","2013-05-10 00:00:00",
40318,2,203667,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s000lbl.pdf","2013-05-14 00:00:00",
10243,1,203667,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s002ltr.pdf","2013-07-12 00:00:00",
19489,2,203667,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf","2013-07-12 00:00:00",
32457,1,203667,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203667Orig1s004ltr.pdf","2014-12-09 00:00:00",
40319,2,203667,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf","2014-12-16 00:00:00",
46483,1,203667,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203667Orig1s007ltr.pdf","2016-12-22 00:00:00",
46495,2,203667,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf","2016-12-21 00:00:00",
49301,2,203667,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203667s009lbl.pdf","2017-08-09 00:00:00",
49383,1,203667,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203667Orig1s009ltr.pdf","2017-08-15 00:00:00",
10244,1,203683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203683Orig1s000Ltr.pdf","2015-12-01 00:00:00",
24445,21,203684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000SumR.pdf","2014-12-05 00:00:00",
32458,1,203684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203684Orig1s000ltr.pdf","2014-10-15 00:00:00",
32459,1,203684,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s001ltr.pdf","2016-04-04 00:00:00",
40320,2,203684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000Lbl.pdf","2014-12-05 00:00:00",
40321,2,203684,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s001lbl.pdf","2016-04-05 00:00:00",
43442,3,203684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000TOC.cfm","2014-12-05 00:00:00",
51596,20,203684,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203684 sulfur hexafluoride clinical prea.pdf","1900-01-01 00:00:00",
51597,18,203684,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203684 sulfur hexafluoride clinpharm prea.pdf","1900-01-01 00:00:00",
51598,17,203684,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203684 sulfur hexafluoride statistical prea.pdf","1900-01-01 00:00:00",
51669,57,203684,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/59_203684 sulfur hexafluoride CDTL clinical prea.pdf","1900-01-01 00:00:00",
46514,2,203684,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s002lbl.pdf","2016-12-22 00:00:00",
46527,1,203684,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s002ltr.pdf","2016-12-23 00:00:00",
49263,1,203689,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203689Orig1s000TAltr.pdf","2017-08-07 00:00:00",
19490,2,203696,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf","2013-11-05 00:00:00",
22932,3,203696,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696_lupaneta_toc.cfm","2013-09-09 00:00:00",
24446,21,203696,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696Orig1s000SumR.pdf","2013-09-09 00:00:00",
32460,1,203696,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf","2013-10-31 00:00:00",
10245,1,203697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203697Orig1s000ltr.pdf","2013-01-16 00:00:00",
22933,3,203697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203697_aspirin_toc.cfm","2013-11-05 00:00:00",
40322,2,203697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203697Orig1s000lbl.pdf","2014-01-14 00:00:00",
44888,21,203697,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203697Orig1s000SumR.pdf","2013-11-05 00:00:00",
50494,2,203697,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203697Orig1s002ltr.pdf","2017-11-27 00:00:00",
55011,1,203697,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203697Orig1s003Ltr.pdf","2018-07-26 00:00:00",
55105,2,203697,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203697Orig1s003Lbl.pdf","2018-08-03 00:00:00",
32461,1,203707,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203707Orig1s000ltr.pdf","2015-09-15 00:00:00",
32462,1,203711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203711Orig1s000ltr.pdf","2014-09-10 00:00:00",
40323,2,203711,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203711Orig1s000lbl.pdf","2014-09-23 00:00:00",
32463,1,203730,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203730Orig1s000ltr.pdf","2015-06-03 00:00:00",
32464,1,203741,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203741Orig1s000ltr.pdf","2015-06-26 00:00:00",
10246,1,203752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203752Orig1s000ltr.pdf","2012-11-01 00:00:00",
19491,2,203752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf","2012-10-29 00:00:00",
22934,3,203752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752_minivelle_toc.cfm","2013-03-28 00:00:00",
24447,21,203752,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752Orig1s000SumR.pdf","2013-03-28 00:00:00",
10247,1,203752,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203752Orig1s004ltr.pdf","2014-09-25 00:00:00",
40324,2,203752,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203752s004lbl.pdf","2014-09-26 00:00:00",
50279,2,203752,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203752s009lbl.pdf","2017-11-02 00:00:00",
10248,1,203756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203756Orig1s000ltr.pdf","2012-11-30 00:00:00",
24448,21,203756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000SumR.pdf","2013-01-04 00:00:00",
40325,2,203756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203756lbl.pdf","2012-11-30 00:00:00",
43443,3,203756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000TOC.cfm","2013-01-04 00:00:00",
32465,1,203756,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203756Orig1s002ltr.pdf","2016-05-24 00:00:00",
40326,2,203756,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203756s002lbl.pdf","2016-05-23 00:00:00",
49961,2,203756,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203756s004lbl.pdf","2017-10-06 00:00:00",
49975,1,203756,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203756Orig1s004ltr.pdf","2017-10-06 00:00:00",
51057,1,203756,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203756Orig1s005ltr.pdf","2018-01-17 00:00:00",
51071,2,203756,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203756s005lbl.pdf","2018-01-17 00:00:00",
10249,1,203790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000ltr.pdf","2015-10-02 00:00:00",
10250,1,203790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000TAltr.pdf","2015-04-13 00:00:00",
22935,3,203791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203791Orig1s000TOC.cfm","2014-01-07 00:00:00",
24449,21,203791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203791Orig1s000SumR.pdf","2014-01-07 00:00:00",
32466,1,203791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203791Orig1s000ltr.pdf","2013-04-16 00:00:00",
40327,2,203791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203791s000lbl.pdf","2013-04-16 00:00:00",
19492,2,203794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf","2012-10-17 00:00:00",
24450,21,203794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794Orig1s000SumR.pdf","2012-11-16 00:00:00",
32467,1,203794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203794Orig1s000ltr.pdf","2012-10-18 00:00:00",
43444,3,203794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794_nucynta_toc.cfm","2012-11-16 00:00:00",
43968,8,203794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000mg.pdf","2012-10-17 00:00:00",
10251,1,203794,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf","2014-11-19 00:00:00",
40328,2,203794,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf","2014-11-20 00:00:00",
19493,2,203794,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf","2014-11-20 00:00:00",
32468,1,203794,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf","2014-11-19 00:00:00",
46301,2,203794,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf","2016-12-20 00:00:00",
46430,1,203794,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203794Orig1s004ltr.pdf","2016-12-21 00:00:00",
55554,2,203794,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf","2018-09-21 00:00:00",
55556,3,203794,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34","2018-09-21 00:00:00",
55723,1,203794,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf","2018-10-01 00:00:00",
55555,2,203794,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf","2018-09-21 00:00:00",
55557,3,203794,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34","2018-09-21 00:00:00",
55724,1,203794,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf","2018-10-01 00:00:00",
32469,1,203797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203797Orig1s000ltr.pdf","2013-03-19 00:00:00",
32470,1,203797,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203797Orig1s000TAltr.pdf","2015-02-19 00:00:00",
24117,14,203807,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351","2015-10-09 00:00:00",
50338,1,203817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203817Orig1s000TAltr.pdf","2017-11-08 00:00:00",
48564,1,203821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203821Orig1s000ltr.pdf","2017-05-30 00:00:00",
32471,1,203823,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203823Orig1s000ltr.pdf","2014-08-04 00:00:00",
10252,1,203826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203826Orig1s000ltr.pdf","2012-12-26 00:00:00",
19494,2,203826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf","2012-12-21 00:00:00",
43445,3,203826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826_phenylephrine_toc.cfm","2013-05-24 00:00:00",
44889,21,203826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826Orig1s000SumR.pdf","2013-05-24 00:00:00",
45240,1,203826,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203826Orig1s002ltr.pdf","2016-09-06 00:00:00",
45268,2,203826,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf","2016-09-12 00:00:00",
32472,1,203835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203835Orig1s000ltr.pdf","2015-08-14 00:00:00",
45200,1,203836,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203836Orig1s000ltr.pdf","2016-08-19 00:00:00",
10253,1,203849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203849Orig1s000ltr.pdf","2015-04-08 00:00:00",
19495,2,203849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf","2015-04-14 00:00:00",
24118,14,203849,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
50578,1,203851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203851Orig1s000ltr.pdf","2017-12-01 00:00:00",
50577,1,203852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203852Orig1s000ltr.pdf","2017-12-01 00:00:00",
10254,1,203856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203856Orig1s000ltr.pdf","2013-09-19 00:00:00",
24451,21,203856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000SumR.pdf","2014-03-06 00:00:00",
40329,2,203856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf","2013-09-18 00:00:00",
43446,3,203856,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000TOC.cfm","2014-03-06 00:00:00",
10255,1,203858,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf","2013-08-15 00:00:00",
19496,2,203858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf","2012-12-31 00:00:00",
22936,3,203858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/2038858_juxtapid_toc.cfm","2013-02-11 00:00:00",
32473,1,203858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_replace.pdf","2012-12-27 00:00:00",
44590,14,203858,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=25","2012-12-28 00:00:00",
19497,2,203858,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf","2013-04-16 00:00:00",
32474,1,203858,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf","2013-04-16 00:00:00",
10256,1,203858,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf","2014-02-19 00:00:00",
19498,2,203858,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf","2014-02-19 00:00:00",
10257,1,203858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf","2014-08-11 00:00:00",
19499,2,203858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf","2014-08-12 00:00:00",
10258,1,203858,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf","2015-04-24 00:00:00",
19500,2,203858,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf","2015-04-24 00:00:00",
32475,1,203858,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf","2016-03-10 00:00:00",
40330,2,203858,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf","2016-03-14 00:00:00",
46672,1,203858,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf","2017-01-05 00:00:00",
19501,2,203858,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf","2016-05-25 00:00:00",
32476,1,203858,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf","2016-05-25 00:00:00",
46673,1,203858,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf","2017-01-05 00:00:00",
49164,2,203858,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf","2017-07-31 00:00:00",
49229,8,203858,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf#page=32","2017-08-04 00:00:00",
49241,1,203858,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s017ltr.pdf","2017-08-04 00:00:00",
54456,1,203858,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203858Orig1s018ltr.pdf","2018-06-05 00:00:00",
32477,1,203873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203873Orig1s000ltr.pdf","2016-05-17 00:00:00",
49552,1,203900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203900Orig1s000ltr.pdf","2017-08-28 00:00:00",
19502,2,203922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203922s000lbl.pdf","2012-02-17 00:00:00",
32478,1,203922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203922s000ltr.pdf","2012-02-21 00:00:00",
43447,3,203922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203922_sodium_nitrite_toc.cfm","2012-03-15 00:00:00",
44890,21,203922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203922Orig1s000SumR.pdf","2012-03-15 00:00:00",
50133,1,203922,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203922Orig1s001ltr.pdf","2017-10-23 00:00:00",
50160,2,203922,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203922s001lbl.pdf","2017-10-24 00:00:00",
19503,2,203923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203923s000lbl.pdf","2012-02-17 00:00:00",
22937,3,203923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923_sodium_thiosulfate_toc.cfm","2012-03-15 00:00:00",
24452,21,203923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923Orig1s000SumR.pdf","2012-03-15 00:00:00",
32479,1,203923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203923s000ltr.pdf","2012-02-21 00:00:00",
50132,1,203923,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203923Orig1s001ltr.pdf","2017-10-23 00:00:00",
50158,2,203923,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203923s001lbl.pdf","2017-10-24 00:00:00",
32480,1,203924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203924Orig1s000ltr.pdf","2014-02-10 00:00:00",
32481,1,203950,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203950Orig1s000ltr.pdf","2015-12-16 00:00:00",
10259,1,203952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203952Orig1s000ltr.pdf","2015-01-15 00:00:00",
22938,3,203952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203952Orig1s000TOC.cfm","2016-07-19 00:00:00",
40331,2,203952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203952s000lbl.pdf","2015-01-14 00:00:00",
45283,1,203952,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203952Orig1s004ltr.pdf","2016-09-19 00:00:00",
45301,2,203952,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203952s004lbl.pdf","2016-09-15 00:00:00",
32482,1,203955,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203955Orig1s000ltr.pdf","2016-04-13 00:00:00",
10260,1,203965,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203965Orig1s000ltr.pdf","2015-03-03 00:00:00",
19504,2,203971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf","2013-05-15 00:00:00",
24453,21,203971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000SumR.pdf","2013-06-21 00:00:00",
32483,1,203971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203971Orig1s000ltr.pdf","2013-05-16 00:00:00",
43448,3,203971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000TOC.cfm","2013-06-21 00:00:00",
10261,1,203971,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203971Orig1s007ltr.pdf","2016-03-22 00:00:00",
19505,2,203971,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203971s007lbl.pdf","2016-03-22 00:00:00",
52397,2,203971,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s012lbl.pdf","2018-02-02 00:00:00",
52507,1,203971,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203971Orig1s012ltr.pdf","2018-02-08 00:00:00",
55381,2,203971,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203971s014lbl.pdf","2018-09-05 00:00:00",
55470,1,203971,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203971Orig1s014ltr.pdf","2018-09-13 00:00:00",
24454,21,203975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000SumR.pdf","2014-01-06 00:00:00",
32484,1,203975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203975Orig1s000ltr.pdf","2013-12-20 00:00:00",
40332,2,203975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203975s000lbl.pdf","2013-12-19 00:00:00",
43449,3,203975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000TOC.cfm","2014-01-06 00:00:00",
10262,1,203975,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203975Orig1s003ltr.pdf","2016-02-26 00:00:00",
40333,2,203975,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203975s003lbl.pdf","2016-02-26 00:00:00",
47656,2,203975,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf","2017-03-23 00:00:00",
47657,8,203975,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf#page=27","2017-03-23 00:00:00",
47680,1,203975,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203975Orig1s005ltr.pdf","2017-03-24 00:00:00",
50099,2,203975,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s007lbl.pdf","2017-10-19 00:00:00",
50118,1,203975,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203975Orig1s007ltr.pdf","2017-10-19 00:00:00",
10263,1,203985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203985Orig1s000ltr.pdf","2012-08-31 00:00:00",
19506,2,203985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf","2012-08-29 00:00:00",
22939,3,203985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985_afinitor_toc.cfm","2013-11-12 00:00:00",
44891,21,203985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985Orig1s000SumR.pdf","2013-11-12 00:00:00",
51097,20,203985,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Orig1s000MedR_PREA.pdf","1900-01-01 00:00:00",
51098,18,203985,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Everolimus_Clinpharm_BPCA.pdf","1900-01-01 00:00:00",
51099,17,203985,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Everolimus_Statistical_BPCA.pdf","1900-01-01 00:00:00",
32485,1,203985,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
40334,2,203985,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
32486,1,203985,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf","2013-11-07 00:00:00",
40335,2,203985,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf","2013-11-08 00:00:00",
10264,1,203985,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
40336,2,203985,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
19507,2,203985,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf","2014-02-21 00:00:00",
32487,1,203985,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf","2014-02-21 00:00:00",
10265,1,203985,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf","2014-07-03 00:00:00",
19508,2,203985,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf","2014-07-02 00:00:00",
10266,1,203985,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203985Orig1s008ltr.pdf","2015-01-26 00:00:00",
19509,2,203985,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf","2015-01-29 00:00:00",
10267,1,203985,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf","2016-02-01 00:00:00",
40337,2,203985,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf","2016-02-02 00:00:00",
53648,2,203985,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf","2018-04-11 00:00:00",
10268,1,203993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203993Orig1s000ltr.pdf","2012-12-20 00:00:00",
19510,2,203993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf","2012-12-18 00:00:00",
43450,3,203993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993_onfi_toc.cfm","2013-07-08 00:00:00",
44892,21,203993,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993Orig1s000SumR.pdf","2013-07-08 00:00:00",
10269,1,203993,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993Orig1s002ltr.pdf","2013-11-26 00:00:00",
40338,2,203993,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf","2013-11-22 00:00:00",
19511,2,203993,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf","2015-05-12 00:00:00",
32488,1,203993,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993Orig1s003ltr.pdf","2014-12-11 00:00:00",
46286,2,203993,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203993s005lbl.pdf","2016-12-20 00:00:00",
46473,1,203993,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202067Orig1s004,203993Orig1s005ltr.pdf","2016-12-22 00:00:00",
54630,1,203993,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202067Orig1s005,203993Orig1s007ltr.pdf","2018-06-20 00:00:00",
54655,2,203993,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf","2018-06-21 00:00:00",
54656,8,203993,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29","2018-06-21 00:00:00",
32489,1,204003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204003Orig1s000ltr.pdf","2015-07-08 00:00:00",
10270,1,204005,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204005Orig1s000ltr.pdf","2014-09-02 00:00:00",
10271,1,204016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204016Orig1s000ltr.pdf","2015-12-30 00:00:00",
32490,1,204016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204016Orig1s000ltr.pdf","2013-07-08 00:00:00",
40339,2,204016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204016s000lbl.pdf","2015-12-31 00:00:00",
43451,3,204016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204016Orig1s000TOC.cfm","2016-06-27 00:00:00",
48752,1,204021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204021Orig1s000ltr.pdf","2017-06-16 00:00:00",
10272,1,204026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf","2013-02-11 00:00:00",
19512,2,204026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf","2013-02-08 00:00:00",
24119,14,204026,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=41","2013-02-12 00:00:00",
24455,21,204026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf","2013-03-20 00:00:00",
43452,3,204026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000TOC.cfm","2013-03-20 00:00:00",
10273,1,204026,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf","2013-11-18 00:00:00",
10274,1,204026,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf","2014-03-19 00:00:00",
19513,2,204026,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf","2014-03-19 00:00:00",
32491,1,204026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf","2014-09-16 00:00:00",
10275,1,204026,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf","2015-04-24 00:00:00",
40340,2,204026,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf","2015-04-28 00:00:00",
10276,1,204026,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf","2015-04-24 00:00:00",
19514,2,204026,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf","2015-04-28 00:00:00",
10277,1,204026,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf","2015-04-24 00:00:00",
40341,2,204026,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf","2015-04-28 00:00:00",
10278,1,204026,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf","2015-09-16 00:00:00",
10279,1,204026,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf","2015-10-28 00:00:00",
10280,1,204026,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf","2015-12-02 00:00:00",
10281,1,204026,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf","2016-07-01 00:00:00",
40342,2,204026,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf","2016-07-05 00:00:00",
10282,1,204026,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf","2016-04-25 00:00:00",
10283,1,204026,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf","2016-07-01 00:00:00",
40343,2,204026,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf","2016-07-05 00:00:00",
48866,1,204026,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s016ltr.pdf","2017-06-29 00:00:00",
53256,2,204026,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf","2018-03-23 00:00:00",
53257,8,204026,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf#page=31","2018-03-23 00:00:00",
53495,1,204026,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204026Orig1s017ltr.pdf","2018-03-28 00:00:00",
50541,2,204026,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf","2017-12-01 00:00:00",
50569,1,204026,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s018ltr.pdf","2017-12-01 00:00:00",
50948,1,204026,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s019ltr.pdf","2017-12-29 00:00:00",
50955,2,204026,"SUPPL",19,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf","2018-01-02 00:00:00",
32492,1,204028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204028Orig1s000ltr.pdf","2015-07-08 00:00:00",
48366,1,204029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204029Orig1s000ltr.pdf","2017-05-12 00:00:00",
48375,2,204029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204029Orig1s000lbl.pdf","2017-05-15 00:00:00",
10284,1,204031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204031Orig1s000ltr.pdf","2014-03-13 00:00:00",
10285,1,204031,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204031Orig2s001ltr.pdf","2015-03-13 00:00:00",
19515,2,204031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204031s000lbl.pdf","2014-03-13 00:00:00",
40344,2,204031,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204031s001lbl.pdf","2015-03-17 00:00:00",
43453,3,204031,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204031Orig1s000TOC.cfm","2014-04-18 00:00:00",
46300,2,204031,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf","2016-12-20 00:00:00",
46431,1,204031,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204031Orig1s003ltr.pdf","2016-12-21 00:00:00",
46598,8,204031,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf#page=32","2016-12-30 00:00:00",
55550,2,204031,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf","2018-09-21 00:00:00",
55552,8,204031,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf#page=34","2018-09-21 00:00:00",
55664,1,204031,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204031Orig1s004s005ltr.pdf","2018-09-28 00:00:00",
55551,2,204031,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf","2018-09-21 00:00:00",
55553,8,204031,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf#page=34","2018-09-21 00:00:00",
55665,1,204031,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204031Orig1s004s005ltr.pdf","2018-09-28 00:00:00",
24456,21,204042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000SumR.pdf","2013-05-10 00:00:00",
32493,1,204042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204042Orig1s000ltr.pdf","2013-04-01 00:00:00",
40345,2,204042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf","2013-04-01 00:00:00",
43454,3,204042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000TOC.cfm","2013-05-10 00:00:00",
10286,1,204042,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204042Orig1s002ltr.pdf","2014-05-20 00:00:00",
40346,2,204042,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf","2014-05-19 00:00:00",
10287,1,204042,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s005ltr.pdf","2015-03-04 00:00:00",
40347,2,204042,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf","2015-03-05 00:00:00",
19516,2,204042,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf","2015-09-11 00:00:00",
32494,1,204042,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s011ltr.pdf","2016-03-30 00:00:00",
40348,2,204042,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf","2016-03-30 00:00:00",
19517,2,204042,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf","2015-12-08 00:00:00",
32495,1,204042,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s013ltr.pdf","2015-12-08 00:00:00",
19518,2,204042,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf","2016-05-23 00:00:00",
32496,1,204042,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf","2016-05-24 00:00:00",
47084,1,204042,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s018ltr.pdf","2017-02-01 00:00:00",
47085,2,204042,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s018lbl.pdf","2017-02-01 00:00:00",
10288,1,204042,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf","2016-05-24 00:00:00",
40349,2,204042,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf","2016-05-23 00:00:00",
45094,2,204042,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf","2016-08-22 00:00:00",
45142,1,204042,"SUPPL",22,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s022ltr.pdf","2016-08-17 00:00:00",
49064,2,204042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf","2017-07-25 00:00:00",
49065,8,204042,"SUPPL",26,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf#page=45","2017-07-25 00:00:00",
49116,1,204042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204042Orig1s026ltr.pdf","2017-07-28 00:00:00",
52736,3,204042,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204042Orig1s026.pdf","2018-02-27 00:00:00",
47444,19,204043,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204043","2017-03-03 00:00:00",
45503,1,204051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204051Orig1s000TAltr.pdf","2016-10-06 00:00:00",
10289,1,204060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204060Orig1s000ltr.pdf","2016-04-20 00:00:00",
46010,2,204060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204060lbl.pdf","2016-12-02 00:00:00",
19519,2,204061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204061s000lbl.pdf","2013-04-01 00:00:00",
22940,3,204061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061_quartette_toc.cfm","2013-04-25 00:00:00",
32497,1,204061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204061Orig1s000ltr.pdf","2013-03-29 00:00:00",
44893,21,204061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061Orig1s000SumR.pdf","2013-04-25 00:00:00",
51302,20,204061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204061 levo ee clinpharm prea.pdf","1900-01-01 00:00:00",
51303,17,204061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204061 levo ee statistical prea.pdf","1900-01-01 00:00:00",
51304,62,204061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204061 lev ee clinpharm addendum prea.pdf","1900-01-01 00:00:00",
51305,18,204061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204061 levo ee clinpharm prea.pdf","1900-01-01 00:00:00",
49333,2,204061,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204061s002lbl.pdf","2017-08-11 00:00:00",
49382,1,204061,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204061Orig1s002ltr.pdf","2017-08-15 00:00:00",
10290,1,204063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf","2013-03-29 00:00:00",
22941,3,204063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000TOC.cfm","2013-04-25 00:00:00",
24457,21,204063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000SumR.pdf","2013-04-25 00:00:00",
40350,2,204063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf","2013-03-29 00:00:00",
44432,10,204063,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm424806.htm","2014-12-23 00:00:00",
32498,1,204063,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf","2014-12-04 00:00:00",
40351,2,204063,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf","2014-12-10 00:00:00",
19520,2,204063,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf","2014-12-10 00:00:00",
32499,1,204063,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf","2014-12-04 00:00:00",
10291,1,204063,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s009ltr.pdf","2014-11-18 00:00:00",
19521,2,204063,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf","2014-12-10 00:00:00",
22942,3,204063,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204063Orig1s010.pdf","2016-07-28 00:00:00",
32500,1,204063,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf","2014-12-04 00:00:00",
19522,2,204063,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf","2016-03-03 00:00:00",
32501,1,204063,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204063Orig1s014ltr.pdf","2016-03-02 00:00:00",
46950,2,204063,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf","2017-01-24 00:00:00",
46955,1,204063,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s017ltr.pdf","2017-01-24 00:00:00",
50784,1,204063,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s020ltr.pdf","2017-12-20 00:00:00",
50835,2,204063,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s020lbl.pdf","2017-12-22 00:00:00",
10292,1,204068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204068Orig1s000ltr.pdf","2016-07-20 00:00:00",
19523,2,204078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf","2013-06-04 00:00:00",
32502,1,204078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204078Orig1s000ltr.pdf","2013-06-04 00:00:00",
43455,3,204078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000TOC.cfm","2014-05-27 00:00:00",
44894,21,204078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000SumR.pdf","2014-05-27 00:00:00",
51399,20,204078,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204078 neostigmine methylsulfate Bloxiverz clinical prea.pdf","1900-01-01 00:00:00",
51400,18,204078,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204078 neostigmine methylsulfate Bloxiverz clinical prea.pdf","1900-01-01 00:00:00",
10293,1,204078,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204078Orig1s004ltr.pdf","2014-12-12 00:00:00",
40352,2,204078,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf","2014-12-16 00:00:00",
19524,2,204078,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf","2015-10-22 00:00:00",
32503,1,204078,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204078Orig1s007ltr.pdf","2015-10-21 00:00:00",
32504,1,204079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204079Orig1s000ltr.pdf","2015-06-02 00:00:00",
32505,1,204082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204082Orig1s000ltr.pdf","2016-02-18 00:00:00",
32506,1,204083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204083Orig1s000ltr.pdf","2016-02-18 00:00:00",
32507,1,204085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204085Orig1s000ltr.pdf","2014-09-16 00:00:00",
10294,1,204096,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s001ltr.pdf","2014-02-12 00:00:00",
19526,2,204096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf","2013-07-23 00:00:00",
22943,3,204096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204096Orig1s000OTOC.cfm","2014-12-18 00:00:00",
32509,1,204096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204096Orig1s000ltr.pdf","2013-07-26 00:00:00",
43971,8,204096,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362199.pdf","2013-07-24 00:00:00",
44895,21,204096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096Orig1s000SumR.pdf","2014-11-17 00:00:00",
10295,1,204096,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s002ltr.pdf","2014-03-04 00:00:00",
40353,2,204096,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf","2014-03-04 00:00:00",
19527,2,204096,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf","2015-12-17 00:00:00",
32510,1,204096,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf","2015-12-18 00:00:00",
10296,1,204096,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf","2015-12-18 00:00:00",
40354,2,204096,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf","2015-12-17 00:00:00",
19528,2,204114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf","2013-05-29 00:00:00",
24120,14,204114,"ORIG",1,"Office Director Memo","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000ODMemo.pdf","2013-06-07 00:00:00",
24458,21,204114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf","2013-06-07 00:00:00",
32511,1,204114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204114Orig1s000ltr.pdf","2013-05-30 00:00:00",
32512,1,204114,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204114Orig1s001ltr.pdf","2014-01-10 00:00:00",
40355,2,204114,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf","2014-01-09 00:00:00",
43456,3,204114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204114Orig1s000TOC.cfm","2013-07-08 00:00:00",
32513,1,204114,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204114Orig1s004ltr.pdf","2015-11-23 00:00:00",
40356,2,204114,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf","2015-11-20 00:00:00",
48810,2,204114,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s005lbl.pdf","2017-06-22 00:00:00",
48835,1,204114,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s005ltr.pdf","2017-06-27 00:00:00",
47338,2,204114,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s006lbl.pdf","2017-02-27 00:00:00",
47436,1,204114,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s006ltr.pdf","2017-03-03 00:00:00",
53872,2,204114,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s007lbl.pdf","2018-04-30 00:00:00",
53991,1,204114,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s007ltr.pdf","2018-05-03 00:00:00",
52922,2,204114,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s008lbl.pdf","2018-03-13 00:00:00",
52996,1,204114,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s008ltr.pdf","2018-03-15 00:00:00",
54016,2,204114,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114Orig1s009lbl.pdf","2018-05-04 00:00:00",
54043,1,204114,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s009ltr.pdf","2018-05-08 00:00:00",
10297,1,204115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204115Orig1s000ltr.pdf","2015-03-03 00:00:00",
10298,1,204119,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204119Orig1s000TAltr.pdf","2012-11-13 00:00:00",
45478,1,204120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204120Orig1s000ltr.pdf","2016-09-26 00:00:00",
32514,1,204132,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204132Orig1s000ltr.pdf","2015-08-25 00:00:00",
45901,1,204135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204135Orig1s000TAltr.pdf","2016-11-17 00:00:00",
10299,1,204137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204137Orig1s000ltr.pdf","2016-07-20 00:00:00",
19529,2,204137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204137Orig1s000lbl.pdf","2016-07-21 00:00:00",
22944,3,204141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141_topicort_toc.cfm","2013-11-05 00:00:00",
32515,1,204141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf","2013-04-16 00:00:00",
40357,2,204141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf","2013-04-16 00:00:00",
44896,21,204141,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141Orig1s000SumR.pdf","2013-11-05 00:00:00",
19530,2,204141,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf","2015-12-17 00:00:00",
32516,1,204141,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf","2015-12-17 00:00:00",
10300,1,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf","2013-01-07 00:00:00",
22945,3,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150_desvenlafaxine_toc.cfm","2013-09-26 00:00:00",
24459,21,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf","2013-09-26 00:00:00",
32517,1,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf","2013-01-11 00:00:00",
32518,1,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf","2013-03-05 00:00:00",
32519,1,204150,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf","2014-07-09 00:00:00",
40358,2,204150,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf","2013-03-08 00:00:00",
40359,2,204150,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf","2014-07-08 00:00:00",
10301,1,204150,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf","2014-07-09 00:00:00",
40360,2,204150,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf","2014-07-08 00:00:00",
32520,1,204150,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204150Orig1s003ltr.pdf","2015-05-19 00:00:00",
40361,2,204150,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf","2015-05-21 00:00:00",
45327,1,204150,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204150Orig1s004ltr.pdf","2016-09-15 00:00:00",
46967,2,204150,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf","2017-01-24 00:00:00",
46687,2,204150,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s005lbl.pdf","2017-01-06 00:00:00",
46737,1,204150,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s005ltr.pdf","2017-01-10 00:00:00",
50809,2,204150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf","2017-12-21 00:00:00",
50810,8,204150,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf#page=30","2017-12-21 00:00:00",
50893,1,204150,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s007ltr.pdf","2017-12-27 00:00:00",
10302,1,204152,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204152Orig1s000ltr.pdf","2015-08-03 00:00:00",
19531,2,204153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf","2013-11-15 00:00:00",
24460,21,204153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000SumR.pdf","2013-12-12 00:00:00",
32521,1,204153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204153Orig1s000ltr.pdf","2013-11-15 00:00:00",
43457,3,204153,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000TOC.cfm","2013-12-12 00:00:00",
47139,1,204153,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204153Orig1s002ltr.pdf","2017-02-09 00:00:00",
47148,2,204153,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204153s002lbl.pdf","2017-02-09 00:00:00",
52690,2,204153,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf","2018-02-23 00:00:00",
52728,1,204153,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf","2018-02-26 00:00:00",
52691,2,204153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf","2018-02-23 00:00:00",
52729,1,204153,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf","2018-02-26 00:00:00",
19532,2,204154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf","2014-10-30 00:00:00",
32522,1,204154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204154Orig1s000ltr.pdf","2014-10-28 00:00:00",
10303,1,204168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204168Orig1s000ltr.pdf","2013-07-29 00:00:00",
19533,2,204168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf","2013-07-30 00:00:00",
22946,3,204168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000TOC.cfm","2014-03-14 00:00:00",
24461,21,204168,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000SumR.pdf","2014-03-14 00:00:00",
32523,1,204168,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s001ltr.pdf","2014-05-27 00:00:00",
40362,2,204168,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf","2014-08-05 00:00:00",
10304,1,204168,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s002ltr.pdf","2014-07-23 00:00:00",
40363,2,204168,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf","2014-07-23 00:00:00",
46690,2,204168,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s004lbl.pdf","2017-01-06 00:00:00",
46743,1,204168,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s004ltr.pdf","2017-01-10 00:00:00",
50807,2,204168,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf","2017-12-21 00:00:00",
50808,8,204168,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf#page=27","2017-12-21 00:00:00",
50895,1,204168,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s005ltr.pdf","2017-12-27 00:00:00",
10305,1,204172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204172Orig1s000ltr.pdf","2015-07-08 00:00:00",
32524,1,204200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204200Orig1s000ltr.pdf","2012-12-27 00:00:00",
40364,2,204200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf","2012-12-10 00:00:00",
43458,3,204200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200_adrenalin_toc.cfm","2013-08-19 00:00:00",
44897,21,204200,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200Orig1Orig2s000SumR.pdf","2013-08-19 00:00:00",
47128,1,204200,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s004ltr.pdf","2017-02-07 00:00:00",
47129,2,204200,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200Orig1s004lbl.pdf","2017-02-07 00:00:00",
10306,1,204200,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf","2016-05-19 00:00:00",
40365,2,204200,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf","2016-05-20 00:00:00",
49338,2,204200,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf","2017-08-11 00:00:00",
49401,1,204200,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204200Orig1s007,204640Orig1s008ltr.pdf","2017-08-15 00:00:00",
45590,1,204209,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204209Orig1s000ltr.pdf","2016-10-05 00:00:00",
45796,1,204216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204216Orig1s000ltr.pdf","2016-11-03 00:00:00",
10307,1,204223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204223Orig1s000ltr.pdf","2013-11-06 00:00:00",
19534,2,204223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204223s000lbl.pdf","2013-10-31 00:00:00",
22947,3,204223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000TOC.cfm","2014-03-06 00:00:00",
24462,21,204223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000SumR.pdf","2014-03-06 00:00:00",
46432,1,204223,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204223Orig1s006ltr.pdf","2016-12-21 00:00:00",
46438,2,204223,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204223s006lbl.pdf","2016-12-21 00:00:00",
10308,1,204227,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204227Orig1s000ltr.pdf","2016-07-13 00:00:00",
10309,1,204228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204228Orig1s000ltr.pdf","2016-07-19 00:00:00",
49694,1,204230,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204230Orig1s000TAltr.pdf","2017-09-07 00:00:00",
10310,1,204239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204239Orig1s000ltrl.pdf","2015-12-22 00:00:00",
32525,1,204239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204239Orig1s000TAltr.pdf","2015-04-13 00:00:00",
10311,1,204242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf","2013-07-08 00:00:00",
40366,2,204242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf","2013-07-05 00:00:00",
43459,3,204242,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000TOC.cfm","2014-06-27 00:00:00",
43972,8,204242,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362203.pdf","2013-07-24 00:00:00",
44591,14,204242,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2013-07-23 00:00:00",
32526,1,204242,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf","2013-09-09 00:00:00",
10312,1,204242,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf","2014-12-12 00:00:00",
19535,2,204242,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf","2015-02-03 00:00:00",
32527,1,204242,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf","2015-08-11 00:00:00",
40367,2,204242,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf","2015-08-11 00:00:00",
32528,1,204242,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf","2015-02-17 00:00:00",
19536,2,204242,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf","2015-06-10 00:00:00",
32529,1,204242,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf","2015-06-10 00:00:00",
45505,1,204242,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s007ltr.pdf","2016-10-06 00:00:00",
45598,2,204242,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf","2016-10-07 00:00:00",
32530,1,204242,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf","2016-07-12 00:00:00",
46433,1,204242,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s009ltr.pdf","2016-12-21 00:00:00",
46436,2,204242,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf","2016-12-21 00:00:00",
49708,2,204242,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf","2017-09-11 00:00:00",
49709,1,204242,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s011ltr.pdf","2017-09-11 00:00:00",
48521,1,204242,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s012ltr.pdf","2017-05-25 00:00:00",
52244,2,204242,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf","2018-02-01 00:00:00",
52289,1,204242,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s014ltr.pdf","2018-02-02 00:00:00",
19537,2,204251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204251s000lbl.pdf","2013-04-23 00:00:00",
22948,3,204251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251_simbrinza_toc.cfm","2013-09-26 00:00:00",
24463,21,204251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251Orig1s000SumR.pdf","2013-09-26 00:00:00",
32531,1,204251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204251Orig1s000ltr.pdf","2013-04-24 00:00:00",
19538,2,204251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204251s006lbl.pdf","2015-11-12 00:00:00",
32532,1,204251,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204251Orig1s006ltr.pdf","2015-11-09 00:00:00",
47445,19,204255,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204255","2017-03-03 00:00:00",
47484,2,204255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204255Orig1s000lbl.pdf","2017-03-08 00:00:00",
10314,1,204268,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204268Orig1s000ltr.pdf","2015-08-06 00:00:00",
24121,14,204268,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?REMS=348&event=IndvRemsDetails.page&source=govdelivery&utm_medium=email&utm_source=govdelivery","2015-08-14 00:00:00",
19539,2,204275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf","2013-05-14 00:00:00",
22949,3,204275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204275Orig1s000TOC.cfm","2013-06-10 00:00:00",
32533,1,204275,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf","2013-05-13 00:00:00",
32534,1,204275,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s001ltr.pdf","2015-05-04 00:00:00",
40368,2,204275,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf","2015-05-04 00:00:00",
10315,1,204275,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s002ltr.pdf","2015-03-03 00:00:00",
19540,2,204275,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf","2015-03-05 00:00:00",
32535,1,204275,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s004ltr.pdf","2015-09-16 00:00:00",
40369,2,204275,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf","2015-09-23 00:00:00",
32536,1,204275,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s009ltr.pdf","2016-02-18 00:00:00",
40370,2,204275,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf","2016-02-18 00:00:00",
45776,1,204275,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s011ltr.pdf","2016-11-02 00:00:00",
45804,2,204275,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s011lbl.pdf","2016-11-04 00:00:00",
48387,2,204275,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s012lbl.pdf","2017-05-17 00:00:00",
48403,1,204275,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s012ltr.pdf","2017-05-17 00:00:00",
50842,2,204275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s015lbl.pdf","2017-12-22 00:00:00",
50879,1,204275,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s015ltr.pdf","2017-12-27 00:00:00",
10316,1,204278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204278Orig1s000ltr.pdf","2015-04-08 00:00:00",
43973,8,204278,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf","2015-04-14 00:00:00",
44592,14,204278,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
19541,2,204286,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204286s001lbl.pdf","2014-10-15 00:00:00",
24464,21,204286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286Orig1s000SumR.pdf","2013-10-03 00:00:00",
32537,1,204286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204286Orig1s000ltr.pdf","2013-07-01 00:00:00",
32538,1,204286,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s001ltr.pdf","2014-10-14 00:00:00",
40371,2,204286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204286s000lbl.pdf","2013-07-11 00:00:00",
43460,3,204286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286_naftin_toc.cfm","2013-10-03 00:00:00",
51444,20,204286,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204286 nafttifine clinical prea.pdf","1900-01-01 00:00:00",
51445,18,204286,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204286 naftifine clinpharm prea.pdf","1900-01-01 00:00:00",
32539,1,204286,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s002ltr.pdf","2014-09-25 00:00:00",
53983,2,204286,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf","2018-05-02 00:00:00",
53992,1,204286,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019356Orig1s008,019599Orig1s014,204286Orig1s003ltr.pdf","2018-05-03 00:00:00",
10317,1,204287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204287Orig1s000TAltr.pdf","2014-12-30 00:00:00",
32540,1,204300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204300Orig1s000ltr.pdf","2014-06-30 00:00:00",
40372,2,204300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204300lbl.pdf","2014-06-30 00:00:00",
43461,3,204300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000TOC.cfm","2015-05-14 00:00:00",
44898,21,204300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000SumR.pdf","2015-05-14 00:00:00",
32541,1,204300,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204300Orig1s005ltr.pdf","2015-05-29 00:00:00",
46839,1,204304,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204304Orig1s000ltr.pdf","2017-01-13 00:00:00",
10318,1,204307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204307Orig1s000ltr.pdf","2013-02-25 00:00:00",
19542,2,204307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204307s000lbl.pdf","2013-02-21 00:00:00",
22950,3,204307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204307_vituz_toc.cfm","2013-09-20 00:00:00",
24465,21,204307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204307Orig1s000SumR.pdf","2013-09-20 00:00:00",
46868,2,204307,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204307s003lbl.pdf","2017-01-13 00:00:00",
46913,1,204307,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf","2017-01-19 00:00:00",
54765,2,204307,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf","2018-07-05 00:00:00",
54804,8,204307,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf#page=25","2018-07-06 00:00:00",
54837,1,204307,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf","2018-07-06 00:00:00",
10319,1,204308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204308Orig1s000ltr.pdf","2013-08-15 00:00:00",
22951,3,204308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000TOC.cfm","2014-06-27 00:00:00",
24466,21,204308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000SumR.pdf","2014-06-27 00:00:00",
40373,2,204308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204308s000lbl.pdf","2013-08-15 00:00:00",
10320,1,204308,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf","2014-09-08 00:00:00",
19543,2,204308,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf","2014-09-09 00:00:00",
19544,2,204308,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf","2014-09-09 00:00:00",
32542,1,204308,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf","2014-09-08 00:00:00",
10321,1,204308,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204308Orig1s005ltr.pdf","2016-01-29 00:00:00",
40374,2,204308,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204308s005lbl.pdf","2016-02-02 00:00:00",
47655,2,204308,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s006lbl.pdf","2017-03-23 00:00:00",
47679,1,204308,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204308Orig1s006ltr.pdf","2017-03-24 00:00:00",
49152,2,204308,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s007lbl.pdf","2017-07-31 00:00:00",
49184,1,204308,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204308Orig1s007ltr.pdf","2017-08-02 00:00:00",
10322,1,204309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204309Orig1s000ltr.pdf","2015-06-12 00:00:00",
10323,1,204311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204311Orig1s000TAltr.pdf","2014-10-24 00:00:00",
10324,1,204312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204312Orig1s000ltr.pdf","2016-02-03 00:00:00",
19545,2,204312,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf","2016-02-11 00:00:00",
46508,1,204323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204323Orig1s000ltr.pdf","2016-12-23 00:00:00",
49765,2,204325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf","2017-09-18 00:00:00",
49766,8,204325,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf#page=26","2017-09-18 00:00:00",
51523,20,204325,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/183_204325 amphetamine clinical prea.pdf","1900-01-01 00:00:00",
51524,18,204325,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/182_204325 amphetamine clinpharm prea.pdf","1900-01-01 00:00:00",
52784,1,204325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204325Orig1s000ltr.pdf","2018-03-01 00:00:00",
53638,3,204325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204325Orig1s000TOC.cfm","2018-04-09 00:00:00",
45921,1,204326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf","2016-01-28 00:00:00",
45922,2,204326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf","2016-01-28 00:00:00",
45923,1,204326,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf","2016-11-22 00:00:00",
45987,2,204326,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf","2016-12-01 00:00:00",
46434,3,204326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.cfm","2016-12-21 00:00:00",
51525,20,204326,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204326 amphetamine clinical prea.pdf","1900-01-01 00:00:00",
51526,18,204326,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204326 amphetamine clinpharm prea.pdf","1900-01-01 00:00:00",
46685,2,204326,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf","2017-01-06 00:00:00",
46727,1,204326,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf","2017-01-09 00:00:00",
10326,1,204353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204353Orig1s000ltr.pdf","2014-08-11 00:00:00",
19547,2,204353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf","2014-08-12 00:00:00",
22952,3,204353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000TOC.cfm","2014-09-03 00:00:00",
44899,21,204353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf","2014-09-03 00:00:00",
10327,1,204353,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s002ltr.pdf","2015-03-04 00:00:00",
40375,2,204353,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf","2015-03-20 00:00:00",
19548,2,204353,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf","2015-09-11 00:00:00",
32543,1,204353,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s003ltr.pdf","2015-09-14 00:00:00",
10328,1,204353,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf","2016-05-24 00:00:00",
40376,2,204353,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf","2016-05-23 00:00:00",
10329,1,204353,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s010ltr.pdf","2016-03-30 00:00:00",
19549,2,204353,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf","2016-03-30 00:00:00",
10330,1,204353,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s012ltr.pdf","2015-12-08 00:00:00",
40377,2,204353,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf","2015-12-08 00:00:00",
47083,1,204353,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s014ltr.pdf","2017-02-01 00:00:00",
47086,2,204353,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s014lbl.pdf","2017-02-01 00:00:00",
32544,1,204353,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf","2016-05-24 00:00:00",
40378,2,204353,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf","2016-05-23 00:00:00",
45050,1,204353,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s020ltr.pdf","2016-08-17 00:00:00",
45092,2,204353,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf","2016-08-22 00:00:00",
49062,2,204353,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s023lbl.pdf","2017-07-25 00:00:00",
49117,1,204353,"SUPPL",23,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s023ltr.pdf","2017-07-28 00:00:00",
49357,2,204353,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf","2017-08-14 00:00:00",
49358,8,204353,"SUPPL",24,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf#page=53","2017-08-14 00:00:00",
49482,1,204353,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s024ltr.pdf","2017-08-21 00:00:00",
10331,1,204354,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204354Orig1s000ltr.pdf","2015-11-27 00:00:00",
19550,2,204354,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204354Orig1s000lbl.pdf","2015-12-01 00:00:00",
49041,1,204363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204363Orig1s000ltr.pdf","2017-07-21 00:00:00",
10332,1,204369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204369Orig1s000ltr.pdf","2013-02-26 00:00:00",
22953,3,204369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000TOC.cfm","2014-01-07 00:00:00",
24467,21,204369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000SumR.pdf","2014-01-07 00:00:00",
40379,2,204369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204369lbl.pdf","2013-02-25 00:00:00",
10333,1,204370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204370Orig1Orig2s000ltr.pdf","2015-09-18 00:00:00",
22954,3,204370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204370Orig2s000TOC.cfm","2015-10-28 00:00:00",
40380,2,204370,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf","2015-09-18 00:00:00",
47308,2,204370,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s001lbl.pdf","2017-02-24 00:00:00",
47397,1,204370,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204370Orig1s001ltr.pdf","2017-03-02 00:00:00",
50404,2,204370,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf","2017-11-14 00:00:00",
50430,1,204370,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf","2017-11-15 00:00:00",
50405,2,204370,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf","2017-11-14 00:00:00",
50431,1,204370,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf","2017-11-15 00:00:00",
32545,1,204372,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204372Orig1s000ltr.pdf","2015-07-24 00:00:00",
50333,1,204383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204383Orig1s000TAltr.pdf","2017-11-08 00:00:00",
54286,3,204383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/204383Orig1s000OtherActionLtrs.pdf","2018-05-22 00:00:00",
22955,3,204384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000TOC.cfm","2013-02-13 00:00:00",
23510,8,204384,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333729.pdf","2013-01-03 00:00:00",
24468,21,204384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000SumR.pdf","2013-02-13 00:00:00",
32546,1,204384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204384Orig1s000ltr.pdf","2013-01-02 00:00:00",
40381,2,204384,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf","2012-12-31 00:00:00",
32547,1,204384,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204384Orig1s002ltr.pdf","2013-08-29 00:00:00",
40382,2,204384,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204384s002lbl.pdf","2013-08-29 00:00:00",
10334,1,204384,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204384Orig1s004ltr.pdf","2014-10-22 00:00:00",
19551,2,204384,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204384s004lbl.pdf","2014-10-21 00:00:00",
19552,2,204384,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s005lbl.pdf","2015-05-21 00:00:00",
32548,1,204384,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s005ltr.pdf","2015-05-19 00:00:00",
10335,1,204384,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s006ltr.pdf","2015-12-10 00:00:00",
19553,2,204384,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s006lbl.pdf","2015-12-15 00:00:00",
55231,1,204393,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204393Orig1s000ltr.pdf","2018-08-20 00:00:00",
49892,1,204398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204398Orig1s000ltr.pdf","2017-09-29 00:00:00",
10336,1,204399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204399Orig1s000TAltr.pdf","2013-08-21 00:00:00",
10337,1,204399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204399Orig1s000ltr.pdf","2014-06-05 00:00:00",
22956,3,204399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000TOC.cfm","2015-04-22 00:00:00",
24122,14,204399,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=318","2014-06-26 00:00:00",
40383,2,204399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204399s000lbl.pdf","2014-06-10 00:00:00",
44900,21,204399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000SumRedt.pdf","2015-04-22 00:00:00",
10338,1,204399,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204399Orig1s002ltr.pdf","2015-05-13 00:00:00",
23511,8,204399,"SUPPL",2,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM448177.pdf","2015-05-27 00:00:00",
40384,2,204399,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf","2015-05-13 00:00:00",
45681,1,204399,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204399Orig1s004ltr.pdf","2016-10-27 00:00:00",
45743,2,204399,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204399s004lbl.pdf","2016-11-01 00:00:00",
32549,1,204403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000ltr.pdf","2015-09-08 00:00:00",
32550,1,204403,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000TAltr.pdf","2015-07-23 00:00:00",
24123,14,204410,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=76","2013-11-01 00:00:00",
24469,21,204410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000SumR.pdf","2013-11-18 00:00:00",
32551,1,204410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204410Orig1s000ltr.pdf","2013-10-22 00:00:00",
40385,2,204410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf","2013-10-22 00:00:00",
43462,3,204410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000TOC.cfm","2013-11-18 00:00:00",
19554,2,204410,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf","2015-11-19 00:00:00",
32552,1,204410,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s002ltr.pdf","2015-11-19 00:00:00",
32553,1,204410,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s003ltr.pdf","2015-05-04 00:00:00",
40386,2,204410,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s003lbl.pdf","2015-05-04 00:00:00",
19555,2,204410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf","2016-02-18 00:00:00",
32554,1,204410,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s006ltr.pdf","2016-02-19 00:00:00",
10339,1,204410,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s007ltr.pdf","2016-02-24 00:00:00",
32555,1,204410,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s008ltr.pdf","2016-06-21 00:00:00",
40387,2,204410,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s008lbl.pdf","2016-06-21 00:00:00",
45635,1,204410,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s009ltr.pdf","2016-10-25 00:00:00",
47635,2,204410,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf","2017-03-22 00:00:00",
47636,8,204410,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf#page=18","2017-03-22 00:00:00",
47673,1,204410,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204410Orig1s011ltr.pdf","2017-03-23 00:00:00",
49549,1,204410,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204410Orig1s013ltr.pdf","2017-08-28 00:00:00",
19556,2,204412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf","2013-02-05 00:00:00",
32556,1,204412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204412Orig1s000ltr.pdf","2013-02-05 00:00:00",
43463,3,204412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204412_delzicol_toc.cfm","2013-06-10 00:00:00",
51347,20,204412,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412 mesalamine clinical prea.pdf","1900-01-01 00:00:00",
51348,18,204412,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412 mesalamine clinpharm prea.pdf","1900-01-01 00:00:00",
51349,17,204412,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412 mesalamine statistical prea.pdf","1900-01-01 00:00:00",
19557,2,204412,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf","2014-04-29 00:00:00",
32557,1,204412,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s003ltr.pdf","2014-04-29 00:00:00",
51344,20,204412,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412s003 mesalamine clinical prea.pdf","1900-01-01 00:00:00",
51345,58,204412,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412s003 mesalamine clinical add prea.pdf","1900-01-01 00:00:00",
51346,18,204412,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204412s003 mesalamine clinpharm prea.pdf","1900-01-01 00:00:00",
10340,1,204412,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s004ltr.pdf","2014-10-28 00:00:00",
40388,2,204412,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf","2014-10-29 00:00:00",
10341,1,204412,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204412Orig1s006ltr.pdf","2015-09-10 00:00:00",
40389,2,204412,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf","2015-09-22 00:00:00",
49124,1,204412,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf","2017-07-28 00:00:00",
49140,2,204412,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204412s008lbl.pdf","2017-07-28 00:00:00",
10342,1,204421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204421Orig1s000ltr.pdf","2015-10-22 00:00:00",
19558,2,204421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf","2015-11-04 00:00:00",
19559,2,204426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf","2013-04-23 00:00:00",
22957,3,204426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426_minastrin_toc.cfm","2013-09-26 00:00:00",
24470,21,204426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426Orig1s000SumR.pdf","2013-09-26 00:00:00",
32558,1,204426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204426Orig1s000ltr.pdf","2013-04-24 00:00:00",
40390,2,204426,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf","2015-07-24 00:00:00",
51410,20,204426,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne clinical prea.pdf","1900-01-01 00:00:00",
51411,18,204426,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne clinpharm prea.pdf","1900-01-01 00:00:00",
51412,17,204426,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204426 ee ne statistical prea.pdf","1900-01-01 00:00:00",
45107,2,204426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf","2016-08-23 00:00:00",
45153,1,204426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204426Orig1s004ltr.pdf","2016-08-19 00:00:00",
49364,2,204426,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204426s007lbl.pdf","2017-08-15 00:00:00",
49474,1,204426,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204426Orig1s007ltr.pdf","2017-08-21 00:00:00",
19560,2,204427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf","2014-07-08 00:00:00",
32559,1,204427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204427Orig1s000ltr.pdf","2014-07-09 00:00:00",
43464,3,204427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204427Orig1s000TOC.cfm","2014-08-05 00:00:00",
44901,21,204427,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204427Orig1s000SumR.pdf","2014-08-05 00:00:00",
10343,1,204427,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204427Orig1s003ltr.pdf","2015-03-02 00:00:00",
40391,2,204427,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204427s003lbl.pdf","2015-03-04 00:00:00",
55063,2,204427,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204427s006lbl.pdf","2018-07-31 00:00:00",
55087,1,204427,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204427Orig1s006Ltr.pdf","2018-08-03 00:00:00",
19561,2,204431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204431Orig1s000lbl.pdf","2015-11-25 00:00:00",
32560,1,204431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204431Orig1s000ltr.pdf","2015-10-21 00:00:00",
44593,14,204431,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2016-02-03 00:00:00",
53813,1,204441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s000ltr.pdf","2018-04-24 00:00:00",
54478,3,204441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000TOC.cfm","2018-06-08 00:00:00",
55088,1,204441,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s001Ltr.pdf","2018-08-03 00:00:00",
55386,2,204441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf","2018-09-05 00:00:00",
55387,8,204441,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf#page=18","2018-09-05 00:00:00",
45818,19,204442,"APPL",0,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=356","2016-11-04 00:00:00",
19562,2,204442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204442Orig1s000lbl.pdf","2016-05-26 00:00:00",
32561,1,204442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204442Orig1s000ltr.pdf","2016-05-26 00:00:00",
52395,19,204442,"ORIG",1,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=356","2018-02-05 00:00:00",
55493,3,204442,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204442Orig1s000TOC.cfm","2018-09-18 00:00:00",
49154,2,204442,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf","2017-07-31 00:00:00",
48082,1,204442,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204442Orig1s003ltr.pdf","2017-04-21 00:00:00",
49155,2,204442,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf","2017-07-31 00:00:00",
52243,2,204442,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf","2018-02-01 00:00:00",
52290,1,204442,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204442Orig1s006ltr.pdf","2018-02-02 00:00:00",
52742,8,204442,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf","2018-02-28 00:00:00",
32562,1,204446,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204446Orig1s000ltr.pdf","2015-06-02 00:00:00",
19563,2,204447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204447s000lbl.pdf","2013-10-01 00:00:00",
32563,1,204447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf","2013-10-02 00:00:00",
43465,3,204447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000TOC.cfm","2013-10-30 00:00:00",
44902,21,204447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000SumR.pdf","2013-10-30 00:00:00",
52749,8,204447,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/BRINTELLIXMedGuide.pdf","2018-02-28 00:00:00",
40392,2,204447,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s004lbl.pdf","2014-09-09 00:00:00",
10344,1,204447,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204447Orig1s005ltr.pdf","2014-07-21 00:00:00",
19564,2,204447,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s005lbl.pdf","2014-07-29 00:00:00",
54002,1,204447,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204447Orig1s006ltr.pdf","2018-05-03 00:00:00",
54014,2,204447,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s006lbl.pdf","2018-05-04 00:00:00",
10345,1,204447,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s007ltr.pdf","2016-05-04 00:00:00",
40393,2,204447,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s007lbl.pdf","2016-05-03 00:00:00",
47850,2,204447,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s008lbl.pdf","2017-04-04 00:00:00",
47872,1,204447,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447ORig1s008ltr.pdf","2017-04-05 00:00:00",
47533,2,204447,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s009lbl.pdf","2017-03-13 00:00:00",
47556,1,204447,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447Orig1s009ltr.pdf","2017-03-14 00:00:00",
45183,1,204447,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s011ltr.pdf","2016-08-30 00:00:00",
45219,2,204447,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s011lbl.pdf","2016-08-30 00:00:00",
45560,1,204447,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s012ltr.pdf","2016-10-19 00:00:00",
47278,2,204447,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s012lbl.pdf","2017-02-22 00:00:00",
47988,2,204447,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s013lbl.pdf","2017-04-12 00:00:00",
48034,1,204447,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447Orig1s013ltr.pdf","2017-04-14 00:00:00",
53620,1,204453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204453Orig1s000ltr.pdf","2018-04-05 00:00:00",
10346,1,204475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204475Orig1s000ltr.pdf","2016-06-24 00:00:00",
40394,2,204475,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf","2016-06-27 00:00:00",
10347,1,204485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204485Orig1s000ltr.pdf","2014-04-18 00:00:00",
19565,2,204485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf","2014-09-03 00:00:00",
19566,2,204485,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf","2015-01-07 00:00:00",
22958,3,204485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000TOC.cfm","2015-01-28 00:00:00",
24471,21,204485,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000SumR.pdf","2015-01-28 00:00:00",
10348,1,204485,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204485Orig1s002ltr.pdf","2015-05-07 00:00:00",
19567,2,204485,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf","2015-05-07 00:00:00",
47991,2,204485,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf","2017-04-12 00:00:00",
48420,3,204485,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/2044850Orig1s003.pdf","2017-05-17 00:00:00",
47990,2,204485,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s004lbl.pdf","2017-04-12 00:00:00",
48858,3,204485,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204485Orig1s004.pdf","2017-06-29 00:00:00",
32564,1,204505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204505Orig1s000ltr.pdf","2013-10-22 00:00:00",
19568,2,204508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf","2013-10-08 00:00:00",
32565,1,204508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf","2013-10-04 00:00:00",
43466,3,204508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000TOC.cfm","2014-10-07 00:00:00",
44903,21,204508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000SumR.pdf","2014-10-07 00:00:00",
10349,1,204508,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf","2016-07-22 00:00:00",
40395,2,204508,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf","2016-07-21 00:00:00",
32566,1,204516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204516Orig1s000ltr.pdf","2013-07-02 00:00:00",
40396,2,204516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204516s000lbl.pdf","2013-07-10 00:00:00",
43467,3,204516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000TOC.cfm","2014-07-25 00:00:00",
44904,21,204516,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000SumR.pdf","2014-07-25 00:00:00",
19569,2,204516,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf","2014-12-03 00:00:00",
32567,1,204516,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204516Orig1s003ltr.pdf","2014-12-02 00:00:00",
46722,2,204516,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s004lbl.pdf","2017-01-06 00:00:00",
46834,1,204516,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s004ltr.pdf","2017-01-13 00:00:00",
48177,2,204516,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf","2017-05-01 00:00:00",
48178,8,204516,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf#page=22","2017-05-01 00:00:00",
48201,1,204516,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s005ltr.pdf","2017-05-02 00:00:00",
47006,1,204522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204522Orig1s000ltr.pdf","2017-01-30 00:00:00",
10350,1,204536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000ltr.pdf","2015-12-22 00:00:00",
10351,1,204536,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204536Orig1s000TAltr.pdf","2015-05-28 00:00:00",
10352,1,204538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204538Orig1s000ltr.pdf","2013-11-27 00:00:00",
46578,2,204553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204553s001lbl.pdf","2016-12-29 00:00:00",
46587,1,204553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204553Orig1s000(2)ltr.pdf","2016-12-29 00:00:00",
50466,3,204553,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204553Orig1s000TOC.cfm","2017-11-21 00:00:00",
10354,1,204568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204568Orig1s000TAltr.pdf","2013-12-31 00:00:00",
10355,1,204569,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf","2014-11-12 00:00:00",
19570,2,204569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf","2014-08-14 00:00:00",
19571,2,204569,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf","2014-11-10 00:00:00",
32568,1,204569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf","2014-08-14 00:00:00",
43468,3,204569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000TOC.cfm","2014-09-12 00:00:00",
44905,21,204569,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000SumR.pdf","2014-09-12 00:00:00",
10356,1,204569,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf","2016-05-31 00:00:00",
54881,2,204569,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf","2018-07-13 00:00:00",
54882,8,204569,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf#page=22","2018-07-13 00:00:00",
54896,1,204569,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204569Orig1s005ltr.pdf","2018-07-16 00:00:00",
49693,1,204570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000TAltr.pdf","2017-09-07 00:00:00",
54164,1,204570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000TAltr.pdf","2018-05-11 00:00:00",
55490,1,204570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000ReplacementTAltr.pdf","2018-09-14 00:00:00",
10357,1,204571,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf","2015-08-10 00:00:00",
24125,14,204571,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?REMS=349&event=IndvRemsDetails.page&source=govdelivery&utm_medium=email&utm_source=govdelivery","2015-08-14 00:00:00",
10358,1,204574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204574Orig1s000ltr.pdf","2016-02-05 00:00:00",
32569,1,204582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204582Orig1s000ltr.pdf","2015-09-24 00:00:00",
10359,1,204592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204592Orig1s000ltr.pdf","2013-10-22 00:00:00",
19572,2,204592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204592s000lbl.pdf","2013-10-22 00:00:00",
22959,3,204592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000TOC.cfm","2014-03-26 00:00:00",
23515,8,204592,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372061.pdf","2013-10-24 00:00:00",
24472,21,204592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000SumR.pdf","2014-03-26 00:00:00",
19573,2,204592,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf","2014-08-26 00:00:00",
32570,1,204592,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf","2014-08-27 00:00:00",
52766,3,204592,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204592Orig1s002.pdf","2018-02-28 00:00:00",
10360,1,204592,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf","2014-08-27 00:00:00",
19574,2,204592,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf","2014-08-26 00:00:00",
52767,3,204592,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204592Orig1s004.pdf","2018-02-28 00:00:00",
10361,1,204592,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf","2016-05-10 00:00:00",
40397,2,204592,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf","2016-05-11 00:00:00",
10362,1,204592,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf","2016-05-10 00:00:00",
19575,2,204592,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf","2016-05-11 00:00:00",
32571,1,204605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204605Orig1s000ltr.pdf","2014-06-23 00:00:00",
10363,1,204621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204621Orig1s000ltr.pdf","2015-11-17 00:00:00",
10364,1,204623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s000ltr.pdf","2014-01-17 00:00:00",
24473,21,204623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000SumR.pdf","2014-10-07 00:00:00",
40398,2,204623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s000lbl.pdf","2014-01-17 00:00:00",
43469,3,204623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000TOC.cfm","2014-10-07 00:00:00",
19576,2,204623,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf","2014-07-11 00:00:00",
10365,1,204623,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s003ltr.pdf","2014-11-07 00:00:00",
40399,2,204623,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf","2014-11-07 00:00:00",
10366,1,204623,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s005ltr.pdf","2016-05-10 00:00:00",
40400,2,204623,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf","2016-05-11 00:00:00",
19577,2,204629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf","2014-08-04 00:00:00",
19578,2,204629,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf","2015-07-01 00:00:00",
24474,21,204629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf","2014-09-09 00:00:00",
32572,1,204629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf","2014-08-04 00:00:00",
32573,1,204629,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf","2015-06-30 00:00:00",
43470,3,204629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm","2014-09-09 00:00:00",
10367,1,204629,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf","2015-06-30 00:00:00",
40401,2,204629,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf","2015-07-01 00:00:00",
32574,1,204629,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf","2015-06-30 00:00:00",
40402,2,204629,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf","2015-07-01 00:00:00",
19579,2,204629,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf","2016-03-04 00:00:00",
32575,1,204629,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf","2016-02-09 00:00:00",
10368,1,204629,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf","2016-03-22 00:00:00",
19580,2,204629,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf","2016-03-22 00:00:00",
19581,2,204629,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf","2015-12-08 00:00:00",
32576,1,204629,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf","2015-12-08 00:00:00",
46011,2,204629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf","2016-12-05 00:00:00",
46031,1,204629,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s008ltr.pdf","2016-12-06 00:00:00",
10369,1,204629,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf","2016-07-12 00:00:00",
50692,2,204629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf","2017-12-14 00:00:00",
50715,1,204629,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204629Orig1s016ltr.pdf","2017-12-15 00:00:00",
10370,1,204630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204630Orig1s000ltr.pdf","2016-04-12 00:00:00",
19582,2,204630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204630s000lbl.pdf","2016-04-12 00:00:00",
47191,3,204630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204630Orig1_toc.cfm","2017-02-13 00:00:00",
47192,21,204630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204630Orig1s000SumR.pdf","2017-02-13 00:00:00",
50950,2,204630,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204630s005lbl.pdf","2018-01-02 00:00:00",
50979,1,204630,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204630Orig1s005ltr.pdf","2017-12-29 00:00:00",
54310,2,204630,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204630s006lbl.pdf","2018-05-23 00:00:00",
54326,1,204630,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204630Orig1s006ltr.pdf","2018-05-24 00:00:00",
53057,1,204636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204636Orig1s000ltr.pdf","2018-04-05 00:00:00",
10371,1,204637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204637Orig1s000TAltr.pdf","2016-02-19 00:00:00",
10372,1,204640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204640Orig1s000ltr.pdf","2013-12-20 00:00:00",
24475,21,204640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204640Orig1s000SumR.pdf","2014-03-06 00:00:00",
40403,2,204640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204640s000lbl.pdf","2013-12-19 00:00:00",
43471,3,204640,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204640Orig1s000TOC.cfm","2014-03-06 00:00:00",
10373,1,204640,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204640Orig1s002ltr.pdf","2015-12-30 00:00:00",
40404,2,204640,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204640s002lbl.pdf","2015-12-28 00:00:00",
10374,1,204640,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf","2016-05-19 00:00:00",
40405,2,204640,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf","2016-05-20 00:00:00",
49339,2,204640,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf","2017-08-11 00:00:00",
49402,1,204640,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204200Orig1s007,204640Orig1s008ltr.pdf","2017-08-15 00:00:00",
46986,1,204645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204645Orig1s000ltr.pdf","2017-01-27 00:00:00",
24476,21,204654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf","2014-03-06 00:00:00",
32577,1,204654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf","2013-07-26 00:00:00",
40406,2,204654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf","2013-07-30 00:00:00",
43472,3,204654,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000TOC.cfm","2014-03-06 00:00:00",
48865,1,204654,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s006ltr.pdf","2017-06-29 00:00:00",
48869,2,204654,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s006lbl.pdf","2017-06-29 00:00:00",
49302,2,204654,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s008lbl.pdf","2017-08-09 00:00:00",
49381,1,204654,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s008ltr.pdf","2017-08-15 00:00:00",
10375,1,204655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s000ltr.pdf","2014-04-02 00:00:00",
10376,1,204655,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s001ltr.pdf","2014-10-06 00:00:00",
22960,3,204655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000TOC.cfm","2014-12-09 00:00:00",
24477,21,204655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000SumR.pdf","2014-12-09 00:00:00",
40407,2,204655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s000Lbl.pdf","2014-03-31 00:00:00",
40408,2,204655,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s001lbl.pdf","2014-10-06 00:00:00",
19583,2,204655,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204655Orig1s002lbl.pdf","2015-06-03 00:00:00",
46854,1,204655,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204655Orig1s006ltr.pdf","2017-01-17 00:00:00",
46953,2,204655,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s006lbl.pdf","2017-01-24 00:00:00",
47104,2,204655,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s007lbl.pdf","2017-02-06 00:00:00",
47105,1,204655,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204655Orig1s007ltr.pdf","2017-02-06 00:00:00",
51906,1,204655,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204655Orig1s009ltr.pdf","2018-01-26 00:00:00",
52422,2,204655,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204655Orig1s009lbl.pdf","2018-02-06 00:00:00",
48882,1,204663,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204663Orig1s000ltr.pdf","2017-06-30 00:00:00",
10377,1,204671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204671Orig1s000ltr.pdf","2013-12-09 00:00:00",
19584,2,204671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf","2013-12-12 00:00:00",
22961,3,204671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000TOC.cfm","2014-01-27 00:00:00",
24478,21,204671,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf","2014-01-27 00:00:00",
32578,1,204671,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204671Orig1s001ltr.pdf","2014-11-18 00:00:00",
40409,2,204671,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf","2014-11-20 00:00:00",
10378,1,204671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s002ltr.pdf","2015-08-21 00:00:00",
19585,2,204671,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf","2015-08-20 00:00:00",
10379,1,204671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s004ltr.pdf","2015-03-24 00:00:00",
40410,2,204671,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf","2015-03-24 00:00:00",
47919,2,204671,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s006lbl.pdf","2017-04-10 00:00:00",
47977,1,204671,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204671Orig1s006ltr.pdf","2017-04-12 00:00:00",
51491,20,204671,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/112_204671 S006 sofosbuvir CD clinical prea.pdf","1900-01-01 00:00:00",
51492,18,204671,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/113_204671 S006 sofosbuvir clinpharm prea.pdf","1900-01-01 00:00:00",
47215,2,204671,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf","2017-02-15 00:00:00",
50374,1,204671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204671Orig1s012ltr.pdf","2017-11-13 00:00:00",
50392,2,204671,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s012lbl.pdf","2017-11-13 00:00:00",
19586,2,204677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf","2014-04-08 00:00:00",
24479,21,204677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000SumR.pdf","2014-04-14 00:00:00",
32579,1,204677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s000ltr.pdf","2014-03-21 00:00:00",
32580,1,204677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s001ltr.pdf","2014-04-04 00:00:00",
40411,2,204677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf","2014-03-20 00:00:00",
43473,3,204677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000TOC.cfm","2014-04-14 00:00:00",
45474,1,204677,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s011ltr.pdf","2016-10-04 00:00:00",
45494,2,204677,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf","2016-10-06 00:00:00",
45057,1,204677,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s012ltr.pdf","2016-08-25 00:00:00",
45166,2,204677,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf","2016-08-25 00:00:00",
48757,2,204677,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204677s014lbl.pdf","2017-06-19 00:00:00",
48772,1,204677,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204677Orig1s014ltr.pdf","2017-06-19 00:00:00",
19587,2,204683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s000lbl.pdf","2013-07-11 00:00:00",
22962,3,204683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000TOC.cfm","2014-03-06 00:00:00",
32581,1,204683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s000ltr.pdf","2013-07-12 00:00:00",
32582,1,204683,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s001ltr.pdf","2013-10-01 00:00:00",
40412,2,204683,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf","2013-09-30 00:00:00",
44906,21,204683,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000SumR.pdf","2014-03-06 00:00:00",
32583,1,204683,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204683Orig1s002ltr.pdf","2014-07-17 00:00:00",
40413,2,204683,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf","2014-07-17 00:00:00",
45245,2,204683,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf","2016-09-06 00:00:00",
45276,1,204683,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204683Orig1s003ltr.pdf","2016-09-07 00:00:00",
46715,2,204683,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf","2017-01-06 00:00:00",
46773,1,204683,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s004ltr.pdf","2017-01-10 00:00:00",
50804,2,204683,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf","2017-12-21 00:00:00",
50805,8,204683,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf#page=24","2017-12-21 00:00:00",
50897,1,204683,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s005,022104Orig1s016ltr.pdf","2017-12-27 00:00:00",
10380,1,204684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204684Orig1s000ltr.pdf","2014-03-21 00:00:00",
22963,3,204684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204684Orig1s000TOC.cfm","2014-04-18 00:00:00",
40414,2,204684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204684s000lbl.pdf","2014-03-20 00:00:00",
49577,1,204695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204695Orig1s000ltr.pdf","2017-08-29 00:00:00",
10381,1,204706,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204706Orig1s000ltr.pdf","2015-12-09 00:00:00",
10382,1,204708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204708Orig1s000ltr.pdf","2013-08-27 00:00:00",
19588,2,204708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204708lbl.pdf","2013-08-27 00:00:00",
43474,3,204708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000TOC.cfm","2014-03-14 00:00:00",
44907,21,204708,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000SumR.pdf","2014-03-14 00:00:00",
40415,2,204708,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204708s003lbl.pdf","2015-10-27 00:00:00",
10383,1,204708,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204708Orig1s005ltr.pdf","2016-07-28 00:00:00",
19589,2,204708,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204708s005lbl.pdf","2016-07-28 00:00:00",
51023,1,204717,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204717Orig1s000TAltr.pdf","2018-01-10 00:00:00",
47867,1,204726,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204726Orig1s000ltr.pdf","2017-04-05 00:00:00",
47038,1,204732,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204732Orig1s000ltr.pdf","2017-01-31 00:00:00",
44979,1,204734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021468Orig1s020,204734Orig1s001ltr.pdf","2014-09-24 00:00:00",
44980,2,204734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf","2014-09-24 00:00:00",
44981,1,204734,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204734Orig1s000ltr.pdf","2016-02-24 00:00:00",
44982,2,204734,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204734s000lbl.pdf","2016-02-24 00:00:00",
44984,3,204734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000TOC.cfm","2014-09-24 00:00:00",
44985,21,204734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000SumR.pdf","2014-09-24 00:00:00",
10385,1,204736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204736Orig1s000ltr.pdf","2013-03-28 00:00:00",
40417,2,204736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf","2013-04-01 00:00:00",
43476,3,204736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204736_aciphex_toc.cfm","2013-12-06 00:00:00",
51630,20,204736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350720.pdf","1900-01-01 00:00:00",
51631,18,204736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350721.pdf","1900-01-01 00:00:00",
51632,17,204736,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/UCM350723.pdf","1900-01-01 00:00:00",
19591,2,204736,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf","2016-04-05 00:00:00",
32585,1,204736,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf","2016-04-06 00:00:00",
32586,1,204736,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf","2014-10-21 00:00:00",
40418,2,204736,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf","2014-10-16 00:00:00",
32587,1,204736,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf","2014-12-24 00:00:00",
40419,2,204736,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf","2014-12-29 00:00:00",
45644,1,204736,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204736Orig1s007ltr.pdf","2016-10-26 00:00:00",
49121,1,204736,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204736Orig1s008ltr.pdf","2017-07-28 00:00:00",
49135,2,204736,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204736s008lbl.pdf","2017-07-28 00:00:00",
54519,2,204736,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf","2018-06-11 00:00:00",
54520,8,204736,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf#page=21","2018-06-11 00:00:00",
54580,1,204736,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204736Orig1s010ltr.pdf","2018-06-14 00:00:00",
10386,1,204737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204737Orig1s000ltr.pdf","2015-07-07 00:00:00",
50023,1,204748,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204748Orig1s000ltr.pdf","2017-10-12 00:00:00",
50037,1,204749,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204749Orig1s000ltr.pdf","2017-10-12 00:00:00",
49576,1,204751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204751Orig1s000ltr.pdf","2017-08-29 00:00:00",
10387,1,204760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204760Orig1s000ltr.pdf","2014-09-17 00:00:00",
10388,1,204760,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s001ltr.pdf","2016-07-26 00:00:00",
19592,2,204760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf","2014-09-19 00:00:00",
19593,2,204760,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf","2016-07-25 00:00:00",
43477,3,204760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000TOC.cfm","2014-10-17 00:00:00",
44908,21,204760,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000SumR.pdf","2014-10-17 00:00:00",
45112,2,204760,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf","2016-08-23 00:00:00",
45159,1,204760,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf","2016-08-22 00:00:00",
45113,2,204760,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf","2016-08-23 00:00:00",
45158,1,204760,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf","2016-08-22 00:00:00",
49212,1,204760,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204760Orig1s005ltr.pdf","2017-08-02 00:00:00",
49223,2,204760,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf","2017-08-03 00:00:00",
52783,1,204760,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204760Orig1s007ltr.pdf","2018-03-01 00:00:00",
52798,2,204760,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf","2018-03-02 00:00:00",
52799,8,204760,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf#page=16","2018-03-02 00:00:00",
10389,1,204764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204764Orig1s000ltr.pdf","2016-03-17 00:00:00",
48650,1,204766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204766Orig1s000TAltr.pdf","2017-06-06 00:00:00",
10390,1,204767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204767Orig1s000ltr.pdf","2015-10-30 00:00:00",
19594,2,204767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204767s000lbl.pdf","2015-10-29 00:00:00",
22964,3,204767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204767Orig1s000TOC.cfm","2016-07-19 00:00:00",
10391,1,204768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204768Orig1s000ltr.pdf","2014-02-26 00:00:00",
19595,2,204768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204768s000lbl.pdf","2014-02-25 00:00:00",
22965,3,204768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000TOC.cfm","2014-08-07 00:00:00",
44909,21,204768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000SumR.pdf","2014-08-07 00:00:00",
10392,1,204768,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf","2016-05-10 00:00:00",
19596,2,204768,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf","2016-05-11 00:00:00",
10393,1,204768,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf","2016-05-10 00:00:00",
19597,2,204768,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf","2016-05-11 00:00:00",
43974,8,204768,"SUPPL",4,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501662.pdf","2016-05-18 00:00:00",
32588,1,204771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204771Orig1s000ltr.pdf","2016-03-29 00:00:00",
40420,2,204771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204771Orig1s000lbl.pdf","2016-04-11 00:00:00",
45236,1,204773,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204773Orig1s000ltr.pdf","2016-08-22 00:00:00",
19598,2,204781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781s000lbl.pdf","2013-03-26 00:00:00",
32589,1,204781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204781Orig1s000ltr.pdf","2013-03-22 00:00:00",
43478,3,204781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000TOC.cfm","2013-05-10 00:00:00",
44910,21,204781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000SumR.pdf","2013-05-10 00:00:00",
49558,2,204781,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s001lbl.pdf","2017-08-28 00:00:00",
49559,1,204781,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204781Orig1s001ltr.pdf","2017-08-28 00:00:00",
51144,18,204781,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204781 gadoterate meglumine Dotarem ClinPharm prea.pdf","1900-01-01 00:00:00",
51145,20,204781,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204781 gadoterate meglumine Dotarem Clinical prea.pdf","1900-01-01 00:00:00",
51146,17,204781,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204781 gadoterate meglumine Dotarem Statistical prea.pdf","1900-01-01 00:00:00",
49744,2,204781,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s005lbl.pdf","2017-09-15 00:00:00",
49792,1,204781,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204781Orig1s005ltr.pdf","2017-09-19 00:00:00",
53835,2,204781,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf","2018-04-27 00:00:00",
53836,8,204781,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf#page=29","2018-04-27 00:00:00",
53911,1,204781,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204781Orig1s008Ltr.pdf","2018-05-01 00:00:00",
10394,1,204785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204785Orig1s000ltr.pdf","2014-12-03 00:00:00",
40421,2,204785,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204785Orig1s000lbl.pdf","2014-12-19 00:00:00",
10395,1,204790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204790Orig1s000ltr.pdf","2013-08-20 00:00:00",
19599,2,204790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf","2013-08-19 00:00:00",
24481,21,204790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1S000SumR.pdf","2013-09-13 00:00:00",
32590,1,204790,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s001ltr.pdf","2014-05-13 00:00:00",
40422,2,204790,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf","2014-05-13 00:00:00",
43479,3,204790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1s000TOC.cfm","2013-09-13 00:00:00",
52614,20,204790,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790_dolutegravir_Tivicay_Clinical Rev_PREA.pdf","1900-01-01 00:00:00",
52615,20,204790,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinical prea.pdf","1900-01-01 00:00:00",
52616,17,204790,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790_dolutegravir_Tivicay_Stat Rev_PREA.pdf","1900-01-01 00:00:00",
19600,2,204790,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf","2015-01-08 00:00:00",
32591,1,204790,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s002ltr.pdf","2014-12-24 00:00:00",
10396,1,204790,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204790Orig1s005ltr.pdf","2015-08-10 00:00:00",
19601,2,204790,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf","2015-08-07 00:00:00",
32592,1,204790,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s007ltr.pdf","2016-04-26 00:00:00",
40423,2,204790,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790s007lbl.pdf","2016-04-29 00:00:00",
19602,2,204790,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf","2016-06-10 00:00:00",
32593,1,204790,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s008ltr.pdf","2016-06-10 00:00:00",
52618,57,204790,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinical CDTL prea.pdf","1900-01-01 00:00:00",
52619,18,204790,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinpharm prea.pdf","1900-01-01 00:00:00",
54054,18,204790,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir_Tivicay_ClinPharm_PREA.pdf","1900-01-01 00:00:00",
47734,2,204790,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s013lbl.pdf","2017-03-28 00:00:00",
47763,1,204790,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204790Orig1s013ltr.pdf","2017-03-29 00:00:00",
50480,2,204790,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s014lbl.pdf","2017-11-24 00:00:00",
50499,1,204790,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204790Orig1s014ltr.pdf","2017-11-27 00:00:00",
55417,2,204790,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf","2018-09-10 00:00:00",
55443,1,204790,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204790Orig1s016s018Ltr.pdf","2018-09-12 00:00:00",
55416,2,204790,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf","2018-09-10 00:00:00",
55444,1,204790,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204790Orig1s016s018Ltr.pdf","2018-09-12 00:00:00",
32594,1,204802,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204802Orig1s000ltr.pdf","2015-11-09 00:00:00",
10397,1,204806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204806Orig1s000TAltr.pdf","2014-02-04 00:00:00",
10398,1,204819,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf","2014-06-12 00:00:00",
22966,3,204819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm","2013-11-05 00:00:00",
32595,1,204819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf","2013-10-10 00:00:00",
40424,2,204819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf","2013-10-17 00:00:00",
44594,14,204819,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=149","2013-10-15 00:00:00",
44911,21,204819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000SumR.pdf","2013-11-05 00:00:00",
10399,1,204819,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf","2014-05-08 00:00:00",
40425,2,204819,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf","2014-05-12 00:00:00",
10400,1,204819,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf","2015-12-07 00:00:00",
46904,1,204819,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s006ltr.pdf","2017-01-19 00:00:00",
46962,2,204819,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf","2017-01-24 00:00:00",
47206,8,204819,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf#page=24","2017-02-15 00:00:00",
45504,1,204819,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf","2016-10-06 00:00:00",
47326,2,204819,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf","2017-02-24 00:00:00",
47416,1,204819,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s008ltr.pdf","2017-03-02 00:00:00",
51056,1,204819,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819Orig1s011ltr.pdf","2018-01-17 00:00:00",
51072,2,204819,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf","2018-01-17 00:00:00",
19603,2,204820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf","2014-09-30 00:00:00",
22967,3,204820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000TOC.cfm","2014-10-10 00:00:00",
24482,21,204820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000SumR.pdf","2014-10-10 00:00:00",
32596,1,204820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204820Orig1s000ltr.pdf","2014-09-30 00:00:00",
43975,8,204820,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf","2014-10-06 00:00:00",
10401,1,204822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204822Orig1s000ltr.pdf","2014-05-20 00:00:00",
19604,2,204822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204822s000lbl.pdf","2014-05-19 00:00:00",
22968,3,204822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204822Orig1s000TOC.cfm","2015-06-26 00:00:00",
24483,21,204822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204822Orig1s000SumR.pdf","2015-06-26 00:00:00",
19605,2,204824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000, 204824Orig2s000lbledt.pdf","2013-10-17 00:00:00",
22969,3,204824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm","2014-02-04 00:00:00",
32597,1,204824,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf","2013-10-16 00:00:00",
43480,3,204824,"ORIG",1,"Orig1","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000TOC.cfm","2014-02-03 00:00:00",
44595,14,204824,"ORIG",1,"Orig2","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm","2014-02-03 00:00:00",
10402,1,204824,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204824Orig1s003ltr.pdf","2014-11-12 00:00:00",
40426,2,204824,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf","2014-11-10 00:00:00",
19606,2,204824,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf","2016-05-27 00:00:00",
49087,2,204824,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204824s006lbl.pdf","2017-07-27 00:00:00",
53044,2,204824,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204824s008lbl.pdf","2018-03-16 00:00:00",
53062,1,204824,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2018/204824Orig1s008ltr.pdf","2018-03-20 00:00:00",
49086,1,204832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204832Orig1s000ltr.pdf","2017-07-26 00:00:00",
32598,1,204833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204833Orig1s000ltr.pdf","2016-02-29 00:00:00",
32599,1,204835,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204835Orig1s000ltr.pdf","2015-04-24 00:00:00",
52757,8,204839,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf","2018-02-28 00:00:00",
46855,1,204846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204846Orig1s000ltr.pdf","2017-01-17 00:00:00",
49701,1,204849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204849Orig1s000ltr.pdf","2017-09-08 00:00:00",
10403,1,204854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204854Orig1s000ltr.pdf","2015-12-22 00:00:00",
52758,8,204855,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf","2018-02-28 00:00:00",
52759,8,204857,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf","2018-02-28 00:00:00",
46983,1,204872,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204872Orig1s000ltr.pdf","2017-01-27 00:00:00",
48943,1,204876,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204876Orig1s000ltr.pdf","2017-07-11 00:00:00",
10405,1,204886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204886Orig1s000ltr.pdf","2014-05-09 00:00:00",
19608,2,204886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204886s000lbl.pdf","2014-05-12 00:00:00",
24484,21,204886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204886Orig1s000SumR.pdf","2014-06-18 00:00:00",
43481,3,204886,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204886Orig1s000TOC.cfm","2014-06-18 00:00:00",
19609,2,204886,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204886s002lbl.pdf","2015-04-17 00:00:00",
23518,8,204886,"SUPPL",2,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf","2015-05-27 00:00:00",
32603,1,204886,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204886Orig1s002ltr.pdf","2015-04-17 00:00:00",
50014,1,204889,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204889Orig1s000ltr.pdf","2017-10-11 00:00:00",
46880,1,204891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204891Orig1s000ltr.pdf","2017-01-18 00:00:00",
32604,1,204900,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204900Orig1s000ltr.pdf","2015-07-28 00:00:00",
45149,1,204910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204910Orig1s000ltr.pdf","2016-08-17 00:00:00",
10406,1,204914,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204914Orig1s000TAltr.pdf","2014-02-11 00:00:00",
10407,1,204915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204915Orig1s000TAltr.pdf","2014-10-24 00:00:00",
10409,1,204936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204936Orig1s000ltr.pdf","2015-04-22 00:00:00",
10410,1,204958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204958Orig1s000ltr.pdf","2015-06-22 00:00:00",
22970,3,204958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000TOC.cfm","2015-07-29 00:00:00",
24485,21,204958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000SumR.pdf","2015-07-29 00:00:00",
40428,2,204958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958lbl.pdf","2015-06-22 00:00:00",
47056,1,204960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204960Orig1s000ltr.pdf","2017-01-31 00:00:00",
48652,1,204972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204972Orig1s000TAltr.pdf","2017-06-06 00:00:00",
22971,3,204977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204977Orig1s000TOC.cfm","2014-12-18 00:00:00",
32607,1,204977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204977s000lbl.pdf","2014-04-25 00:00:00",
40429,2,204977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204977Orig1s000ltr.pdf","2014-04-25 00:00:00",
40430,2,204977,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204977s006lbl.pdf","2016-03-22 00:00:00",
10411,1,204979,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204979Orig1s000ltr.pdf","2015-06-03 00:00:00",
32608,1,204988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204988Orig1s000ltr.pdf","2016-05-18 00:00:00",
40431,2,204988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204988Orig1s000lbl.pdf","2016-06-01 00:00:00",
10412,1,204989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204989Orig1s000ltr.pdf","2016-02-22 00:00:00",
45927,1,204990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204990Orig1s000TAltr.pdf","2016-11-22 00:00:00",
47791,1,204990,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204990Orig1s000ltr.pdf","2017-03-30 00:00:00",
32609,1,205001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205001Orig1s000ltr.pdf","2016-07-07 00:00:00",
53975,14,205001,"ORIG",1,"Safety Labeling Change Order Letter","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/205001_SLCOrderLtr.pdf","2018-05-01 00:00:00",
10414,1,205003,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s001ltr.pdf","2015-08-27 00:00:00",
19612,2,205003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf","2015-01-22 00:00:00",
19613,2,205003,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s001lbl.pdf","2015-08-26 00:00:00",
32610,1,205003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s000ltr.pdf","2015-01-23 00:00:00",
46075,3,205003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205003Orig1s000TOC.cfm","2016-08-24 00:00:00",
45957,1,205003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205003Orig1s002ltr.pdf","2016-11-25 00:00:00",
46002,2,205003,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205003Ss002lbl.pdf","2016-12-02 00:00:00",
49914,2,205003,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205003s003lbl.pdf","2017-10-03 00:00:00",
49927,1,205003,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205003Orig1s003ltr.pdf","2017-10-03 00:00:00",
50320,2,205004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205004s000lbl.pdf","2017-11-07 00:00:00",
50454,1,205004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205004Orig1s000ltr.pdf","2017-11-17 00:00:00",
50696,3,205004,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205004Orig1s000TOC.cfm","2017-12-14 00:00:00",
54877,2,205004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf","2018-07-13 00:00:00",
54895,1,205004,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205004Orig1s002Ltr.pdf","2018-07-16 00:00:00",
32612,1,205006,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205006Orig1s000TAltr.pdf","2015-10-30 00:00:00",
32613,1,205015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205015Orig1s000TAltr.pdf","2016-05-04 00:00:00",
50044,19,205022,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2017-10-12 00:00:00",
45495,1,205022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205022Orig1s000ltr.pdf","2016-09-21 00:00:00",
19615,2,205029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf","2014-08-14 00:00:00",
19616,2,205029,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf","2015-10-27 00:00:00",
32616,1,205029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf","2014-07-31 00:00:00",
32617,1,205029,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf","2015-10-26 00:00:00",
43482,3,205029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205029Orig1s000TOC.cfm","2015-03-31 00:00:00",
32618,1,205029,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf","2016-02-12 00:00:00",
40433,2,205029,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf","2016-02-18 00:00:00",
10415,1,205029,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf","2016-05-19 00:00:00",
40434,2,205029,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf","2016-05-20 00:00:00",
10418,1,205035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205035Orig1s000ltr.pdf","2016-01-22 00:00:00",
10419,1,205040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205040Orig1s000TAltr.pdf","2015-04-03 00:00:00",
10420,1,205049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205049Orig1s000ltr.pdf","2016-06-01 00:00:00",
19617,2,205049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf","2016-06-01 00:00:00",
22972,3,205053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000TOC.cfm","2015-03-16 00:00:00",
32619,1,205053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205053Orig1s000ltr.pdf","2013-11-27 00:00:00",
32620,1,205053,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205053Orig1s001ltr.pdf","2014-06-12 00:00:00",
40436,2,205053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205053s000lbl.pdf","2013-11-26 00:00:00",
40437,2,205053,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205053s1lbl.pdf","2015-08-19 00:00:00",
44912,21,205053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000SumR.pdf","2015-03-16 00:00:00",
51584,17,205053,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_posaconazole Noxafil_Statistical prea.pdf","1900-01-01 00:00:00",
51586,20,205053,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_ posaconazole Noxafil_Clinical prea.pdf","1900-01-01 00:00:00",
51588,18,205053,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_posaconazole Noxafil_Clinpharm prea.pdf","1900-01-01 00:00:00",
32621,1,205053,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
40438,2,205053,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
32622,1,205053,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
40439,2,205053,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
45296,1,205053,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf","2016-09-15 00:00:00",
46969,2,205053,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf","2017-01-24 00:00:00",
50984,1,205053,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf","2018-01-08 00:00:00",
51008,2,205053,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf","2018-01-09 00:00:00",
55508,1,205054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205054Orig1s001ltr.pdf","2018-09-18 00:00:00",
32623,1,205055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205055Orig1s000ltr.pdf","2015-12-16 00:00:00",
19618,2,205060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf","2014-05-06 00:00:00",
32624,1,205060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205060Orig1s000ltr.pdf","2014-05-06 00:00:00",
43483,3,205060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205060Orig1EpanovaTOC.cfm","2016-03-28 00:00:00",
45524,1,205060,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s002ltr.pdf","2016-10-12 00:00:00",
45608,2,205060,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf","2016-10-12 00:00:00",
47521,2,205060,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205060s003lbl.pdf","2017-03-10 00:00:00",
47548,1,205060,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205060Orig1s003ltr.pdf","2017-03-14 00:00:00",
46928,1,205060,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s004ltr.pdf","2017-01-23 00:00:00",
19619,2,205065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf","2013-12-23 00:00:00",
19620,2,205065,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf","2016-04-08 00:00:00",
22973,3,205065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000TOC.cfm","2014-03-06 00:00:00",
24486,21,205065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000SumR.pdf","2014-03-06 00:00:00",
32625,1,205065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf","2013-12-20 00:00:00",
45021,2,205065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf","2016-08-09 00:00:00",
45036,1,205065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205065Orig1s002ltr.pdf","2016-08-09 00:00:00",
19621,2,205075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205075Orig1s000lbl.pdf","2016-05-26 00:00:00",
32626,1,205075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205075Orig1s000ltr.pdf","2016-05-18 00:00:00",
32627,1,205076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205076Orig1s000ltr.pdf","2016-03-09 00:00:00",
40440,2,205076,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205076Orig1s000lbl.pdf","2016-03-08 00:00:00",
10421,1,205082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205082Orig1s000ltr.pdf","2015-09-09 00:00:00",
19622,2,205095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf","2016-05-20 00:00:00",
32628,1,205095,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf","2016-05-18 00:00:00",
10422,1,205096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205096Orig1s000ltr.pdf","2016-07-13 00:00:00",
10423,1,205098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205098Orig1s000ltr.pdf","2013-11-27 00:00:00",
10424,1,205098,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205098Origs001ltr.pdf","2014-06-27 00:00:00",
19623,2,205098,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205098s001lbl.pdf","2014-07-03 00:00:00",
40441,2,205098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205098s000lbl.pdf","2013-11-26 00:00:00",
43484,3,205098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000TOC.cfm","2014-07-28 00:00:00",
44913,21,205098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000SumR.pdf","2014-07-28 00:00:00",
10425,1,205098,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205098Orig1s005ltr.pdf","2015-01-09 00:00:00",
40442,2,205098,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf","2015-01-12 00:00:00",
32629,1,205098,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205098Orig1s018ltr.pdf","2016-06-24 00:00:00",
40443,2,205098,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205098s018lbl.pdf","2016-06-27 00:00:00",
50921,2,205098,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205098s026lbl.pdf","2017-12-27 00:00:00",
50922,1,205098,"SUPPL",26,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205098Orig1s026ltr.pdf","2017-12-27 00:00:00",
32630,1,205101,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205101Orig1s000ltr.pdf","2016-02-11 00:00:00",
45386,1,205103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205103Orig1s000ltr.pdf","2016-09-19 00:00:00",
45387,2,205103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205103s000lbl.pdf","2016-09-15 00:00:00",
49951,2,205103,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205103s001lbl.pdf","2017-10-05 00:00:00",
49972,1,205103,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205103Origs001ltr.pdf","2017-10-06 00:00:00",
53639,3,205103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205103Orig1s000TOC.cfm","2018-04-09 00:00:00",
54525,2,205103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf","2018-06-12 00:00:00",
54526,8,205103,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf#page=37","2018-06-12 00:00:00",
54584,1,205103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205103Orig1s004ltr.pdf","2018-06-14 00:00:00",
22974,3,205108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205108Orig1s000TOC.cfm","2014-12-18 00:00:00",
32631,1,205108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205108Orig1s000Approv.pdf","2014-12-18 00:00:00",
40444,2,205108,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205108s000lbl.pdf","2014-10-24 00:00:00",
10426,1,205109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205109Orig1s000ltr.pdf","2013-11-29 00:00:00",
22975,3,205109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000TOC.cfm","2014-08-07 00:00:00",
32632,1,205109,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205109Orig1s001ltr.pdf","2014-09-26 00:00:00",
40445,2,205109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205109s000lbl.pdf","2014-03-24 00:00:00",
40446,2,205109,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf","2014-09-26 00:00:00",
44914,21,205109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000SumR.pdf","2014-08-07 00:00:00",
49254,2,205109,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205109s005lbl.pdf","2017-08-07 00:00:00",
49262,1,205109,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205109Orig1s005ltr.pdf","2017-08-07 00:00:00",
53821,2,205109,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf","2018-04-26 00:00:00",
53867,1,205109,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205109Orig1s006ltr.pdf","2018-04-27 00:00:00",
32633,1,205120,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205120Orig1s000ltr.pdf","2015-11-03 00:00:00",
10427,1,205122,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205122Orig1s001ltr.pdf","2015-04-02 00:00:00",
22976,3,205122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000TOC.cfm","2015-05-14 00:00:00",
32634,1,205122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205122Orig1s000ltr.pdf","2014-03-13 00:00:00",
40447,2,205122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205122s000lbl.pdf","2014-03-13 00:00:00",
40448,2,205122,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205122s001lbl.pdf","2015-04-01 00:00:00",
44915,21,205122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000SumR.pdf","2015-05-14 00:00:00",
10428,1,205122,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205122Orig1s003TAltr.pdf","2016-04-20 00:00:00",
47782,2,205122,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf","2017-03-30 00:00:00",
47783,8,205122,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf#page=69","2017-03-30 00:00:00",
47792,1,205122,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205122Orig1s003s005ltr.pdf","2017-03-30 00:00:00",
47780,2,205122,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf","2017-03-30 00:00:00",
47781,8,205122,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf#page=69","2017-03-30 00:00:00",
47793,1,205122,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205122Orig1s003s005ltr.pdf","2017-03-30 00:00:00",
19624,2,205123,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf","2013-12-06 00:00:00",
22977,3,205123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000TOC.cfm","2013-12-24 00:00:00",
24487,21,205123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000SumR.pdf","2013-12-24 00:00:00",
32635,1,205123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s000ltr.pdf","2013-11-25 00:00:00",
32636,1,205123,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s001ltr.pdf","2013-12-09 00:00:00",
40449,2,205123,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s000lbledt.pdf","2013-11-26 00:00:00",
32637,1,205123,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s002ltr.pdf","2014-11-07 00:00:00",
40450,2,205123,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s002lbledt.pdf","2014-11-07 00:00:00",
19625,2,205123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf","2014-09-09 00:00:00",
32638,1,205123,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s003ltr.pdf","2014-09-08 00:00:00",
32639,1,205123,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s005ltr.pdf","2015-10-06 00:00:00",
40451,2,205123,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s005lbl.pdf","2015-10-08 00:00:00",
32640,1,205123,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s006ltr.pdf","2015-10-06 00:00:00",
40452,2,205123,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s006lbl.pdf","2015-12-10 00:00:00",
22978,3,205123,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205123Orig1s008.pdf","2015-08-21 00:00:00",
32641,1,205123,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s008ltr.pdf","2015-04-17 00:00:00",
40453,2,205123,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s008lbl.pdf","2015-04-16 00:00:00",
32642,1,205123,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s009ltr.pdf","2015-04-13 00:00:00",
40454,2,205123,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s009lbl.pdf","2015-04-14 00:00:00",
10429,1,205123,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s010ltr.pdf","2016-03-02 00:00:00",
19626,2,205123,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s010lbl.pdf","2016-03-03 00:00:00",
19627,2,205123,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s011lbl.pdf","2016-05-23 00:00:00",
32643,1,205123,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s011ltr.pdf","2016-05-24 00:00:00",
47217,1,205123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s012ltr.pdf","2017-02-15 00:00:00",
47249,2,205123,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s012lbl.pdf","2017-02-16 00:00:00",
48371,2,205123,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s013lbl.pdf","2017-05-12 00:00:00",
48407,1,205123,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s013ltr.pdf","2017-05-17 00:00:00",
50382,1,205123,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s014ltr.pdf","2017-11-13 00:00:00",
50401,2,205123,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s014lbl.pdf","2017-11-14 00:00:00",
50661,1,205154,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205154Orig1s000ltr.pdf","2017-12-12 00:00:00",
10430,1,205175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205175Orig1s000ltr.pdf","2013-10-25 00:00:00",
22979,3,205175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205175Orig1s000TOC.cfm","2014-06-27 00:00:00",
24488,21,205175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205175Orig1s000SumR.pdf","2014-06-27 00:00:00",
40455,2,205175,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205175s000lbl.pdf","2013-10-25 00:00:00",
52440,17,205175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205175_ECONAZOLE_NITRATE_STATISTICAL_BPCA.pdf","1900-01-01 00:00:00",
52444,20,205175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205175_ECONAZOLE_NITRATE_CLINICAL_BPCA.pdf","1900-01-01 00:00:00",
52445,18,205175,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205175_ECONAZOLE_NITRATE_CLINPHARM_BPCA.pdf","1900-01-01 00:00:00",
32644,1,205177,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205177Orig1s000ltr.pdf","2016-04-04 00:00:00",
50729,1,205181,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205181Orig1s000ltr.pdf","2017-12-18 00:00:00",
19628,2,205208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205208s000lbl.pdf","2013-10-17 00:00:00",
19629,2,205208,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205208Orig1s001lbl.pdf","2014-07-29 00:00:00",
22980,3,205208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205208Orig1s000TOC.cfm","2014-03-26 00:00:00",
24489,21,205208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205208Orig1s000SumR.pdf","2014-03-26 00:00:00",
32645,1,205208,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205208Orig1s000ltr.pdf","2013-10-16 00:00:00",
32646,1,205208,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205208Orig1s001ltr.pdf","2014-07-25 00:00:00",
43979,8,205208,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372058.pdf","2013-10-24 00:00:00",
10431,1,205220,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205220Orig1s000ltr.pdf","2016-07-22 00:00:00",
10432,1,205223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205223Orig1s000ltr.pdf","2014-03-25 00:00:00",
24490,21,205223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205223Orig1s000SumR.pdf","2014-10-07 00:00:00",
40456,2,205223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf","2014-03-25 00:00:00",
43485,3,205223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205223Orig1s000TOC.cfm","2014-10-07 00:00:00",
55120,2,205223,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205223s002lbl.pdf","2018-08-06 00:00:00",
55127,1,205223,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205223Orig1s002ltr.pdf","2018-08-07 00:00:00",
49042,1,205228,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205228Orig1s000ltr.pdf","2017-07-21 00:00:00",
10433,1,205233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205233Orig1s000ltr.pdf","2015-12-23 00:00:00",
46029,1,205234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205234Orig1s000ltr.pdf","2016-12-06 00:00:00",
19630,2,205239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205239Orig1s000lbl.pdf","2016-03-04 00:00:00",
32647,1,205239,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205239Orig1s000ltr.pdf","2016-02-22 00:00:00",
32648,1,205248,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205248Orig1s000ltr.pdf","2016-07-11 00:00:00",
32649,1,205258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205258Orig1s000ltr.pdf","2014-04-04 00:00:00",
22981,3,205266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205266Orig1s000TOC.cfm","2015-08-28 00:00:00",
32650,1,205266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205266Orig1s000ltr.pdf","2015-07-24 00:00:00",
40457,2,205266,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266s000lbl.pdf","2015-07-24 00:00:00",
10434,1,205266,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205266Orig1s002ltr.pdf","2016-05-16 00:00:00",
19631,2,205266,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf","2016-05-17 00:00:00",
46655,8,205266,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf#page=12","2017-01-03 00:00:00",
40458,2,205266,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s003lbl.pdf","2016-03-30 00:00:00",
49776,2,205266,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205266s004lbl.pdf","2017-09-19 00:00:00",
49845,1,205266,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205266Orig1s004ltr.pdf","2017-09-22 00:00:00",
54627,1,205299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205299Orig1s000ltr.pdf","2018-06-20 00:00:00",
47762,1,205300,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205300Orig1s000ltr.pdf","2017-03-29 00:00:00",
32651,1,205302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205302Orig1s000TALtr_corrected.pdf","2015-09-30 00:00:00",
45589,1,205309,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205309Orig1s000ltr.pdf","2016-10-05 00:00:00",
10435,1,205318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205318Orig1s000ltr.pdf","2016-02-03 00:00:00",
47136,1,205323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205323Orig1s000ltr.pdf","2017-02-08 00:00:00",
49194,1,205327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205327Orig1s000ltr.pdf","2017-08-02 00:00:00",
49511,2,205327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205327Orig1s000lbl.pdf","2017-08-22 00:00:00",
49368,1,205328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205328Orig1s000ltr.pdf","2017-08-15 00:00:00",
32652,1,205332,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205332Orig1s000ltr.pdf","2015-08-21 00:00:00",
32653,1,205342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205342Orig1s000ltr.pdf","2016-04-15 00:00:00",
40459,2,205342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205342Orig1s000lbl.pdf","2016-04-20 00:00:00",
10436,1,205352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s000ltr_corrected.pdf","2014-01-17 00:00:00",
19632,2,205352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_corrected.pdf","2014-01-28 00:00:00",
19633,2,205352,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s001lbl.pdf","2014-09-23 00:00:00",
22982,3,205352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000TOC.cfm","2015-05-14 00:00:00",
32654,1,205352,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s001ltr.pdf","2014-09-03 00:00:00",
44916,21,205352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000SumR.pdf","2015-05-14 00:00:00",
51394,20,205352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205352 naproxen clinical prea.pdf","1900-01-01 00:00:00",
51395,18,205352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205352 naproxen clinpharm prea.pdf","1900-01-01 00:00:00",
51396,17,205352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205352 naproxen statistical prea.pdf","1900-01-01 00:00:00",
32655,1,205352,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s002ltr.pdf","2014-11-24 00:00:00",
40460,2,205352,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s002lbl.pdf","2015-01-08 00:00:00",
32656,1,205352,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s003ltr.pdf","2015-02-27 00:00:00",
40461,2,205352,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s003lbl.pdf","2015-03-12 00:00:00",
10437,1,205352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s004ltr.pdf","2015-07-16 00:00:00",
19634,2,205352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s004lbl.pdf","2015-07-22 00:00:00",
19635,2,205352,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s005lbl.pdf","2015-08-26 00:00:00",
32657,1,205352,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s005ltr.pdf","2015-08-18 00:00:00",
32658,1,205352,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s006ltr.pdf","2015-10-30 00:00:00",
40462,2,205352,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s006lbl.pdf","2015-10-29 00:00:00",
32659,1,205352,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s007ltr.pdf","2015-12-30 00:00:00",
49754,1,205352,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205352Orig1s009ltr.pdf","2017-09-15 00:00:00",
49820,2,205352,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205352Orig1s009lbl.pdf","2017-09-21 00:00:00",
51075,1,205352,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205352Orig1s010ltr.pdf","2018-01-17 00:00:00",
51080,2,205352,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352Orig1s010lbl.pdf","2018-01-18 00:00:00",
55347,1,205352,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205352Orig1s011ltr.pdf","2018-08-28 00:00:00",
55352,2,205352,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352s011lbl.pdf","2018-08-29 00:00:00",
22983,3,205353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000TOC.cfm","2015-03-17 00:00:00",
23519,8,205353,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf","2015-03-03 00:00:00",
24126,14,205353,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=344","2015-02-25 00:00:00",
24491,21,205353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000SumR.pdf","2015-03-17 00:00:00",
32660,1,205353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205353Orig1s000ltr.pdf","2015-02-24 00:00:00",
32661,1,205353,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205353Orig1s001ltr.pdf","2016-06-08 00:00:00",
40463,2,205353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf","2015-02-23 00:00:00",
32662,1,205355,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205355Orig1s000ltr.pdf","2014-03-19 00:00:00",
10438,1,205356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205356Orig1s000ltr.pdf","2015-06-02 00:00:00",
48823,1,205358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205358rig1s000ltr.pdf","2017-06-26 00:00:00",
48844,2,205358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205358Orig1s000lbl.pdf","2017-06-27 00:00:00",
10439,1,205366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205366Orig1s000ltr.pdf","2015-12-09 00:00:00",
40464,2,205366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205366Orig1s000lbl.pdf","2015-12-11 00:00:00",
19636,2,205379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf","2015-11-25 00:00:00",
32663,1,205379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205379Orig1s000ltr.pdf","2015-10-02 00:00:00",
10440,1,205382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205382Orig1s000ltr.pdf","2014-05-01 00:00:00",
19637,2,205382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205382s000lbl.pdf","2014-05-02 00:00:00",
22984,3,205382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000TOC.cfm","2015-08-11 00:00:00",
44917,21,205382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000SumR.pdf","2015-08-11 00:00:00",
19638,2,205382,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf","2016-02-26 00:00:00",
32664,1,205382,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205382Orig1s002ltr.pdf","2016-02-26 00:00:00",
48714,2,205382,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s006lbl.pdf","2017-06-14 00:00:00",
48751,1,205382,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s006ltr.pdf","2017-06-16 00:00:00",
50131,1,205382,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s008ltr.pdf","2017-10-23 00:00:00",
50167,2,205382,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s008lbl.pdf","2017-10-24 00:00:00",
10441,1,205383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205383Orig1s000ltr.pdf","2015-04-03 00:00:00",
19639,2,205383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205383s000lbl.pdf","2015-04-28 00:00:00",
22985,3,205383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205383Orig1s000TOC.cfm","2015-04-22 00:00:00",
24492,21,205383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205383Orig1s000SumR.pdf","2015-04-22 00:00:00",
51203,20,205383,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205383 iohexol clinical prea.pdf","1900-01-01 00:00:00",
51204,18,205383,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205383 iohexol clinpharm prea.pdf","1900-01-01 00:00:00",
51206,17,205383,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205383 iohexol statistical prea.pdf","1900-01-01 00:00:00",
32665,1,205385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205385Orig1s000TAltr.pdf","2016-05-16 00:00:00",
46808,19,205386,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2017-01-13 00:00:00",
19640,2,205388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf","2014-06-03 00:00:00",
19641,2,205388,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf","2016-06-24 00:00:00",
22986,3,205388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000TOC.cfm","2014-12-09 00:00:00",
24493,21,205388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000SumR.pdf","2014-12-09 00:00:00",
32666,1,205388,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf","2014-06-03 00:00:00",
50654,2,205388,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf","2017-12-11 00:00:00",
50778,1,205388,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205388Orig1s006ltr.pdf","2017-12-20 00:00:00",
51553,57,205388,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/213_205388S6 phenylephrine and ketorolac CDTL clinical bpca.pdf","1900-01-01 00:00:00",
51554,20,205388,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/214_205388S6 phenylephrine and ketorolac clinical bpca.pdf","1900-01-01 00:00:00",
51555,17,205388,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/215_205388S6 phenylephrine and ketorolac statistical bpca.pdf","1900-01-01 00:00:00",
52717,1,205389,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205389Orig1s000TAltredt.pdf","2018-02-23 00:00:00",
48132,1,205391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205391Orig1s000ltr.pdf","2017-04-25 00:00:00",
10442,1,205395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205395Orig1s000ltr.pdf","2015-02-02 00:00:00",
10443,1,205395,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s001ltr.pdf","2016-04-04 00:00:00",
19642,2,205395,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf","2016-04-27 00:00:00",
24494,21,205395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000SumR.pdf","2016-06-15 00:00:00",
40465,2,205395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205395s000lbl.pdf","2015-01-30 00:00:00",
43486,3,205395,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000TOC.cfm","2016-06-15 00:00:00",
45414,2,205395,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s002lbl.pdf","2016-09-29 00:00:00",
45523,1,205395,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s002ltr.pdf","2016-10-12 00:00:00",
48720,2,205395,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205395s004lbl.pdf","2017-06-15 00:00:00",
48723,1,205395,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205395Orig1s004ltr.pdf","2017-06-15 00:00:00",
52124,1,205395,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s006s007ltr.pdf","2018-01-30 00:00:00",
52428,2,205395,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf","2018-02-06 00:00:00",
52125,1,205395,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s006s007ltr.pdf","2018-01-30 00:00:00",
52427,2,205395,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf","2018-02-06 00:00:00",
54437,2,205395,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s009lbl.pdf","2018-06-05 00:00:00",
54457,1,205395,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s009ltr.pdf","2018-06-05 00:00:00",
55423,2,205395,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s010lbl.pdf","2018-09-10 00:00:00",
55445,1,205395,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1so10Ltr.pdf","2018-09-12 00:00:00",
50060,1,205397,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205397Orig1s000TAltr.pdf","2017-10-13 00:00:00",
10444,1,205410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205410Orig1s000ltr.pdf","2014-03-19 00:00:00",
19643,2,205410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf","2014-03-19 00:00:00",
43487,3,205410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205410Orig1s000TOC.cfm","2015-03-31 00:00:00",
32668,1,205412,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205412Orig1s000TAltr.pdf","2014-09-29 00:00:00",
46174,1,205414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205414Orig1s000TAltr.pdf","2016-12-15 00:00:00",
32669,1,205415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205415Orig1s000ltr.pdf","2016-01-15 00:00:00",
32670,1,205421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205421Orig1s000TAltr.pdf","2016-07-05 00:00:00",
10445,1,205422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205422Orig1Orig2s000ltr.pdf","2015-07-13 00:00:00",
40466,2,205422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422s000lbl.pdf","2015-07-13 00:00:00",
43488,3,205422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205422s000TOC.cfm","2015-08-19 00:00:00",
45396,1,205422,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205422Orig1s001ltr.pdf","2016-09-26 00:00:00",
45419,2,205422,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf","2016-09-29 00:00:00",
47307,2,205422,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf","2017-02-24 00:00:00",
47404,1,205422,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205422Orig1s002ltr.pdf","2017-03-02 00:00:00",
52557,2,205422,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf","2018-02-12 00:00:00",
52558,8,205422,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf#page=28","2018-02-12 00:00:00",
52636,1,205422,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205422Orig1s003ltr.pdf","2018-02-14 00:00:00",
10446,1,205425,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205425Orig1s000TAltr.pdf","2015-05-22 00:00:00",
19644,2,205433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf","2014-12-03 00:00:00",
22987,3,205433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.cfm","2015-04-06 00:00:00",
32671,1,205433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf","2014-12-03 00:00:00",
32672,1,205433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf","2014-08-27 00:00:00",
10447,1,205434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205434Orig1s000ltr.pdf","2014-07-25 00:00:00",
19645,2,205434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434Orig1s001lbledt.pdf","2015-10-15 00:00:00",
22988,3,205434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205434Orig1s000TOC.cfm","2016-03-18 00:00:00",
32673,1,205434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s001ltr.pdf","2015-10-02 00:00:00",
40467,2,205434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205434Orig1s000lbl.pdf","2014-07-25 00:00:00",
19646,2,205434,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434s003lbl.pdf","2015-12-09 00:00:00",
32674,1,205434,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s003ltr.pdf","2015-11-27 00:00:00",
49654,2,205434,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205434Orig1s005lbl.pdf","2017-09-01 00:00:00",
49655,1,205434,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205434Orig1s005ltr.pdf","2017-09-01 00:00:00",
22989,3,205435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000TOC.cfm","2014-07-16 00:00:00",
32675,1,205435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205435Orig1s000ltr.pdf","2014-06-23 00:00:00",
32676,1,205435,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf","2015-03-06 00:00:00",
40468,2,205435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205435s000lbl.pdf","2014-06-23 00:00:00",
40469,2,205435,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf","2015-03-09 00:00:00",
44918,21,205435,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000SumR.pdf","2014-07-16 00:00:00",
45737,1,205435,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf","2016-10-31 00:00:00",
45802,2,205435,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.pdf","2016-11-04 00:00:00",
10448,1,205435,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s005ltr.pdf","2016-06-07 00:00:00",
45282,1,205435,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s006ltr.pdf","2016-09-19 00:00:00",
45408,2,205435,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s006lbl.pdf","2016-09-28 00:00:00",
49433,2,205435,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf","2017-08-16 00:00:00",
49477,1,205435,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s007,205436Orig1s003ltr.pdf","2017-08-21 00:00:00",
49430,2,205435,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s008,205436s004lbl.pdf","2017-08-16 00:00:00",
49475,1,205435,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s008,205436Orig1s004ltr.pdf","2017-08-21 00:00:00",
10449,1,205436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205436Orig1s000ltr.pdf","2014-06-23 00:00:00",
10450,1,205436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf","2015-03-06 00:00:00",
19647,2,205436,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf","2015-03-09 00:00:00",
24495,21,205436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000SumR.pdf","2014-10-10 00:00:00",
40470,2,205436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205436s000lbl.pdf","2014-06-23 00:00:00",
43489,3,205436,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000TOC.cfm","2014-10-10 00:00:00",
45736,1,205436,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf","2016-10-31 00:00:00",
45803,2,205436,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.pdf","2016-11-04 00:00:00",
49432,2,205436,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf","2017-08-16 00:00:00",
49478,1,205436,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s007,205436Orig1s003ltr.pdf","2017-08-21 00:00:00",
49431,2,205436,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s008,205436s004lbl.pdf","2017-08-16 00:00:00",
49476,1,205436,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s008,205436Orig1s004ltr.pdf","2017-08-21 00:00:00",
22990,3,205437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205437Orig1s000TOC.cfm","2014-04-17 00:00:00",
32677,1,205437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf","2014-03-25 00:00:00",
40471,2,205437,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf","2014-03-25 00:00:00",
19648,2,205437,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf","2015-12-28 00:00:00",
32678,1,205437,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf","2015-12-22 00:00:00",
48875,2,205437,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf","2017-06-30 00:00:00",
48897,1,205437,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205437Orig1s006ltr.pdf","2017-07-05 00:00:00",
55403,1,205444,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205444Orig1s000TAltr.pdf","2018-09-07 00:00:00",
55232,1,205457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205457Orig1s000ltr.pdf","2018-08-20 00:00:00",
47758,1,205468,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205468Orig1s000ltr.pdf","2017-03-29 00:00:00",
10451,1,205473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205473Orig1s000ltr.pdf","2015-08-03 00:00:00",
19649,2,205474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205474s000lbl.pdf","2014-11-20 00:00:00",
22991,3,205474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205474Orig1s000TOC.cfm","2015-04-06 00:00:00",
32679,1,205474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205474Orig1s000ltr.pdf","2014-11-18 00:00:00",
44919,21,205474,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205474Orig1s000SumR.pdf","2015-04-06 00:00:00",
46869,2,205474,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205474s003lbl.pdf","2017-01-13 00:00:00",
46889,1,205474,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205474Orig1s003ltr.pdf","2017-01-18 00:00:00",
54766,2,205474,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205474s005lbl.pdf","2018-07-05 00:00:00",
54805,8,205474,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205474s005lbl.pdf#page=23","2018-07-06 00:00:00",
54834,1,205474,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205474Orig1s005ltr.pdf","2018-07-06 00:00:00",
19650,2,205476,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205476Orig1s000lbl.pdf","2016-04-11 00:00:00",
10453,1,205488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205488Orig1s000ltr.pdf","2014-06-02 00:00:00",
19651,2,205488,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205488s001lbl.pdf","2015-05-13 00:00:00",
22992,3,205488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205488Orig1s000TOC.cfm","2015-01-29 00:00:00",
32680,1,205488,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205488Orig1s001ltr.pdf","2015-05-13 00:00:00",
40472,2,205488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205488s000lbl.pdf","2014-05-30 00:00:00",
44920,21,205488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205488Orig1s000SumR.pdf","2015-01-29 00:00:00",
45682,1,205488,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205488Orig1s002ltr.pdf","2016-10-27 00:00:00",
45751,2,205488,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205488s002lbl.pdf","2016-11-01 00:00:00",
48786,2,205489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf","2017-06-19 00:00:00",
48787,8,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf#page=21","2017-06-20 00:00:00",
48790,1,205489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf","2017-06-22 00:00:00",
51367,20,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/143_205489 methylphenidate clinical prea.pdf","1900-01-01 00:00:00",
51369,18,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/145_205489 methylphenidate clinpharm prea.pdf","1900-01-01 00:00:00",
51370,18,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/146_205489 methylphenidate clinpharm resubmission prea.pdf","1900-01-01 00:00:00",
51371,17,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/148_205489 methylphenidate statistical prea.pdf","1900-01-01 00:00:00",
51372,17,205489,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/147_205489 methylphenidate stat resubmission prea.pdf","1900-01-01 00:00:00",
52883,3,205489,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.cfm","2018-03-09 00:00:00",
10454,1,205490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205490Orig1s000ltr.pdf","2015-09-04 00:00:00",
19652,2,205490,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf","2015-10-22 00:00:00",
52122,1,205493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205493Orig1s000TAltr.pdf","2018-01-30 00:00:00",
10455,1,205494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205494Orig1s000ltr.pdf","2014-08-20 00:00:00",
19653,2,205494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf","2014-08-22 00:00:00",
22993,3,205494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000TOC.cfm","2014-09-17 00:00:00",
24496,21,205494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000SumR.pdf","2014-09-17 00:00:00",
52743,8,205494,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494Orig1s000lbl.pdf","2018-02-28 00:00:00",
55376,2,205494,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf","2018-08-31 00:00:00",
55469,1,205494,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205494Orig1s003ltr.pdf","2018-09-13 00:00:00",
10456,1,205501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205501Orig1s000ltr.pdf","2015-07-20 00:00:00",
32681,1,205508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205508Orig1s000TAltr.pdf","2014-03-19 00:00:00",
53766,1,205509,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205509Orig1s000ltr.pdf","2018-04-20 00:00:00",
32682,1,205517,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205517Orig1s000TAltr.pdf","2015-09-01 00:00:00",
10457,1,205519,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205519Orig1s000ltr.pdf","2016-05-24 00:00:00",
10458,1,205520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205520Orig1s000ltr.pdf","2015-07-28 00:00:00",
46984,2,205525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205525s000lbl.pdf","2016-07-05 00:00:00",
46985,1,205525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205525Orig1s000ltr.pdf","2016-07-05 00:00:00",
47745,22,205525,"ORIG",1,"0","https://www.federalregister.gov/documents/2017/03/23/2017-05809/schedules-of-controlled-substances-placement-of-fda-approved-products-of-oral-solutions-containing","2017-03-29 00:00:00",
52666,3,205525,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205525Orig1s000TOC.cfm","2018-02-16 00:00:00",
48551,1,205525,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205525Orig1s003ltr.pdf","2018-01-18 00:00:00",
48661,2,205525,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205525s003lbl.pdf","2017-06-06 00:00:00",
55495,2,205525,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205525s007lbl.pdf","2018-09-18 00:00:00",
55505,1,205525,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205525Orig1s007ltr.pdf","2018-09-18 00:00:00",
19655,2,205551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf","2014-08-26 00:00:00",
32684,1,205551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205551Orig1s000ltr.pdf","2014-08-27 00:00:00",
43490,3,205551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205551Orig1s000TOC.cfm","2015-08-11 00:00:00",
10459,1,205551,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s002ltr.pdf","2015-08-10 00:00:00",
19656,2,205551,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf","2015-08-07 00:00:00",
10460,1,205551,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s004ltr.pdf","2015-09-30 00:00:00",
40473,2,205551,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf","2015-10-07 00:00:00",
10461,1,205551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205551Orig1s005ltr.pdf","2016-04-22 00:00:00",
40474,2,205551,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf","2016-04-27 00:00:00",
47733,2,205551,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf","2017-03-28 00:00:00",
47761,1,205551,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s010ltr.pdf","2017-03-29 00:00:00",
47777,8,205551,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf#page=38","2017-03-30 00:00:00",
50483,2,205551,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s011lbl.pdf","2017-11-24 00:00:00",
50500,1,205551,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s011ltr.pdf","2017-11-27 00:00:00",
51221,20,205551,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/209_205551S11_clinical prea.pdf","1900-01-01 00:00:00",
51222,18,205551,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/210_205551S11_clinpharm prea.pdf","1900-01-01 00:00:00",
54178,2,205551,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf","2018-05-14 00:00:00",
54200,1,205551,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s013ltr.pdf","2018-05-16 00:00:00",
55421,2,205551,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf","2018-09-10 00:00:00",
55450,1,205551,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf","2018-09-12 00:00:00",
55422,2,205551,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf","2018-09-10 00:00:00",
55451,1,205551,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf","2018-09-12 00:00:00",
10462,1,205552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf","2013-11-15 00:00:00",
10464,1,205552,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf","2014-07-29 00:00:00",
40475,2,205552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf","2013-11-15 00:00:00",
40477,2,205552,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf","2014-07-29 00:00:00",
43491,3,205552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205552Orig1S001.pdf","2017-12-06 00:00:00",
44921,21,205552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000SumR.pdf","2013-11-25 00:00:00",
50617,3,205552,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552s001.pdf","2017-12-06 00:00:00",
32685,1,205552,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf","2015-01-29 00:00:00",
40478,2,205552,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf","2015-01-29 00:00:00",
45438,2,205552,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf","2014-02-12 00:00:00",
45439,1,205552,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig2s000ltr.pdf","2014-02-14 00:00:00",
45440,3,205552,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000TOC.cfm","2015-04-13 00:00:00",
45441,21,205552,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000SumR.pdf","2015-04-13 00:00:00",
32686,1,205552,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s007ltr.pdf","2016-03-08 00:00:00",
40479,2,205552,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf","2016-03-08 00:00:00",
10465,1,205552,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s010,s013ltr.pdf","2016-05-09 00:00:00",
40480,2,205552,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf","2016-05-09 00:00:00",
19657,2,205552,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf","2016-07-18 00:00:00",
32687,1,205552,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s012ltr.pdf","2016-06-29 00:00:00",
40481,2,205552,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf","2016-05-09 00:00:00",
46946,1,205552,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s016ltr.pdf","2017-01-24 00:00:00",
47884,2,205552,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf","2017-04-07 00:00:00",
49200,2,205552,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf","2017-08-02 00:00:00",
49244,1,205552,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s017ltr.pdf","2017-08-04 00:00:00",
54290,3,205552,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/205552Orig1s017SumR.pdf","2018-05-22 00:00:00",
50854,2,205552,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf","2017-12-26 00:00:00",
50905,1,205552,"SUPPL",20,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s020ltr.pdf","2017-12-27 00:00:00",
55340,2,205552,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s024lbl.pdf","2018-08-28 00:00:00",
55341,1,205552,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s024,210563Orig1s001ltr.pdf","2018-08-28 00:00:00",
55338,2,205552,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf","2018-08-28 00:00:00",
55348,1,205552,"SUPPL",25,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s025ltr.pdf","2018-08-28 00:00:00",
48236,2,205555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205555s000lbl.pdf","2017-05-04 00:00:00",
48284,1,205555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205555Orig1s000ltr.pdf","2017-05-08 00:00:00",
49867,3,205555,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205555Orig1s000TOC.cfm","2017-09-27 00:00:00",
48643,1,205570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205570Orig1s000ltr.pdf","2017-06-05 00:00:00",
10466,1,205572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205572Orig1s000ltr.pdf","2015-04-08 00:00:00",
19658,2,205572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205572s000lbl.pdf","2015-04-10 00:00:00",
24498,21,205572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000SumR.pdf","2016-03-02 00:00:00",
43493,3,205572,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000TOC.cfm","2016-03-02 00:00:00",
19659,2,205572,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205572s002lbl.pdf","2016-07-26 00:00:00",
32688,1,205572,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205572Orig1s002ltr.pdf","2016-07-26 00:00:00",
43982,8,205572,"SUPPL",2,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088619.pdf","2016-07-26 00:00:00",
32689,1,205574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf","2015-12-08 00:00:00",
32690,1,205574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf","2016-05-20 00:00:00",
40482,2,205574,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf","2016-05-26 00:00:00",
10467,1,205579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205579Orig1s000ltr.pdf","2014-07-24 00:00:00",
40483,2,205579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205579s000lbl.pdf","2014-07-24 00:00:00",
43494,3,205579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000TOC.cfm","2016-03-23 00:00:00",
44922,21,205579,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000SumR.pdf","2016-03-23 00:00:00",
54226,2,205580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf","2018-05-23 00:00:00",
54313,1,205580,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205580s000ltr.pdf","2018-05-23 00:00:00",
55465,1,205580,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205580Orig1s002ltr.pdf","2018-09-13 00:00:00",
10469,1,205582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205582Orig1s000ltr.pdf","2014-01-24 00:00:00",
19660,2,205582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf","2014-01-28 00:00:00",
22994,3,205582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000TOC.cfm","2014-06-27 00:00:00",
44923,21,205582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205582Orig1s000SumR.pdf","2014-06-27 00:00:00",
10470,1,205583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s000ltr.pdf","2014-01-29 00:00:00",
19661,2,205583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf","2014-01-31 00:00:00",
22995,3,205583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000TOC.cfm","2014-10-10 00:00:00",
32691,1,205583,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf","2014-07-23 00:00:00",
40484,2,205583,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf","2014-07-23 00:00:00",
44924,21,205583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000SumR.pdf","2014-10-10 00:00:00",
19662,2,205583,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf","2014-07-23 00:00:00",
32692,1,205583,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf","2014-07-23 00:00:00",
46714,2,205583,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s005lbl.pdf","2017-01-06 00:00:00",
46771,1,205583,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s005ltr.pdf","2017-01-10 00:00:00",
50798,2,205583,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf","2017-12-21 00:00:00",
50799,8,205583,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf#page=30","2017-12-21 00:00:00",
50900,1,205583,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s006ltr.pdf","2017-12-27 00:00:00",
10471,1,205596,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205596Orig1s000ltr.pdf","2014-03-14 00:00:00",
19663,2,205596,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf","2014-03-19 00:00:00",
19664,2,205596,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
22996,3,205596,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000TOC.cfm","2014-10-10 00:00:00",
32693,1,205596,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
44925,21,205596,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000SumR.pdf","2014-10-10 00:00:00",
10472,1,205596,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf","2015-11-18 00:00:00",
19665,2,205596,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf","2015-11-19 00:00:00",
45297,1,205596,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf","2016-09-15 00:00:00",
46968,2,205596,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf","2017-01-24 00:00:00",
50985,1,205596,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf","2018-01-08 00:00:00",
51009,2,205596,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf","2018-01-09 00:00:00",
50824,2,205598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205598s000lbl.pdf","2017-12-21 00:00:00",
50825,1,205598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205598Orig1s000ltr.pdf","2017-12-27 00:00:00",
52232,3,205598,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205598Orig1s000TOC.cfm","2018-01-31 00:00:00",
10473,1,205604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205604Orig1s000ltr.pdf","2015-12-11 00:00:00",
10474,1,205605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205605Orig1s000ltr.pdf","2015-12-11 00:00:00",
10475,1,205609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205609Orig1s000ltr.pdf","2016-07-05 00:00:00",
19666,2,205609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205609Orig1s000lbl.pdf","2016-07-18 00:00:00",
10476,1,205612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205612Orig1s000ltr.pdf","2016-07-15 00:00:00",
40485,2,205612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205612Orig1s000lbl.pdf","2016-07-18 00:00:00",
10477,1,205613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf","2014-10-08 00:00:00",
19667,2,205613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf","2014-10-09 00:00:00",
32694,1,205613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.pdf","2014-09-17 00:00:00",
43495,3,205613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm","2015-07-02 00:00:00",
44926,21,205613,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000SumR.pdf","2015-07-02 00:00:00",
10478,1,205625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205625Orig1s000ltr.pdf","2014-08-21 00:00:00",
10479,1,205625,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205625Orig1s001ltr.pdf","2015-03-24 00:00:00",
19668,2,205625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205625s000lbl.pdf","2014-08-22 00:00:00",
40486,2,205625,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205625Orig1s001Lbl.pdf","2015-03-24 00:00:00",
43496,3,205625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000TOC.cfm","2015-10-07 00:00:00",
44927,21,205625,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000SumR.pdf","2015-10-07 00:00:00",
51110,18,205625,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone clinpharm prea.pdf","1900-01-01 00:00:00",
51111,17,205625,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone statistical prea.pdf","1900-01-01 00:00:00",
51112,20,205625,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone clinical prea.pdf","1900-01-01 00:00:00",
54260,2,205625,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205625s005lbl.pdf","2018-05-21 00:00:00",
54267,1,205625,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205625Orig1s005ltr.pdf","2018-05-21 00:00:00",
55178,2,205626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf","2018-08-15 00:00:00",
55179,8,205626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf#page=50","2018-08-15 00:00:00",
55213,1,205626,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205626Orig1s000ltr.pdf","2018-08-20 00:00:00",
10480,1,205629,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205629Orig1s000ltr.pdf","2016-07-11 00:00:00",
44596,14,205629,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-07-22 00:00:00",
45820,19,205634,"APPL",0,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-11-04 00:00:00",
22997,3,205636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000TOC.cfm","2016-03-02 00:00:00",
32695,1,205636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf","2015-04-03 00:00:00",
32696,1,205636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.pdf","2015-03-10 00:00:00",
40487,2,205636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf","2015-04-28 00:00:00",
44928,21,205636,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000SumR.pdf","2016-03-02 00:00:00",
51457,20,205636,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636 albuterol sulfate clinical prea.pdf","1900-01-01 00:00:00",
51459,18,205636,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636 albuterol sulfate clinpharm prea.pdf","1900-01-01 00:00:00",
51461,17,205636,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636 albuterol sulfate statistical prea.pdf","1900-01-01 00:00:00",
10481,1,205636,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s004ltr.pdf","2016-05-02 00:00:00",
19669,2,205636,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf","2016-04-29 00:00:00",
51468,20,205636,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636S004 albuterol sulfate clinical prea.pdf","1900-01-01 00:00:00",
51481,18,205636,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636s004 albuterol sulfate clinpharm prea.pdf","1900-01-01 00:00:00",
51482,17,205636,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205636s004 albuterol sulfate statistical prea.pdf","1900-01-01 00:00:00",
45264,2,205636,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s006lbl.pdf","2016-09-09 00:00:00",
45292,1,205636,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s006ltr.pdf","2016-09-12 00:00:00",
10482,1,205637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205637Orig1s000ltr.pdf","2014-06-10 00:00:00",
19670,2,205637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf","2014-06-10 00:00:00",
22998,3,205637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000TOC.cfm","2015-05-28 00:00:00",
24499,21,205637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000SumR.pdf","2015-05-28 00:00:00",
44597,14,205637,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2015-01-08 00:00:00",
10483,1,205637,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf","2015-02-17 00:00:00",
48166,2,205637,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf","2017-04-28 00:00:00",
48184,1,205637,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf","2017-05-02 00:00:00",
32697,1,205637,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf","2016-07-11 00:00:00",
46325,2,205637,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf","2016-12-20 00:00:00",
46435,1,205637,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s011ltr.pdf","2016-12-21 00:00:00",
48167,2,205637,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf","2017-04-28 00:00:00",
48183,1,205637,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf","2017-05-02 00:00:00",
48522,1,205637,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s014ltr.pdf","2017-05-25 00:00:00",
52241,2,205637,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf","2018-02-01 00:00:00",
52242,8,205637,"SUPPL",16,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf#page=33","2018-02-01 00:00:00",
52291,1,205637,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s016ltr.pdf","2018-02-02 00:00:00",
10484,1,205641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205641Orig1s000ltr.pdf","2014-05-01 00:00:00",
19671,2,205641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205641s000lbl.pdf","2014-05-12 00:00:00",
43497,3,205641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000TOC.cfm","2014-11-03 00:00:00",
44929,21,205641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000SumR.pdf","2014-11-03 00:00:00",
51380,20,205641,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205641 mometasone clinical prea.pdf","1900-01-01 00:00:00",
51381,18,205641,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205641 mometasone clinpharm prea.pdf","1900-01-01 00:00:00",
51382,17,205641,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205641 mometasone statistical prea.pdf","1900-01-01 00:00:00",
32698,1,205641,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205641Orig1s002ltr.pdf","2015-06-18 00:00:00",
40488,2,205641,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s002lbl.pdf","2015-07-10 00:00:00",
40489,2,205641,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s004lbl.pdf","2015-08-04 00:00:00",
10485,1,205641,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf","2016-07-13 00:00:00",
40490,2,205641,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf","2016-07-13 00:00:00",
51383,20,205641,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205641 mometasone clinical prea.pdf","1900-01-01 00:00:00",
53460,2,205641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf","2018-03-27 00:00:00",
53515,1,205641,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205641Orig1s007s008ltr.pdf","2018-03-29 00:00:00",
53461,2,205641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf","2018-03-27 00:00:00",
53516,1,205641,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205641Orig1s007s008ltr.pdf","2018-03-29 00:00:00",
32699,1,205645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205645Orig1s000ltr.pdf","2016-12-06 00:00:00",
46014,2,205645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205645lbl.pdf","2016-12-05 00:00:00",
48852,3,205645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205645Orig1s000TOC.cfm","2017-06-28 00:00:00",
49451,2,205645,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205645s001lbl.pdf","2017-08-17 00:00:00",
49571,1,205645,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205645Orig1s001ltr.pdf","2017-08-29 00:00:00",
54154,1,205648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205648Orig1s000TAltr.pdf","2018-05-11 00:00:00",
10486,1,205649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205649Orig1s000ltr.pdf","2014-10-31 00:00:00",
24500,21,205649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf","2015-04-06 00:00:00",
40491,2,205649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf","2014-11-04 00:00:00",
43498,3,205649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000TOC.cfm","2015-04-06 00:00:00",
32700,1,205649,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205649Orig1s003ltr.pdf","2015-12-07 00:00:00",
40492,2,205649,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf","2015-12-08 00:00:00",
32701,1,205649,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s004ltr.pdf","2016-06-16 00:00:00",
40493,2,205649,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s004lbl.pdf","2016-06-17 00:00:00",
45051,1,205649,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s005ltr.pdf","2016-08-17 00:00:00",
45093,2,205649,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf","2016-08-22 00:00:00",
47393,2,205649,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf","2017-03-02 00:00:00",
47461,1,205649,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205649Orig1s006ltr.pdf","2017-03-03 00:00:00",
52234,2,205649,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf","2018-02-01 00:00:00",
52235,8,205649,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf#page=40","2018-02-01 00:00:00",
10487,1,205677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s000ltr.pdf","2014-02-03 00:00:00",
10488,1,205677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s001ltr.pdf","2014-12-16 00:00:00",
22999,3,205677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000TOC.cfm","2014-03-07 00:00:00",
24501,21,205677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000SumR.pdf","2014-03-07 00:00:00",
40494,2,205677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbl.pdf","2014-10-03 00:00:00",
40495,2,205677,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbledt.pdf","2014-01-31 00:00:00",
40496,2,205677,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s001lbl.pdf","2014-12-16 00:00:00",
10489,1,205690,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205690Orig1s000ltr.pdf","2015-11-03 00:00:00",
10490,1,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf","2015-12-18 00:00:00",
10491,1,205692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s001ltr.pdf","2016-06-21 00:00:00",
19672,2,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf","2015-12-17 00:00:00",
19673,2,205692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s001lbl.pdf","2016-06-21 00:00:00",
32702,1,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf","2014-08-19 00:00:00",
32703,1,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf","2015-01-30 00:00:00",
43499,3,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm","2016-04-26 00:00:00",
44930,21,205692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf","2016-04-26 00:00:00",
19674,2,205692,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf","2016-06-02 00:00:00",
32704,1,205692,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s005ltr.pdf","2016-06-06 00:00:00",
55388,2,205692,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205692s019lbl.pdf","2018-09-06 00:00:00",
55410,1,205692,"SUPPL",19,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205692Orig1s019ltr.pdf","2018-09-07 00:00:00",
32705,1,205703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205703Orig1s000ltr.pdf","2014-04-16 00:00:00",
32706,1,205703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205703Orig1s000ltr.pdf","2016-04-11 00:00:00",
40497,2,205703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205703s000lbl.pdf","2016-04-08 00:00:00",
46049,3,205703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000TOC.cfm","2016-10-20 00:00:00",
46050,21,205703,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000SumR.pdf","2016-10-20 00:00:00",
32707,1,205704,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205704MGLtr.pdf","2015-09-30 00:00:00",
32708,1,205712,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205712MGLtr.pdf","2015-09-30 00:00:00",
10492,1,205713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205713MGLtr.pdf","2015-10-02 00:00:00",
19675,2,205718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf","2014-10-14 00:00:00",
23000,3,205718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm","2014-11-07 00:00:00",
24502,21,205718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000SumR.pdf","2014-11-07 00:00:00",
32709,1,205718,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf","2014-10-10 00:00:00",
19676,2,205718,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf","2015-05-06 00:00:00",
19677,2,205718,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s003lbl.pdf","2015-05-04 00:00:00",
32710,1,205718,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf","2015-04-29 00:00:00",
10493,1,205737,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205737MGLtr.pdf","2015-09-30 00:00:00",
32711,1,205738,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205738MGLtr.pdf","2015-10-02 00:00:00",
19678,2,205739,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf","2016-05-23 00:00:00",
32712,1,205739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205739Orig1s000ltr.pdf","2015-10-23 00:00:00",
32713,1,205739,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s001ltr.pdf","2016-05-24 00:00:00",
40498,2,205739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf","2015-10-22 00:00:00",
43500,3,205739,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000TOC.cfm","2015-11-25 00:00:00",
45963,1,205739,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s009ltr.pdf","2016-11-28 00:00:00",
45981,2,205739,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf","2016-12-01 00:00:00",
54004,1,205739,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205739Orig1s016ltr.pdf","2018-05-03 00:00:00",
54019,2,205739,"SUPPL",16,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf","2018-05-04 00:00:00",
10494,1,205747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205747Orig1s000ltr.pdf","2015-05-28 00:00:00",
40499,2,205747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205747s000lbl.pdf","2015-05-29 00:00:00",
46074,3,205747,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205747Orig1s000TOC.cfm","2016-09-28 00:00:00",
46766,2,205747,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf","2017-01-06 00:00:00",
46792,1,205747,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf","2017-01-11 00:00:00",
48664,2,205747,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205747s010lbl.pdf","2017-06-07 00:00:00",
48686,1,205747,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205747Orig1s010ltr.pdf","2017-06-09 00:00:00",
19679,2,205750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205750lbl.pdf","2015-03-18 00:00:00",
32714,1,205750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205750Orig1s000ltr.pdf","2015-03-18 00:00:00",
43501,3,205750,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205750Orig1s000TOC.cfm","2015-04-13 00:00:00",
19680,2,205755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755s000lbl.pdf","2014-04-29 00:00:00",
24503,21,205755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000SumR.pdf","2014-05-16 00:00:00",
32715,1,205755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf","2014-04-30 00:00:00",
43502,3,205755,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000TOC.cfm","2014-05-16 00:00:00",
10495,1,205755,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf","2015-07-23 00:00:00",
19681,2,205755,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf","2015-07-24 00:00:00",
32716,1,205755,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf","2015-07-23 00:00:00",
40500,2,205755,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf","2015-07-24 00:00:00",
45256,2,205755,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf","2016-09-09 00:00:00",
45271,1,205755,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205755Orig1s006ltr.pdf","2016-09-08 00:00:00",
48601,1,205755,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s009ltr.pdf","2017-05-31 00:00:00",
48638,2,205755,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf","2017-06-02 00:00:00",
50855,2,205755,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s010lbl.pdf","2017-12-26 00:00:00",
50928,1,205755,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s010ltr.pdf","2017-12-27 00:00:00",
50468,2,205755,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s011lbl.pdf","2017-11-21 00:00:00",
50493,1,205755,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s011ltr.pdf","2017-11-27 00:00:00",
49028,2,205755,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s012lbl.pdf","2017-07-20 00:00:00",
49036,1,205755,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s012ltr.pdf","2017-07-21 00:00:00",
32717,1,205758,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205758Orig1s000ltr.pdf","2015-05-27 00:00:00",
10496,1,205764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205764MGLtr.pdf","2015-10-02 00:00:00",
32718,1,205765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205765MGltr.pdf","2015-10-06 00:00:00",
10497,1,205766,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205766MGLtr.pdf","2015-10-02 00:00:00",
32719,1,205767,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205767MGLtr.pdf","2015-10-02 00:00:00",
10498,1,205771,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205771Orig1s000ltr.pdf","2016-03-04 00:00:00",
32720,1,205772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205772Orig1s000ltr.pdf","2015-06-11 00:00:00",
10499,1,205776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205776Orig1s000ltr.pdf","2014-07-11 00:00:00",
10500,1,205776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205776Orig1s001ltr.pdf","2015-08-25 00:00:00",
19682,2,205776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf","2014-07-11 00:00:00",
19683,2,205776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205776s001lbl.pdf","2015-08-25 00:00:00",
23001,3,205776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205776Orig1s000TOC.cfm","2015-04-13 00:00:00",
53045,2,205776,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205776s002lbl.pdf","2018-03-16 00:00:00",
53063,1,205776,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205776Orig1s002ltr.pdf","2018-03-20 00:00:00",
19684,2,205777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf","2014-07-23 00:00:00",
23002,3,205777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205777Orig1s000TOC.cfm","2014-08-27 00:00:00",
24127,14,205777,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-04 00:00:00",
32721,1,205777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s000ltr.pdf","2014-07-23 00:00:00",
32722,1,205777,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s001ltr.pdf","2014-08-20 00:00:00",
44598,14,205777,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-06-30 00:00:00",
10501,1,205777,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205777Orig1s002ltr.pdf","2015-07-07 00:00:00",
32723,1,205777,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s003ltr.pdf","2016-04-22 00:00:00",
46324,2,205777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf","2016-12-20 00:00:00",
46437,1,205777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s004ltr.pdf","2016-12-21 00:00:00",
46576,8,205777,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf#page=46","2016-12-29 00:00:00",
45454,1,205777,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s005ltr.pdf","2016-10-03 00:00:00",
48587,1,205777,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205777Orig1s007ltr.pdf","2017-05-31 00:00:00",
55546,2,205777,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf","2018-09-21 00:00:00",
55548,8,205777,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf#page=47","2018-09-21 00:00:00",
55666,1,205777,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf","2018-09-28 00:00:00",
55547,2,205777,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf","2018-09-21 00:00:00",
55549,8,205777,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf#page=47","2018-09-21 00:00:00",
55667,1,205777,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf","2018-09-28 00:00:00",
50049,19,205781,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=366","2017-10-12 00:00:00",
48990,1,205781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205781Orig1s000ltr.pdf","2017-07-14 00:00:00",
49008,2,205781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf","2017-07-18 00:00:00",
10502,1,205786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf","2013-12-31 00:00:00",
24504,21,205786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205786Orig1s000SumR.pdf","2014-06-27 00:00:00",
32724,1,205786,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf","2014-04-10 00:00:00",
40501,2,205786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf","2013-12-23 00:00:00",
40502,2,205786,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf","2014-04-10 00:00:00",
43503,3,205786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205786Orig1s000TOC.cfm","2014-06-27 00:00:00",
51469,20,205786,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205786 raltegravir clinical prea.pdf","1900-01-01 00:00:00",
51470,18,205786,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205786 raltegravir clinpharm prea.pdf","1900-01-01 00:00:00",
32725,1,205786,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf","2015-02-19 00:00:00",
40503,2,205786,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf","2015-02-20 00:00:00",
32726,1,205786,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf","2015-02-24 00:00:00",
40504,2,205786,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf","2015-02-23 00:00:00",
48577,2,205786,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf","2017-05-31 00:00:00",
48597,1,205786,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022145Orig1s036,203045Orig1s013,205786Orig1s004ltr.pdf","2017-05-31 00:00:00",
50476,2,205786,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf","2017-11-24 00:00:00",
50506,1,205786,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205786Orig1s006,022145Orig1s037,203045Orig1s014ltr.pdf","2017-12-06 00:00:00",
52827,2,205786,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf","2018-03-06 00:00:00",
53011,1,205786,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s038,205786Orig1s007,203045Orig2s015ltr.pdf","2018-03-15 00:00:00",
19685,2,205787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205787Orig1s000lbl.pdf","2014-04-03 00:00:00",
23003,3,205787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000TOC.cfm","2014-12-18 00:00:00",
24505,21,205787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000SumR.pdf","2014-04-03 00:00:00",
32727,1,205787,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205787Orig1s000ltr.pdf","2014-04-03 00:00:00",
50119,1,205790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205790Orig1s000ltr.pdf","2017-10-19 00:00:00",
10503,1,205794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205794Orig1s000ltr.pdf","2016-03-03 00:00:00",
32728,1,205796,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205796MGLtr.pdf","2015-10-13 00:00:00",
55402,1,205801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205801Orig1s000TAltr.pdf","2018-09-07 00:00:00",
32729,1,205803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205803MGLtr.pdf","2015-10-02 00:00:00",
10504,1,205804,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205804MGLtr.pdf","2015-09-29 00:00:00",
54626,1,205806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205806Orig1s000ltr.pdf","2018-06-20 00:00:00",
32730,1,205809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205809MGLtr.pdf","2015-10-01 00:00:00",
45100,1,205811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205811Orig1s000ltr.pdf","2016-08-23 00:00:00",
45104,2,205811,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205811Orig1s000lbl.pdf","2016-08-23 00:00:00",
32731,1,205815,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205815MGLtr.pdf","2015-10-01 00:00:00",
32732,1,205816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205816MGLtr.pdf","2015-10-02 00:00:00",
32733,1,205817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205817MGLtr.pdf","2015-10-01 00:00:00",
32734,1,205818,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205818MGLtr.pdf","2015-10-01 00:00:00",
32735,1,205819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205819MGltr.pdf","2015-10-06 00:00:00",
32736,1,205820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205820MGLtr.pdf","2015-10-01 00:00:00",
32737,1,205821,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205821MGLtr.pdf","2015-10-02 00:00:00",
10505,1,205826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205826MGLtr.pdf","2015-10-02 00:00:00",
32738,1,205827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205827MGLtr.pdf","2015-10-02 00:00:00",
10506,1,205828,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205828MGLtr.pdf","2015-10-02 00:00:00",
19686,2,205831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205831s000lbl.pdf","2015-05-12 00:00:00",
23004,3,205831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205831Orig1s000TOC.cfm","2015-06-05 00:00:00",
24506,21,205831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205831Orig1s000SumR.pdf","2015-06-05 00:00:00",
32739,1,205831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205831Orig1s000ltr.pdf","2015-04-27 00:00:00",
51356,20,205831,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205831_methylphenidate clinical prea.pdf","1900-01-01 00:00:00",
51357,18,205831,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205831_methylphenidate clinpharm prea.pdf","1900-01-01 00:00:00",
51358,17,205831,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205831_methylphenidate Statistical  prea.pdf","1900-01-01 00:00:00",
51359,17,205831,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205831_methylphenidate Statistical 1  prea.pdf","1900-01-01 00:00:00",
46701,2,205831,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205831s003lbl.pdf","2017-01-06 00:00:00",
46751,1,205831,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205831Orig1s003ltr.pdf","2017-01-10 00:00:00",
10507,1,205832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205832Orig1s000ltr.pdf","2014-10-21 00:00:00",
10508,1,205832,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205832Orig1s001ltr.pdf","2016-02-05 00:00:00",
19687,2,205832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf","2014-10-16 00:00:00",
19688,2,205832,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf","2016-03-04 00:00:00",
23005,3,205832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000TOC.cfm","2014-11-21 00:00:00",
24507,21,205832,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000SumR.pdf","2014-12-17 00:00:00",
47168,2,205832,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s004lbl.pdf","2017-02-10 00:00:00",
47176,1,205832,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s004ltr.pdf","2017-02-13 00:00:00",
49276,2,205832,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s005lbl.pdf","2017-08-08 00:00:00",
49362,1,205832,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s005ltr.pdf","2017-08-15 00:00:00",
50679,2,205832,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s007lbl.pdf","2017-12-13 00:00:00",
50753,1,205832,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s007ltr.pdf","2017-12-18 00:00:00",
52081,2,205832,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205832s009lbl.pdf","2018-01-30 00:00:00",
52272,1,205832,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205832Orig1s009ltr.pdf","2018-02-02 00:00:00",
10509,1,205834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205834Orig1s000ltr.pdf","2014-10-14 00:00:00",
32740,1,205834,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s001ltr.pdf","2015-03-24 00:00:00",
40505,2,205834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf","2014-10-15 00:00:00",
40506,2,205834,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf","2015-03-24 00:00:00",
43504,3,205834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000TOC.cfm","2014-11-03 00:00:00",
44932,21,205834,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000SumR.pdf","2014-11-03 00:00:00",
32741,1,205834,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s002ltr.pdf","2015-11-16 00:00:00",
40507,2,205834,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf","2015-11-19 00:00:00",
10510,1,205834,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf","2015-11-16 00:00:00",
40508,2,205834,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf","2015-11-19 00:00:00",
10511,1,205834,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s004ltr.pdf","2015-11-16 00:00:00",
40509,2,205834,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf","2015-11-19 00:00:00",
32742,1,205834,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf","2015-11-16 00:00:00",
40510,2,205834,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf","2015-11-19 00:00:00",
10512,1,205834,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s006ltr.pdf","2015-11-16 00:00:00",
19689,2,205834,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf","2015-11-19 00:00:00",
10513,1,205834,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf","2016-02-16 00:00:00",
19690,2,205834,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf","2016-02-25 00:00:00",
44933,21,205834,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf","2016-03-03 00:00:00",
24508,21,205834,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf","2016-03-03 00:00:00",
32743,1,205834,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf","2016-02-16 00:00:00",
40511,2,205834,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf","2016-02-25 00:00:00",
10514,1,205834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf","2016-02-16 00:00:00",
40512,2,205834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf","2016-02-25 00:00:00",
44934,21,205834,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf","2016-03-03 00:00:00",
32744,1,205834,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s010ltr.pdf","2016-06-09 00:00:00",
40513,2,205834,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf","2016-06-13 00:00:00",
32745,1,205834,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s011ltr.pdf","2016-03-31 00:00:00",
40514,2,205834,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf","2016-03-30 00:00:00",
47920,2,205834,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s017lbl.pdf","2017-04-10 00:00:00",
47980,1,205834,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s017ltr.pdf","2017-04-12 00:00:00",
51285,20,205834,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/116_205834S017 ledipasvir-sofosbuvir CD clinical.pdf","1900-01-01 00:00:00",
51286,18,205834,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/114_205834 ledipasvir-sofosbuvir clinpharm prea.pdf","1900-01-01 00:00:00",
51287,17,205834,"SUPPL",17,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/115_205834 ledipasvir-sofosbuvir statistical prea.pdf","1900-01-01 00:00:00",
47213,2,205834,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf","2017-02-15 00:00:00",
47218,1,205834,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s018ltr.pdf","2017-02-15 00:00:00",
50375,1,205834,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s024ltr.pdf","2017-11-13 00:00:00",
50393,2,205834,"SUPPL",24,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s024lbl.pdf","2017-11-13 00:00:00",
19691,2,205836,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836s001,205837s001,205838s001lbl.pdf","2016-06-06 00:00:00",
23006,3,205836,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205836-205837-205838-Briviact-TOC.cfm","2016-03-30 00:00:00",
32746,1,205836,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,0205837Orig1s000,0205838Orig1s000ltr.pdf","2016-02-19 00:00:00",
32747,1,205836,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837Orig1s001,205838Orig1s001ltr.pdf","2016-06-06 00:00:00",
40515,2,205836,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf","2016-02-19 00:00:00",
47887,22,205836,"ORIG",1,"0","https://www.federalregister.gov/documents/2016/05/12/2016-11245/schedules-of-controlled-substances-placement-of-brivaracetam-into-schedule-v","2017-04-07 00:00:00",
49742,2,205836,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205836s003,205837s003,205838s002lbl.pdf","2017-09-15 00:00:00",
49793,1,205836,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205836s003,205837s003,205838s002ltr.pdf","2017-09-19 00:00:00",
54180,2,205836,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf","2018-05-14 00:00:00",
54181,8,205836,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17","2018-05-14 00:00:00",
54201,1,205836,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205836Orig1s005,205837Orig1s004,205838Orig1s003ltr(2).pdf","2018-05-16 00:00:00",
10515,1,205837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,0205837Orig1s000,0205838Orig1s000ltr.pdf","2016-02-19 00:00:00",
19692,2,205837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf","2016-02-19 00:00:00",
32748,1,205837,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837Orig1s001,205838Orig1s001ltr.pdf","2016-06-06 00:00:00",
40516,2,205837,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836s001,205837s001,205838s001lbl.pdf","2016-06-06 00:00:00",
43505,3,205837,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205836-205837-205838-Briviact-TOC.cfm","2016-03-30 00:00:00",
47888,22,205837,"ORIG",1,"0","https://www.federalregister.gov/documents/2016/05/12/2016-11245/schedules-of-controlled-substances-placement-of-brivaracetam-into-schedule-v","2017-04-07 00:00:00",
49740,2,205837,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205836s003,205837s003,205838s002lbl.pdf","2017-09-15 00:00:00",
49794,1,205837,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205836s003,205837s003,205838s002ltr.pdf","2017-09-19 00:00:00",
54182,2,205837,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf","2018-05-14 00:00:00",
54185,8,205837,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17","2018-05-14 00:00:00",
54202,1,205837,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205836Orig1s005,205837Orig1s004,205838Orig1s003ltr(2).pdf","2018-05-16 00:00:00",
10516,1,205838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/0205836Orig1s000,0205837Orig1s000,0205838Orig1s000ltr.pdf","2016-02-19 00:00:00",
19693,2,205838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf","2016-02-19 00:00:00",
32749,1,205838,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205836Orig1s001,205837Orig1s001,205838Orig1s001ltr.pdf","2016-06-06 00:00:00",
40517,2,205838,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836s001,205837s001,205838s001lbl.pdf","2016-06-06 00:00:00",
43506,3,205838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205836-205837-205838-Briviact-TOC.cfm","2016-03-30 00:00:00",
47889,22,205838,"ORIG",1,"0","https://www.federalregister.gov/documents/2016/05/12/2016-11245/schedules-of-controlled-substances-placement-of-brivaracetam-into-schedule-v","2017-04-07 00:00:00",
49738,2,205838,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205836s003,205837s003,205838s002lbl.pdf","2017-09-15 00:00:00",
49795,1,205838,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205836s003,205837s003,205838s002ltr.pdf","2017-09-19 00:00:00",
54183,2,205838,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf","2018-05-14 00:00:00",
54184,8,205838,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17","2018-05-14 00:00:00",
54203,1,205838,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205836Orig1s005,205837Orig1s004,205838Orig1s003ltr(2).pdf","2018-05-16 00:00:00",
32750,1,205840,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205840MGLtr.pdf","2015-10-02 00:00:00",
10517,1,205843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205843MGLtr.pdf","2015-10-02 00:00:00",
32751,1,205845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205845MGLtr.pdf","2015-10-01 00:00:00",
32752,1,205846,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205846MGLtr.pdf","2015-09-30 00:00:00",
32753,1,205847,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205847MGLtr.pdf","2015-10-02 00:00:00",
10518,1,205849,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205849MGLtr.pdf","2015-09-30 00:00:00",
32754,1,205850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205850MGLtr.pdf","2015-09-30 00:00:00",
32755,1,205851,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205851MGLtr.pdf","2015-09-30 00:00:00",
10519,1,205852,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205852MGLtr.pdf","2015-09-30 00:00:00",
10520,1,205858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf","2014-07-24 00:00:00",
23007,3,205858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000TOC.cfm","2015-02-06 00:00:00",
40518,2,205858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf","2014-07-23 00:00:00",
44599,14,205858,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321","2014-08-01 00:00:00",
44935,21,205858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000SumR.pdf","2015-02-06 00:00:00",
45362,1,205858,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf","2016-09-22 00:00:00",
45411,2,205858,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf","2016-09-29 00:00:00",
46678,1,205858,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s005ltr.pdf","2017-01-05 00:00:00",
50529,2,205858,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf","2017-11-30 00:00:00",
50567,1,205858,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s007ltr.pdf","2017-12-01 00:00:00",
52083,2,205858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf","2018-01-30 00:00:00",
52127,1,205858,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s009ltr.pdf","2018-01-30 00:00:00",
52518,1,205858,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s010ltr.pdf","2018-02-08 00:00:00",
52399,2,205858,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf","2018-02-05 00:00:00",
52400,8,205858,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf#page=1","2018-02-05 00:00:00",
52509,1,205858,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s011ltr.pdf","2018-02-08 00:00:00",
53502,1,205858,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s012ltr.pdf","2018-03-28 00:00:00",
32756,1,205859,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205859MGLtr.pdf","2015-09-30 00:00:00",
10521,1,205861,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205861Orig1s000TAltr.pdf","2014-08-15 00:00:00",
32757,1,205862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205862MGLtr.pdf","2015-09-29 00:00:00",
32758,1,205864,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205864MGLtr.pdf","2015-09-29 00:00:00",
32759,1,205865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205865MGLtr.pdf","2015-09-29 00:00:00",
10522,1,205866,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205866MGLtr.pdf","2015-09-29 00:00:00",
10523,1,205874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s000ltr.pdf","2014-09-08 00:00:00",
19694,2,205874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s000lbl.pdf","2014-09-09 00:00:00",
19695,2,205874,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf","2014-11-20 00:00:00",
23008,3,205874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000TOC.cfm","2015-04-22 00:00:00",
32760,1,205874,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s001ltr.pdf","2014-11-17 00:00:00",
44936,21,205874,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000SumR.pdf","2015-04-22 00:00:00",
19696,2,205874,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf","2015-07-22 00:00:00",
32761,1,205874,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205874Orig1s004ltr.pdf","2015-07-23 00:00:00",
50319,2,205874,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205874s013lbl.pdf","2017-11-06 00:00:00",
50352,1,205874,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205874Orig1s013ltr.pdf","2017-11-09 00:00:00",
10524,1,205878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205878Orig1s000ltr.pdf","2015-12-11 00:00:00",
45409,1,205879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205879Orig1s000ltr.pdf","2016-09-29 00:00:00",
45410,2,205879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205879s000lbl.pdf","2016-09-29 00:00:00",
50516,3,205879,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205879Orig1s000TOC.cfm","2017-11-28 00:00:00",
50957,2,205879,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s002lbl.pdf","2018-01-03 00:00:00",
50958,1,205879,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205879s002ltr.pdf","2018-01-03 00:00:00",
49060,2,205879,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s005lbl.pdf","2017-07-25 00:00:00",
49118,1,205879,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205879Orig1s005ltr.pdf","2017-07-28 00:00:00",
49359,2,205879,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s006lbl.pdf","2017-08-14 00:00:00",
49463,8,205879,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s006lbl.pdf#page=53","2017-08-18 00:00:00",
49483,1,205879,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205879Orig1s006ltr.pdf","2017-08-21 00:00:00",
45522,1,205880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205880Orig1s000ltr.pdf","2016-10-12 00:00:00",
45688,2,205880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205880Orig1s000lbl.pdf","2016-10-27 00:00:00",
19697,2,205883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf","2016-04-14 00:00:00",
32762,1,205883,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205883Orig1s000ltr.pdf","2016-04-14 00:00:00",
50112,1,205888,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205888Orig1s000ltr.pdf","2017-10-19 00:00:00",
10525,1,205889,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205889MGLtr.pdf","2015-09-29 00:00:00",
32763,1,205890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205890MGLtr.pdf","2015-10-01 00:00:00",
32764,1,205891,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205891MGLtr.pdf","2015-09-29 00:00:00",
10526,1,205895,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205895Orig1s000TAltr.pdf","2016-01-06 00:00:00",
50122,1,205897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205897Orig1s000ltr.pdf","2017-10-19 00:00:00",
10527,1,205901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205901Orig1s000ltr.pdf","2016-04-26 00:00:00",
19698,2,205901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205901Orig1s000lbl.pdf","2016-05-03 00:00:00",
45442,1,205905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205905Orig1s000ltr.pdf","2016-10-03 00:00:00",
45604,2,205905,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205905Orig1s000lbl.pdf","2016-10-11 00:00:00",
10528,1,205909,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205909MGLtr.pdf","2015-09-29 00:00:00",
10529,1,205910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205910MGLtr.pdf","2015-09-29 00:00:00",
10530,1,205911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205911Orig1s000ltr.pdf","2015-09-29 00:00:00",
32765,1,205912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205912MGLtr.pdf","2015-09-29 00:00:00",
23009,3,205917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205917Orig1s000TOC.cfm","2015-01-29 00:00:00",
32766,1,205917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205917Orig1s000ltr.pdf","2014-11-19 00:00:00",
40519,2,205917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205917s000lbl.pdf","2014-11-20 00:00:00",
10531,1,205919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s000ltr.pdf","2014-04-29 00:00:00",
10532,1,205919,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s001ltr.pdf","2014-12-31 00:00:00",
23010,3,205919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205919Orig1s000TOC.cfm","2014-12-18 00:00:00",
40520,2,205919,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205919s000lbl.pdf","2014-04-28 00:00:00",
48319,2,205919,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205919s002lbl.pdf","2017-05-09 00:00:00",
48348,1,205919,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205919Orig1s002ltr.pdf","2017-05-10 00:00:00",
52692,2,205919,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf","2018-02-23 00:00:00",
52727,1,205919,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205919Orig1s003ltr.pdf","2018-02-26 00:00:00",
10533,1,205921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205921Orig1s000ltr.pdf","2014-08-28 00:00:00",
48983,2,205927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf","2017-07-14 00:00:00",
48989,1,205927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205927Orig1s000ltr.pdf","2017-07-14 00:00:00",
19699,2,205931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf","2014-07-28 00:00:00",
32767,1,205931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205931Orig1s000ltr.pdf","2014-07-28 00:00:00",
43507,3,205931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205931Orig1s000TOC.cfm","2014-12-18 00:00:00",
32768,1,205931,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf","2016-04-28 00:00:00",
40521,2,205931,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf","2016-04-27 00:00:00",
50416,1,205931,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205931Orig1s003,208253Orig1s001ltr.pdf","2017-11-15 00:00:00",
50519,2,205931,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf","2017-11-29 00:00:00",
10534,1,205934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205934Orig1s000ltr.pdf","2015-12-23 00:00:00",
19700,2,205934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf","2015-12-28 00:00:00",
43508,3,205934,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205934Orig1s000TOC.cfm","2016-07-28 00:00:00",
10535,1,205941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205941Orig1s000TAltr.pdf","2016-01-22 00:00:00",
32769,1,205942,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205942Orig1s000TAltr.pdf","2016-01-22 00:00:00",
45085,1,205959,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205959Orig1s000TAltr.pdf","2016-08-22 00:00:00",
54819,1,205961,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205961Orig1s000TAltr.pdf","2018-07-06 00:00:00",
32770,1,205962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205962TAltr.pdf","2015-12-31 00:00:00",
55233,1,205971,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205971Orig1s000TAltr.pdf","2018-08-20 00:00:00",
32771,1,205972,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205972Orig1s000TAltr.pdf","2016-01-29 00:00:00",
10536,1,205985,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205985MGLtr.pdf","2015-09-29 00:00:00",
10537,1,205986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205986MGLtr.pdf","2015-09-30 00:00:00",
32772,1,205992,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205992MGLtr.pdf","2015-09-30 00:00:00",
48784,14,205994,"ORIG",1,"Tentative Approval Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205994Orig1s000TAltr.pdf","2017-06-20 00:00:00",
32773,1,205999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205999MGLtr.pdf","2015-09-30 00:00:00",
10538,1,206014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/206014MGLtr.pdf","2015-09-30 00:00:00",
46484,1,206015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206015Orig1s000ltr.pdf","2016-12-22 00:00:00",
47078,2,206015,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206015Orig1s000lbl.pdf","2017-01-31 00:00:00",
55234,1,206020,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206020Orig1s000TAltr.pdf","2018-08-20 00:00:00",
32774,1,206025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/206025MGLtr.pdf","2015-09-30 00:00:00",
45445,1,206028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206028Orig1s000ltr.pdf","2016-10-03 00:00:00",
45605,2,206028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206028Orig1s000lbl.pdf","2016-10-11 00:00:00",
45521,1,206030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206030Orig1s000ltr.pdf","2016-10-12 00:00:00",
45609,2,206030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206030s000lbl.pdf","2016-10-12 00:00:00",
50467,3,206030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206030Orig1s000TOC.cfm","2017-11-21 00:00:00",
45446,1,206032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206032Orig1s000ltr.pdf","2016-10-03 00:00:00",
10539,1,206038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206038Orig1s000ltr.pdf","2015-07-02 00:00:00",
10540,1,206038,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s001ltr.pdf","2016-05-20 00:00:00",
19701,2,206038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf","2015-07-02 00:00:00",
23011,3,206038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000TOC.cfm","2015-08-07 00:00:00",
24509,21,206038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000SumR.pdf","2015-08-07 00:00:00",
40522,2,206038,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf","2016-05-20 00:00:00",
45500,1,206038,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s005ltr.pdf","2016-09-30 00:00:00",
47284,2,206038,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf","2017-02-22 00:00:00",
45277,1,206038,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s006ltr.pdf","2016-09-07 00:00:00",
52097,1,206038,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s007ltr.pdf","2018-01-30 00:00:00",
52425,2,206038,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s007lbl.pdf","2018-02-06 00:00:00",
55192,2,206038,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s010lbl.pdf","2018-08-17 00:00:00",
55211,1,206038,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s010Ltr.pdf","2018-08-20 00:00:00",
10541,1,206040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206040Orig1s000TAltr.pdf","2014-09-08 00:00:00",
32775,1,206041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206041Orig1s000TAltr.pdf","2014-09-08 00:00:00",
10542,1,206042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206042Orig1s000TAltr.pdf","2014-09-16 00:00:00",
54458,1,206049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206049Orig1s000ltr.pdf","2018-06-05 00:00:00",
50512,1,206071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206071Orig1s000ltr.pdf","2017-11-27 00:00:00",
19702,2,206073,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf","2015-09-04 00:00:00",
32776,1,206073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s000ltr.pdf","2015-02-03 00:00:00",
32777,1,206073,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf","2015-09-01 00:00:00",
40523,2,206073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s000lbl.pdf","2015-02-03 00:00:00",
43509,3,206073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000TOC.cfm","2016-04-11 00:00:00",
44937,21,206073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf","2016-04-11 00:00:00",
10543,1,206073,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s003ltr.pdf","2015-12-07 00:00:00",
19703,2,206073,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf","2015-12-08 00:00:00",
10544,1,206073,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf","2016-07-11 00:00:00",
46556,1,206073,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf","2016-12-27 00:00:00",
46641,2,206073,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf","2017-01-03 00:00:00",
47605,1,206073,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf","2017-03-20 00:00:00",
47613,2,206073,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s008lbl.pdf","2017-03-21 00:00:00",
46557,1,206073,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf","2016-12-27 00:00:00",
46640,2,206073,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf","2017-01-03 00:00:00",
49355,2,206073,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s011lbl.pdf","2017-08-14 00:00:00",
49415,1,206073,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s011ltr.pdf","2017-08-15 00:00:00",
50693,2,206073,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf","2017-12-14 00:00:00",
50694,8,206073,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf#page=31","2017-12-14 00:00:00",
50716,1,206073,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s012ltr.pdf","2017-12-15 00:00:00",
49341,2,206073,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s013lbl.pdf","2017-08-11 00:00:00",
49411,1,206073,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf","2017-08-15 00:00:00",
50989,1,206074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206074Orig1s000ltr.pdf","2018-01-08 00:00:00",
48206,1,206084,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206084Orig1s000ltr.pdf","2017-05-02 00:00:00",
48976,1,206087,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206087TA_ltr.pdf","2017-07-13 00:00:00",
19704,2,206088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf","2014-09-26 00:00:00",
24510,21,206088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000SumR.pdf","2015-04-06 00:00:00",
32778,1,206088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206088Orig1s000ltr.pdf","2014-09-24 00:00:00",
43510,3,206088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000TOC.cfm","2015-04-06 00:00:00",
49687,1,206098,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206098Orig1s000TAltr.pdf","2017-09-07 00:00:00",
10545,1,206099,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206099Orig1s000ltr.pdf","2016-01-29 00:00:00",
19705,2,206099,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206099s000lbl.pdf","2016-02-18 00:00:00",
23012,3,206099,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206099Orig1s000TOC.cfm","2016-07-19 00:00:00",
55235,1,206107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206107Orig1s000ltr.pdf","2018-08-20 00:00:00",
46658,2,206110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf","2017-01-03 00:00:00",
46668,1,206110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206110Orig1s000ltr.pdf","2017-01-05 00:00:00",
50204,3,206110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm","2017-10-27 00:00:00",
50206,3,206110,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm","2017-10-27 00:00:00",
54767,2,206110,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf","2018-07-05 00:00:00",
54829,1,206110,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206110Orig1s001ltr.pdf","2018-07-06 00:00:00",
32779,1,206111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s000ltr.pdf","2015-09-02 00:00:00",
32780,1,206111,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf","2016-07-12 00:00:00",
40524,2,206111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf","2015-09-02 00:00:00",
46077,3,206111,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206111Orig1s000TOC.cfm","2016-08-04 00:00:00",
46665,2,206111,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf","2017-01-04 00:00:00",
32781,1,206111,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s002ltr.pdf","2015-12-07 00:00:00",
40525,2,206111,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf","2015-12-08 00:00:00",
46545,2,206111,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf","2016-12-27 00:00:00",
46558,1,206111,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s004ltr.pdf","2016-12-27 00:00:00",
45357,1,206111,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf","2016-09-22 00:00:00",
46664,2,206111,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf","2017-01-04 00:00:00",
45356,1,206111,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf","2016-09-22 00:00:00",
46663,2,206111,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf","2017-01-04 00:00:00",
50688,2,206111,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf","2017-12-14 00:00:00",
50691,8,206111,"SUPPL",15,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf#page=39","2017-12-14 00:00:00",
50713,1,206111,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf","2017-12-15 00:00:00",
50045,19,206122,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=354","2017-10-12 00:00:00",
45502,1,206122,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206122Orig1s000ltr.pdf","2016-10-06 00:00:00",
52997,1,206125,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206125Orig1s000ltr.pdf","2018-04-05 00:00:00",
32782,1,206128,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206128Orig1s000ltr.pdf","2016-06-01 00:00:00",
10547,1,206129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206129Orig1s000ltr.pdf","2015-08-19 00:00:00",
40526,2,206129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206129Orig1s000lbl.pdf","2015-08-26 00:00:00",
54148,1,206133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206133Orig1s000ltr.pdf","2018-05-11 00:00:00",
45696,1,206137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206137Orig1s000ltr.pdf","2016-10-28 00:00:00",
45767,2,206137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206137s000lbl.pdf","2016-11-01 00:00:00",
10548,1,206143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206143Orig1s000ltr.pdf","2015-04-16 00:00:00",
19706,2,206143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf","2015-04-16 00:00:00",
23013,3,206143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206143Orig1s000TOC.cfm","2015-11-20 00:00:00",
46804,2,206143,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf","2017-01-11 00:00:00",
46856,1,206143,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206143Orig1s002ltr.pdf","2017-01-19 00:00:00",
46915,8,206143,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf#page=20","2017-01-19 00:00:00",
19707,2,206162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf","2014-12-19 00:00:00",
23014,3,206162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000TOC.cfm","2014-12-19 00:00:00",
24511,21,206162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000SumR.pdf","2014-12-19 00:00:00",
32783,1,206162,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206162Orig1s000ltr.pdf","2014-12-19 00:00:00",
45574,1,206162,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206162Orig1s002ltr.pdf","2016-10-20 00:00:00",
45684,2,206162,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206162s002lbl.pdf","2016-10-28 00:00:00",
46996,2,206162,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s003lbl.pdf","2017-01-26 00:00:00",
47016,1,206162,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s003ltr.pdf","2017-01-30 00:00:00",
49495,1,206162,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s007ltr.pdf","2017-08-21 00:00:00",
49500,2,206162,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s007lbl.pdf","2017-08-22 00:00:00",
50128,2,206162,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf","2017-10-23 00:00:00",
50129,8,206162,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf#page=16","2017-10-23 00:00:00",
50212,1,206162,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s008ltr.pdf","2017-10-30 00:00:00",
55750,1,206162,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206162Orig1s011ltr.pdf","2018-10-01 00:00:00",
55816,2,206162,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf","2018-10-04 00:00:00",
55817,8,206162,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16","2018-10-04 00:00:00",
32784,1,206163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206163Orig1s000ltr.pdf","2016-07-01 00:00:00",
40527,2,206163,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206163ORig1s000lbl.pdf","2016-07-18 00:00:00",
54894,1,206166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206166Orig1s000ltr.pdf","2018-07-16 00:00:00",
45328,1,206174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206174Orig1s000ltr.pdf","2016-09-15 00:00:00",
55482,1,206185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206185Orig1s000ltr.pdf","2018-09-14 00:00:00",
55483,2,206185,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206185s000lbl.pdf","2018-09-14 00:00:00",
10549,1,206192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206192Orig1s000Ltr.pdf","2015-11-10 00:00:00",
19708,2,206192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf","2015-11-10 00:00:00",
23015,3,206192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000TOC.cfm","2015-12-08 00:00:00",
32785,1,206192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206192Orig1s001ltr.pdf","2016-06-01 00:00:00",
40528,2,206192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf","2016-06-01 00:00:00",
44938,21,206192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000SumR.pdf","2015-12-08 00:00:00",
52086,2,206192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206192s002lbl.pdf","2018-01-30 00:00:00",
52128,1,206192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206192Orig1s002ltr.pdf","2018-01-30 00:00:00",
19709,2,206197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf","2016-06-13 00:00:00",
32786,1,206197,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206197Orig1s000ltr.pdf","2016-06-10 00:00:00",
45481,1,206214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206214Orig1s000ltr.pdf","2016-09-27 00:00:00",
45611,2,206214,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206214Orig1s000lbl.pdf","2016-10-12 00:00:00",
51074,1,206223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206223Orig1s000ltr.pdf","2018-01-17 00:00:00",
10550,1,206229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206229Orig1s000ltr.pdf","2015-03-11 00:00:00",
10551,1,206229,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206229Orig1s001ltr.pdf","2016-02-01 00:00:00",
40529,2,206229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206229s000lbl.pdf","2015-03-18 00:00:00",
40530,2,206229,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206229s001lbl.pdf","2016-02-02 00:00:00",
46073,3,206229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206229Orig1s000TOC.cfm","2016-09-28 00:00:00",
51298,20,206229,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206229 levonorgestrel clinical prea.pdf","1900-01-01 00:00:00",
51299,18,206229,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206229 levonorgestrel clinpharm prea.pdf","1900-01-01 00:00:00",
51300,62,206229,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206229 levonorgestrel clinpharm prea2.pdf","1900-01-01 00:00:00",
51301,17,206229,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206229 levonorgestrel statistical prea.pdf","1900-01-01 00:00:00",
49249,2,206229,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206229s004lbl.pdf","2017-08-04 00:00:00",
49261,1,206229,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206229Orig1s004ltr.pdf","2017-08-07 00:00:00",
10552,1,206243,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206243Orig1s000ltr.pdf","2015-12-30 00:00:00",
46107,1,206251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206251Orig1s000ltr.pdf","2016-12-09 00:00:00",
10553,1,206255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206255Orig1s000ltr.pdf","2014-12-24 00:00:00",
23016,3,206255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000TOC.cfm","2016-03-23 00:00:00",
24512,21,206255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000SumR.pdf","2016-03-23 00:00:00",
40531,2,206255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206255lbl.pdf","2015-01-08 00:00:00",
53748,2,206255,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206255s004lbl.pdf","2018-04-20 00:00:00",
53785,1,206255,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206255Orig1s004ltr.pdf","2018-04-23 00:00:00",
23017,3,206256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206256Orig1s000TOC.cfm","2014-08-05 00:00:00",
32787,1,206256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206256Orig1s000ltr.pdf","2014-07-03 00:00:00",
40532,2,206256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206256lbl.pdf","2014-07-02 00:00:00",
44939,21,206256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206256Orig1s000SumR.pdf","2014-08-05 00:00:00",
48003,2,206256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206256s002lbl.pdf","2017-04-13 00:00:00",
48035,1,206256,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206256Orig1s002ltr.pdf","2017-04-14 00:00:00",
48367,1,206260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206260Orig1s000ltr.pdf","2017-05-12 00:00:00",
48376,2,206260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206260Orig1s000lbl.pdf","2017-05-15 00:00:00",
19710,2,206263,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206263Orig1s000lbl.pdf","2016-06-21 00:00:00",
32788,1,206271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206271Orig1s000ltr.pdf","2015-11-13 00:00:00",
40533,2,206271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206271Orig1s000lbl.pdf","2015-11-25 00:00:00",
10554,1,206276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206276Orig1s000ltr.pdf","2015-02-11 00:00:00",
19711,2,206276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206276s000lbl.pdf","2015-03-27 00:00:00",
23018,3,206276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206276Orig1s000TOC.cfm","2015-04-13 00:00:00",
43511,3,206276,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206276Orig1s001.pdf","2016-02-03 00:00:00",
51446,20,206276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206276 olopatadine clinical bpca (2).pdf","1900-01-01 00:00:00",
51447,18,206276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206276 olopatadine clinpharm bpca.pdf","1900-01-01 00:00:00",
51448,17,206276,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206276 olopatadine statistical bpca.pdf","1900-01-01 00:00:00",
54455,1,206285,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206285Orig1s000ltr.pdf","2018-06-05 00:00:00",
32789,1,206286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206286Orig1s000TAltr.pdf","2015-10-20 00:00:00",
54454,1,206286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206286Orig1s000ltr.pdf","2018-06-05 00:00:00",
32790,1,206287,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206287Orig1s000ltr.pdf","2016-05-26 00:00:00",
50995,1,206288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206288Orig1s000TAltr.pdf","2018-01-08 00:00:00",
19712,2,206289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf","2014-07-23 00:00:00",
32791,1,206289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf","2014-07-23 00:00:00",
43512,3,206289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000TOC.cfm","2015-04-07 00:00:00",
44940,21,206289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000SumR.pdf","2015-04-07 00:00:00",
51755,20,206289,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/82_206289 atropine clinical prea.pdf","1900-01-01 00:00:00",
51756,18,206289,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/83_206289 atropine clinpharm prea.pdf","1900-01-01 00:00:00",
51757,17,206289,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/84_206289 atropine statistical prea.pdf","1900-01-01 00:00:00",
10555,1,206297,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206297Orig1s000ltr.pdf","2015-08-12 00:00:00",
32792,1,206298,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206298Orig1s000ltr.pdf","2016-05-04 00:00:00",
32793,1,206302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206302Orig1s000ltr.pdf","2016-06-06 00:00:00",
40534,2,206302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206302s000lbl.pdf","2016-06-06 00:00:00",
45269,3,206302,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206302Orig1ByvalsonTOC.cfm","2016-09-12 00:00:00",
32794,1,206306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206306Orig1s000ltr.pdf","2015-12-09 00:00:00",
10556,1,206307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206307Orig1s000ltr.pdf","2014-12-19 00:00:00",
19713,2,206307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf","2014-12-19 00:00:00",
43513,3,206307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000TOC.cfm","2015-01-14 00:00:00",
44941,21,206307,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000SumR.pdf","2015-01-14 00:00:00",
51106,20,206307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin clinical bpca.pdf","1900-01-01 00:00:00",
51107,18,206307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin ClinPharm bpca.pdf","1900-01-01 00:00:00",
51108,17,206307,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin Statistical bpca.pdf","1900-01-01 00:00:00",
48828,1,206308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206308Orig1s000ltr.pdf","2017-06-26 00:00:00",
10557,1,206316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf","2015-01-09 00:00:00",
32795,1,206316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s000ltr.pdf","2015-01-09 00:00:00",
40535,2,206316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf","2015-01-09 00:00:00",
43514,3,206316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm","2015-02-13 00:00:00",
43558,5,206316,"ORIG",1,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm","2015-01-09 00:00:00",
44942,21,206316,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf","2015-02-13 00:00:00",
10558,1,206316,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s002ltr.pdf","2015-09-14 00:00:00",
40536,2,206316,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316s002lbl.pdf","2015-09-11 00:00:00",
45281,1,206316,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206316Orig1s004ltr.pdf","2016-09-19 00:00:00",
45300,2,206316,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206316s004lbl.pdf","2016-09-20 00:00:00",
49908,1,206316,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206316Orig1s012ltr.pdf","2017-10-02 00:00:00",
49911,2,206316,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf","2017-10-02 00:00:00",
49941,8,206316,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf#page=32","2017-10-04 00:00:00",
10559,1,206317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206317Orig1s000ltr.pdf","2015-01-26 00:00:00",
19714,2,206317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206317s000lbl.pdf","2015-01-29 00:00:00",
43515,3,206317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000TOC.cfm","2016-03-02 00:00:00",
44943,21,206317,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000SumR.pdf","2016-03-02 00:00:00",
50062,2,206317,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206317s009lbl.pdf","2017-10-17 00:00:00",
50111,1,206317,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206317Orig1s009ltr.pdf","2017-10-19 00:00:00",
53574,2,206317,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206317s010lbl.pdf","2018-04-01 00:00:00",
53580,1,206317,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206317Orig1s010ltr.pdf","2018-04-01 00:00:00",
10560,1,206321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf","2014-12-31 00:00:00",
19715,2,206321,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf","2015-04-01 00:00:00",
32796,1,206321,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf","2015-03-31 00:00:00",
40537,2,206321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf","2014-12-31 00:00:00",
43516,3,206321,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000TOC.cfm","2015-10-01 00:00:00",
44600,14,206321,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=342","2014-12-31 00:00:00",
32797,1,206321,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf","2016-02-02 00:00:00",
45412,2,206321,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf","2016-09-29 00:00:00",
45520,1,206321,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s003ltr.pdf","2016-10-12 00:00:00",
48123,2,206321,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf","2017-04-27 00:00:00",
48125,8,206321,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf#page=26","2017-04-27 00:00:00",
48208,1,206321,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf","2017-05-02 00:00:00",
48614,1,206321,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s005ltredt.pdf","2017-06-01 00:00:00",
48124,2,206321,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf","2017-04-27 00:00:00",
48126,8,206321,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf#page=26","2017-04-27 00:00:00",
48207,1,206321,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf","2017-05-02 00:00:00",
10561,1,206323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206323Orig1s000ltr.pdf","2015-06-26 00:00:00",
40538,2,206323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206323s000lbl.pdf","2015-06-24 00:00:00",
43517,3,206323,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206323Orig1s000TOC.cfm","2016-05-25 00:00:00",
45571,2,206323,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206323s002lbl.pdf","2016-10-21 00:00:00",
46865,2,206323,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf","2017-01-13 00:00:00",
46891,1,206323,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206323Orig1s004ltr.pdf","2017-01-18 00:00:00",
49605,2,206323,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf","2017-08-30 00:00:00",
49637,1,206323,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206323Orig1s005ltr.pdf","2017-08-31 00:00:00",
54768,2,206323,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf","2018-07-05 00:00:00",
54806,8,206323,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf#page=28","2018-07-06 00:00:00",
54833,1,206323,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206323Orig1s006ltr.pdf","2018-07-06 00:00:00",
24513,21,206333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000SumR.pdf","2015-05-28 00:00:00",
32798,1,206333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206333Orig1s000ltr.pdf","2015-04-29 00:00:00",
40539,2,206333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf","2015-04-29 00:00:00",
43518,3,206333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000TOC.cfm","2015-05-28 00:00:00",
51087,2,206333,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206333s001lbl.pdf","2018-01-18 00:00:00",
51867,1,206333,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206333Orig1s001ltr.pdf","2018-01-26 00:00:00",
19716,2,206334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf","2014-08-08 00:00:00",
32799,1,206334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206334Orig1s000ltr.pdf","2014-08-07 00:00:00",
43519,3,206334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000TOC.cfm","2014-09-05 00:00:00",
44944,21,206334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000SumR.pdf","2014-09-05 00:00:00",
10562,1,206334,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s002ltr.pdf","2016-01-21 00:00:00",
40540,2,206334,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s002lbl.pdf","2016-01-26 00:00:00",
45561,1,206334,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s003ltr.pdf","2016-10-19 00:00:00",
47277,2,206334,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s003lbl.pdf","2017-02-22 00:00:00",
53250,2,206334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206334s004lbl.pdf","2018-03-23 00:00:00",
53492,1,206334,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206334Orig1s004ltr.pdf","2018-03-28 00:00:00",
32800,1,206336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206336Orig1s000ltr.pdf","2015-09-10 00:00:00",
53614,1,206348,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206348Orig1s000ltr.pdf","2018-04-05 00:00:00",
10563,1,206352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf","2014-06-03 00:00:00",
19717,2,206352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf","2014-06-03 00:00:00",
23019,3,206352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm","2015-04-07 00:00:00",
24514,21,206352,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf","2015-04-07 00:00:00",
51737,20,206352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000,021567Orig1s035_Atazanavir_Clinical.pdf","1900-01-01 00:00:00",
51741,18,206352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Clinpharm.pdf","1900-01-01 00:00:00",
51744,17,206352,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352Orig1s000, 021567Orig1s035_Atazanavir_Statistical.pdf","1900-01-01 00:00:00",
10564,1,206352,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf","2015-04-01 00:00:00",
40541,2,206352,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf","2015-04-02 00:00:00",
19718,2,206352,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf","2015-12-10 00:00:00",
32801,1,206352,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf","2015-09-28 00:00:00",
51740,20,206352,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir clinical both.pdf","1900-01-01 00:00:00",
51745,18,206352,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir clinpharm both.pdf","1900-01-01 00:00:00",
51748,17,206352,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206352 atazanavir statistical both.pdf","1900-01-01 00:00:00",
45306,2,206352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf","2016-09-15 00:00:00",
45338,1,206352,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf","2016-09-20 00:00:00",
48527,1,206352,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s040,206352Orig1s005ltr.pdf","2017-05-25 00:00:00",
48541,2,206352,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf","2017-05-25 00:00:00",
50141,1,206352,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s041,206352Orig1s006ltr.pdf","2017-10-23 00:00:00",
50166,2,206352,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf","2017-10-24 00:00:00",
53741,2,206352,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf","2018-04-19 00:00:00",
53768,1,206352,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021567Orig1s042,206352Orig1s007ltr.pdf","2018-04-20 00:00:00",
10565,1,206353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s000ltr.pdf","2015-02-02 00:00:00",
10566,1,206353,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s001ltr.pdf","2015-07-24 00:00:00",
19719,2,206353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf","2015-01-30 00:00:00",
23020,3,206353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000TOC.cfm","2016-04-15 00:00:00",
24515,21,206353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000SumR.pdf","2016-04-15 00:00:00",
40542,2,206353,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s001lbl.pdf","2015-07-24 00:00:00",
10567,1,206353,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206353Orig1s002ltr.pdf","2016-07-05 00:00:00",
40543,2,206353,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206353s002lbl.pdf","2016-07-05 00:00:00",
47018,1,206353,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206353Orig1s003ltr.pdf","2017-01-30 00:00:00",
47022,2,206353,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206353s003lbl.pdf","2017-01-30 00:00:00",
53739,2,206353,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206353s005lbl.pdf","2018-04-19 00:00:00",
53770,1,206353,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206353Orig1s005ltr.pdf","2018-04-23 00:00:00",
10568,1,206356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206356Orig1s000ltr.pdf","2016-04-26 00:00:00",
40544,2,206356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s000lbl.pdf","2016-04-27 00:00:00",
46621,3,206356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206356Orig1_toc.cfm","2016-12-30 00:00:00",
46622,21,206356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206356Orig1s000SumR.pdf","2016-12-30 00:00:00",
45182,1,206356,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206356Orig1s002ltr.pdf","2016-08-30 00:00:00",
45205,2,206356,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s002lbl.pdf","2016-08-30 00:00:00",
49662,2,206356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206356s003lbl.pdf","2017-09-05 00:00:00",
49675,1,206356,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206356Orig1s003ltr.pdf","2017-09-06 00:00:00",
32802,1,206367,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206367Orig1s000ltr.pdf","2015-12-16 00:00:00",
19720,2,206369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206369Orig1s000lbl.pdf","2015-10-22 00:00:00",
32803,1,206369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206369Orig1s000ltr.pdf","2015-09-04 00:00:00",
49843,1,206391,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206391Orig1s000ltr.pdf","2017-09-22 00:00:00",
10569,1,206406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s000ltr.pdf","2015-07-14 00:00:00",
32804,1,206406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206406Orig1s000TAltr.pdf","2014-11-04 00:00:00",
32805,1,206406,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s001ltr.pdf","2015-08-13 00:00:00",
40545,2,206406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s000lbl.pdf","2015-07-13 00:00:00",
40546,2,206406,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s001lbl.pdf","2015-08-13 00:00:00",
46454,3,206406,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1_toc.cfm","2016-12-21 00:00:00",
32806,1,206406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206406Orig1s003ltr.pdf","2016-06-24 00:00:00",
40547,2,206406,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206406s003lbl.pdf","2016-06-23 00:00:00",
48782,1,206409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206409Orig1s000ltr.pdf","2017-06-20 00:00:00",
32807,1,206422,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206422Orig1s000ltr.pdf","2015-09-04 00:00:00",
32808,1,206426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206426Orig1s000ltr.pdf","2014-12-23 00:00:00",
40548,2,206426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf","2015-01-08 00:00:00",
43520,3,206426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000TOC.cfm","2015-01-16 00:00:00",
44945,21,206426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000SumR.pdf","2015-01-16 00:00:00",
45074,2,206426,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf","2016-08-17 00:00:00",
45125,1,206426,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206426Orig1s003ltr.pdf","2016-08-12 00:00:00",
49832,2,206426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206426s004lbl.pdf","2017-09-22 00:00:00",
49836,1,206426,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206426Orig1s004ltr.pdf","2017-09-22 00:00:00",
51546,20,206426,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/188_206426S4 peramivir CDTL statistical prea.pdf","1900-01-01 00:00:00",
51547,18,206426,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/189_206426S4 peramivir clinpharm prea.pdf","1900-01-01 00:00:00",
53543,17,206426,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/188_206426S4 peramivir CDTL statistical prea.pdf","1900-01-01 00:00:00",
54021,2,206426,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206426s005lbl.pdf","2018-05-04 00:00:00",
54041,1,206426,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206426Orig1s005ltr.pdf","2018-05-08 00:00:00",
46027,1,206433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206433Orig1s000ltr.pdf","2016-12-06 00:00:00",
10570,1,206439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206439Orig1s000ltr.pdf","2014-12-30 00:00:00",
24516,21,206439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000SumR.pdf","2015-05-14 00:00:00",
40549,2,206439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206439lbl.pdf","2015-01-08 00:00:00",
43521,3,206439,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000TOC.cfm","2015-05-14 00:00:00",
10571,1,206439,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206439Orig1s003ltr.pdf","2016-07-19 00:00:00",
19721,2,206439,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206439s003lbl.pdf","2016-07-21 00:00:00",
10572,1,206448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206448Orig1s000ltr.pdf","2015-10-21 00:00:00",
19722,2,206448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206448Orig1s000lbl.pdf","2015-11-25 00:00:00",
50239,1,206451,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206451Orig1s000TAltr.pdf","2017-10-31 00:00:00",
32809,1,206456,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206456Orig1s000ltr.pdf","2015-06-18 00:00:00",
10573,1,206473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206473Orig1s000ltr.pdf","2015-06-22 00:00:00",
23021,3,206473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206473Orig1s000TOC.cfm","2016-07-19 00:00:00",
40550,2,206473,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206473s000lbl.pdf","2015-06-19 00:00:00",
50785,1,206473,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206473Orig1s001ltr.pdf","2017-12-20 00:00:00",
50833,2,206473,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206473s001lbl.pdf","2017-12-22 00:00:00",
55274,2,206473,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206473s002lbl.pdf","2018-08-23 00:00:00",
55312,1,206473,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206473Orig1s002Ltr.pdf","2018-08-24 00:00:00",
45365,1,206488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206488Orig1s000ltr.pdf","2016-09-19 00:00:00",
45366,2,206488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206488lbl.pdf","2016-09-19 00:00:00",
45367,21,206488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary review_Redacted.pdf","2016-09-19 00:00:00",
45640,3,206488,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_TOC.cfm","2016-10-26 00:00:00",
52524,2,206488,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206488s006lbl.pdf","2018-02-09 00:00:00",
52544,1,206488,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206488Orig1s006ltr.pdf","2018-02-09 00:00:00",
54298,3,206488,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/206488Orig1s006.pdf","2018-05-22 00:00:00",
10574,1,206493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206493Orig1s000ltr.pdf","2015-12-07 00:00:00",
24517,21,206494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000SumR.pdf","2015-03-12 00:00:00",
32810,1,206494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494Orig1s000ltr.pdf","2015-02-27 00:00:00",
32811,1,206494,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494orig1s001ltr.pdf","2015-09-04 00:00:00",
40551,2,206494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s000lbl.pdf","2015-02-27 00:00:00",
40552,2,206494,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s001lbl.pdf","2015-09-04 00:00:00",
43522,3,206494,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000TOC.cfm","2015-03-12 00:00:00",
32812,1,206494,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206494Orig1s002ltr.pdf","2016-06-23 00:00:00",
40553,2,206494,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206494s002lbl.pdf","2016-06-23 00:00:00",
46994,2,206494,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206494s003lbl.pdf","2017-01-26 00:00:00",
47015,1,206494,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206494Orig1s003ltr.pdf","2017-01-30 00:00:00",
52267,2,206494,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206494s004lbl.pdf","2018-02-02 00:00:00",
52279,1,206494,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206494Orig1s004ltr.pdf","2018-02-02 00:00:00",
10575,1,206500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206500Orig1s000ltr.pdf","2015-09-02 00:00:00",
19723,2,206500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206500s000lbl.pdf","2015-09-02 00:00:00",
23022,3,206500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206500Orig1s000TOC.cfm","2015-10-09 00:00:00",
24518,21,206500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206500Orig1s000SumR.pdf","2015-10-09 00:00:00",
53686,2,206500,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206500s003,208399s002lbl.pdf","2018-04-16 00:00:00",
53698,1,206500,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206500Orig1s003,208399Orig1s002ltr.pdf","2018-04-16 00:00:00",
10576,1,206510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206510Orig1s000ltr.pdf","2015-02-12 00:00:00",
23023,3,206510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206510Orig1s000TOC.cfm","2016-04-11 00:00:00",
40554,2,206510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206510lbl.pdf","2015-02-10 00:00:00",
44946,21,206510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206510Orig1s000SumR.pdf","2016-04-11 00:00:00",
32813,1,206511,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206511Orig1s000ltr.pdf","2015-09-08 00:00:00",
48287,1,206515,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206515Orig1s000ltr.pdf","2017-05-09 00:00:00",
32814,1,206530,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206530Orig1s000ltr.pdf","2015-12-30 00:00:00",
49367,1,206534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206534Orig1s000ltr.pdf","2017-08-15 00:00:00",
10577,1,206538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf","2015-02-27 00:00:00",
24519,21,206538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000SumR.pdf","2016-03-02 00:00:00",
40555,2,206538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf","2015-02-27 00:00:00",
43523,3,206538,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000TOC.cfm","2016-03-02 00:00:00",
49434,2,206538,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s001lbl.pdf","2017-08-16 00:00:00",
53455,2,206538,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf","2018-03-27 00:00:00",
53517,1,206538,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206538Orig1s006ltr.pdf","2018-03-29 00:00:00",
10578,1,206544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206544Orig1s000ltr.pdf","2015-10-09 00:00:00",
10579,1,206544,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s001ltr.pdf","2016-04-22 00:00:00",
24128,14,206544,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-10-16 00:00:00",
40556,2,206544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206544lbl.pdf","2015-10-09 00:00:00",
44601,14,206544,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-04 00:00:00",
46065,3,206544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000TOC.cfm","2016-10-20 00:00:00",
46066,21,206544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000SumR.pdf","2016-10-20 00:00:00",
46322,2,206544,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf","2016-12-20 00:00:00",
46439,1,206544,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf","2016-12-21 00:00:00",
45453,1,206544,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s004ltr.pdf","2016-10-03 00:00:00",
46323,2,206544,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf","2016-12-20 00:00:00",
46440,1,206544,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf","2016-12-21 00:00:00",
48592,1,206544,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206544Orig1s006ltr.pdf","2017-05-31 00:00:00",
54424,2,206544,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf","2018-06-04 00:00:00",
54425,8,206544,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf#page=35","2018-06-04 00:00:00",
54426,1,206544,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s007ltr.pdf","2018-06-04 00:00:00",
55542,2,206544,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf","2018-09-21 00:00:00",
55544,8,206544,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf#page=36","2018-09-21 00:00:00",
55676,1,206544,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf","2018-10-01 00:00:00",
55543,2,206544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf","2018-09-21 00:00:00",
55545,8,206544,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf#page=36","2018-09-21 00:00:00",
55677,1,206544,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf","2018-10-01 00:00:00",
19724,2,206545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf","2014-07-23 00:00:00",
24520,21,206545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206545Orig1s000SumR.pdf","2014-08-13 00:00:00",
32815,1,206545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206545Orig1s000ltr.pdf","2014-07-23 00:00:00",
43524,3,206545,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206545Orig1s000TOC.cfm","2014-08-13 00:00:00",
44602,14,206545,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321","2014-08-01 00:00:00",
10580,1,206551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000TAltr.pdf","2016-05-04 00:00:00",
50511,1,206551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000ltr.pdf","2017-11-27 00:00:00",
10581,1,206552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206552Orig1s000ltr.pdf","2016-06-14 00:00:00",
19725,2,206552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206552Orig1s000lbl.pdf","2016-06-17 00:00:00",
49035,1,206561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206561Orig1s000ltr.pdf","2017-07-21 00:00:00",
49083,2,206561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206561Orig1s000lbl.pdf","2017-07-26 00:00:00",
54818,1,206575,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206575Orig1s000TAltr.pdf","2018-07-06 00:00:00",
19726,2,206581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206581Orig1s000lbl.pdf","2015-08-06 00:00:00",
32816,1,206581,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206581Orig1s000ltr.pdf","2015-08-06 00:00:00",
50730,1,206582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206582Orig1s000TAltr.pdf","2017-12-18 00:00:00",
10582,1,206586,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206586Orig1s000ltr.pdf","2015-07-30 00:00:00",
54893,1,206608,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206608Orig1s000ltr.pdf","2018-07-16 00:00:00",
23024,3,206619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000TOC.cfm","2015-01-23 00:00:00",
32817,1,206619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206619Orig1s000ltr.pdf","2014-12-23 00:00:00",
40557,2,206619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206619lbl.pdf","2014-12-23 00:00:00",
44947,21,206619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000SumR.pdf","2015-01-23 00:00:00",
32818,1,206619,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s003ltr.pdf","2015-03-26 00:00:00",
40558,2,206619,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf","2015-03-26 00:00:00",
10583,1,206619,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s005ltr.pdf","2015-07-22 00:00:00",
19727,2,206619,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf","2015-07-22 00:00:00",
19728,2,206619,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s006lbl.pdf","2015-10-15 00:00:00",
32819,1,206619,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s006ltr.pdf","2015-10-14 00:00:00",
10584,1,206619,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s008ltr.pdf","2015-10-26 00:00:00",
40559,2,206619,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf","2015-10-23 00:00:00",
10585,1,206619,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s009ltr.pdf","2016-04-26 00:00:00",
40560,2,206619,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s009lbl.pdf","2016-04-27 00:00:00",
10586,1,206619,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s010ltr.pdf","2016-01-29 00:00:00",
40561,2,206619,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s010lbl.pdf","2016-02-01 00:00:00",
10587,1,206619,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s011ltr.pdf","2016-06-23 00:00:00",
40562,2,206619,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619Orig1s011lbl.pdf","2016-06-23 00:00:00",
47648,2,206619,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf","2017-03-23 00:00:00",
47675,1,206619,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s013,206619Orig1s015ltr.pdf","2017-03-24 00:00:00",
47212,2,206619,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s014lbl.pdf","2017-02-15 00:00:00",
47219,1,206619,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s014ltr.pdf","2017-02-15 00:00:00",
47649,2,206619,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf","2017-03-23 00:00:00",
47674,1,206619,"SUPPL",15,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s013,206619Orig1s015ltr.pdf","2017-03-24 00:00:00",
50378,1,206619,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s017ltr.pdf","2017-11-13 00:00:00",
50396,2,206619,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s017lbl.pdf","2017-11-13 00:00:00",
54975,1,206619,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206619Orig1s018ltr.pdf","2018-07-25 00:00:00",
55357,2,206619,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206619s018lbl.pdf","2018-08-29 00:00:00",
55360,8,206619,"SUPPL",18,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206619s018lbl.pdf#page=50","2018-08-29 00:00:00",
10588,1,206623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206623Orig1s000ltr.pdf","2016-04-11 00:00:00",
24129,14,206627,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-04 00:00:00",
24130,14,206627,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2014-12-11 00:00:00",
24521,21,206627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000SumR.pdf","2015-04-07 00:00:00",
32820,1,206627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206627Orig1s000ltr.pdf","2014-11-20 00:00:00",
32821,1,206627,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206627Orig1s001ltr.pdf","2015-07-08 00:00:00",
40563,2,206627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206627s000lbl.pdf","2014-11-20 00:00:00",
43525,3,206627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000TOC.cfm","2015-04-07 00:00:00",
43559,5,206627,"ORIG",1,"0","http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm","2014-11-20 00:00:00",
44433,10,206627,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm420978.htm","2014-11-20 00:00:00",
32822,1,206627,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s003ltr.pdf","2016-04-22 00:00:00",
46319,2,206627,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf","2016-12-20 00:00:00",
46443,1,206627,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s004ltr.pdf","2016-12-21 00:00:00",
46580,8,206627,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf#page=35","2016-12-29 00:00:00",
45452,1,206627,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s005ltr.pdf","2016-10-03 00:00:00",
48588,1,206627,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206627Orig1s006ltr.pdf","2017-05-31 00:00:00",
55538,2,206627,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf","2018-09-21 00:00:00",
55540,8,206627,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf#page=36","2018-09-21 00:00:00",
55686,1,206627,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206627Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
55539,2,206627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf","2018-09-21 00:00:00",
55541,8,206627,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf#page=36","2018-09-21 00:00:00",
55687,1,206627,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206627Orig1s007s008ltr.pdf","2018-10-01 00:00:00",
10589,1,206628,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206628Orig1s000ltr.pdf","2015-10-23 00:00:00",
19729,2,206628,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206628s000lbl.pdf","2015-10-26 00:00:00",
43526,3,206628,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206628Orig1s000TOC.cfm","2016-05-27 00:00:00",
45352,1,206628,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206628Orig1s002ltr.pdf","2016-09-21 00:00:00",
45380,2,206628,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206628s002lbl.pdf","2016-09-21 00:00:00",
49481,1,206641,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206641Orig1s000ltr.pdf","2017-08-21 00:00:00",
50041,19,206647,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=360","2017-10-12 00:00:00",
48654,1,206649,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206649Orig1s000TAltr.pdf","2017-06-06 00:00:00",
10590,1,206674,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206674Orig1s000ltr.pdf","2016-02-12 00:00:00",
10591,1,206679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206679Orig1s000ltr.pdf","2016-04-28 00:00:00",
19730,2,206679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206679s000lbl.pdf","2016-04-27 00:00:00",
46045,3,206679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206679Orig1s000TOC.cfm","2016-10-20 00:00:00",
46048,21,206679,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206679Orig1s000SumR.pdf","2016-10-20 00:00:00",
49950,2,206679,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206679s002lbl.pdf","2017-10-05 00:00:00",
49974,1,206679,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206679Orig1s002ltr.pdf","2017-10-06 00:00:00",
55332,2,206685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206685Orig1s000Lbl.pdf","2018-08-27 00:00:00",
55408,1,206685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206685Orig1s000ltr.pdf","2018-09-07 00:00:00",
55250,2,206709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf","2018-08-21 00:00:00",
55251,8,206709,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17","2018-08-21 00:00:00",
55327,1,206709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206709Orig1s000,207223Orig1s000Ltr.pdf","2018-08-27 00:00:00",
55461,3,206709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000TOC.cfm","2018-09-12 00:00:00",
48901,1,206713,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206713Orig1s000ltr.pdf","2017-07-05 00:00:00",
10592,1,206756,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s001ltr.pdf","2015-06-18 00:00:00",
19731,2,206756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf","2015-05-21 00:00:00",
19732,2,206756,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756s001lbl.pdf","2015-06-19 00:00:00",
32823,1,206756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s000ltr.pdf","2015-05-21 00:00:00",
43527,3,206756,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206756Orig1s000TOC.cfm","2016-06-27 00:00:00",
19733,2,206756,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf","2016-03-22 00:00:00",
32824,1,206756,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s002ltr.pdf","2016-03-22 00:00:00",
10593,1,206756,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s006ltr.pdf","2016-06-10 00:00:00",
19734,2,206756,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf","2016-06-13 00:00:00",
47262,8,206756,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf#page=14","2017-02-17 00:00:00",
55848,2,206756,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206756s009lbl.pdf","2018-10-05 00:00:00",
48113,1,206763,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205391Orig1s000ltr.pdf","2017-04-26 00:00:00",
19735,2,206769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206769s000lbl.pdf","2014-12-16 00:00:00",
23025,3,206769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000TOC.cfm","2015-01-27 00:00:00",
32826,1,206769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206769Orig1s000ltr.pdf","2014-12-17 00:00:00",
44948,21,206769,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000SumR.pdf","2015-01-27 00:00:00",
32827,1,206769,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206769Orig1s002ltr.pdf","2016-05-27 00:00:00",
40564,2,206769,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206769s002lbl.pdf","2016-06-01 00:00:00",
49537,2,206769,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206769s003lbl.pdf","2017-08-25 00:00:00",
49548,1,206769,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206769Orig1s003ltr.pdf","2017-08-28 00:00:00",
10594,1,206781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206781Orig1s000ltr.pdf","2015-12-03 00:00:00",
32828,1,206792,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206792Orig1s000ltr.pdf","2016-05-16 00:00:00",
19736,2,206814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.pdf","2014-12-23 00:00:00",
32829,1,206814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206814Orig1s000ltr.pdf","2014-12-30 00:00:00",
43528,3,206814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000TOC.cfm","2015-03-10 00:00:00",
44949,21,206814,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000SumR.pdf","2015-03-10 00:00:00",
49574,1,206822,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206822Orig1s000ltr.pdf","2017-08-29 00:00:00",
10595,1,206826,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206826MGLtr.pdf","2015-10-02 00:00:00",
10596,1,206827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206827Orig1s000ltr.pdf","2016-02-03 00:00:00",
40565,2,206827,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206827Orig1s000lbl.pdf","2016-02-11 00:00:00",
10597,1,206829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206829Orig1s000ltr.pdf","2014-12-23 00:00:00",
10598,1,206829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206829Orig1s001ltr.pdf","2015-05-22 00:00:00",
23026,3,206829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000TOC.cfm","2015-01-27 00:00:00",
40566,2,206829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf","2014-12-22 00:00:00",
40567,2,206829,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206829s001lbl.pdf","2015-05-20 00:00:00",
44950,21,206829,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000SumR.pdf","2015-01-27 00:00:00",
45237,1,206829,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s002ltr.pdf","2016-09-06 00:00:00",
45241,2,206829,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206829s002lbl.pdf","2016-09-06 00:00:00",
45697,1,206829,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s003ltr.pdf","2016-10-28 00:00:00",
45768,2,206829,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206829s003lbl.pdf","2016-11-01 00:00:00",
10599,1,206843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206843Orig1s000ltr.pdf","2015-07-28 00:00:00",
10600,1,206843,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s001ltr.pdf","2016-02-09 00:00:00",
19737,2,206843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843Orig1s000lbl.pdf","2015-07-30 00:00:00",
19738,2,206843,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf","2016-02-25 00:00:00",
23027,3,206843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206843Orig1s000TOC.cfm","2015-08-28 00:00:00",
44951,21,206843,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf","2016-03-03 00:00:00",
45164,3,206843,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm","2016-08-24 00:00:00",
32830,1,206843,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s002ltr.pdf","2016-02-09 00:00:00",
40568,2,206843,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf","2016-02-25 00:00:00",
10601,1,206843,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s003ltr.pdf","2016-02-09 00:00:00",
40569,2,206843,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf","2016-02-25 00:00:00",
44952,21,206843,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf","2016-03-03 00:00:00",
45165,3,206843,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm","2016-08-24 00:00:00",
19739,2,206843,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf","2016-04-14 00:00:00",
47221,1,206843,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206843Orig1s006ltr.pdf","2017-02-15 00:00:00",
47250,2,206843,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf","2017-02-16 00:00:00",
50381,1,206843,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206843Orig1s007ltr.pdf","2017-11-13 00:00:00",
50400,2,206843,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s007lbl.pdf","2017-11-14 00:00:00",
32831,1,206845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206845Orig1s000ltr.pdf","2016-03-14 00:00:00",
45738,1,206858,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206858Orig1s000TAltr.pdf","2016-11-01 00:00:00",
48837,1,206869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206869Orig1s000ltr.pdf","2017-06-27 00:00:00",
50994,1,206877,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206877Orig1s000TAltr.pdf","2018-01-08 00:00:00",
45699,1,206884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206884Orig1s000ltr.pdf","2016-10-28 00:00:00",
10602,1,206901,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206901Orig1s000ltr.pdf","2016-01-08 00:00:00",
10603,1,206910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s000ltr.pdf","2015-04-03 00:00:00",
32832,1,206910,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf","2015-10-26 00:00:00",
40570,2,206910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf","2015-04-07 00:00:00",
40571,2,206910,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf","2015-10-26 00:00:00",
46076,3,206910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206910Orig1s000TOC.cfm","2016-08-04 00:00:00",
32833,1,206910,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf","2015-10-26 00:00:00",
40572,2,206910,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf","2015-10-26 00:00:00",
45081,2,206910,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf","2016-08-17 00:00:00",
45122,1,206910,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206910Orig1s004ltr.pdf","2016-08-12 00:00:00",
52117,2,206910,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s005lbl.pdf","2018-01-30 00:00:00",
52129,1,206910,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s005ltr.pdf","2018-01-30 00:00:00",
54175,2,206910,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s006lbl.pdf","2018-05-14 00:00:00",
54204,1,206910,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s006ltr.pdf","2018-05-16 00:00:00",
52681,2,206910,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s007lbl.pdf","2018-02-22 00:00:00",
52703,1,206910,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s007ltr.pdf","2018-02-23 00:00:00",
55116,2,206910,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf","2018-08-06 00:00:00",
55128,1,206910,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s10,207968Orig1s005Ltr.pdf","2018-08-07 00:00:00",
32834,1,206911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206911Orig1s000ltr.pdf","2016-04-12 00:00:00",
40573,2,206911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206911s000lbl.pdf","2016-04-13 00:00:00",
52885,3,206911,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206911Orig1s000TOC.cfm","2018-03-09 00:00:00",
50969,1,206918,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206918Orig1s000ltr.pdf","2017-12-29 00:00:00",
52640,1,206921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206921Orig1s000ltr.pdf","2018-02-14 00:00:00",
49969,1,206936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206936Orig1s000ltr.pdf","2017-10-06 00:00:00",
47132,2,206939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206939Orig1s000lbl.pdf","2017-02-08 00:00:00",
47137,1,206939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206939Orig1s000ltr.pdf","2017-02-08 00:00:00",
23028,3,206940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206940Orig1s000TOC.cfm","2015-07-02 00:00:00",
32835,1,206940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206940Orig1s000ltr.pdf","2015-05-28 00:00:00",
32836,1,206940,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206940Orig1s001ltr.pdf","2016-02-12 00:00:00",
40574,2,206940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf","2015-05-29 00:00:00",
40575,2,206940,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206940s001lblmg.pdf","2017-02-14 00:00:00",
44953,21,206940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206940Orig1s000SumR.pdf","2015-07-02 00:00:00",
48081,1,206940,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206940Orig1s002ltr.pdf","2017-04-21 00:00:00",
48092,2,206940,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206940s002lbl.pdf","2017-04-24 00:00:00",
53683,2,206940,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s003lbl.pdf","2018-04-16 00:00:00",
53700,1,206940,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206940Orig1s003ltr.pdf","2018-04-16 00:00:00",
50366,1,206940,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206940Orig1s005ltr.pdf","2017-11-13 00:00:00",
50408,2,206940,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206940s005lbl.pdf","2017-11-14 00:00:00",
54719,2,206940,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s006lbl.pdf","2018-06-28 00:00:00",
54807,8,206940,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s006lbl.pdf#page=19","2018-07-06 00:00:00",
54854,1,206940,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206940Orig1s006ltr.pdf","2018-07-06 00:00:00",
19740,2,206947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf","2015-02-13 00:00:00",
24522,21,206947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000SumR.pdf","2015-03-12 00:00:00",
32837,1,206947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206947Orig1s000ltr.pdf","2015-02-17 00:00:00",
43529,3,206947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000TOC.cfm","2015-03-12 00:00:00",
19952,2,206947,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf","2016-05-13 00:00:00",
32838,1,206947,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s003ltr.pdf","2016-05-16 00:00:00",
10604,1,206947,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s004ltr.pdf","2016-04-26 00:00:00",
40576,2,206947,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf","2016-04-29 00:00:00",
49178,2,206947,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206947s005lbl.pdf","2017-08-01 00:00:00",
49205,1,206947,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206947Orig1s005ltr.pdf","2017-08-02 00:00:00",
55180,2,206947,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf","2018-08-16 00:00:00",
55181,1,206947,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s007ltr.pdf","2018-08-16 00:00:00",
54491,2,206947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s008lbl.pdf","2018-06-11 00:00:00",
54556,1,206947,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s008ltr.pdf","2018-06-14 00:00:00",
45819,19,206952,"APPL",0,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-11-04 00:00:00",
48655,1,206959,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206959Orig1s000TAltr.pdf","2017-06-06 00:00:00",
52519,1,206959,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206959Orig1s000ltr.pdf","2018-02-08 00:00:00",
46215,1,206977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206977Orig1s000ltr.pdf","2016-12-19 00:00:00",
46423,2,206977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206977s000lbl.pdf","2016-12-21 00:00:00",
47368,2,206977,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206977s001lbl.pdf","2017-02-28 00:00:00",
47429,1,206977,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206977Orig1s001ltr.pdf","2017-03-02 00:00:00",
48851,3,206977,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206977Orig1s000TOC.cfm","2017-06-28 00:00:00",
51309,20,206977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/92_206977 levothyroxine clinical prea.pdf","1900-01-01 00:00:00",
51310,57,206977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/91_206977 levothyroxine CDTL clinical prea.pdf","1900-01-01 00:00:00",
51311,18,206977,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/93_206977 levothyroxine clinpharm prea.pdf","1900-01-01 00:00:00",
48656,1,206986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206986Orig1s000TAltr.pdf","2017-06-06 00:00:00",
10605,1,206995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206995Orig1s000ltr.pdf","2015-07-15 00:00:00",
19953,2,206995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf","2015-07-13 00:00:00",
23029,3,206995,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206995Orig1s000TOC.cfm","2016-07-28 00:00:00",
55273,2,206995,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206995s003lbl.pdf","2018-08-23 00:00:00",
55313,1,206995,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206995Orig1s003Ltr.pdf","2018-08-24 00:00:00",
53146,1,207014,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207014Orig1s000ltr.pdf","2018-03-22 00:00:00",
49970,1,207016,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207016Orig1s000ltr.pdf","2017-10-06 00:00:00",
10606,1,207021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207021Orig1s000ltr.pdf","2016-05-16 00:00:00",
10607,1,207026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207026Orig1s000ltr.pdf","2015-01-15 00:00:00",
10608,1,207026,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026Orig1s001ltr.pdf","2015-12-17 00:00:00",
19954,2,207026,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf","2015-12-17 00:00:00",
40577,2,207026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207026s000lbl.pdf","2015-01-14 00:00:00",
43530,3,207026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207026Orig1s000TOC.cfm","2015-04-07 00:00:00",
44954,21,207026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207026Orig1s000SumR.pdf","2015-04-07 00:00:00",
19955,2,207026,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf","2016-07-21 00:00:00",
32839,1,207026,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026Orig1s002ltr.pdf","2016-07-22 00:00:00",
48891,2,207026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021703s018,207026s004lbl.pdf","2017-07-03 00:00:00",
48904,1,207026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21703Orig1s018,207026Orig1s004ltr.pdf","2017-07-05 00:00:00",
24523,21,207027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207027Orig1s000SumR.pdf","2016-06-03 00:00:00",
32840,1,207027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207027Orig1s000ltr.pdf","2015-08-25 00:00:00",
40578,2,207027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207027s000lbl.pdf","2015-08-25 00:00:00",
43531,3,207027,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207027Orig1s000TOC.cfm","2016-06-03 00:00:00",
45555,1,207027,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207027Orig1s001ltr.pdf","2016-10-14 00:00:00",
45616,2,207027,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf","2016-10-17 00:00:00",
51700,23,207027,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022291_eltrombopag_Orig_WR.pdf","2010-01-25 00:00:00",
51702,25,207027,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N022291_eltrombopag_Amend_1.pdf","2011-11-23 00:00:00",
47522,2,207027,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s002lbl.pdf","2017-03-10 00:00:00",
47549,1,207027,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291Orig1s017,207027Orig1s002ltr.pdf","2017-03-14 00:00:00",
48931,2,207027,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s003lbl.pdf","2017-07-10 00:00:00",
54372,1,207027,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207027Orig1s004ltr.pdf","2018-05-30 00:00:00",
54388,2,207027,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf","2018-05-31 00:00:00",
54968,8,207027,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf#page=29","2018-07-25 00:00:00",
54969,2,207027,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf","2018-07-25 00:00:00",
55000,1,207027,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022291Orig1s020,207027Orig1s005Ltr.pdf","2018-07-26 00:00:00",
55752,1,207027,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207027Orig1s006ltr.pdf","2018-10-01 00:00:00",
55814,2,207027,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf","2018-10-04 00:00:00",
55815,8,207027,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf#page=30","2018-10-04 00:00:00",
32841,1,207036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207036MGLtr.pdf","2015-10-01 00:00:00",
10609,1,207042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207042Orig1s000ltr.pdf","2015-12-30 00:00:00",
40579,2,207042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207042lbl.pdf","2016-02-11 00:00:00",
10610,1,207058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207058Orig1s000ltr.pdf","2016-06-08 00:00:00",
40580,2,207058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207058Orig1s000lbl.pdf","2016-06-10 00:00:00",
10611,1,207064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207064Orig1s000TAltr.pdf","2015-07-08 00:00:00",
23030,3,207070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207070Orig1s000TOC.cfm","2016-06-27 00:00:00",
24524,21,207070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207070Orig1s000SumR.pdf","2015-09-17 00:00:00",
32842,1,207070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207070Orig1s000ltr.pdf","2015-09-17 00:00:00",
40581,2,207070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207070s000lbl.pdf","2015-09-23 00:00:00",
51683,20,207070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207070_tiotropium bromide_Spiriva_Clinical_PREA.pdf","1900-01-01 00:00:00",
51684,58,207070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207070_tiotropium bromide_Spiriva_Clinical addendum_PREA.pdf","1900-01-01 00:00:00",
51685,18,207070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207070_tiotropium bromide_Spiriva_Clinpharm_PREA.pdf","1900-01-01 00:00:00",
51686,17,207070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207070_tiotropium bromide_Spiriva_stat_PREA.pdf","1900-01-01 00:00:00",
51687,61,207070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207070_tiotropium bromide_Spiriva_stat 2_PREA.pdf","1900-01-01 00:00:00",
19956,2,207071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207071s000lbl.pdf","2015-08-04 00:00:00",
32843,1,207071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207071Orig1s000ltr.pdf","2015-07-31 00:00:00",
43532,3,207071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207071Orig1s000TOC.cfm","2016-04-13 00:00:00",
44955,21,207071,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207071Orig1s000SumR.pdf","2016-04-13 00:00:00",
54257,2,207078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207078s000lbl.pdf","2018-05-18 00:00:00",
54271,1,207078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207078Orig1s000ltr.pdf","2018-05-21 00:00:00",
54477,3,207078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207078Orig1s000TOC.cfm","2018-06-08 00:00:00",
49957,1,207092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207092Orig1s000ltr.pdf","2017-10-05 00:00:00",
32844,1,207096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207096Orig1s000ltr.pdf","2016-02-26 00:00:00",
40582,2,207096,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207096Orig1s000lbl.pdf","2016-03-04 00:00:00",
23031,3,207103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000TOC.cfm","2015-03-13 00:00:00",
32845,1,207103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207103Orig1s000ltr.pdf","2015-02-04 00:00:00",
40583,2,207103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf","2015-02-03 00:00:00",
44956,21,207103,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000SumR.pdf","2015-03-13 00:00:00",
10612,1,207103,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207103Orig1s002ltr.pdf","2016-02-22 00:00:00",
19957,2,207103,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf","2016-02-19 00:00:00",
52658,3,207103,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207103Orig1s002.pdf","2018-02-15 00:00:00",
47817,1,207103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207103Orig1s004ltr.pdf","2017-04-03 00:00:00",
47847,2,207103,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf","2017-04-03 00:00:00",
52495,2,207103,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207103s007lbl.pdf","2018-02-07 00:00:00",
52535,1,207103,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207103Orig1s007ltr.pdf","2018-02-09 00:00:00",
45581,1,207113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207113Orig1s000TAltr.pdf","2016-10-03 00:00:00",
32846,1,207114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207114MGLtr.pdf","2015-10-01 00:00:00",
19958,2,207131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207131s000lbl.pdf","2015-09-09 00:00:00",
23032,3,207131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000TOC.cfm","2016-04-13 00:00:00",
24525,21,207131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000SumR.pdf","2016-04-13 00:00:00",
32847,1,207131,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207131Orig1s000ltr.pdf","2015-08-24 00:00:00",
45551,1,207131,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207131Orig1s003ltr.pdf","2016-10-14 00:00:00",
47279,2,207131,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207131s003lbl.pdf","2017-02-22 00:00:00",
45189,1,207133,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207133Orig1s000ltr.pdf","2016-08-30 00:00:00",
46026,1,207137,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207137Orig1s000ltr.pdf","2016-12-06 00:00:00",
48794,1,207139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207139Orig1s000ltr.pdf","2017-06-22 00:00:00",
48842,2,207139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207139Orig1s000lbl.pdf","2017-06-27 00:00:00",
47630,2,207145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf","2017-03-22 00:00:00",
47730,1,207145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s000ltr.pdf","2017-03-28 00:00:00",
48180,3,207145,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000TOC.cfm","2017-05-01 00:00:00",
48756,2,207145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145s001lbl.pdf","2017-06-19 00:00:00",
48775,1,207145,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s001ltr.pdf","2017-06-20 00:00:00",
48780,14,207149,"ORIG",1,"Tentative Approval Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207149Orig1s000TAltr.pdf","2017-06-20 00:00:00",
19959,2,207154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf","2016-02-26 00:00:00",
32848,1,207154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207154Orig1s000ltr.pdf","2016-02-26 00:00:00",
46009,3,207154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207154Orig1s000TOC.cfm","2016-12-02 00:00:00",
52585,20,207154,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/117_207154 dapsone clinical prea.pdf","1900-01-01 00:00:00",
52586,18,207154,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/118_207154 dapsone clinpharm prea.pdf","1900-01-01 00:00:00",
52587,17,207154,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/119_207154 dapsone statistical prea.pdf","1900-01-01 00:00:00",
54282,2,207154,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf","2018-05-22 00:00:00",
54321,1,207154,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207154Orig1s003ltr.pdf","2018-05-24 00:00:00",
19960,2,207155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207155s000lbl.pdf","2016-03-15 00:00:00",
32849,1,207155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207155Orig1s000,Orig2s000ltr.pdf","2016-03-14 00:00:00",
46006,3,207155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207155Orig1s000_Orig2s000TOC.cfm","2016-12-02 00:00:00",
50934,2,207155,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207155s001lbl.pdf","2017-12-27 00:00:00",
46005,3,207155,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207155Orig1s000_Orig2s000TOC.cfm","2016-12-02 00:00:00",
46837,1,207160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207160Orig1s000ltr.pdf","2017-01-13 00:00:00",
46954,2,207160,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207160Orig1s000lbl.pdf","2017-01-24 00:00:00",
10613,1,207166,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/207166MGltr.pdf","2015-10-13 00:00:00",
48830,1,207172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207172Orig1s000ltr.pdf","2017-06-26 00:00:00",
19961,2,207174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.pdf","2016-03-04 00:00:00",
32850,1,207174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207174Orig1s000ltr.pdf","2016-02-09 00:00:00",
46032,3,207174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000TOC.cfm","2016-12-06 00:00:00",
46033,21,207174,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000SumR.pdf","2016-12-06 00:00:00",
49259,1,207179,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207179Orig1s000ltr.pdf","2017-08-07 00:00:00",
49692,1,207188,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207188Orig1s000ltr.pdf","2017-09-07 00:00:00",
49508,1,207193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207193Orig1s000ltr.pdf","2017-08-22 00:00:00",
49516,2,207193,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207193Orig1s000lbl.pdf","2017-08-22 00:00:00",
46675,1,207201,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207201Orig1s000ltr.pdf","2017-01-05 00:00:00",
50398,2,207202,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf","2017-11-13 00:00:00",
50415,1,207202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207202Orig1s000ltr.pdf","2017-11-15 00:00:00",
55134,3,207202,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207202Orig1s000TOC.cfm","2018-08-08 00:00:00",
48685,1,207210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207210Orig1s000ltr.pdf","2017-06-09 00:00:00",
55252,2,207223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf","2018-08-21 00:00:00",
55253,8,207223,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17","2018-08-21 00:00:00",
55328,1,207223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206709Orig1s000,207223Orig1s000Ltr.pdf","2018-08-27 00:00:00",
55462,3,207223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000TOC.cfm","2018-09-12 00:00:00",
45970,1,207231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207231Orig1s000ltr.pdf","2016-11-30 00:00:00",
23033,3,207233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207233Orig1s000TOC.cfm","2016-07-19 00:00:00",
32851,1,207233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207233Orig1s000ltr.pdf","2015-10-28 00:00:00",
40584,2,207233,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207233s000lbl.pdf","2015-10-27 00:00:00",
45224,1,207235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207235Orig1s000ltr.pdf","2016-08-12 00:00:00",
48395,2,207238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207238ORig1s000lbl.pdf","2017-05-17 00:00:00",
48404,1,207238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207238Orig1s000ltr.pdf","2017-05-17 00:00:00",
49688,1,207252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207252Orig1s000ltr.pdf","2017-09-07 00:00:00",
50042,19,207276,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9","2017-10-12 00:00:00",
48313,1,207315,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207315Orig1s000TAltr.pdf","2017-05-09 00:00:00",
10614,1,207318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207318Orig1s000ltr.pdf","2016-05-02 00:00:00",
23034,3,207318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000TOC.cfm","2016-06-02 00:00:00",
40585,2,207318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf","2016-05-02 00:00:00",
44957,21,207318,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000SumR.pdf","2016-06-02 00:00:00",
50106,1,207318,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207318Orig1s001ltr.pdf","2017-10-19 00:00:00",
50152,2,207318,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf","2017-10-23 00:00:00",
52823,2,207318,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf","2018-03-06 00:00:00",
53014,1,207318,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf","2018-03-15 00:00:00",
54826,1,207318,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf","2018-07-06 00:00:00",
55384,2,207318,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf","2018-09-05 00:00:00",
52824,2,207318,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf","2018-03-06 00:00:00",
53015,1,207318,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf","2018-03-15 00:00:00",
54486,2,207318,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf","2018-06-08 00:00:00",
54552,1,207318,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s005ltr.pdf","2018-06-14 00:00:00",
54442,1,207329,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207329Orig1s000ltr.pdf","2018-06-05 00:00:00",
49878,1,207333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207333Orig1s000ltr.pdf","2017-09-28 00:00:00",
50731,1,207338,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207338Orig1s000ltr.pdf","2017-12-18 00:00:00",
55673,2,207356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdf","2018-09-28 00:00:00",
55859,1,207356,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207356Orig1s000ltr.pdf","2018-10-10 00:00:00",
32852,1,207358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207358Orig1s000ltr.pdf","2016-03-02 00:00:00",
49674,1,207364,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207364Orig1s000TAltr.pdf","2017-09-06 00:00:00",
45576,1,207366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207366Orig1s000ltr.pdf","2016-10-14 00:00:00",
10615,1,207369,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207369Orig1s000TAltr.pdf","2015-11-19 00:00:00",
50732,1,207382,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207382Orig1s000ltr.pdf","2017-12-18 00:00:00",
46585,1,207407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207407Orig1s000ltr.pdf","2016-12-29 00:00:00",
47077,2,207407,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207407Orig1s000lbl.pdf","2017-01-31 00:00:00",
55401,1,207409,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207409Orig1s000TAltr.pdf","2018-09-07 00:00:00",
10616,1,207416,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207416Orig1s000ltr.pdf","2015-09-24 00:00:00",
46129,1,207426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207426Orig1s000ltr.pdf","2016-12-13 00:00:00",
47111,2,207426,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207426Orig1s000lbl.pdf","2017-02-06 00:00:00",
45730,1,207449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207449Orig1s000ltr.pdf","2016-10-31 00:00:00",
45816,2,207449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf","2016-11-04 00:00:00",
52815,1,207457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207457Orig1s000ltr.pdf","2018-03-05 00:00:00",
48880,1,207482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207482Orig1s000ltr.pdf","2017-06-30 00:00:00",
47399,1,207487,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207487Orig1s000ltr.pdf","2017-03-02 00:00:00",
19962,2,207500,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf","2015-04-28 00:00:00",
32853,1,207500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s000ltr.pdf","2015-03-06 00:00:00",
32854,1,207500,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf","2015-04-06 00:00:00",
40586,2,207500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500Orig1s000lbl.pdf","2015-03-06 00:00:00",
43533,3,207500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000TOC.cfm","2015-04-03 00:00:00",
44958,21,207500,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000Lbl.pdf","2015-04-03 00:00:00",
10617,1,207501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207501Orig1s000ltr.pdf","2015-03-06 00:00:00",
10618,1,207501,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf","2015-04-06 00:00:00",
23035,3,207501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000TOC.cfm","2015-04-03 00:00:00",
40587,2,207501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207501Orig1s000lbl.pdf","2015-03-06 00:00:00",
40588,2,207501,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf","2015-04-28 00:00:00",
44959,21,207501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000Lbl.pdf","2015-04-03 00:00:00",
48647,1,207531,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207531Orig1s000TAltr.pdf","2017-06-06 00:00:00",
10619,1,207533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207533Orig1s000ltr.pdf","2015-10-13 00:00:00",
19963,2,207533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533s000lbl.pdf","2015-10-13 00:00:00",
23036,3,207533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207533Orig1s000TOC.cfm","2015-10-28 00:00:00",
24526,21,207533,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207533Orig1s000SumR.pdf","2015-10-16 00:00:00",
45097,2,207533,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207533s003lbl.pdf","2016-08-22 00:00:00",
45143,1,207533,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207533Orig1s003ltr.pdf","2016-08-18 00:00:00",
48659,2,207533,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf","2017-06-06 00:00:00",
48660,8,207533,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf#page=35","2017-06-06 00:00:00",
48666,1,207533,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207533Orig1s004ltr.pdf","2017-06-07 00:00:00",
47322,2,207533,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s006lbl.pdf","2017-02-24 00:00:00",
47406,1,207533,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207533Orig1s006ltr.pdf","2017-03-02 00:00:00",
52123,1,207533,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207533Orig1s009ltr.pdf","2018-01-30 00:00:00",
48725,2,207534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207534lbl.pdf","2017-06-15 00:00:00",
48731,1,207534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207534Orig1s000ltr.pdf","2017-06-16 00:00:00",
49517,3,207534,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207534Orig1s0000TOC.cfm","2017-08-23 00:00:00",
55753,1,207534,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207534Orig1s003ltr.pdf","2018-10-01 00:00:00",
55804,2,207534,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207534s003lbl.pdf","2018-10-03 00:00:00",
46025,1,207549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207549Orig1s000ltr.pdf","2016-12-06 00:00:00",
47112,2,207549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207549Orig1s000lbl.pdf","2017-02-07 00:00:00",
50988,1,207550,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207550Orig1s000ltr.pdf","2018-01-08 00:00:00",
19964,2,207561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf","2015-11-12 00:00:00",
23037,3,207561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000TOC.cfm","2015-12-08 00:00:00",
32855,1,207561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207561Orig1s000ltr.pdf","2015-11-09 00:00:00",
44960,21,207561,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000SumR.pdf","2015-12-08 00:00:00",
45242,2,207561,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s001lbl.pdf","2016-09-08 00:00:00",
45248,1,207561,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561Orig1s001ltr.pdf","2016-09-09 00:00:00",
52451,20,207561,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207561_Genvoya_clinical_prea.pdf","1900-01-01 00:00:00",
52452,18,207561,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207561_Genvoya_clinpharm_prea.pdf","1900-01-01 00:00:00",
52453,17,207561,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207561_Genvoya_statistical_prea.pdf","1900-01-01 00:00:00",
46093,2,207561,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s002lbl.pdf","2016-12-08 00:00:00",
46100,1,207561,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s002ltr.pdf","2016-12-08 00:00:00",
32856,1,207561,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s003ltr.pdf","2016-03-10 00:00:00",
40589,2,207561,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf","2016-03-14 00:00:00",
47254,2,207561,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf","2017-02-16 00:00:00",
47255,2,207561,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf","2017-02-16 00:00:00",
45280,1,207561,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s007ltr.pdf","2016-09-19 00:00:00",
45312,2,207561,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s007lbl.pdf","2016-09-15 00:00:00",
47909,2,207561,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s010lbl.pdf","2017-04-10 00:00:00",
47984,1,207561,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s010ltr.pdf","2017-04-12 00:00:00",
49455,2,207561,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s011lbl.pdf","2017-08-17 00:00:00",
49488,1,207561,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s011ltr.pdf","2017-08-21 00:00:00",
50477,2,207561,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s013lbl.pdf","2017-11-24 00:00:00",
50508,1,207561,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s013ltr.pdf","2017-11-27 00:00:00",
49860,2,207561,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s014lbl.pdf","2017-09-26 00:00:00",
49877,1,207561,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s014ltr.pdf","2017-09-28 00:00:00",
52454,20,207561,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/184_207561S14 genvoya clinical prea.pdf","1900-01-01 00:00:00",
54153,18,207561,"SUPPL",14,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/186_207561S14 genvoya clinpharm prea.pdf","1900-01-01 00:00:00",
55072,2,207561,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s017lbl.pdf","2018-08-02 00:00:00",
55094,1,207561,"SUPPL",17,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s017Ltr.pdf","2018-08-03 00:00:00",
49686,1,207563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207563Orig1s000ltr.pdf","2017-09-07 00:00:00",
52816,1,207567,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207567Orig1s000ltr.pdf","2018-03-05 00:00:00",
55237,1,207568,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207568Orig1s000ltr.pdf","2018-08-20 00:00:00",
45575,1,207582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207582Orig1s000ltr.pdf","2016-10-19 00:00:00",
50993,1,207584,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207584Orig1s000TAltr.pdf","2018-01-08 00:00:00",
10620,1,207589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207589Orig1s000ltr.pdf","2015-10-20 00:00:00",
19965,2,207589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf","2015-10-22 00:00:00",
19966,2,207589,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf","2016-03-14 00:00:00",
24527,21,207589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000SumR.pdf","2016-05-04 00:00:00",
32857,1,207589,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207589Orig1s001ltr.pdf","2016-03-10 00:00:00",
43534,3,207589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000TOC.cfm","2016-05-04 00:00:00",
54624,1,207607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s000Ltr.pdf","2018-06-20 00:00:00",
54727,1,207607,"ORIG",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s001ltr_2.pdf","2018-06-20 00:00:00",
55238,1,207619,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207619Orig1s000TAltr.pdf","2018-08-20 00:00:00",
19967,2,207620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf","2015-07-07 00:00:00",
23038,3,207620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207620Orig1s000TOC.cfm","2015-08-14 00:00:00",
32858,1,207620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207620Orig1s000ltr.pdf","2015-07-07 00:00:00",
44961,21,207620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207620Orig1s000SumR.pdf","2015-08-14 00:00:00",
50478,2,207620,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207620s008lbl.pdf","2017-11-24 00:00:00",
50507,1,207620,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207620Orig1s008ltr.pdf","2017-11-27 00:00:00",
45821,19,207621,"APPL",0,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-11-04 00:00:00",
45041,2,207621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s000lbl.pdf","2016-08-19 00:00:00",
45047,1,207621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s000ltr.pdf","2016-08-19 00:00:00",
45368,19,207621,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-09-21 00:00:00",
45369,5,207621,"ORIG",1,"0","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2016-09-21 00:00:00",
45450,1,207621,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s001ltr.pdf","2016-10-03 00:00:00",
45568,14,207621,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2016-10-20 00:00:00",
46079,3,207621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207621Orig1toc.cfm","2016-12-06 00:00:00",
46080,21,207621,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207621Orig1s000SumR.pdf","2016-12-06 00:00:00",
46317,2,207621,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf","2016-12-20 00:00:00",
46444,1,207621,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s004ltr.pdf","2016-12-21 00:00:00",
46581,8,207621,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf#page=32","2016-12-29 00:00:00",
48590,1,207621,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207621Orig1s005ltr.pdf","2017-05-31 00:00:00",
48722,1,207624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207624Orig1s000ltr.pdf","2017-06-15 00:00:00",
48724,2,207624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf","2017-06-15 00:00:00",
55202,1,207630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207630Orig1s000ltr.pdf","2018-08-17 00:00:00",
32859,1,207631,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207631Orig1s000ltr.pdf","2016-07-19 00:00:00",
40590,2,207631,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207631Orig1s000lbl.pdf","2016-07-21 00:00:00",
48838,1,207639,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207639Orig1s000ltr.pdf","2017-06-27 00:00:00",
10621,1,207648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207648Orig1s000ltr.pdf","2016-07-14 00:00:00",
40591,2,207648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf","2016-07-28 00:00:00",
51045,3,207648,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207648Orig1s000TOC.cfm","2018-01-12 00:00:00",
46165,1,207695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207695Orig1s000ltr.pdf","2016-12-15 00:00:00",
46421,2,207695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf","2016-12-21 00:00:00",
46929,3,207695,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207695Orig1s000TOC.cfm","2017-01-23 00:00:00",
52578,57,207695,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/49_207695 crisaborole CDTL clinical prea.pdf","1900-01-01 00:00:00",
52579,20,207695,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50_207695 crisaborole clinical prea-EMV.pdf","1900-01-01 00:00:00",
52580,18,207695,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/51_207695 crisaborole clinpharm prea.pdf","1900-01-01 00:00:00",
52581,17,207695,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/52_207695 crisaborole statistical prea.pdf","1900-01-01 00:00:00",
50089,1,207695,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207695Orig1s002ltr.pdf","2017-10-18 00:00:00",
50148,2,207695,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207695s002lbl.pdf","2017-10-23 00:00:00",
54443,1,207735,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207735Orig1s000ltr.pdf","2018-06-05 00:00:00",
55239,1,207736,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207736Orig1s000TAltr.pdf","2018-08-20 00:00:00",
55242,1,207740,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207740Orig1s000TAltr.pdf","2018-08-20 00:00:00",
19968,2,207768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207768lbl.pdf","2015-05-06 00:00:00",
23039,3,207768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207768Orig1s000TOC.cfm","2015-12-09 00:00:00",
32860,1,207768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207768Orig1s000ltr.pdf","2015-05-05 00:00:00",
44962,21,207768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207768Orig1s000SumR.pdf","2015-12-09 00:00:00",
46864,2,207768,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s004lbl.pdf","2017-01-13 00:00:00",
46893,1,207768,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207768Orig1s004ltr.pdf","2017-01-18 00:00:00",
49607,2,207768,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s006lbl.pdf","2017-08-30 00:00:00",
49643,1,207768,"SUPPL",6,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207768Orig1s006ltr.pdf","2017-08-31 00:00:00",
54769,2,207768,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf","2018-07-05 00:00:00",
54808,8,207768,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf#page=27","2018-07-06 00:00:00",
54832,1,207768,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207768Orig1s007ltr.pdf","2018-07-06 00:00:00",
19969,2,207793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf","2015-10-22 00:00:00",
32861,1,207793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207793Orig1s000ltr.pdf","2015-10-26 00:00:00",
46072,3,207793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207793Orig1s000TOC.cfm","2016-09-29 00:00:00",
50364,2,207795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207795Orig1s000lbl.pdf","2017-11-13 00:00:00",
50465,1,207795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207795Orig1s000ltr.pdf","2017-11-20 00:00:00",
50754,3,207795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207795Orig1s000TOC.cfm","2017-12-18 00:00:00",
54597,1,207795,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207795Orig1s002ltr.pdf","2018-06-14 00:00:00",
54609,2,207795,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207795s002lbl.pdf","2018-06-19 00:00:00",
47670,1,207809,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207809Orig1s000ltr.pdf","2017-03-23 00:00:00",
24528,21,207844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207844Orig1s000SumR.pdf","2016-03-23 00:00:00",
32862,1,207844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207844Orig1s000ltr.pdf","2015-06-12 00:00:00",
40592,2,207844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207844s000lbl.pdf","2015-06-12 00:00:00",
43535,3,207844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207844Orig1s000TOC.cfm","2016-03-23 00:00:00",
10622,1,207865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207865Orig1s000ltr.pdf","2015-12-18 00:00:00",
40593,2,207865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207865lbl.pdf","2015-12-18 00:00:00",
46071,3,207865,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207865Orig1s000TOC.cfm","2016-09-30 00:00:00",
48617,2,207865,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf","2017-06-01 00:00:00",
48634,1,207865,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021549Orig1s027,207865Orig1s001ltr.pdf","2017-06-02 00:00:00",
51590,20,207865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant clinical prea.pdf","1900-01-01 00:00:00",
51591,18,207865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant clinpharm-467340.pdf","1900-01-01 00:00:00",
51602,62,207865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant clinpharm addendum prea.pdf","1900-01-01 00:00:00",
51603,17,207865,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant statistical prea.pdf","1900-01-01 00:00:00",
55400,1,207873,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207873Orig1s000TAltr.pdf","2018-09-07 00:00:00",
10623,1,207884,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207884Orig1s000ltr.pdf","2015-11-18 00:00:00",
10624,1,207916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207916Orig1s000ltr.pdf","2016-02-02 00:00:00",
19970,2,207916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf","2016-02-11 00:00:00",
45885,3,207916,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207916_toc.cfm","2016-11-10 00:00:00",
48065,2,207916,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf","2017-04-19 00:00:00",
48066,1,207916,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207916Orig1s003ltr.pdf","2017-04-19 00:00:00",
10625,1,207917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207917Orig1s000ltr.pdf","2015-07-20 00:00:00",
40594,2,207917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207917s000lbl.pdf","2015-07-16 00:00:00",
43536,3,207917,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207917Orig1s000TOC.cfm","2016-05-25 00:00:00",
51443,20,207917,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207917 adapalene benzoyl clinical prea.pdf","1900-01-01 00:00:00",
51449,18,207917,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207917 adapalene benzoyl clinpharm prea.pdf","1900-01-01 00:00:00",
51451,17,207917,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207917 adapalene benzoyl statistical prea.pdf","2018-01-01 00:00:00",
47113,2,207920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207920Orig1s000lbl.pdf","2017-02-07 00:00:00",
47114,1,207920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207920Orig1s000ltr.pdf","2017-02-07 00:00:00",
47115,3,207920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000TOC.cfm","2017-02-07 00:00:00",
47116,21,207920,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000SumR.pdf","2017-02-07 00:00:00",
47117,2,207920,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920orig1s001lbl.pdf","2017-02-07 00:00:00",
47118,1,207920,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207920orig1s001ltr.pdf","2017-02-07 00:00:00",
49250,2,207921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207921s000lbl.pdf","2017-08-04 00:00:00",
49256,1,207921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207921Orig1s000ltr.pdf","2017-08-07 00:00:00",
52667,3,207921,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207921Orig1s000TOC.cfm","2018-02-16 00:00:00",
19972,2,207923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207923lbl.pdf","2015-11-03 00:00:00",
32864,1,207923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207923Orig1s000ltr.pdf","2015-11-03 00:00:00",
46028,3,207923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207923Orig1_toc.cfm","2016-12-06 00:00:00",
46078,21,207923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207923Orig1s000SumR.pdf","2016-12-06 00:00:00",
46942,1,207923,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207923Orig1s002ltr.pdf","2017-01-24 00:00:00",
46945,2,207923,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207923s002lbl.pdf","2017-01-24 00:00:00",
54401,2,207924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924Orig1s000lbl.pdf","2018-06-01 00:00:00",
54402,8,207924,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924s000lbl.pdf#page=18","2018-06-01 00:00:00",
54403,1,207924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207924Orig1s000ltr.pdf","2018-06-01 00:00:00",
54749,3,207924,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207924Orig1s000TOC.cfm","2018-07-05 00:00:00",
10626,1,207925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207925Orig1s000ltr.pdf","2015-03-24 00:00:00",
19973,2,207925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf","2015-04-07 00:00:00",
23041,3,207925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000TOC.cfm","2016-04-13 00:00:00",
44964,21,207925,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000SumR.pdf","2016-04-13 00:00:00",
48441,2,207925,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207925s001lbl.pdf","2017-05-18 00:00:00",
48446,1,207925,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf","2017-05-18 00:00:00",
47156,1,207925,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s022,207925Orig1s003ltr.pdf","2017-02-09 00:00:00",
47160,2,207925,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf","2017-02-10 00:00:00",
49202,2,207925,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf","2017-08-02 00:00:00",
49207,1,207925,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s026,207925Orig1s005ltr.pdf","2017-08-02 00:00:00",
55210,1,207925,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203188Orig1s028,207925Orig1s007ltr.pdf","2018-08-20 00:00:00",
55264,2,207925,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf","2018-08-21 00:00:00",
10627,1,207926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207926Orig1s000ltr.pdf","2015-01-21 00:00:00",
19974,2,207926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207926s000lbl.pdf","2015-01-20 00:00:00",
43537,3,207926,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207926Orig1s000TOC.cfm","2015-04-13 00:00:00",
10628,1,207930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207930Orig1s000ltr.pdf","2015-11-03 00:00:00",
40595,2,207930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207930s000lbl.pdf","2015-11-04 00:00:00",
45969,3,207930,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207930Orig1s000TOC.cfm","2016-11-29 00:00:00",
46972,2,207930,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207930s002lbl.pdf","2017-01-25 00:00:00",
47007,1,207930,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207930Orig1s002ltr.pdf","2017-01-30 00:00:00",
10629,1,207931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s000ltr.pdf","2015-07-24 00:00:00",
10630,1,207931,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s001ltr.pdf","2015-10-26 00:00:00",
40596,2,207931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931Orig1s000lbl.pdf","2015-07-24 00:00:00",
40597,2,207931,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf","2015-10-23 00:00:00",
43538,3,207931,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207931Orig1s000TOC.cfm","2016-05-25 00:00:00",
32865,1,207931,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s002ltr.pdf","2016-01-29 00:00:00",
40598,2,207931,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931s002lbl.pdf","2016-02-01 00:00:00",
10631,1,207931,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s004ltr.pdf","2016-06-23 00:00:00",
40599,2,207931,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931Orig1s004lbl.pdf","2016-06-23 00:00:00",
47369,2,207931,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s006lbl.pdf","2017-02-28 00:00:00",
47441,1,207931,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s006Replacementltr.pdf","2017-03-03 00:00:00",
47644,2,207931,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf","2017-03-23 00:00:00",
47677,1,207931,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf","2017-03-24 00:00:00",
47211,2,207931,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s008lbl.pdf","2017-02-15 00:00:00",
47222,1,207931,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s008ltr.pdf","2017-02-15 00:00:00",
47645,2,207931,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf","2017-03-23 00:00:00",
47676,1,207931,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf","2017-03-24 00:00:00",
50379,2,207931,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s011lbl.pdf","2017-11-13 00:00:00",
54974,1,207931,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207931Orig1s012ltr.pdf","2018-07-25 00:00:00",
55361,2,207931,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207931s012lbl.pdf","2018-08-29 00:00:00",
55363,8,207931,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207931s012lbl.pdf#page=38","2018-08-29 00:00:00",
10632,1,207932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207932Orig1s000ltr.pdf","2015-10-26 00:00:00",
10633,1,207932,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s001ltr.pdf","2016-04-22 00:00:00",
24131,14,207932,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2015-10-28 00:00:00",
40600,2,207932,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207932s000lbl.pdf","2015-10-26 00:00:00",
46314,2,207932,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf","2016-12-20 00:00:00",
46446,1,207932,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s002ltr.pdf","2016-12-21 00:00:00",
46582,8,207932,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf#page=28","2016-12-29 00:00:00",
45451,1,207932,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s003ltr.pdf","2016-10-03 00:00:00",
48589,1,207932,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207932Orig1s006ltr.pdf","2017-05-31 00:00:00",
55536,2,207932,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf","2018-09-21 00:00:00",
55696,1,207932,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207932Orig1s008s009ltr.pdf","2018-10-01 00:00:00",
55537,2,207932,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf","2018-09-21 00:00:00",
48781,14,207934,"ORIG",1,"Tentative Approval Letter","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207934Orig1s000TAltr.pdf","2017-06-20 00:00:00",
45329,1,207938,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207938Orig1s000ltr.pdf","2016-09-15 00:00:00",
50331,1,207941,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207941Orig1s000TAltr.pdf","2017-11-08 00:00:00",
10634,1,207946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207946Orig1s000ltr.pdf","2015-05-21 00:00:00",
10635,1,207946,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf","2016-03-03 00:00:00",
19975,2,207946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207946s000lbl.pdf","2015-05-20 00:00:00",
23042,3,207946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000TOC.cfm","2016-02-08 00:00:00",
40601,2,207946,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207946s001lbl.pdf","2016-03-03 00:00:00",
44965,21,207946,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000SumR.pdf","2016-02-08 00:00:00",
47317,2,207946,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207946s003lbl.pdf","2017-02-24 00:00:00",
47409,1,207946,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf","2017-03-02 00:00:00",
55056,1,207946,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf","2018-07-30 00:00:00",
55564,2,207946,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207946s006lbl.pdf","2018-09-21 00:00:00",
19976,2,207947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207947s000lbl.pdf","2015-12-22 00:00:00",
23043,3,207947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000TOC.cfm","2016-01-28 00:00:00",
24529,21,207947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000SumR.pdf","2016-01-28 00:00:00",
32866,1,207947,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf","2015-12-22 00:00:00",
49054,2,207947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf","2017-07-25 00:00:00",
49078,1,207947,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s001ltr.pdf","2017-07-25 00:00:00",
49881,2,207947,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf","2017-09-29 00:00:00",
49895,1,207947,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s003ltr.pdf","2017-09-29 00:00:00",
50845,2,207947,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf","2017-12-22 00:00:00",
50906,1,207947,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s005ltr.pdf","2017-12-27 00:00:00",
48649,1,207948,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207948Orig1s000TAltr.pdf","2017-06-06 00:00:00",
32867,1,207949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207949Orig1s000ltr.pdf","2015-06-26 00:00:00",
47223,1,207952,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207952Orig1s000ltr.pdf","2017-02-15 00:00:00",
19977,2,207953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207953s000lbl.pdf","2015-10-23 00:00:00",
23044,3,207953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207953Orig1s000TOC.cfm","2015-12-02 00:00:00",
32868,1,207953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207953Orig1s000ltr.pdf","2015-10-23 00:00:00",
32869,1,207953,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207953Orig1s001ltr.pdf","2016-07-22 00:00:00",
40602,2,207953,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207953s001lbl.pdf","2016-07-21 00:00:00",
44966,21,207953,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207953Orig1s000SumR.pdf","2015-12-02 00:00:00",
48450,2,207953,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207953s003lbl.pdf","2017-05-19 00:00:00",
48461,1,207953,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207953Orig1s003ltr.pdf","2017-05-19 00:00:00",
54770,2,207953,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf","2018-07-05 00:00:00",
54809,8,207953,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf#page=20","2018-07-06 00:00:00",
54828,1,207953,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207953Orig1s004ltr.pdf","2018-07-06 00:00:00",
23045,3,207958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207958Orig1s000TOC.cfm","2016-05-27 00:00:00",
32870,1,207958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207958Orig1s000ltr.pdf","2015-08-04 00:00:00",
40603,2,207958,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207958s000lbl.pdf","2015-08-04 00:00:00",
10636,1,207958,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207958Orig1s002ltr.pdf","2016-02-02 00:00:00",
19978,2,207958,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207958s002lbl.pdf","2016-02-02 00:00:00",
48696,2,207958,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf","2017-06-12 00:00:00",
48697,8,207958,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf#page=36","2017-06-12 00:00:00",
48699,1,207958,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207958Orig1s004ltr.pdf","2017-06-12 00:00:00",
55486,1,207958,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207958Orig1s008Ltr.pdf","2018-09-14 00:00:00",
55786,2,207958,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf","2018-10-02 00:00:00",
55787,8,207958,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf#page=34","2018-10-02 00:00:00",
23046,3,207960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207960Orig1s000TOC.cfm","2016-07-19 00:00:00",
32871,1,207960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207960Orig1s000ltr.pdf","2015-12-08 00:00:00",
40604,2,207960,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207960s000lbl.pdf","2015-12-08 00:00:00",
51363,57,207960,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207960 methyphenidate clinical CDTL prea.pdf","1900-01-01 00:00:00",
51364,20,207960,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207960 methylphenidate clinical prea.pdf","1900-01-01 00:00:00",
51365,18,207960,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207960 methyphenidate clinpharm prea.pdf","1900-01-01 00:00:00",
51366,17,207960,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207960 methylphenidate statistical prea.pdf","1900-01-01 00:00:00",
46711,2,207960,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s004lbl.pdf","2017-01-06 00:00:00",
46843,1,207960,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s012,207960Orig1s004ltr.pdf","2017-01-17 00:00:00",
47459,1,207960,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207960Orig1s005ltr.pdf","2017-03-03 00:00:00",
47494,2,207960,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf","2017-03-08 00:00:00",
47496,8,207960,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf#page=13","2017-03-08 00:00:00",
52797,2,207962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207962s000lbl.pdf","2018-03-02 00:00:00",
53016,1,207962,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207962Orig1s000ltr.pdf","2018-03-15 00:00:00",
45111,2,207963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207963s000lbl.pdf","2016-08-23 00:00:00",
45157,1,207963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207963Orig1s000ltr.pdf","2016-08-22 00:00:00",
46108,3,207963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207963Orig1_toc.cfm","2016-12-09 00:00:00",
46109,21,207963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207963Orig1s000SumR.pdf","2016-12-09 00:00:00",
48451,2,207968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf","2017-05-19 00:00:00",
48464,1,207968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207968Orig1s000ltr.pdf","2017-05-19 00:00:00",
48816,3,207968,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000TOC.cfm","2017-06-23 00:00:00",
48817,21,207968,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000SumR.pdf","2017-06-23 00:00:00",
54174,2,207968,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf","2018-05-14 00:00:00",
54205,1,207968,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s001ltr.pdf","2018-05-16 00:00:00",
52682,2,207968,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf","2018-02-22 00:00:00",
52702,1,207968,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s002ltr.pdf","2018-02-23 00:00:00",
55119,2,207968,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf","2018-08-06 00:00:00",
55129,1,207968,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s10,207968Orig1s005Ltr.pdf","2018-08-07 00:00:00",
32872,1,207970,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207970Orig1s000TAltr.pdf","2015-08-21 00:00:00",
46884,2,207975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf","2017-01-17 00:00:00",
46902,8,207975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf#page=39","2017-01-19 00:00:00",
46903,1,207975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207975Orig1s000ltr.pdf","2017-01-19 00:00:00",
46963,19,207975,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2017-01-24 00:00:00",
47572,3,207975,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207975Orig1s000TOC.cfm","2017-03-16 00:00:00",
48013,14,207975,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2017-04-14 00:00:00",
48593,1,207975,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207975Orig1s002ltr.pdf","2017-05-31 00:00:00",
10638,1,207981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207981Orig1s000ltr.pdf","2015-09-22 00:00:00",
40605,2,207981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf","2015-09-22 00:00:00",
43539,3,207981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207981Orig1s000TOC.cfm","2015-10-23 00:00:00",
44967,21,207981,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207981Orig1s000SumR.pdf","2015-10-23 00:00:00",
47809,2,207981,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s004lbl.pdf","2017-03-30 00:00:00",
47820,1,207981,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207981Orig1s004ltr.pdf","2017-04-03 00:00:00",
48874,2,207981,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s006lbl.pdf","2017-06-30 00:00:00",
48898,1,207981,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207981Orig1s006ltr.pdf","2017-07-05 00:00:00",
10639,1,207986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207986Orig1s000ltr.pdf","2015-12-14 00:00:00",
32873,1,207986,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207986Orig1s001ltr.pdf","2016-01-28 00:00:00",
40606,2,207986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207986s000lbl.pdf","2015-12-15 00:00:00",
40607,2,207986,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207986s001lbl.pdf","2016-02-18 00:00:00",
43540,3,207986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000TOC.cfm","2016-02-19 00:00:00",
44968,21,207986,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000SumR.pdf","2016-02-19 00:00:00",
52573,20,207986,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin clinical prea.pdf","1900-01-01 00:00:00",
52574,18,207986,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin clinpharm prea.pdf","1900-01-01 00:00:00",
52575,17,207986,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin statistical_prea.pdf","1900-01-01 00:00:00",
52576,61,207986,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin statistical addendum prea.pdf","1900-01-01 00:00:00",
52820,2,207986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207986s002lbl.pdf","2018-03-06 00:00:00",
53009,1,207986,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207986Orig1s002ltr.pdf","2018-03-15 00:00:00",
54702,1,207987,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207987Orig1s000ltr.pdf","2018-06-27 00:00:00",
54747,2,207987,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf","2018-07-04 00:00:00",
24530,21,207988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207988Orig1s000SumR.pdf","2016-02-02 00:00:00",
32874,1,207988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207988Orig1s000ltr.pdf","2015-12-23 00:00:00",
40608,2,207988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf","2015-12-23 00:00:00",
43541,3,207988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207988Orig1s000TOC.cfm","2016-02-02 00:00:00",
47259,8,207988,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf#page=17","2017-02-17 00:00:00",
48160,2,207997,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf","2017-04-28 00:00:00",
48163,1,207997,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf","2017-04-28 00:00:00",
48161,2,207997,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf","2017-06-28 00:00:00",
48162,1,207997,"ORIG",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf","2017-06-28 00:00:00",
48639,3,207997,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207997Orig1Orig2s000TOC.cfm","2017-06-05 00:00:00",
54693,2,207997,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207997s002lbl.pdf","2018-06-27 00:00:00",
54703,1,207997,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207997Orig1s002ltr.pdf","2018-06-27 00:00:00",
32875,1,207999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207999Orig1s000ltr.pdf","2016-05-31 00:00:00",
40609,2,207999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf","2016-05-31 00:00:00",
43542,3,207999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207999Orig1s000TOC.cfm","2016-07-08 00:00:00",
44969,21,207999,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207999Orig1s000SumR.pdf","2016-07-08 00:00:00",
52238,2,207999,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf","2018-02-01 00:00:00",
52239,8,207999,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf#page=23","2018-02-01 00:00:00",
52293,1,207999,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207999Orig1s003ltr.pdf","2018-02-02 00:00:00",
50733,1,208001,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208001Orig1s000TAltr.pdf","2017-12-18 00:00:00",
50335,1,208003,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208003Orig1s000TAltr.pdf","2017-11-08 00:00:00",
32876,1,208010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208010Orig1s000ltr.pdf","2016-06-21 00:00:00",
40610,2,208010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208010s000lbl.pdf","2016-06-21 00:00:00",
46660,3,208010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1_toc.cfm","2017-01-03 00:00:00",
46661,21,208010,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1s000SumR.pdf","2017-01-03 00:00:00",
10640,1,208019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208019Orig1s000ltr.pdf","2015-08-21 00:00:00",
23047,3,208019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208019Orig1s000TOC.cfm","2016-05-04 00:00:00",
40611,2,208019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208019lbl.pdf","2015-08-20 00:00:00",
44970,21,208019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208019Orig1s000SumR.pdf","2016-05-04 00:00:00",
54444,1,208021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208021Orig1s000ltr.pdf","2018-06-05 00:00:00",
32877,1,208025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208025Orig1s000ltr.pdf","2016-06-13 00:00:00",
45930,3,208025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208025Orig1s000TOC.cfm","2016-11-22 00:00:00",
47009,1,208025,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s001ltr.pdf","2017-01-30 00:00:00",
47013,2,208025,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s001lbl.pdf","2017-01-30 00:00:00",
48368,1,208025,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s003ltr.pdf","2017-05-12 00:00:00",
48377,2,208025,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s003lbl.pdf","2017-05-15 00:00:00",
50418,1,208025,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s005ltr.pdf","2017-11-15 00:00:00",
50590,2,208025,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025s006lbl.pdf","2017-12-04 00:00:00",
50591,1,208025,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025s006ltr.pdf","2017-12-04 00:00:00",
50568,1,208025,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s007ltr.pdf","2017-12-01 00:00:00",
50588,2,208025,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s007lbl.pdf","2017-12-04 00:00:00",
32878,1,208026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf","2016-06-01 00:00:00",
40612,2,208026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s000lbl.pdf","2016-06-01 00:00:00",
48818,3,208026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000TOC.cfm","2017-06-23 00:00:00",
48819,21,208026,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000SumR.pdf","2017-06-23 00:00:00",
47606,1,208026,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf","2017-03-20 00:00:00",
47616,2,208026,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s003lbl.pdf","2017-03-21 00:00:00",
46541,2,208026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s004lbl.pdf","2016-12-27 00:00:00",
46554,1,208026,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201280Orig1s015,208026Orig1s004ltr.pdf","2016-12-27 00:00:00",
49343,2,208026,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s005lbl.pdf","2017-08-11 00:00:00",
49344,8,208026,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s005lbl.pdf","2017-08-11 00:00:00",
49410,1,208026,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf","2017-08-15 00:00:00",
23048,3,208030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208030Orig1s000TOC.cfm","2016-06-09 00:00:00",
24531,21,208030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208030Orig1s000SumR.pdf","2016-06-09 00:00:00",
32879,1,208030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208030Orig1s000ltr.pdf","2015-09-10 00:00:00",
47812,2,208030,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208030lbl.pdf","2017-03-31 00:00:00",
53787,1,208030,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208030Orig1s002ltr.pdf","2018-04-23 00:00:00",
53793,2,208030,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf","2018-04-23 00:00:00",
53794,8,208030,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf#page=11","2018-04-23 00:00:00",
32880,1,208032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208032Orig1s000ltr.pdf","2016-07-11 00:00:00",
40613,2,208032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208032s000lbl.pdf","2016-07-08 00:00:00",
50515,3,208032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208032Orig1s000TOC.cfm","2017-11-28 00:00:00",
51576,20,208032,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208032 tetracaine and oxymetazoline clinical prea.pdf","1900-01-01 00:00:00",
51577,18,208032,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208032 tetracaine and oxymetazoline clinpharm prea.pdf","1900-01-01 00:00:00",
51578,17,208032,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208032 tetracaine and oxymetazoline statistical prea.pdf","1900-01-01 00:00:00",
32881,1,208036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208036Orig1s000Approvedt.pdf","2016-01-12 00:00:00",
40614,2,208036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208036s000lbl.pdf","2016-01-12 00:00:00",
46004,3,208036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208036Orig1s000TOC.cfm","2016-12-02 00:00:00",
51876,20,208036,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208036 barium sulfate clinical prea.pdf","1900-01-01 00:00:00",
46666,2,208036,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s002lbl.pdf","2017-01-04 00:00:00",
46674,1,208036,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s002ltr.pdf","2017-01-05 00:00:00",
47905,2,208036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s005lbl.pdf","2017-04-10 00:00:00",
48044,1,208036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s005ltr.pdf","2017-04-14 00:00:00",
47146,2,208036,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208036s006lbl.pdf","2017-02-09 00:00:00",
47157,1,208036,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208036Orig1s006ltr.pdf","2017-02-09 00:00:00",
55414,2,208042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208042s000lbl.pdf","2018-09-10 00:00:00",
55415,8,208042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208042s000lbl.pdf#page=34","2018-09-10 00:00:00",
55438,1,208042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208042Orig1s000ltr.pdf","2018-09-12 00:00:00",
48975,1,208046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208046TA_ltr.pdf","2017-07-13 00:00:00",
48998,2,208051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf","2017-07-17 00:00:00",
49007,1,208051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208051Orig1s000Ltr.pdf","2017-07-18 00:00:00",
49467,3,208051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208051Orig1s000TOC.cfm","2017-08-21 00:00:00",
54771,2,208051,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf","2018-07-05 00:00:00",
54810,8,208051,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf#page=19","2018-07-06 00:00:00",
54830,1,208051,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208051Orig1s002ltr.pdf","2018-07-06 00:00:00",
48974,1,208052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208052TA_ltr.pdf","2017-07-13 00:00:00",
24532,21,208054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000SumR.pdf","2016-06-21 00:00:00",
32882,1,208054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208054Orig1s000ltr.pdf","2016-05-27 00:00:00",
40615,2,208054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf","2016-05-27 00:00:00",
43543,3,208054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000TOC.cfm","2016-06-21 00:00:00",
19979,2,208056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208056lbl.pdf","2016-02-03 00:00:00",
19980,2,208056,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf","2016-07-20 00:00:00",
32883,1,208056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208056Orig1s000ltr.pdf","2016-02-03 00:00:00",
32884,1,208056,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf","2016-07-12 00:00:00",
49023,3,208056,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208056Orig1s000TOC.cfm","2017-07-20 00:00:00",
45668,1,208056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s026,208056Orig1s003ltr.pdf","2016-11-10 00:00:00",
45872,2,208056,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf","2016-11-10 00:00:00",
48973,1,208057,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208057TA_ltr.pdf","2017-07-13 00:00:00",
50231,1,208061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208061Orig1s000ltr.pdf","2017-10-30 00:00:00",
10641,1,208065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208065Orig1s000Ltr.pdf","2015-11-13 00:00:00",
19981,2,208065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf","2015-11-13 00:00:00",
23049,3,208065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000TOC.cfm","2015-12-23 00:00:00",
44971,21,208065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000SumR.pdf","2015-12-11 00:00:00",
45077,2,208065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf","2016-08-17 00:00:00",
45128,1,208065,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s002ltr.pdf","2016-08-12 00:00:00",
45499,1,208065,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s003ltr.pdf","2016-09-30 00:00:00",
47283,2,208065,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf","2017-02-22 00:00:00",
47794,2,208065,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf","2017-03-30 00:00:00",
47821,1,208065,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208065Orig1s006ltr.pdf","2017-04-03 00:00:00",
50246,2,208065,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s007lbl.pdf","2017-10-31 00:00:00",
50307,1,208065,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208065Orig1s007ltr.pdf","2017-11-06 00:00:00",
53732,2,208065,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf","2018-04-19 00:00:00",
53772,1,208065,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s008ltr.pdf","2018-04-23 00:00:00",
53773,1,208065,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s009ltr.pdf","2018-04-23 00:00:00",
55351,2,208065,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s011lbl.pdf","2018-08-29 00:00:00",
55371,1,208065,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208065Orig1s011ltr.pdf","2018-08-30 00:00:00",
32885,1,208068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208068Orig1s000TAltr.pdf","2015-10-21 00:00:00",
32886,1,208069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/208069MGLtr.pdf","2015-10-13 00:00:00",
10642,1,208073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208073Orig1s000ltr.pdf","2016-07-12 00:00:00",
19982,2,208073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208073s000lbl.pdf","2016-07-13 00:00:00",
45000,3,208073,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208073Orig1s000TOC.cfm","2016-07-11 00:00:00",
50786,1,208073,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208073Orig1s002ltr.pdf","2017-12-20 00:00:00",
50826,2,208073,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208073s002lbl.pdf","2017-12-21 00:00:00",
19983,2,208079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208079lbl.pdf","2016-02-09 00:00:00",
32887,1,208079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208079Orig1s000ltr.pdf","2016-02-09 00:00:00",
49518,3,208079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208079Orig1s000TOC.cfm","2017-08-23 00:00:00",
10643,1,208081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208081Orig1s000ltr.pdf","2016-05-16 00:00:00",
19984,2,208081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208081s000lbl.pdf","2016-05-11 00:00:00",
47165,3,208081,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208081Orig1s000TOC.cfm","2017-02-10 00:00:00",
49683,2,208081,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf","2017-09-07 00:00:00",
49702,1,208081,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208081Orig1s002ltr.pdf","2017-09-08 00:00:00",
47844,1,208082,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208082Orig1s000ltr.pdf","2017-04-03 00:00:00",
47845,2,208082,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf","2017-04-03 00:00:00",
47846,8,208082,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf#page=21","2017-04-03 00:00:00",
48378,3,208082,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000TOC.cfm","2017-05-15 00:00:00",
54488,2,208082,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208082s002lbl.pdf","2018-06-08 00:00:00",
54553,1,208082,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208082Orig1s002ltr.pdf","2018-06-14 00:00:00",
48072,2,208083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf","2017-04-21 00:00:00",
48080,1,208083,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208083Orig1s000ltr.pdf","2017-04-21 00:00:00",
48821,3,208083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208083Orig1s000TOC.cfm","2017-06-26 00:00:00",
53822,2,208085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208085s000lbl.pdf","2018-04-26 00:00:00",
53865,1,208085,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208085Orig1s000ltr.pdf","2018-04-27 00:00:00",
24132,14,208090,"ORIG",1,"REMS","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2016-04-29 00:00:00",
32890,1,208090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s000ltr.pdf","2016-04-27 00:00:00",
40616,2,208090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s000lbl.pdf","2016-04-27 00:00:00",
44603,14,208090,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2015-11-06 00:00:00",
47584,3,208090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208090Orig1s000TOC.cfm","2017-03-17 00:00:00",
45447,1,208090,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s002ltr.pdf","2016-10-03 00:00:00",
46312,2,208090,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s003lbl.pdf","2016-12-20 00:00:00",
46447,1,208090,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s003ltr.pdf","2016-12-21 00:00:00",
50317,2,208090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf","2017-11-06 00:00:00",
50318,8,208090,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf#page=35","2017-11-07 00:00:00",
50351,1,208090,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208090Orig1s004ltr.pdf","2017-11-09 00:00:00",
48586,1,208090,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208090Orig1s006ltr.pdf","2017-05-31 00:00:00",
55527,2,208090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf","2018-09-19 00:00:00",
55529,8,208090,"SUPPL",8,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf#page=36","2018-09-19 00:00:00",
55701,1,208090,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208090Orig1s008s010ltr.pdf","2018-10-01 00:00:00",
55528,2,208090,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf","2018-09-19 00:00:00",
55530,8,208090,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf#page=36","2018-09-19 00:00:00",
55702,1,208090,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208090Orig1s008s010ltr.pdf","2018-10-01 00:00:00",
49130,1,208092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208092Orig1s000ltr.pdf","2017-07-28 00:00:00",
10644,1,208097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208097Orig1s000TAltr.pdf","2016-04-27 00:00:00",
50469,2,208109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208109s000lbl.pdf","2017-11-22 00:00:00",
50501,1,208109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208109Orig1s000ltr.pdf","2017-11-27 00:00:00",
55854,3,208109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208109Orig1s000TOC.cfm","2018-10-09 00:00:00",
24533,21,208114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208114Orig1s000SumR.pdf","2016-05-10 00:00:00",
32892,1,208114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208114Orig1s000ltr.pdf","2016-04-04 00:00:00",
40617,2,208114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114Orig1s000Lbl.pdf","2016-03-30 00:00:00",
43544,3,208114,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208114Orig1s000TOC.cfm","2016-05-10 00:00:00",
53616,1,208124,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208124Orig1s000ltr.pdf","2018-04-05 00:00:00",
53617,1,208129,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208129Orig1s000ltr.pdf","2018-04-05 00:00:00",
32893,1,208135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208135Orig1s000ltr.pdf","2016-03-02 00:00:00",
40618,2,208135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208135s000lbl.pdf","2016-03-03 00:00:00",
46035,3,208135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208135Orig1s000TOC.cfm","2016-10-27 00:00:00",
46037,21,208135,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208135Orig1s000SumR.pdf","2016-10-27 00:00:00",
51679,60,208135,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208135 tetracaine DD clinical prea.pdf","1900-01-01 00:00:00",
51680,20,208135,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208135 tetracaine clinical prea.pdf","1900-01-01 00:00:00",
51681,18,208135,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208135 tetracaine clinpharm prea.pdf","1900-01-01 00:00:00",
51682,17,208135,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208135 tetracaine statistical prea.pdf","1900-01-01 00:00:00",
19985,2,208143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208143s000lbl.pdf","2016-01-26 00:00:00",
32894,1,208143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208143Orig1s000Approvedt.pdf","2016-01-20 00:00:00",
45863,3,208143,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208143_toc.cfm","2016-11-09 00:00:00",
54030,20,208143,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208143 barium sulfate clinical prea.pdf","1900-01-01 00:00:00",
47389,2,208143,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s002lbl.pdf","2017-03-02 00:00:00",
47463,1,208143,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s002ltr.pdf","2017-03-03 00:00:00",
47147,2,208143,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s003lbl.pdf","2017-02-09 00:00:00",
47158,1,208143,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s003ltr.pdf","2017-02-09 00:00:00",
48935,2,208143,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s004lbl.pdf","2017-07-10 00:00:00",
48947,1,208143,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s004ltr.pdf","2017-07-11 00:00:00",
49274,2,208143,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208143s005lbl.pdf","2017-08-08 00:00:00",
49283,1,208143,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208143Orig1s005ltr.pdf","2017-08-08 00:00:00",
51858,2,208143,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s006lbl.pdf","2018-01-26 00:00:00",
51902,1,208143,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208143Orig1s006ltr.pdf","2018-01-26 00:00:00",
53454,2,208143,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208143s007lbl.pdf","2018-03-27 00:00:00",
53518,1,208143,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208143Orig1s007ltr.pdf","2018-03-29 00:00:00",
50894,1,208144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208144Orig1s000ltr.pdf","2017-12-22 00:00:00",
50935,2,208144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208144Orig1s000lbl.pdf","2017-12-28 00:00:00",
53640,3,208144,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208144Orig1s000TOC.cfm","2018-04-09 00:00:00",
54138,20,208144,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/227_208144 brimonidine clinical prea.pdf","1900-01-01 00:00:00",
54139,57,208144,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/228_208144 brimonidine CDTL clinical prea.pdf","1900-01-01 00:00:00",
54140,17,208144,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/225_208144 brimonidine statistical prea.pdf","1900-01-01 00:00:00",
19986,2,208147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208147s000lbl.pdf","2015-10-22 00:00:00",
23050,3,208147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208147Orig1DyanavelTOC.cfm","2016-06-30 00:00:00",
24534,21,208147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208147Orig1s000SumR_6pgs_rev1rev2kc_Redacted.pdf","2016-06-30 00:00:00",
32895,1,208147,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208147Orig1s000ltr.pdf","2015-10-22 00:00:00",
51527,20,208147,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine clinical prea.pdf","1900-01-01 00:00:00",
51528,18,208147,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine clinpharm prea.pdf","1900-01-01 00:00:00",
51529,17,208147,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine statistical prea.pdf","1900-01-01 00:00:00",
46712,2,208147,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s002lbl.pdf","2017-01-06 00:00:00",
46759,1,208147,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208147Orig1s002ltr.pdf","2017-01-10 00:00:00",
48469,2,208147,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf","2017-05-22 00:00:00",
48470,8,208147,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf#page=15","2017-05-22 00:00:00",
46013,2,208151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208151lbl.pdf","2016-12-05 00:00:00",
46024,1,208151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208151Orig1s000ltr.pdf","2016-12-06 00:00:00",
47583,3,208151,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208151Orig1s000TOC.cfm","2017-03-17 00:00:00",
51752,20,208151,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/53_208151 atropine sulfate clinical prea.pdf","1900-01-01 00:00:00",
51753,18,208151,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/54_208151 atropine sulfate clinpharm prea.pdf","1900-01-01 00:00:00",
51754,17,208151,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/55_208151 atropine sulfate statistical prea.pdf","1900-01-01 00:00:00",
49040,1,208154,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208154Orig1s000ltr.pdf","2017-07-21 00:00:00",
10645,1,208159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208159Orig1s000ltr.pdf","2015-12-14 00:00:00",
10646,1,208159,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208159Orig1s001ltr.pdf","2016-03-31 00:00:00",
40619,2,208159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208159s000lbl.pdf","2015-12-11 00:00:00",
40620,2,208159,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208159s001lbl.pdf","2016-03-31 00:00:00",
46068,3,208159,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208159Orig1s000TOC.cfm","2016-09-30 00:00:00",
10647,1,208169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208169Orig1s000ltr.pdf","2015-09-10 00:00:00",
23051,3,208169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208169Orig1s000TOC.cfm","2015-10-08 00:00:00",
40621,2,208169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208169s000lbl.pdf","2015-09-22 00:00:00",
44972,21,208169,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208169Orig1s000SumR.pdf","2015-10-08 00:00:00",
23052,3,208183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208183Orig1s000TOC.cfm","2016-06-29 00:00:00",
24535,21,208183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208183Orig1s000SumR.pdf","2016-06-29 00:00:00",
32896,1,208183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208183Orig1s000ltr.pdf","2015-11-13 00:00:00",
40622,2,208183,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208183s000lbl.pdf","2015-11-12 00:00:00",
45121,1,208191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208191s001ltr.pdf","2016-08-31 00:00:00",
10648,1,208194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208194Orig1s000ltr.pdf","2015-12-09 00:00:00",
19987,2,208194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf","2015-12-08 00:00:00",
23053,3,208194,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208194Orig1s000TOC.cfm","2016-06-27 00:00:00",
32897,1,208194,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf","2016-06-24 00:00:00",
40623,2,208194,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf","2016-08-02 00:00:00",
10649,1,208194,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf","2016-06-24 00:00:00",
40624,2,208194,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf","2016-06-27 00:00:00",
52651,3,208194,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208194Orig1s003.pdf","2018-02-15 00:00:00",
52652,3,208194,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208194Orig1s004.pdf","2018-02-15 00:00:00",
47169,2,208194,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf","2017-02-10 00:00:00",
47180,1,208194,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208194Orig1s005ltr.pdf","2017-02-13 00:00:00",
55065,2,208194,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf","2018-07-31 00:00:00",
55089,1,208194,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208194Orig1s013ltr.pdf","2018-08-03 00:00:00",
49691,1,208213,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208213Orig1s000TAltr.pdf","2017-09-07 00:00:00",
32898,1,208215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208215Orig1s000ltr.pdf","2016-04-13 00:00:00",
40625,2,208215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf","2016-04-12 00:00:00",
46605,3,208215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1_toc.cfm","2016-12-30 00:00:00",
46606,21,208215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1s000SumR.pdf","2016-12-30 00:00:00",
47910,2,208215,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf","2017-04-10 00:00:00",
52462,62,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208351 emtricitabine rilpivirine tenofovir clinpharm addendum prea.pdf","1900-01-01 00:00:00",
52463,62,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208215 emtricitabine and tenofovir alafenamide clinpharm addendum prea.pdf","1900-01-01 00:00:00",
52464,61,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208215 emtricitabine and tenofovir alafenamide clinpharm addendum prea.pdf","1900-01-01 00:00:00",
52465,18,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208215 emtricitabine and tenofovir alafenamide clinpharm  prea.pdf","1900-01-01 00:00:00",
52466,17,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208215 emtricitabine and tenofovir alafenamide statistical prea.pdf","1900-01-01 00:00:00",
53533,18,208215,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/185_208215s005 descovy clinical prea.pdf","1900-01-01 00:00:00",
49884,2,208215,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf","2017-09-29 00:00:00",
49907,1,208215,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208215Orig1s005ltr.pdf","2017-10-02 00:00:00",
52468,18,208215,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/187_208125s005 descovy clinpharm prea.pdf","1900-01-01 00:00:00",
10650,1,208216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208216Orig1s000ltr.pdf","2016-05-04 00:00:00",
40626,2,208216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208216s000lbl.pdf","2016-05-03 00:00:00",
49024,3,208216,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208216Orig1s000TOC.cfm","2017-07-20 00:00:00",
51027,2,208216,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208216s001lbl.pdf","2018-01-11 00:00:00",
51031,1,208216,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208216Orig1s001ltr.pdf","2018-01-11 00:00:00",
48187,1,208218,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208218Orig1s000ltr.pdf","2017-05-02 00:00:00",
32899,1,208223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208223Orig1s000ltr.pdf","2016-02-01 00:00:00",
40627,2,208223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208223Orig1s000lbl.pdf","2016-02-11 00:00:00",
50197,3,208223,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208223Orig1s000TOC.cfm","2017-10-26 00:00:00",
47626,2,208223,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208223Orig1s003lbledt.pdf","2017-03-28 00:00:00",
47692,1,208223,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208223Orig1s003ltredt.pdf","2017-03-28 00:00:00",
45373,1,208224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208224Orig1s000ltr.pdf","2016-09-20 00:00:00",
45374,2,208224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf","2016-09-20 00:00:00",
50198,3,208224,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208224Orig1s000TOC.cfm","2017-10-26 00:00:00",
52794,2,208224,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.pdf","2018-03-02 00:00:00",
52814,1,208224,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203159Orig1s010,208224Orig1s001ltr.pdf","2018-03-05 00:00:00",
55407,1,208231,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208231Orig1s000ltr.pdf","2018-09-07 00:00:00",
52817,1,208234,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208234Orig1s000ltr.pdf","2018-03-05 00:00:00",
32900,1,208246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208246Orig1s000ltr.pdf","2016-02-25 00:00:00",
40628,2,208246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208246s000lbl.pdf","2016-02-26 00:00:00",
48822,3,208246,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208246Orig1s000TOC.cfm","2017-06-26 00:00:00",
49529,2,208246,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf","2017-08-24 00:00:00",
49532,2,208246,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf","2017-08-24 00:00:00",
50701,2,208246,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf","2017-12-15 00:00:00",
50709,1,208246,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203214Orig1s017,208246ORig1s003ltr.pdf","2017-12-15 00:00:00",
55217,1,208246,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s021,208246Orig1s007ltr.pdf","2018-08-20 00:00:00",
55260,2,208246,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf","2018-08-21 00:00:00",
55261,8,208246,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf#page=49","2018-08-21 00:00:00",
10651,1,208251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208251Orig1s000ltr.pdf","2016-05-02 00:00:00",
40629,2,208251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208251orig1s000lbl.pdf","2016-05-03 00:00:00",
50126,3,208251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208251Orig1s000TOC.cfm","2017-10-20 00:00:00",
52570,20,208251,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208251 ciprofloxacin and fluocinolone acetonide clinical prea.pdf","1900-01-01 00:00:00",
52571,18,208251,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208251 ciprofloxacin and fluocinolone acetonide clinpharm prea.pdf","1900-01-01 00:00:00",
52572,17,208251,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208251 ciprofloxacin and fluocinolone acetonide statistical prea.pdf","1900-01-01 00:00:00",
19988,2,208253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208253s000lbl.pdf","2016-04-27 00:00:00",
32901,1,208253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208253Orig1s000ltr.pdf","2016-04-27 00:00:00",
46040,3,208253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208253Orig1s000TOC.cfm","2016-10-26 00:00:00",
46041,21,208253,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208253Orig1s000SumR.pdf","2016-10-26 00:00:00",
50417,1,208253,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205931Orig1s003,208253Orig1s001ltr.pdf","2017-11-15 00:00:00",
50520,2,208253,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205931s003,208253s001lbl.pdf","2017-11-29 00:00:00",
50757,2,208254,"ORIG",1,"0","httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf","2017-12-18 00:00:00",
50758,1,208254,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208254Orig1s000ltr.pdf","2017-12-18 00:00:00",
52052,3,208254,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208254Orig1s000TOC.cfm","2018-01-29 00:00:00",
52770,2,208255,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208255s000lbl.pdf","2018-02-06 00:00:00",
52771,1,208255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208255Orig1s000ltr.pdf","2018-02-09 00:00:00",
55857,3,208255,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208255Orig1s000TOC.cfm","2018-10-10 00:00:00",
54445,1,208256,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208256Orig1s000ltr.pdf","2018-06-05 00:00:00",
48651,1,208257,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208257Orig1s000TAltr.pdf","2017-06-06 00:00:00",
47865,2,208258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208258Orig1s000lbl.pdf","2017-04-05 00:00:00",
47871,1,208258,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208258Orig1s000ltr.pdf","2017-04-05 00:00:00",
10652,1,208261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208261Orig1s000ltr.pdf","2016-01-29 00:00:00",
19989,2,208261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208261Orig1s000lbl.pdf","2016-02-02 00:00:00",
43545,3,208261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208261Orig1s000TOC.cfm","2016-03-08 00:00:00",
44973,21,208261,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208261Orig1s000SumR.pdf","2016-03-08 00:00:00",
46806,2,208261,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208261s001lbl.pdf","2017-01-11 00:00:00",
46853,1,208261,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208261Orig1s001ltr.pdf","2017-01-17 00:00:00",
47244,1,208261,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208261Orig1s002ltr.pdf","2017-02-16 00:00:00",
47245,2,208261,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208261s002lbl.pdf","2017-02-16 00:00:00",
50383,1,208261,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208261Orig1s003ltredt.pdf","2017-11-13 00:00:00",
50402,2,208261,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208261Orig1s003lbledt.pdf","2017-11-14 00:00:00",
54772,2,208261,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208261s005lbl.pdf","2018-07-05 00:00:00",
54827,1,208261,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208261Orig1s005ltr.pdf","2018-07-06 00:00:00",
46992,2,208264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208264s000lbl.pdf","2017-01-26 00:00:00",
47010,1,208264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208264Orig1s000ltr.pdf","2017-01-30 00:00:00",
54776,3,208264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208264Orig1s000TOC.cfm","2018-07-06 00:00:00",
32902,1,208271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208271Orig1s000ltr.pdf","2016-07-22 00:00:00",
40630,2,208271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208271s000lbl.pdf","2016-07-21 00:00:00",
48436,2,208271,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf","2017-05-18 00:00:00",
48458,1,208271,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s017,208271Orig1s001ltr.pdf","2017-05-19 00:00:00",
49221,8,208271,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29","2017-08-03 00:00:00",
50471,3,208271,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208271Orig1s000TOC.cfm","2017-11-22 00:00:00",
49220,2,208271,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf","2017-08-03 00:00:00",
49563,1,208271,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s018;208271Orig1s002ltr.pdf","2017-08-29 00:00:00",
52967,2,208271,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf","2018-03-15 00:00:00",
52980,1,208271,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021964Orig1s019,208271Orig1s003ltr.pdf","2018-03-15 00:00:00",
55067,2,208276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf","2018-07-31 00:00:00",
55081,1,208276,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf","2018-08-03 00:00:00",
32903,1,208277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208277Orig1s000ltr.pdf","2016-05-06 00:00:00",
40631,2,208277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208277s000lbl.pdf","2016-05-03 00:00:00",
49106,1,208277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202834Orig1s012,208277Orig1s001ltr.pdf","2017-07-28 00:00:00",
49132,2,208277,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf","2017-07-28 00:00:00",
49133,8,208277,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24","2017-07-28 00:00:00",
50485,3,208277,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208277Orig1s000TOC.cfm","2017-11-27 00:00:00",
51556,20,208277,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208277 perampanel clinical prea.pdf","1900-01-01 00:00:00",
51557,18,208277,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208277 perampanel clinpharm MTL prea.pdf","1900-01-01 00:00:00",
51558,20,208277,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208277 perampanel clinical prea.pdf","1900-01-01 00:00:00",
55764,1,208277,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202834Orig1s014,208277Orig1s002ltr.pdf","2018-10-01 00:00:00",
55801,2,208277,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf","2018-10-03 00:00:00",
55802,8,208277,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24","2018-10-03 00:00:00",
32904,1,208286,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208286Orig1s000TAltr.pdf","2016-01-29 00:00:00",
55137,2,208288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208288s000lbl.pdf","2018-08-08 00:00:00",
55161,1,208288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208288Orig1s000ltr.pdf","2018-08-10 00:00:00",
10653,1,208289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208289Orig1s000ltr.pdf","2016-05-04 00:00:00",
19990,2,208289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf","2016-05-05 00:00:00",
23054,3,208289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000TOC.cfm","2016-05-24 00:00:00",
44974,21,208289,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000SumR.pdf","2016-05-24 00:00:00",
55166,2,208289,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf","2018-08-13 00:00:00",
55227,1,208289,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208289Orig1s002ltr.pdf","2018-08-20 00:00:00",
19991,2,208294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf","2016-04-27 00:00:00",
32905,1,208294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208294Orig1s000ltr.pdf","2016-04-27 00:00:00",
43987,8,208294,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501636.pdf","2016-05-18 00:00:00",
52884,3,208294,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208294Orig1s000TOC.cfm","2018-03-09 00:00:00",
55329,1,208299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208299Orig1s000TAltr.pdf","2018-08-27 00:00:00",
53622,1,208305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208305Orig1s000ltr.pdf","2018-04-05 00:00:00",
50343,1,208306,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208306Orig1s000ltr.pdf","2017-11-08 00:00:00",
54908,2,208313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208313s000lbl.pdf","2018-07-17 00:00:00",
54953,1,208313,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208313Orig1s000ltr.pdf","2018-07-23 00:00:00",
47131,2,208325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf","2017-02-08 00:00:00",
47138,1,208325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208325Orig1s000ltr.pdf","2017-02-08 00:00:00",
47628,3,208325,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208325Orig1s000TOC.cfm","2017-03-21 00:00:00",
55255,2,208325,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208325s001lbl.pdf","2018-08-21 00:00:00",
55324,1,208325,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208325Orig1s001ltr.pdf","2018-08-27 00:00:00",
50336,1,208327,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208327Orig1s000TAltr.pdf","2017-11-08 00:00:00",
47057,1,208328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208328Orig1s000ltr.pdf","2017-01-31 00:00:00",
47076,2,208328,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208328Orig1s000lbl.pdf","2017-01-31 00:00:00",
54446,1,208335,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208335Orig1s000ltr.pdf","2018-06-05 00:00:00",
54447,1,208336,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208336Orig1s000ltr.pdf","2018-06-05 00:00:00",
32906,1,208341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208341Orig1s000ltr.pdf","2016-06-28 00:00:00",
40632,2,208341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf","2016-06-28 00:00:00",
44999,3,208341,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208341Orig1s000TOC.cfm","2016-06-28 00:00:00",
49211,1,208341,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0208341Orig1s001ltr.pdf","2017-08-02 00:00:00",
49225,2,208341,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s001lbl.pdf","2017-08-03 00:00:00",
47224,1,208341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s002ltr.pdf","2017-02-15 00:00:00",
47251,2,208341,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s002lbl.pdf","2017-02-16 00:00:00",
49649,2,208341,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf","2017-09-01 00:00:00",
49656,1,208341,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s007ltr.pdf","2017-09-01 00:00:00",
50376,1,208341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s009ltr.pdf","2017-11-13 00:00:00",
50394,2,208341,"SUPPL",9,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s009lbl.pdf","2017-11-13 00:00:00",
53758,1,208342,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208342Orig1s000ltr.pdf","2018-04-20 00:00:00",
19992,2,208351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208351s000lbl.pdf","2016-03-03 00:00:00",
32907,1,208351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208351Orig1s000ltr.pdf","2016-03-03 00:00:00",
46008,3,208351,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208351Orig1s000TOC.cfm","2016-12-02 00:00:00",
47907,2,208351,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s001lbl.pdf","2017-04-10 00:00:00",
47986,1,208351,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s001ltr.pdf","2017-04-12 00:00:00",
52458,20,208351,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208351 emtricitabine rilpivirine tenofovir clinical prea.pdf","1900-01-01 00:00:00",
52459,57,208351,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208351 emtricitabine rilpivirine tenofovir CDTL clinical prea.pdf","1900-01-01 00:00:00",
52460,18,208351,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208351 emtricitabine rilpivirine and tenofovir alafenamide clinpharm prea.pdf","1900-01-01 00:00:00",
52461,61,208351,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208351 emtricitabine rilpivirine tenofovir clinpharm addendum prea.pdf","1900-01-01 00:00:00",
49502,2,208351,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf","2017-08-22 00:00:00",
49509,1,208351,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s002s003ltr.pdf","2017-08-22 00:00:00",
49503,2,208351,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208351s002s003lbl.pdf","2017-08-22 00:00:00",
49510,1,208351,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208351Orig1s002s003ltr.pdf","2017-08-22 00:00:00",
49580,1,208362,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208362Orig1s000ltr.pdf","2017-08-29 00:00:00",
54169,1,208366,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208366Orig1s000TAltr.pdf","2018-05-11 00:00:00",
50865,2,208374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208374s000lbl.pdf","2017-12-26 00:00:00",
50918,1,208374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208374Orig1s000ltr.pdf","2017-12-27 00:00:00",
52671,3,208374,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208374Orig1s000TOC.cfm","2018-02-20 00:00:00",
48999,2,208379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208379s000lbl.pdf","2017-07-17 00:00:00",
49001,1,208379,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208379Orig1s000ltr.pdf","2017-07-17 00:00:00",
49651,3,208379,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208379_toc.cfm","2017-09-01 00:00:00",
49652,21,208379,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208379Orig1s000SumR.pdf","2017-09-01 00:00:00",
50358,1,208380,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208380Orig1s000TAltr.pdf","2017-11-09 00:00:00",
48811,2,208383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf","2017-06-23 00:00:00",
48812,8,208383,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20","2017-06-23 00:00:00",
48813,1,208383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208383Orig1s000ltr.pdf","2017-06-23 00:00:00",
48997,1,208383,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208383Orig1s001ltr.pdf","2017-07-17 00:00:00",
49000,2,208383,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s001lbl.pdf","2017-07-17 00:00:00",
49056,3,208383,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208383Orig1s000TOC.cfm","2017-07-25 00:00:00",
49753,1,208385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208385Orig1s000ltr.pdf","2017-09-15 00:00:00",
50517,2,208385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208385Orig1s000lbl.pdf","2017-11-28 00:00:00",
54473,3,208385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208385Orig1s000TOC.cfm","2018-06-07 00:00:00",
55377,2,208385,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208385s001lbl.pdf","2018-08-31 00:00:00",
55468,1,208385,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208385Orig1001ltr.pdf","2018-09-13 00:00:00",
53804,1,208390,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208390Orig1s000TAltr.pdf","2018-04-24 00:00:00",
45628,1,208398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208398Orig1s000ltr.pdf","2016-10-21 00:00:00",
45686,2,208398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208398s000lbl.pdf","2016-10-27 00:00:00",
46614,3,208398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208398Orig1_toc.cfm","2016-12-30 00:00:00",
46615,21,208398,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208398Orig1s000SumR.pdf","2016-12-30 00:00:00",
50195,2,208399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208399s000lbl.pdf","2017-10-26 00:00:00",
50229,1,208399,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208399Orig1s000ltr.pdf","2017-10-30 00:00:00",
53685,2,208399,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206500s003,208399s002lbl.pdf","2018-04-16 00:00:00",
53699,1,208399,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206500Orig1s003,208399Orig1s002ltr.pdf","2018-04-16 00:00:00",
48114,2,208400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf","2017-04-26 00:00:00",
48153,1,208400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf","2017-04-27 00:00:00",
50055,3,208400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.cfm","2017-10-13 00:00:00",
48118,2,208400,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf","2017-04-26 00:00:00",
48154,1,208400,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf","2017-04-27 00:00:00",
50054,3,208400,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.cfm","2017-10-13 00:00:00",
53046,2,208400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208004s002lbl.pdf","2018-03-16 00:00:00",
53064,1,208400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208400Orig1s002ltr.pdf","2018-03-20 00:00:00",
10654,1,208401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208401Orig1s000ltr.pdf","2016-08-02 00:00:00",
19993,2,208401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208401s000lbl.pdf","2016-08-02 00:00:00",
46455,3,208401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208401Orig1s000_toc.cfm","2016-12-21 00:00:00",
49153,2,208401,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208401s002lbl.pdf","2017-07-31 00:00:00",
49185,1,208401,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208401Orig1s002ltr.pdf","2017-08-02 00:00:00",
32908,1,208411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208411Orig1s000ltr.pdf","2015-11-19 00:00:00",
40633,2,208411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf","2015-11-18 00:00:00",
43546,3,208411,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208411Orig1s000TOC.cfm","2016-07-28 00:00:00",
46979,2,208411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208411s001lbl.pdf","2017-01-24 00:00:00",
46990,21,208411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/208411s001SumR.pdf","2017-01-27 00:00:00",
46993,1,208411,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208411Orig1s001ltr.pdf","2017-01-27 00:00:00",
51391,60,208411,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208411 naloxone DD clinical prea.pdf","1900-01-01 00:00:00",
51392,18,208411,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208411 naloxone clinpharm prea.pdf","1900-01-01 00:00:00",
51393,57,208411,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208411 naloxone CDTL clinical prea.pdf","1900-01-01 00:00:00",
48977,1,208415,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208415TA_ltr.pdf","2017-07-13 00:00:00",
48730,2,208418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf","2017-06-16 00:00:00",
48746,1,208418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208418Orig1s000ltr.pdf","2017-06-16 00:00:00",
52401,20,208418,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/141_208418 calcium gluconate clinical prea.pdf","1900-01-01 00:00:00",
52402,57,208418,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/140_208418 calcium gluconate CDTL clinical prea.pdf","1900-01-01 00:00:00",
52403,18,208418,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/142_208418 calcium gluconate clinpharm prea.pdf","1900-01-01 00:00:00",
54230,3,208418,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208418Orig1s000TOC.cfm","2018-05-17 00:00:00",
54464,3,208418,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/review/2018/208418Orig1s001.pdf","2018-06-05 00:00:00",
50734,1,208420,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208420Orig1s000TAltr.pdf","2017-12-18 00:00:00",
50359,1,208421,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208421Orig1s000TAltr.pdf","2017-11-09 00:00:00",
50735,1,208423,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208423Orig1s000TAltr.pdf","2017-12-18 00:00:00",
19994,2,208424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208424s000lbl.pdf","2016-06-13 00:00:00",
32909,1,208424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208424Orig1s000ltr.pdf","2016-06-10 00:00:00",
46030,3,208424,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208424Orig1toc.cfm","2016-12-06 00:00:00",
50736,1,208431,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208431Orig1s000TAltr.pdf","2017-12-18 00:00:00",
50059,1,208433,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208433Orig1s000TAltr.pdf","2017-10-13 00:00:00",
19995,2,208434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf","2015-12-11 00:00:00",
43547,3,208434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000TOC.cfm","2016-01-28 00:00:00",
44975,21,208434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000SumR.pdf","2016-01-28 00:00:00",
45826,1,208434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208434Orig1s001ltr.pdf","2016-11-08 00:00:00",
45846,2,208434,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf","2016-11-08 00:00:00",
50314,2,208434,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf","2017-11-06 00:00:00",
50356,1,208434,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208434Orig1s003ltr.pdf","2017-11-09 00:00:00",
54485,2,208434,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208434s004lbl.pdf","2018-06-08 00:00:00",
54554,1,208434,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf","2018-06-14 00:00:00",
54555,1,208434,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf","2018-06-14 00:00:00",
50620,2,208437,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208437lbl.pdf","2017-12-06 00:00:00",
50621,1,208437,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208437Orig1s000ltr.pdf","2017-12-06 00:00:00",
47716,2,208447,"ORIG",1,"0","httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf","2017-03-27 00:00:00",
47760,1,208447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208447Orig1s000Ltr.pdf","2017-03-29 00:00:00",
48076,3,208447,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208447_zejula_toc.cfm","2017-04-21 00:00:00",
50737,1,208452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208452Orig1s000TAltr.pdf","2017-12-18 00:00:00",
50360,1,208457,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208457Orig1s000TAltr.pdf","2017-11-09 00:00:00",
10656,1,208462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208462Orig1s000ltr.pdf","2015-11-20 00:00:00",
40634,2,208462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf","2015-11-20 00:00:00",
43548,3,208462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000TOC.cfm","2015-12-30 00:00:00",
44976,21,208462,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000SumR.pdf","2015-12-01 00:00:00",
45956,1,208462,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208462Orig1s001ltr.pdf","2016-11-25 00:00:00",
45998,2,208462,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208462s001lbl.pdf","2016-12-01 00:00:00",
45888,2,208464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf","2016-11-14 00:00:00",
45896,1,208464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208464Orig1s000ltr.pdf","2016-11-15 00:00:00",
47911,2,208464,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf","2017-04-10 00:00:00",
47983,1,208464,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208464Orig1s001ltr.pdf","2017-04-12 00:00:00",
50486,3,208464,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208464Orig1s000TOC.cfm","2017-11-27 00:00:00",
54780,1,208464,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208464Orig1s004ltr.pdf","2018-07-06 00:00:00",
45902,2,208470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf","2016-11-16 00:00:00",
45905,1,208470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208470Orig1s000ltr.pdf","2016-11-17 00:00:00",
51046,3,208470,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000TOC.cfm","2018-01-12 00:00:00",
52624,2,208470,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208470s001lbl.pdf","2018-02-14 00:00:00",
32910,1,208471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf","2016-07-28 00:00:00",
40635,2,208471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf","2016-07-28 00:00:00",
45985,3,208471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.cfm","2016-12-01 00:00:00",
47164,8,208471,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf#page=31","2017-02-10 00:00:00",
54144,1,208472,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208472Orig1s000TAltr.pdf","2018-05-11 00:00:00",
52537,1,208505,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208505Orig1s000TAltr.pdf","2018-02-09 00:00:00",
55330,1,208508,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208508Orig1s000TAltr.pdf","2018-08-27 00:00:00",
47037,2,208510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf","2017-01-27 00:00:00",
47073,1,208510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208510Orig1s000ltr.pdf","2017-01-31 00:00:00",
48489,2,208510,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf","2017-05-23 00:00:00",
48499,1,208510,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Origs045,208510Orig1s001ltr.pdf","2017-05-23 00:00:00",
50056,3,208510,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208510Orig1s000TOC.cfm","2017-10-13 00:00:00",
51312,20,208510,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/63_208510 Vyvanse clinical prea.pdf","1900-01-01 00:00:00",
51313,18,208510,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/64_208510 Vyvanse clinpharm prea.pdf","1900-01-01 00:00:00",
49175,2,208510,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf","2017-08-01 00:00:00",
49176,8,208510,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf#page=38","2017-08-01 00:00:00",
49199,1,208510,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s034,208510Orig1s002ltr.pdf","2017-08-02 00:00:00",
50987,1,208518,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208518Orig1s000ltr.pdf","2018-01-08 00:00:00",
48349,1,208521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208521Orig1s000ltr.pdf","2017-05-10 00:00:00",
32911,1,208524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208524Orig1s000ltr.pdf","2016-07-19 00:00:00",
40636,2,208524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208524s000lbl.pdf","2016-07-18 00:00:00",
46038,3,208524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208524Orig1s000TOC.cfm","2016-10-26 00:00:00",
46039,21,208524,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208524Orig1s000SumR.pdf","2016-10-26 00:00:00",
48530,1,208524,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022529Orig1s005,022529Orig1s007,208524Orig1s001ltr.pdf","2017-05-25 00:00:00",
48545,2,208524,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf","2017-05-26 00:00:00",
50738,1,208531,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208531Orig1s000TAltr.pdf","2017-12-18 00:00:00",
55404,1,208532,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208532Orig1s000ltr.pdf","2018-09-07 00:00:00",
55399,1,208539,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208539Orig1s000TAltr.pdf","2018-09-07 00:00:00",
54786,1,208544,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208544Orig1s000TAltr.pdf","2018-07-06 00:00:00",
10657,1,208547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s000ltr.pdf","2016-06-06 00:00:00",
19996,2,208547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf","2016-06-02 00:00:00",
43549,3,208547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000TOC.cfm","2016-06-21 00:00:00",
44977,21,208547,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000SumR.pdf","2016-06-21 00:00:00",
45202,2,208547,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s002lbl.pdf","2016-09-02 00:00:00",
45225,1,208547,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s002ltr.pdf","2016-09-02 00:00:00",
46951,2,208547,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208547s004lbl.pdf","2017-01-24 00:00:00",
46958,1,208547,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208547Orig1s004ltr.pdf","2017-01-24 00:00:00",
53666,2,208547,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208547s011lbl.pdf","2018-04-13 00:00:00",
53690,1,208547,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208547Orig1s011ltr.pdf","2018-04-16 00:00:00",
10658,1,208551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208551Orig1s000ltr.pdf","2016-04-27 00:00:00",
19997,2,208551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208551s000lbl.pdf","2016-04-27 00:00:00",
46043,3,208551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208551Orig1s000TOC.cfm","2016-10-21 00:00:00",
46044,21,208551,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208341Orig1s000SumR.pdf","2016-10-21 00:00:00",
50063,2,208551,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208551s003lbl.pdf","2017-10-17 00:00:00",
50110,1,208551,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208551Orig1s003ltr.pdf","2017-10-19 00:00:00",
53575,2,208551,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208551s005lbl.pdf","2018-04-01 00:00:00",
53579,1,208551,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208551Orig1s005ltr.pdf","2018-04-01 00:00:00",
46908,1,208552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208552Orig1s000ltr.pdf","2017-01-19 00:00:00",
46916,2,208552,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208552s000lbl.pdf","2017-01-18 00:00:00",
49443,2,208558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf","2017-08-17 00:00:00",
49444,8,208558,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf#page=23","2017-08-17 00:00:00",
49493,1,208558,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208558Orig1s000ltr.pdf","2017-08-21 00:00:00",
49660,3,208558,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558_toc.cfm","2017-09-05 00:00:00",
51041,2,208558,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf","2018-01-12 00:00:00",
51059,1,208558,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208558Orig1s001ltr.pdf","2018-01-17 00:00:00",
52493,2,208558,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s002lbl.pdf","2018-02-07 00:00:00",
55632,2,208558,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf","2018-09-27 00:00:00",
55633,8,208558,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf#page=27","2018-09-27 00:00:00",
55760,1,208558,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208558Orig1s005ltr.pdf","2018-10-01 00:00:00",
54163,1,208560,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208560Orig1s000TAltr.pdf","2018-05-11 00:00:00",
48321,2,208562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208562s000lbl.pdf","2017-03-10 00:00:00",
48322,1,208562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208562Orig1s000ltr.pdf","2017-03-14 00:00:00",
54472,3,208562,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208562Orig1s000TOC.cfm","2018-06-07 00:00:00",
53457,2,208562,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf","2018-03-27 00:00:00",
53632,1,208562,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208562s002ltr.pdf","2018-04-09 00:00:00",
54392,2,208564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf","2018-05-31 00:00:00",
54411,1,208564,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208564Orig1s000ltr.pdf","2018-06-01 00:00:00",
19998,2,208573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf","2016-04-11 00:00:00",
24536,21,208573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208573Orig1s000SumR.pdf","2016-05-19 00:00:00",
32912,1,208573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208573Orig1s000ltr.pdf","2016-04-11 00:00:00",
43550,3,208573,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208573Orig1s000TOC.cfm","2016-05-19 00:00:00",
50852,2,208573,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208573s003lbl.pdf","2017-12-26 00:00:00",
54479,2,208573,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf","2018-06-08 00:00:00",
54481,8,208573,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf#page=30","2018-06-08 00:00:00",
54590,1,208573,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s004s005ltr.pdf","2018-06-14 00:00:00",
54480,2,208573,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf","2018-06-08 00:00:00",
54482,8,208573,"SUPPL",5,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf#page=30","2018-06-08 00:00:00",
54591,1,208573,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s004s005ltr.pdf","2018-06-14 00:00:00",
55428,2,208573,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s007s010lbl.pdf","2018-09-11 00:00:00",
55446,1,208573,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s007s010Ltr.pdf","2018-09-12 00:00:00",
55427,2,208573,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s007s010lbl.pdf","2018-09-11 00:00:00",
55447,1,208573,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208573Orig1s007s010Ltr.pdf","2018-09-12 00:00:00",
55248,1,208576,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208576Orig1s000TAltr.pdf","2018-08-20 00:00:00",
50779,1,208582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208582Orig1s000ltr.pdf","2017-12-20 00:00:00",
53469,2,208582,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208582Orig1s000lbl.pdf","2018-03-28 00:00:00",
53641,3,208582,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208582Orig1s000TOC.cfm","2018-04-09 00:00:00",
50050,19,208583,"APPL",0,"0","https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=358","2017-10-12 00:00:00",
45928,1,208583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf","2016-11-22 00:00:00",
45933,2,208583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf","2016-11-21 00:00:00",
45960,8,208583,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm530717.pdf","2016-11-28 00:00:00",
50487,3,208583,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208583Orig1s000TOC.cfm","2017-11-27 00:00:00",
50744,1,208583,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208583Orig1s001ltr.pdf","2017-12-18 00:00:00",
48926,2,208587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf","2017-07-07 00:00:00",
48945,1,208587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208587Orig1s000ltr.pdf","2017-07-11 00:00:00",
53646,3,208587,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208587Orig1s000TOC.cfm","2018-04-10 00:00:00",
48653,1,208592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208592Orig1s000TAltr.pdf","2017-06-06 00:00:00",
49080,1,208593,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208593Orig1s000ltr.pdf","2017-07-25 00:00:00",
46728,2,208603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf","2017-01-09 00:00:00",
46731,1,208603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s000ltr.pdf","2017-01-09 00:00:00",
46738,8,208603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf#page=32","2017-01-10 00:00:00",
46807,19,208603,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17","2017-01-13 00:00:00",
47517,3,208603,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208603Orig1s000TOC.cfm","2017-03-10 00:00:00",
48029,14,208603,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2017-04-14 00:00:00",
48596,1,208603,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s002ltr.pdf","2017-05-31 00:00:00",
55520,2,208603,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf","2018-09-19 00:00:00",
55522,8,208603,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf#page=32","2018-09-19 00:00:00",
55725,1,208603,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf","2018-10-01 00:00:00",
55521,2,208603,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf","2018-09-19 00:00:00",
55523,8,208603,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf#page=32","2018-09-19 00:00:00",
55726,1,208603,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf","2018-10-01 00:00:00",
49119,1,208605,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208605Orig1s000ltr.pdf","2017-07-28 00:00:00",
47386,2,208609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208609s000lbl.pdf","2017-03-02 00:00:00",
47462,1,208609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208609Orig1s000ltr.pdf","2017-03-03 00:00:00",
52882,3,208609,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208609Orig1s000TOC.cfm","2018-03-09 00:00:00",
48766,2,208610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf","2017-06-19 00:00:00",
48768,8,208610,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24","2017-06-19 00:00:00",
48769,1,208610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208610Orig1s000,208611Orig1s000ltr.pdf","2017-06-19 00:00:00",
49058,3,208610,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208610Orig1s000,208611Orig1s000TOC.cfm","2017-07-25 00:00:00",
48765,2,208611,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf","2017-06-19 00:00:00",
48767,8,208611,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24","2017-06-19 00:00:00",
48770,1,208611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208610Orig1s000,208611Orig1s000ltr.pdf","2017-06-19 00:00:00",
49059,3,208611,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208610Orig1s000,208611Orig1s000TOC.cfm","2017-07-25 00:00:00",
51026,2,208612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208612s000lbl.pdf","2018-01-11 00:00:00",
51029,1,208612,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208612Orig1s000ltr.pdf","2018-01-11 00:00:00",
54970,2,208614,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208614s000lbl.pdf","2018-07-25 00:00:00",
54995,1,208614,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208614Orig1s000ltr.pdf","2018-07-26 00:00:00",
50992,1,208620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000TAltr.pdf","2018-01-08 00:00:00",
54159,1,208620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000TAltr.pdf","2018-05-11 00:00:00",
55491,1,208620,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000ReplacementTAltr.pdf","2018-09-14 00:00:00",
55165,2,208623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf","2018-08-10 00:00:00",
55172,1,208623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208623Orig1s000ltr.pdf","2018-08-14 00:00:00",
55432,3,208623,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208623Orig1s000TOC.cfm","2018-09-11 00:00:00",
19999,2,208624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf","2016-07-25 00:00:00",
32913,1,208624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208624Orig1s000ltr.pdf","2016-07-26 00:00:00",
47640,2,208624,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf","2017-03-23 00:00:00",
47672,1,208624,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf","2017-03-24 00:00:00",
48850,3,208624,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208624Orig1s000TOC.cfm","2017-06-28 00:00:00",
47210,2,208624,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf","2017-02-15 00:00:00",
47225,1,208624,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s002ltr.pdf","2017-02-15 00:00:00",
47641,2,208624,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf","2017-03-23 00:00:00",
47671,1,208624,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf","2017-03-24 00:00:00",
50380,2,208624,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf","2017-11-13 00:00:00",
54993,1,208624,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208624Orig1s006ltr.pdf","2018-07-26 00:00:00",
55358,2,208624,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf","2018-08-29 00:00:00",
55359,8,208624,"SUPPL",6,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf?page48","2018-08-29 00:00:00",
54884,2,208627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf","2018-07-13 00:00:00",
54885,1,208627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208627Orig1s000ltr.PDF","2018-07-13 00:00:00",
55177,3,208627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208627Orig1s000TOC.cfm","2018-08-15 00:00:00",
48662,2,208630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208630s000lbl.pdf","2017-06-07 00:00:00",
48663,1,208630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208630Orig1s000Ltr.pdf","2017-06-07 00:00:00",
55135,3,208630,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208630Orig1s000TOC.cfm","2018-08-08 00:00:00",
54600,1,208630,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208630Orig1s002ltr.pdf","2018-06-14 00:00:00",
54663,2,208630,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s002lbl.pdf","2018-06-21 00:00:00",
55277,2,208630,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208630s003lbl.pdf","2018-08-23 00:00:00",
55314,1,208630,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208630Orig1s003Ltr.pdf","2018-08-24 00:00:00",
45630,1,208645,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208645Orig1s000TAltr.pdf","2016-10-21 00:00:00",
52710,2,208653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf","2018-02-26 00:00:00",
52711,8,208653,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf#page=35","2018-02-26 00:00:00",
52722,1,208653,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s000ltr.pdf","2018-02-26 00:00:00",
55518,2,208653,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf","2018-09-19 00:00:00",
55711,1,208653,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf","2018-10-01 00:00:00",
55519,2,208653,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf","2018-09-19 00:00:00",
55712,1,208653,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf","2018-10-01 00:00:00",
50558,1,208656,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208656Orig1s000TAltr.pdf","2017-12-01 00:00:00",
46128,1,208658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s000ltr.pdf","2016-12-13 00:00:00",
46166,2,208658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s000lbl.pdf","2016-12-15 00:00:00",
46542,2,208658,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s001lbl.pdf","2016-12-27 00:00:00",
46555,1,208658,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s001ltr.pdf","2016-12-27 00:00:00",
50199,3,208658,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208658Orig1s000TOC.cfm","2017-10-26 00:00:00",
50689,2,208658,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf","2017-12-14 00:00:00",
50690,8,208658,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf#page=39","2017-12-14 00:00:00",
50714,1,208658,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf","2017-12-15 00:00:00",
45929,1,208673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208673Orig1s000ltr.pdf","2016-11-22 00:00:00",
45932,2,208673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208673s000lbl.pdf","2016-11-21 00:00:00",
46601,3,208673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1_toc.cfm","2016-12-30 00:00:00",
46603,21,208673,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208673Orig1s000SumR.pdf","2016-12-30 00:00:00",
49617,2,208673,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf","2017-08-30 00:00:00",
49618,8,208673,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf#page=37","2017-08-30 00:00:00",
49644,1,208673,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208673Orig1s002ltr.pdf","2017-08-31 00:00:00",
47140,1,208684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208684Orig1s000,208685Orig1s000ltr.pdf","2017-02-09 00:00:00",
47143,2,208684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf","2017-02-09 00:00:00",
47511,3,208684,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208684,208685Orig1s000TOC.cfm","2017-03-09 00:00:00",
47141,1,208685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208684Orig1s000,208685Orig1s000ltr.pdf","2017-02-09 00:00:00",
47142,2,208685,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf","2017-02-09 00:00:00",
45496,1,208686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208686Orig1s000ltr.pdf","2016-09-22 00:00:00",
46007,3,208686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208686Orig1s000TOC.cfm","2016-12-02 00:00:00",
46971,2,208686,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208686s000lbl.pdf","2017-01-24 00:00:00",
49151,2,208686,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208686s002lbl.pdf","2017-07-31 00:00:00",
24133,14,208692,"ORIG",1,"Package Labeling","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692Orig1s000pkglbl.pdf","2016-04-27 00:00:00",
32914,1,208692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208692Orig1s000ltr.pdf","2016-04-27 00:00:00",
40637,2,208692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf","2016-04-25 00:00:00",
50443,1,208692,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s001ltr.pdf","2017-11-17 00:00:00",
51047,3,208692,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208692Orig1s000TOC.cfm","2018-01-12 00:00:00",
50776,2,208692,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf","2017-12-19 00:00:00",
50903,1,208692,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s002ltr.pdf","2017-12-27 00:00:00",
48612,2,208694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208694s000lbl.pdf","2017-06-01 00:00:00",
48628,1,208694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208694Orig1s000ltr.pdf","2017-06-02 00:00:00",
51477,23,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N208694_cetirizine_Orig_WR.pdf","2015-09-15 00:00:00",
51478,25,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N208694_cetirizine_Amend_1.pdf","2016-03-29 00:00:00",
52417,20,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/136_208694 cetirizine clinical resub both.pdf","1900-01-01 00:00:00",
52418,20,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/135_208694 cetirizine clinical both.pdf","1900-01-01 00:00:00",
52419,18,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/137_208694 cetirizine clinpharm both.pdf","1900-01-01 00:00:00",
52420,17,208694,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/138_208694 cetirizine statistical both.pdf","2018-01-01 00:00:00",
54733,3,208694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208694Orig1s000TOC.cfm","2018-07-02 00:00:00",
54734,3,208694,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208694Orig1s000TOC.cfm","2018-07-02 00:00:00",
51796,2,208700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf","2018-01-26 00:00:00",
51797,1,208700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208700Orig1s000ltr.pdf","2018-01-26 00:00:00",
52916,3,208700,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208700Orig1s000TOC.cfm","2018-03-12 00:00:00",
49872,2,208716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf","2017-09-28 00:00:00",
49891,1,208716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208716Orig1s000ltr.pdf","2017-09-29 00:00:00",
50236,3,208716,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208716Orig1s000TOC.cfm","2017-10-31 00:00:00",
55214,1,208716,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208716Orig1s001ltr.pdf","2018-08-20 00:00:00",
55257,2,208716,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208716s001lbl.pdf","2018-08-21 00:00:00",
48944,1,208719,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208719Orig1s000ltr.pdf","2017-07-11 00:00:00",
49029,1,208722,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208722Orig1s000TAltr.pdf","2017-07-20 00:00:00",
45579,1,208723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208723Orig1s000ltr.pdf","2016-10-03 00:00:00",
45580,2,208723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208723s000lbl.pdf","2016-10-06 00:00:00",
45817,3,208723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208723Orig1s000TOC.cfm","2016-11-04 00:00:00",
47664,1,208723,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208723Orig1s002ltr.pdf","2017-03-24 00:00:00",
47700,2,208723,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208723s002lbl.pdf","2017-03-24 00:00:00",
48157,2,208743,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf","2017-04-28 00:00:00",
48158,1,208743,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208743Orig1s000ltr.pdf","2017-04-28 00:00:00",
48159,8,208743,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf#page=18","2017-04-28 00:00:00",
48680,3,208743,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000TOC.cfm","2017-06-08 00:00:00",
48681,21,208743,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000SumR.pdf","2017-06-08 00:00:00",
52396,2,208743,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf","2018-02-05 00:00:00",
52539,1,208743,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s001ltr.pdf","2018-02-09 00:00:00",
54704,1,208743,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s004ltr.pdf","2018-06-27 00:00:00",
54745,2,208743,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf","2018-07-04 00:00:00",
51089,2,208744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208744s000lbl.pdf","2018-01-18 00:00:00",
51866,1,208744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208744Orig1s000ltr.pdf","2018-01-26 00:00:00",
55856,3,208744,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208744Orig1s000TOC.cfm","2018-10-10 00:00:00",
46926,2,208745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf","2017-01-23 00:00:00",
46927,1,208745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208745Orig1s000ltr.pdf","2017-01-23 00:00:00",
47466,3,208745,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208745Orig1s000TOC.cfm","2017-03-03 00:00:00",
51918,2,208745,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf","2018-01-24 00:00:00",
51919,8,208745,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf#page=14","2018-01-26 00:00:00",
52106,1,208745,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s001ltr.pdf","2018-01-30 00:00:00",
55016,1,208745,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s002Ltr.pdf","2018-07-26 00:00:00",
49903,2,208751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf","2017-10-02 00:00:00",
49906,1,208751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208751Orig1s000ltr.pdf","2017-10-02 00:00:00",
52858,2,208751,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s001lbl.pdf","2018-03-08 00:00:00",
53008,1,208751,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s001ltr.pdf","2018-03-15 00:00:00",
53875,3,208751,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208751Orig1s000TOC.cfm","2018-04-30 00:00:00",
55747,1,208751,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s003ltr.pdf","2018-10-01 00:00:00",
55380,2,208751,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s005lbl.pdf","2018-09-05 00:00:00",
55455,1,208751,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s005ltr.pdf","2018-09-12 00:00:00",
55247,1,208757,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208757Orig1s000TAltr.pdf","2018-08-20 00:00:00",
48721,1,208765,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208765Orig1s000ltr.pdf","2017-06-15 00:00:00",
54448,1,208768,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208768Orig1s000ltr.pdf","2018-06-05 00:00:00",
48164,2,208772,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf","2017-04-28 00:00:00",
48165,1,208772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208772Orig1s000ltr.pdf","2017-04-28 00:00:00",
48573,3,208772,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208772Orig1s000TOC.cfm","2017-05-30 00:00:00",
46800,2,208780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208780s000lbl.pdf","2017-01-11 00:00:00",
46876,1,208780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208780Orig1s000ltr.pdf","2017-01-18 00:00:00",
52676,3,208780,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208780Orig1s000TOC.cfm","2018-02-21 00:00:00",
50334,1,208786,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208786Orig1s000TAltr.pdf","2017-11-08 00:00:00",
50970,1,208788,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208788Orig1s000ltr.pdf","2017-12-29 00:00:00",
54080,1,208790,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208790Orig1s000ltr.pdf","2018-05-10 00:00:00",
49869,2,208791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208791s000lbl.pdf","2017-09-28 00:00:00",
49875,1,208791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208791Orig1s000ltr.pdf","2017-09-28 00:00:00",
53078,3,208791,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208791Orig1s000TOC.cfm","2018-03-21 00:00:00",
47385,1,208794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208794Orig1s00ltredt.pdf","2017-03-01 00:00:00",
47434,2,208794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208794s000lbl.pdf","2017-03-03 00:00:00",
47848,3,208794,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208794Orig1s000TOC.cfm","2017-04-04 00:00:00",
47034,2,208798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208798s000lbl.pdf","2017-01-27 00:00:00",
47041,1,208798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208798Orig1s000ltr.pdf","2017-01-31 00:00:00",
48046,3,208798,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208798Orig1s000TOC.cfm","2017-04-14 00:00:00",
51122,20,208798,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208798 ArmonAir Clinical prea.pdf","1900-01-01 00:00:00",
51123,18,208798,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208798 ArmonAir Clinpharm prea.pdf","1900-01-01 00:00:00",
51124,17,208798,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208798 ArmonAir statistical prea.pdf","1900-01-01 00:00:00",
52821,2,208798,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208798s002lbl.pdf","2018-03-06 00:00:00",
53013,1,208798,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208798Orig1s002,208799Orig1s001ltr.pdf","2018-03-15 00:00:00",
47035,2,208799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf","2017-01-27 00:00:00",
47040,1,208799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s000ltr.pdf","2017-01-31 00:00:00",
48045,3,208799,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208799Orig1s000TOC.cfm","2017-04-14 00:00:00",
51126,20,208799,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208799 AirDuo clinical prea.pdf","1900-01-01 00:00:00",
51127,18,208799,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208799 AirDuo Clinpharm prea.pdf","1900-01-01 00:00:00",
51128,17,208799,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208799 AirDuo statistical prea.pdf","1900-01-01 00:00:00",
52822,2,208799,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf","2018-03-06 00:00:00",
52915,1,208799,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208798Orig1s002,208799Orig1s001ltr.pdf","2018-03-12 00:00:00",
50843,2,208799,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf","2017-12-22 00:00:00",
50880,1,208799,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s002ltr.pdf","2017-12-27 00:00:00",
50739,1,208800,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208800Orig1s000TAltr.pdf","2017-12-18 00:00:00",
54449,1,208806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208806Orig1s000ltr.pdf","2018-06-05 00:00:00",
55246,1,208807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208807Orig1s000TAltr.pdf","2018-08-20 00:00:00",
50559,1,208820,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208820Orig1s000ltr.pdf","2017-12-01 00:00:00",
48633,1,208838,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208838Orig1s000ltr.pdf","2017-06-02 00:00:00",
50817,2,208843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf","2017-12-21 00:00:00",
50818,8,208843,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf#page=17","2017-12-21 00:00:00",
50925,1,208843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208843Orig1s000ltr.pdf","2017-12-27 00:00:00",
54775,3,208843,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208843Orig1s000TOC.cfm","2018-07-06 00:00:00",
45739,1,208844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208844Orig1s000ltr.pdf","2016-11-01 00:00:00",
45771,2,208844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208844lbl.pdf","2016-11-01 00:00:00",
45884,3,208844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208844_toc.cfm","2016-11-10 00:00:00",
51883,60,208844,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208844 barium sulfate DD review prea.pdf","1900-01-01 00:00:00",
49996,2,208845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208845s000lbl.pdf","2017-10-10 00:00:00",
50022,1,208845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208845Orig1s000ltr.pdf","2017-10-12 00:00:00",
53645,3,208845,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208845Orig1s000TOC.cfm","2018-04-10 00:00:00",
54792,1,208850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208850Orig1s000TAltr.pdf","2018-07-06 00:00:00",
47669,1,208854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208854Orig1s000ltr.pdf","2017-03-24 00:00:00",
47697,2,208854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf","2017-03-24 00:00:00",
48241,3,208854,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208854Orig1s000TOC.cfm","2017-05-05 00:00:00",
49203,2,208854,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s001lbl.pdf","2017-08-02 00:00:00",
49210,1,208854,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208854Orig1s001ltr.pdf","2017-08-02 00:00:00",
51911,2,208854,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf","2018-01-26 00:00:00",
51913,8,208854,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf#page=13","2018-01-26 00:00:00",
52093,1,208854,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208854Orig1s002ltr.pdf","2018-01-30 00:00:00",
52714,2,208855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208855s000lbl.pdf","2018-02-26 00:00:00",
52780,1,208855,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208855Orig1s000ltr.pdf","2018-03-01 00:00:00",
49465,2,208870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208870s000lbl.pdf","2017-08-18 00:00:00",
49507,1,208870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208870Orig1s000ltr.pdf","2017-08-22 00:00:00",
53644,3,208870,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208870Orig1s000TOC.cfm","2018-04-10 00:00:00",
47456,1,208871,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208871Orig1s000ltr.pdf","2017-03-03 00:00:00",
52807,1,208875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208875Orig1s000TAltr.pdf","2018-03-02 00:00:00",
47859,2,208878,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208878Orig1s000lbl.pdf","2017-04-05 00:00:00",
55245,1,208890,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208890Orig1s000TAltr.pdf","2018-08-20 00:00:00",
52084,2,208910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208910s000lbl.pdf","2018-01-30 00:00:00",
52130,1,208910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208910Orig1s000ltr.pdf","2018-01-30 00:00:00",
55860,3,208910,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208910Orig1s000TOC.cfm","2018-10-10 00:00:00",
52529,2,208912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208912s000lbl.pdf","2018-02-09 00:00:00",
52548,1,208912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208912Orig1s000ltr.pdf","2018-02-09 00:00:00",
55861,3,208912,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208912Orig1s000TOC.cfm","2018-10-10 00:00:00",
47036,2,208943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf","2017-01-27 00:00:00",
47058,1,208943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208943Orig1s000ltr.pdf","2017-01-31 00:00:00",
53817,3,208943,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208943Orig1s000TOC.cfm","2018-04-25 00:00:00",
49536,2,208944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf","2017-08-25 00:00:00",
49540,1,208944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208944Orig1s000ltr.pdf","2017-08-25 00:00:00",
54735,3,208944,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208944Orig1s000TOC.cfm","2018-07-02 00:00:00",
50649,2,208945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208945lbl.pdf","2017-12-11 00:00:00",
50650,1,208945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208945Orig1s000ltr.pdf","2017-12-11 00:00:00",
51082,3,208945,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208945Orig1s000TOC.cfm","2018-01-18 00:00:00",
54165,20,208945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/221_208945 ozenoxacin clinical prea.pdf","1900-01-01 00:00:00",
54166,18,208945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/222_208945 ozenoxacin clinpharm prea.pdf","1900-01-01 00:00:00",
54167,17,208945,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/223_208945 ozenoxacin statistical prea.pdf","1900-01-01 00:00:00",
48872,2,208956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208956s000lbl.pdf","2017-06-30 00:00:00",
48900,1,208956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208956Orig1s000ltr.pdf","2017-07-05 00:00:00",
48911,8,208956,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208956s000lbl.pdf#page=12","2017-06-29 00:00:00",
52677,3,208956,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208956Orig1s000TOC.cfm","2018-02-21 00:00:00",
45847,2,208984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf","2016-11-08 00:00:00",
45861,1,208984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208984Orig1s000,022128Orig1s17ltr.pdf","2016-11-09 00:00:00",
50200,3,208984,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208984Orig1s000,022128Orig1s017TOC.cfm","2017-10-26 00:00:00",
51323,20,208984,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/35_208984 maraviroc clinical prea.pdf","1900-01-01 00:00:00",
51324,18,208984,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/36_208984 maraviroc clinpharm prea.pdf","1900-01-01 00:00:00",
54917,2,208984,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf","2018-07-19 00:00:00",
54918,8,208984,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43","2018-07-19 00:00:00",
54933,1,208984,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022128Orig1s018,208984Orig1s001Ltr.pdf","2018-07-20 00:00:00",
48075,1,209011,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209011Orig1s000ltr.pdf","2017-04-21 00:00:00",
48149,1,209012,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209012Orig1s000ltr.pdf","2017-04-27 00:00:00",
50332,1,209018,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209018Orig1s000TAltr.pdf","2017-11-08 00:00:00",
50337,1,209019,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209019Orig1s000TAltr.pdf","2017-11-08 00:00:00",
50425,1,209021,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209021Orig1s000ltr.pdf","2017-11-15 00:00:00",
49818,2,209022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209022s000lbl.pdf","2017-09-21 00:00:00",
49846,1,209022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209022Orig1s000ltr.pdf","2017-09-22 00:00:00",
52672,3,209022,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209022Orig1s000_revTOC.cfm","2018-02-20 00:00:00",
54817,1,209040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209040Orig1s000TAltr.pdf","2018-07-06 00:00:00",
48074,1,209058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209058Orig1s000ltr.pdf","2017-04-21 00:00:00",
55389,2,209080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209080s000lbl.pdf","2018-09-06 00:00:00",
55452,1,209080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209080Orig1s000Ltr.pdf","2018-09-12 00:00:00",
52806,1,209086,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209086Orig1s000TAltr.pdf","2018-03-02 00:00:00",
49258,1,209088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209088Orig1s000ltr.pdf","2017-08-07 00:00:00",
47065,2,209089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf","2017-01-31 00:00:00",
47067,1,209089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209089Orig1s000,209090Orig1s000ltr.pdf","2017-01-31 00:00:00",
49021,3,209089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000TOC.cfm","2017-07-20 00:00:00",
47066,2,209090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf","2017-01-31 00:00:00",
47068,1,209090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209089Orig1s000,209090Orig1s000ltr.pdf","2017-01-31 00:00:00",
49022,3,209090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000TOC.cfm","2017-07-20 00:00:00",
47361,2,209091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209091s000lbl.pdf","2017-02-28 00:00:00",
47454,1,209091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209091Orig1s000ltr.pdf","2017-03-03 00:00:00",
52744,8,209091,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s000lbl.pdf","2018-02-28 00:00:00",
55863,3,209091,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209091Orig1s000TOC.cfm","2018-10-10 00:00:00",
47529,2,209092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf","2017-03-13 00:00:00",
47530,1,209092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209092s000ltredt.pdf","2017-03-13 00:00:00",
47732,3,209092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209092Orig1s000TOC.cfm","2017-03-28 00:00:00",
54954,1,209092,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209092Orig1s001ltr.pdf","2018-07-24 00:00:00",
55355,2,209092,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209092s001lbl.pdf","2018-08-29 00:00:00",
50740,1,209102,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209102Orig1s000ltr.pdf","2017-12-18 00:00:00",
55185,1,209107,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209107Orig1s000ltr.pdf","2018-08-16 00:00:00",
49935,2,209112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209112s000lbl.pdf","2017-10-03 00:00:00",
49937,1,209112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209112Orig1s000ltr.pdf","2017-10-04 00:00:00",
52670,3,209112,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209112Orig1s000TOC.cfm","2018-02-20 00:00:00",
49796,1,209113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209113Orig1s000ltr.pdf","2017-09-19 00:00:00",
49824,2,209113,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209113Orig1s000lbl.pdf","2017-09-21 00:00:00",
46206,2,209115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf","2016-12-19 00:00:00",
46445,1,209115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209115Orig1s000ltr.pdf","2016-12-21 00:00:00",
47024,3,209115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209115Orig1s000TOC.cfm","2017-01-30 00:00:00",
53633,2,209115,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf","2018-04-06 00:00:00",
53658,1,209115,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209115Orig1s003ltr.pdf","2018-04-12 00:00:00",
50759,2,209139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209139s000lbl.pdf","2017-12-19 00:00:00",
50902,1,209139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209139Orig1s000ltr.pdf","2017-12-27 00:00:00",
54736,3,209139,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209139Orig1s000TOC.cfm","2018-07-02 00:00:00",
49690,1,209148,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209148Orig1s000TAltr.pdf","2017-09-07 00:00:00",
48276,2,209176,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf","2017-05-08 00:00:00",
48297,1,209176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209176Orig1s000ltr.pdf","2017-05-09 00:00:00",
48785,3,209176,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209176Orig1s000TOC.cfm","2017-06-20 00:00:00",
48131,1,209191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209191Orig1s000TAltr.pdf","2017-04-27 00:00:00",
54878,2,209191,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209191lbl.pdf","2018-07-13 00:00:00",
49016,2,209195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s000lbl.pdf","2017-07-19 00:00:00",
49031,1,209195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209195Orig1s000ltr.pdf","2017-07-21 00:00:00",
49650,3,209195,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209195_toc.cfm","2017-09-01 00:00:00",
50377,1,209195,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209195Orig1s002ltr.pdf","2017-11-13 00:00:00",
50395,2,209195,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s002lbl.pdf","2017-11-13 00:00:00",
50675,2,209196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209196s000lbl.pdf","2017-12-13 00:00:00",
50682,1,209196,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209196Orig1s000ltr.pdf","2017-12-13 00:00:00",
54229,3,209196,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209196Orig1s000TOC.cfm","2018-05-17 00:00:00",
49498,2,209203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf","2017-08-22 00:00:00",
49499,8,209203,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf#page=27","2017-08-22 00:00:00",
49506,1,209203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209203Orig1s000ltr.pdf","2017-08-22 00:00:00",
53643,3,209203,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209203Orig1s000TOC.cfm","2018-04-10 00:00:00",
54892,1,209206,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209206Orig1s000.pdf","2018-07-16 00:00:00",
50156,2,209210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf","2017-10-24 00:00:00",
50208,8,209210,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf#page=23","2017-10-27 00:00:00",
50488,1,209210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209210Orig1s000ltr.pdf","2017-11-27 00:00:00",
55864,3,209210,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209210Orig1s000TOC.cfm","2018-10-10 00:00:00",
54891,1,209215,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209215Orig1s000ltr.pdf","2018-07-16 00:00:00",
54219,2,209229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209229s000lbl.pdf","2018-05-16 00:00:00",
54220,1,209229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209229Orig1s000ltr.pdf","2018-05-16 00:00:00",
54725,3,209229,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209229Orig1s000TOC.cfm","2018-06-28 00:00:00",
50986,1,209235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209235s000ltr.pdf","2018-01-08 00:00:00",
47937,1,209241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209241Orig1s000ltr.pdf","2017-04-12 00:00:00",
47938,2,209241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf","2017-04-12 00:00:00",
48609,3,209241,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000TOC.cfm","2017-06-01 00:00:00",
48610,21,209241,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241Orig1s000SumR.pdf","2017-06-01 00:00:00",
55226,1,209241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209241Orig1s003ltr.pdf","2018-08-20 00:00:00",
55364,2,209241,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209241s003lbl.pdf","2018-08-30 00:00:00",
48130,1,209259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209259Orig1s000TAltr.pdf","2017-04-27 00:00:00",
52080,2,209260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209260s000lbl.pdf","2018-01-30 00:00:00",
52131,1,209260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209260Orig1s000ltr.pdf","2018-01-30 00:00:00",
54726,3,209260,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/2018/209260Orig1s0000TOC.cfm","2018-06-29 00:00:00",
50121,1,209264,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209264Orig1s000ltr.pdf","2017-10-19 00:00:00",
54737,3,209269,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209269Orig1s000TOC.cfm","2018-07-02 00:00:00",
49667,2,209279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209279s000lbl.pdf","2018-06-25 00:00:00",
49669,8,209279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209279Orig1s000ltr.pdf#page=9","2018-06-25 00:00:00",
50142,1,209279,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s035,209279Orig1s001Ltr.pdf","2017-12-29 00:00:00",
55865,3,209279,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.cfm","2018-10-10 00:00:00",
55866,3,209279,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.cfm","2018-10-10 00:00:00",
50368,1,209296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209296Orig1s000ltr.pdf","2017-11-13 00:00:00",
50385,2,209296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209296s000lbl.pdf","2017-11-13 00:00:00",
52881,3,209296,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209296Orig1s000TOC.cfm","2018-03-09 00:00:00",
53706,2,209299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209299lbl.pdf","2018-04-17 00:00:00",
53711,1,209299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209299Orig1s000ltr.pdf","2018-04-17 00:00:00",
54188,3,209299,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209299Orig1s000TOC.cfm","2018-05-15 00:00:00",
50704,2,209305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209305s000lbl.pdf","2017-12-15 00:00:00",
50710,1,209305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209305Orig1s000ltr.pdf","2017-12-15 00:00:00",
52880,3,209305,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209305Orig1s000TOC.cfm","2018-03-09 00:00:00",
50651,2,209310,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209310lbl.pdf","2017-12-11 00:00:00",
50652,1,209310,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209310Orig1s000ltr.pdf","2017-12-11 00:00:00",
51051,2,209310,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209310s001lbl.pdf","2018-01-16 00:00:00",
51063,1,209310,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209310Orig1s001ltr.pdf","2018-01-17 00:00:00",
55151,2,209311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf","2018-08-10 00:00:00",
55152,8,209311,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf#page=19","2018-08-10 00:00:00",
55164,1,209311,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209311Orig1s000ltr.pdf","2018-08-10 00:00:00",
47265,2,209347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347lbl.pdf","2017-02-21 00:00:00",
47266,1,209347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209347Orig1s000ltr.pdf","2017-02-21 00:00:00",
49835,1,209347,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209347Orig1s001ltr.pdf","2017-09-22 00:00:00",
49865,2,209347,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347s001lbl.pdf","2017-09-27 00:00:00",
52673,3,209347,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209347Orig1s000TOC.cfm","2018-02-20 00:00:00",
55284,2,209353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209353s000lbl.pdf","2018-08-24 00:00:00",
55304,1,209353,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209353Orig1s000Ltr.pdf","2018-08-24 00:00:00",
50566,1,209359,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209359Orig1s000TAltr.pdf","2017-12-01 00:00:00",
50866,2,209360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209360s000lbl.pdf","2017-12-26 00:00:00",
50923,1,209360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209360Orig1s000ltr.pdf","2017-12-27 00:00:00",
52233,3,209360,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209360Orig1s000TOC.cfm","2018-01-31 00:00:00",
49750,1,209363,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209363Orig1s000Ltr.pdf","2017-09-15 00:00:00",
49751,2,209363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf","2017-09-15 00:00:00",
50053,3,209363,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209363Orig1s000TOC.cfm","2017-10-13 00:00:00",
54450,1,209373,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209373Orig1s000ltr.pdf","2018-06-05 00:00:00",
54032,2,209381,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf","2018-05-07 00:00:00",
54033,8,209381,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf#page=17","2018-05-07 00:00:00",
54047,1,209381,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209381Orig1s000ltr.pdf","2018-05-08 00:00:00",
47516,2,209387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209387s000lbl.pdf","2017-03-09 00:00:00",
47545,1,209387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209387Orig1s000ltr.pdf","2017-03-14 00:00:00",
49519,3,209387,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209387Orig1s000TOC.cfm","2017-08-23 00:00:00",
54334,1,209387,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209387Orig1s003ltr.pdf","2018-05-24 00:00:00",
54341,2,209387,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s003lbl.pdf","2018-05-25 00:00:00",
49251,2,209394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf","2017-08-07 00:00:00",
49257,1,209394,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s000ltr.pdf","2017-08-07 00:00:00",
49722,3,209394,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394_toc.cfm","2017-09-13 00:00:00",
49723,21,209394,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394Orig1s000SumR.pdf","2017-09-13 00:00:00",
55124,2,209394,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf","2018-08-07 00:00:00",
55130,1,209394,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209394Orig1s002ltr.pdf","2018-08-07 00:00:00",
50676,2,209394,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf","2017-12-13 00:00:00",
50719,1,209394,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s003ltr.pdf","2017-12-18 00:00:00",
48942,1,209400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209400Orig1s000ltr.pdf","2017-07-11 00:00:00",
48948,2,209400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209400Orig1s000lbl.pdf","2017-07-11 00:00:00",
52785,1,209400,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s001ltr.pdf","2018-03-01 00:00:00",
53019,2,209400,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s001lbl.pdf","2018-03-15 00:00:00",
53077,3,209400,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209400Orig1s000TOC.cfm","2018-03-21 00:00:00",
54598,1,209400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s002ltr.pdf","2018-06-14 00:00:00",
54653,2,209400,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s002lbl.pdf","2018-06-21 00:00:00",
54890,1,209400,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s003Ltr.pdf","2018-07-16 00:00:00",
55104,2,209400,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s003Lbl.pdf","2018-08-03 00:00:00",
49218,2,209401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf","2017-08-03 00:00:00",
49243,1,209401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209401Orig1s000ltr.pdf","2017-08-04 00:00:00",
53816,3,209401,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209401Orig1s000TOC.cfm","2018-04-25 00:00:00",
55406,1,209408,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209408Orig1s000ltr.pdf","2018-09-07 00:00:00",
52687,2,209410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209410s000lbl.pdf","2018-02-22 00:00:00",
52699,1,209410,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209410Orig1s000ltr.pdf","2018-02-23 00:00:00",
50058,1,209414,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209414Orig1s000TAltr.pdf","2017-10-13 00:00:00",
50741,1,209419,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209419Orig1s000ltr.pdf","2017-12-18 00:00:00",
55186,1,209448,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209448Orig1s000ltr.pdf","2018-08-16 00:00:00",
49096,2,209449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf","2017-07-27 00:00:00",
49120,1,209449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209449Orig1s000ltr.pdf","2017-07-28 00:00:00",
50202,3,209449,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209449Orig1s000TOC.cfm","2017-10-27 00:00:00",
51408,20,209449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/176_209449 Nitisinone clinical prea.pdf","1900-01-01 00:00:00",
51409,18,209449,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/177_209449 Nitisinone clinpharm prea.pdf","1900-01-01 00:00:00",
50991,1,209452,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209452Orig1s000TAltr.pdf","2018-01-08 00:00:00",
50120,1,209453,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209453Orig1s000ltr.pdf","2017-10-19 00:00:00",
48894,2,209463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209463s000lbl.pdf","2017-07-03 00:00:00",
48906,1,209463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209463Orig1s000ltr.pdf","2017-07-05 00:00:00",
52678,3,209463,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209463Orig1s000TOC.cfm","2018-02-21 00:00:00",
54451,1,209467,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209467Orig1s000ltr.pdf","2018-06-05 00:00:00",
49268,2,209478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209478s000lbl.pdf","2017-08-08 00:00:00",
49404,1,209478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209478Orig1s000ltr.pdf","2017-08-15 00:00:00",
53642,3,209478,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209478Orig1s000TOC.cfm","2018-04-10 00:00:00",
50659,1,209480,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209480Orig1s000ltr.pdf","2017-12-12 00:00:00",
54867,2,209481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209481s000lbl.pdf","2018-07-11 00:00:00",
54889,1,209481,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209481Orig1s000ltr.pdf","2018-07-16 00:00:00",
49811,2,209482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf","2017-09-20 00:00:00",
49812,8,209482,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf#page=33","2017-09-20 00:00:00",
49847,1,209482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209482Orig1s000ltr.pdf","2017-09-22 00:00:00",
52674,3,209482,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209482Orig1s000TOC.cfm","2018-02-20 00:00:00",
53803,2,209482,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209482s001lbl.pdf","2018-04-24 00:00:00",
53814,1,209482,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209482Orig1s001ltr.pdf","2018-04-24 00:00:00",
50524,2,209483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209483s000lbl.pdf","2017-11-29 00:00:00",
50561,1,209483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209483Orig1s000ltr.pdf","2017-12-01 00:00:00",
52959,3,209483,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209483Orig1s000TOC.cfm","2018-03-14 00:00:00",
50017,2,209501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf","2017-10-12 00:00:00",
50018,8,209501,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29","2017-10-12 00:00:00",
50021,1,209501,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209501Orig1s000ltr.pdf","2017-10-12 00:00:00",
50088,1,209506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209506Orig1s000ltr.pdf","2017-10-18 00:00:00",
50095,2,209506,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209506Orig1s000lbl.pdf","2017-10-18 00:00:00",
48671,2,209512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512lbl.pdf","2017-06-08 00:00:00",
48878,2,209512,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf","2017-06-30 00:00:00",
48886,1,209512,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf","2017-06-30 00:00:00",
52853,1,209512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s000Approv.pdf","2018-03-08 00:00:00",
52958,3,209512,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209512Orig1s000TOC.cfm","2018-03-14 00:00:00",
49919,2,209512,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf","2017-10-03 00:00:00",
49926,1,209512,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf","2017-10-03 00:00:00",
55244,1,209520,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209520Orig1s000TAltr.pdf","2018-08-20 00:00:00",
55784,1,209521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209521Orig1s000ltr.pdf","2018-10-01 00:00:00",
55785,2,209521,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf","2018-10-02 00:00:00",
54816,1,209522,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209522Orig1s000TAltr.pdf","2018-07-06 00:00:00",
46517,2,209531,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf","2016-12-23 00:00:00",
46518,1,209531,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209531Orig1s000ltr.pdf","2016-12-23 00:00:00",
46895,3,209531,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209531Orig1s000TOC.cfm","2017-01-18 00:00:00",
50472,2,209531,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209531s002lbl.pdf","2017-11-22 00:00:00",
50496,1,209531,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209531Orig1s002ltr.pdf","2017-11-27 00:00:00",
54214,1,209531,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209531Orig1s003s004ltr.pdf","2018-05-16 00:00:00",
54236,2,209531,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf","2018-05-17 00:00:00",
54215,1,209531,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209531Orig1s003s004ltr.pdf","2018-05-16 00:00:00",
54237,2,209531,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf","2018-05-17 00:00:00",
55198,1,209549,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209549Orig1s000ltr.pdf","2018-08-17 00:00:00",
53557,2,209550,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209550lbl.pdf","2018-03-30 00:00:00",
50742,1,209556,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209556Orig1s000ltr.pdf","2017-12-18 00:00:00",
55506,1,209566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209566Orig1s000ltr.pdf","2018-09-18 00:00:00",
49609,1,209570,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209570Orig1s000ltr.pdf","2017-08-30 00:00:00",
49610,2,209570,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209570lbl.pdf","2017-08-30 00:00:00",
49990,3,209570,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209570Orig1s000TOC.cfm","2017-10-10 00:00:00",
50522,2,209589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf","2017-11-29 00:00:00",
50523,8,209589,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf#page=12","2017-11-29 00:00:00",
50560,1,209589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209589Orig1s000ltr.pdf","2017-12-01 00:00:00",
55136,3,209589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209589Orig1s000TOC.cfm","2018-08-08 00:00:00",
53142,1,209592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209592Orig1s000ltr.pdf","2018-03-22 00:00:00",
53498,2,209592,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209592Orig1s000lbl.pdf","2018-03-28 00:00:00",
53618,1,209594,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209594Orig1s000ltr.pdf","2018-04-05 00:00:00",
49240,2,209604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf","2017-08-04 00:00:00",
49255,1,209604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209604Orig1s000ltr.pdf","2017-08-07 00:00:00",
50203,3,209604,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209604Orig1s000TOC.cfm","2017-10-27 00:00:00",
55066,2,209604,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf","2018-07-31 00:00:00",
55083,1,209604,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604s003ltr.pdf","2018-08-03 00:00:00",
49170,2,209606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf","2017-08-01 00:00:00",
49171,8,209606,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf#page=16","2017-08-01 00:00:00",
49208,1,209606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209606Orig1s000.pdf","2017-08-02 00:00:00",
49522,3,209606,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209606Orig1s000TOC.cfm","2017-08-24 00:00:00",
55045,2,209607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209607s000lbl.pdf","2018-07-30 00:00:00",
55084,1,209607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209607Orig1s000ltr.pdf","2018-08-03 00:00:00",
49543,1,209618,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209618Orig1s000TAltr.pdf","2017-08-25 00:00:00",
55163,2,209627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209627s000lbl.pdf","2018-08-10 00:00:00",
55199,1,209627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209627Orig1s000ltr.pdf","2018-08-17 00:00:00",
55419,3,209627,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209627Orig1s000TOC.cfm","2018-09-10 00:00:00",
50622,2,209637,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf","2017-12-06 00:00:00",
50623,1,209637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209637s000ltr.pdf","2017-12-07 00:00:00",
51050,3,209637,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm","2018-01-16 00:00:00",
45855,2,209661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf","2016-11-09 00:00:00",
45858,1,209661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209661Orig1s000ltr.pdf","2016-11-09 00:00:00",
49898,3,209661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209661Orig1s000TOC.cfm","2017-09-29 00:00:00",
54639,1,209661,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209661Orig1s004ltr.pdf","2018-06-21 00:00:00",
54673,2,209661,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209661s004lbl.pdf","2018-06-21 00:00:00",
50341,1,209662,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209662Orig1s000ltr.pdf","2017-11-08 00:00:00",
49248,1,209670,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209670Orig1s000TAltr.pdf","2017-08-04 00:00:00",
55405,1,209721,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209721Orig1s000ltr.pdf","2018-09-07 00:00:00",
50502,1,209734,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209734Orig1s000ltr.pdf","2017-11-27 00:00:00",
52724,1,209764,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209764Orig1s000TAltr.pdf","2018-02-26 00:00:00",
49613,2,209776,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf","2017-08-30 00:00:00",
49614,1,209776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209776Orig1s000ltr.pdf","2017-08-30 00:00:00",
49936,3,209776,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209776Orig1s000TOC.cfm","2017-10-04 00:00:00",
54864,2,209776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209776s001lbl.pdf","2018-07-09 00:00:00",
54883,1,209776,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209776Orig1s001ltr.pdf","2018-07-13 00:00:00",
48084,14,209777,"ORIG",1,"FDA has determined that this product has abuse-deterrent properties","https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm","2017-04-24 00:00:00",
48085,2,209777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf","2017-04-24 00:00:00",
48086,8,209777,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf#page=43","2017-04-24 00:00:00",
48087,1,209777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209777Orig1s000ltr.pdf","2017-04-24 00:00:00",
49665,3,209777,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209777Orig1s000TOC.cfm","2017-09-05 00:00:00",
55514,2,209777,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf","2018-09-19 00:00:00",
55516,8,209777,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf#page=35","2018-09-19 00:00:00",
55707,1,209777,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf","2018-10-01 00:00:00",
55515,2,209777,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf","2018-09-19 00:00:00",
55517,8,209777,"SUPPL",3,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf#page=35","2018-09-19 00:00:00",
55708,1,209777,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf","2018-10-01 00:00:00",
53485,1,209781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209781Orig1s000ltr.pdf","2018-03-28 00:00:00",
49689,1,209784,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209784Orig1s000ltr.pdf","2017-09-07 00:00:00",
52540,1,209801,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209801Orig1s000TAltr.pdf","2018-02-09 00:00:00",
50796,2,209803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf","2017-12-20 00:00:00",
50797,8,209803,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf#page=24","2017-12-20 00:00:00",
50885,1,209803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209803Orig1s000ltr.pdf","2017-12-27 00:00:00",
52808,3,209803,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm","2018-03-05 00:00:00",
50791,2,209805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf","2017-12-20 00:00:00",
50886,1,209805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209805Orig1s000ltr.pdf","2017-12-27 00:00:00",
52809,3,209805,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm","2018-03-05 00:00:00",
52856,2,209805,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf","2018-03-08 00:00:00",
52857,8,209805,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf#page=32","2018-03-08 00:00:00",
53001,1,209805,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209805Orig1s001ltr.pdf","2018-03-15 00:00:00",
50793,2,209806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209806s000lbl.pdf","2017-12-19 00:00:00",
50887,1,209806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209806Orig1s000ltr.pdf","2017-12-27 00:00:00",
52810,3,209806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm","2018-03-05 00:00:00",
55789,2,209816,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf","2018-10-03 00:00:00",
55792,1,209816,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209816Orig1s000,209817Orig1s000Ltr.pdf","2018-10-03 00:00:00",
55790,2,209817,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf","2018-10-03 00:00:00",
55791,1,209817,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209816Orig1s000,209817Orig1s000Ltr.pdf","2018-10-03 00:00:00",
50537,2,209819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf","2017-12-01 00:00:00",
50576,1,209819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209819Orig1s000ltr.pdf","2017-12-01 00:00:00",
52851,2,209819,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf","2018-03-08 00:00:00",
52852,8,209819,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf#page=40","2018-03-08 00:00:00",
52999,1,209819,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209819Orig1s001ltr.pdf","2018-03-15 00:00:00",
53069,21,209819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/209819Orig1s000SumR.pdf","2018-03-21 00:00:00",
55867,3,209819,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209819Orig1s000TOC.cfm","2018-10-11 00:00:00",
54821,2,209830,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf","2018-07-06 00:00:00",
55243,1,209831,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209831Orig1s000TAltr.pdf","2018-08-20 00:00:00",
54634,1,209844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209844Orig1s000ltr.pdf","2018-06-21 00:00:00",
54671,2,209844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209844s000lbl.pdf","2018-06-21 00:00:00",
45633,1,209862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209862Orig1s000ltr.pdf","2016-10-20 00:00:00",
45687,2,209862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf","2016-10-27 00:00:00",
46135,3,209862,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209862Orig1s000TOC.cfm","2016-12-13 00:00:00",
55794,2,209863,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf","2018-10-03 00:00:00",
55795,8,209863,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf#page=16","2018-10-03 00:00:00",
53693,1,209869,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209869Orig1s000ltr.pdf","2018-04-16 00:00:00",
49275,2,209875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209875s000lbl.pdf","2017-08-08 00:00:00",
49278,1,209875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209875Orig1s000ltr.pdf","2017-08-08 00:00:00",
49851,3,209875,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209875Orig1s000TOC.cfm","2017-09-25 00:00:00",
52541,1,209877,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209877Orig1s000TAltr.pdf","2018-02-09 00:00:00",
49620,2,209885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209885lbl.pdf","2017-08-30 00:00:00",
49621,1,209885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209885Orig1s000ltr.pdf","2017-08-30 00:00:00",
54471,3,209885,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000TOC.cfm","2018-06-07 00:00:00",
49703,1,209897,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209897Orig1s000ltr.pdf","2017-09-08 00:00:00",
53047,1,209927,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/NDA209927-DeemedGranted-signed.pdf","2018-03-18 00:00:00",
48246,2,209935,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209935s000lbl.pdf","2017-05-05 00:00:00",
48296,1,209935,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209935Orig1s000ltr.pdf","2017-05-09 00:00:00",
49520,3,209935,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209935Orig1s000TOC.cfm","2017-08-23 00:00:00",
53798,2,209935,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209935s001lbl.pdf","2018-04-24 00:00:00",
53815,1,209935,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209935Orig1s001ltr.pdf","2018-04-24 00:00:00",
49730,2,209936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf","2017-09-14 00:00:00",
49731,1,209936,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209936Orig1s000Ltr.pdf","2017-09-14 00:00:00",
50061,3,209936,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209936Orig1_toc.cfm","2017-10-16 00:00:00",
50344,1,209939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209939Orig1s000209940Orig1s000ltr.pdf","2017-11-08 00:00:00",
50345,2,209939,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf","2017-11-08 00:00:00",
50755,3,209939,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209939Orig1s000,209940Orig1s000TOC.cfm","2017-12-18 00:00:00",
50346,2,209940,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf","2017-11-08 00:00:00",
50347,1,209940,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209939Orig1s000209940Orig1s000ltr.pdf","2017-11-08 00:00:00",
50756,3,209940,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209939Orig1s000,209940Orig1s000TOC.cfm","2017-12-18 00:00:00",
50130,1,209949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209949Orig1s000ltr.pdf","2017-10-23 00:00:00",
50180,2,209949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209949s000lbl.pdf","2017-10-25 00:00:00",
52675,3,209949,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209949Orig1s000TOC.cfm","2018-02-20 00:00:00",
50780,1,209963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209963Orig1s000ltr.pdf","2017-12-20 00:00:00",
53874,3,209963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209963Orig1s000TOC.cfm","2018-04-30 00:00:00",
55385,2,209963,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209963lbl.pdf","2018-09-05 00:00:00",
46849,1,209989,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209989MG_ltr.pdf","2017-01-17 00:00:00",
54796,1,210026,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210026Orig1s000TAltr.pdf","2018-07-06 00:00:00",
54399,2,210045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210045s000lbl.pdf","2018-05-31 00:00:00",
54407,1,210045,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210045Orig1s000ltr.pdf","2018-06-01 00:00:00",
50057,1,210064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210064_TA_ltr.pdf","2017-10-13 00:00:00",
52273,1,210077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210077Orig1s000ltr.pdf","2018-02-02 00:00:00",
54168,1,210088,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210088Orig1s000ltr.pdf","2018-05-11 00:00:00",
54346,2,210115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf","2018-05-29 00:00:00",
54352,1,210115,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf","2018-05-29 00:00:00",
52985,1,210155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210155Orig1s000ltr.pdf","2018-03-15 00:00:00",
55241,1,210158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210158Orig1s000TAltr.pdf","2018-08-20 00:00:00",
50479,2,210192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210192s000lbl.pdf","2017-11-24 00:00:00",
50503,1,210192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210192Orig1s000ltr.pdf","2017-11-27 00:00:00",
51081,2,210192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf","2018-01-18 00:00:00",
51864,1,210192,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s001ltr.pdf","2018-01-26 00:00:00",
54738,3,210192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210192Orig1s000TOC.cfm","2018-07-02 00:00:00",
55429,2,210192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf","2018-09-11 00:00:00",
55448,1,210192,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf","2018-09-12 00:00:00",
55430,2,210192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf","2018-09-11 00:00:00",
55449,1,210192,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf","2018-09-12 00:00:00",
52802,1,210209,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210209Orig1s000TAltr.pdf","2018-03-02 00:00:00",
53050,1,210235,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/NDA210235-NADA141479-DeemedGranted-signed.pdf","2018-03-18 00:00:00",
52637,1,210237,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210237Orig1s000TAltr.pdf","2018-02-14 00:00:00",
54258,2,210238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf","2018-05-21 00:00:00",
54319,1,210238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210238Orig1s000ltr.pdf","2018-05-24 00:00:00",
54724,3,210238,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210238Orig1s000TOC.cfm","2018-06-28 00:00:00",
55398,1,210240,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210240Orig1s000TAltr.pdf","2018-09-07 00:00:00",
52498,2,210251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf","2018-02-07 00:00:00",
52499,1,210251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210251Orig1s000Ltr.pdf","2018-02-07 00:00:00",
53053,3,210251,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210251Orig1s000TOC.cfm","2018-03-19 00:00:00",
53496,1,210252,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210252Orig1s000TAltr.pdf","2018-03-28 00:00:00",
50237,2,210259,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf","2017-10-31 00:00:00",
50244,1,210259,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210259Orig1s000ltr.pdf","2017-10-31 00:00:00",
50655,3,210259,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210259Orig1s000TOC.cfm","2017-12-12 00:00:00",
54682,1,210303,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210303Orig1s000Ltr.pdf","2018-06-26 00:00:00",
54683,2,210303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303Orig1s000lbl.pdf","2018-06-26 00:00:00",
55017,3,210303,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210303Orig1s000TOC.cfm","2018-07-27 00:00:00",
54311,2,210308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210308s000lbl.pdf","2018-05-23 00:00:00",
54328,1,210308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210308Orig1s000ltr.pdf","2018-05-24 00:00:00",
55868,3,210308,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210308Orig1s000TOC.cfm","2018-10-11 00:00:00",
54823,1,210326,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210326Orig1s000TAltr.pdf","2018-07-06 00:00:00",
54155,1,210333,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210333Orig1s000ltr.pdf","2018-05-11 00:00:00",
54146,1,210334,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210334Orig1s000ltr.pdf","2018-05-11 00:00:00",
54748,2,210361,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210361lbl.pdf","2018-07-05 00:00:00",
54958,1,210361,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210361Orig1s000Ltr.pdf","2018-07-24 00:00:00",
54679,2,210365,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf","2018-06-25 00:00:00",
54680,1,210365,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210365Orig1s000Ltr.pdf","2018-06-25 00:00:00",
54681,8,210365,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf#page=23","2018-06-25 00:00:00",
55018,3,210365,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm","2018-07-27 00:00:00",
51901,1,210375,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210375Orig1s000ltr.pdf","2018-01-26 00:00:00",
55397,1,210385,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210385Orig1s000TAltr.pdf","2018-09-07 00:00:00",
55396,1,210402,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210402Orig1s000TAltr.pdf","2018-09-07 00:00:00",
52082,2,210428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lbl.pdf","2018-01-30 00:00:00",
52132,1,210428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210428Orig1s000ltr.pdf","2018-01-30 00:00:00",
54245,2,210428,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf","2018-05-17 00:00:00",
55870,3,210428,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210428Orig1s000TOC.cfm","2018-10-11 00:00:00",
55616,1,210434,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210434Orig1s000ltr.pdf","2018-09-25 00:00:00",
54956,1,210450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210450Orig1s000Ltr.pdf","2018-07-24 00:00:00",
54957,2,210450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210450s000lbl.pdf","2018-07-24 00:00:00",
55267,3,210450,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210450Orig1s000TOC.cfm","2018-08-22 00:00:00",
54912,2,210455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210455s000lbl.pdf","2018-07-18 00:00:00",
54955,1,210455,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210455Orig1s000ltr.pdf","2018-07-24 00:00:00",
52601,2,210491,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf","2018-02-13 00:00:00",
52602,1,210491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210491Orig1s000ltr.pdf","2018-02-13 00:00:00",
52945,3,210491,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210491Orig1s000TOC.cfm","2018-03-13 00:00:00",
53747,2,210493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf","2018-04-20 00:00:00",
53774,1,210493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210493Orig1s000ltr.pdf","2018-04-23 00:00:00",
54390,3,210493,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210493Orig1s000ApprovTOC.cfm","2018-05-31 00:00:00",
54695,2,210496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf","2018-06-27 00:00:00",
54811,8,210496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf#page=17","2018-07-06 00:00:00",
54852,1,210496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210496Orig1s000ltr.pdf","2018-07-06 00:00:00",
54909,3,210496,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210496Orig1s000TOC.cfm","2018-07-18 00:00:00",
54694,2,210498,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf","2018-06-27 00:00:00",
54696,1,210498,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210498Orig1s000ltr.pdf","2018-06-27 00:00:00",
54853,1,210498,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210498Orig1s000ltr.pdf","2018-07-06 00:00:00",
55266,3,210498,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210498Orig1s000TOC.cfm","2018-08-22 00:00:00",
55224,1,210540,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210540Orig1s000TALtr.pdf","2018-08-20 00:00:00",
52679,2,210563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s000lbl.pdf","2018-02-21 00:00:00",
52698,1,210563,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210563Orig2s000ltr.pdf","2018-02-23 00:00:00",
55345,2,210563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s001lbl.pdf","2018-08-28 00:00:00",
55349,1,210563,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s024,210563Orig1s001ltr.pdf","2018-08-28 00:00:00",
54222,2,210563,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf","2018-05-17 00:00:00",
55271,2,210565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210565s000lbl.pdf","2018-08-23 00:00:00",
55311,1,210565,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210565Orig1s000Ltr.pdf","2018-08-24 00:00:00",
54349,2,210566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210566s000lbl.pdf","2018-05-24 00:00:00",
54355,1,210566,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210566Orig1s000ltr.pdf","2018-05-29 00:00:00",
55034,2,210589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf","2018-07-27 00:00:00",
55049,1,210589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210589Orig1s000ltr.pdf","2018-07-30 00:00:00",
55294,3,210589,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210589Orig1s000TOC.cfm","2018-08-24 00:00:00",
55138,2,210607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210607lbl.pdf","2018-08-08 00:00:00",
55162,1,210607,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210607Orig1s000ltr.pdf","2018-08-10 00:00:00",
55085,1,210655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210655Orig1s000ltr.pdf","2018-08-03 00:00:00",
55125,2,210655,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210655s000lbl.pdf","2018-08-07 00:00:00",
53528,1,210661,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210661Orig1s000TAltr.pdf","2018-03-29 00:00:00",
50413,2,210709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210709s000lbl.pdf","2017-11-15 00:00:00",
50423,1,210709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210709Orig1s000ltr.pdf","2017-11-15 00:00:00",
53076,3,210709,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210709Orig1s000TOC.cfm","2018-03-21 00:00:00",
53558,20,210709,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206_210709 aliskiren CDTL clinical bpca.pdf","1900-01-01 00:00:00",
53559,18,210709,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207_210709 aliskiren clin and clinpharm bpca.pdf","1900-01-01 00:00:00",
53560,17,210709,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208_210709 aliskiren statistical bpca.pdf","1900-01-01 00:00:00",
54785,1,210720,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210720Orig1s000TAltr.pdf","2018-07-06 00:00:00",
54815,1,210723,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210723Orig1s000ltr.pdf","2018-07-06 00:00:00",
54825,1,210793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf","2018-07-06 00:00:00",
55383,2,210793,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf","2018-09-05 00:00:00",
54939,2,210795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210795s000lbl.pdf","2018-07-20 00:00:00",
54940,1,210795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210795Orig1s000Ltr.pdf","2018-07-23 00:00:00",
55295,3,210795,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210795Orig1s000TOC.cfm","2018-08-24 00:00:00",
55372,1,210806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210806Orig1s000ltr.pdf","2018-08-30 00:00:00",
55373,2,210806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210806s000lbl.pdf","2018-08-30 00:00:00",
55852,3,210806,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210806Orig1s000,210807Orig1s000TOC.cfm","2018-10-09 00:00:00",
55374,1,210807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210807Orig1s000ltr.pdf","2018-08-30 00:00:00",
55375,2,210807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210807s000lbl.pdf","2018-08-30 00:00:00",
55853,3,210807,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210806Orig1s000,210807Orig1s000TOC.cfm","2018-10-09 00:00:00",
55467,1,210833,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210833Orig1s000ltr.pdf","2018-09-13 00:00:00",
53048,1,210844,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/NDA210844-NADA141486-DeemedGranted-signed.pdf","2018-03-18 00:00:00",
52719,1,210850,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210850Orig1s000TAltr.pdf","2018-02-26 00:00:00",
54546,2,210867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210867lbl.pdf","2018-06-14 00:00:00",
54547,1,210867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210867Orig1s000Ltr.pdf","2018-06-14 00:00:00",
54773,3,210867,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210867Orig1s000TOC.cfm","2018-07-05 00:00:00",
55236,1,210880,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210880Orig1s000TAltr.pdf","2018-08-20 00:00:00",
54452,1,210892,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210892Orig1s000ltr.pdf","2018-06-05 00:00:00",
55175,2,210913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210913s000lbl.pdf","2018-08-15 00:00:00",
55212,1,210913,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210913Orig1s000ltr.pdf","2018-08-20 00:00:00",
54793,1,210915,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210915Orig1s000TAltr.pdf","2018-07-06 00:00:00",
55153,2,210922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf","2018-08-10 00:00:00",
55169,1,210922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210922Orig1s000ltr.pdf","2018-08-13 00:00:00",
55395,3,210922,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210922Orig1s000TOC.cfm","2018-09-07 00:00:00",
55062,2,210923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210923s000lbl.pdf","2018-07-31 00:00:00",
55077,1,210923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210923Orig1s000Ltr.pdf","2018-08-02 00:00:00",
55265,3,210923,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210923Orig1s000TOC.cfm","2018-08-22 00:00:00",
55240,1,210928,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210928Orig1s000TAltr.pdf","2018-08-20 00:00:00",
52629,2,210951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf","2018-02-14 00:00:00",
52643,1,210951,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210951Orig1s000ltr.pdf","2018-02-14 00:00:00",
53051,3,210951,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm","2018-03-19 00:00:00",
54874,2,210997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf","2018-07-12 00:00:00",
54887,1,210997,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf","2018-07-16 00:00:00",
54875,2,210997,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf","2018-07-12 00:00:00",
54888,1,210997,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf","2018-07-16 00:00:00",
55182,1,211067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211067Orig1s000ltr.pdf","2018-08-16 00:00:00",
55342,2,211109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf","2018-08-28 00:00:00",
55343,1,211109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211109Orig1s000ltr.pdf","2018-08-28 00:00:00",
55782,3,211109,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211109Orig1s000TOC.cfm","2018-10-02 00:00:00",
55609,2,211155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211155s000lbl.pdf","2018-09-24 00:00:00",
55741,1,211155,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig1s000ltr.pdf","2018-10-01 00:00:00",
55740,1,211155,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig2s000ltr.pdf","2018-10-01 00:00:00",
55080,2,211158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211158s000lbl.pdf","2018-08-03 00:00:00",
55100,1,211158,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211158Orig1s000Ltr.pdf","2018-08-03 00:00:00",
55850,2,211172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf","2018-10-05 00:00:00",
55851,8,211172,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf#page=41","2018-10-05 00:00:00",
54926,2,211192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf","2018-07-20 00:00:00",
54927,8,211192,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf#page=18","2018-07-20 00:00:00",
54928,1,211192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211192Orig1s000ltr.pdf","2018-07-20 00:00:00",
55173,3,211192,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211192Orig1s000TOC.cfm","2018-08-15 00:00:00",
53049,1,211270,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/NDA211270-NADA141493-DeemedGranted-signed.pdf","2018-03-18 00:00:00",
55639,2,211288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf","2018-09-27 00:00:00",
55640,1,211288,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211288Orig1s000ltr.pdf","2018-09-27 00:00:00",
55142,2,211358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf","2018-08-09 00:00:00",
55155,1,211358,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211358Orig1s000ltr.pdf","2018-08-10 00:00:00",
55333,1,211781,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/NDA211781-NADA141500-DeemedGranted.pdf","2018-08-27 00:00:00",
54868,2,212319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf","2018-07-11 00:00:00",
55871,3,212319,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/212319Orig1s000TOC.cfm","2018-10-11 00:00:00",
45479,1,761024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761024Orig1s000ltr.pdf","2016-09-26 00:00:00",
45510,8,761024,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524671.pdf","2016-10-12 00:00:00",
45862,3,761024,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm","2016-11-09 00:00:00",
49717,2,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf","2017-09-12 00:00:00",
51431,57,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22_761024 adalimumab-atto DPARP CDTL clinical prea.pdf","1900-01-01 00:00:00",
51432,20,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/23_761024 adalimumab-atto gi clinical prea.pdf","1900-01-01 00:00:00",
51433,20,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21_761024 adalimumab-atto Clinical prea.pdf","1900-01-01 00:00:00",
51434,60,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20_761024 adalimumab-atto clinical DD prea.pdf","1900-01-01 00:00:00",
51435,18,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19_761024 adalimumab atto DPARP clinpharm prea.pdf","1900-01-01 00:00:00",
51436,18,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19_761024 adalimumab atto DPARP clinpharm prea.pdf","1900-01-01 00:00:00",
51437,17,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/26_761024 adalimumab-atto statistical prea.pdf","1900-01-01 00:00:00",
51438,17,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/24_761024 adalimumab-atto statistical 2 prea.pdf","1900-01-01 00:00:00",
51439,17,761024,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/25_761024 adalimumab-atto statistical 3 prea.pdf","1900-01-01 00:00:00",
53040,2,761024,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf","2018-03-16 00:00:00",
53059,1,761024,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761024Orig1s003ltr.pdf","2018-03-20 00:00:00",
10660,1,761025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761025Orig1s000ltr.pdf","2015-10-20 00:00:00",
40638,2,761025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf","2015-10-16 00:00:00",
43551,3,761025,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0761025Orig1000TOC.cfm","2015-11-13 00:00:00",
53660,2,761025,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761025s002lbl.pdf","2018-04-12 00:00:00",
53689,1,761025,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761025Orig1s002ltr.pdf","2018-04-16 00:00:00",
49729,2,761028,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf","2017-09-14 00:00:00",
49732,1,761028,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761028Orig1s000ltr.pdf","2017-09-14 00:00:00",
20000,2,761029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf","2016-06-01 00:00:00",
23055,3,761029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000TOC.cfm","2016-07-07 00:00:00",
24537,21,761029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000SumR.pdf","2016-07-07 00:00:00",
32915,1,761029,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf","2016-05-31 00:00:00",
46809,19,761029,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=357","2017-01-13 00:00:00",
48574,2,761029,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf","2017-05-31 00:00:00",
48575,8,761029,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf#page=24","2017-05-31 00:00:00",
48602,1,761029,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s001ltr.pdf","2017-05-31 00:00:00",
49584,2,761029,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf","2017-08-30 00:00:00",
49640,1,761029,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf","2017-08-31 00:00:00",
50322,1,761029,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s005ltr.pdf","2017-11-07 00:00:00",
49583,2,761029,"SUPPL",7,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf","2017-08-30 00:00:00",
49639,1,761029,"SUPPL",7,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf","2017-08-31 00:00:00",
47226,2,761032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf","2017-02-15 00:00:00",
47227,1,761032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s000Ltr.pdf","2017-02-16 00:00:00",
47228,8,761032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf#page=13","2017-02-16 00:00:00",
47443,19,761032,"ORIG",1,"0","http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761032","2017-03-03 00:00:00",
47731,3,761032,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000TOC.cfm","2017-03-28 00:00:00",
48689,1,761032,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s001ltr.pdf","2017-06-09 00:00:00",
52126,1,761032,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761032Orig1s004ltr.pdf","2018-01-30 00:00:00",
10661,1,761033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761033Orig1s000ltr.pdf","2016-03-29 00:00:00",
20001,2,761033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf","2016-03-29 00:00:00",
23056,3,761033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761033Orig1s000TOC.cfm","2016-05-05 00:00:00",
44978,21,761033,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761033Orig1s000SumR.pdf","2016-05-05 00:00:00",
51637,20,761033,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/761033 reslizumab clinical prea.pdf","1900-01-01 00:00:00",
51638,18,761033,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/761033 reslizumab clinpharm prea.pdf","1900-01-01 00:00:00",
51639,17,761033,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/761033 reslizumab statistical prea.pdf","1900-01-01 00:00:00",
10662,1,761034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf","2016-05-19 00:00:00",
24538,21,761034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000SumR.pdf","2016-06-21 00:00:00",
40639,2,761034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf","2016-05-18 00:00:00",
43552,3,761034,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000TOC.cfm","2016-06-21 00:00:00",
48094,2,761034,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf","2017-04-24 00:00:00",
53999,1,761034,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s003ltr.pdf","2018-05-03 00:00:00",
54008,2,761034,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s003lbl.pdf","2018-05-03 00:00:00",
52965,2,761034,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s005lbl.pdf","2018-03-14 00:00:00",
52989,1,761034,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s005ltr.pdf","2018-03-15 00:00:00",
54633,1,761034,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034s008ltr.pdf","2018-06-20 00:00:00",
54667,2,761034,"SUPPL",8,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s008lbl.pdf","2018-06-21 00:00:00",
54614,2,761034,"SUPPL",10,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf","2018-06-20 00:00:00",
54649,1,761034,"SUPPL",10,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s010ltr.pdf","2018-06-21 00:00:00",
54720,2,761034,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf","2018-06-28 00:00:00",
54812,8,761034,"SUPPL",11,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf#page=27","2018-07-06 00:00:00",
54851,1,761034,"SUPPL",11,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s011ltr.pdf","2018-07-06 00:00:00",
54739,2,761034,"SUPPL",12,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s012lbl.pdf","2018-07-02 00:00:00",
54797,1,761034,"SUPPL",12,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s012ltr.pdf","2018-07-06 00:00:00",
10663,1,761035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761035Orig1s000ltr.pdf","2015-11-30 00:00:00",
24539,21,761035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761035Orig1s000SumR.pdf","2015-12-01 00:00:00",
40640,2,761035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf","2015-11-30 00:00:00",
43553,3,761035,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761035Orig1s000TOC.cfm","2016-01-07 00:00:00",
48356,1,761035,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761035Orig1s005ltr.pdf","2017-05-12 00:00:00",
48380,2,761035,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761035s005lbl.pdf","2017-05-15 00:00:00",
10664,1,761036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761036Orig1s000ltr.pdf","2015-11-17 00:00:00",
20002,2,761036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf","2015-11-19 00:00:00",
24540,21,761036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000SumR.pdf","2015-12-01 00:00:00",
43554,3,761036,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000TOC.cfm","2015-12-08 00:00:00",
45924,1,761036,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761036Orig1s003ltr.pdf","2016-11-22 00:00:00",
45931,2,761036,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s003lbl.pdf","2016-11-21 00:00:00",
45910,2,761036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf","2016-11-18 00:00:00",
45925,1,761036,"SUPPL",4,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761036Orig1s004ltr.pdf","2016-11-22 00:00:00",
48761,2,761036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf","2017-06-19 00:00:00",
48774,1,761036,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761036Orig1s005ltr.pdf","2017-06-19 00:00:00",
54049,1,761036,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761036Orig1s013ltr.pdf","2018-05-08 00:00:00",
54056,2,761036,"SUPPL",13,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s013lbl.pdf","2018-05-08 00:00:00",
54640,1,761036,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761036Orig1s014ltr.pdf","2018-06-21 00:00:00",
54674,2,761036,"SUPPL",14,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s014lbl.pdf","2018-06-21 00:00:00",
48518,2,761037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf","2017-05-24 00:00:00",
48520,1,761037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761037Orig1s000ltr.pdf","2017-05-25 00:00:00",
48887,3,761037,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761037Orig1s000TOC.cfm","2017-07-03 00:00:00",
53669,2,761037,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf","2018-04-13 00:00:00",
53670,8,761037,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf#page=27","2018-04-13 00:00:00",
53692,1,761037,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761037Orig1s001ltr.pdf","2018-04-16 00:00:00",
45627,2,761038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf","2016-10-19 00:00:00",
45631,1,761038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761038Orig1s000ltr.pdf","2016-10-20 00:00:00",
45966,3,761038,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761038Orig1s000TOC.cfm","2016-11-29 00:00:00",
49442,2,761040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf","2017-08-17 00:00:00",
49460,1,761040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761040Orig1s000ltr.pdf","2017-08-18 00:00:00",
49866,3,761040,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000TOC.cfm","2017-09-27 00:00:00",
45626,2,761041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s000lbl.pdf","2016-10-18 00:00:00",
45632,1,761041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761041Orig1s000ltr.pdf","2016-10-20 00:00:00",
45959,8,761041,"ORIG",1,"0","http://www.fda.gov/downloads/Drugs/DrugSafety/ucm530718.pdf","2016-11-28 00:00:00",
46565,3,761041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761041Orig1_toc.cfm","2016-12-27 00:00:00",
46566,21,761041,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761041Orig1s000SumR.pdf","2016-12-27 00:00:00",
45123,1,761042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761042Orig1s000ltr.pdf","2016-08-30 00:00:00",
45124,2,761042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf","2016-08-30 00:00:00",
45596,3,761042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm","2016-10-25 00:00:00",
46042,21,761042,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1s000SumR.pdf","2016-12-06 00:00:00",
52085,2,761042,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf","2018-01-30 00:00:00",
52133,1,761042,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761042Orig1s001ltr.pdf","2018-01-30 00:00:00",
52490,20,761042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/132_761042 etanercept-SZZS_clinical prea.pdf","1900-01-01 00:00:00",
52491,17,761042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/133_761042 etanercept-SZZS statistical prea.pdf","1900-01-01 00:00:00",
52492,18,761042,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/134_761042 etanercept-SZZS clinpharm prea.pdf","1900-01-01 00:00:00",
53730,3,761042,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761042Orig1s01.pdf","2018-04-18 00:00:00",
49044,2,761043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761043lbl.pdf","2017-07-25 00:00:00",
49066,1,761043,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761043Orig1s000ltr.pdf","2017-07-25 00:00:00",
54705,1,761043,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf","2018-06-27 00:00:00",
54729,2,761043,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf","2018-06-29 00:00:00",
45422,2,761044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf","2016-09-29 00:00:00",
45480,1,761044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761044Orig1s000ltr.pdf","2016-09-26 00:00:00",
51048,3,761044,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm","2018-01-12 00:00:00",
45639,1,761046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761046Orig1s000ltr.pdf","2016-10-25 00:00:00",
45683,2,761046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf","2016-10-28 00:00:00",
46104,3,761046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761046_toc.cfm","2016-12-09 00:00:00",
46110,21,761046,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761046Orig1s000SumR.pdf","2016-12-09 00:00:00",
50419,1,761047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761047Orig1s000ltr.pdf","2017-11-15 00:00:00",
50521,2,761047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761047s000lbl.pdf","2017-11-29 00:00:00",
50930,3,761047,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761047Orig1s000TOC.cfm","2017-12-27 00:00:00",
47651,2,761049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf","2017-03-23 00:00:00",
47662,1,761049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s000ltredt.pdf","2017-03-24 00:00:00",
48150,1,761049,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf","2017-04-27 00:00:00",
48227,3,761049,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761049Orig1s000TOC.cfm","2017-05-02 00:00:00",
50178,2,761049,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf","2017-10-25 00:00:00",
50179,8,761049,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf","2017-10-25 00:00:00",
50215,1,761049,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf","2017-10-30 00:00:00",
55132,2,761051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf","2018-08-08 00:00:00",
55133,1,761051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761051Orig1s000Ltr.pdf","2018-08-08 00:00:00",
55394,3,761051,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761051Orig1s000TOC.cfm","2018-09-07 00:00:00",
48155,2,761052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf","2017-04-28 00:00:00",
48156,1,761052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761052Orig1s000ltr.pdf","2017-04-28 00:00:00",
48669,3,761052,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761052Orig1s000TOC.cfm","2017-06-07 00:00:00",
47770,2,761053,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf","2017-03-30 00:00:00",
47771,8,761053,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17","2017-03-30 00:00:00",
47772,1,761053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf","2017-03-30 00:00:00",
48328,3,761053,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000TOC.cfm","2017-05-09 00:00:00",
48077,2,761054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf","2017-04-21 00:00:00",
48083,8,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054lbl.pdf#page=51","2017-04-21 00:00:00",
48088,1,761054,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761054Orig1s000ltr.pdf","2017-04-24 00:00:00",
51175,57,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/120_761054 renflexis CDDD clinical prea.pdf","1900-01-01 00:00:00",
51176,20,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/123_761054 renflexis clinical prea.pdf","1900-01-01 00:00:00",
51177,18,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/124_761054 renflexis clinpharm prea.pdf","1900-01-01 00:00:00",
51178,17,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/126_761054 renflexis statistical prea.pdf","1900-01-01 00:00:00",
51179,17,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125_761054 renflexis statistical 2 prea.pdf","1900-01-01 00:00:00",
51180,20,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/121_761054 renflexis clinical 2 prea.pdf","1900-01-01 00:00:00",
51181,20,761054,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/122_761054 renflexis clinical 3 prea.pdf","1900-01-01 00:00:00",
47773,1,761055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761055Orig1s000ltr.pdf","2017-03-30 00:00:00",
47774,2,761055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf","2017-03-30 00:00:00",
48179,3,761055,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000TOC.cfm","2017-05-01 00:00:00",
53650,2,761055,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s003lbl.pdf","2018-04-11 00:00:00",
53656,1,761055,"SUPPL",3,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s003ltr.pdf","2018-04-12 00:00:00",
51028,2,761055,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s005lbl.pdf","2018-01-11 00:00:00",
51032,1,761055,"SUPPL",5,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s005ltr.pdf","2018-01-11 00:00:00",
49544,2,761058,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf","2017-08-25 00:00:00",
49545,8,761058,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf#page=30","2017-08-25 00:00:00",
49546,1,761058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761058Orig1s000ltr.pdf","2017-08-28 00:00:00",
55638,3,761058,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm","2018-09-27 00:00:00",
49653,2,761060,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf","2017-09-01 00:00:00",
49679,1,761060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761060Orig1s000Orig2s000ltr.pdf","2017-09-06 00:00:00",
53657,1,761060,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761060Orig1s001ltr.pdf","2018-04-12 00:00:00",
53663,2,761060,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761060s001lbl.pdf","2018-04-12 00:00:00",
54475,3,761060,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761060Orig1s000Orig1Orig2s000TOC.cfm","2018-06-08 00:00:00",
49678,1,761060,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761060Orig1s000Orig2s000ltr.pdf","2017-09-06 00:00:00",
54476,3,761060,"ORIG",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761060Orig1s000Orig1Orig2s000TOC.cfm","2018-06-08 00:00:00",
48978,2,761061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf","2017-07-13 00:00:00",
48979,8,761061,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf#page=14","2017-07-13 00:00:00",
48980,1,761061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761061Orig1s000ltr.pdf","2017-07-13 00:00:00",
49466,3,761061,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000TOC.cfm","2017-08-21 00:00:00",
55641,2,761063,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf","2018-09-28 00:00:00",
55761,1,761063,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761063Orig1s000ltr.pdf","2018-10-01 00:00:00",
48800,2,761064,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf","2017-06-22 00:00:00",
48801,8,761064,"SUPPL",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf#page=29","2017-06-22 00:00:00",
48827,1,761064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761064Orig1s000ltr.pdf","2017-06-26 00:00:00",
55872,3,761064,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761064Orig1s000TOC.cfm","2018-10-11 00:00:00",
52849,2,761065,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf","2018-03-07 00:00:00",
52850,1,761065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s000ltr.pdf","2018-03-07 00:00:00",
53561,3,761065,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/TROGARZO_761065_TOC.cfm","2018-03-30 00:00:00",
54387,1,761065,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s001ltr.pdf","2018-05-31 00:00:00",
54394,2,761065,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf","2018-05-31 00:00:00",
53080,1,761067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761067Orig1s000REPLACEMENT_ltr.pdf","2018-03-22 00:00:00",
53248,2,761067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf","2018-03-23 00:00:00",
53249,8,761067,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10","2018-03-23 00:00:00",
53824,3,761067,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000TOC.cfm","2018-04-26 00:00:00",
53709,2,761068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761068s000lbl.pdf","2018-04-17 00:00:00",
53710,1,761068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf","2018-04-17 00:00:00",
54189,3,761068,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000TOC.cfm","2018-05-15 00:00:00",
48172,2,761069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf","2017-05-01 00:00:00",
48214,1,761069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761069Orig1s000ltr.pdf","2017-05-02 00:00:00",
48707,3,761069,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000TOC.cfm","2017-06-13 00:00:00",
52668,2,761069,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf","2018-02-16 00:00:00",
52669,8,761069,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf#page=24","2018-02-16 00:00:00",
52697,1,761069,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761069Orig1s002ltr.pdf","2018-02-23 00:00:00",
50414,2,761070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf","2017-11-15 00:00:00",
50424,1,761070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761070Orig1s000ltr.pdf","2017-11-15 00:00:00",
50943,3,761070,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000TOC.cfm","2017-12-29 00:00:00",
51888,20,761070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/217_761070 benralizumab clinical prea.pdf","1900-01-01 00:00:00",
51889,18,761070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/216_761070  benralizumab clinpharm prea.pdf","1900-01-01 00:00:00",
51890,17,761070,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/218_761070 benralizumab statistical prea.pdf","1900-01-01 00:00:00",
50680,2,761072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf","2017-12-13 00:00:00",
50681,8,761072,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf#page=33","2017-12-13 00:00:00",
50752,1,761072,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761072Orig1s000ltr.pdf","2017-12-18 00:00:00",
50536,2,761074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761074s000lbl.pdf","2017-12-01 00:00:00",
50582,1,761074,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074Orig1s000ltr.pdf","2017-12-01 00:00:00",
54434,2,761075,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf","2018-06-04 00:00:00",
54435,1,761075,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761075Orig1s000Ltr.pdf","2018-06-04 00:00:00",
54247,2,761077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf","2018-05-18 00:00:00",
54248,1,761077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761077Orig1s000ltr.pdf","2018-05-18 00:00:00",
54606,3,761077,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000TOC.cfm","2018-06-14 00:00:00",
48323,2,761078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf","2017-05-09 00:00:00",
48324,8,761078,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23","2017-05-09 00:00:00",
48326,1,761078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761078Orig1s000ltr.pdf","2017-05-09 00:00:00",
54474,3,761078,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761078Orig1s000TOC.cfm","2018-06-08 00:00:00",
54337,2,761079,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf","2018-05-24 00:00:00",
54338,8,761079,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23","2018-05-24 00:00:00",
54339,1,761079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig1s000ltr.pdf","2018-05-25 00:00:00",
54723,3,761079,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000TOC.cfm","2018-06-28 00:00:00",
54938,2,761080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf","2018-07-20 00:00:00",
54949,1,761080,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761080Orig1s000ltr.pdf","2018-07-23 00:00:00",
50432,2,761083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf","2017-11-16 00:00:00",
50444,1,761083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761083Orig1s000ltr.pdf","2017-11-17 00:00:00",
50944,3,761083,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761083Orig1s000TOC.cfm","2017-12-29 00:00:00",
55807,2,761083,"SUPPL",2,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf","2018-10-04 00:00:00",
55810,8,761083,"SUPPL",2,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf#page=21","2018-10-04 00:00:00",
55808,2,761083,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf","2018-10-04 00:00:00",
55809,8,761083,"SUPPL",4,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf#page=21","2018-10-04 00:00:00",
55492,2,761089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf","2018-09-14 00:00:00",
55509,1,761089,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761089Orig1s000ltr.pdf","2018-09-18 00:00:00",
55283,2,761090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf","2018-08-24 00:00:00",
55507,1,761090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761090Orig1s000ltr.pdf","2018-09-18 00:00:00",
55532,3,761090,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761090Orig1s000TOC.cfm","2018-09-20 00:00:00",
55849,2,761092,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761092s000lbl.pdf","2018-10-05 00:00:00",
55276,2,761094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf","2018-08-23 00:00:00",
55310,1,761094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761094Orig1s000Ltr.pdf","2018-08-24 00:00:00",
55531,3,761094,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000TOC.cfm","2018-09-20 00:00:00",
55672,2,761097,"SUPPL",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf","2018-09-28 00:00:00",
55765,1,761097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761097Orig1s000ltr.pdf","2018-10-01 00:00:00",
55811,2,761097,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf","2018-10-04 00:00:00",
55475,2,761104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf","2018-09-13 00:00:00",
55476,8,761104,"ORIG",1,"0","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf#page=18","2018-09-13 00:00:00",
55487,1,761104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761104Orig1s000Ltr.pdf","2018-09-14 00:00:00",
55873,3,761104,"ORIG",1,"0","http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761104Orig1s000TOC.cfm","2018-10-11 00:00:00",
